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CSR Tool Plugin for IUCLID 5.2 User Manual

1. IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed repeated dose toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt Epes lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed repeated dose toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt type Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed repeated dose toxici
2. No relevant information available Rule Print if applicable The data from distribution modelling studies are summarised in the following table Table 37 Distribution modelling studies Method Results Remarks Reference Media lt Media gt lt Model gt Calculation programme lt Calculation programme gt Input data lt Test substance input data gt Percent distribution in media Air lt Air gt Water lt Water gt Soil lt Soil gt Sediment lt Sediment gt Susp sediment lt Susp sediment gt Biota lt Biota gt Aerosol lt Aerosol gt Other distribution results lt Other distribution results gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt Data waiving Information requirement Distribution modelling Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Distribution modelling Model lt Model gt Media lt Media gt Planned study period lt Study period gt 4 2 4 Summary and discussion of environmental distribution lt Discussion gt UCLID source Endpoint summary 5 4 Transport and distribution 4 3 Bioaccumulation 4 3
3. lt Estimation method if used gt lt Temp gt Rate constant lt Hydrolysis rate constant gt Type lt Type gt lt Remarks gt Recovery in pH lt pH gt lt Recovery gt at lt Temp value gt lt Temp unit gt after lt Duration gt Transformation products lt Transformation products gt Method Results Remarks Reference lt Guideline gt Half life DT50 lt Reliability gt lt Author gt lt Year gt lt Principles of method if other t1 2 pH lt pH gt lt Half life gt at lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Hydrolysis Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Hydrolysis Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 1 2 Hydrolysis lt Discussion gt The following information is taken into account for any hazard risk persistency assessment 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 25 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt lt Short
4. lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated Method Results Remarks Reference lt Type of study gt lt Type of Evaluation of results lt Reliability gt lt Author gt lt Year gt genotoxicity gt Data waiving Information requirement In vitro genotoxicity lt Type of study gt lt Type of genotoxicity gt Rule If Type of study is populated and does not start with in vitro Information requirement In vitro genotoxicity lt Type of genotoxicity gt Rule If Type of study is empty Information requirement In vitro genotoxicity lt Type of study gt lt Type of genotoxicity gt Rule If Type of study starts with in vitro Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement In vitro genotoxicity lt Type of study gt lt Type of genotoxicity gt Rule If Type of study is populated and does not start with in vitro Information requirement In vitro genotoxicity lt Type of genotoxicity gt Rule If Type of study is empty Information requirement In vitro genotoxicity lt Type of study gt lt Type of genotoxicity gt Rule If Type of study starts with in vitro Proposed test guideline lt Guideline gt Species strain lt Species strain gt repeatable field Principles of m
5. Information requirement Partition coefficient n octanol water log value Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Water solubility Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Solubility in organic solvents fat solubility Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Surface tension Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Flash point Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Self ignition temperature Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Flammability Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Explosive properties Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Oxidising properties Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Oxidation reduction potential Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Stability in organic solvents and identity of relevant degradation
6. TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed neurotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 84 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt OR Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed neurotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Details on study design gt Test material identity See description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Fonn eTest material form gt If field is populated
7. 4 disregarded study II Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Effect type 1 carcinogenicity 2 lt gt carcinogenicity No relevant information available Rule Print if applicable The results of studies on carcinogenicity other routes are summarised in the following table Table 68 Studies on carcinogenicity other routes Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect type gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based on lt Effect concentration lt Doses concentrations gt lt Basis gt type gt lt Basis for effect level lt Study result type gt lt Route of administration gt lt Purpose flag gt Vehicle lt Vehicle gt Remarks gt Test material Exposure lt Duration of treatment _ Neoplastic effects observed in identity See exposure gt lt Frequency of any test group descr iption of rules treatment gt lt Histopathology neoplastic gt 1 oductory part lt Guideline gt Form lt Test material nui form gt Jf field is lt Principles of method if other than populated guideline gt Data waiving Information requirement Carcinogenicity other routes Reason lt Data waiving gt Justification lt Justification for data waiv
8. Table 88 Information on flash point Method Results Remarks Reference Determination of flash Flash point lt Reliability gt lt Author gt lt Year gt point lt Flash point gt at lt Pressure gt lt Purpose flag gt lt Type of method gt lt Remarks gt lt Study result type gt lt Guideline gt Remarks Test material identity See description of rules in introductory part lt Principles of method ar lt Any other information on results incl if other than guideline gt y tables gt Form lt Test material form gt If field is populated Data waiving see CSR section 1 3 Physicochemical properties Insert if field Data waiving is populated in any record of IUCLID section 4 11 Testing proposal see CSR section 1 3 Physicochemical properties Insert if field Study result type contains experimental study planned in any record of IUCLID section 4 11 Discussion UCLID source Endpoint summary 4 11 Flash point lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Classification according to GHS TUCLID source section 2 1 GHS Name lt Name gt Related composition lt Related composition gt State form of the substance lt Form of the substance gt Classification lt Explosives gt Hazard statement lt Hazard statement gt Reason for no classification lt Reason for
9. 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 117 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Short term EC50 or LCS0 for soil micro organisms lt Short term EC50 or LC50 for soil micro organisms gt lt Unit gt Long term EC10 LC10 or NOEC for soil micro organisms lt Long term EC10 LC10 or NOEC for soil micro organisms gt lt Unit gt 7 2 4 Toxicity to other terrestrial organisms IUCLID source section 6 3 2 Toxicity to terrestrial arthropods only if non soil organisms are involved as triggered by the absence of any indication of soil macro organisms but explicit indication of non soil organisms in the following fields Guideline Application method Test organisms Animal group Note If no explicit indication of non soil organisms is given e g all four trigger fields are filled with other freetext or blank the study is moved to CSR section 7 2 1 Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 LC10 LD10 EC50 LC50 LD50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 or LC10 or LD10 4 EC50 or LC50 or LD50 5 any other No relevant information available Rule Print if applicable
10. 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed skin sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed skin sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt ORS Outcome of incidence lt Outcome of
11. EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt lt Principles of method if other than guideline gt lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Cornea score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Iris score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Conjunctivae score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Chemosis score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt lt Irritation parameter gt lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt in introductory part Form lt Test material form gt If field is populated Studies with results indicating corrosivity to the eye are summarised in section 5 4 Corrosivity Insert if field Interpretation of results corrosive highly corrosive Category 1 or Category I Data waiving Information requirement Eye irritation Reason lt Data waiving gt Justi
12. Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed respiratory sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Pots Tesh matena form gt If field is populated 5 5 3 Summary and discussion of sensitisation Skin sensitisation JUCLID source Endpoint summary 7 4 Sensitisation Skin sensitisation lt Skin sensitisation Discussion gt The following information is taken into account for any hazard risk assessment lt Skin sensitisation Short description of key information gt Value used for CSA lt Endpoint conclusion gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human informa
13. Remarks gt Test material exposure gt lt Frequency of Neoplastic effects observed in identity See treatment gt any test group description of rules lt Guideline gt lt Histopathology neoplastic gt introductory part Form lt Test material form gt If field is populated lt Principles of method if other than guideline gt Data waiving Information requirement Carcinogenicity after dermal administration Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Carcinogenicity after dermal administration Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 12 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 5 8 1 4 Carcinogenicity other routes IUCLID source section 7 7 Carcinogenicity if field Route of administration does not contain oral we moe gavage oral capsule oral feed oral drinking water oral unspecified inhalation gas inhalation aerosol inhalation dust inhalation vapour inhalation dermal Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence
14. The results are summarised in the following table Table 100 Effects on terrestrial arthropods Method Results Remarks Reference lt Test organisms species gt lt Animal lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt group gt cca conc gt lt Conc lt Purpose flag gt Application method lt Application asegon gt eee P lt Nominal Measured gt lt Study result type gt f based on lt Basis for effect gt Test material lt Test duration type gt lt Study type gt lt Remarks gt identity See lt Guideline gt description of rules lt Principles of method if other than in introductory part guideline gt Form lt Test material form gt If field is populated Data waiving Note Data waivers not explicitly indicated for non soil organisms are covered by CSR section 7 2 1 Toxicity to soil macro organisms Information requirement Toxicity to terrestrial arthropods other than soil macro organisms Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Note Testing proposals not explicitly indicated for non soil organisms are covered by CSR section 7 2 1 Toxicity to soil macro organisms Information requirement Toxicity to terrestrial arthropods other than soil macro organisms Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Animal group gt Test duration type lt
15. The results of studies on neurotoxicity are summarised in the following table 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 81 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 75 Studies on neurotoxicity Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Generation if applicable gt lt Effect level gt lt Sex gt based on lt Effect concentration type gt lt Basis for effect level Remarks gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Purpose flag gt lt Route of administration gt lt Type of inhalation exposure if applicable gt lt Study result type gt Test material identity See description of rules in introductory part lt Doses concentrations gt lt Basis gt Vehicle lt Vehicle gt Exposure lt Duration of treatment exposure gt lt Frequency of treatment gt Form lt Test material form gt If field is opulated lt Guideline gt oe lt Principles of method if other than guideline gt Data waiving Information requirement Neurotoxicity lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Neurotoxicity lt Test type gt lt Route of administration gt Proposed test guideline lt Guideline gt Speci
16. Vehicle lt Vehicle gt lt Guideline gt lt Principles of method if other than guideline gt lt Interpretation of results gt Overall irritation score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Maximum mean total score MMTS lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Cornea score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Iris score lt Score gt of max lt Max score gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 54 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Conjunctivae score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Chemosis score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Re
17. toxicity to reproduction fertility Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt Dee Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed ae in introductory part lt Endpoint addressed gt Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed toxicity to reproduction fertility Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Foti ef stm terial form gt If field is populated 5 9 2 Developmental toxicity 5 9 2 1 Non human information IUCLID source section 7 8 2 Developmental toxicity teratogenicity Sort rule in tables I Field Purpose flag 1 key study
18. 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 rabbit 3 guinea pig 4 mouse 5 any other or empty No relevant information available Rule Print if applicable The results of studies on developmental toxicity are summarised in the following table Table 73 Studies on developmental toxicity Method Results Remarks Reference 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 78 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect type gt lt Reliability gt lt Author gt lt Year gt lt Route of administration gt lt Type of rae ie vee lt Purpose flag gt inhalation exposure if applicable gt SEMECt Concentration type gt p P P lt Basis for effect level lt Study result type gt lt Doses concentrations gt lt Basis gt Remarks gt Test material Vehicle lt Vehicle gt identity See Exposure lt Duration of treatment descr iption of rules exposure gt lt Frequency of in introductory part treatment gt Form lt Test material lt Guideline gt form gt If field is a populated lt Principles of method if other than guideline gt Data waiving Information requirement Developmental toxicity teratogenicity lt Route of administration gt Reason lt Data waiving gt J
19. If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed basic toxicokinetics or dermal absorption Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 41 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Porn Testmaterial form gt If field is populated 5 1 3 Summary and discussion of toxicokinetics lt Discussion gt IUCLID source Endpoint summary 7 1 Toxicokinetics metabolism and distribution The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA Bioaccumulation potential lt Bioaccumulation potential gt Absorption rate oral lt Absorption rate oral gt Absorption rate dermal lt Absorption rate dermal gt Absorption rate inhalation lt Absorption rate inhalation gt Discussion of human information See Sum
20. Relative density Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Granulometry Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Vapour pressure Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Planned study period lt Study period gt Information requirement Partition coefficient n octanol water log value Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Water solubility Proposed test guideline lt Guideline gt Principles of method if other than guideline
21. Rule Print if applicable The results are summarised in the following table Table 99 Effects on soil micro organisms Method Results Remarks Reference Species Inoculum lt Test organisms lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt inoculum gt lt Effect conc gt lt Conc lt Purpose flag gt dali based on gt lt Guideline gt a lt Nominal Measured gt lt Study result type gt lt Principles of method if other than based on lt Basis for effect gt Test material guideline gt lt Remarks gt identity See description of rules in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Effects on soil micro organisms Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Effects on soil micro organisms Proposed test guideline lt Guideline gt Species Inoculum lt Test organisms inoculum gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 3 4 Toxicity to soil microorganisms lt Discussion gt The following information is taken into account for toxicity on soil micro organisms for the derivation of PNEC lt Short description of key information gt Value used for CSA
22. Table 79 Exposure related observations on immunotoxicity Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed immunotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt Jf field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed immunotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed
23. dwelling arthropods gt lt Unit gt 7 2 2 Toxicity to terrestrial plants IUCLID source section 6 3 3 Toxicity to terrestrial plants Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results are summarised in the following table Table 98 Effects on terrestrial plants Method Results Remarks Reference lt Test organisms species gt lt Plant lt Species gt Only if effect lt Reliability gt lt Author gt lt Year gt group gt concentrations for multiple lt Purpose flag gt lt Test duration type gt lt Study type gt species lt Endpoint gt ype gt y type gt lt Duration gt lt Effect lt Study result type gt lt Test type gt conc gt lt Conc based on gt Test material Substrate lt Substrate type gt lt Nominal Measured gt identity See lt Guidelines based on lt Basis for effect gt description of rules aaa lt Remarks gt in introductory part lt Principles of method if other than i i guideline gt Form lt Test material form gt If field is populated Data waiving Information requirement Effects on terrestrial plants Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Short term toxicity testing on plants Long term toxicity testi
24. lt Discussion gt Data waiving IUCLID source endpoint study records of sections 4 2 Melting point freezing point 4 3 Boiling point 4 4 Density 4 5 Particle size distribution Granulometry 4 6 Vapour pressure 4 7 Partition coefficient 4 8 Water solubility 4 9 Solubility in organic solvents fat solubility 4 10 Surface tension 4 11 Flash point 4 12 Auto flammability 4 13 Flammability 4 14 Explosiveness 4 15 Oxidising properties 4 16 Oxidation reduction potential 4 17 Stability in organic solvents 4 18 Storage stability and reactivity 4 19 Stability thermal sunlight metals 4 21 Dissociation constant 4 22 Viscosity Information requirement Melting freezing point Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Boiling point Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Relative density Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Granulometry Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Vapour pressure 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT EC number lt Chemical name gt lt EC number gt CAS number lt CAS number gt Reason lt Data waiving gt Justification lt Justification for data waiving gt
25. lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 52 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed respiratory irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Foti cT estmaten l form gt If field is populated 5 3 4 Summary and discussion of irritation IUCLID source Endpoint summary 7 3 Irritation corrosion lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA Skin irritation corrosion lt Endpoint conclusion gt lt Effect level value
26. rat 2 lt gt rat Sort rule for multiple Effect levels Field Endpoint 1 no NOAEL C identified 2 NOAEL C 3 NOEL C 4 LOAEL C 5 LOEL C 6 BMD CO5 7 BMD C10 8 BMD C 9 any other or empty No relevant information available Rule Print if applicable The results of studies on repeated dose toxicity other routes are summarised in the following table Table 60 Studies on repeated dose toxicity other routes Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Route of lt Sex gt based on lt Effect lt Purpose flag gt administration gt concentration type gt lt Basis lt Study result type gt for effect level Remarks gt lt Doses concentrations gt Test material Vehicle lt Vehicle gt identity See Exposure lt Duration of treatment description of rules exposure gt lt Frequency of in introductory part treatment gt Form lt Test material lt Guideline gt form gt If field is lt Principles of method if other than populated guideline gt Data waiving Information requirement Repeated dose toxicity lt Test type gt lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Repeated
27. supporting study 3 weight of evidence 4 disregarded study Sort rule for multiple Irritation parameter Field Irritation parameter 1 overall irritation score 2 primary dermal irritation index PDIT 3 erythema score 4 edema score No relevant information available Rule Print if applicable The results of studies on skin irritation are summarised in the following table Table 47 Studies on skin irritation Method Results Remarks Reference in vitro study Tf field lt Interpretation of results gt lt Reliability gt lt Author gt lt Year gt Type of method in Overall irritation score lt Purpose flag gt vitro lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt lt Study result type gt lt Species gt lt Strain gt y yp Test material identity See description of rules in introductory part Coverage lt Type of coverage gt lt Preparation of test site gt Vehicle lt Vehicle gt lt Guideline gt Primary dermal irritation index PDID lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Form lt Test material form gt If field is lt Principles of method if populated other than guideline gt Erythema score lt Score gt of max lt Max score gt lt Basis gt Time point lt
28. 2 Identified uses IUCLID source section 3 5 Life Cycle description if not otherwise stated Justification why no identified uses are reported lt Justification why no identified uses are reported gt No information available Rule Print if none of the specified fields is populated in this section Table 10 Formulation IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repeatable block Formulation Identifiers Use descriptors Rule Print multiple items in separate lines Other information Confidential Rule Print if Confidentiality flag CBI F lt Identified use number gt lt Identified use name gt e g F 2 Formulation of liquid mixtures e Environmental Release Category ERC lt ERC gt e Process Category PROC lt Process Category gt e Product Category formulated lt Product Category formulated gt e Technical function of the substance during formulation lt Technical function of the substance during formulation gt Tonnage of substance for that use lt Tonnage of substance gt tonnes Number of sites lt Number of sites range gt Substance supplied to that use lt Substance supplied to that use in form of gt Rule Print multiple items in separate lines Remarks lt Remarks gt Table 11 Uses at industrial sites IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repea
29. 2 as for Inhalation Systemic effects Acute lt Hazard assessment conclusion gt e g No hazard identified Further explanation on hazard conclusions Rule Print only if at least one source field Justification and comments is populated e Inhalation Systemic effects Long term lt Justification and comments gt Rule Print bulleted paragraph if source field is populated for this route type of effects e cont d for each route type of effects 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 93 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 83 Further explanation on DNEL derivation for workers IUCLID source Endpoint summary 7 Toxicological information Rule 1 Print table only if at least one of the source fields specified in the table below is populated Rule 2 Create a row for a given Route Type of effect if at least one of the source fields related to that item is populated Rule 3 Items e g AF for dose response relationship lt AF for dose response relationship gt lt Justification gt are only printed if information is retrieved from the corresponding source field s Rule 4 AF items are skipped if AF I and the related field Justification is empty Route Type DNEL derivation Assessment factors AF for DNEL derivation of effect Inhalation DNEL derivation method lt DNEL AF for dose response relationship lt AF for S
30. 6 1 1 Short term toxicity to fish lt Discussion gt The following information is taken into account for acute fish toxicity for the derivation of PNEC lt Short description of key information gt Value used for CSA LC50 for freshwater fish lt LC50 for freshwater fish gt lt Unit gt LC50 for marine water fish lt LC50 for marine water fish gt lt Unit gt 7 1 1 2 Long term toxicity to fish IUCLID source section 6 1 2 Long term toxicity to fish Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture according to the following order of priority NOEC LOEC EC10 IC10 or LC10 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 4 LC10 5 IC10 6 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 91 Long term effects on fish Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt L
31. Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Value used for CSA route inhalation lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 5 9 Toxicity for reproduction 5 9 1 Effects on fertility 5 9 1 1 Non human information IUCLID source section 7 8 1 Toxicity to reproduction Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 rabbi
32. Hazard assessment conclusion STP gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC STP derivation gt conclusion air gt lt PNEC value gt lt Unit gt Soil lt Hazard assessment Assessment factor lt assessment factor gt conclusion soil gt Extrapolation method lt Extrapolation method gt lt PNEC value gt lt Unit gt lt Justification for no PNEC soil derivation gt Air lt Hazard assessment lt Justification for no PNEC air derivation gt Secondary poisoning 2013 01 28 CSR PI 5 4 1 lt Hazard assessment conclusion secondary poisoning gt lt PNEC CHEMICAL SAFETY REPORT Assessment factor lt assessment factor gt lt Justification for n PNEC oral derivation gt 122 EC number lt Chemical name gt CAS number lt EC number gt lt CAS numbe r gt value gt lt Unit gt Environmental classification justification lt Environmental classification justification gt T UCLID source Endpoint summary 6 Ecotoxicological information General discussion lt Discussion gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 123 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 8 PBT AND vPvB ASSESSMENT 8 1 Assessment of PBT vPvB Properties 8 1 1 PBT vPvB criteria and justification IUCL
33. If field is lt Principles of method if other than populated guideline gt Data waiving Information requirement short term toxicity study 28 days oral sub chronic toxicity study 90 days oral lt Test type gt oral If Test type subacute subchronic lt gt subacute or subchronic respectively Information requirement Repeated dose toxicity after oral administration If Test type is empty Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement short term toxicity study 28 days oral sub chronic toxicity study 90 days oral chronic toxicity study oral lt Test type gt oral If Test type subacute subchronic chronic lt gt subacute or subchronic or chronic e g Information requirement sub chronic toxicity study 90 days oral Information requirement Repeated dose toxicity after oral administration If Test type is empty Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 61 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 6 1 2 Repeated dose toxicity inhalation IUCLID source section 7 5 3 Repeated
34. Print if applicable The studies on phototransformation in water are summarised in the following table Table 30 Studies on phototransformation in water Method Results Remarks Reference Study type lt Study type gt Spectrum of substance lt Reliability gt lt Author gt lt Year gt lt Guideline gt lt Parameter gt lt Value gt lt Unit gt lt Purpose flag gt lt Principles of method if other than lt Remarks gt lt Study result guideline gt Half life DT50 type gt lt Computational methods gt lt DT50 gt lt Test condition gt Test material identity See Light source lt Light source gt ne description of Degradation Light spectrum lt Light spectrum gt lt Degr gt after lt Sampling rules in Rel light intensity lt Rel light time gt lt Test condition gt introductory part intensity gt Quantum yield lt Quantum yield Form lt Test Se siti er for direct photolysis gt material form gt f Rate constant lt Rate constant gt field is populated lt Type of sensitiser gt lt RANGE_UNIT Concentration of sensitiser gt Transformation products lt Transformation products gt Data waiving Information requirement Phototransformation in water Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Phototransformation in water Proposed test guideline lt Guideline gt Planned s
35. Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Effect conc gt lt Conc based on gt based on lt Basis Doses lt Nominal and measured doses for effect gt lt Remarks gt lt Study result type gt concentrations gt lt Test type gt lt Dose method gt lt Purpose flag gt ites Repellency factors Test material lt Guideline gt lt Repellency factors if identity See lt Principles of method if other than applicable gt descr iption of rules guideline gt in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Long term or reproductive toxicity to birds Toxicity to birds If Test type reproduction toxicity lt gt reproduction toxicity respectively Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Long term or reproductive toxicity to birds Toxicity to birds If Test type 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 120 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt reproduction toxicity lt gt reproduction toxicity respectively Proposed test guideline lt Guideline gt Species lt Test organisms species gt Test type lt Test type gt lt Dose method gt Principles of
36. Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test type gt lt Nominal Measured gt lt Study result type gt lt Guideline gt based on lt Basis for effect gt Test material lt Principles of method if other than lt Remarks gt identity See guideline gt description of rules in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Short term toxicity testing on aquatic invertebrates Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 108 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Information requirement Short term toxicity testing on aquatic invertebrates Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 1 3 Short term toxicity to aquatic invertebrates lt Discussion gt The following information is taken into account for short term toxicity to aquatic
37. SAFETY REPORT 21 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt lt Notes gt 3 2 2 Self classification s IUCLID source section 2 2 DSD DPD condition if field Status 67 548 EEC self classification No relevant information available Rule Print if none of the fields specified below is populated Note This default text is not printed if any field Reason for no classification is populated with the IUCLID default phrase data lacking Chemical name lt Name gt Alternatively Substance lt Reference substance name gt if lt Name gt is blank Related composition lt Related composition gt Remarks lt Remarks gt Table 26 Self classification according to Directive 67 548 EEC criteria classification gt Endpoint Classification Reason for no CSR section classification Explosiveness lt Explosiveness gt lt Reason for no 6 1 classification gt Oxidising properties lt Oxidising properties gt lt Reason for no 6 3 classification gt Flammability lt Flammability gt lt Reason for no 6 2 classification gt Thermal stability lt Thermal stability gt lt Reason for no classification gt Acute toxicity lt Acute toxicity gt lt Reason for no 5 2 3 classification gt Acute toxicity irreversible lt Acute toxicity irreversible damage lt Reason for no 5 2 3 damage after single a
38. Test duration type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 3 2 Toxicity to terrestrial arthropods 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 118 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt gt gt gt NOTE please delete this instruction Move any information related to soil arthropods to the CSR section 7 2 1 Toxicity to soil macro organisms subheading Discussion of effects on soil arthropods lt lt lt _ If field Discussion is populated and any field indicates soil arthropods lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt 7 3 Atmospheric compartment gt gt gt NOTE please delete this instruction Move any information related to this section manually from other sections e g from Toxicity to terrestrial plants if fumigation study or from Toxicity to other terrestrial organisms e g if spray application study with honeybees lt lt lt Insert if any endpoint study record is captured from section 6 3 3 Tox to terr plants with field Study type field study or from section 6 3 2 Tox to terr arthropods with field Application method spray 7 4 Microbiological activity in sewage treatment s
39. addressed gt Foun lt lt Tesi materal form gt If field is populated 5 3 2 Eye 5 3 2 1 Non human information IUCLID source section 7 3 2 Eye irritation Rule Insert if field Interpretation of results lt gt corrosive highly corrosive Category 1 or Category I Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Sort rule for multiple Irritation parameter Field Irritation parameter 1 overall irritation score 2 Maximum mean total score MMTS 3 cornea score 4 iris score 5 conjunctivae score 6 chemosis score No relevant information available Rule Print if applicable The results of studies on eye irritation are summarised in the following table Table 49 Studies on eye irritation Method Results Remarks Reference in vitro study If field lt Interpretation of results gt lt Reliability gt lt Author gt lt Year gt Typ method in Ovyerall irritation score lt Purpose flag gt vitro Speci Strai lt Score gt of max lt Max score gt lt Study result type gt S m lt ee lt Basis gt Time point lt Time point gt Test material Vehicle lt Vehicle gt lt Reversibility gt lt Remarks gt identity See lt Guideline gt Maximum mean total score MMTS description of rules 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 49
40. criterion gt gt gt CAUTION Remark field lt lt lt e T1 2 lt 120 days in soil lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Remark field lt lt lt Remarks on Annex XIII criteria P vP Rule If checkbox 3 is not ticked and at least one of the related Remark fields is populated Rule for items listed Each bulleted item is printed if the corresponding Remark field is populated e T1 2 lt 60 days in marine water lt Remark gt e T1 2 lt 40 days in fresh or estuarine water lt Remark gt e T1 2 lt 180 days in marine sediment lt Remark gt e T1 2 lt 120 days in fresh or estuarine sediment lt Remark gt e T1 2 lt 120 days in soil lt Remark gt P but not vP based on criteria laid down in Annex XIII of REACH Rule If checkbox 4 is ticked e T1 2 lt 60 days in marine fresh or estuarine water lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Please complete the corresponding Remark field in IUCLID for this T1 2 criterion Please note If the substance is P but not vP based on criteria laid down in Annex XIII of REACH then it has to be confirmed that all T1 2 criteria are fulfilled In case no appropriate half life data are available justify that the half li
41. dermal ssseeeseeeseseeessereesssererereseeerseerrsserrreresrene 5 8 1 4 Carcinogenicity other routes s essseesseeeseseeeeeresreerrserrssrrrreresrees 5 8 2 Human information 0 cece eeeeeeesceeseeseeeecesecssecaecsaecsaeceeeneeeneeees 5 8 3 Summary and discussion of carcinogenicity 0 0 eee cece ese ereeeeeees 5 9 Toxicity for reproduction ee eecesscesecssecssecseecseecseeeeeeeeseeeeeseenseenseesaeenaes 539 1 Effects on fertility rer rarena r ener deed nana SEs 5 9 1 1 Non human information eseseesseeseseeesesreersserrreresreerrsrerrsserrrerrsrent 5 9 1 2 Human information esssseesseeseseeeseeesesreesesrerrssrrrreresresrrsrerrsserrrsresrent 5 9 2 Developmental toxicity eee cece eeesceeeeesecesecsecaecaecsaeceeeneeeneeees 5 9 2 1 Non human information eee eeeeseeeeceeeceseceseessecsseceeeseeeneeees 5 9 2 2 Human information eee eseeseceeeeeeeeeeessecesecsaecssecsaecseseneeees 5 9 3 Summary and discussion of reproductive toxicity 0 eee ee eeeeeee eens 5 10 Other eects 222 sect oe e esto Se esis Nevaln ead asa ea 5 10 1 Non human information 2 0 0 eee eeceseceseceecesecesecseecseeeseseaeeeeeeereees 5 10 1 1 Neurotoxicity 0 0 e a E ES EE A RE S ii 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt SLOT 2 TmMUnOtOXI Citys ces veces E E EE T E E su vebecnsvedhcevensep dene E A 5 10 1 3 Spe
42. descriptors Rule Print multiple items in Other information separate lines Confidential Rule e Environmental Release Category ERC Tonnage of substance for that Print if Confidentiality lt ERC gt use lt Tonnage of substance gt flag CBI e Process Category PROC tonnes PW lt Identified use lt Process Category gt Substance supplied to that use number gt e Product Category used lt Substance supplied to that lt Identified use name gt lt Product Category used gt use in form of gt Rule Print x multiple items in separate e Sector of end use Hines lt Sector of end use gt PORTO Subsequent service life relevant for that use lt Subsequent service life relevant for that use gt e Technical function of the substance lt Technical function of the substance gt Link to the subsequent service life lt Link to the subsequent service life gt Rule Print multiple items in separate lines Remarks lt Remarks gt Table 13 Consumer uses IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repeatable block Consumer uses Identifiers Use descriptors Rule Print multiple items in Other information separate lines Confidential Rule e Environmental Release Category ERC Tonnage of substance for that Print if Confidentiality lt ERC gt use lt Tonnage of substance gt flag CBI e Product Category used tonnes C lt Identified use lt Pr
43. gt gt gt gt CAUTION Complete the corresponding field in the endpoint summary of IUCLID section 2 3 lt lt lt Rule Print this default statement if this field is empty Justification of minimisation of emission exposure The justification of the minimisation of emissions and subsequent exposures of humans and the environment is reported in sections 9 and 10 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 129 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 9 EXPOSURE ASSESSMENT Rule This heading is printed if the option Select a Chesar file is skipped in step 2 of the CSR generation process that is only IUCLID data are captured In this case only subheadings are printed with no information except for the following note and table which occurs under the subheading 9 0 Introduction 9 0 1 Overview of uses and Exposure Scenarios gt gt gt NOTE As the Chesar tool has not been used for generating this CSR the Brief description of use process is reported below as provided in IUCLID section 3 5 for each use identified in CSR section 2 2 Such information may be reported within each exposure scenario lt lt lt Rule Print if if any field specified in the table is populated Table 105 Brief description of the use process for all identified uses Rule A separate row is generated for each use with the following order first Formulation second Uses at industrial sites third U
44. gt lt Effect conc gt lt Conc based on gt lt Nominal Measured gt based on lt Basis for effect gt lt Remarks gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is lt Author gt lt Year gt Application method lt Application method gt Rule If other is selected Note that the phrase soil is ignored as this would be redundant to the table title lt Test duration type gt lt Study type gt based on gt lt Nominal Measured gt based on lt Basis for effect gt lt Remarks gt lt Study result type gt Test material identity See description of rules in introductory part populated IUCLID source section 6 3 2 Toxicity to terrestrial arthropods lt Test organisms species gt lt Animal lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt group gt lt Effect conc gt lt Conc lt Purpose flag gt CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 114 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Guideline gt Form lt Test material form gt If field is lt Principles of method if other than populated guideline gt Data waiving Note Data waivers explicitly indicated for non soil dwelling organisms are covered by CSR s
45. gt e g Skin irritation corrosion Adverse effect observed slightly irritating Eye irritation lt Endpoint conclusion gt lt Effect level value gt Respiratory irritation lt Endpoint conclusion gt lt Effect level value gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 5 4 Corrosivity 5 4 1 Non human information IUCLID source sections 7 3 1 Skin irritation corrosion Rule Insert if field Interpretation of results corrosive highly corrosive Category I corrosive Category 1A corrosive Category 1B corrosive Category 1C corrosive Category 1 Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 we
46. gt lt Strain gt lt Sex gt Local lymph node assay Rule If Type of study LLNA lt Type of study gt Rule If Type of study lt gt LLNA Induction lt Route of induction exposure gt Rule If Type of study lt gt LLNA Challenge lt Route of challenge exposure gt Rule If Type of study lt gt LLNA Vehicle lt Vehicle gt lt Guideline gt lt Principles of method if other than guideline gt lt Interpretation of results gt Stimulation index lt Stimulation index gt Rule If Type of study LLNA No with positive reactions Rule If Type of study lt gt LLNA lt Reading gt lt No with reactions gt out of lt Total no in group gt lt Group gt lt Hours after challenge gt h after chall dose lt Dose level gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt Data waiving Information requirement Skin sensitisation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Skin sensitisation Proposed test guideline lt Guideline gt Type of study lt Type of study gt lt Type of method gt Species lt Species gt lt Strain gt lt Sex gt Princ
47. gt dermal If lt Test type gt subacute subchronic lt gt subacute or subchronic respectively Information requirement Repeated dose toxicity after dermal administration Jf Test type is empty Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement short term toxicity study 28 days dermal sub chronic toxicity study 90 days dermal chronic toxicity study dermal lt Test type gt dermal If lt Test type gt subacute subchronic chronic lt gt subacute or subchronic or chronic e g Information requirement sub chronic toxicity study 90 days dermal Information requirement Repeated dose toxicity after dermal administration If Test type is empty Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 63 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 5 6 1 4 Repeated dose toxicity other routes IUCLID source section 7 5 4 Repeated dose toxicity other routes Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1
48. gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test type gt lt Nominal Measured gt lt Study result type gt lt Guideline gt based on lt Basis for effect gt Test material lt Remarks gt identity See lt Principles of method if other than ie description of rules guideline gt es in introductory part Form lt Test material form gt Jf field is populated Data waiving Information requirement Effects on other aquatic organisms Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Effects on other aquatic organisms Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 113 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 1 8 Toxicity to other aquatic organisms lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt 7 2 Terrestrial compartment lt Discussion gt UCLID source Endpoint summary 6 3 Terrestrial toxicity 7
49. immunotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 85 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt OR Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed immunotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Details on study design gt Test material identity See description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Fonn eTest imaterial form gt If field is populated Table 80 Exposure related observations endpoint not specified Method Results Remarks Reference IUCLID sour
50. in vitro in vivo inhalation oral dermal 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT Dose descriptor or qualitative effect characterisation test type e g NOAEL 12 mg kg bw day chronic rat Target organs cardiovascular hematological spleen lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt lt Endpoint conclusion gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt lt Endpoint conclusion gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt lt Endpoint conclusi
51. information on materials and methods incl tables gt Planned study period lt Study period gt Discussion of physicochemical properties lt Discussion gt UCLID source Endpoint summary 4 Physical and chemical properties 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 10 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 2 MANUFACTURE AND USES No information available on quantities Rule Print if none of the specified fields is populated Table 6 Quantities in tonnes year IUCLID source section 3 2 Estimated quantities Year Total tonnage Uses exempted from CSR Used for article lt Year gt Manufactured Uses as intermediate under strictly Imported in articles lt Manufactured gt controlled conditions on site lt Tonnage imported in Imported lt Imported gt lt Tonnage used as intermediate under articles gt Directly exported strictly controlled conditions on site gt Tonnage in produced articles lt Directly exported gt Used as intermediate under strictly lt Tonnage in produced controlled conditions transported articles gt lt Tonnage used as intermediate under strictly controlled conditions transported gt Used for research purposes lt Tonnage used for research purposes gt lt Remarks gt 2 1 Manufacture No information available on manufacture Rule Print if none of the specified fields is populated Table 7 Manufacture
52. intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt CHEMICAL SAFETY REPORT 99 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Dermal Local effects Long term Dermal Local effects Acute Oral Systemic effects Long term 2013 01 28 CSR PI 5 4 1 DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for th
53. invertebrates for the derivation of PNEC lt Short description of key information gt Value used for CSA ECS50 LCS50 for freshwater invertebrates lt EC50 LC50 for freshwater invertebrates gt lt Unit gt ECS50 LCS50 for marine invertebrates lt EC50 LC50 for marine invertebrates gt lt Unit gt 7 1 2 2 Long term toxicity to aquatic invertebrates IUCLID source section 6 1 4 Long term toxicity to aquatic invertebrates Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 IC10 or LC10 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 4 LC10 5 IC10 6 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 93 Long term effects on aquatic invertebrates Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test type gt lt Nominal Measured gt lt Study re
54. is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA route oral lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route dermal lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route inhalation lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 2013 01 28 CSR
55. lt CAS number gt Table 85 Further explanation on DNEL derivation for the general population IUCLID source Endpoint summary 7 Toxicological information Rules as stated for workers Route Type DNEL derivation Assessment factors AF for DNEL derivation of effect Inhalation DNEL derivation method lt DNEL AF for dose response relationship lt AF for Systemic derivation method gt dose response relationship gt lt Justification gt effects Long term Inhalation Systemic effects Acute Inhalation Local effects Long term 2013 01 28 CSR PI 5 4 1 Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies diff
56. lt Endpoint conclusion gt lt Author gt lt Year gt see section toxicity lt Effect level gt lt Value gt lt Unit gt 5 9 2 1 developmental lt Test type gt lt Species gt toxicity Reproductive dermal lt Endpoint conclusion gt lt Author gt lt Year gt see section seca lt Effect level gt lt Value gt lt Unit gt 5 9 2 1 toxicity lt Test type gt lt Species gt Reproductive inhalation lt Endpoint conclusion gt lt Author gt lt Year gt see section al lt Effect level gt lt Value gt lt Unit gt 5 9 2 1 foxicity lt Test type gt lt Species gt Justification for endpoint selection e Acute toxicity oral lt Justification for selection gt Rule Print bulleted paragraph if source field is populated e cont d for each endpoint 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 91 CAS number lt CAS number gt EC number lt Chemical name gt lt EC number gt 5 11 2 Selection of the DNEL s or other hazard conclusions for critical health effects Table 82 Hazard conclusions for workers IUCLID source Endpoint summary 7 Toxicological information Route Type of effect Hazard conclusion Most sensitive endpoint Inhalation Dermal Systemic effects Long term Systemic effects Acute Local effects Long term Local effects Acute Systemic effects Long term Systemic lt Hazard assessment conclusi
57. lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Reactivity towards container material Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Thermal stability Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Dissociation constant Proposed test guideline lt Guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 9 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Viscosity Proposed test guideline lt Guideline gt Planned type of method lt Type of method gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other
58. lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Solubility in organic solvents fat solubility Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Surface tension Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Flash point Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Self ignition temperature Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Flammability Proposed test guideline lt Guideli
59. of administration gt lt Type of description of rules inhalation exposure if applicable gt in introductory part lt Doses concentrations gt lt Basis gt Form lt Test material Vehicle lt Vehicle gt form gt If field is populated Exposure lt Duration of treatment exposure gt lt Frequency of treatment gt lt Guideline gt lt Principles of method if other than guideline gt Data waiving 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 83 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Information requirement Specific investigations other studies Type of effects studied lt Type of effects studied gt lt Type of method gt lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Specific investigations other studies Type of effects studied lt Type of effects studied gt lt Type of method gt lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 10 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in an
60. pee ew ba 15 3 CLASSIFICATION AND LABELLING io ssssiscissssvsssessssescsasepsaseatiaiagussotasssdcvesevasesbavegesocsesenestasesssseasnseseisasven3 17 3 1 Classification and labelling according to CLP GHS sssessesssseseseresrsreesesreerssesresresreeresrerreserrreresreeresrt 17 3 2 Classification and labelling according to DSD DPD sssssssessessesesrssresrsreesesrerrsrerresresreeresreereserrreresrenresre 20 3 2 1 Classification and labelling in Annex I of Directive 67 548 EEC s sssessereesesrssierrsrrerrsrerreserreeresrees 20 PAPAR AEAEE ATO ni OO E E A E A ek A kA siete 22 e PAER O AAEN STOA I E E E A E EN 23 4 ENVIRONMENTAL FATE PROPERTIES iieiea pttp iea t o ae aan 25 AMD De gradation xg sectesesssscsszesautdenvsistigesvctsstasbiedsressehssi at cedasdsechs sosasdsdapacdteisvat AE EEST 25 A J Vc Abiotic d gradation seinere oerset resa orror ks pa PEEPS EEEE ER SORE costesdhes ssdsuesdevesvess esssesvedasees 25 AsV Vel m BEIKON EEEE E 25 4 1 1 2 Phototransformation photolysis 2 0 0 0 eeceecesecesecesecesecseecseecseeeaeeeeeeeeceeceseeseceaecaecaessaeeaeeens 26 4 1 1 2 1 Phototransformation if Alt seei eiee aa aa aiaa a AOE E E AAEE EOE AIONE TESES AR 26 4 1 1 2 2 Phototransformation in Water cecceesscceseceesseceenceeeeceereesseeceeneeeneeceeeeeseeceeeeeenaeceneeeenaeees 27 4 1 1 2 3 Phototransformation in Soils ssi arinira riae EE E AENEA KAONE TREE RE 28 AND Biode grad ath ones E EEEE 29 4 1 2 1 Biodegfadation in W
61. products Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Reactivity towards container material Reason lt Data waiving gt Justification lt Justification for data waiving gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT EC number lt Chemical name gt lt EC number gt CAS number lt CAS number gt Information requirement Thermal stability Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Dissociation constant Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Viscosity Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal IUCLID source as for Data waiving see above Information requirement Melting freezing point Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Boiling point Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement
62. reasonForNoClassif 5 6 3 organ toxicity ication gt aA d y Affected organs p lt Affected organs gt Route of exposure lt Route of exposure gt Justification for non classification can be found in the CSR section indicated Specific concentration limits Concentration Classification lt Concentration range gt lt Hazard categories gt Table 21 Classification and labelling according to CLP GHS for the environment Endpoint Hazard category Hazard statement Reason for no CSR classification section Hazards to the lt category gt lt hazardStatement gt lt reasonForNoClassif 7 6 aquatic ication gt environment acute short term Hazards to the lt category gt lt hazardStatement gt lt reasonForNoClassif 7 6 aquatic ication gt environment long term M Factor acute lt mfactor acute gt M Factor chronic lt mfactor chronic gt Hazardous to the lt category gt lt hazardStatement gt lt reasonForNoClassif 7 6 ozone layer ication gt Justification for non classification can be found in the CSR section indicated Table 22 Classification and labelling according to CLP GHS for additional hazard classes classes Additional hazard lt Additional hazard classes gt CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 19 EC number lt Chemical name gt CAS number lt EC numbe
63. the following table Table 34 Simulation tests for biodegradation in soil Method Results Remarks Reference Test type lt Test type gt Half life DT50 lt Reliability gt lt Author gt lt Year gt Soil type lt Half life gt lt Soil No gt lt Purpose flag gt lt Soil type gt lt Soil No gt lt Remarks gt lt Study result type gt lt Guideline gt Pesadangn of test Test material lt Principles of method if other than EUn identity See guideline gt lt Degradation of test description of rules substance gt after lt Sampling in introductory part time gt lt Parameter gt Form lt Test material lt Soil No gt form gt lf field is Evaporation of parent populated compound lt Evaporation of parent compound gt Volatile metabolites lt Volatile metabolites gt Residues lt Residues gt Transformation products lt Transformation products gt Rule Print if no or not measured Transformation products lt Identity gt Rule Print all transformation products in separate lines Data waiving Information requirement Soil simulation testing Reason lt Data waiving gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 31 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Justification lt Justification for data waiving gt Testing proposal UCLID source Endpoint summary 5 2 3 Biodegradation in soil Informa
64. the following table Table 55 Studies on respiratory sensitisation Method Results Remarks Reference in vitro study If field Type of lt Interpretation of results gt lt Reliability gt lt Author gt lt Year gt method in vitro lt Results gt lt Purpose flag gt lt Species gt lt Strain gt lt Sex gt lt Study result type gt Induction lt Route of induction Test material exposute gt identity See Challenge lt Route of challenge description of rules exposure gt in introductory part Vehicle lt Vehicle gt Form lt Test material lt Guideline gt form gt If field is lt Principles of method if other than populated guideline gt Data waiving Information requirement Respiratory sensitisation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Respiratory sensitisation Proposed test guideline lt Guideline gt Type of method lt Type of method gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 58 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Planned study period lt Study period gt 5 5 2 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addres
65. 013 hPa lt Discussion gt Flammability lt Short description of key information gt Value used for CSA lt Flammability gt lt Discussion gt CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Explosive properties lt Short description of key information gt Value used for CSA lt Explosiveness gt lt Discussion gt Oxidising properties lt Short description of key information gt Value used for CSA Oxidising lt Oxidising gt lt Discussion gt Oxidation reduction potential lt Short description of key information gt Value used for CSA Oxidation reduction potential in mV at 20 C lt Oxidation reduction potential in mV at 20 C gt lt Discussion gt Stability in organic lt Short description of key information gt lt Discussion gt solvents and identity of relevant degradation products Storage stability and lt Short description of key information gt lt Discussion gt reactivity towards container material Stability thermal lt Short description of key information gt lt Discussion gt sunlight metals Dissociation constant lt Short description of key information gt Value used for CSA pKa at 20 C lt pKa at 20 C gt lt Discussion gt Viscosity lt Short description of key information gt Value used for CSA Viscosity at 20 C lt Viscosity at 20 C gt lt Unit gt
66. 1 Aquatic bioaccumulation IUCLID source section 5 3 1 Bioaccumulation aquatic sediment Sort rule I Field Route of exposure 1 aqueous 2 sediment 3 feed 4 other 5 empty II Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty III Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 35 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt The studies on aquatic bioaccumulation are summarised in the following table Table 38 Studies on aquatic bioaccumulation Method Results Remarks Reference lt Test organisms species gt lt Route of exposure gt lt Water media type gt lt Test type gt Sediment type lt Type of sediment if sediment study gt Total exposure uptake duration lt Total exposure uptake duration gt lt Unit gt Total depuration duration lt Total depuration duration gt lt Unit gt Details on estimation of bioconcentration lt Details on estimation of bioconcentration gt Print only if field Details on estimation of bioconcentration is populated lt Guideline gt lt Principles of method if other than guideline gt lt Bioaccumulation
67. 2 1 Toxicity to soil macro organisms IUCLID source sections 6 3 1 Toxicity to soil macroorganisms except arthropods 6 3 2 Toxicity to terrestrial arthropods For records in section 6 3 2 only if soil macro organisms are involved as triggered by the absence of any indication of non soil organisms in the following fields Guideline Application method Test organisms Animal group or if all four trigger fields are blank Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 LC10 LD10 EC50 LC50 LD50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 or LC10 or LD10 4 EC50 or LC50 or LD50 5 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 97 Effects on soil macro organisms Method Results Remarks Reference TUCLID source section 6 3 1 Toxicity to soil macroorganisms except arthropods lt Test organisms species gt lt Animal group gt lt Test duration type gt lt Study type gt Substrate lt Substrate type gt lt Guideline gt lt Principles of method if other than guideline gt lt Endpoint gt lt Duration
68. CSA ECS50 LCS50 for freshwater sediment lt EC50 LCS50 for freshwater sediment gt lt Unit gt ECS50 LCS50 for marine water sediment lt EC50 LCS0 for marine water sediment gt lt Unit gt EC10 LC10 or NOEC for freshwater sediment lt EC10 LC10 or NOEC for freshwater sediment gt lt Unit gt EC10 LC10 or NOEC for marine water sediment lt EC10 LC10 or NOEC for marine water sediment gt lt Unit gt 7 1 5 Other aquatic organisms IUCLID source section 6 1 8 Toxicity to other aquatic organisms Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 IC10 LC10 EC50 TC50 LC50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 or IC10 or LC10 4 EC50 or IC50 or LC50 5 ECO or ICO or LCO 6 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 96 Effects on other aquatic organisms Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type
69. CSR PLUG IN FOR IUCLID 5 4 USER MANUAL FEBRUARY 2013 VERSION 4 1 PART Il SPECIFICATIONS OF THE CSR TEMPLATE This part provides the Specifications of the CSR Template including the most relevant rules and conditions implemented in the CSR plug in unless described in the section 5 2 General rules CONVENTIONS The following conventions are used e Placeholders for IUCLID 5 source fields are set between less than greater than signs i e lt placeholder gt Example lt Reference substance name gt e Annotations are set between brackets and formatted in italics Examples IUCLID source section 5 1 1 Phototransformation in air Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IUCLID source Endpoint summary 5 1 1 Phototransformation in air lf field Type of method in vitro e Rules described in Part of this User s Guide section 5 Format and general rules underlying the CSR generation are normally not repeated Please refer to that section CHEMICAL SAFETY REPORT Substance Name lt Reference substance name gt Substance Name lt Chemical name gt If no lt Reference substance name gt available EC Number lt Chemical name gt CAS Number lt CAS number EC inventory gt CAS Number lt CAS number CAS information gt Only if no CAS number EC inventory available Registrant s Identity lt Lega
70. ForNoClassif 5 3 4 eye irritation ication gt Respiration lt category gt lt hazardStatement gt lt reasonForNoClassif 5 5 3 sensitization ication gt Skin sensitation lt category gt lt hazardStatement gt lt reasonForNoClassif 5 5 3 ication gt Aspiration lt category gt lt hazardStatement gt lt reasonForNoClassif 5 2 3 hazard ication gt Reproductive lt category gt lt hazardStatement gt lt reasonForNoClassif 5 9 3 Toxicity ication gt y Specific effect lt Specific effect gt Route of exposure lt Route of exposure gt Reproductive lt category gt lt hazardStatement gt lt reasonForNoClassif 5 9 3 Toxicity Effects ication gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 18 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt on or via lactation Germ cell lt category gt lt hazardStatement gt lt reasonForNoClassif 5 7 3 mutagenicity ication gt 8 y Route of exposure lt Route of exposure gt Carcinogenicity lt category gt lt hazardStatement gt lt reasonForNoClassif 5 8 3 ication gt Route of exposure lt Route of exposure gt Specific target lt category gt lt hazardStatement gt lt reasonForNoClassif 5 2 3 and organ toxicity ication gt 5 3 4 si S y Affected organs lt A ffected organs gt Route of exposure lt Route of exposure gt Specific target lt category gt lt hazardStatement gt lt
71. ID source endpoint study record s of 2 3 PBT assessment 8 1 1 n Assessed substance lt Assessed substance gt Rule If field Assessed substance is populated 8 1 1 n Assessed substance not specified Rule If field Assessed substance is blank Rule A subheading with a consecutive section number is created for each substance assessed in the following order 1 Substance itself 2 Constituent 3 Transformation product 4 not specified Reference substance lt Reference substance gt gt gt gt CAUTION Please specify the Reference Substance in the corresponding field of IUCLID section 2 3 lt lt lt Rule Print default statement if field Assessed substance is populated with Constituent or Transformation product and field Reference Substance is empty Remark on assessed substance lt Remark gt 8 1 1 n 1 Persistence assessment Rule Print the default statement s specified below if the corresponding checkbox es is are ticked i e Checkbox I Not P and not vP based on readily biodegradable Checkbox 2 Not P and not vP based on other screening test s e g enhanced ready biodegradability inherent biodegradability test under valid conditions Checkbox 3 Not P and not vP based on T1 2 Checkbox 4 P but not vP based on T1 2 Evidence of non P non vP properties Rule Print subheading if checkbox 1 2 3 and or 4 are ticked and or any Remark field is populated in the block Screening cri
72. IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repeatable block Manufacture Identifiers Use descriptors Other information Confidential Rule e Environmental Release Category ERC Tonnage of substance for that Print if Confidentiality lt ERC gt use lt Tonnage of substance gt flag CBI e Process Category PROC lt Process tonnes M lt Manufacture Category gt Rule Print multiple PROCs Number of sites lt Number of number gt separated by semicolon e g PROC 1 PROC sites range gt lt Manufacture name gt 8a Remarks lt Remarks gt e g Confidential M 1 Manufacture of the substance 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 11 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt No information available on manufacturing process related to the specified manufacture s Rule Print if none of the specified fields is populated Table 8 Manufacturing process related to the specified manufacture s IUCLID source section 3 1 Technological process Rule Print if at least one source field Methods of manufacture of substance is populated Related manufacture s Description of manufacturing process lt Related manufacture gt lt Methods of manufacture of substance gt Rule 1 Print table if at least one source field Methods of manufacture of substance is populated Rule 2 Print se
73. L SAFETY REPORT 80 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 Developmental toxicity lt Developmental toxicity teratogeniticy Discussion gt The following information is taken into account for any hazard risk assessment lt Developmental toxicity teratogeniticy Short description of key information gt Value used for CSA route oral lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route dermal lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route inhalation lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effe
74. PI 5 4 1 CHEMICAL SAFETY REPORT 87 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Immunotoxicity TUCLID source Endpoint summary 7 9 2 Immunotoxicity lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA route oral lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route dermal lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route inhalation lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and
75. SET pS 106 T LX 2 one term toxicity to LSD oissesssedcessecsseeeses ss ceseehsbe stds Sreo EE sscsascessvachedcsdhes sobsscesencpsbeeastavesbeness 107 7 1 2 Aquatic Invertebrates sssr so sete bags sted iscsi su resar s aE EE T ap eS EEE EEEo Ea S EREE EE E EIE EESTE 108 7 1 2 1 Short term toxicity to aquatic invertebrates sssesesseeseseeesesreerssrrererrsreerrsrerrssrrrreresreeresrent 108 7 1 2 2 Long term toxicity to aquatic invertebrates ssssesesseeseseeesesteersserrtsrrsreeresterrssrrrrnresrreresreet 109 TAB Algae and aquatic plants s sccssesleciss sesssesedslecs sete sess cies csds sete tas so raposos EEEren i SERRES EE E Es SEESE Tpi 110 71 4 Sediment Organis MS e 35 se sirr ea aree etser se retara Aa E SEE E ap SEOs EEEa oa OER EEEE EEEE SEEST pa 112 TAS Other aquatic organis MS z sisese se base retenon sree r i po te base ESEE aoe sens EEE Ees Doa jedaonseesseeoscetseesensse 113 T2 erresa COMP arte ntssecsissescssciseetsstavs sada sncoessczabsessgasbetesdasncobe ce sugtessnobestacesdebsstaabanaagesagessteavusasadetetads 114 7 2 1 Toxicity to soil macro organisms 0 eeeeeeseceeeeecsseceeeeecsseceeeeecsaeceseeecsaeceeeeecsaeceeneecsaeceeeeeesaeeeenees 114 7 2 2 Toxicity to terrestrial plants 2 0 ee ee eecesecesecesecnsecseecneecseeeaeseeeeeeeesceesecsecaecsaecsaecsaecseeeseseneeees 116 7 2 3 Toxicity to soil MICTO OFQAMISMS ee ee ee esse cese esse cee caeecseeeseseaeeseeeeceseesecsaecsaecsaecsa
76. Time point gt lt Reversibility gt lt Remarks gt Edema score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 47 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Irritation parameter gt lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Studies with results indicating corrosivity to the skin are summarised in section 5 4 Corrosivity Insert if field Interpretation of results corrosive highly corrosive Category 1 corrosive Category 1A corrosive Category 1B corrosive Category 1C corrosive Category 1 Data waiving Information requirement Skin irritation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Skin irritation Proposed test guideline lt Guideline gt Type of method lt Type of method gt Type of coverage lt Type of coverage gt Species lt Species gt lt Strain gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 3 1 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint a
77. Transformation products lt Transformation products gt Test material identity See description of rules in introductory part Form lt Test material form gt f field is populated Method Results Remarks Reference lt Guideline gt Spectrum of substance lt Reliability gt lt Author gt lt Year gt lt Principles of method if other than lt Parameter gt lt Value gt lt Unit gt lt Purpose flag gt guideline gt lt Remarks gt lt Study result lt Computational methods gt Half life DT50 type gt Data waiving Information requirement Phototransformation in soil Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Phototransformation in soil Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 1 4 Phototransformation in soil lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt Value used for CSA Half life in soil lt Half life in soil gt lt Unit gt CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 28 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 4 1 2 Biodegradatio
78. Y OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES 1 1 Name and other identifiers of the substance IUCLID source section 1 1 Identification unless otherwise stated Depending on the values of IUCLID fields Composition and Origin one of the following statements is automatically inserted The substance lt Reference substance name Chemical name gt is an element having the following characteristics and physical chemical properties see the IUCLID dataset for further details If field Origin element The substance lt Reference substance name Chemical name gt is a lt Composition gt lt Origin gt having the following characteristics and physical chemical properties see the IUCLID dataset for further details If field Composition lt gt other or lt gt empty and field Origin lt gt element Type of substance lt Reference substance name Chemical name gt lt Composition gt composition lt Origin gt origin The characteristics and physical chemical properties are described below see the IUCLID dataset for further details If field Composition other or empty and field Origin lt gt element The following public name is used lt Public name gt New field in IUCLID 5 2 Table 1 Substance identity EC number lt EC number gt EC name lt EC name gt CAS number EC inventory lt CAS number EC inventory gt CAS number
79. ame gt lt EC number gt rat ABSinh human 6 7 m 8h 10 m 8h 700 mg kg d 1 0 38 m7kg d 0 5 1 0 67 617 mg m It is assumed that oral absorption rate is 50 of that of inhalation absorption ABSoral rat oral absorption rate in rats ABSinh human inhalation absorption rate in humans e cont d for each route type of effects Discussion Rule Print if the source field is populated lt Results and discussions Workers Discussion gt Table 84 Hazard conclusions for the general population Rules as stated for workers Route Type of effect Hazard conclusion Most sensitive endpoint Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Route effects Long lt DN M EL value gt lt Unit gt of original study gt term lt Hazard assessment conclusion gt Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Route effects lt DN M EL value gt lt Unit gt of original study gt Inhalation Acute lt Hazard assessment conclusion gt Local effects lt Hazard assessment conclusion gt lt Most sensitive endpoint gt Long term lt DN M EL value gt lt Unit gt lt Hazard assessment conclusion gt Local effects lt Hazard assessment conclusion gt lt Most sensitive endpoint gt Acute lt DN M EL value gt lt Unit gt lt Hazard assessment conclusion gt Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Rout
80. ameters lt Toxicokinetic parameters gt Test No lt Test No gt Absorption lt Details on absorption gt Rule lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is lt Author gt lt Year gt Print only if field Type Main ADME populated Doses conc lt Doses results does not contain absorption concentrations gt Ena Tee f SPASE Pes Distribution lt Details on distribution in lt Guideline gt tissues gt Rule Print only if field Type y yp lt Principles of method Main ADME results does not contain if other than guideline gt distribution Excretion lt Details on excretion gt Rule Print only if field Type Main ADME results does not contain excretion Metabolites identified lt Metabolites identified gt Details on metabolites lt Details on 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 39 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt metabolites gt Evaluation of results lt Interpretation of results gt disregarded study IUCLID source section 7 1 2 Dermal absorption Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 Dermal absorption study in vitro If field Type of method in vitro lt Species g
81. ard conclusion Remarks Justification Freshwater lt Hazard assessment conclusion freshwater gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC freshwater derivation gt Marine water lt Hazard assessment conclusion marine waters gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC marine water derivation gt Intermittent releases to water lt Hazard assessment conclusion intermittent releases gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC intermittent releases derivation gt Sediments freshwater lt Hazard assessment conclusion sediment freshwater gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC sediment derivation gt Sediments marine water lt Hazard assessment conclusion sediment marine water gt lt PNEC value gt lt Unit gt Assessment factor lt assessment factor gt Extrapolation method lt Extrapolation method gt lt Justification for no PNEC sediment derivation gt Sewage treatment plant lt
82. arded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt EyDee lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed respiratory irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed respiratory irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt Spee Outcome of incidence
83. art than m dinitrobenzene gt Foran Test istenal More sensitive to friction than m form gt Jf field is dinitrobenzene lt More sensitive to friction populated than m dinitrobenzene gt Explosive not specified lt Explosive not specified gt Remarks lt Any other information on results incl tables gt Data waiving see CSR section 1 3 Physicochemical properties Insert if field Data waiving is populated in any record of IUCLID section 4 14 Testing proposal see CSR section 1 3 Physicochemical properties Insert if field Study result type contains experimental study planned in any record of IUCLID section 4 14 Discussion UCLID source Endpoint summary 4 14 Explosiveness lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Classification according to GHS TUCLID source section 2 1 GHS Name lt Name gt Related composition lt Related composition gt State form of the substance lt Form of the substance gt Classification lt Explosives gt Hazard statement lt Hazard statement gt Reason for no classification lt Reason for no classification gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 102 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Classification according to DSD DPD Classification status lt Status gt lt Nam
84. at all criteria are fulfilled If data are lacking justify that long term toxicity to marine and freshwater organisms is expected to be gt 0 01 mg L lt lt lt e Substance is not classified as carcinogenic category I or 2 mutagenic category 1 or 2 or toxic for reproduction category 1 2 or 3 according to Directive 67 548 EEC or the DSD or carcinogenic category 1A or 1B germ cell mutagenic category 1A or 1B or toxic for reproduction category 1A 1B or 2 according to Regulation EC No 1272 2008 or CLP Regulation see also section 3 Classification and labelling lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the prompt gt gt gt CAUTION Please complete the corresponding Remark field in IUCLID for this criterion Please note If the substance is not T based on criteria laid down in Annex XIII of REACH then it has to be confirmed that all criteria are fulfilled If data are lacking justify that long term toxicity to marine and freshwater organisms is expected to be gt 0 01 mg L lt lt lt e No other evidence of chronic toxicity as identified by the classifications T R48 or Xn R48 according to Directive 67 548 EEC or specific target organ toxicity after repeated exposure STOT RE 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 127 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt category I or 2 according to R
85. aterial form gt If field is populated Burning time s lt Solid Burning time s gt lt Remarks gt Flame extension cm lt Aerosol Flame extension cm gt lt Remarks gt Flame projection cm lt Aerosol Flame projection cm gt lt Remarks gt Lower explosion limit lt Gas Lower explosion limit gt lt Remarks gt Upper explosion limit lt Gas Upper explosion limit gt lt Remarks gt Remarks lt Any other information on results incl tables gt Data waiving see CSR section 1 3 Physicochemical properties Insert if field Data waiving is populated in any record of IUCLID section 4 13 Testing proposal see CSR section 1 3 Physicochemical properties Insert if field Study result type contains experimental study planned in any record of IUCLID section 4 13 Discussion UCLID source Endpoint summary 4 13 Flammability 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 103 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Flash point Rule Print subheading if information is available for both Flammability and Flash point No relevant information available Rule Print if applicable The available information on flash point is summarised in the following table
86. atersiin soere eeter sieisen srera TESE EE Ts ROEE ESEE EEE SE TEREE EEE Eoo ESEESE FEE Si 29 e S e A ESEE TS ETT 29 4 1 2 1 2 Simulation tests water and sediments essnsseeeesseseesseeeeertessetetssesessseessereessereesssreessreee 29 4 1 2 1 3 Summary and discussion of biodegradation in water and sediment sssseeeseesereeeeee 30 4 1 2 2 Biodegradation in soll yenin r E E RE E E EE EE E 31 4 1 3 Summary and discussion of degradation seessseseseeseseeesstseessrstessrsttrreserressestenteseentsseerresesrenresre 32 4 2 Environmental distribution ces ceecceesecesecessceceecesscecucesencecsacessneecsaeeseaeecsaeeeeaeecsaceseaeecsaeeeeaeecsaeeeaees 32 4 2 1 Adsorption desorption 0 c ee ceecesecsecseecseeeseeseeeeeeeseeesecesecsecsaecsaecsaecsaecseecaeseseeeaeeeeesaeeeseenaeeseenaes 32 4 2 2 V OlatiliSatiomy 3 ceive E Sap ennai a devaa E A R dun tagey cub ud de dupes babectadbar dae R 34 4 2 3 Distribution modelling oo eee eee e e r Ee eea r EE enrere e Seat 35 4 2 4 Summary and discussion of environmental distribution ssssesesesesseeeseseseresrsresrrseeersseerrssesreeresee 35 A 3 Bio cc m latioi n E e E R R a a lagen E a a te ceveln as 35 4 3 1 Aquatic bioaccumulation esseseeeseeeseseeesssteersstsesresteetrserrrsestesrestentrsretsserteststenteseentssenrrererteeresrt 35 4 3 2 Terrestrial bioaccumulation eeeeeeseceeececsseceeneecsaecesneecsacceseeecsaeceeeecsaeceeeeecsaeeeeeecaee
87. ation gt Value used for CSA Short term EC50 or LCS0 for soil macro organisms lt Short term EC50 or LC50 for soil macro organisms gt lt Unit gt Long term EC10 LC10 or NOEC for soil macro organisms lt Long term EC10 LC10 or NOEC for soil macro organisms gt lt Unit gt Discussion of effects on soil dwelling arthropods JUCLID source Endpoint summary 6 3 2 Toxicity to terrestrial arthropods gt gt gt NOTE please delete this instruction Move any information related to other than soil arthropods to the CSR section 7 2 4 Toxicity to other terrestrial organisms lt lt lt Insert if the fields Guideline Application method Animal group and Test organisms species do not contain any of the predefined Phrases and are not blank meaning that other is selected For such cases it cannot be decided if the study is with soil or non soil organisms lt Discussion gt The following information is taken into account for effects on soil dwelling arthropods for the derivation of PNEC lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 115 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Value used for CSA Short term EC50 or LC50 for soil dwelling arthropods lt Short term EC50 or LC50 for soil dwelling arthropods gt lt Unit gt Long term EC10 LC10 or NOEC for soil dwelling arthropods lt Long term EC10 LC10 or NOEC for soil
88. ber gt lt CAS number gt lt Principles of method if other than guideline gt Data waiving Information requirement Immunotoxicity lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Immunotoxicity lt Test type gt lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 10 1 3 Specific investigations other studies IUCLID source section 7 9 3 Specific investigations other studies Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results of specific investigations other studies are summarised in the following table Table 77 Specific investigations other studies Method Results Remarks Reference Endpoint addressed lt Endpoint lt Details on results gt lt Reliability gt lt Author gt lt Year gt addressed gt lt Purpose flag gt Type of effects studied lt Type of lt Study result type gt effects studied gt lt Type of method gt Test material lt Species gt lt Strain gt lt Sex gt identity See lt Route
89. ce section 7 10 1 Health surveillance data if Endpoint addressed not applicable or empty Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Type of population gt lt Purpose flag gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed not applicable or empty Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed not applicable or empty Sort rule Field Purpose flag 1 key study 2 su
90. centration qualifier gt lt Typical concentration value gt lt Typical concentration unit gt lt Concentration range gt Impurity is relevant for C amp L of the substance Insert if this checkbox is selected lt Remarks gt Table 4 Additives Additive Function Typical Concentration Remarks concentration range lt Reference substance gt lt Function gt lt Typical lt Concentration Additive is relevant EC no lt EC number gt concentration range gt for C amp L of the qualifier gt lt Typical substance Insert if concentration this checkbox is value gt lt Typical selected concentration unit gt lt Remarks gt 1 3 Physicochemical properties IUCLID source endpoint summary records of sections 4 1 Appearance physical state colour 4 2 Melting point freezing point 4 3 Boiling point 4 4 Density 4 5 Particle size distribution Granulometry 4 6 Vapour pressure 4 7 Partition coefficient 4 8 Water solubility 4 9 Solubility in organic solvents fat solubility 4 10 Surface tension 4 11 Flash point 4 12 Auto flammability 4 13 Flammability 4 14 Explosiveness 4 15 Oxidising properties 4 16 Oxidation reduction potential 4 17 Stability in organic solvents 4 18 Storage stability and reactivity 4 19 Stability thermal sunlight metals 4 21 Dissociation constant 4 22 Viscosity No relevant information available Rule Print if none of the follow
91. cies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt Justification for route to route extrapolation Rule Print only if at least one source field Justification for route to route extrapolation is populated e Inhalation Systemic effects Long term lt Justification for route to route extrapolation gt Rule Print bulleted paragraph if source field is populated for this route type of effects e g e Inhalation Systemic effects Long term NOAECcorr NOAELoral 1 0 38 m kg d ABSoral 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 96 CAS number lt CAS number gt EC number lt Chemical n
92. cific investigations Other Studies escceesscceseeeeseeceseeessceceeeeeeaeeceeeeeeneeceeeeseneecetreseneeens 5 10 22 Mirman information 23sec cess ceeegcekeck E E E E E ER E 5 10 3 Summary and discussion of other effects seeseeeeeeeeseseseseeeseseesstesstesstesreseeeseesstrssrrssressresseeseet 5 11 Derivation of DNEL s and other hazard conclusions sssesesessssseseesseesseesstssseseesseerseessrssressresreseeet 5 11 1 Overview of typical dose descriptors for all endpoints 5 11 2 Selection of the DNEL s or other hazard conclusions for critical health effects eee 92 6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES 1 c0c00e008 102 6 TEX PlOSIVILY ics iveds a a E EA aa svou hoes cies cash vba AEEA A AEE EA 102 6 25 FU anti DANCY ARER EAE E tashca hea sbghea cnoeeetandsdtessvasbarnacasdcoevee dbs taatoceoiss 103 6 3 Oxidi sine poten tal sii r setehecsceessbe sess Save cde sacs E a a dees sdahevdhos E aA A TRES E EATE EEEE 105 7 ENVIRONMENTAL HAZARD ASSESSMENT 0 sccsccescsesseesseeseeeeceeecesecesecuaecaaecaaecseeeseeeseesseeseeenseneenaes 106 7 1 Aquatic compartment including SediMeNt 00 eee eee ceeecesecesecaecaeceaecaaecaeseseseaeeeeesseeseenseenaes 106 Po Mss PUSH i 3 5s sects eves essoets deasb tas steebals sty Seta Siee cde tt gs seb d cues E EE 106 PALA Short term toxicity tO fiS senor oet reese ss cascehssbesedebaseseed Era kr EES Esp Ee OERE EEEE OSEE TERE
93. clusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Value used for CSA inhalation local effects lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 5 7 Mutagenicity 5 7 1 Non human information 5 7 1 1 In vitro data TUCLID source section 7 6 1 Genetic toxicity in vitro Sort rule in tables I Field Type of genotoxicity 1 gene mutation 2 chromosome aberration 3 DNA damage and o
94. cription of key information gt lt Discussion gt Vapour pressure lt Short description of key information gt Value used for CSA lt Vapour pressure gt lt Unit gt at lt Temp gt lt Unit gt lt Discussion gt Partition coefficient n octanol water log value lt Short description of key information gt Value used for CSA Log Kow Log Pow lt Log Kow Log Pow gt at lt Temp gt lt Unit gt lt Discussion gt Water solubility lt Short description of key information gt Value used for CSA lt Water solubility gt lt Unit gt at lt Temp gt lt Unit gt lt Discussion gt Solubility in organic solvents fat solubility lt Short description of key information gt Value used for CSA Solubility in mg 100 g standard fat at 20 C lt Solubility in mg 100 g standard fat at 20 C gt Solubility in organic solvents at 20 C lt Solubility in organic solvents at 20 C gt lt Discussion gt Surface tension lt Short description of key information gt Value used for CSA lt Surface tension gt mN m at 20 C and lt Conc gt mg L lt Discussion gt Flash point lt Short description of key information gt Value used for CSA lt Flash point gt lt Unit gt at 1013 hPa lt Discussion gt Autoflammability lt Short description of key information gt Value used for CSA self ignition lt Autoflammability Self ignition temperature temperature gt lt Unit gt at 1
95. ct level Unit gt lt Test type gt lt Species gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 Toxicity to reproduction other studies lt Toxicity to reproduction other studies Discussion gt The following information is taken into account for any hazard risk assessment lt Toxicity to reproduction other studies Short description of key information gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt 5 10 Other effects 5 10 1 Non human information 5 10 1 1 Neurotoxicity TUCLID source section 7 9 1 Neurotoxicity Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable
96. ction 7 10 5 Exposure related observations in humans if Endpoint addressed eye irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Details on study design gt Test material identity See description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Form lt Test material 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 51 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt form gt If field is populated 5 3 3 Respiratory tract 5 3 3 1 Non human information 5 3 3 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 51 Exposure related observations on respiratory irritation in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed respiratory irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disreg
97. ctory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed basic toxicokinetics or dermal absorption Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt typez lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed basic toxicokinetics or dermal absorption Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt type gt Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt
98. ddressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 48 Exposure related observations on skin irritation in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed skin irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed lt Endpoint addressed gt IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed skin irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 48 EC number lt Che
99. default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 Specific investigations studies other studies JUCLID source Endpoint summary 7 9 3 Specific investigations other lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 88 CAS number lt CAS number gt EC number lt Chemical name gt lt EC number gt 5 11 Derivation of DNEL s and other hazard conclusions 5 11 1 Overview of typical dose descriptors for all endpoints Table 81 Available dose descriptor s per endpoint as a result of its hazard assessment IUCLID source endpoint summaries of relevant subsections of section 7 Toxicological information Rule 1 Print a row for a given Endpoint Route only if any data are available for the 3rd column Rule 2 lt Endpoint conclusion gt is always printed in 3rd column if this field is populated Rule 3 Print in 3rd column gt gt gt CAUTION No study available in corresponding IUCLID endpoint summary although an Effect level is provided lt lt lt if applicable except for Sensitisation and Mutagenicity Rule 4 Print in 3rd column gt gt gt CAUTION Adverse effect observed in c
100. description of key information gt Value used for CSA Half life for hydrolysis lt Half life for hydrolysis gt at lt Temperature gt lt Unit gt 4 1 1 2 Phototransformation photolysis 4 1 1 2 1 Phototransformation in air IUCLID source section 5 1 1 Phototransformation in air Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The studies on phototransformation in air are summarised in the following table Table 29 Studies on phototransformation in air Light source lt Light source gt Light spectrum lt Light spectrum gt Rel light intensity lt Rel light intensity gt lt DT50 gt lt Test condition gt Degradation lt Degr gt after lt Sampling time gt lt Test condition gt Degradation rate constant lt Rate constant gt for reaction with lt Reaction with gt Repeat for each record of the block Quantum yield lt Quantum yield for direct photolysis gt Transformation products lt Transformation products gt Test material identity See description of rules in introductory part Form lt Test material form gt Zf field is populated Method Results Remarks Reference lt Guideline gt Spectrum of substance lt Reliability gt lt Author gt lt Year gt lt Principles of method if other than lt Pa
101. dose toxicity lt Test type gt lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 6 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 64 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The exposure related observations in humans are summarised in the following table Table 61 Exposure related observations on repeated dose toxicity in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed repeated dose toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt ype lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated
102. dose toxicity inhalation Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Endpoint 1 no NOAEL C identified 2 NOAEL C 3 NOEL C 4 LOAEL C 5 LOEL C 6 BMD C05 7 BMD C10 8 BMD C 9 any other or empty No relevant information available Rule Print if applicable The results of studies are summarised in the following table Table 58 Studies on repeated dose toxicity after inhalation exposure Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Route of lt Sex gt based on lt Effect lt Purpose flag gt administration gt lt Type of concentration type gt lt Basis lt Study result type gt inhalation exposure gt for effect level Remarks gt i Test material lt Doses concentrations gt identity See Vehicle lt Vehicle gt description of rules Exposure lt Duration of treatment in introductory part exposure gt lt Frequency of Form lt Test material treatment gt form gt Jf field is lt Guideline gt populated lt Principles of method if other than guideline gt Data waiv
103. e Print if the corresponding Remark field is populated lt Remark gt Conclusion on P vP properties lt Conclusion on P vP properties gt Rule Print content of this IUCLID field If not populated print the following warning statement after the prompt gt gt gt CAUTION Please complete the corresponding IUCLID field by selecting the appropriate conclusion for the P assessment lt lt lt lt Remark gt 8 1 1 n 2 Bioaccumulation assessment Rule Print the following default statement s below if the corresponding checkbox es is are ticked i e Checkbox I Not B and not vB based on Log Kow lt 4 5 Checkbox 2 Not B and not vB based on BCF lt 2000 L kg Checkbox 3 B but not vB based on 2000 lt BCF lt 5000 L kg Evidence of non B non vB properties Rule Print subheading if checkbox 1 2 and or 3 are ticked and or any Remark field is populated in the block Screening criteria and or in the block Criteria based on Annex XII of REACH Screening criteria Rule Print subheading if checkbox 1 is ticked and or Remark is populated Not B vB based on Log Kow lt 4 5 Rule If checkbox 1 is ticked and the related Remark field is empty Not B vB based on Log Kow lt 4 5 lt Remark gt Rule If checkbox 1 is ticked and the related Remark field is populated Remarks on criterion Log Kow lt 4 5 lt Remark gt Rule If checkbox 1 is not ticked and the related Remark field
104. e Rule Print if applicable The results of terrestrial bioaccumulation studies are summarised in the following table Table 39 Studies on terrestrial bioaccumulation Method Results Remarks Reference CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 36 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Test organisms species gt lt Bioaccumulation factor_Type gt lt Reliability gt lt Author gt lt Year gt lt Bioaccumulation factor gt lt Unit gt lt Guideline gt lt Purpose Flag gt lt Basis gt lt Time of plateau ea lt Time of plateau gt lt Calculation than guideline gt basis gt lt Remarks gt Test material identity See description of rules lt Principles of method if other lt Study result type gt Elimination lt Elimination gt lt Endpoint gt lt Depuration time DT gt in introductory ws part Lipid content DE Form lt Test lt Lipid content gt lt Time materal toime i point gt gt lt Remarks gt Teld a populated Transformation products lt Metabolites gt Data waiving Information requirement Terrestrial bioaccumulation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Terrestrial bioaccumulation Proposed test guideline lt Guideline gt Species lt Test organisms species gt Principles of method if
105. e effects Long lt DN M EL value gt lt Unit gt of original study gt term lt Hazard assessment conclusion gt Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Route effects lt DN M EL value gt lt Unit gt of original study gt Acute lt Hazard assessment conclusion gt Dermal z 3 Local effects lt Hazard assessment conclusion gt lt Most sensitive endpoint gt Long term lt DN M EL value gt lt Unit gt lt Hazard assessment conclusion gt Local effects lt Hazard assessment conclusion gt lt Most sensitive endpoint gt Acute lt DN M EL value gt lt Unit gt lt Hazard assessment conclusion gt Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Route effects Long lt DN M EL value gt lt Unit gt of original study gt term lt Hazard assessment conclusion gt Oral Systemic lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt Route effects lt DN M EL value gt lt Unit gt of original study gt Acute lt Hazard assessment conclusion gt Eyes Local effects lt Hazard assessment conclusion gt Further explanation on hazard conclusions Rules as stated for workers e Inhalation Systemic effects Long term lt Justification and comments gt e cont d for each route type of effects 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 97 EC number lt EC number gt lt Chemical name gt CAS number
106. e gt TUCLID source section 2 2 DSD DPD Condition lt Status gt lt Reference substance name gt is inserted if lt Name gt not available lt Explosiveness gt Reason for no classification lt Reason for no classification gt Justification for classification or non classification lt Justification for classification or non classification gt 6 2 Flammability IUCLID source section 4 13 Flammability 4 11 Flash point Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable Flammability Rule Print subheading if information is available for both Flammability and Flash point The available information on flammability is summarised in the following table Table 87 Information on flammability Method Results Remarks Reference lt Guideline gt Evaluation of results lt Reliability gt lt Author gt lt Year gt lt Principles of method lt Interpretation of results gt lt Purpose flag gt if other than guideline gt TEE lt Study result type gt Test material Ignition on contact with air lt Solid liquid identity See Ignition on contact with air gt lt Remarks gt description of rules in introductory part Release of flammable gas in contact with water lt Solid liquid Release of flammable gas in contact with water gt lt Remarks gt Form lt Test m
107. e gt Planned study period lt Study period gt 4 1 2 1 3 Summary and discussion of biodegradation in water and sediment Discussion screening testing JUCLID source Endpoint summary 5 2 1 Biodegradation in water screening tests lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 30 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Value used for CSA Biodegradation in water lt Biodegradation in water gt Discussion simulation testing JUCLID source Endpoint summary 5 2 2 Biodegradation in water and sediment simulation tests lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt Value used for CSA Half life in water lt Half life in water gt lt Unit gt at lt Temperature gt lt Unit gt Half life in sediment lt Half life in sediment gt lt Unit gt at lt Temperature gt lt Unit gt 4 1 2 2 Biodegradation in soil IUCLID source section 5 2 3 Biodegradation in soil Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The test results are summarised in
108. e gt lt Unit gt Rule 1 as for Inhalation Systemic effects Long term e g DNEL 7 mg kg bw day lt Hazard assessment conclusion gt Rule 2 as for Inhalation Systemic effects Long term e g No hazard identified CHEMICAL SAFETY REPORT lt Most sensitive endpoint gt lt Route of original study gt e g Repeated dose toxicity Oral lt Most sensitive endpoint gt lt Route of original study gt lt Most sensitive endpoint gt lt Most sensitive endpoint gt lt Most sensitive endpoint gt lt Route of original study gt e g Repeated dose toxicity oral lt Most sensitive endpoint gt lt Route of original study gt 92 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Acute Local effects Long term Local effects Acute Eyes Local effects Inhalation Systemic effects Acute lt Hazard assessment conclusion gt Rule 2 as for Inhalation Systemic effects Acute lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt DN M EL value gt lt Unit gt Rule 1 as for Inhalation Systemic effects Long term lt Hazard assessment conclusion gt Rule 2 as for Inhalation Systemic effects Long term lt Hazard assessment conclusion gt lt Most sensitive endpoint gt lt DNEL value gt lt Unit gt Rule 1 as for Inhalation Systemic effects Acute lt Hazard assessment conclusion gt Rule
109. e is not PBT vPvB is selected in source field PBT assessment overall result AND neither field Conclusion on P vP properties not P vP nor Conclusion on B vB properties not BVB nor Conclusion on T properties not T in the endpoint study records of section 2 3 This pertains to all assessed substances i e substance itself constituent and or transformation product Justification lt Justification gt Rule Print paragraph only if the corresponding source field is populated Justification gt gt gt CAUTION Please complete the field Justification in the endpoint summary for IUCLID section 2 3 lt lt lt Rule Print if the corresponding source field is empty and either the conclusion The substance is not PBT vPvB Further information relevant for the PBT assessment is necessary or PBT assessment does not apply in field PBT assessment overall result 8 2 Emission characterisation Rule Print subsection only if The substance is PBT vPvB or The substance is handled as if it were a PBT PVB is selected in source field PBT assessment overall result Operational conditions and risk management measures The operational conditions and risk management measures put in place are reported in the exposure scenarios in section 9 Residual releases The total release and emissions values are reported in section 9 Likely routes by which humans and the environment are exposed lt Likely routes of exposure
110. e quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaini
111. ecsaeeaeeeneeees 117 7 2 4 Toxicity to other terrestrial organisms eee eee ceeecseeceeeseeeeeeeseesecesecesecsaecsaecsaecsaecaeeeseeeneeees 118 7 3 Atmospheric compartment ern a eeo peee ERE N EEK SE T EEE EE eS EESTE E a SEE V Sesay 119 7 4 Microbiological activity in sewage treatment systems ssssssssesseeesrsreesestesrsserrtsrrsteerrsrertesenrrnsesrenresee 119 7 5 Non compartment specific effects relevant for the food chain secondary poisoning 120 TSA Toxicity 10 DIAS 3 8 sop3 355 A ee ee RA RNY eee eS RR aie Ret aie eh 120 25 2 Toxicity to mammals 25 sci ce a E ee AE Sp he ee ee 121 7 6 PNEC derivation and other hazard CONnCIUSIONS sccceseceeseeceseeeesceceeeesneeceeeeeneeceeeeeneeceeeeeneecsues 122 8 PBT AND VPVB ASSESSMENT isisisccdscvessessipsasesaasissesssbeigutsovsaseanep insadsovsdensdaesieuaaessaseaees cages eutssesbdbedsnssessaves gt 124 8 1 Assessment of PBT VPVB Properties 0 0 ccc eececeesseesceescesscesecesecsecsaecaaecaeecseseaeseaeeseeseseseesseeaeeaeseaes 124 8 1 1 PBT VPVB criteria and justification eee eeseecesecesecesecesecesecseecseecseseaeseaeeeeseesseeseesaeeaeenaes 124 8 1 1 n Assessed substance lt Assessed Substance gt eeccessseceseeeesseceeneecseceeneecaeceeneeeaeceeeeecaeeesnees 124 8 1 1 n Assessed substance not specified oo eee ceecesecsecseecseeeseeeeeeeeeeecesseensecsecsaecsaecsaecsaeeaaeeneeees 124 8 1 1 n 1 Persistence asseSSMen
112. ection 7 2 4 Toxicity to other terrestrial organisms Information requirement Toxicity to soil macro organisms except arthropods Toxicity to soil arthropods Tf record in section 6 3 1 6 3 2 Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Note Testing proposals explicitly indicated for non soil dwelling organisms are covered by CSR section 7 2 4 Toxicity to other terrestrial organisms Information requirement Short term toxicity testing on invertebrates Long term toxicity testing on invertebrates Toxicity testing on invertebrates If record in section 6 3 1 or 6 3 2 with Test duration type short term toxicity 6 3 1 or 6 3 2 with Test duration type long term toxicity 6 3 1 or 6 3 2 with Test duration type empty respectively Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Animal group gt Study type lt Study type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion of effects on soil macro organisms except arthropods UCLID source Endpoint summary 6 3 1 Toxicity to soil macroorganisms except arthropods lt Discussion gt The following information is taken into account for effects on soil macro organisms except arthropods for the derivation of PNEC lt Short description of key inform
113. eeaeecsaeeenees 36 4 3 3 Summary and discussion of bioaccumulation esssseessseeeseetseeesesreesrsterrsserreeestenteseentsserrreserreeresrt 37 4 4 Secondaty polsonihg sonani en aie ons A e a EEA EEEE EEA e ESAE E n E Eor e E E 37 5 HUMAN HEALTH HAZARD ASSESSMENT 0 ccsccssccsseesseesseesceeseeeeeesecesecusecuaecuaecaaecsaeeseeeseeseeeseeeeeenseenaes 39 5 1 Toxicokinetics absorption metabolism distribution and elimination sesssesssesssesesessserssressresreeeee 39 5 1 1 Non human tm fOrmatiOm iie eee a Ea AEE E R EEE aaa aE REEE EEA ESETERE 39 5 12 Human NfOrMatiOns e a a a a e AE aa AEE RA LERLE 41 5 1 3 Summary and discussion of toxicokinetics eeesssesssseeseseeeestsrterestteresterrssesreetesrentesrerrsserereresrese 42 S2 Acute TOXICILY a n a et in ne tet ue eA a A 42 5 2 1 Non human informatione nsise ona e a a e e e r 42 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT i EC number lt Chemical name gt lt EC number gt CAS number lt CAS number gt 5 2 1 1 Acute toxicity Oral oo eee cseeeeeeeeeeeeeeeeessecesecsecsaecsaecaeeeaeeees 5 2 1 2 Acute toxicity inhalation eee sees ceseceecssecsseceecseeeaeeees 5 2 1 3 Acute toxicity dermal cece eee ceeeeeeeeeeeeeeeseceseessecseceeeneeeneeees 5 2 1 4 Acute toxicity other routes eee eee eeceeeceeeceecesecssecsseeseeeneeees 5 2 2 Human information 0 eee eseeeeeeeeeeeeeseeeecesecaecaecsaecsaecaeeeneseneeees 5 2 3 Summary and discussion
114. egulation EC No 1272 2008 lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the prompt gt gt gt CAUTION Please complete the corresponding Remark field in IUCLID for this criterion Please note If the substance is not T based on criteria laid down in Annex XIII of REACH then it has to be confirmed that all criteria are fulfilled If data are lacking justify that long term toxicity to marine and freshwater organisms is expected to be gt 0 01 mg L lt lt lt Remarks on Annex XIII criteria T Rule If checkbox 1 is not ticked and at least one of the related Remark fields is populated e ECIO NOEC gt 0 01 mg L for marine freshwater organisms long term toxicity lt Remark gt Rule If the Remark field is populated e Substance is not classified as carcinogenic category I or 2 mutagenic category I or 2 or toxic for reproduction category 1 2 or 3 according to Directive 67 548 EEC or the DSD or carcinogenic category 1A or 1B germ cell mutagenic category 1A or 1B or toxic for reproduction category 1A 1B or 2 according to Regulation EC No 1272 2008 or CLP Regulation see also section 3 Classification and labelling lt Remark gt Rule If the Remark field is populated e No other evidence of chronic toxicity as identified by the classifications T R48 or Xn R48 according to Directive 67 548 EEC or specific target organ toxicity afte
115. er lt CAS number gt REFERENCES At the end of the CSR a list of all references cited is printed 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 133 European Chemicals Agency IUCLID 5 Guidance and Support CSR plug in for IUCLID 5 4 User Manual February 2013 version 4 1 http iuclid eu
116. er screening test lt Test type gt Proposed test guideline lt Guideline gt Test system lt Inoculum or test system gt lt Oxygen conditions gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 4 1 2 1 2 Simulation tests water and sediments IUCLID source section 5 2 2 Biodegradation in water and sediment simulation tests Sort rule in table I Field Inoculum or test system 1 natural water 2 natural water sediment 3 natural sediment II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 29 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The studies on biodegradation in water and sediments simulation tests are summarised in the following table Table 33 Simulation tests for biodegradation in water and sediment Method Results Remarks Reference Test system lt Inoculum or test Half life DTS0 lt Reliability gt lt Author gt lt Year gt system gt lt Oxygen conditions gt lt Halfife gt in lt Purpose flag gt lt Guideline gt lt Compartment gt at lt Study result type gt lt Principles of method if other than lt Temperature gt Test material guideline gt Degradation of tes
117. erences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intras
118. eresrsreesssreersserresrrsrenreseerrsserreeresreeese 5 6 1 1 Repeated dose toxicity oral ssseesseeesseeeseeesrreresreerrsrrrrsserrreresrens 5 6 1 2 Repeated dose toxicity inhalation eseseeseeeeeeseseeesrsrrrrrsrreresesrees 5 6 1 3 Repeated dose toxicity dermal eee eeeesecesecesecssecseeeeeeneeees 5 6 1 4 Repeated dose toxicity other routes 0c ee cece cesecsseeseeeneeeseeees 5 6 2 Human information sss ss eee eeeeeeeeeeeecesecesecesecssecaecsaecsaecaeseneeeneeegs 5 6 3 Summary and discussion of repeated dose toxicity eee eee eee 5 7 Mutagenicity oeieo rea eeri rE EE E E OET EO Eri E 5 7 1 Non human information eee cece cesecesecneeceecseeeeeeeeeeseeeseenseenseenaes STL Ue Vitro ata sets avcssdeitesacs csbassebeetsnes sapesacoeeiined cages sevdasaoees tpeseeteined DF VDI VIVO Cataiees 8 sits vases eeraa ae sap casc nee a rE sales iets pees ceeded 5 7 2 Human Informatio sss ccssccesiesees visas ce erio e ET Ee rE a Eo E Es EE EE erT Erek 5 7 3 Summary and discussion of mutagenicity eseeeseeeseseeesrsreerrserereserreee 5 8 Carcinogenicity ecrini riberes rei rrei a r EE E EEn EEES E ria e ipe issen 5 8 1 Non human information ssessseeseseseseeesesreeesreereresresrsreeresreresserrrnrerreeess 5 8 1 1 Carcinogenicity oralsesisrsoisis iesper vestiri risi e ipiri isens 5 8 1 2 Carcinogenicity inhalation esssssesssseesseeesesreerereseeerrsrrrrsserrreresreee 5 8 1 3 Carcinogenicity
119. ermal Local effects Acute source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspe
120. erspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Inhalation Local effects Acute Dermal Systemic effects Long term Dermal Systemic effects Acute 2013 01 28 CSR PI 5 4 1 DNEL derivation method lt DNEL derivat
121. es lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 10 1 2 Immunotoxicity IUCLID source section 7 9 2 Immunotoxicity Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results of studies on immunotoxicity are summarised in the following table Table 76 Studies on immunotoxicity Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Sex gt based on lt Effect lt Purpose flag gt concentration type gt lt Basis lt Route of administration gt lt Type of for effect level Remarks gt inhalation exposure if applicable gt lt Study result type gt Test material identity See description of rules in introductory part lt Doses concentrations gt lt Basis gt Vehicle lt Vehicle gt Exposure lt Duration of treatment exposure gt lt Frequency of treatment gt Form lt Test material form gt If field is populated lt Guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 82 EC number lt Chemical name gt CAS number lt EC num
122. es differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for
123. ethod if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 7 1 2 In vivo data IUCLID source section 7 6 2 Genetic toxicity in vivo Sort rule in tables I Field Type of genotoxicity 1 gene mutation 2 chromosome aberration 3 DNA damage and or repair 4 genome mutation 5 other or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 67 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt The results of in vivo genotoxicitystudies are summarised in the following table Table 63 In vivo genotoxicity studies lt Species gt lt Strain gt lt Sex gt lt Route of administration gt Doses lt Doses concentrations gt Positive control substance s lt Positive control substance gt Rule Print multiline text field if populated lt Guideline gt lt Principles of method if other than guideline gt lt Interpretation of results gt Genotoxicity lt Genotoxicity gt lt Sex gt toxicity lt Toxicity gt vehicle controls valid lt vehicle controls valid gt negative controls valid lt negative controls valid gt positive controls valid lt positive controls val
124. factor_Type gt lt Bioaccumulation factor gt lt Unit gt lt Basis gt lt Time of plateau lt Time of plateau gt lt Calculation basis gt lt Remarks gt Elimination lt Elimination gt lt Endpoint gt lt Depuration time DT gt Lipid content lt Lipid content gt lt Time point gt gt lt Remarks gt Transformation products lt Metabolites gt lt Reliability gt lt Purpose Flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt Data waiving Information requirement Aquatic bioaccumulation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Aquatic bioaccumulation Proposed test guideline lt Guideline gt Species lt Test organisms species gt Compartment route lt Route of exposure gt lt Water media type gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 4 3 2 Terrestrial bioaccumulation IUCLID source section 5 3 2 Bioaccumulation terrestrial Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information availabl
125. fe is expected to comply with the given criteria lt lt lt e T 2 lt 180 days in marine fresh or estuarine sediment lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Remark field lt lt lt e T1 2 lt 180 days in soil lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Remark field lt lt lt Remarks on Annex XIII criteria P vP Rule If checkbox 4 is not ticked and at least one of the related Remark fields is populated Rule for items listed Each bulleted item is printed if the corresponding Remark field is populated 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 125 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt e T1 2 lt 60 days in marine fresh or estuarine water lt Remark gt e T1 2 lt 180 days in marine fresh or estuarine sediment lt Remark gt e T1 2 lt 180 days in soil lt Remark gt Other evidence of non P non vP properties Rule Print if the corresponding Remark field is populated lt Remark gt Further information is necessary to conclude on the P or vP properties in the context of the PBT assessment Rule Print if the corresponding Remark field is populated lt Remark gt Evidence of P or vP properties Rul
126. fication lt Justification for data waiving gt Testing proposal Information requirement Eye irritation Proposed test guideline lt Guideline gt Type of method lt Type of method gt Species lt Species gt lt Strain gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 3 2 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 50 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table 50 Exposure related observations on eye irritation in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed eye irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpo
127. following summary has been extracted from the endpoint summary of IUCLID section 7 10 Exposure related observations in humans It may be appropriate to manually move or copy relevant part s to the Summary and discussion part of the corresponding CSR chapter s Key information lt Short description of key information gt UCLID source section 7 10 Endpoint summary Exposure related observations in humans Discussion lt Discussion gt UCLID source section 7 10 Endpoint summary Exposure related observations in humans 5 1 1 Non human information No relevant information available Rule Print if applicable The results of studies on absorption metabolism distribution and elimination are summarised in the following table Table 40 Studies on absorption metabolism distribution and elimination Method Results Remarks Reference disregarded study IUCLID source section 7 1 1 Basic toxicokinetics Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 in vitro study Tf field Type of method in vitro lt Species gt lt Strain gt lt Sex gt lt Route of administration gt Exposure regime lt Duration and frequency of treatment Main ADME results lt Type gt lt Text gt Transfer lt Transfer type gt lt Transfer type gt lt Observation gt Test No lt Test No gt Toxicokinetic par
128. for marine invertebrates gt lt Unit gt 7 1 3 Algae and aquatic plants IUCLID source sections 6 1 5 Toxicity to aquatic algae and cyanobacteria 6 1 6 Toxicity to aquatic plants other than algae Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 IC10 EC20 IC20 EC50 or IC50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations I Field Endpoint 1 EC50 or IC50 2 NOEC 3 LOEC 4 EC10 or IC10 5 EC20 or IC20 6 ECO or ICO 7 EC100 or IC100 8 any other II Field Duration Unit 1 96 h 2 4 d 3 72 h 4 3 d 5 48 h 6 2 d 7 24 h 8 I d 9 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 94 Effects on algae and aquatic plants Method Results Remarks Reference IUCLID source section 6 1 5 Toxicity to aquatic algae and cyanobacteria lt Test organisms species gt algae lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt ba
129. form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed acute toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Botn lt lt Teshinatenal form gt If field is populated 5 2 3 Summary and discussion of acute toxicity IUCLID source Endpoint summary 7 2 Acute toxicity lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA Rule Print item if an Effect level is provided and or Endpoint conclusion is populated Acute oral toxicity lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level unit gt e g Acute oral toxicity No adverse effect observed LD50 gt 2000 mg kg bw 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 46 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt or Acute oral toxicity No study available Acute de
130. fter single exposure gt classification gt exposure Repeated dose toxicity lt Repeated dose toxicity gt lt Reason for no 5 6 3 classification gt Irritation Corrosion lt Irritation Corrosion gt lt Reason for no 5 3 4 and 5 4 3 classification gt Sensitisation lt Sensitisation gt lt Reason for no 5 5 3 classification gt Carcinogenicity lt Carcinogenicity gt lt Reason for no 5 8 3 classification gt Mutagenicity Genetic lt Mutagenicity Genetic Toxicity gt lt Reason for no 5 7 3 Toxicity classification gt Toxicity to reproduction lt Toxicity to reproduction fertility gt lt Reason for no 5 9 3 fertility classification gt Toxicity to reproduction lt Toxicity to reproduction lt Reason for no 5 9 3 development development gt classification gt Toxicity to reproduction lt Toxicity to reproduction breastfed lt Reason for no 5 9 3 breastfed babies babies gt classification gt Environment lt Environment gt lt Reason for no 7 6 Justification for non classification can be found in the CSR section indicated Labelling Indication of danger lt Indication of danger gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 22 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt R phrases lt Risk phrases gt S phrases lt Code gt lt Additional text gt Specific concentration limits Concentration Clas
131. he corresponding Remark field is populated lt Remark gt Conclusion on B vB properties lt Conclusion of B vB properties gt Rule Print content of this IUCLID field If not populated print the following warning statement after the prompt gt gt gt CAUTION Please complete the corresponding IUCLID field by selecting the appropriate conclusion for the B assessment lt lt lt lt Remark gt 8 1 1 n 3 Toxicity assessment Rule Print the following default statements depending on the checkboxes ticked i e Checkbox I Not T based on Checkbox 2 Evidence of T properties Screening criteria L E C50 lt 0 01 mg L Checkbox 3 Evidence of T properties other evidence Evidence of non T properties Rule Print subheading if checkbox 1 is ticked and or any related text fields are populated Criteria based on Annex XIII of REACH Rule If checkbox 1 is ticked and or any related text fields are populated Not T based on criteria laid down in Annex XIII of REACH Rule If checkbox 1 is ticked e ECI0 NOEC gt 0 01 mg L for marine freshwater organisms long term toxicity lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the prompt gt gt gt CAUTION Please complete the corresponding Remark field in IUCLID for this criterion Please note If the substance is not T based on criteria laid down in Annex XIII of REACH then it has to be confirmed th
132. heading if checkbox 3 is ticked and any or all related Remark field s are populated in the block Criteria based on Annex XIII of REACH Not P vP based on criteria laid down in Annex XIII of REACH Rule If checkbox 3 is ticked e T1 2 lt 60 days in marine water lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Please complete the corresponding Remark field in IUCLID for this T1 2 criterion Please note If the substance is not P and not vP based on criteria laid down in Annex XIII of REACH then it has to be confirmed that all T1 2 criteria are fulfilled In case no appropriate half life data are available justify that the half life is expected to comply with the given criteria lt lt lt e T1 2 lt 40 days in fresh or estuarine water lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Remark field lt lt lt e T1 2 lt 180 days in marine sediment lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2 criterion gt gt gt CAUTION Remark field lt lt lt e T1 2 lt 120 days in fresh or estuarine sediment lt Remark gt Rule If the Remark field is populated Otherwise print the following warning statement after the T1 2
133. icity after inhalation exposure Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Exp duration gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based lt Route of administration gt lt Type of on lt Effect concentration lt Purpose flag gt inhalation exposure gt type gt lt Remarks gt lt Study result type gt lt Guideline gt Test material identity See lt Principles of method if other than description of rules eageline in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Acute toxicity after inhalation exposure Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 43 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Information requirement Acute toxicity after inhalation exposure Proposed test guideline lt Guideline gt Test type lt Test type gt lt Route of administration gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 2 1 3 Acute toxicity dermal IUCLID source section 7 2 3 Acute toxicity dermal Sort rule in tables I Field Purp
134. id gt Rule Prompts are only printed if the corresponding fields are populated The following phrases are ignored no data not determined not examined not applicable and other lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated Method Results Remarks Reference lt Type of study gt lt Type of Evaluation of results lt Reliability gt lt Author gt lt Year gt genotoxicity gt Data waiving Information requirement In vivo genotoxicity lt Type of study gt lt Route of administration gt lt Type of genotoxicity gt Rule If Type of study is populated Information requirement In vivo genotoxicity lt Type of genotoxicity gt Rule If Type of study is empty Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement In vivo genotoxicity lt Type of study gt lt Route of administration gt lt Type of genotoxicity gt Rule If Type of study is populated Information requirement In vivo genotoxicity lt Type of genotoxicity gt Rule If Type of study is empty Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned s
135. ife stage endpoint studied gt lt Nominal Measured gt lt Study result type gt lt Test type gt based on lt Basis for effect gt Test material lt Guideline gt lt Remarks gt identity See description of rules lt Principles of method if other than in introductory part guideline gt Form lt Test material form gt If field is populated Data waiving Information requirement Long term toxicity testing on fish Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Long term toxicity testing on fish lt Life stage endpoint studied gt Depending on the phrase selected in this IUCLID field one of the following test types is specified early life stage reproduction sub lethal effects or life cycle reproduction sub lethal effects embryo and sac fry stage sub lethal effects juvenile fish growth Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 107 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 1 2 Long term toxicity to fish lt Discu
136. ight of evidence 4 disregarded study Sort rule for multiple Irritation parameter Field Irritation parameter 1 overall irritation score 2 primary dermal irritation index PDIT 3 erythema score 4 edema score 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 53 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt TUCLID source section 7 3 2 Eye irritation Rule Insert if field Interpretation of results corrosive highly corrosive Category 1 or Category re Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Sort rule for multiple Irritation parameter Field Irritation parameter 1 overall irritation score 2 Maximum mean total score MMTS 3 cornea score 4 iris score 5 conjunctivae score 6 chemosis score No relevant information available Rule Print if no relevant endpoint study records i e field Purpose flag being populated are available in the source sections 7 3 1 and 7 3 2 The results of studies on skin and eye irritation related to corrosivity are summarised in the following table Table 52 Studies on skin and eye irritation related to corrosivity in vitro study Tf field Type of method in vitro lt Species gt lt Strain gt Coverage lt Type of coverage gt lt Preparation of test si
137. ility gt lt Author gt lt Year gt lt Media gt lt Type gt lt Value gt at lt Purpose flag gt lt Type of method gt lt Temperature gt lt Unit gt Org lt Study result type gt lt Guideline gt C lt Org carbon gt Test material identity See description of rules in introductory part e lt Remarks gt lt Principles of method if other or Daas Other adsorption coefficients than guideline gt lt Type gt lt Value gt at lt Temperature gt lt Unit gt lt Remarks gt Form lt Test material form gt If field is Mass balance in at end of populated adsorption phase 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 32 EC number lt Chemical name gt lt EC number gt CAS number lt CAS number gt lt adsorption gt after lt Duration gt lt Sample No gt Mass balance in at end of desorption phase lt desorption gt after lt Duration gt lt Sample No gt Transformation products lt Transformation products gt Rule Print if no or not measured Transformation products lt Identity gt Rule Print all transformation products in separate lines Data waiving Information requirement Adsorption desorption Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Adsorption desorption Proposed test guideline lt Guideline gt Study t
138. ils on study design gt Test material identity See description of rules Endpoint addressed in introductory part lt Endpoint addressed gt FotnseTestm terial form gt If field is 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 69 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt populated 5 7 3 Summary and discussion of mutagenicity IUCLID source Endpoint summary 7 6 Genetic toxicity lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA Genetic toxicity lt Endpoint conclusion gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and field Endpoint conclusion contains either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed i
139. inciples of method if other than guideline gt Planned study period lt Study period gt Information requirement Dermal absorption f source is IUCLID section 7 1 2 Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 40 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Planned study period lt Study period gt 5 1 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 41 Exposure related observations on basic toxicokinetics and or dermal absorption in humans Method Results Remarks Reference TUCLID source section 7 10 1 Health surveillance data if Endpoint addressed basic toxicokinetics or dermal absorption Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introdu
140. ing Information requirement short term toxicity study 28 days inhalation sub chronic toxicity study 90 days inhalation lt Test type gt inhalation If lt Test type gt subacute subchronic lt gt subacute or subchronic respectively Information requirement Repeated dose toxicity after inhalation exposure If Test type is empty Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement short term toxicity study 28 days inhalation sub chronic toxicity study 90 days inhalation chronic toxicity study inhalation lt Test type gt inhalation If lt Test type gt subacute subchronic chronic lt gt subacute or subchronic or chronic e g Information requirement sub chronic toxicity study 90 days oral Information requirement Repeated dose toxicity after inhalation exposure If Test type is empty Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 62 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 5 6 1 3 Repeated dose toxicity dermal IUCLID source section 7 5 2 Repeated dose toxicity dermal Sort rule in
141. ing gt Testing proposal Information requirement Carcinogenicity other routes lt Route of administration gt Rule Print if field Route of administration is populated Information requirement Carcinogenicity Route not specified Rule Print if field Route of administration is empty Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 8 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 73 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The exposure related observations in humans are summarised in the following table Table 69 Exposure related observations on carcinogenicity in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed carcinogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 Weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test
142. ing kind of information is available i endpoint summary information ii value from field Physical state of any endpoint study record of IUCLID section 4 1 iii entry in field Data waiving iv experimental study planned in field Study result type CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 5 Physicochemical properties Property Description of key information Value used for CSA Discussion Physical state lt Short description of key information gt Alternative source endpoint study record s if no endpoint summary value is available for Physical state lt Physical state at 20 C and 1013 hPa gt lt Form gt Colour lt Colour gt lt Odour gt source endpoint study record s Value used for CSA lt Physical state at 20 C and 1013 hPa gt at 20 C and 101 3 kPa lt Discussion gt Melting freezing lt Short description of key information gt Value used for CSA point lt Melting freezing point gt lt Unit gt at 101 3 kPa lt Discussion gt Boiling point lt Short description of key information gt Value used for CSA lt Boiling point gt lt Unit gt at 101 3 kPa lt Discussion gt Relative density lt Short description of key information gt Value used for CSA lt Relative density gt at 20 C lt Discussion gt Granulometry lt Short des
143. ing properties gt Reason for no classification lt Reason for no classification gt Inserted if field Reason for no classification is populated AND Status lt gt 67 548 EEC annex 1 Justification for classification or non classification lt Justification for classification or non classification gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 105 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 7 ENVIRONMENTAL HAZARD ASSESSMENT 7 1 Aquatic compartment including sediment lt Discussion gt UCLID source Endpoint summary 6 1 Aquatic toxicity 7 1 1 Fish 7 1 1 1 Short term toxicity to fish IUCLID source section 6 1 1 Short term toxicity to fish Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture according to the following order of priority LC50 96 h 4 d LC50 72 h 3 d LC50 48 h 2 d LC50 24 h 1 d LC50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations I Field Endpoint 1 LC50 2 LCO 3 LC100 4 any other II Field Duration Unit 1 96 h 2 4 d 3 72 h 4 3 d 5 48h 6 2 d 7 24 h 8 I d 9 any other No re
144. int addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed eye irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt pee lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed eye irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt type gt Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is populated IUCLID source se
145. ion can be found in the CSR section indicated Labelling Indication of danger lt Indication of danger gt R phrases lt Risk phrases gt S phrases lt Code gt lt Additional text gt Specific concentration limits Concentration Classification lt Concentration range gt lt Indication of danger symbols gt Notes lt Notes gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 24 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 4 ENVIRONMENTAL FATE PROPERTIES General discussion of environmental fate and pathways lt Discussion gt UCLID source Endpoint summary 5 Environmental fate and pathways 4 1 Degradation 4 1 1 Abiotic degradation 4 1 1 1 Hydrolysis IUCLID source section 5 1 2 Hydrolysis Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if none of the following kind of information is available i any endpoint study record with field Purpose flag being populated ii any record with field Data waiving being populated but Purpose flag being blank iii any record with field Study result type containing experimental study planned The studies on hydrolysis are summarised in the following table Table 28 Studies on hydrolysis than guideline gt
146. ion method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other in
147. iples of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 5 1 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 56 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The exposure related observations in humans are summarised in the following table Table 54 Exposure related observations on skin sensitisation in humans Method Results Remarks Reference IUCLID source section 7 10 4 Sensitisation data humans if Type of sensitisation studied skin Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt Type of population Test material identity See Subjects lt Subjects gt description of rules in introductory part lt Type of population gt Form lt Test material form gt If field is populated TUCLID source section 7 10 1 Health surveillance data if Endpoint addressed skin sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence
148. is populated Criteria based on Annex XIII of REACH Rule If checkbox 2 and or 3 is ticked and or any of the related Remark fields is populated Not B vB based on BCF lt 2000 L kg Rule If checkbox 2 is ticked and the related Remark field is empty Not B vB based on BCF lt 2000 L kg lt Remark gt Rule If checkbox 2 is ticked and the related Remark field is populated Remarks on criterion BCF lt 2000 L kg lt Remark gt Rule If checkbox 2 is not ticked and the related Remark field is populated B but not vB based on 2000 lt BCF lt 5000 L kg Rule If checkbox 3 is ticked and the related Remark field is empty 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 126 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt B but not vB based on 2000 lt BCF lt 5000 L kg lt Remark gt Rule If checkbox 3 is ticked and the related Remark field is populated Remarks on criterion 2000 lt BCF lt 5000 L kg lt Remark gt Rule If checkbox 3 is not ticked and the related Remark field is populated Other evidence of non B non vB properties Rule If the corresponding Remark field is populated lt Remark gt Further information is necessary to conclude on the B or vB properties in the context of the PBT assessment Rule If the corresponding Remark field is populated lt Remark gt Evidence of B or vB properties Rule Print if t
149. ity for reproduction lt Test type gt lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Toxicity to reproduction other studies IUCLID source section 7 8 3 Toxicity to reproduction other studies Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 rabbit 3 guinea pig 4 mouse 5 any other or empty The results of studies on the toxicity to reproduction other studies are summarised in the following table 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 76 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table 71 Studies on the toxicity to reproduction other studies Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Generation gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based o on lt Effect concentration lt Route of administration gt lt Type of type gt lt Basis for effect level lt Study result type gt inhalation exposure if applicable gt lt Test type gt lt Purpose flag gt Remarks gt Test material
150. l entity name gt EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table of Contents Part A A E E E T E A A T E T A T T T I T TT T 1 1 SUMMARY OF RISK MANAGEMENT MEASURES ccscccsscesscessceecuseeseeeseeeseeseeeeeeeseeesecsecnsecnsecaeesaeens 1 2 DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED 0 0 0cccscceseerseereeeeees 1 3 DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED o on 1 Part B scscccsrssrssssrsersessrsessesersessesersessesensessessnseseesenensssensesessesseseesenensessesenseseesensessessnsssesseneessesenessesesseusesessesseseesess 2 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES csccsccesseeseeeteees 2 1 1 Name and other identifiers of the substance eeeceeeeeesseceeeeeceseceeneecsaeceeeeecsaeceeneecaeceeneecsaeceeneeeaeeees 2 1 2 Composition of the SubStance cee eeseceeneessseceseeeesseceeeessaeceeeeeaseceeeeenaeceseesenseceseeeeaeeceeeeeaaeceereeenaeesaes 3 1 3 Physicochemical properties enni a odes levendeyesncvbsasdesaacbon en e ia 3 2 MANUFACTURE AND USES eurn aii e N E E E R A S e Blak ah Il Qo Ve Mamta Ctr ses 525 35 bes gies i eS Sead RE R ee eee sag cee ak Se sass ded nde Sheed bap sta en seen a 11 2 2 Identified USES 25 03 sas evazves cen schcudayese EAE caver te junsa subeeessnseduecn db uetedess levee T EEE adores 13 2 3 AISES advised AS AINSE vie scps8 i deh ete eee SE Se a eee ee coe
151. lassification and labelling according to CLP GHS for physicochemical properties Endpoint Hazard category Hazard statement Reason for no CSR classification section Explosives lt category gt lt hazardStatement gt lt reasonForNoClassif 6 1 ication gt Flammable gases lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 ication gt Flammable lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 aerosols ication gt Oxidising gases lt category gt lt hazardStatement gt lt reasonForNoClassif 6 3 ication gt Gases under lt category gt lt hazardStatement gt lt reasonForNoClassif pressure ication gt Flammable lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 liquids ication gt Flammable lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 solids ication gt Self reactive lt category gt lt hazardStatement gt lt reasonForNoClassif substances and ication gt mixtures Pyrophoric lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 liquids ication gt Pyrophoric lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 solids ication gt CHEMICAL SAFETY REPORT 2013 01 28 CSR PI 5 4 1 17 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Self heating lt category gt lt haza
152. lation exposure lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 8 1 3 Carcinogenicity dermal IUCLID source section 7 7 Carcinogenicity if field Route of administration dermal Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Effect type 1 carcinogenicity 2 lt gt carcinogenicity No relevant information available Rule Print if applicable The results of studies on carcinogenicity after dermal administration are summarised in the following table Table 67 Studies on carcinogenicity after dermal administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect type gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based on lt Effect concentration type gt lt Basis for effect level lt Doses concentrations gt lt Basis gt Vehicle lt Vehicle gt lt Purpose flag gt lt Study result type gt Exposure lt Duration of treatment
153. ld is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed acute toxicity 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 45 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed acute toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt typs gt Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed ae in introductory part lt Endpoint addressed gt Form lt Test material
154. les in introductory part exposure gt lt Frequency of Form lt Test material treatment gt form gt If field is lt Guideline gt populated lt Principles of method if other than guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 70 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Data waiving Information requirement Carcinogenicity after oral administration Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Carcinogenicity after oral administration lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 8 1 2 Carcinogenicity inhalation IUCLID source section 7 7 Carcinogenicity if field Route of administration inhalation Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IIL Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Effect type 1 carcinogenicity 2 lt gt carcinogenicity No relevant information available Rule Print if applicable The re
155. levant information available Rule Print if applicable The results are summarised in the following table Table 90 Short term effects on fish Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test type gt lt Nominal Measured gt lt Study result type gt lt Guideline gt based on lt Basis for effect gt Test material lt Remarks gt identity See lt Principles of method if other than a description of rules guideline gt ete in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Short term toxicity testing on fish Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Short term toxicity testing on fish Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 106 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Discussion UCLID source Endpoint summary
156. lt CAS number gt If different from lt CAS number EC inventory gt CAS name lt CAS name gt IUPAC name lt IUPAC name gt Description lt Description gt Only if none of the standard identifiers are available Synonyms lt Synonyms gt Only if none of the standard identifiers are available Annex I index number lt Index number gt Source 2 2 DSD DPD General information Molecular formula lt Molecular formula gt Molecular weight range lt RANGE Molecular weight range gt Structural formula Any image included in the field Structural formula is captured and transferred into the CSR template Remarks lt Remarks gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 2 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 1 2 Composition of the substance IUCLID source section 1 2 Composition Name lt Name gt Description lt Brief description gt Degree of purity lt Degree of purity gt Table 2 Constituents Constituent Typical concentration Concentration range Remarks lt Reference substance gt lt Typical concentration lt Concentration range gt lt Remarks gt EC no lt EC number gt qualifier gt lt Typical concentration value gt lt Typical concentration unit gt Table 3 Impurities Impurity Typical concentration Concentration range Remarks lt Reference substance gt EC no lt EC number gt lt Typical con
157. lt Doses concentrations gt lt Basis gt identity See Vehicle lt Vehicle gt description of rules in introductory part Exposure lt Duration of treatment exposure gt lt Frequency of Form lt Test material treatment gt form gt If field is opulated lt Guideline gt hove lt Principles of method if other than guideline gt Data waiving Information requirement Toxicity to reproduction other studies lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Toxicity to reproduction other studies lt Route of administration gt lt Type of method gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 9 1 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 72 Exposure related observations on toxicity to reproduction fertility in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed toxicity to repr
158. lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 57 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed skin sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt F r lt Testimatenal form gt If field is populated 5 5 2 Respiratory system 5 5 2 1 Non human information IUCLID source section 7 4 2 Respiratory sensitisation Sort rule in tables Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results of studies on respiratory sensitisation are summarised in
159. lt Remarks gt Test material guideline gt identity See description of rules 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 42 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Acute toxicity after oral administration Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Acute toxicity after oral administration Proposed test guideline lt Guideline gt Test type lt Test type gt lt Route of administration gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 2 1 2 Acute toxicity inhalation IUCLID source section 7 2 2 Acute toxicity inhalation Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IIL Field Species 1 rat 2 lt gt rat Rule for multiple Effect levels Capture only LC50 values or if not available any other No relevant information available Rule Print if applicable The results of studies on acute toxicity after inhalation exposure are summarised in the following table Table 43 Studies on acute tox
160. lts gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed genetic toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt DPE Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt in introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed genetic toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Deta
161. marks gt lt Irritation parameter gt lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt 5 4 2 Human information 5 4 3 Summary and discussion of corrosion The studies with results indicating corrosivity are discussed in section 5 3 4 Summary and discussion of irritation Insert if field Interpretation of results corrosive highly corrosive Category 1 corrosive Category 1A corrosive Category 1B corrosive Category 1C corrosive Category I Category 1 5 5 Sensitisation 5 5 1 Skin 5 5 1 1 Non human information IUCLID source sections 7 3 1 Skin irritation corrosion Sort rule in tables I Field Type of study 1 Mouse local lymphnode assay LLNA 2 lt gt Mouse local lymphnode assay LLNA IIL Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results of studies on skin sensitisation are summarised in the following table 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 55 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 53 Studies on skin sensitisation Method Results Remarks Reference in vitro study Rule If field Type of method in vitro lt Species
162. mary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 5 2 Acute toxicity 5 2 1 Non human information 5 2 1 1 Acute toxicity oral IUCLID source section 7 2 1 Acute toxicity oral Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IIL Field Species 1 rat 2 lt gt rat Rule for multiple Effect levels Capture only LD50 values or if not available any other No relevant information available Rule Print if applicable The results of studies on acute toxicity after oral administration are summarised in the following table Table 42 Studies on acute toxicity after oral administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Route of administration gt lt Sex gt based on lt Effect lt Purpose flag gt lt Guideline gt concentration type gt lt Study result type gt lt Principles of method if other than
163. material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt Jf field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed carcinogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed carcinogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt DPE Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See Endpoint addressed description of rules lt Endpoint addressed gt i
164. mation is taken into account for effects on aquatic plants other than algae for the derivation of PNEC lt Short description of key information gt Value used for CSA EC50 LC50 for freshwater plants lt EC50 LC50 for freshwater plants gt lt Unit gt EC50 LC50 for marine water plants lt EC50 LC50 for marine water plants gt lt Unit gt EC10 LC10 or NOEC for freshwater plants lt EC10 LC10 or NOEC for freshwater plants gt lt Unit gt EC10 LC10 or NOEC for marine water plants lt EC10 LC10 or NOEC for marine water plants gt lt Unit gt 7 1 4 Sediment organisms IUCLID source section 6 2 Sediment toxicity Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 LC10 LD10 EC50 LC50 LD50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 or LC10 or LD10 4 EC50 or LC50 or LD50 5 ECO or LCO or LDO 6 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 95 Effects on sediment organisms Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media ty
165. method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion JUCLID source Endpoint summary 6 3 5 Toxicity to birds lt Discussion gt The following information is taken into account for effects on birds for the derivation of PNEC lt Short description of key information gt Value used for CSA Short term EC50 or LCS0 for birds lt Short term EC50 or LC50 for birds gt lt Unit gt Long term EC10 LC10 or NOEC for birds lt Long term EC10 LC10 or NOEC for birds gt lt Unit gt 7 5 2 Toxicity to mammals IUCLID source section 6 3 6 Toxicity to other above ground organisms Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 Weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results are summarised in the following table Table 103 Effects on mammals Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Study type gt lt Effect conc gt lt Conc lt Purpose flag gt cee based on gt lt Guideline gt lt Nominal Measured gt lt Study result type gt lt Principles of method if other than based on lt Basis for effect gt Test material guideline gt lt Remarks gt identity See description of rules in introductory part Form l
166. methods gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt Data waiving Information requirement Volatilisation Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Volatilisation Proposed test guideline lt Guideline gt Details on methods lt Details on methods gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion JUCLID source Endpoint summary 5 4 2 Henry s Law constant lt Discussion gt The following information is taken into account for any environmental exposure assessment lt Short description of key information gt Value used for CSA Henry s law constant H lt Henry s law constant H gt in Pa m3 mol or dimensionless at lt Temperature gt lt Unit gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 34 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 4 2 3 Distribution modelling IUCLID source section 5 4 3 Distribution modelling Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study
167. mical name gt CAS number lt EC number gt lt CAS number gt Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed skin irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 Weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt type gt Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed iver in introductory part lt Endpoint addressed gt Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed skin irritation corrosion Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint
168. n 4 1 2 1 Biodegradation in water 4 1 2 1 1 Screening tests IUCLID source section 5 2 1 Biodegradation in water screening tests Sort rule in table I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Oxygen conditions 1 aerobic 2 anaerobic No relevant information available Rule Print if applicable The studies on biodegradation in water screening tests are summarised in the following table Table 32 Screening tests for biodegradation in water Method Results Remarks Reference Test type lt Test type gt lt Interpretation of results gt lt Reliability gt lt Author gt lt Year gt lt Inoculum or test system gt Degradation of test lt Purpose flag gt lt Oxygen conditions gt If Oxygen substance lt Study result type gt conamons is anaerobic and lt Degradation of test __ Test material Inoculum lt gt anaerobic substance gt after lt Sampling identity See lt Guideline gt ae a ro description of rules lt Remarks gt n lt Principles of method if other than in introductory part guideline gt Form lt Test material form gt If field is populated Data waiving Information requirement Biodegradation in water screening test Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Biodegradation in wat
169. n is populated e Inhalation Systemic effects Long term lt Justification for route to route extrapolation gt Rule Print bulleted paragraph if source field is populated for this route type of effects e cont d for each route type of effects Discussion Rule Print if the source field is populated lt General population Discussion gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 101 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 6 HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES 6 1 Explosivity IUCLID source section 4 14 Explosiveness Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The available information on explosivity is summarised in the following table Table 86 Information on explosivity Method Results Remarks Reference lt Guideline gt Evaluation of results lt Interpretation of lt Reliability gt lt Author gt lt Year gt lt Principles of method Fesults gt if other than guideline gt Study results lt Purpose flag gt lt Study result type gt Explosive under influence of flame Test material lt Explosive under influence of flame gt identity See More sensitive to shock than m description of rules dinitrobenzene lt More sensitive to shock in introductory p
170. n introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed carcinogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Details on study design gt Test material identity See description of rules Endpoint addressed in introductory part lt Endpoint addressed gt FotnseTestm terial form gt If field is 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 74 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt populated 5 8 3 Summary and discussion of carcinogenicity IUCLID source Endpoint summary 7 7 Carcinogenicity lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA route oral lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Value used for CSA route dermal lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt
171. n the Endpoint summary 7 10 5 8 Carcinogenicity 5 8 1 Non human information 5 8 1 1 Carcinogenicity oral IUCLID source section 7 7 Carcinogenicity if field Route of administration oral Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Effect type 1 carcinogenicity 2 lt gt carcinogenicity No relevant information available Rule Print if applicable The results of studies on carcinogenicity after oral administration are summarised in the following table Table 65 Studies on carcinogenicity after oral administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect type gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based on lt Effect concentration type gt lt Basis for effect level lt Study result type gt Remarks gt Test material lt Doses concentrations gt lt Basis gt identity See Neoplastic effects Vehicle lt Vehicle gt lt Histopathology neoplastic gt Exposure lt Duration of treatment lt Route of administration gt If oral but lt gt oral unspecified lt Purpose flag gt description of ru
172. ne gt Principles of method if other than guideline lt Principles of method if other than guideline gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 8 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Explosive properties Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Oxidising properties Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Oxidation reduction potential Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt lt Any other information on materials and methods incl tables gt Planned study period lt Study period gt Information requirement Stability in organic solvents and identity of relevant degradation products Proposed test guideline lt Guideline gt Principles of method if other than guideline
173. ng on plants lt specify Short Long term gt toxicity testing on plants If Test duration type short term toxicity long term toxicity empty respectively Proposed test guideline lt Guideline gt lt Test organisms species gt lt Plant group gt Study type lt Study type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion lt Discussion gt The following information is taken into account for toxicity on terrestrial plants for the derivation of PNEC lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 116 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Value used for CSA Short term EC50 or LC50 for terrestrial plants lt Short term EC50 or LC50 for terrestrial plants gt lt Unit gt Long term EC10 LC10 or NOEC for terrestrial plants lt Long term EC10 LC10 or NOEC for terrestrial plants gt lt Unit gt 7 2 3 Toxicity to soil micro organisms IUCLID source section 6 3 4 Toxicity to soil microorganisms Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 EC10 3 EC25 4 EC50 5 EC100 6 any other No relevant information available
174. ng uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt CHEMICAL SAFETY REPORT 100 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Oral Systemic effects Acute DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt Justification for route to route extrapolation Rule Print only if at least one source field Justification for route to route extrapolatio
175. no classification gt Classification according to DSD DPD Classification status lt Status gt lt Name gt TUCLID source section 2 2 DSD DPD Condition lt Status gt lt Reference substance name gt is inserted if lt Name gt not available lt Flammability gt Reason for no classification lt Reason for no classification gt Inserted if field Reason for no classification is populated AND Status lt gt 67 548 EEC annex 1 Justification for classification or non classification lt Justification for classification or non classification gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 104 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 6 3 Oxidising potential IUCLID source section 4 15 Oxidising properties Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The available information on the oxidising potential is summarised in the following table Table 89 Information on oxidising potential Method Results Remarks Reference Contact with lt Contact Evaluation of results lt Interpretation of lt Reliability gt lt Author gt lt Year gt with gt lt Duration of results gt lt Purpose flag gt test contact time gt lt Test result result gt lt Test result range gt ee lt Study resul
176. oduct Category used gt Substance supplied to that use mirber e Technical function of the substance lt Substance supplied to that lt Identified use name gt lt Technical function of the substance gt use in form of gt Rule Print multiple items in separate lines Subsequent service life relevant for that use lt Subsequent service life relevant for that use gt Link to the subsequent service life lt Link to the subsequent service life gt Rule Print multiple items in separate lines Remarks lt Remarks gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 14 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table 14 Article service life IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repeatable block Article service life Identifiers Use descriptors Rule Print multiple items in Other information separate lines Confidential Rule e Article category related to subsequent Article used by Print if Confidentiality service life AC lt Article used by gt Rule flag CBI lt Article category related to subsequent service Print multiple items in SL lt Service life life gt separate lines number gt e Exposure related description of article Tonnage of substance for that lt Service life name gt lt Exposure related description of article gt use lt Tonnage of substance gt e Environmental Release Categ
177. oduction fertility Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Type of population gt lt Purpose flag gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 77 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed toxicity to reproduction fertility Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed
178. of acute tOXICILY eee cece eeeeeeceeeceseeeeesseenees Ds SUPA ON eaten eed isey eel Set Soe A VE GR AS eR AAA S J32 BYE Ys erie St aie alah cy ee ek eee ee Ate Senta ee an 5 3 2 1 Non human information cccccccccccccecsceescsceceeeeeeseeesessseueseseeeseeenees 5 3 2 2 Human information eri essei ne ee se oa EE 5 33 Respitatory Tatt crnci eneon do er EE e o EK Eea oeo EEC E 5 3 3 1 Non human information esesesesesesesesesesesesesereseresersrerererererererererere 5 3 3 2 Human information neiise enue oa oe e a Eso eases 5 3 4 Summary and discussion of irritation ss esseeseseeeseeesesreesrseeerrserrreserreese DAs 0 a KORI NA I D AE S E E EEEE E E A E E 5 4 1 Non human information cccccccccccccccccccccccccccccccccececececececevecesscesesevevees 5 4 2 Human information cccccccccccccccccccccccccccccccccccecccecscececececececevecsvecscevevevees 5 4 3 Summary and discussion Of COLrOSION eeeeeseeeseceeecseeeeeceeeneeeneeees SO Sensit safio cies 26s cods ce oe odk a e e aee a Badseceode cove colecsvbecdscovbeotatenss 5 5 2 Respitatory Syste Mi eni e a R E a eva tehaeeees 5 5 2 1 Non human information eseseesseesesreesesreereserrreresreeresrerrsserrreresreet 3 3 22 Human informato i ie a E artes iete 5 5 3 Summary and discussion of sensitisation e seeseeeeeseeesesererserrrreserreeee 3 6 Repeated dose toxicity rarene en E 5 6 1 Non human information sssessessessees
179. on lt Sensitisation gt KreasonForNoClassifi 5 5 3 cation gt Carcinogenicity lt Carcinogenicity gt KreasonForNoClassifi 5 8 3 cation gt Mutagenicity Genetic lt Mutagenicity Genetic Toxicity gt KreasonForNoClassifi 5 7 3 Toxicity cation gt Toxicity to reproduction lt Toxicity to reproduction fertility gt lt reasonForNoClassifi 5 9 3 fertility cation gt Toxicity to reproduction lt Toxicity to reproduction development gt lt reasonForNoClassifi 5 9 3 development cation gt Toxicity to reproduction lt Toxicity to reproduction breastfed babies gt lt reasonForNoClassifi 5 9 3 breastfed babies cation gt Justification for non classification can be found in the CSR section indicated Table 25 Classification and labelling in Annex I of Directive 67 548 EEC for the environment Endpoint Classification Reason for no CSR classification section Environment lt Environment gt lt reasonForNoClassifi 7 6 cation gt Justification for non classification can be found in the CSR section indicated Labelling Indication of danger lt Indication of danger gt R phrases lt Risk phrases gt S phrases lt Code gt lt Additional text gt Specific concentration limits Concentration Classification lt Concentration range gt lt Indication of danger symbols gt Notes 2013 01 28 CSR PI 5 4 1 CHEMICAL
180. on fields is populated Table 23 Classification and labelling in Annex I of Directive 67 548 EEC for physicochemical properties Endpoint Classification Reason for no CSR classification section IExplosiveness lt Explosiveness gt KreasonForNoClassifi 6 1 cation gt Oxidising properties lt Oxidising properties gt KreasonForNoClassifi 6 2 cation gt Flammability lt Flammability gt KreasonForNoClassifi 6 3 cation gt Thermal stability lt Thermal stability gt KreasonForNoClassifi cation gt Justification for non classification can be found in the CSR section indicated 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 20 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 24 Classification and labelling in Annex I of Directive 67 548 EEC for health hazards Endpoint Classification Reason for no CSR classification section Acute toxicity lt Acute toxicity gt KreasonForNoClassifi 5 2 3 cation gt Acute toxicity irreversible lt Acute toxicity irreversible damage after KreasonForNoClassifi 5 2 3 damage after single single exposure gt cation gt exposure Repeated dose toxicity lt Repeated dose toxicity gt lt reasonForNoClassifi 5 6 3 cation gt Irritation Corrosion lt Irritation Corrosion gt KreasonForNoClassifi 5 3 4 and cation gt 5 4 3 Sensitisati
181. on gt lt Effect level gt lt Value gt lt Unit gt lt Test type gt lt Species gt Reference to selected study see footnotes for justification lt Author gt lt Year gt see section 5 6 1 3 lt Author gt lt Year gt see section 5 6 1 3 lt Author gt lt Year gt see section 5 6 1 2 lt Author gt lt Year gt see section 5 6 1 2 lt Author gt lt Year gt see section 5 7 1 15 1 2 see section 5 7 1 5 7 2 Rule Print if field Endpoint selection is empty but either No adverse effect observed negative or Adverse effect observed positive was entered in Endpoint conclusion Note This is to cover cases where no single endpoint study is identified because the conclusion is based on several studies lt Author gt lt Year gt see section 5 8 1 1 lt Author gt lt Year gt see section 5 8 1 3 lt Author gt lt Year gt see section 5 8 1 2 lt Author gt lt Year gt see section 5 9 1 1 lt Author gt lt Year gt see section 5 9 1 1 90 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt ef ef ah ACLU Isd Ai L Y PE i UIUS J eae inhalation lt Endpoint conclusion gt lt Author gt lt Year gt see section TOXICITY Saves lt Effect level gt lt Value gt lt Unit gt 5 9 1 1 lt Test type gt lt Species gt on fertility Reproductive oral
182. on gt effects lt DNEL value gt lt Unit gt Rule 1 as for 2013 01 28 CSR PI 5 4 1 lt Hazard assessment conclusion gt lt DN M EL value gt lt Unit gt Rule 1 If DNEL or DMEL or other toxicological threshold selected e g DNEL 24 7 mg m lt Hazard assessment conclusion gt Rule 2 If phrase but no DNEL or DMEL or other toxicological threshold selected e g Low hazard no threshold derived gt gt gt CAUTION IUCLID field Hazard assessment conclusion populated with an obsolete value migrated from a previous version lt lt lt Rule 3 Print if any of the values is selected that appear greyed in the corresponding IUCLID picklist e g No data available testing technically not feasible obsolete lt Hazard assessment conclusion gt lt DNEL value gt lt Unit gt Rule 1 If DNEL or other toxicological threshold selected lt Hazard assessment conclusion gt Rule 2 If phrase but no DNEL or other toxicological threshold selected lt Hazard assessment conclusion gt lt DN M EL value gt lt Unit gt Rule 1 as for Systemic effects Long term lt Hazard assessment conclusion gt Rule 2 as for Systemic effects Long term lt Hazard assessment conclusion gt lt DNEL value gt lt Unit gt Rule las for Systemic effects Acute lt Hazard assessment conclusion gt Rule 2 as for Systemic effects Acute lt Hazard assessment conclusion gt lt DN M EL valu
183. orresponding IUCLID endpoint summary but no Effect level is provided lt lt lt if applicable except for Sensitisation and Mutagenicity Rule 5 In 4th column print lt Author gt lt Year gt see section xxx as triggered by the source field Endpoint selection Instead of the record name which is indicated in this field the values for Author and Year are extracted from the referenced endpoint study record if a link is provided In addition a reference to the relevant CSR section is printed but only if a bibliographic reference is provided Please note If the link entered in any field Endpoint selection was deleted in the IUCLID source dataset no reference Author Year can be output This can happen either by intentionally removing the link or removing the related endpoint study record Endpoint Route Dose descriptor or qualitative Reference to selected study see effect characterisation test type footnotes for justification Acute toxicity oral lt Endpoint conclusion gt lt Author gt lt Year gt see section e g 5 2 1 1 No adverse effect observed e g see rules above Smith T E et al 1999 see section lt Effect level gt lt Value gt lt Unit gt 5 2 1 1 e g LD50 20 mg kg bw Acute toxicity dermal lt Endpoint conclusion gt lt Author gt lt Year gt see section lt Effect level gt lt Value gt lt Unit gt 5 2 1 3 Acute toxicity inhalation lt Endpoint conclusion gt lt Autho
184. ory ERC tonnes lt ERC gt Typical concentration of the e Process Category PROC for articles used substance in article lt Typical by workers concentration of the substance lt Process Category for articles used by in article gt workers gt Remarks e Technical function of the substance lt Remarks gt lt Technical function of the substance gt 2 3 Uses advised against IUCLID source section 3 6 Uses advised against No information available Rule Print if none of the specified fields is populated in this section Table 15 Formulation Rules as stated for the corresponding table in the previous section Identifiers Use descriptors Other information Confidential Rule e Environmental Release Category ERC Remarks Print if Confidentiality lt ERC gt lt Remarks gt flag Cee e Process Category PROC F lt Identified use lt Process Category gt mmber e Product Category formulated lt Identified use name gt lt Product Category formulated gt e g e Technical function of the substance during F 2 Formulation of formulation liquid mixtures lt Technical function of the substance during formulation gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 15 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 16 Uses at industrial sites Rules as stated for the corresponding table in the previous section Identifiers Use desc
185. osal Information requirement Effects on algae If record in section 6 1 5 Information requirement Effects on aquatic plants If record in section 6 1 6 Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion Effects on algae cyanobacteria TUCLID source Endpoint summary 6 1 5 Toxicity to aquatic algae and cyanobacteria lt Discussion gt The following information is taken into account for effects on algae cyanobacteria for the derivation of PNEC lt Short description of key information gt Value used for CSA EC50 LC50 for freshwater algae lt EC50 LCS50 for freshwater algae gt lt Unit gt EC50 LC50 for marine water algae lt EC50 LC50 for marine water algae gt lt Unit gt EC10 LC10 or NOEC for freshwater algae lt EC10 LC10 or NOEC for freshwater algae gt lt Unit gt EC10 LC10 or NOEC for marine water algae lt EC10 LC10 or NOEC for marine water algae gt lt Unit gt Effects on aquatic plants other than algae JUCLID source Endpoint summary 6 1 6 Toxicity to aquatic plants other than algae lt Discussion gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 111 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The following infor
186. ose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IIL Field Species 1 rat 2 lt gt rat Rule for multiple Effect levels Capture only LD50 values or if not available any other No relevant information available Rule Print if applicable The results of studies on acute toxicity after dermal administration are summarised in the following table Table 44 Studies on acute toxicity after dermal administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt Coverage lt Type of coverage gt lt Sex gt based on lt Effect lt Purpose flag gt f concentration type gt Vehicle lt Vehicle gt lt Remarks gt lt Study result type gt lt Guideline gt Test material identity See lt Principles of method if other than ae description of rules guideline gt cea in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Acute toxicity after dermal administration Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Acute toxicity after dermal administration Proposed test guideline lt Guideline gt Test type lt Test type gt Type of coverage lt Type of coverage gt Specie
187. other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 4 3 3 Summary and discussion of bioaccumulation lt Discussion gt IUCLID source Endpoint summary 5 3 Bioaccumulation Aquatic bioaccumulation JUCLID source Endpoint summary 5 3 1 Bioaccumulation aquatic sediment lt Discussion gt The following information is taken into account for any hazard risk bioaccumulation assessment lt Short description of key information gt Value used for CSA BCF lt BCF aquatic species gt lt Unit gt Terrestrial bioaccumulation TUCLID source Endpoint summary 5 3 2 Bioaccumulation terrestrial lt Discussion gt The following information is taken into account for any hazard risk bioaccumulation assessment lt Short description of key information gt Value used for CSA BCF lt BCF terrestrial species gt lt Unit gt 4 4 Secondary poisoning Rule If Hazard assessment conclusion No potential for bioaccumulation or No potential to cause toxic effects if accumulated in higher organisms via the food chain the following default statement is inserted 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 37 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Based on the available information there is no indication of a bioaccumulation potential and hence secondary poisoning is not considered relevan
188. outes Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Acute toxicity other routes Proposed test guideline lt Guideline gt Route of administration lt Route of administration gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 2 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 46 Exposure related observations on acute toxicity in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed acute toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Type of population gt lt Purpose flag gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If fie
189. parate rows for each Methods of manufacture of substance Rule 3 Print all Related manufacture values concatenated with the use type i e M and manufacture number Example Related manufacture s Description of manufacturing process M 1 Production of Freetext M 2 Production of M Production of Freetext No information available on production of articles covered by the specified use s Rule Print if none of the specified fields is populated Table 9 Method of production of articles covered by the specified use s IUCLID source section 3 1 Technological process Rule Print if at least one source field Methods of article production is populated Related use s Description of article production process lt Related use gt lt Methods of article production gt Rules as above for Manufacturing process Please note If the link of any related manufacture or use was deleted in the IUCLID source dataset nothing can be output in either of the tables above This can happen either by intentionally removing the link in IUCLID section 3 1 or by pasting IUCLID section 3 1 from the IUCLID clipboard Tip If section 3 5 containing the referenced uses are pasted first followed by section 3 1 the links are kept 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 12 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 2
190. pe gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test duration type gt lt Study type gt lt Nominal Measured gt lt Study result type gt lt Test type gt based on lt Basis for effect gt Test material lt Remarks gt identity See Sediment lt Type of sediment gt ale description of rules lt Guideline gt in introductory part lt Principles of method if other than Form lt Test material guideline gt form gt If field is populated Data waiving Information requirement Effects on sediment organisms Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Effects on sediment organisms Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt lt Study type gt lt Test duration type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 112 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Discussion UCLID source Endpoint summary 6 2 Sediment toxicity lt Discussion gt The following information is taken into account for sediment toxicity for the derivation of PNEC lt Short description of key information gt Value used for
191. pecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt CHEMICAL SAFETY REPORT 98 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Inhalation Local effects Acute Dermal Systemic effects Long term Dermal Systemic effects Acute 2013 01 28 CSR PI 5 4 1 DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspeci
192. pporting study 3 weight of evidence 4 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 86 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt type gt Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed ae in introductory part lt Endpoint addressed gt Form lt Test material form gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed not applicable or empty Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Forme Testmatenal form gt If field is populated 5 10 3 Summary and discussion of other effects Neurotoxicity IUCLID source Endpoint summary 7 9 1 Neurotoxicity lt Discussion gt The following information
193. quirement Effects on aquatic micro organisms Proposed test guideline lt Guideline gt Activated sludge sewage species lt Test organisms species gt lt Water media type gt Test type lt Test type gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 119 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 1 7 Toxicity to microorganisms lt Discussion gt The following information is taken into account for effects on aquatic micro organisms for the derivation of PNEC lt Short description of key information gt Value used for CSA EC50 LC50 for aquatic micro organisms lt EC50 LC50 for aquatic micro organisms gt lt Unit gt EC10 LC10 or NOEC for aquatic micro organisms lt EC10 LC10 or NOEC for aquatic micro organisms gt lt Unit gt 7 5 Non compartment specific effects relevant for the food chain secondary poisoning 7 5 1 Toxicity to birds TUCLID source section 6 3 5 Toxicity to birds Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results are summarised in the following table Table 102 Effects on birds Method Results
194. r gt lt CAS number gt Additional hazard lt Additional hazard statements gt statements Labelling Signal word lt Signal word gt Hazard pictogram lt Hazard pictogram gt Hazard statements lt Hazard statement gt lt Additional text gt Precautionary statements lt Precautionary statement gt lt Additional text gt Additional labelling requirements CLP supplemental hazard statement lt CLP supplemental hazard statement gt Additional text lt Additional text gt lt Additional labelling gt Notes lt Notes gt 3 2 Classification and labelling according to DSD DPD 3 2 1 Classification and labelling in Annex I of Directive 67 548 EEC IUCLID source section 2 2 DSD DPD condition if field Status 67 548 EEC annex 1 No relevant information available Rule Print if none of the fields specified below is populated and the checkbox not classified is not ticked Note This default text is not printed if any field Reason for no classification is populated with the IUCLID default phrase data lacking Chemical name lt Name gt Alternatively Substance lt Reference substance name gt if lt Name gt is blank Related composition lt Related composition gt Classification The substance is not classified Rule Print if the checkbox not classified is selected The substance is classified as follows Rule Print if either of the Classificati
195. r gt lt Year gt see section lt Effect level gt lt Value gt lt Unit gt 5 2 1 2 Irritation skin lt Endpoint conclusion gt lt Author gt lt Year gt see section Corrosivity lt Effect level gt 5 3 1 1 e g highly irritating Irritation eye lt Endpoint conclusion gt lt Author gt lt Year gt see section C opit lt Effect level gt 5 3 2 1 Irritation resp tract lt Endpoint conclusion gt en lt Effect level gt Sensitisation skin lt Endpoint conclusion gt lt Author gt lt Year gt see section 5 5 1 1 Sensitisation resp tract lt Endpoint conclusion gt lt Author gt lt Year gt see section 5 5 2 1 Repeated dose oral lt Endpoint conclusion gt lt Author gt lt Year gt see section toxicity lt Effect level gt lt Value gt lt Unit gt 5 6 1 1 lt Test type gt lt Species gt Target organs lt Target organ gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 89 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Endpoint Repeated dose toxicity Repeated dose toxicity Repeated dose toxicity Repeated dose toxicity Mutagenicity Carcinogenicity Carcinogenicity Carcinogenicity Reproductive toxicity effects on fertility Reproductive toxicity effects on fertility Route dermal systemic effects dermal local effects inhalation systemic effects inhalation local effects
196. r repair 4 genome mutation 5 other or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The results of in vitro genotoxicity studies are summarised in the following table 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 66 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Table 62 In vitro genotoxicity studies lt Species strain gt Met act lt Metabolic activation gt Test concentrations lt Test concentrations gt Positive control substance s lt Positive control substances gt Rule Print multiple values of each available block of fields separated by semi colon lt Guideline gt lt Principles of method if other than guideline gt lt Interpretation of results gt Test results lt Genotoxicity gt for lt Species strain gt lt Test system gt met act lt Metabolic activation gt cytotoxicity lt Cytotoxicity gt vehicle controls valid lt vehicle controls valid gt negative controls valid lt negative controls valid gt positive controls valid lt positive controls valid gt Rule Prompts are only printed if the corresponding fields are populated The following phrases are ignored no data not determined not examined not applicable and other lt Purpose flag gt
197. r repeated exposure STOT RE category I or 2 according to Regulation EC No 1272 2008 lt Remark gt Rule If the Remark field is populated Other evidence of non T properties Rule If the corresponding Remark field is populated lt Remark gt Further information is necessary to conclude on the T properties in the context of the PBT assessment Rule If the corresponding Remark field is populated lt Remark gt Evidence of T properties Rule Print if checkbox 2 and or 3 are ticked and or the corresponding Remark field is populated Screening criteria L E C50 lt 0 01 mg L fulfilled Rule Print if checkbox 2 is ticked Other evidence Rule Print if checkbox 3 is ticked Remark lt Remark gt Rule Print if Remark field is populated Conclusion on T properties lt Conclusion on T properties gt Rule Print content of this IUCLID field If not populated print the following warning statement after the prompt gt gt gt CAUTION Please select from the pick list the appropriate conclusion for the T assessment lt lt lt lt Remark gt 8 1 2 Summary and overall conclusions on PBT or vPvB properties IUCLID source endpoint summary 2 3 PBT assessment unless otherwise stated Overall conclusion Based on the assessment described in the subsections above the submission substance is not a PBT vPvB substance Rule If The substance is not PBT vPvB is selected in source field PBT assessment overall
198. rameter gt lt Value gt lt Unit gt lt Purpose flag gt guideline gt lt Remarks gt lt Study result lt Estimation method if used gt Half life DT50 type gt Data waiving Information requirement Phototransformation in air Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Phototransformation in air Proposed test guideline lt Guideline gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 1 1 Phototransformation in air lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 26 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Value used for CSA Half life in air lt Half life in air gt lt Unit gt Degradation rate constant with OH radicals lt Degradation rate constant with OH radicals gt lt Unit gt 4 1 1 2 2 Phototransformation in water IUCLID source section 5 1 3 Phototransformation in water Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule
199. rce section 7 10 2 Epidemiological data if Endpoint addressed developmental toxicity teratogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 79 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated TUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed developmental toxicity teratogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt ORS Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed ma in introductory part lt Endpoint addressed gt Form lt Test material fo
200. rdStatement gt lt reasonForNoClassif substances and ication gt mixtures Substances and lt category gt lt hazardStatement gt lt reasonForNoClassif 6 2 mixtures which in ication gt contact with water emit flammable gases Oxidising liquids lt category gt lt hazardStatement gt lt reasonForNoClassif 6 3 ication gt Oxidising solids lt category gt lt hazardStatement gt lt reasonForNoClassif 6 3 ication gt Organic lt category gt lt hazardStatement gt lt reasonForNoClassif peroxides ication gt Corrosive to lt category gt lt hazardStatement gt lt reasonForNoClassif metals ication gt Justification for non classification can be found in the CSR section indicated Table 20 Classification and labelling according to CLP GHS for health hazards Endpoint Hazard category Hazard statement Reason for no CSR classification section Acute toxicity lt category gt lt hazardStatement gt lt reasonForNoClassif 5 2 3 oral ication gt Acute toxicity lt category gt lt hazardStatement gt lt reasonForNoClassif 5 2 3 dermal ication gt Acute toxicity lt category gt lt hazardStatement gt lt reasonForNoClassif 5 2 3 inhalation ication gt Skin corrosion lt category gt lt hazardStatement gt lt reasonForNoClassif 5 3 4 and irritation ication gt 5 4 3 Serious damage lt category gt lt hazardStatement gt lt reason
201. result Based on the assessment described in the subsections above the submission substance is a PBT vPvB substance Rule If The substance is PBT vPvB is selected in source field PBT assessment overall result 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 128 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The submission substance is handled as if it were a PBT vPvB substance Rule If The substance is handled as if it were a PBT VPVB is selected in source field PBT assessment overall result PBT assessment does not apply Rule If PBT assessment does not apply is selected in source field PBT assessment overall result Further information relevant for the PBT assessment is necessary Rule If Further information relevant for the PBT assessment is necessary is selected in source field PBT assessment overall result gt gt gt CAUTION Please complete the field PBT assessment overall result in the endpoint summary for IUCLID section 2 3 by selecting the appropriate conclusion from the picklist lt lt lt Rule If source field PBT assessment overall result is empty gt gt gt CAUTION Check if the overall conclusion non PBT non vPvB is consistent with the PBT criteria given in IUCLID section 2 3 Not all fields Conclusion on P vP or B vB or T properties indicate not P vP not B vB and not T respectively lt lt lt Rule Print if The substanc
202. riptors Other information Confidential Rule Print if Confidentiality flag CBI IW lt Identified use number gt lt Identified use name gt e Environmental Release Category ERC lt ERC gt e Process Category PROC lt Process Category gt e Product Category used lt Product Category used gt e Sector of end use lt Sector of end use gt e Technical function of the substance lt Technical function of the substance gt Remarks lt Remarks gt Table 17 Uses by professional workers Rules as stated for the corresponding table in the previous section Identifiers Use descriptors Other information Confidential Rule Print if Confidentiality flag CBI PW lt Identified use number gt lt Identified use name gt e Environmental Release Category ERC lt ERC gt e Process Category PROC lt Process Category gt e Product Category used lt Product Category used gt e Sector of end use lt Sector of end use gt e Technical function of the substance lt Technical function of the substance gt Remarks lt Remarks gt Table 18 Consumer uses Rules as stated for the corresponding table in the previous section Identifiers Use descriptors Other information Confidential Rule Print if Confidentiality flag CBI C lt Identified use number gt lt Identified use name gt e Environmental Release Catego
203. rm gt If field is populated IUCLID source section 7 10 5 Exposure related observations in humans if Endpoint addressed developmental toxicity teratogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study Test material design lt Details on identity See study design gt description of rules Endpoint addressed in introductory part lt Endpoint addressed gt Potne2 Test material form gt Jf field is populated 5 9 3 Summary and discussion of reproductive toxicity IUCLID source Endpoint summary 7 8 Toxicity to reproduction Effects on fertility lt Effects on fertility Discussion gt The following information is taken into account for any hazard risk assessment lt Effects on fertility Short description of key information gt Value used for CSA route oral lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route dermal lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Value used for CSA route inhalation 2013 01 28 CSR PI 5 4 1 CHEMICA
204. rm gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed respiratory sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 3 Direct observations clinical cases poisoning incidents and other if Endpoint addressed respiratory sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results of examinations gt lt Reliability gt lt Author gt lt Year gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 59 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Ree Outcome of incidence lt Outcome of lt Purpose flag gt lt Type of population gt incidence gt Test material Subjects lt Subjects gt identity See description of rules Endpoint addressed Bg in introductory part lt Endpoint addressed gt
205. rmal toxicity lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level unit gt Acute inhalation toxicity lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level unit gt Justification for classification or non classification Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 5 3 Irritation 5 3 1 Skin 5 3 1 1 Non human information IUCLID source section 7 3 1 Skin irritation corrosion Rule Insert if field Interpretation of results lt gt corrosive highly corrosive Category I corrosive Category 1A corrosive Category 1B corrosive Category 1C corrosive Category 1 Sort rule in tables Field Purpose flag 1 key study 2
206. ry ERC lt ERC gt e Product Category used lt Product Category used gt e Technical function of the substance lt Technical function of the substance gt Remarks lt Remarks gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 16 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 3 CLASSIFICATION AND LABELLING 3 1 Classification and labelling according to CLP GHS IUCLID source section 2 1 GHS No relevant information available Rule Print if none of the fields specified below is populated and the checkbox not classified is not ticked Note This default text is not printed if any field Reason for no classification is populated with the IUCLID default phrase data lacking Substance lt Name gt Alternatively Substance lt Reference substance name gt if lt Name gt is blank Implementation lt Implementation gt State form of the substance lt State form of the substance gt Remarks lt Remarks gt Classification The substance is not classified Rule Print if the checkbox not classified is selected The substance is classified as follows Rule Print if either of the Classification fields is populated Rule 2 This also triggers the output of the following table s Rule 3 Print each item row if any of the fields Hazard category Hazard statement Reason for no classification is populated Table 19 C
207. s lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 2 1 4 Acute toxicity other routes IUCLID source section 7 2 4 Acute toxicity other routes Sort rule in table I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study IIL Field Species 1 rat 2 lt gt rat No relevant information available Rule Print if applicable 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 44 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The results of studies on acute toxicity other routes are summarised in the following table Table 45 Studies on acute toxicity other routes Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt o lt Sex gt based on lt Effect lt Purpose flag gt lt Route of administration gt concentration type gt lt Remarks gt lt Study result type gt Test material identity See description of rules lt Guideline gt lt Principles of method if other than guideline gt in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Acute toxicity other r
208. sed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 56 Exposure related observations on respiratory sensitisation in humans Method Results Remarks Reference IUCLID source section 7 10 4 Sensitisation data humans if Type of sensitisation studied respiratory Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt Type of population Test material lt Type of population gt identity See Subjects lt Subjects gt description of rules in introductory part Form lt Test material form gt If field is populated IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed respiratory sensitisation Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt fo
209. sed on gt lt Test type gt lt Nominal Measured gt lt Study result type gt lt Guideline gt based on lt Basis for effect gt Test material lt Remarks gt identity See lt Principles of method if other than guideline gt description of rules in introductory part Form lt Test material form gt If field is populated 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 110 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt IUCLID source section 6 1 6 Toxicity to aquatic plants other than algae lt Test organisms species gt aquatic lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt plants lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Water media type gt H lt Nominal Measured gt lt Study result type gt lt Test type gt based on lt Basis for effect gt Test material lt Guideline gt lt Remarks gt identity See lt Principles of method if other than description of rules guideline gt in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Growth inhibition study with algae cyanobacteria Growth inhibition study with aquatic plants other than algae If record in section 6 1 5 6 1 6 respectively Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing prop
210. ses by professional workers Identified use Brief description of use process Confidential Rule Print if lt Brief description of use process gt Confidentiality flag CBI lt Identified use number gt lt Identified use name gt Rule Instead of the relevant acronym is printed ie F IW PW e g F 2 Formulation of liquid mixtures 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 130 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 9 EXPOSURE ASSESSMENT AND RELATED RISK CHARACTERISATION Rule This heading is printed if the option Select a Chesar file is choosen in step 2 of the CSR generation process that is both IUCLID and Chesar data are captured In this case the CSR section 9 is generated and filled with Chesar information as described in the Chesar user manual part 4 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 131 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt 10 RISK CHARACTERISATION Rule This heading is printed if the option Select a Chesar file is choosen in step 2 of the CSR generation process that is both IUCLID and Chesar data are captured In this case the CSR section 10 is generated and filled with Chesar information as described in the Chesar user manual part 4 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 132 EC number lt EC number gt lt Chemical name gt CAS numb
211. sification lt Concentration range gt lt Indication of danger symbols gt Notes lt Notes gt 3 2 3 Other classification s IUCLID source section 2 2 DSD DPD condition if field Status other free text or blank No relevant information available Rule Print if none of the fields specified below is populated and the checkbox not classified is not ticked Note This default text is not printed if any field Reason for no classification is populated with the IUCLID default phrase data lacking For technical reasons this default text is not printed if any information captured from IUCLID section 2 2 is included in CSR section 3 2 1 and or 3 2 2 Status lt Status gt Alternatively Status gt gt gt IUCLID field empty lt lt lt if lt Status gt is blank Chemical name lt Name gt Alternatively Substance lt Reference substance name gt if lt Name gt is blank Related composition lt Related composition gt Remarks lt Remarks gt The substance is not classified Rule Print if the checkbox not classified is selected Table 27 lt Status gt Endpoint Classification Reason for no CSR section classification Explosiveness lt Explosiveness gt lt Reason for no 6 1 classification gt Oxidising properties lt Oxidising properties gt lt Reason for no 6 3 classification gt Flammability lt Flammability gt lt Reason for no 6 2 classification gt Thermal stability l
212. ssion gt The following information is taken into account for long term fish toxicity for the derivation of PNEC lt Short description of key information gt Value used for CSA EC10 LC10 or NOEC for freshwater fish lt EC10 LC10 or NOEC for freshwater fish gt lt Unit gt EC10 LC10 or NOEC for marine water fish lt EC10 LC10 or NOEC for marine water fish gt lt Unit gt 7 1 2 Aquatic invertebrates 7 1 2 1 Short term toxicity to aquatic invertebrates IUCLID source section 6 1 3 Short term toxicity to aquatic invertebrates Sort rule in table I Field Water media type 1 freshwater 2 brackish water 3 saltwater 4 no data or empty II Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture according to the following order of priority EC IC LC50 24 h 1 d EC IC LC50 48 h 2 d EC IC LC50 any other if none of these endpoints applies Sort rule for multiple Effect concentrations I Field Endpoint 1 EC50 or IC50 or LC50 2 ECO or ICO or LCO 3 EC100 or LC100 4 any other II Field Duration Unit 1 48 h 2 2 d 3 24 h 4 I d 5 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 92 Short term effects on aquatic invertebrates Method
213. sult type gt lt Guideline gt based on lt Basis for effect gt Test material lt Principles of method if other than lt Remarks gt identity See guideline gt description of rules in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Long term toxicity testing on aquatic invertebrates Reason lt Data waiving gt Justification lt Justification for data waiving gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 109 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Testing proposal Information requirement Long term toxicity testing on aquatic invertebrates Proposed test guideline lt Guideline gt Species lt Test organisms species gt lt Water media type gt Test type lt Test type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion JUCLID source Endpoint summary 6 1 4 Long term toxicity to aquatic invertebrates lt Discussion gt The following information is taken into account for long term toxicity to aquatic invertebrates for the derivation of PNEC lt Short description of key information gt Value used for CSA EC10 LC10 or NOEC for freshwater invertebrates lt EC10 LC10 or NOEC for freshwater invertebrates gt lt Unit gt EC10 LC10 or NOEC for marine invertebrates lt EC10 LC10 or NOEC
214. sults of studies on carcinogenicity after inhalation exposure are summarised in the following table Table 66 Studies on carcinogenicity after inhalation exposure Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect type gt lt Reliability gt lt Author gt lt Year gt lt Effect level gt lt Sex gt based on lt Effect concentration type gt lt Basis for effect level lt Study result type gt j Remarks gt Test material lt Doses concentrations gt lt Basis gt identity See i Neoplastic effects Vehicle lt Vehicle gt lt Histopathology neoplastic gt Exposure lt Duration of treatment exposure gt lt Frequency of Form lt Test material treatment gt form gt Jf field is populated lt Route of administration gt lt Type of inhalation exposure if applicable gt lt Route of administration gt lt Purpose flag gt description of rules in introductory part lt Guideline gt lt Principles of method if other than guideline gt Data waiving Information requirement Carcinogenicity after inhalation exposure Reason lt Data waiving gt Justification lt Justification for data waiving gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 71 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Testing proposal Information requirement Carcinogenicity after inha
215. t sceeececsseceececsseceeneecsccesneecaeceeaeecsaeeeeaeecsaeeeeneecsaeeeeaeecaeeeeeeeces 124 8 1 1 n 2 Bioaccumulation assessment eceeeeceseceeececeeceeceeceseceeaeecsaeceeneecsaeeeeeeecsaeeeeaeesaeeeeeeee 126 8 1 1 11 3 Toxicity assessment sanen in epee ee e ne e rete EEEa N eK E roate t eest 127 8 1 2 Summary and overall conclusions on PBT or vPvB properties eseseesseeeseseseeeresreersererenseseeeresee 128 8 2 Emission characterisation snese E E E R EE i E eaa ieaS 129 9 EXPOSURE ASSESSMENT issiria vessizsasesivsedeesvsbsignviessacesscpsasaat oo tdeasecbsasestessacisechoagssivetdsaseebcisesoessavesss 130 9 EXPOSURE ASSESSMENT AND RELATED RISK CHARACTERISATION 1 1 ccsscsssesseeeseeessesseeseeaes 131 10 RISK CHARACTERISATION rrien cosuhad a R podsag sbgovevede vase sueedenvecd e a 132 REFERENCES scccsssssssssssessessssessessssesscssssessessssessessssessessssessessssessassssesscssssessessssessesessessesessessesessessessssessesers 133 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT iii EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Part A 1 SUMMARY OF RISK MANAGEMENT MEASURES 2 DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED 3 DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Part B 1 IDENTIT
216. t 5 6 Repeated dose toxicity 5 6 1 Non human information 5 6 1 1 Repeated dose toxicity oral IUCLID source section 7 5 1 Repeated dose toxicity oral Sort rule in tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 mouse 3 dog 4 lt gt rat or mouse or dog Sort rule for multiple Effect levels Field Endpoint 1 no NOAEL identified 2 NOAEL 3 NOEL 4 LOAEL 5 LOEL 6 BMDO5 7 BMD10 8 BMD 9 any other or empty No relevant information available Rule Print if applicable The results of studies are summarised in the following table Table 57 Studies on repeated dose toxicity after oral administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Route of lt Sex gt based on lt Effect lt Purpose flag gt administration gt concentration type gt lt Basis lt Study result type gt i for effect level Remarks gt lt Doses concentrations gt Test material Vehicle lt Vehicle gt identity See Exposure lt Duration of treatment description of rules exposure gt lt Frequency of in introductory part treatment gt Form lt Test material lt Guideline gt form gt
217. t 3 guinea pig 4 mouse 5 any other or empty No relevant information available Rule Print if applicable The results of studies on fertility are summarised in the following table 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 75 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table 70 Studies on fertility Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Generation gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Effect level gt lt Sex gt based lt Purpose flag gt on lt Effect concentration lt Route of administration gt lt Type of type gt lt Basis for effect level inhalation exposure if applicable gt lt Study result type gt Remarks gt Test material lt Doses concentrations gt lt Basis gt identity See Vehicle lt Vehicle gt description of rules i in introductory part Exposure lt Duration of treatment exposure gt lt Frequency of treatment gt Form lt Test material form gt If field is opulated lt Guideline gt oe lt Principles of method if other than guideline gt Data waiving Information requirement Toxicity for reproduction fertility lt Route of administration gt Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Toxic
218. t lt Strain gt lt Sex gt Coverage dermal absorption study lt Type of coverage gt lt Duration of exposure gt Doses conc lt Doses concentrations gt lt Details on in vitro test system if applicable gt lt Guideline gt lt Principles of method if other than guideline gt lt Absorption in different matrices gt Total recovery lt Total recovery gt Percutaneous absorption rate lt Absorption gt at lt Time point gt lt Dose gt lt Remarks gt lt Reliability gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated lt Author gt lt Year gt Data waiving Information requirement Basic toxicokinetics If source is IUCLID section 7 1 1 Reason lt Data waiving gt Justification lt Justification for data waiving gt Information requirement Dermal absorption If source is IUCLID section 7 1 2 Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Basic toxicokinetics If source is IUCLID section 7 1 1 Proposed test guideline lt Guideline gt Type of method lt Type of method gt Route of administration lt Route of administration gt Species lt Species gt lt Strain gt lt Sex gt Principles of method if other than guideline lt Pr
219. t see CSR chapter 7 6 PNEC derivation and other hazard conclusions Rule If Hazard assessment conclusion No or insufficient data available at present or No data available testing technically not feasible or blank the following default statement is inserted Based on the available information the bioaccumulation potential cannot be judged see CSR chapter 7 6 PNEC derivation and other hazard conclusions Rule If a PNEC oral is provided the following default statements are inserted The hazard assessment conclusion for secondary poisoning PNECoral is lt PNEC oral gt lt Unit gt see CSR chapter 7 6 PNEC derivation and other hazard conclusions Interpretation of the available data with regard to the potential to bio accumulate in the food chain gt gt gt NOTE please delete this instruction As appropriate enter relevant information manually lt lt lt lt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 38 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 5 HUMAN HEALTH HAZARD ASSESSMENT 5 1 Toxicokinetics absorption metabolism distribution and elimination Summary and discussion of human information Rule This subheading and the pieces of information below are only printed if Short description of key information and or Discussion are populated in IUCLID source section 7 10 Endpoint summary Exposure related observations in humans Note The
220. t Test material form gt If field is populated Data waiving Information requirement Effects on other above ground organisms mammals Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Effects on other above ground organisms mammals Proposed test guideline lt Guideline gt Species lt Test organisms species gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 121 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Study type lt Study type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 6 3 6 Toxicity to other above ground organisms lt Discussion gt The following information is taken into account for effects on mammals for the derivation of PNEC lt Short description of key information gt Value used for CSA Short term EC50 or LC50 for mammals lt Short term EC50 or LC50 for mammals gt lt Unit gt Value used for CSA Long term EC10 LC10 or NOEC for mammals lt Long term EC10 LC10 or NOEC for mammals gt lt Unit gt 7 6 PNEC derivation and other hazard conclusions IUCLID source Endpoint summary 6 Ecotoxicological information Table 104 Hazard assessment conclusion for the environment Compartment Haz
221. t Thermal stability gt lt Reason for no classification gt Acute toxicity lt Acute toxicity gt lt Reason for no 5 2 3 classification gt Acute toxicity irreversible lt Acute toxicity irreversible damage lt Reason for no damage after single after single exposure gt classification gt exposure Repeated dose toxicity lt Repeated dose toxicity gt lt Reason for no 5 6 3 classification gt Irritation Corrosion lt Irritation Corrosion gt lt Reason for no 5 3 4 and 5 4 3 classification gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 23 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Sensitisation lt Sensitisation gt lt Reason for no 5 5 3 classification gt Carcinogenicity lt Carcinogenicity gt lt Reason for no 5 8 3 classification gt Mutagenicity Genetic lt Mutagenicity Genetic Toxicity gt lt Reason for no 5 7 3 Toxicity classification gt Toxicity to reproduction lt Toxicity to reproduction fertility gt lt Reason for no 5 9 3 fertility classification gt Toxicity to reproduction lt Toxicity to reproduction lt Reason for no 5 9 3 development development gt classification gt Toxicity to reproduction lt Toxicity to reproduction breastfed lt Reason for no 5 9 3 breastfed babies babies gt classification gt Environment lt Environment gt lt Reason for no 7 6 classification gt Justification for non classificat
222. t identity See substance description of rules lt Degradation of test in introductory part substance gt after lt Sampling form lt Test material time gt lt Parameter gt form gt If field is lt Remarks gt populated Mineralization rate lt Mineralization rate gt lt Unit gt Transformation products lt Transformation products gt Rule Print if no or not measured Transformation products lt Identity gt Rule Print all transformation products in separate lines Data waiving Information requirement Simulation testing for biodegradation in water and sediment Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information requirement Simulation testing on ultimate degradation in surface water Rule Print if field Inoculum or test system is not natural sediment Information requirement Sediment simulation testing Rule Print of field Inoculum or test system natural sediment Proposed test guideline lt Guideline gt Test system lt Inoculum or test system gt lt Oxygen conditions gt Source and properties of surface water lt Details on source and properties of surface water gt Source and properties of sediment lt Details on source and properties of sediment gt Study design lt Details on study design gt Principles of method if other than guideline lt Principles of method if other than guidelin
223. t type gt lt Guideline gt lt Remarks gt Pe Test material lt Principles of method Remarks identity See if other than guideline gt lt Any other information on results incl description of rules tables gt in introductory part Form lt Test material form gt If field is populated Data waiving see CSR section 1 3 Physicochemical properties Insert if field Data waiving is populated in any record of IUCLID section 4 15 Testing proposal see CSR section 1 3 Physicochemical properties Insert if field Study result type contains experimental study planned in any record of IUCLID section 4 15 Discussion UCLID source Endpoint summary 4 15 Oxidising properties lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Classification according to GHS TUCLID source section 2 1 GHS Name lt Name gt Related composition lt Related composition gt State form of the substance lt Form of the substance gt Classification lt Explosives gt Hazard statement lt Hazard statement gt Reason for no classification lt Reason for no classification gt Classification according to DSD DPD Classification status lt Status gt lt Name gt TUCLID source section 2 2 DSD DPD Condition lt Status gt lt Reference substance name gt is inserted if lt Name gt not available lt Oxidis
224. table block Uses at industrial sites Identifiers Use descriptors Rule Print multiple items in separate lines Other information Confidential Rule Print if Confidentiality flag CBI IW lt Identified use number gt lt Identified use name gt e Environmental Release Category ERC lt ERC gt e Process Category PROC lt Process Category gt e Product Category used lt Product Category used gt e Sector of end use lt Sector of end use gt e Technical function of the substance lt Technical function of the substance gt Tonnage of substance for that use lt Tonnage of substance gt tonnes Number of sites lt Number of sites range gt Substance supplied to that use lt Substance supplied to that use in form of gt Rule Print multiple items in separate lines Subsequent service life relevant for that use lt Subsequent service life relevant for that use gt Link to the subsequent service life lt Link to the subsequent service life gt Rule Print multiple items in separate lines Remarks lt Remarks gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 13 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Table 12 Uses by professional workers IUCLID source section 3 5 Life Cycle description Rule Create a row for each item of the repeatable block Uses by professional workers Identifiers Use
225. tables I Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study II Field Species 1 rat 2 lt gt rat Sort rule for multiple Effect levels Field Endpoint 1 no NOAEL identified 2 NOAEL 3 NOEL 4 LOAEL 5 LOEL 6 BMDO05 7 BMD10 8 BMD 9 any other or empty No relevant information available Rule Print if applicable The results of studies are summarised in the following table Table 59 Studies on repeated dose toxicity after dermal administration Method Results Remarks Reference lt Species gt lt Strain gt lt Sex gt lt Endpoint gt lt Effect level gt lt Reliability gt lt Author gt lt Year gt lt Test type gt lt Sex gt based on lt Effect lt Purpose flag gt concentration type gt lt Basis Conetage SL ype OF coverage for effect level Remarks gt lt Study result type gt lt Doses concentrations gt Test material Vehicle lt Vehicle gt identity See Exposure lt Duration of treatment descr iption of rules exposure gt lt Frequency of in introductory part treatment gt Form lt Test material lt Guideline gt form gt If field is lt Principles of method if other than populated guideline gt Data waiving Information requirement short term toxicity study 28 days dermal sub chronic toxicity study 90 days dermal lt Test type
226. te gt Vehicle lt Vehicle gt lt Guideline gt lt Principles of method if other than guideline gt Overall irritation score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Primary dermal irritation index PDII lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Erythema score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt Edema score lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt lt Irritation parameter gt lt Score gt of max lt Max score gt lt Basis gt Time point lt Time point gt lt Reversibility gt lt Remarks gt lt Purpose flag gt lt Study result type gt Test material identity See description of rules in introductory part Form lt Test material form gt If field is populated Method Results Remarks Reference IUCLID source section 7 3 1 Skin irritation corrosion Tissue studied skin lt Interpretation of results gt lt Reliability gt lt Author gt lt Year gt TUCLID source section 7 3 2 Eye irritation Tissue studied eye in vitro study If field Type of method in vitro lt Species gt lt Strain gt
227. teria and or in the block Criteria based on Annex XII of REACH Screening criteria Rule Print subheading if checkbox 1 and or 2 are ticked and or any Remark field is populated in the block Screening criteria Not P vP based on ready biodegradability Rule If checkbox 1 is ticked and the related Remark field is empty Not P vP based on ready biodegradability lt Remark gt Rule If checkbox 1 is ticked and the related Remark field is populated Remarks on ready biodegradability lt Remark gt Rule If checkbox 1 is not ticked and the related Remark field is populated Not P vP based on other screening test s e g enhanced ready biodegradability inherent biodegradability under valid conditions Rule If checkbox 2 is ticked and the related Remark field is empty Not P vP based on other screening test s e g enhanced ready biodegradability inherent biodegradability under valid conditions lt Remark gt Rule If checkbox 2 is ticked and the related Remark field is populated Remarks on other screening test s e g enhanced ready biodegradability inherent biodegradability under valid conditions lt Remark gt Rule If checkbox 2 is not ticked and the related Remark field is populated 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 124 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Criteria based on Annex XIII of REACH Rule Print sub
228. terspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt AF for other interspecies differences lt AF for other interspecies differences gt AF for intraspecies differences lt AF for intra species differences gt AF for the quality of the whole database lt AF for the quality of the whole database gt AF for remaining uncertainties lt AF for remaining uncertainties gt Overall Assessment Factor lt Overall Assessment Factor gt AF for dose response relationship lt AF for dose response relationship gt lt Justification gt AF for interspecies differences allometric scaling gt AF for interspecies differences CHEMICAL SAFETY REPORT 95 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Dermal Local effects Long term D
229. tion for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 Respiratory sensitisation JUCLID source Endpoint summary 7 4 Sensitisation Respiratory sensitisation lt Respiratory sensitisation Discussion gt The following information is taken into account for any hazard risk assessment lt Respiratory sensitisation Short description of key information gt Value used for CSA lt Endpoint conclusion gt Discussion of human information See Summary and discussion of human information in chapter 5 HUMAN HEALTH HAZARD ASSESSMENT Note As appropriate copy any relevant information from there or delete this default text Rule This subheading and default text are only inserted if at least one endpoint study record is available in the overview table of human information for this endpoint indirect evidence that these studies are discussed in the Endpoint summary 7 10 Justification for classification or non classification TUCLID source Endpoint summary 7 4 Sensitisation 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 60 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt Rule This subheading is not printed if the corresponding source field is empty and all fields Endpoint conclusion contain either No study available or No study available further information necessary lt Justification for classification or non classification g
230. tion requirement Soil simulation testing Proposed test guideline lt Guideline gt Soil type lt Soil type gt Study design lt Details on experimental conditions gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 2 3 Endpoint summary Biodegradation in soil lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt Value used for CSA Half life in soil lt Half life in soil gt lt Unit gt at lt Temperature gt lt Unit gt 4 1 3 Summary and discussion of degradation Abiotic degradation lt Discussion gt UCLID source Endpoint summary 5 1 Stability Biotic degradation lt Discussion gt UCLID source Endpoint summary 5 2 Biodegradation 4 2 Environmental distribution 4 2 1 Adsorption desorption IUCLID source section 5 4 1 Adsorption desorption Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The studies on adsorption desorption are summarised in the following table Table 35 Studies on adsorption desorption Method Results Remarks Reference Study type lt Study type gt Adsorption coefficient lt Reliab
231. tudy period lt Study period gt 5 7 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 68 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt The exposure related observations in humans are summarised in the following table Table 64 Exposure related observations genetic toxicity in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed genetic toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt Jf field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed genetic toxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Resu
232. tudy type lt Study type gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 1 3 Phototransformation in water lt Discussion gt The following information is taken into account for any hazard risk persistency assessment lt Short description of key information gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 27 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt Value used for CSA Half life in water lt Half life in water gt lt Unit gt 4 1 1 2 3 Phototransformation in soil IUCLID source section 5 1 4 Phototransformation in soil Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The studies on phototransformation in soil are summarised in the following table Table 31 Studies on phototransformation in soil Light source lt Light source gt Light spectrum lt Light spectrum gt Rel light intensity lt Rel light intensity gt Details on soil lt Details on soil gt lt DT50 gt lt Test condition gt Degradation lt Degr gt after lt Sampling time gt lt Test condition gt Quantum yield lt Quantum yield for direct photolysis gt
233. ty Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Type of lt Results gt lt Reliability gt lt Author gt lt Year gt information gt lt Purpose flag gt Details on study design lt Details on study design gt Test material identity See description of rules Endpoint addressed in introductory part 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 65 EC number lt Chemical name gt CAS number lt EC number gt lt CAS number gt lt Endpoint addressed gt Porn Testimatenal form gt If field is populated 5 6 3 Summary and discussion of repeated dose toxicity IUCLID source Endpoint summary 7 5 Repeated dose toxicity lt Discussion gt The following information is taken into account for any hazard risk assessment lt Short description of key information gt Value used for CSA via oral route systemic effects lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Value used for CSA dermal local effects lt Endpoint conclusion gt lt Effect level gt lt Effect level value gt lt Effect level Unit gt lt Test type gt lt Species gt Target organs lt Target organ gt Value used for CSA inhalation systemic effects lt Endpoint con
234. ustification lt Justification for data waiving gt Testing proposal Information requirement Developmental toxicity teratogenicity lt Route of administration gt Proposed test guideline lt Guideline gt Species lt Species gt lt Strain gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt 5 9 2 2 Human information No relevant information available Rule Print if applicable i e if field Endpoint addressed does not contain the relevant endpoint in any available record The exposure related observations in humans are summarised in the following table Table 74 Exposure related observations on the developmental toxicity in humans Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed developmental toxicity teratogenicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Purpose flag gt lt Type of population gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID sou
235. y available record The exposure related observations in humans are summarised in the following table Table 78 Exposure related observations on neurotoxicity Method Results Remarks Reference IUCLID source section 7 10 1 Health surveillance data if Endpoint addressed neurotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Type of population gt lt Purpose flag gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated IUCLID source section 7 10 2 Epidemiological data if Endpoint addressed neurotoxicity Sort rule Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Study type lt Study lt Results gt lt Reliability gt lt Author gt lt Year gt type gt lt Type of population gt lt Purpose flag gt Test material Details on study identity See design lt Details on description of rules study design gt in introductory part Endpoint addressed Form lt Test material lt Endpoint addressed gt form gt If field is populated
236. ype lt Study type gt lt Media gt Type of method lt Type of method gt Principles of method if other than guideline lt Principles of method if other than guideline gt Planned study period lt Study period gt Discussion UCLID source Endpoint summary 5 4 1 Adsorption desorption lt Discussion gt The following information is taken into account for any environmental exposure assessment lt Short description of key information gt Value used for CSA Koc at 20 C lt Koc at 20 C gt Log Koc at 20 C lt Log Koc at 20 C gt Other adsorption coefficients lt Type gt lt Value gt lt Unit gt at lt Temperature gt lt Unit gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 33 EC number lt EC number gt lt Chemical name gt CAS number lt CAS number gt 4 2 2 Volatilisation IUCLID source section 5 4 2 Henry s Law constant Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study No relevant information available Rule Print if applicable The studies on volatilisation are summarised in the following table Table 36 Studies on volatilisation Method Results Remarks Reference lt Principles of method if other than guideline gt Henry s Law constant H lt H gt at lt Temp C gt C and lt Atm press gt lt Atm press unit gt lt Remarks gt lt Details on
237. ystemic derivation method gt dose response relationship gt lt Justification gt effects Long term Inhalation Systemic effects Acute Inhalation Local effects Long term e g DNEL derivation method ECHA REACH guidance Dose descriptor starting point lt Dose descriptor starting point gt e g Dose descriptor starting point NOAEC 617 mg m DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is not ticked Dose descriptor starting point lt Dose descriptor starting point gt long term extrapolated to acute short term Rule Print if source field populated and tickbox DNEL extrapolated from long term DNEL is ticked DNEL derivation method lt DNEL derivation method gt Dose descriptor starting point lt Dose descriptor starting point gt 2013 01 28 CSR PI 5 4 1 CHEMICAL SAFETY REPORT 94 AF for difference in duration of exposure lt AF for difference in duration of exposure gt lt Justification gt e g AF for difference in duration of exposure 2 DNEL is based on an oral 90 day study AF for interspecies differences allometric scaling gt AF for interspecies differences allometric scaling gt e g AF for interspecies differences allometric scaling 1 AF not used for inhalation route AF for other int
238. ystems IUCLID source section 6 1 7 Toxicity to microorganisms Sort rule in table Field Purpose flag 1 key study 2 supporting study 3 weight of evidence 4 disregarded study Rule for multiple Effect concentrations Capture if NOEC LOEC EC10 IC10 EC50 IC50 or any other if none of these endpoints applies Sort rule for multiple Effect concentrations Field Endpoint 1 NOEC 2 LOEC 3 EC10 or IC10 4 ECS0 or IC50 5 ECO or ICO 6 any other No relevant information available Rule Print if applicable The results are summarised in the following table Table 101 Effects on micro organisms Method Results Remarks Reference lt Test organisms species gt lt Endpoint gt lt Duration gt lt Reliability gt lt Author gt lt Year gt lt Water media type gt lt Effect conc gt lt Conc lt Purpose flag gt based on gt lt Test type gt lt Nominal Measured gt lt Study result type gt lt Guideline gt based on lt Basis for effect gt Test material lt Principles of method if other than lt Remarks gt identity See guideline gt description of rules in introductory part Form lt Test material form gt If field is populated Data waiving Information requirement Effects on aquatic micro organisms Reason lt Data waiving gt Justification lt Justification for data waiving gt Testing proposal Information re

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