Building knowledge from available degradation simulation studies: analysis of the most influential factors & development of a grouping approach

Background

Degradation simulation studies are complex and technically challenging. Additionally, they are used to evaluate a broad range of industrial chemicals, with increasing data/testing requirements e.g. NER, testing temperature. Over the last few years, there has been an increase in requests from ECHA to generate degradation simulation studies in the scope of Dossier Evaluation. Furthermore, the inclusion of the new PMT/vPvM hazard classes within CLP in 2023 (and the guidance revision 2023-2024) and possibly as SVHCs in the REACH revision (2024), will lead to more substances needing a P assessment.

Objectives

• Collect and curate the information available from degradation simulation studies
• Identify the most influential factors driving results in simulation studies, and potential limitations in current test set-up and data interpretation
• Compare screening study mineralisation rates with half-lives in OECD 309 studies
• Build read-across / grouping strategy for persistence assessment

The concepts in the ECHA read-across assessment framework (RAAF), published in 2017, will be considered in terms of the read-across/grouping.

Timeline

The Task Force started work in October 2023 and plans to submit their findings to the ET&C special issue on Simulating Aquatic Environmental Degradation in Laboratory Tests.

Deliverables

• Curated database of simulation studies
• Manuscript describing any correlations using available simulation studies and potential recommendations.
• Manuscript on regulatory relevant read-across / grouping strategy.