Risk Assessment Tools

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I. Integrated GSSMaker (Support tool for risk assessment and creation of the GPS Safety Summaries)

1. Download Integrated GSSMaker and ECETOC TRA Tool

(1) Download Integrated GSSMaker
Click the file icon below to start the download of Integrated GSSMaker. (Zip format)

GSSMaker_3.1jp_v1g_20170720_20181231Limit.zip (TRA 3.1 compatible, Japanese version) [Registered Users Only]
GSSMaker_3.1en_v1g_20170720_20181231Limit.zip (TRA 3.1 compatible, English version) [Registered Users Only]

The following are the updates since the previous release.
Date of update Contents of update File in
Japanese
File in
English
2014/09/27 ·Integrated GSSMaker was updated to be compatible with the TRA 3.1, following the release of ECETOC TRA 3.1.
·o Display of the phrase options for exposure and risk management measures was added to the auto-created GSS sheet to enable the users to see and enter the appropriate phrases from the options.
GSSMaker_3.1_v1c_140917.zip
2014/12/11 ·Among the SPERC codes of the scenario parameters for environmental exposure assessment, the selectable codes were made clear, along with the addition of a description for each code.
·Display of the checkpoint for TRA calculation when RCR ≥ 1.0 was added.
GSSMaker_3.1_v1d_141217.zip
2015/04/16 ·Corrections were made for the log Kow value check and the check logic used when some standard values are missing.
·English version was released.
GSSMaker_3.1jp_v1d_150416.zip GSSMaker_3.1en_v1e_150416.zip
2015/04/28 ·Small bugs in the English version were corrected. GSSMaker_3.1jp_v1d_150416.zip
(No changes from 2015/04/16 version)
GSSMaker_3.1en_v1e_150428.zip
2015/06/22,24 ·Errors, found in the part of the Japanese text of PROC (some parts after PROC18) in the PROC pull-down menu for risk assessment for workers in the Japanese version of Integrated GSSMaker (Version: v1d_150416 or older), were corrected as Version: v1d_150619. (The errors were confined to the translated Japanese texts, and therefore the calculations had been performed based on the selected PROC# (code) even before the errors were corrected.) Please accept our apologies for any inconveniences caused.
·Parts of the inscriptions and the small bugs were corrected after the overall inspection of Integrated GSSMaker. (for both Japanese and English versions)
GSSMaker_3.1jp_v1d_150619.zip GSSMaker_3.1en_v1e_150619.zip→
GSSMaker_3.1en_v1e_150624.zip
2016/04/28 ·Errors in displaying units and exposure scenarios were corrected. GSSMaker_3.1jp_v1f_160428.zip GSSMaker_3.1en_v1f_160428.zip
* Compatible with the ECETOC TRA Tool Version 3.1 (the latest version as of April 2015).
   Please note that this version of Integrated GSSMaker does not operate normally with any other versions of the ECETOC TRA Tool.
* GPS Safety Summaries (GSS) created by Integrated GSSMaker are not guaranteed by the JCIA. The contents of the GSSs should be verified sufficiently and published at the discretion of each company.

(2) Download the ECETOC TRA Tool
The ECETOC TRA Tool must be downloaded in order for Integrated GSSMaker to operate.
Please download ECETOC TRA from ECETOC website.

http://www.ecetoc.org/tra

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2. Procedure Manuals for Integrated GSSMaker

The procedure manuals for Integrated GSSMaker can be accessed at once in the PDF file below.

Procedure Manual for Integrated GSSMaker

STEP (1) Download the ECETOC TRA Tool

•Download the TRA Tool as stated above.

STEP (2) Enter the location where the TRA Tool is saved

•Enter the location (folder address) of the downloaded TRA Tool in the "Path to the TRA ver. 3" section (Cell D4) of the "Settings" sheet.
(Overwrite the temporary value entered.)

STEP (3) Select a Calculation Mode

•Select a mode from the three types of calculation mode available on the top right of the "Main" sheet. The three types of mode are as described below.
Mode Settings Calculation mode for TRA
Physicochemical properties Workers Consumers Environment
TierI-
Easy mode
Required Parameters Required Parameters Required Parameters Calculation based on the ERCs manual
TierI-
Normal mode
Required Parameters + Options Required Parameters + Options Required Parameters + Options Calculation based on the ERCs + Calculation based on the SPERCs manual
TierII Required Parameters + Tier I options + Tier II options
(Melting point, decomposition rate, etc.)
Required Parameters + Options Required Parameters + Options Calculation based on the ERCs + Calculation based on the SPERCs + calculation using the amount of release, secondary toxicity risk assessment batch

STEP (4) Enter the name and information of the chemical substance and build scenarios

•In the "Main" sheet, enter the name, physicochemical properties, and hazard information of a substance (default values are entered automatically when selecting a substance name from the pull-down list) and build scenarios.
•When physicochemical properties and hazard information are entered manually on the left side of the stored default values, the manually entered values are used for the calculations, instead of the default values.

STEP (5) Perform the TRA calculation and confirm the results

•After entering all the information in STEP (4), press the "Run TRA" button at the bottom of the sheet. The TRA tool is launched and the calculations are performed.
•Once the calculations are completed, the risk characterization ratios (RCRs) on the "Main" sheet are updated. The RCRs are displayed in blue when RCR < 1 and in red when RCR ≥ 1.

STEP (6) Create a GPS Safety Summary (GSS)

•After confirming that all the RCRs are less than 1, click the "Create GSS" button at the bottom of the "Main" sheet. A GPS Safety Summary (GSS) is created automatically.
•The "GSS" sheet appears once the GSS creation is completed.
•The contents of the GSS can be edited. After editing, copy and save the sheet.
(The contents of the "GSS" sheet will be overwritten the next time you click the "Create GSS" button.)

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3. Q & A for Integrated GSSMaker

[Operations]

Why can't I click the buttons (such as the "Help" and "Run TRA" buttons) on the "Main" Sheet of Integrated GSSMaker?
Excel macro may not be activated.
The message stating "Security Warning: Some active content has been disabled" is displayed at the top of the screen when a file is opened. Click the "Options" button at the right side of the message. Then, select "Enable this content," and click "OK."

The message stating "This workbook contains one or more links that cannot be updated" appears when I activate macro after opening Integrated GSSMaker.
Click "Continue."
This does not affect the risk assessment and Integrated GSS creation.

The error message stating "Cannot find C:\---. Make sure you typed the name correctly, and then try again" is displayed when I click the "Run TRA" button on the "Main" Sheet.
The path to the folder in which the ECETOC TRA Tool is saved needs to be entered in the "Settings" sheet screen. Copy the path found at the top of the folder and enter it in the "Path to the TRA ver. 3" section (Cell D4) of the "Settings" sheet. Do not forget to put "\" at the end of the path.

Why can't I select some categories of the "Scenario Settings" on the "Main" sheet even when they are defined in the REACH Use Descriptors*?
* PROC: Process Category, PC: Product Category, AC: Article Category
Some use descriptors cannot be selected in Integrated GSSMaker because they are not supported in the ECETOC TRA Tool, which is the basis of calculations for Integrated GSSMaker. Please choose the code closest to the exposure format from the selectable use descriptors.

[Flow of process]

What do Tier I (Easy Mode, Normal Mode) and Tier II Mode on the “Main” sheet mean? Which Mode should I select?
The following are the expected scenarios for each mode.
[Tier I - Easy Mode]
·You do not know about risk assessment well but want to try the whole process from risk assessment to GSS creation.
·You want to perform a risk assessment of a substance known to be safe.
[Tier I - Normal Mode]
·You want to build the exposure scenarios in detail and run a risk assessment.
·You want to use SPERCs for detailed assessment because the risk characterization ratio (RCR) derived in the Easy Mode exceeded 1.
[Tier II Mode]
·You are familiar with the TRA Tool and want to assess risks by setting all the parameters in detail.
·You want to use the actual amounts of releases, such as a PRTR release amount, in the assessment because the risk characterization ratio (RCR) derived in Tier I - Normal Mode exceeded 1.

Which values should I set for hazard reference values?
Go to the "Risk Assessment Practice" tab at the top of the screen and find "How to Derive the Hazard Assessment Values from Key Studies" section. How to calculate hazard reference values (hazard assessment values) using the existing hazard assessment reports is explained in the PDF file in this section.

[Assessment Results]


TRA calculation resulted in an RCR (Risk Characterization Ratio) > 1, but I don't know how to deal with the results.
Please see the suggested how to deal with the result by checking the checkbox of "Points to Check when RCR > 1" under the "Run TRA" button, and displaying the points to check in a popup balloon. Uncheck the checkbox to make the balloon disappear.
If the RCRs for workers exceed 1, go to the "Risk Assessment Practice" tab at the top of the screen and find the section titled "In Case RCRs for Worker Exposure Exceed 1 in the TRA Calculation." The PDF file in this section contains a table that summarizes which options for worker exposure scenarios change RCRs and by how much (sensitivity analysis results). Please refer to the table when redefining an alternative scenario.

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Disclaimer

Disclaimer

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