Consumer Tool user manual - European Centre for Ecotoxicology
Contents
1. Targeted Risk Assessment Addendum to the User Guide for the Standalone Consumer Tool Version 3 1 June 2014 G e EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS www ecetoc org User Guide for the TRA integrated tool TRAM version 3 1 Contents ADDENDUM INTRODUCTION NEW APPLICATIONS IN CONSUMER TOOL VERSION 3 1 ACCOUNTING FOR LOW FREQUENCY EVENTS INHALATION TRANSFER FACTOR INDOOR OR OUTDOOR INHALATION EXPOSURE ADDITIONAL BODY PART SELECTION FOR DERMAL EXPOSURE USER GUIDE FOR THE STANDALONE CONSUMER TOOL VERSION 3 1 GETTING STARTED 2 3 4 5 6 7 INTRODUCTION USING THE TOOL Default Product and Article Types REFINING EXPOSURE ESTIMATES VIEWING RESULTS ENTERING NEW PRODUCT SUBCATEGORIES VIEWING DEFAULT PARAMETERS WN N e FP Be eB wn A Aa PB 10 14 16 20 User Guide for the TRA integrated tool TRAM version 3 1 ADDENDUM INTRODUCTION This Addendum provides guidance for use of the new applications introduced into version 3 1 of the ECETOC TRA standalone consumer tool The Addendum is meant to be used in conjunction with the User guide for the standalone consumer tool version 3 which is included at the end of this Addendum To understand the underlying science assumptions and limitations of the tool refer to the ECETOC Technical Reports No 93 No 107 No 114 and the 2014 Addendum to 114 Technical Report No 124 NEW APPLICATIONS IN2. putties plasters modelling cla 0 co 4 OD mo amp to hI Sm 32 MA KH User Input Add Subcategories Results by Sentinel Prod R o child a adu Nef ult is mon Default is LEAVE BLANK if Free Text spray non solid exposure pathway relevant Productis Product _is a solid Dermal Oral The sheet by default contains 10 editable entries that allow building up to ten new subcategories To add more subcategories click the CLICK TO ADD BLANK ROWS button on the top left of the worksheet Macros must be enabled for the rows to be successfully added Enter the number of new product subcategories you want to add in a text box that pops up after clicking the add blank rows button Page 17 User Guide for the TRA integrated tool TRAM version 3 1 CLICK TO ADD BLANK ROWS _ ROUTES OF EXPOSURE _ALL i Added rows cannot be deleted s E lm 1 but can be edited s n mA idle hig iti Macros must be Desfauk ig ron Osfault is LEAVE BLANK if exposure pathwz Praduct Select from drop down Free Tent spis mon sakd nat Det enabled to add more ral product subcategories Enter Prof AEE Descriptor _ Product Subcategor Enter mew subcategory How many new subeabegories the number of new subcategories in a pop up box that displays upon clicking the add blank rows button Bw co ml oF on om te DP In Columns H to J use the dropdown to select c
3. worksheet Once the molecular weight is entered the SVC is automatically calculated in cell B15 pink cell When the user places the mouse over cell B15 which has a red triangle in the top right corner of the cell a text box displays the equation and assumptions used to calculate the SVC ora Me serdey Molecular weight Saturated vapour ak 0 00E 00 SVC MW x VP x 10 6 VPambient x 24 45 Use x only MW molecular weight VPambient 1 0133x10 5 Pa Select Use 24 45 conversion factor ppm te mg m3 Descriptor by Sentinel P Product To view whether the inhalation exposure estimate is based on the substance s SVC go to the Results by Sentinel Prod column AL or the Inhalation Prod Subcat column R worksheet Page 11 User Guide for the TRA integrated tool TRAM version 3 1 Inhalation Conversion Room Exposure Exposure Basis for Rate F actor Y olume mg kgiday mgim inhalation mhr m exposure SY C saturated I 1000 t Yr I BEY Tapour concentration Product Subcategory Aircare continuous action solid amp liquid Waterborne latex wall paint dede NN Serosol spray can L3f 1000 0 60 4 72E 01 6 26E 03 Removers paint glue wall paper sealant remover Fillers and putty FA Plasters and floor equalizers 1 37 1000 20 60 6 46E 00 141E 02 SVC Modelling clay Inhalation Prod Subcat hcategories Results by Sentinel Prod 4 Results by Pro
4. CONSUMER TOOL VERSION 3 1 The new applications in the version 3 1 of the consumer tool added to those in version 3 include A Possibility of accounting for low frequency events when calculating exposure B Possibility of introducing an inhalation transfer factor similar to the oral and dermal transfer factors in version 3 C Application of Indoor or Outdoor scenarios when calculating inhalation exposure D Possibility of selecting two additional body parts two fingertips and palm of one hand when calculating dermal exposure All these new applications are implemented as part of the feature for entering new product article subcategories Add Subcategories sheet already existing in version 3 of the tool see section 6 of User Guide for the standalone consumer tool version 3 They are all optional How to use these applications is briefly explained below These changes in the TRA consumer module are aligned with the concept of the Specific Consumer Exposure Determinants SCED which are being developed by various industry sectors for their consumer uses and documented in SCED factsheets ACCOUNTING FOR LOW FREQUENCY EVENTS Version 3 1 of the consumer tool allows distinguishing among events depending on how frequent they are In previous versions of the tool all events were assumed to occur daily except for those that occurred several times per day Version 3 1 considers four frequency categories a
5. and 1 Pa 0 01 D Vapour pressure lt 0 1 Pa 0 001 For sprays the vapour 8 pressure has no effect on the amount released to air because the default released to air is always 1 Some products and all articles are never sprays e g finger paint diapers For products and articles that are never sprays column E is hatched out and the user cannot change the default setting However the tool does allow users to determine whether or not some preparations are sprays Cells in column E for these products are shaded blue which means input is optional Marking the product as a spray i e putting an x in column E assigns 1 as the fraction released to air If this column is left blank the tool assigns the default fraction released to air based on the substance s vapour pressure TIP For sentinel products changing a product subcategory to a spray may change the worst case product subcategory for inhalation exposures This is because the tool calculates exposure estimates and RCRs by using the highest exposure estimate calculated for the product subcategories within each sentinel group The worst case product subcategory is not necessarily the same for all exposure routes Page 8 User Guide for the TRA integrated tool TRAM version 3 1 A C D E ia 48 Select Use Select Use by Prodictia Descriptor by Sentinel Product Subcategory Product ppop a Product Subcategory idd Y PC12 Fertilize
6. gt wf Add Subcategories Results by Sentinel Prod Results by Prod Subcat Dermal Prod Subcat Oral Prod Subcat Inhalation Prod Subcat Defaults Defaults2 lt a Ready NUM Page 19 User Guide for the TRA integrated tool TRAM version 3 1 7 VIEWING DEFAULT PARAMETERS Relevant routes of exposure and default parameters used in the exposure estimate calculations are listed in the Defaults and Defaults2 worksheets These worksheets are for information only and are therefore protected and cannot be changed by the user Data that can be overridden can be done only in the User Input worksheet or the Add Subcategories worksheet for new subcategories SE File Edit view Insert Format Tools Data Window Help Adobe PDF Typ eee NEUFS BLU UP NEEN Rae AR oe ee Tahoma Default Route of Relevance ADULT CHILD Product Adult Contact Descriptor Product Subcategory ee a E ed Ingredient Body Part Considered Area z D E 7 yn z sa r tmd v O Sealants OO O noon y n y n 0 3 1 fingertips 35 7 Dermal Exposure PC3 Air care products Aircare instant action aerosol sprays n n y n n n 0 5 En LE Aircare continuous action solid amp liquid y n y n n n 0 1 1 fingertips 35 7 PC3a Coatings paints EAEE SEE steerbalipakke y A j n m 3 Os 2 inside hands one hand 428 8 18 thinners removers palm of hands Solvent rich high
7. maut A mtd hk ke Pd A ola mg kg da 7 Columns cannot be mg kg day resized to protect hidden columns with equations that have no effect on the algorithms used Some formatting is allowed for ease of viewing Freeze columns or row headings when scrolling down rows or columns Resize rows or format cells e g change color font etc for easier viewing Page 5 User Guide for the TRA integrated tool TRAM version 3 1 3 USING THE TOOL Default Product and Article Types Exposure estimates and RCRs can be calculated for a group of consumer products articles sentinel products articles or for individual product article subcategories Selecting the default product article types First identify which product or article to assess in the User Input worksheet For sentinel a products articles put an x in column B for the respective preparation or article listed in column A Similarly for a specific product article subcategory column C put an x in column D of the respective product or article More than one sentinel product article and or product article subcategory can be evaluated simultaneously There is no limit to the number of sentinel products articles and subcategories that can be evaluated at the same time 16 Use x only Use x or Select Use Select Use by Descriptor by Sentinel Product Subcategory Product Product Subcategory 19 50 PC1 Adhesives sealants
8. selected include the following e Product Ingredient Fraction by Weight e Transfer Factor dermal e Skin Contact area cm2 This value is automatically generated by selecting in column M the body part exposed The area value will show up in either column N or O depending on whether it corresponds to an adult or a child value e Transfer Factor oral e Contact area mouthed cm2 This value is generated by selecting in column Q the body part mouthed The area value will show up in either column R or S depending on whether it corresponds to an adult or a child value If no body part is chosen in column Q and area of product mouthed is chosen instead users can enter a numerical value for the area of product mouthed in column S e Frequency of use events per day e Amount of Product used per Application g event e Exposure Time hr Page 16 User Guide for the TRA integrated tool TRAM version 3 1 ee PC1 Achesives sealants H CLICK TO ADD BLANK ROWS RL Added rows cannot be deleted but can be edited c Default is non Default is BLAN Select from drop down Free Text spray non solid Product is a Product is Product Subcateqgor spra a solid Derm Enter new subcategory Descriptor PC on Adsorbents PCS Air care products PC4_n Anti freeze and de icing products PCF n Base metals and alloys PCB _n Biocidal products PCQa Coatings paints thinners removers Pgb Fillers
9. the Defaults2 worksheet Enter a different value if more product specific use information is available This parameter only affects calculations for inhalation exposures Default values are listed in column U of the Defaults worksheet Enter a fraction transferred gt 0 to 1 from the product to the skin in Column L As a conservative estimate 100 is assumed Note this value is not the same as the amount absorbed through the Skin Enter a fraction transferred gt 0 to 1 from the product to the mouth during mouthing behavior in Column M As a conservative estimate 100 is assumed The oral transfer factor is not the same as the amount bioavailable once ingested Page 10 User Guide for the TRA integrated tool TRAM version 3 1 Refining Inhalation Exposure Estimates Saturated Vapour Concentration New for Version 3 users have the option of refining inhalation exposure estimates by comparing them against the saturated vapour concentration SVC of the substance If the estimated exposure value exceeds the SVC the tool will use the SVC value This was previously defined as a refinement which users could apply outside of the TRA tool and discussed in Appendix F of Technical Report No 107 This option has now been incorporated into Version 3 of the tool The SVC is only calculated for non sprays products and the comparison is triggered by entering the chemical s molecular weight in cell B14 in the User Input
10. way to avoid error messages when viewing results is to enter reference values for all exposure routes Entering vapour pressure values A vapour pressure is needed for inhalation exposures Enter the vapour pressure in units of Pascal Pa in cell C8 The tool automatically selects the vapour pressure band that is used to assign a default fraction released to the air cells C2 and E4 E7 The selected default fraction released to the air is only applicable for non sprays and if inhalation is a significant exposure route associated with the use of the product article For sprays the default fraction released to the air is always 1 and cannot be changed Spray products are identified by an x marked in column E Page User Guide for the TRA integrated tool TRAM version 3 1 DEFAULT WP nan spray Default fraction CLASSES Default Vapour Pressure Band non spray released to air A A Vapour pressure gt 10 Pa 1 B B Vapour pressure between 1 and 10 Pa Z C Vapour pressure between 0 1 and 1 Pa D D Yapour pressure lt 0 1 Pa 0 When a vapour pressure is entered the tool automatically selects the fraction released to air based on the vapour pressure band Yapour Pressure Pa Default fraction CLASSES Default Vapour Pressure Band non spray nr i ab A Vapour pressure gt 10 Pa 1 B B Vapour pressure between 1 and 10 Pa 0 1 C C Vapour pressure between 0 1
11. Glues hobby use Glues DIY use carpet glue tile glue wood parquet glue 21 on Glue from spray 23 Sealants DEET EEE EEE TETE EET ETE EEEKEEKKKNNMKEEKKEEKEKKEKK EE EL ennen nnen nnen nnn nnn ees _ PC3 Air care products Aircare instant action aerosol sprays Aircare continuous action solid amp liquid PC9a Coatings paints rar hi specific product put an x in Column D the column thinners removers 32 next to the Product Subcategory you want to evaluate Waterborne latex wall paint Solvent rich high solid water borne paint Here the user has selected to evaluate Glues DIY use User does not need to put an x in Column B erosol spray can For sentinel products put an x in Column B Entering reference values Next enter reference value s e g DNEL for the chemical being evaluated The tool lists four reference values but only a total of three reference values can be entered This is because the user can only enter the inhalation reference value either in units of mg m or in units of mg kg day When an inhalation reference value has already been entered and the user attempts to enter a second value in different units an error message displays informing the user that only one inhalation reference value can be entered into the tool When this occurs select cancel to exit the error message box The tool does not convert the inhalation reference value from m
12. Ingredient Contact Area Transfer Factor FreQuency of use Thickness of Layer Density Conversion Factor Body Weight Dermal a a m unitless events day cm g cm ka Exposure Dermal s Characteri Estimate Ratic Descriptor mg kg day Dermal Exp PC1 Adhesives sealants a Rows for the sentinel products previously selected in the User Input worksheet are highlighted in pink Risk characterisation ratios exceeding 1 are displayed in red If no reference value or vapour pressure has been entered when those values are needed error messages will be displayed prompting the user to enter values in the User Input worksheet The combined RCR value in column AN is the sum of the dermal oral and inhalation RCRs Page 14 User Guide for the TRA integrated tool TRAM version 3 1 COMBINED skein Basis for Inhalation Risk Total Risk Estimate inhalation Characterisation Characterisation mg m exposure Ratio Ratio S C saturated Inh Exposure Inh vapour Ref Yalue concentration i Inhalati Pin Dermal Risk Oral Exposure Oral Risk rm bn neg Basis for Inhalation Risk Total Risk aes Characterisation Estimate Characterisation Estimate Estimate alation Characterisation dracterisation Descriptor mgikg day jaa mg kg day mg kg day mg m Kn gia A Dermal Exposure Oral Exposure Oral al ms Inh Exposure inh Dermal Ref Value Ref Value ehs Ref Value concentrao PC3c Fi
13. User Input User specific entries and selections are entered to generate exposure estimates and risk characterisation ratios RCR Add Subcategories new for Allows users to add new product and article subcategories if relevant specific data are available for the Version 3 new subcategories Results by Sentinel Prod Displays exposure estimates and RCRs for sentinel products and shows route specific algorithms and parameters used to calculate them Resul P bcat l Soule DY Prog SUDC Displays exposure estimates and RCRs for product article subcategories Dermal Prod Displays dermal exposure estimates and RCRs for the product subcategories including any new added Subcat ones and shows the algorithm and parameters used to calculate them Oral Prod Subcat Displays oral exposure estimates and RCRs for the product subcategories including any new added ones and shows the algorithm and parameters used to calculate them Inhalation Prod Subcat Displays inhalation exposure estimates and RCRs for the product subcategories including any new added ones and shows the algorithm and parameters used to calculate them Defaults Lists default exposure parameters and relevant exposure routes for each product article Defaults2 Lists subpopulation specific child adult default parameters used to estimate exposure 1 The term sentinel product is used to describe a group of related product subcategories An example is AC8 paper prod
14. d Subcat Dermal Prod Subcat Oral Prod Subcat Air Exchange Rate Dilution Factor Also new for Version 3 of the tool a Dilution Factor DF has been included in the algorithm for calculating inhalation exposure column in the Inhalation Prod Subcat Tab The DF is calculated based on the duration of exposure Exposure Time hr and a conservative default value for air exchange rate see algorithm in column in the Inhalation Product Subcategory Tab This DF is included automatically by the tool without any intervention by the user Refinement is achieved when users enter a specific value for the Exposure Time parameter This was previously defined as a refinement which users could apply outside of the TRA tool and discussed in Appendix F of Technical Report No 107 This option has now been incorporated into Version 3 of the tool mm Ue WT VV PSUS YS YS FIL VISIT yi ye VV ieunveryewyer dede Y Ww aha a yew J ff mn nn nn EE EN EE EE EE DE EE N F ubcategory ADF V V ACH x ET x V This is a new parameter for Version 3 Parameter Product FreQuency of Fraction Released Dilution Ingredient Us to Air Fraction gg unitless See Defaults2 worksheet for air gevent changes per hour ACH used Algorithm PI x Page 12 User Guide for the TRA integrated tool TRAM version 3 1 A powerful additional alternative for refinement of exposure estimates is the building of new tailor made product subca
15. g m to mg kg day this will have to be calculated outside of the tool by using a general population inhalation rate and body weight In some cases the worst case product subcategory for inhalation exposures may change depending on the units Page 6 User Guide for the TRA integrated tool TRAM version 3 1 CLASSES Default Vapour Pressure Band non spray il ee Mandatory entries A 4 Vapour pressure gt 10 Pa 1 Optional entries B B Vapour pressure between 1 and 10 Pa 0 1 Automatically selected C C Vapour pressure between 0 1 and 1 Pa 0 01 D Vapour pressure lt 0 1 Pa 0 001 Vapour Pressure Pa Microsoft Excel Reference Value Inhalation Enter only one inhalation reference value mg kg day or mg m3 Select lt Cancel gt to exit ENTER ONLY VALUES Reference Value Inhalation Reference Value Dermal Reference Value Oral To calculate RCRs enter reference values such as DNELs in cells A9 to A12 If no reference values are entered RCRs will not be calculated However exposure estimates except for the inhalation pathway will still be calculated Preferred units for inhalation reference value are mg m A route specific reference value is only needed if the exposure route is of significance for the selected product Exposure routes included for a sentinel product or product subcategory can be viewed in the Defaults worksheet Columns D to I The simplest
16. hild or adult exposures This automatically selects sub population specific exposure values e g body weight inhalation rate that will be used to estimate exposure For the inhalation exposure pathway only adult exposure values can be selected at this time This is based on the Tier 1 assumption that weighted exposure estimates when taking into account body weight and inhalation rate is higher for adult than for children O J G H KLM N ROUTES OF EXPOSURE ALL c child a adult Enter value lt 1 ADULT Default is LEAVE BLANK if non solid exposure pathway not Product Detault 1 l EN relevant Ingredient 1007 Skin gt Product Fraction by Select body Contact En is a solid Dermal Oral Inh _ Weight TF dermal part exposed Area cm Select a for adult and c for child exposure parameters that will be used for calculating exposure estimates If nothing is selected for an exposure pathway no exposure estimate or RCR will be calculated for that pathway Enter the body parts exposed from a dropdown list and Column N or O will be automatically populated with the skin surface area for that body part and for the subpopulation selected in Column H EO ia A ORAL DERMALIORAL INHALATION ADULT CHILD ADULT CHILD x Default 1 Amount Skin Skin OD Product used Exposure Contact Contact Select surface area Contact Area Contact FreGQAfUse perApplication Time FreQ of Arealcm Area cmt TF oral mo
17. nd assigns an adjusting factor to the exposure estimate depending on the respective category chosen Page 1 User Guide for the TRA integrated tool TRAM version 3 1 Frequency Definition Proposed TRA Rationale for Multiplier of Use Multiplier Event occurs at Equates to daily use Frequent leastonce a week q y Event occurs Exposure reduction factor reflects O anni between once a 0 2 5x fact that average exposures ccasiona week and once a expected to be at least one order month less than daily exposures Event occurs Exposure reduction factor reflects between once a fact that average exposures Infreq uent month and once 0 04 25x typically expected to be at least 50 every 6 months fold less than daily exposures Eventoccurs no Exposure reduction factor reflects Very more than once in 6 0 01 100 fact that average exposures Infrequent months 01 100x expected to be at least two orders less than daily exposures For using this application go to the Add Subcategories sheet Then use the drop down in column L to enter the frequency of use as in above table or a numerical value for the number of uses per day as needed The selected frequency will apply to all exposure routes relevant to the assessment of the respective sub category INHALATION TRANSFER FACTOR For entering an inhalation Transfer Factor TF Inhalation go to the Add Subcategories sheet Then column Y can be used to enter a value between 0 and 1 for
18. ners removers Aircare continuous action solid amp liquid Waterborne latex wall paint Solvent rich high solid water borne paint Aerosol spray can Removers paint glue wall paper sealant remover PCI Fillers putties plasters modelling clay Fillers and putty Plasters and floor equalizers Modelling clay Page 15 User Guide for the TRA integrated tool TRAM version 3 1 6 ENTERING NEW PRODUCT SUBCATEGORIES Users now have the option to add new product subcategories if product article specific information for a number of parameters is available for such subcategories As with the parameters in the User Input sheet parameter values for yellow cells are required before the tool will calculate exposure estimates and RCRs Blue cells contain pre populated default values which will be used unless specific values are entered by the user Go to the Add Subcategories sheet to add a new product subcategory Select a list of products from a dropdown list of PCs and ACs in Column B This list contains both PCs and ACs already calculated with default input parameters In Column D enter the product subcategory name Select the relevant exposure routes for the new subcategory in columns H J and K At the same time select adult or child exposure for the selected routes Enter the values for the parameters in yellow required and blue cells for each row The parameters for which specific values can be
19. nger paints PC24 Lubricants greases and release products TIP To view exposure estimates for a specific exposure route only enter a dummy reference value for that exposure route in the User Input worksheet Cells B9 to B12 This will display the exposure concentration and not an error message that tells you the reference value is missing You can ignore the RCRs generated using the dummy reference value Product Subcategories Go to the Results by Prod Subcat worksheet to view results for product subcategories previously selected in column D of the User Input sheet Only route specific exposure estimates and RCRs and also the combined RCR resulting from adding the RCRs from each route of exposure are displayed in this sheet To view the algorithms and parameters used to calculate route specific exposure estimates select either the Dermal Prod Subcat Oral Prod Subcat or Inhalation Prod Subcat tab These sheets are always locked to prevent accidental deletion or modification of equations so users cannot change or edit values in these sheets Change default parameter values by going to the User Input sheet i Ll summary Of Resul onsumer Produc xposure E Glues hobby use Glues DIY use carpet glue tile glue wood parquet glue Glue from spray Sealants Aircare instant action aerosol sprays PC3 Air care products PC3a Coatings paints thin
20. rs Lawn and garden preparations a PC13 Fuels Liquids Lubricants greases and release products B Pastes Y f Y w Sprays X ae and wax Polishes wax cream floor furnitu yy Polishes spray furniture shoes X Liquids Page 9 User Guide for the TRA integrated tool TRAM version 3 1 4 REFINING EXPOSURE ESTIMATES Optional Change of Default Parameter Values for the Listed Categories and Subcategories The user has the option to change default values for the Product Ingredient Fraction by Weight Skin Contact Area dermal exposures Contact Area oral exposures and the Amount of Product used per Application inhalation exposure only Parameters that can be modified are identified by red letters that define the acronyms for the parameter in an algorithm For example the red letters in skin contact area define the parameter CA which is used in the equation for calculating dermal exposures Note that although these changes are made at the product subcategory level they could result in a change to the worst case product subcategory used to estimate exposure for sentinel products New for Version 3 users can also enter transfer factors for the dermal and oral routes of exposure Refer to the technical reference document for more information on transfer factors and how they can be used to refine exposure estimates If no values are entered in columns F to M the tool automatically assigns defaul
21. solid w ater borne paint y n y n n n 0 5 ai risa foc decal bandi 428 8 19 palm of hands 20 Aerosol spray can n 0 5 Removers paint glue wall paper sealant remover n 0 3 3 hands 657 5 PC3b Fillers putties A s E plasters modelling clay Fillers and putty n 1 1 fingertips 35 7 A Plasters and floor equalizers y n y n n n 1 3 hands 857 5 pa Modelling clay n n n y y n 0 1 3 hands 25 PC3e Finger paints Finger paints Jo n n n y y n 0 5 3 hands 28 PC12 Fertilizers Lawn and garden preparations f y n n n y n 0 5 3 hands 857 5 29 PC13 Fuels Liquids En y n y n n n 0 5 3 hands 657 5 PC24 Lubricants greases Liquids y n y n n n 0 5 3 hands 657 5 and release products Fi Pastes y n n n n n 0 2 3 hands 857 5 2 inside hands one hand PS Sprays y n y n n n 0 5 palm ofherds 428 8 oe balie and wax Polishes wax cream floor furniture shoes y n y n n n 0 5 3 hands 857 5 M 4 gt gt 4 Add Subcategories Results by Sentinel Prod Results by Prod Subcat Dermal Prod Subcat Oral Prod Subcat Inhalation Prod Subcat Defaults Defaults2 Page 20 ECETOC AISBL Av E Van Nieuwenhuyse 2 box 8 B 1160 Brussels Belgium VAT BE 0418344469 www ecetoc org
22. t values listed in the Defaults worksheet Transfer factors are not included in the Defaults worksheet but are assigned default values of 100 or fraction of 1 Table 2 Parameters for which default values can be changed by the user Product Ingredient Fraction by Weight Skin Contact Area dermal exposure cm Contact Area oral exposure cm Amount Product per Application inhalation exposure g event Dermal Transfer Factor Oral Transfer Factor Enter the fraction of substance gt 0 to 1 in the product This parameter is used to calculate exposure estimates for all three exposure pathways where applicable inhalation dermal oral Default values are listed in Column H of Defaults worksheet Enter different skin contact area in columns G or H for the adult and child respectively The tool predetermines whether adult or child conditions are used and therefore the skin contact area can only be entered for either the adult or child but not both Although any value can be entered in columns G or H user should refer to the contact areas listed in the Defaults2 worksheet rows 4 to 15 for dermal exposure Enter different contact area in column J Oral exposures are based on a child mouthing a surface or an area of skin Therefore the skin contact area should be based on child rather than adult values Same as above user should refer to the skin contact areas listed in rows 18 21 of
23. tegories see Section 6 Entering New Product Subcategories in this guide This is a new capability in version 3 of the tool and it requires knowledge by the user of data specific for the new subcategories Page 13 User Guide for the TRA integrated tool TRAM version 3 1 5 VIEWING RESULTS Sentinel Products For sentinel products refer to the Results by Sentinel Prod worksheet for both exposure and RCR estimates By default the algorithms and parameters used to calculate the exposure estimates are hidden from view and the only outputs displayed are exposure estimates and the RCRs To view the hidden algorithms and parameters click on the buttons at the top of the worksheet me 4 Summary of Results for Consumer Product Exposure Worst Case for Sentinel Products DERMAL EXPOSURE DERMAL EXPOSURE ORAL EXPOSURE EXPOSURE PARAMETERS PARAMETERS PARAMETERS PARAMETERS CLICK TO CLICK TO INH EXPOSURE EXPOSURE PARAMETERS PARAMETERS Inhalati Inhalation R gt brad Dermal Risk Oral Exposure Oral Risk mee Exposure Basis for Inhalation Risk b Characterisation Estimate Characterisation p g inhalation Characterisation Estimate Ratio Estimate Estimate exposure i Descriptor mg kg day mg kg day Relo mg kg day mg m oe Dermal Exposure Oral Exposure Oral Ref maik Pd Inh Exposure Inh Ref 7 Dermal Ref Value Yalue P a Yalue concentration PC1 Adhesives sealants DERMAL 5 Product
24. the TF inhalation This is an optional entry and the tool will use a default value of 1 if no TF inhalation value is specified To note that this TF inhalation is separate and in addition to the adjustment that the tool performs for non spray products taking into account the saturated vapour concentration SVC of the substance Section 4 of the User Guide for the Standalone Consumer Tool Version 3 INDOOR OR OUTDOOR INHALATION EXPOSURE For choosing between an indoor 20 m room volume 0 6 air changes per hour or outdoor 100 m volume 2 5 air changes per hour scenario when calculating inhalation exposure go to the Add Subcategories sheet Then use the drop down in column X to enter place of use If no entry was made the tool will use indoor as the conservative default Page 2 User Guide for the TRA integrated tool TRAM version 3 1 ADDITIONAL BODY PART SELECTION FOR DERMAL EXPOSURE There are two more selection options in the drop down list in column N see example in screenshot below Examples for assessment parameters available in version 3 1 for entering New Product Subcategories are shown below compare chapter 6 of the attached user guide for version 3 G H K M N O 3 YPC O Enter value lt 1 ADULT c child a adult LEAVE 4 BLANK if exposure pathway FreQ of Use Default 1 Product is not relevant Product gt 1 event s day 100 a solid Ingredient as Value or defaul
25. tis Dermal Oral Inh Fraction by events year from TF dermal Select body part Skin Contact 6 No Weight drop down exposed Area cm 210 0 428 8 R S T U V WwW X ti 2 l ORAL INHALATION 3 Place of use 4 Default 1 select indoor or 100 Amount Product outdoor from TF Inhalation 5 used per Exposure drop down Skin Contact Skin Contact fora Select surface area AC5 subcat type fo Contact Area Contact Arga Application Time default is 6 Area cm Area cm mouthed default assessment cm cm g event hr indoor 0 value lt 1 C 210 0 10 428 8 wo 0 01 Page 3 User Guide for the TRA integrated tool TRAM version 3 1 TARGETED RISK ASSESSMENT USER GUIDE FOR THE STANDALONE CONSUMER TOOL VERSION 3 1 INTRODUCTION The ECETOC TRA Consumer Tool allows calculation of consumer exposures to substances that are present in preparations and articles used by consumers The calculated exposures correspond to a first tier level of assessment based on simple models and limited data The tool calculates exposure via inhalation dermal and oral routes separately It is available as a stand alone Excel tool and as an integrated tool that combines worker environmental and consumer calculations This User Manual provides guidance only for working with Version 3 of the stand alone consumer tool To understand the underlying science assumptions and limitations of the tool refer to the ECETOC Technical Repor
26. ts No 93 No 107 and the 2011 update of those reports 2 GETTING STARTED Upon opening the tool the user will be presented with a Security Warning To ensure the tool functions properly select Enable Macros The screenshot below is for Microsoft Office Excel 2003 and lower Security Warning C Documents and Settings u 398547 Data My Documents REACH CSA risk assessment tools ECETOC TRA TRA tables JK ECETOC TRA Dec10 2008 xls contains macros Macros may contain viruses It is usually safe to disable macros but if the macros are legitimate you might lose some functionality Disable Macros Enable Macros Ware dlg Excel 2003 security warning pop up message box The previous version of the Consumer TRA contained eight worksheets A new worksheet has been added to Version 3 which allows users to add new product and article subcategories Each of the worksheets can be navigated via the tabs at the bottom of the tool Table 1 summarises these worksheets and explains the information provided within each sheet a i eee m o wa veen En Prod E Oral Prod Subcat in Defaults E m 4 gt hf User Input Add Subcategories Results by Sentinel Prod Results by Ready Click on the tabs at the bottom of Excel to navigate between worksheets NUM Page 4 User Guide for the TRA integrated tool TRAM version 3 1 Table 1 Worksheets contained in the TRA Consumer Tool Version 3
27. ucts which includes the following product subcategories diapers sanitary towels tissues and printed paper Exposure estimates for sentinel products represent the most conservative highest values for all product subcategories within the group By default upon opening the User Input worksheet is shown because it is where all user required entries are made This worksheet contains colour coded cells that identify inputs necessary for running the tool Yellow cells are for information that must be entered before the tool can generate results Blue cells are optional if nothing is entered in these cells the tool automatically selects default parameters listed in the Defaults tab Pink cells are automatically populated based on user made entries Changes can be made only in the yellow and blue cells All other cells are locked to protect equations from being unintentionally deleted and to prevent users from over riding default parameters set in the tool Users can still format cells and rows and for better viewing Columns cannot be formatted iE File Edit View Insert Format Tools Data Window Help Adobe PDF METET FENE Now Window TENEN Tahoma 10 B Z U fe Detaults D5 Compare Side by Side w B Hide Ey F Arrange pagin Vapour Pressure Pa Reference Value Inhalation Reference Value Inhalation Reference Value Dermal Reference Value Oral ma rn Spit mg kg da ik id El Mamm
28. uthed Area cmt eventsida glevent hr eventsid Enter product specific values and exposure values needed to estimate exposure by the exposure pathway dermal oral inhalation Page 18 User Guide for the TRA integrated tool TRAM version 3 1 View results and exposure estimates following the same steps as discussed in Section 5 above The only difference is that new product subcategories will not be used to calculate sentinel products RCRs for the new product subcategories are displayed only in the Results by Prod Subcat sheet beginning from row 102 3 Dermal Dermal Risk Oral Oral Risk Inhalation Inhalati 4 i Exposure kt Exposure are Exposure Exposu Descriptor Product Subcategory Characterisation g Characterisation f i Estimate Ratio Estimate Ratio Estimate Estima mg kg day mg kg day mg kg day mg m 5 a4 ACTI Wood articles Furniture chair 85 Walls and flooring also applicable to non wood materials 8 Smalltoys ear train Exposure estimates and RCRs are displayed at the bottom of 87 Toys outdoor equipment ee each worksheet except i i astic larger articles plastic chair tlooring lawn 66 55 AE Planta stiolas nouu PE Results by Sentinel Prod Toys doll car animals teething rings 30 Plastic small artjclestBall pen mobile phone 31 101 102 1 PC Adhesives sealants Enter new subcategory 0 00E 00 no ref value 0 00E 00 no ref value 103 2 104 3 ie Mi M 4
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