ECETOC TRA Integrated Tool User Guide June 2014
Contents
1. For specifying Daily amount used at site kg d for SpERC assessment column L for wide dispersive uses the emission assessment the cell in column L is grey and no entry is possible irrespective of ERC or SPERC emission assessment The above options for specifying Daily amount used at site kg d for SpERC assessment are analogous to the approaches taken in ECHA s CHESAR For more information about SpERCs please refer to the CEFIC SPERC Guidance and the ECETOC Technical 107 and the available SpERC Factsheets SpERC Factsheets Further down cells D135 D141 the reference values for the different endpoints need to be entered for a risk characterisation as well as the indication which reference value it is e g PNEC Practical note ERC is a mandatory entry even if the assessment may be based on SpERCs or higher TIER approaches as it will define whether the assessment refers to a point source or a wide dispersive use For a higher TIER assessment the user is advised to enter the data directly into the datasheets see batch mode For details on the release estimation options see section 4 datasheets the ECETOC Technical Reports 107 and TR114 Page 15 User Guide for the TRA integrated tool TRAM version 3 1 Figure 7 Part VI Environmental exposure assessment input jay Microsoft Decel ecetoc TRAM xis MEK ad De Et Er peet Fy Joes a Were Hee gerne giek peek Tea2. Targeted Risk Assessment User Guide for the integrated tool TRAM Version 3 update to version 3 1 June 2014 H e EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS www ecetoc org User Guide for the TRA integrated tool TRAM version 3 1 Contents 1 Introduction Manual and Batch Mode Data Entry Standard and Refined Assessments Working in EXCEL 2007 2 Starting Exiting the Application 2 1 Starting 2 2 Exit the ECETOC TRA integrated tool 3 User Interface 3 1 Overview e e FP FP Be N 4 4 3 2 Part General Workflow Retrieval and Storage from and to the Datasheets and Batch Processing 4 Colour Codes for Input Fields Indicator Manual or Batch Mode Entering Data into the User Interface for Manual Mode Assessment Run Single Substance Assessment from User Interface in Manual Mode Save Store Single Substance Assessment Data from User Interface to Datasheets Read Retrieve Assessment Data from Datasheets into User Interface from Manual Run Clear Delete Entries of Single Substance from User Interface Batch Mode Standard vs Advanced 3 3 Part II Identification of substance 3 4 Part Ill General physico chemical data entry 3 5 Part IV Data Entry Worker Assessment 3 6 Part V Data Entry Consumer Assessment Working with existing categories and sub categories Creating New Sub Categories 3 7 Part VI Data Entry for Environmental Assessment Amounts Used 4 Output
3. chemical data of the substance to be assessed Page User Guide for the TRA integrated tool TRAM version 3 1 Some data need to be entered as numbers e g molecular weight vapour pressure some others need to be selected from a drop down menu like physical form The fields displayed in blue are optional entries but at least one of the optional fields needs to be filled in Some fields Partition coefficient octanol water and Koc offer the selection of entering either the value for Kow cell D42 and Koc D45 or their log units which has to be specified by the user in cells E42 and E45 respectively Also for the vapour pressure cell D40 the user can select to enter the value in Pa or hPa cell E40 Figure 4 Part III General physico chemical data el Microsoft Excel ecetocTRAM xls Sex BM Eile Edit View Insert Format Tools Data Window Help ecetocTRAM ecetocTRAM AWR MEMS BCU A Ue Merwe AR ERGE eee vee T E EB he EEE le 2a EEN EEEN P D46 v f A Phgsical chemical properties minimum input for Human Health and Environmental Assessment Molecular weight g mol Vapour pressure Pa OR hPa i VP Pa at C Water solubility mg L atc Partition coefficient octanol water OR Log Kow i Kow Biodegradability test result Chemical class for Koc QSAR mandatory if QSAR estimation of ksoilfwater and Ksedimenttwater is required Koc L kg OR Log Koc 1 00E 02 Koc Koc 1 00E 02 L kg Part
4. the TRA integrated tool TRAM version 3 1 Figure 6 2 General part of the input area for new sub categories in the consumer sub module sheet Add Subcategories B D L CLICK TO ADD BLANK ROWS Use Frequency Added rows cannot be deleted but can be edited Finish new subcategory ies ROUTES OF EAPUSURE es Enter value lt 1 c child a adult LEAVE Select from drop down Free Text BLANK if exposure FreQ of Use Productisa Productis Pathway not relevant Product gt 1event s iday spray a solid Ingredient as value or it in column left indicates default is default iS Dermal Oral Inh Fraction by events year from duplication of name Ma Mo Weight drop down PC3 new _SC_1 PC13 new SC 1 PC24 new SC 1 Product Subcategory k PC35 new SC 1 PI new SC 1 PEI new SC 2 glues hobby uze1 glues DY uzel glue from spray1 zealante1 So Ca Men de La hd am The button CLICK TO ADD ROWS is next to cell B2 user will be asked how many rows i e new sub categories shall be added The button Finish new subcategories next to cell D2 is required to add the recently created New sub categories to the selection lists in the ecetocTRAM xls file for batch processing Figure 6 3 Dermal and oral part of the input area for new sub categories in the consumer sub module sheet Add Subcategories Default 1 Default 1 100 100 Skin TF dermal Select body Skin Contact Contact TF oral Select surf
5. 14 Figure 5 Part IV Worker exposure entry fields Type of setting PROC 7 and 22 always ar entries if you Use of ventilation 7 industrial PROC Mand 20 Is substance a solid change column F to Duration of activity addresses outdoor use always professional esino No hoursida eneral ventilati alalala ini iw an ian enon rep gis 5 saae brad hdd brad jmi P w cess synthesis where opportanitg for exposere arises aziz of reference value maka day OR PO 400E01 mam 8 hour average Doo 5 00E00 makada wa cm 2 2 00E 01 mq m 15 minute average A Ee SS RE RIE joo jor fe Lm je Jo Lines 55 to 69 represent the input and output cells of the worker exposure and risk scenarios In each line one PROC can be selected from a drop down menu A descriptive text can be assigned as a scenario name Under type of setting the user needs to select whether the task is operated within a professional or an industrial setting Whether the physical form during the process is solid or not can selected from a drop down menu also the dustiness in case it is a solid and the vapour pressure at operating temperature in case it is not a solid The duration of activity the use of local exhaust or and general building ventilation or if the operation takes place outdoors the use of respiratory and dermal protection including efficiency and if the substance is used in a preparation including percentage can be
6. 27 set to Advanced and are displayed in lines760 and below see Figure 17 As for the PNEC derivation a macro button is available in line 760 to expand this area with the scaling results and a second macro button to collapse it Two sets of data are generated per environmental scenarios related to point sources NOT for wide dispersive uses and directly feed into scaling tools e g the GEST tool in preparation For other scaling tools using these parameters the order format etc may need to be adjusted for input Practical note After running a manual run via the user interface results are not automatically saved in the datasheets For saving the results of a manual run via the user interface the save button has to be activated to save the results and the input parameters to the datasheets see Safe function in Part 1 of this user guide Page 31 User Guide for the TRA integrated tool TRAM version 3 1 Figure 18 Example output of scaling parameters for environment feeding into a simple scaling tool DU ES Conformity tool as currently developed 1 2 A 1 2 ECETOC TRA FLAT DATABASE 760 769 Open Scaling output foo 783 724 734 Output for Scaling DU ES Conformity Tool 735 785 Meceac OF Mare kg d 786 736 Receiving Water Dilution Fresh or Marine TET 787 Wastewater treatment plant flow m 788 728 Receiving water body flowrate md for alternative to dilution factor T29 729 Optional Emi
7. 6 The other columns allow for choosing between calculating the PECs based on the ERCs or SpERCs specific ERCs The entry in column Use ERC or SpERC determines which approach will be used for the calculation in column ERC the corresponding ERC for this use has to be selected as use descriptor and for calculation of aggregated WDU with or without STP in column STP Alternatively if SoERC is selected the industry sector or sector organisation can be selected in column Industry sector for SERC which provided SpERCs to the ECETOC TRA In the last input column the corresponding SpERC can then be selected column J and K Notes Column L allows the entry of the daily amount used at a site in kg d where applicable and needed see further details in Figure 7 2 Column H will show a warning if the selected SpERC does not correspond to the ERC selected check against the specification of the underlying ERC refined by the selected SpERC Practical note Reference values for the assessment of exposure of man via the environment have to be entered in the consumer section to compare with the predicted oral and inhalation exposure Page 16 User Guide for the TRA integrated tool TRAM version 3 1 Figure 7 1 Part VI Environmental exposure assessment input General and ERC input Fraction of tonnage to region Use ERC or spERC as for ERCs 1 7 and 12a 12b 1 release estimation ERC mandatory in all STP
8. AM as shown below 7 nome sent Pope Layout Formas Owe b at Cales 10 N Pe le a Copy gt SJ Format Porter m2 a A A se Cape oerd fore EEA T Page 2 User Guide for the TRA integrated tool TRAM version 3 1 2 2 Exit the ECETOC TRA integrated tool To save and leave the ECETOC TRA integrated tool and close all 9 files press Ctrl e while the ecetocTRAM xls is active Alternatively the button ecetocTRAM in the Excel command line may be used while the ecetocTRAM xls is active which offers Save and exit To leave the ECETOC TRA integrated tool and close all 9 files WITHOUT saving data press Ctrl t while the ecetocTRAM xls is active Example for Excel 2003 For Excel 2007 2010 the Safe and exit can be accessed via Add ins x WH als ecetocTRAM xls Compatibility Mode Microsoft Excel File Home Insert Page Layout Formulas Data Review View Developer Add Ins quasi dynamic computation Save and Exit utation guasi dynamic computation quasi dynamic computation Menu Commands 3 4 General workflow 5 6 STEP Identification of substance usi fj STEP 2 Input of physical chemical par _8 STEP 3 Set up assessments select one g a 10 b DATABASE a Ready Calculate J ENTS datasheeti datasheet lijd ill Page 3 User Guide for the TRA integrated tool TRAM version 3 1 3 USER INTERFACE 3 1 Overvie
9. Figure 7 3 Part VI Environmental exposure assessment input Reference value input Manual entry of reference values Basis of reference value Microorganisms in STP 40E 02 mp he PNEC Freshwater aquatic 1 12E 01 mgl PNEC Freshwater sediment 2 17E 01 mg kg PNEC i Marine water 12E 00 mg Lt PNEC Marine sediment 2 17E 00 mg kau PNEC i Terrestrial compartment 5 00E 00 mg kga PNEC Secondary poisoning for TIER I only mg kg haa PNEC Freshwater aquatic intermittent release for TIER Il only mgt PNEC Marine water intermittent release for TIER II only mel PNEC Man via the environment total daily intake 4 80E 01 mg ka d DNEL The reference values for inhalation and oral from consumer part will be used unless a worst case consumer reference value lower of inhalation or oral in mg kgBW 1 d 1 is entered here Page 18 User Guide for the TRA integrated tool TRAM version 3 1 4 OUTPUT OF RESULTS IN THE USER INTERFACE yy tt The output of the three parts consumer worker and environment exposure and risk assessment are structured in a similar way The first columns always show the estimated exposure values the following columns show the risk characterisation ratios RCRs the exposure divided by the reference value If a risk is estimated for a use the respective cell is highlighted in red Figure 9 The outputs are always arranged adjacent to the columns of the use in
10. OC Technical Reports 107 and 114 together with the Addendum to 114 Technical Report 124 The ECETOC TRA v3 1 uses colour codes to mark the differences between data fields For that reason it is recommended to obtain a multicolour print of this user guide Subsequent to the 2010 REACH registration the ECETOC TRA v2 was developed to account for exposure assessments needing to be refined based on the scientific basis described in the ECETOC Technical Report 107 and 114 TR 107 and TR 114 ECETOC TRA v3 which implements many of the refinement options outlined in TR 107 The introduction of v3 1 of the TRA enables the exposures and risks associated with the infrequent consumer uses of substances to be better the addressed The ECETOC TRA integrated tool offers the exposure and risk assessment for workers consumers and the environment in one single tool the so called integrated tool or ECETOC TRAM In addition the consumer assessment tool is available as a Standalone version Manual and Batch Mode The ECETOC TRAM can be operated in a manual and a batch mode In the manual mode assessments are performed and saved one by one In the manual mode one substance can be assessed with fifteen scenarios in one single run The batch mode allows for serial assessments Both modes are administered via the datasheet Interface Data Entry Data entry can occur via the Interface or via the datasheets of the ECETOC TRAM Assessments in the batch mod
11. a manual assessment of one substance Run button in cell E 22 or to run a batch process For batch processes all assessments for human health worker and consumer and environment can be performed using the Run batch button in cell E 26 to calculate the exposure and risk for several substances as entered into the datasheets Alternatively assessments for human health or environment can be run separately by using the Run batch Human health or Run batch Environment button both in cell E27 This may reflect the work process in companies or just speeds up the batch run if e g refinement of only one part is required New features included in version 3 1 are the options to export and import data sets for single substances from into datasheets To export the parameters for a substance select the substance from the drop down list in cell 124 this is equivalent to the list in the Contents sheet and click on the macro Export substance to the right cell J24 25 Click on Delete when prompted The toll has now created an Excel file Book lt x gt with one sheet named Import containing the data substance data and assessment parameters only no results of the selected substance in the structure of the TRAM datasheets This can be saved under a name of your choice and used for sharing This is also the file structure required for the import function NOTE do not re name Page 4 User Guide for
12. ace area ACS subcat type for Contact Area Contact Area art exposed Area cm Area cm mouthed default assessment 210 0 428 8 857 5 Jar 35 7 35 7 15 428 8 For dermal exposure the selection of two additional body parts two fingertips and palm of one hand was included Parameters in columns S are only applicable for AC5 when 5 default was selected in column R Column S fields will then turn from grey shading into active cells with entry options from drop down Page 13 User Guide for the TRA integrated tool TRAM version 3 1 Figure 6 4 Inhalation part of the input area for new sub categories in the consumer sub module sheet Add Subcategories Place of use select indoor or Amount Product outdoor from TF Inhalation used per Exposure drop down Application Time default is 0 lt value lt 1 COMMENTS Enter your justification here New parameters are the Place of use and the specification of a Transfer Factor TF for inhalation NOTE For using the New sub categories created in the Add subcategories sheet in the Consumer sub module in the batch processing of the datasheets in ecetocTRAM xls master file it is required to add the recently created New sub categories to the selection lists in the ecetocTRAM xls file by clicking the macro button Finish new subcategories on the Add subcategories sheet If one of the New sub categories is then sele
13. ad Retrieve Assessment Data from Datasheets into User Interface from Manual Run In manual mode one can read a substance with its scenarios from the datasheets by selecting a substance from the drop down menu in cell D21 and then clicking on Read in cell E21 The data entered into the datasheets for this substance are then transferred to the interface Practical note Only the first 15 worker and consumer scenarios will be read into the user interface limitation of the user interface and only ERC and SpERC inputs for environmental assessments will be transferred no TIER Il assessments ERC and SpERC assessments will be assigned in G114 G128 in the Interface but any TIER Il assessments will be blank as they cannot be operated from the Interface Please note that also the specification of the environmental assessment needs to be re entered in column G because TIER II selection cannot be reflected in the INTERFACE Clear Delete Entries of Single Substance from User Interface To clear all entries of a substance in the Interface click on Clear cell 121 All data visible in the user interface are then removed The cells G114 G128 set to the default assessment ERC and the type of reference value per default set to PNEC or DNEL for environment only Practical note The combination of the Clear and Safe function can be used to remove datasets from Datasheets to create a blank sheet for new entries Batch Mode Wh
14. addressed via drop downs In column M the assessor can set the assessment to consider the effect of local exhaust ventilation on dermal exposure Lines 76 to 79 represent entry fields for reference values against which the calculated exposure will be compared This can be DNELs or OELs or other reference value preferably mg m 3 for inhalation exposure mg 1 kg 1 d 1 for systemic dermal exposure and ug cm 2 for local dermal exposure The type of value may be specified in the field basis for reference value Practical note TRAM version 3 offers the option to do a first estimate for short term inhalation exposure and the related short term DNEL inhalation can be entered here as well Same applies to a long term local dermal exposure assessment 3 6 Part V Data Entry Consumer Assessment Working with existing categories and sub categories Part V Figure 6 1 covers the entries which specifically relate to consumer exposure and risk assessment Up Page 9 User Guide for the TRA integrated tool TRAM version 3 1 to fifteen different scenarios can be entered into the drop down menu fields and free text fields lines 83 97 The scenario name B83 B97 can again be entered as free text Cells D83 D97 are used for the selection of PCs or ACs from a drop down list This drop down list is structured to start with PCs and then ACs that are covered by the TRA with default values and allow TIER assessments for sentinel products or
15. ance Number retrieved 24 to be saved as Ecetoc Substance Number Yellow fields are data entry fields at the top of Part The new export import features are placed on the right side of the Userlnterface sheet Colour Codes for Input Fields Input fields are marked with specific colours as indicated in cells H17 and H18 Yellow cells represent mandatory inputs blue cells represent optional inputs However in some cases e g D44 D48 partition coefficients at least one of the blue fields needs to be filled In addition there are grey fields which do not accept input or do not use any input that maybe made Indicator Manual or Batch Mode Cell D18 indicates whether one operates in manual m or batch mode b This is not an entry field but automatically set by the TRAM if an assessment of one substance is run from the user interface Run button in cell E22 or a batch process is used Run batch buttons in cell E26 or E27 Entering Data into the User Interface for Manual Mode Assessment How to enter the relevant data into the user interface for a manual calculation or for saving them to the datasheets is explained further down for Parts Il VI The Clear button can be used to clear any existing Page 5 User Guide for the TRA integrated tool TRAM version 3 1 entries in the user interface in order to avoid confusion Run Single Substance Assessment from User Interface in Manual Mode To
16. anges will be addressed in Chapter 2 1 2 2 of this user guide Page 1 User Guide for the TRA integrated tool TRAM version 3 1 2 STARTING EXITING THE APPLICATION 2 1 Starting To start the integrated TRA extract the file Integrated tool v3 1 zip into one single folder using WinZip or any other program capable of extracting zip files The folder will then look as displayed in Figure 1 To run the application double click on the file ecetocTRAM xls The tool will then start Enable macros when asked in message box and allow for linking to the remaining eight files They will then open automatically Figure 1 Extracted TRA folder B C ecetoc TRAM Datei Bearbeiten Armichtk Favoriten Extras 7 Qura O B suchen Pr oe EE Adresse jC heceter TRAM Datei und Ordreraufgaben i ecetoc TRAMCcons sis af ecetocTRAMers ide d ecetoc TRAMWork xis ff EUTGOsheet TRAM xis SarpleBox TRAM xls Simple TreatC TRAM xls 28 Sieple Treatl TRAM is 0 Simple Treatht TRAM zis Andere Orte Extract the Integrated tool v3 1 zip into one folder and double click on ecetocTRAM xls to start the application Enable macros when asked in message box The remaining files will open automatically Users of EXCEL 2007 are recommended to manually check all 9 files opened and to enable before entering data into the ecetocTRAM Interface spreadsheet Users of EXCEL 2007 and 2010 have to enable the macros in the ECETOC TR
17. articles or specific sub categories if selected The glossary for PCs and ACs can be found in lines 100 and 101 or in the ECHA guidance R12 Further down in the drop down list all other PCs and ACs are available for the creation of new subcategories see below for more information on new sub categories In E83 E97 one can optionally select a product or article subcategory for refinement The drop downs allow the selection of subcategories depending on the PC or AC selected in column D of the same row For more details on the subcategories please refer to ECETOC Technical Report 93 107 114 together with the Addendum to 114 Technical Report 124 In column F it may be selectable if the product is a spray However there are some categories which can never be a spray or are always a spray The drop down is therefore only active to select yes or no where applicable For more details on this topic see the consumer tool guidance and the report The remaining input cells in this section amount of product used per application product ingredient fraction by weight skin surface area dermal and oral are optional inputs If nothing is specified here default values will be used For more details on the scientific issues and the meaning of the input fields and default values please refer to the ECETOC Technical Report 93 107 and the amendment to TR 107 in preparation Further down in this section cells D105 D107
18. cted for batch processing in the datasheets the respective entry fields in the datasheets are de activated no editing possible All parameter setting can only be done in the Add subcategories sheet 3 7 Part VI Data Entry for Environmental Assessment Part VI Figure 7 covers the entries for an environmental exposure and risk assessment The input via the user interface manual mode offers the possibility to assess exposure using the environmental release classes ERC defined in ECHA guidance R16 or using some more refined specific environmental release classes SpERC as a first step For the environmental exposure assessment up to 15 different uses lines 114 128 each characterised by a combination of life cycle stage tonnage ERC as the use descriptor related to environment column H and a fraction of the tonnage considered for a regional assessment can be considered The scenario name B114 B128 is an optional free text field the entry of the life cycle stage is also optional and several life cycles can be selected from a drop down menu D114 D128 The annual EU tonnage needs to be entered as a number In cells E114 E128 the fraction of the tonnage considered for a regional assessment is selected via a drop down menu For more information on regional assessments please refer to the TRA report and the ECHA guidance Part D and R16 In cells G114 G128 the user needs to select whether he wants to use an ERC or a SpERC as a determi
19. e environment In lines 165 173 refined physico chemical data can be entered and in lines 176 181 degradation and transformation rates can be entered Practical note TRAM version 3 reduced the TIER II inputs for release estimation to release fractions and release rates in kg day and provides fields in lines 109 119 of the datasheets to explain justify the TIER II parameters used for refinement Please note that the RMM efficiency documented in this part will also be used in the generation of scaling parameters Therefore any combined RMMs can be described in free text in the RMM lines but the resulting total efficiency needs to be entered in the efficiency lines If an ERC of SpERC based assessment is to be refined by additional RMMss the release fractions can be picked from lines 153 155 of the original scenario assessed and entered into the TIER Il section of the refined scenario lines 125 127 e g by copy paste special values The additional RMM efficiency can then be directly factored into the refined release fraction using the efficiencies specified in lines 115 117 and or 119 as follows Refined release fraction original release fraction 1 efficieny of RMM Example 2 release in ERC 2 to air to be refined via RMM efficiency in cell D115 Refined release fraction 0 02 1 D115 Page 26 User Guide for the TRA integrated tool TRAM version 3 1 Figure 13 1 Optional input for a TIER Il environment assessm
20. e require that data are entered into the datasheets prior to the assessment In the batch mode up to 60 scenarios can be assessed per substance In addition to the serial assessments the batch mode allows for enhanced reporting or results and supports advanced environmental assessments Alternatively data entered in the Interface may be stored to the datasheets see chapter 3 2 Standard and Refined Assessments Standard assessments can be performed in the manual and the batch mode Advanced assessments available in the manual mode include all refinements of worker assessments generating customised subcategories for consumer assessments and the use of specific Environmental Release Categories SPERCs for environmental assessments These options are also available via the batch mode In addition the batch mode exclusively offers the possibility to enter data to refine the environmental fate modelling partition coefficients between water and various sub compartments and degradation rate constants to derive PNECs following the R16 Technical Guidance and to generate customised emission assessments Working in EXCEL 2007 The ECETOC TRA has been developed in the 2003 version of EXCEL So far it was found that operating the integrated ECETOC TRA from the 2007 version of EXCEL differs from the 2003 version for a small number of operations This is due to the altered structure of the menu setup of these higher versions of EXCEL Some of the ch
21. ed Page 34 ECETOC AISBL Av E Van Nieuwenhuyse 2 box 8 B 1160 Brussels Belgium VAT BE 0418344469 www ecetoc org
22. en processing data in the batch mode one needs to enter the starting substance number into cell 126 and the last substance to be processed into cell K26 of the interface The substance number is the number under Page 6 User Guide for the TRA integrated tool TRAM version 3 1 which a substance is stored in the datasheets The sheet contents gives an overview which substances are stored in the data base and where By clicking Run batch in cell E26 the tool starts to calculate all scenarios entered into the datasheets for the selected substances Alternatively assessments for human health or environment can be run separately by using the Run batch Human health or Run batch Environment in cell E27 Standard vs Advanced Cell 127 allows the user to select Standard or Advanced form of the Batch mode This only applies to environmental assessments Using the advanced mode more detailed results for the environmental assessment will be shown e g PECregional compare output list on datasheets line 517 and below It is also required to derive PNEC by the model based on ecotoxicological data inputs in the datasheets line 188 Practical note A single substance can be run by entering the substance number in both cell 126 and K26 The results of the batch mode runs will be displayed in the respective area of the datasheet from row 444 onwards assessed scenarios by column Selective assessment of e
23. ent with release estimates based on release fraction displayed example e g from OECD emission scenario documents or release rates e g from measured data not populated in example 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 Select approach ERC Select approach spERC TIER Il Assessment Approaches Select approach using SPECIFIC RELEASE FRACTIONS Select appraoch using MEASURED DATA releases in kg day ECETOC TRA FLAT DATABASE INPUT TIER 2 Justifications for refined release parameters Basis used for refinement e g ERC SPERC Fraction of EU tonnage to region modified in line 78 Daily amount used at site kg d Release times per year d year Local release to air RMM Local release to air efficiency of RMM Local release to sewage RMM beyond STP Local release to sewage efficiency of RMM Local release to soil RMM Local release to soil efficiency of RMM RELEASE ESTIMATION BASED ON SPECIFIC RELEASE FRACTIONS Comments 1 Comments 2 Daily amount used at site kg d release fractions Release times per year d year Local release fraction to air Local release fraction to sewage Local release fraction to soil RELEASE ESTIMATION BASED ON RELEASE RATES e g measured data releases in kg day Daily amount u
24. expanded mode The Expand Collapse function will also apply to the PNEC results area in the results section of the datasheets Page 28 User Guide for the TRA integrated tool TRAM version 3 1 Figure 14 Optional input for PNEC derivation based on eco toxicological data og Microsoft Excel ecetoc TRAM xls 8 File Edit View Insert Format Tools Data Window Help ecetocTRAM ecetocTRAM DETRAN i Aau da iia Sa 3 183 Open PNEC derivation area 85 185 TOXICOLOGICAL SUBSTANCE PROPERTIES r 86 186 Toxicity to micro organisms mg 1 Hide PHEC derivation area 871187 Respirotion bition EU Annex VC 11 OECD 209 ECSO for micro organisms in an STP i u 1 ieres race ae Expand button N or micro organisms in an STP n Dose set tests nisms in an STP ali tstemroaqnansnarste Collapse button sin an STP ganisms in an STP 71207 Growth f Growtrt The PNECs are derived the same way as within EUSES or the TGD Excel Spreadsheet model Practical note Alert Upon pushing the button Open PNEC derivation area line 183 the screen moves to the far left i e the columns of the first substance in the respective datasheet Hence make sure to input the data into the correct substance i e check that the inputs are made into the correct columns 5 3 Output within the Datasheets The output within the datasheets is structured in the same way as the input worker consumer environment TIER follo
25. fields the respective results of the calculation are shown after the run button was activated and the scenarios were calculated Displayed is the calculated exposure for the different routes and the resulting risk characterisation ratio Red fields indicate an RCR gt 1 green fields indicate an RCR lt 1 Page 19 User Guide for the TRA integrated tool TRAM version 3 1 Practical note The total exposure for human health was removed from the report and only the total RCR is reported in version 3 However important comments remarks regarding the predicted exposure is now provided to the user in column R Particularly the effectiveness of LEV for inhalation exposure and dermal exposure where applicable is reported 4 2 Output of the Consumer Exposure and Risk The consumer results are structured in the same way as the worker results with one specialty Columns N V show the results calculated for the product subcategories if a product or article subcategory was specified and columns X AF show the results calculated for the sentinel product categories if no product or article sub category was specified Figure 9 For details on subcategories and sentinel products please refer to the user guide for the consumer tool and the TRA report Figure 9 1 Consumer output fields for Product Subcategory in the user interface OUTPUT BY PRODUCT SUBCATEGORY Risk Risk Risk Inhalation exposure Dermal exposure mg kg Oral exposure In
26. for ERC default is Yes unless for ERC 1 7 Life cycle stage Annual EU Tonnage tonnes year ERC 8 11b 0 1 approach cases as use descriptor jand 12a 12b direct discharge is given Manufacturing Formulation Formulation Formulation Processing Processing Processing Figure 7 2 Part VI Environmental exposure assessment input SpERC related input for spERC approach for information Msperc kg d used if Wide dispersive use spERC select appropriate spERC Remark check on spERCs not overwritten in WDU automatically set Industry sector for spERC default STP setting is linked to spERC selection column L by ERC selection no no AISE SPERC 2 1 a v1 CEPE SPERC 2 1a v1 CEPE SPERC 8a n v1 CEPE SPERC 5 na vl Check spERC vs ERC The daily amount used at a site kg d may be entered for point source assessments If there is NO Meperc defined the cell is formatted in yellow indicating a mandatory input example CEPE SPERC 2 1a v1 If a M lt sperc is defined the cell is formatted in blue indicating an optional input example AISE SPERC 2 1a v1 Msperc is 16700 kg d If ERCs or SpERCs for wide dispersive uses are selected the cell is formatted in grey no entry should be done will be ignored Note The last SoERC selected was not a refinement of the selected ERC use descriptor and the warning message alerts the user to check for consistency Page 17 User Guide for the TRA integrated tool TRAM version 3 1
27. g substance 1 5 9 etc in batch mode is not possible 3 3 Part Il Identification of substance Part Il Figure 3 asks the user to enter required data for the identification of the substance to be assessed like substance name and CAS number Figure 3 Part Il Identification of substance Lel Microsoft Excel ecetocTRAM xls JEE 0 Eile Edit View Insert Format Tools Data Window Help ecetocTRAM T tion for h T FX Oelde NEA Oe mere rf KEREN U Bi z0 g LE EE er Pr Arg le de Sed man a 5 A1 v fe SUBSTANCE USE A UNIQUE NAME FOR EACH SUBSTANCE Test_1 for user guide Identification of use Use as an example General description name Assesment identifier Test_example_version1 CAS no 1111 22 3 Assesment date 23Dec2011 en Comments Demo for user guide Cell D30 SUBSTANCE is a mandatory input Here enter the substance name under which the substance will be saved in the datasheets The name needs to be unique Cell D32 is for entering the CAS No of the substance This field is also mandatory All other cells in this section are optional entries general name of the substance CAS No EC No identification of use assessment identifier assessment date and comments PCs PROCs ACs are entered in the respective human health parts further down because they directly determine the assessed scenarios 3 4 Part Ill General physico chemical data entry Part Ill Figure 4 is the screen for entering general physico
28. geer er ieTeLAR geet EAN o x eee ENE NS es ee BoE ril il A fia oe ee ee ee ee AE Der oe ee oe a ee i EEEN Lia we l Tal a ee z Teer etn A Perim p rera En Em e beg i p r Paimets a m pn Liila ir n ra Bnn hm M aa i De mn d Bita BADEN fian F u i Faasi Tisd APD idari l z Lil 1 Passe Frar Ln a mo oa a wy me T as r _ i ha T _ EE a ue Er eee nd me i h ma g Fa ee a eed i londi o ora Dde fab din mo a denise ii ee eee ee a a a eee m Ara ET iaa mp jener daneerener fas eee ne Lm EPE E og BIE Den dee el Be Lapan ka ghedaen Peon selon ensen Heise gani Mi z P ea mme en en nn ee peer eee Ls bl def Pe Pe oa Ca Inl F ti ih EN oR PE B Np pg nl ba T 1 vI nn it naie os 2 rur Ful herme Le f a a e r 5 de nj A NEEN contbits e Uea omeen dnar cicusteets f ofa Oran of ee e A mo O dd dak Ceria hik Peg store i pe X GD Frani Sctreecter i F Agencia hs i Fi bom rn DE i et Pgs rn The environmental input is also set up in the same way as the human health input fields There is an optional free text entry field for a descriptive use name and a drop down field for the selection of a life cycle stage The annual EU tonnage is entered per life cycle stage also the fraction of this tonnage that goes into the region Here a value of 1 100 or 0 1 10 can be selected in line with the ECHA guidance document R1
29. h mode CPU and RAM of your PC The TRA uses as much CPU power as it can get This means that during a large batch process it may happen that other work on the same computer may be very slow However if you have a multi core CPU the TRA uses only one core and other work on the same computer should not be affected too much It may also happen that the TRA requires a lot of memory RAM during operation 100 MB or more depending on the number of entered data especially when running a large batch process Country settings of your windows system Please be aware that the country settings of your windows system may have an influence on the operation of the TRA Lines 102 103 and 105 106 of the datasheets have a drop down selection of true and false for example for the approach you select for the environmental assessment ERC SpERC release fractions release rates If your computer uses a different language than English problems might occur because true and false are not the right words for your computer If you cannot change your language and country settings to English a workaround is to copy and paste the terms in your computers language into the fields rather than selecting them from the drop down menu TIER II data TIER Il input data can be given for refining the assessments in lines 110 181 in the datasheets Please consider that inputs made in these lines will only be taken into account when using the ru
30. halation exposure Risk Characterisation Characterisation Characterisation Characterisation mg kg 1 d 1 1 day 1 mg kg 1 day 1 mg m 3 Ratio Inhalation Ratio Dermal Ratio Oral Ratio Total 1 78E 00 1 88E 00 In the columns adjacent to the consumer input fields the respective results of the calculation are shown after the run button was activated and the scenarios were calculated The calculated exposure for the different routes is displayed and the resulting risk characterisation ratio for the sub categories Red fields indicate an RCR gt 1 green fields indicate an RCR lt 1 Note Empty line may occur if no sub category was specified and thus only results for sentinel products were calculated see Figure 9 2 Page 20 User Guide for the TRA integrated tool TRAM version 3 1 Figure 9 2 Consumer output fields for Sentinel Products in the user interface OUTPUT BY SENTINEL PRODUCT CATEGORY Risk Risk Risk Inhalation exposure Oral exposure Inhalation exposure Dermal exposure Characterisation Characterisation Characterisation Risk Characterisation mg kg 1 d 1 mg kg 1 day 1 mg m 3 mg kg 1 day 1 Ratio Inhalation Ratio Dermal Ratio Oral Ratio Total Exposure In the columns adjacent to the consumer input fields the respective results of the calculation are shown after the run button was activated and the scenarios were calculated The calculated exposure for the different routes and the resulting
31. ility was measured degrees C 169 Melting point degrees C 170 Solids water partition coefficient raw sewage sludge I kg 1 171 Solids water partition coefficient settled sewage sludge l kg 1 172 Solids water partition coefficient activated sewage sludge I kg 1 173 Solids water partition coefficient effluent sewage sludge l kg 1 174 175 DEGRADATION AND TRANSFORMATION RATES 176 Rate constant for degradation in STP d 1 177 Total rate constant for degradation in surface water at env Temp d 1 178 Total rate constant for degradation in marine water at env Temp d 1 179 Total rate constant for degradation in bulk sediment at env Temp d 1 180 Rate constant for degradation in air d 1 181 Total rate constant for degradation in bulk soil at env Temp d 1 Also some additional physical chemical data and degradation rates can be entered for a refined assessment PNEC Derivation analogous to EUSES Lines 183 441 offer the possibility to enter data for deriving the PNECs in the same way as it was done in the TGD Excel spreadsheet version of EUSES Figure 14 This option is only available in the advanced batch mode However many users will have derived PNECs outside of the TRAM and will not use these rows Therefore a new feature was added to expand the related rows in the input and output by a macro button in line 183 To collapse the PNEC derivation area a second button is available in line 186 only visible in
32. input parameters of the TRA The datasheets interact with the user interface via the read and save buttons Since the user interface does not cover all cells which can be filled in the datasheets only those reflected in the user interface can be read via the read button and be saved via the save button i e worker scenarios 1 15 consumer scenarios 1 15 and environmental scenarios 1 15 Page 23 User Guide for the TRA integrated tool TRAM version 3 1 Figure 11 1 Upper part of a datasheet with worker inputs ECETOC TRA FLAT DATABASE INPUT TIER 1 Identification of Substance SUBSTANCE General detcription 0 A no EL no a Hentificatian of ute Assesment identifier Assesment date Comments Physical chemical properties minimum input for Human Health and Environmental Assessment Molecular weight gma1 Vapour pressure Pa temperature range 15 25 C temp can be specified in line 166 Water solubility mgJ 1 temperature range 15 25 C temp can be specified im line 168 3 Kow a Bodegradahdity test result Chemical class far Koc t 54R Koc lkg 1 7 Partition coefficient kinywa Legi j Parion gpefficient kaimanan leg 1 Partition coeflicient to suspended solids Lig 1 i2 Workers scenario number Scenario name Process Category PROC pType Of setting PROC 7 and 22 abways industrial PROC 11 and 20 always professional b substance a sold yes na Bustimess of solids highimedums
33. it ici l ion coe fficient kusiiustee Elko optional can be estimated by QSAR Partition coefficient ke saraizuater Lkg optional can be estimated by QSAR Partition coefficient to suspended solids L kg optional Additional physico chemical parameter input for refined environmental assessment TIER 2 Input of additional PC data go to row 165 of datasheets Lines 39 to 48 cover the entries of substance specific data which are of general relevance for the exposure assessment Most fields require the entry of a number These fields are molecular weight vapour pressure water solubility and the relevant partition coefficients Some fields require an input by selection of one option of the drop down menus These fields are Biodegradability test result Chemical class for KOC QSAR and Physical form Special fields are Kow Koc and Vapour pressure besides entering a value the type of value needs to be selected from a drop down menu Kow or logKow Koc or logKoc Pa or hPa The fields displayed in blue are optional inputs however one of the options must be used either a chemical class forKoc QSAR has to be selected or at least one partition coefficient has to be entered Column K indicates where the parameters are used and comments e g on the source of the data can be recorded in column L Cell G50 Input for additional PC data states that additional PC data e g various solid water partition coefficients rate constants for vari
34. le or set in line 125 156 Local release to air kg d will be set to O for WDU see ECHA guidance R 16 157 Local release to waste water kg d 158 Local release to soil kg d will be set to O for WDU see ECHA guidance R 16 159 Regional release from all uses to air kg d 160 Regional release from all uses to waste water kg d 161 Regional release from all uses to fresh water directly kg d Regional release from all uses to soil kg d Additional output is generated by TRAM version 3 1 for the environmental assessments at the bottom end datasheets to correspond to the REACH Chemical Safety Report template ECHA ES format Page 30 User Guide for the TRA integrated tool TRAM version 3 1 Figure 17 Example output of additional assessment results for the environmental compartment for the REACH Chemical Safety Report template A 1 2 ECETOC TRA FLAT DATABASE Drinking water 606 206 Fish elr 207 Leaf crops 308 Root crops 209 Meat 810 Milk Drinking water 4 Fish Drinking water 2 Fish Leaf crops 4 Root crops Milk Leaf crops Root crops Scaling Parameters for Environmental Scenarios Assessed A new output section was added to the TRAMv3 environmental results in order to support the generation of data required for scaling These results are only provided in the advanced batch mode i e via Run batch or Run batch Environment in the INTERFACE with Cell 1
35. mes of the new sub categories can be entered by the user Please make sure to use unique names in order to avoid confusion in the look up functions may return incorrect results Column C supports the user by indicating that a sub category name was already used in the existing sub categories by displaying a red exclamation mark see comment in cell D6 So he just needs to ensure no duplication within column D of this sheet Columns F G K N Q S and V Y allow the entry of an advanced set of model parameters Some of them are the same as used in the user interface before e g column F Product is a spray column K Product Ingredient Fraction by Weight In general the input area is structure to address Product is a spray and Product is a solid for PCs in columns F and G Routes of exposure and differentiation for adults and children in columns H J Product Ingredient Fraction by Weight in column K Frequency of use for all routes in column L Dermal parameters in columns M and N related contact area values returned in column O and P Oral parameters in columns Q R and S related contact area values returned in column T and U Inhalation parameters in columns V Y User comments can be captured in column AB For more details on the use of new subcategories please refer to the updated user guide for the consumer tool version 3 1 and the ECETOC TRA technical report and the addenda to it Page 12 User Guide for
36. n batch mode in the user interface Those data cannot be loaded into the user interface and will therefore not be considered in the run mode PNEC derivation The PNEC derivation can also only be used in the run batch mode not in the run mode Running batch mode for a single substance Some functions like PNEC derivation or TIER II data are only taken into account by the tool if run batch is selected in the user interface If you want to use these functions you need to calculate your substance s via the run batch The run batch can be used for many or for just one substance Just specify the starting substance and the last Page 33 User Guide for the TRA integrated tool TRAM version 3 1 substance to be calculated in the user interface cells 126 and K26 If you want to run a batch for just one substance the start substance number cell 126 and the end substance number K26 are identical Run batch Run model usingbatch made from database From substance ae substance pm pn Differences between the consumers standalone version and the integrated version For sentinel products the stand alone tool allows users to change product subcategory parameters within each sentinel group This could result in changes in the worst case scenario In the Integrated Tool users cannot change product subcategory parameters within each sentinel group so the worst case scenario is always fix
37. n button in cell D98 Row 92 shoes an example of a new sub category selected for assessment with the entry cells for model parameters labeled to prevent user from entering data here Column C also provides the information that data need to be edited in the sub module navigate via button in cell D98 Practical note Reference values for consumers entered in this section are used in the environmental assessment to compare with oral and inhalation exposure of man via the environment Creating New Sub Categories Working with new sub categories Columns D and E are set up to select new subcategories defined by the user and calculate the results in the assessment as for the existing TRA sub categories i e one or more of the rows in the user interface maybe a new subcategories while other are existing ones It is the intention that information available from the activity coordinated by DUCC DUCC SCED Guidance and intended to generate Specific Consumer Exposure Determinants SCEDs for common uses of consumer products is referred to at this stage Before they can be used in the assessment by simple selection in columns D and E they need to be created and populated by the user To do this click on the button Create or edit new subcategory in cell D98 See Figure 6 1 and a macro will take the user to respective work area in the consumer sub module sheet Add Subcategories In the sheet Add Subcategories a second macro can be activa
38. n to navigate to the consumer sub module to create or edit new sub categories is located in column B cell B53 Page 24 User Guide for the TRA integrated tool TRAM version 3 1 Figure 11 2 Consumer input part of a datasheet Microsoft Excel scetoc TRAM xls I Bie Eat Vier Insert Format Tools Data indo H INEA RENE ENA el E E hale AE 445 gt bt en EA70 r fe B 2 2 ECETOC TRA FLAT DATABASE One use is represented in one column pink ellipse Yellow fields are mandatory inputs blue fields are optional as in the user interface Button to navigate to the consumer sub module is in cell B53 5 2 Datasheets Entering Input for Advanced Assessments Emission Assessment via Datasheet All entries for refinement are formatted as optiona but are required for TIER Il exposure assessments i e not required for ERC or SpERC based assessments In the datasheets the daily site amount for SpERCs may be entered in line 79 Msperc would be reported in line 89 and a related message in line 90 following the same logic as described for the Interface For TIER II assessments the daily site amount is entered in lines 123 and 130 Where a daily site amount Msite in kg d is entered and this also applies to SoERCs where applicable Fmainsource is calculated as Msite EU Tonnage 1000 Fregion Temis OR Msite Tregion 1000 Temis The selection of the release estimation method ap
39. nant for the exposure assessment If ERC is selected here column of the environment section need to be filled to specify if there is a sewage treatment plant considered for this ERC column 1 A glossary for the ERCs can be found in line 131 and the ECHA guidance document R16 If SpERC is selected as emission assessment method in column G the organisation industry sector for which the SpERC is relevant is selected in column J In column K the particular SPERC is selected for the assessment All SpERCs are based on the assumption that a municipal STP is available for wastewater treatment Hence for SPERC assessments column I can be left empty Page 14 User Guide for the TRA integrated tool TRAM version 3 1 Amounts Used For specifying Daily amount used at site kg d for SoERC assessment column L for point sources several scenarios are possible the emission assessment is based on an ERC the cell in column L is grey and no entry is possible The Daily amount used at site kg d for SoERC assessment is derived based on Chapter R16 of the ECHA Guidance the emission assessment is based on a SPERC for which no value of Mspgrc is specified the cell in column L is yellow A value must be entered the emission assessment is based on a SPERC for which a value of Msprrc is been specified the cell in column L is light blue The value of Mspgrc displayed in column N It can be overwritten by entering a value into column L
40. of Results in the User Interface 4 1 Output of the Worker Exposure and Risk 4 2 Output of the Consumer Exposure and Risk 5 Oo WO O N N N DM DW O OA O A MH m e m e 14 15 19 19 20 User Guide for the TRA integrated tool TRAM version 3 1 4 3 Output of the Environmental Exposure Risk and Safe Amount for Handling Msare 5 Datasheets 5 1 Datasheets Entering Input for Standard Assessments 5 2 Datasheets Entering Input for Advanced Assessments Emission Assessment via Datasheet Refining Environmental Assessments beyond SPERCs Refined Physical Chemical and Degradation Data PNEC Derivation analogous to EUSES 5 3 Output within the Datasheets Interim Results of the Environmental Emission Assessment Scaling Parameters for Environmental Scenarios Assessed 6 Practical Considerations for Users Microsoft Windows clipboard CPU and RAM of your PC Country settings of your windows system TIER II data PNEC derivation Running batch mode for a single substance Differences between the consumers standalone version and the integrated version 21 23 23 25 25 26 28 28 29 30 31 33 33 33 33 33 33 33 34 User Guide for the TRA integrated tool TRAM version 3 1 1 INTRODUCTION This User Guide is to help the reader in operating the ECETOC TRA v3 1 integrated tool This User Guide does not provide guidance on the technical basis for the TRA For that the reader is referred to the ECET
41. offers no warranty cither to the reliability of the tool and of the provided information or to the conclusions or assumptions made br of the use of this tool or the use of such information All usage is at the discretion of the user and ECETOC iz not liable for any consequences resulting from such use Operation mode Entry guidance manual batch m b automatically zet by system Optional entries b Read ECETOC substance from database Read substance info from data base for manual input via interface Oeser Clear input and output data Run model with the input data from the interface o zo op i Imports ONE substance in datas 2 Save as new substance in database moetst Import TRAYS format into fi 4 ComsTest Exports s za rd cell left in 25 Batch datasheet 26 Run zeten Run model using batch mode from database From substance d en to substance Batch mode extends the number of scenarios per substance from 15 to 60 Entries need to be in the Note Advanced mode shows me datasheets direct entries on datasheets or from user Run beten Humen hesith assessment e g PECregional interface by the Save function The riliat Select Standard or Advanced version of the ene and below It is alzo required to estimation for the environment iz also extended Run batch Environment batch mode ecotoxicological data inputs in t ar drs and spERCs to three additional TIER scaling information to support approaches 22 23 Ecctoc Subst
42. ol TRAM version 3 1 5 DATASHEETS The datasheets consist of 20 tabs in the ecetocTRAM xls called datasheet1 to datasheet20 Each datasheet offers the possibility to save four substances with up to 60 contributing scenarios for worker and consumer and up to 24 scenarios for environment In total up to 80 substances with up to 60 uses for consumer and worker and 24 for environment can be saved in the datasheets Substances can be saved there via the save button in the user interface limited to 15 uses or by direct entry into the datasheets Entering data directly into the datasheets is for advanced users and offers also the possibility to enter data which might become necessary for a refinement The datasheets offer the possibility to enter more detailed physico chemical data environmental fate data and eco toxicological data for deriving PNECs 5 1 Datasheets Entering Input for Standard Assessments The upper part of the datasheets is structured in a similar way as the user interface Figure 11 The first part is the identification of substance followed by the basic physico chemical data The next parts cover up to 60 scenarios for worker consumer and 24 for the environment In contrary to the user interface one use is not arranged in one line but in one column e g cells D34 D42 covers the input parameters for the first worker scenario per datasheet Column B of the datasheets contains the description of all possible
43. ous degradation reactions can be entered if a refinement for some reasons will be necessary Those additional data cannot be entered via the user interface They have to be entered directly into the datasheets in lines 164 181 3 5 Part IV Data Entry Worker Assessment Part IV Figure 5 shows the entry fields for worker exposure and risk assessment Fifteen different uses can be entered here lines 55 to 69 each with its own combination of PROC D55 D69 operating conditions and exposure modifying factors The glossary for PROCs can be found in line 72 or in the ECHA guidance R12 The entries to all fields except the optional scenario name B55 B69 which is a free text field need to be done via a selection from drop down menus except a numerical value for vapour pressure in case of an Page 8 User Guide for the TRA integrated tool TRAM version 3 1 assessment for volatile substances at elevated process temperature in column G Further down in this section there is an option to enter indicative reference values D76 or H76 and D77 which can be DNELs or any other reference value TRA version 3 includes also reference values for short term inhalation and long term dermal local exposure H78 and D79 In column Basis of reference value F76 F79 it should be stated which reference value is entered e g DNEL OEL etc For more details on the single parameters please refer to the ECETOC Technical Reports TR 93 and 107 and 1
44. output of one column reflects the result of the estimation for a use put in the same column Interim Results of the Environmental Emission Assessment Lines 151 162 display the results of the emission assessment see Figure 16 The following information is specified per use the amount used locally line 151 the number of days at which emissions occur line 152 the release fractions lines 153 155 to air water and soil respectively these are the release fractions as stated in the ERC or SPERC background tables or set in line 125 of the Datasheet and the local release rate line 156 158 to air water and soil respectively the release rates take into account that for wide dispersive uses the local release will be considered O in accordance with the ECHA Guidance document R 16 Lines 159 161 specify the regional releases to air water and soil which are cumulated over all individual uses These regional releases are used as input to the PECregiona calculation Figure 16 Example output of Interim results for volumes and releases in environment assessments 148 VOLUMES and RELEASES INTERIM RESULTS 149 EU tonnage for use tpa 151 Amount used locally kg d 152 Release times per year d year 153 Release fraction air as in ERC or SPERC background table or set in line 125 154 Release fraction waste water as in ERC or SPERC background table or set in line 125 155 Release fraction soil as in ERC or SPERC background tab
45. ow OF WP of volatiles Pa at process temperature Duration of activity hours day Une of wentilation addresses outdoor ute LEV and Genear ventilation Use of respiratory protection and ff so minimum efficiency 1 Substance in preparation 2 Dermal PPE Glows Consider LEY for dermal exposure conservative default is Ho A Reference value long term inhalation workers mg kg 1 day 1 on Reference vale long term inhalation workers mg m 3 8 hour average Reterence value short term inhalation DMEL mg m 3 15 minute average T Reference value long term dermal workers mg ig 1 diay 1 Reference value long term local dermal workers pg cm 2 Column B contains the description of all possible input and output parameters The structure of the upper part equals the structure of the user interface One use is represented in one column red ellipse Yellow fields are mandatory inputs for exposure parameters blue fields are optional as in the user interface Reference values in column C have been extended to short term inhalation 15 minutes average and long tern local dermal in TRA v3 1 In total the ecetocTRAM xls offers 20 datasheets to cover 80 substances with up to 60 contributing scenarios for worker and consumer and 24 for the environment For the consumer assessment part the same parameters as used in the Interface sheets are available but in columns instead of rows same as for worker assessments The butto
46. proach for environmental assessments in the datasheets is done via 4 drop down cells lines 102 103 and 105 106 Figure 12 Only one can be set to TRUE warning message will appear in line 107 if more than 1 TRUE was selected Page 25 User Guide for the TRA integrated tool TRAM version 3 1 Figure 12 Selection of the release estimation method for environmental assessments in the datasheets TIER I and TIER II 102 Select approach ERC 103 Select approach spERC 104 TIER Il Assessment Approaches 105 Select approach using SPECIFIC RELEASE FRACTIONS 106 Select appraoch using MEASURED DATA releases in kg day 107 ECETOC TRA FLAT DATABASE INPUT TIER 2 only 1 TRUE 108 The example shows the error message returned if two methods were set to TRUE Refining Environmental Assessments beyond SPERCs Lines 109 181 are for entering input parameters for a refined environmental assessment Figures 13 1 and 13 2 In lines 116 the type of RMM is specified as free text In line 117 the associated efficiency of the RMM is entered as numerical value in Lines 121 127 can be used for entering release factors e g from OECD ESDs lines 130 138 for entering amounts release in kg day derived e g from measured data Lines 141 146 cover specific data on sewage treatment plants Line 143 offers the possibility to override the default specify that a sewage treatment plant treats wastewater which is discharged to the marin
47. puts in the same line so that one line always displays the input and the result for a specific use e g line 55 is the first worker use with its PROC and conditions as input in cells D55 L55 and the corresponding results in O55 X55 4 1 Output of the Worker Exposure and Risk The output of the calculated exposures and RCRs for workers can be found in cells 054 to Z69 Column O covers the results for inhalative exposure in ppm column P covers inhalative exposure in mg m and column Q dermal exposure in mg kg day In TRA version 3 short term inhalation in mg m column R and long term dermal local exposure in ug cm column S were included in the assessment If for a certain route inhalative or dermal no exposure can be estimated the result is NV Figure 8 Columns V to Z show the RCRs for the corresponding routes Figure 8 Worker output fields in the user interface Long term Inhalative Long term Risk Risk Risk Risk Exposure Estimate ppm Inhalative Long term Dermal Short term Inhalative Local Dermal Characterisation Characterisation Risk Characterisation Characterisation Characterisation for volatiles mg m3 Exposure Estimate Exposure Estimate Exposure Estimate Exposure Estimate Notes comments on Ratio Long term Ratio Long term Ratio Long term Ratio Short term Ratio Local for solids mg m3 mg kg day mg m3 ug cm2 exposure estimates Inhalation Dermal Total Exposure Inhalation Dermal In the columns adjacent to the input
48. risk characterisation ratio for the sentinel products Red fields indicate an RCR gt 1 yellow fields indicate an RCR lt 1 Note No sentinel product results will be reported for NEW sub categories created by the user see example in row 10 above 4 3 Output of the Environmental Exposure Risk and Safe Amount for Handling Msare The consumer results are structured in the same way as the results for workers There is one exception Besides the exposure or predicted environmental concentrations PECs and the RCRs also the maximum amount for safe handling Msare is shown in columns AA AG Figure 10 For details on this parameter please refer to the TRA report Page 21 User Guide for the TRA integrated tool TRAM version 3 1 Figure 10 Environmental output fields in the user interface PEP Tee PEC fea aral FECR faringa AOF farkagsi larval ECR faa larai SCE dar hureorg eci rr mt FEC Tee lorail reinste mgl FES fot local radimare Aft dar laced matinee vila torheaaringh dng i In the columns adjacent to the environmental input fields the respective results of the calculation are shown after the run button was activated and the scenarios were calculated Displayed is the calculated exposure for the different routes the resulting risk characterisation ratios and the maximum amount for safe handling Red fields indicate an RCR gt 1 green fields indicate an RCR lt 1 Page 22 User Guide for the TRA integrated to
49. run the entered scenarios for the selected substance in the user interface one simply needs to click on the Run button in cell E 22 All input data in the user interface are then transferred to the respective calculation tools consumer worker and environment and are processed Afterwards the results are written back into the user interface into the results cells next to the input cells of each scenario scroll right in each scenario line in the Interface to view results Save Store Single Substance Assessment Data from User Interface to Datasheets To save a substance just entered into the Interface into the datasheets click on Save cell E24 All data visible in the user interface are then transferred into one of the datasheets datasheet1 datasheets20 at the position indicated in cell D24 Datasheet1 contains substances 1 to 4 datasheet2 contains substances 5 8 and so on Practical note The TRAM identifies the first available area substance in the Datasheets for saving the substance information entered in the user interface by checking for the substance name to be empty in the datasheets row 8 columns C BL etc You may use a substance number that had been populated before in the Datasheet by entering empty as the substance name Check whether the TRAM has identified the substance number in D24 of the Interface and you can save the dataset from the Interface to this substance in the Datasheet Re
50. sed at site kg d release rates Release times per year d year Name of Monitoring Site or other source of information Remark Monitoring regime Remark Measured Release to air kg d Measured Release to sewage kg d Measured Release to soil kg d STP PARAMETERS can be used to refine also ERCs and spERCs except for STP yes no Use of local STP yes no Local STP with primary settler Use STP local marine SludgeToSoil yes no River flow m3 d Effluent discharge rate of local STP m3 d Page 27 ERC default ERC default a Oil water separation 0 ERC default eb ke Co 5 o lo m o o J DIe O ollo s ct lt o ilio c lt O H IES gt 3 la olt oI SJS oa wn Ro YIM User Guide for the TRA integrated tool TRAM version 3 1 Refined Physical Chemical and Degradation Data Also some additional physical chemical data and degradation rates can be entered for a refined assessment Figure 13 2 Optional input for a TIER Il environment assessment with release estimates based on release fraction e g from OECD emission scenario documents or release rates e g from measured data 164 PHYSICAL CHEMICAL SUBSTANCE PROPERTIES 165 Vapour pressure at the temperature of the data set Pa from TIER 166 Temperature at which vapour pressure was measured degrees C 167 Water solubility at the temperature of the data set mg l 1 from TIER 168 Temperature at which solub
51. ssion days per year 790 790 Onsite Removal Efficiency Air 3 731 791 Onsite Removal Efficiency Wastewater Pes o B o 792 792 Release rate air after on site AMIE kgiday ENEN 793 723 Felease rate wastewater after on site Bis kgfdau 9 04040401 E See ey 794 794 Municipal Sewage Treatment Plant STP used 795 795 Municipal Sewage Treatment Plant STP removal rate 2 8736699305 8736698356 fe 756 796 On site industrial Sewage Treatment Plant used 7 es LS See aes 797 797 Municipal Sewage Sludge applied to soil ne en 798 738 Risk Driving Compartment Code Re ne 799758 Mare kata 1574398289 315 569065 200 800 Risk Driving ACR Air compartment driven 0008396592 362253E 05 201 801 Risk Driving ACA water compartment driven DBFFAA174 0950663526 Page 32 User Guide for the TRA integrated tool TRAM version 3 1 6 PRACTICAL CONSIDERATIONS FOR USERS There are some known issues which need consideration when using the TRA integrated tool Microsoft Windows clipboard Please be aware that the TRA when calculating uses a number of Microsoft Windows copy paste functions During this time values from different sheets are transferred to the Microsoft Windows clipboard It is strongly advised to not using the windows clipboard during TRA calculation to avoid wrong information being put into the TRA from the Windows clipboard This is extremely important when using the run batc
52. ted by clicking on the button CLICK TO ADD ROWS next to cell B2 Figure 6 2 The user will be asked how many rows i e new sub categories shall be added Please note that rows cannot be removed any more once they have been added Once the model parameters have been entered see paragraph below the new sun category ies need to be added to the drop down for selection in the TRA by pushing the button Finish new subcategories next to cell D2 The user will be taken back to the ecetocTRAM master file and can run the assessments for both existing and new sub categories from the Interface and in batch mode from the datasheets see Page 11 User Guide for the TRA integrated tool TRAM version 3 1 section on batch mode below Practical note Please note that the entry fields for model parameters in the TRA Interface and datasheets will be displayed in different format and the user will receive a respective warning message if a new sub category was selected in order to advise that the parameters for new sub categories cannot be edited in the user interface and datasheets but only in the consumer sub module Use macro to navigate to the consumer sub module and edit existing new sub categories Parameters for new sub categories in the consumer sub module Column B is the same drop down as already known from cells D83 D97 of the Interface for the selection of all PCs or ACs In column D the na
53. the TRA integrated tool TRAM version 3 1 the sheet Import as this is needed for the import function To import substance data from suitable files click on the macro Import substance cell 122 23 select the Excel source file to import the data browse directories as usual if needed and click Open Click Continue when prompted and No in next Window popping up The TRAM identifies the first available area substance in the Datasheets for saving the substance information imported by checking for the substance name to be empty in the datasheets row 8 columns C BL etc compare Safe function further down in this chapter Figure 2 Overview of Part I of the user interface G p ECETOC TARGETED RISK ASSESSMENT MODEL General workflow STEP 1 identification of zubatance uze and ececoment STEP 2 Input of physical chemical parameters a papo M STEP 3 Set up assessments select one or more a b c STEP 4 Safe assessment set up to database or load from database DISCLAIMER Please note that this tool is provided for your personal use only It should not be copied or Forwarded to third partics The tool has been subjected to thorough testing Despite this ECETOC docs not guarantee that the ECETOC TRA tool works error free The tool contains has been provided by third parties ECETOC is making this tool available for users to aid them in the risk assessment of their materials ECETOC
54. there is an option to enter indicative reference values which can be DNELs or any other reference value In column Basis of reference value F105 F107 it can be stated which reference value is entered e g DNEL OEL A special feature here is in cells D105 and H105 where the inhalation reference value can be specified in different dimensions either mg m or me ke d5 Page 10 User Guide for the TRA integrated tool TRAM version 3 1 Figure 6 1 Overview of the consumer input cells in the Interface sheet PC AC sub category For PC only optional for calculating Is product a spray value must be Skin surface area ingestion unitless value must unitless value must subcat outcomes a oral be 0 lt value gt 1 be 0 lt value gt 11 1 some Fingertips 0 1 2 inside hands ome hand palm of hands 0 2 1 some Fingertips 2 inside hands one hand pals fingers one hand 0 05 SCZ CZ CAZEZCZEEEEECEEEECCCCCCCCCECCECEECEECECQQ0EEEAEEEE 1 Create or edit mew sabcategorg Each row represents one contributing consumer scenario Scenario names can be entered in column B PC and AC categories and their related sub categories in column D and E respectively Further parameters are in columns F L Glossary for PCs and AC are in lines 100 and 102 just for reference no model inputs here Reference values e g DNELs for consumers can be entered in rows 105 107 For new subcategories Navigatio
55. w The user interface allows for the exposure and risk assessment of a single substance in several uses for worker consumer and the environment maximum 15 scenarios each The environmental assessment is limited to ERC and SpERC based exposure estimates TIER Il estimates are possible via the datasheets and using the batch mode exclusively The user interface is structured in the following way l General workflow and assessment management i e options for running assessments from the User Interface manual mode clearing entries from Interface retrieval from and storage to the datasheets and batch processing of datasets in the datasheets NEW features in version 3 1 export and import of data sets for single substances from into datasheets II Identification of substance III General physico chemical data entry IV Data entry for worker assessment V Data entry for consumer assessment VI Data entry for environmental assessment 3 2 Part I General Workflow Retrieval and Storage from and to the Datasheets and Batch Processing Part Figure 2 gives a short overview of the general workflow for an assessment A substance from the datasheets can be read into the user interface Read button in cell E 21 or the entered data can be stored into the datasheets Save button in cell E 24 The Clear button in cell I 21 allows for clearing all input and output fields in the user interface The user can select to run
56. wed by environment TIER II Figure 15 Derived PNECs are displayed if the respective area was expanded by using the macro button in line 183 as described above As in the user interface the output is arrange in a way that it related directly to the input The output in a certain column is the result of the estimation for the use put in the same column output of column D is the result of the scenario put in column D Page 29 User Guide for the TRA integrated tool TRAM version 3 1 Figure 15 Output of a worker assessment within the datasheets 444 ECTETOC TRA FLAT DATABASE OUTPUT TIER 1 445 447 Estimate of exposures 448 Long term Inhalative Exposure Estimate ppm volatiles mg m 3 solids 449 Long term Inhalative Exposure Estimate mg m3 450 Long term Dermal Exposure Estimate mg kg day 451 Short term Inhalation Exposure Estimate mg m3 452 Long term Local Dermal Exposure Estimate ug cm2 Notes comments on exposure estimates 453 454 Risk characterization 455 Risk Characterisation Ratio Long term Inhalation 456 Risk Characterisation Ratio Long term Dermal 1 371428571 457 Risk Characterisation Ratio Long term Total Exposure 1 429403571 458 Risk characterisation Ratio Short term Inhalation 459 Risk characterisation Ratio Long term Local Dermal No Local Dermal DNEL No Local Dermal DNEL No Local Dermal DNEL No Local Dermal DNEL No Local Dermal DNEL The output is structured in the same way as the input The
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