Potential impact on Chemicals Risk Assessments - update of ECETOC TRA to version 3.2
In response to the publication of the E-Team project* findings on the evaluation of the available REACH tier 1 exposure models that questioned whether the ECETOC TRA v3.1 worker tool is sufficiently conservative, ECETOC has conducted a systematic review of the validation studies on ECETOC TRA worker exposure predictions as part of their obligations under REACH Review Action 3.2.
The review consisted of identifying the studies that had evaluated ECETOC TRA specifically and retrieving the original publications with the underlying datasets and workplace descriptions. ECETOC determined the TRA estimates for the scenarios with valid datasets based on their best understanding of the data and adopting some necessary corrections such as, for example, assigning a more appropriate process category (PROC) for a given scenario or more appropriate dilation ventilation. ECETOC then evaluated the TRA worker tool performance, including identifying the potential tool improvements.
The outcome of the evaluation of the tool performance was that, essentially, inhalation and dermal estimates are conservative, but for some PROCs, there was an underestimation. Therefore, ECETOC has updated the tool to address the underestimation of specific PROCs, such as for PROC7 and PROC8b when LEV is applied, the efficiency will reduce from 95% to 90%, and for PROC8a (industrial), the base dermal estimate will increase from 13.71 to 27.43 mg/kg/day. ECETOC are also working on publishing a Technical Report entailing the details of the analysis and the tool improvements, including the agreed changes to the dermal and inhalation exposure estimation. The updated standalone version 3.2 of ECETOC TRA is expected to be released early next year by the end of Q1.
Please get in touch with knoell if you would like to discuss or would like us to assess the specific impact this anticipated update of the ECETOC TRA model will have on your registrations.
*E-TEAM project (2014): Evaluation of Tiered Exposure Assessment Models under REACH