July 16, 2024 by Becky Brown

wca have contributed to two new papers on endocrine disruption published last week. The first “A Decision Logic for the Reliability Assessment and Interpretation of Vitellogenin Measurements” we hope will become a valuable resource for our industry and regulatory colleagues as an aide to interpreting vitellogenin measurements in fish studies, where concluding on biological relevance in a regulatory context can be a challenge due to high variability in the vitellogenin response (Brown et al. 2023; Burden et al. 2023). We also hope that this paper can form the basis of some much-needed OECD guidance on vitellogenin methodology and interpretation.

The second “Resource and animal use implications of the proposed REACH information requirements for endocrine disruptor assessment” is a bigger picture analysis of how endocrine disruptor testing may look if introduced under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. It is based on Policy Options from the European Commission and highlights the millions of new animal tests that could be necessary. It also advocates for better use of New Approach Methodologies for endocrine disruptor (ED) assessment.

When considered alongside each other the challenges for ED assessment are clear. There is expected to be an increasing need to conclude on ED for substances to meet obligations to classify for an ED hazard under new  Classification Labelling and Packaging (CLP) legislation but even tests with well established endpoints (such as vitellogenin) can be difficult to interpret. Given the precautionary approach often taken by regulators, and the introduction of a new classification criteria under CLP as a suspected ED, there is expected to be many new substances that could fall within scope. We encourage colleagues to reach out if they need support in conducting ED assessments for their substances.

We thank the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and our industry and government collaborators for choosing to work with wca on these projects. The publications are open access, and we hope that you will take the opportunity to read them. Please do not hesitate to contact myself (becky.brown@wca-consulting.com), Rhiannon (rhiannon.smith@wca-consulting.com) or Grace (grace.panter@wca-consulting.com) if you have any questions on the papers or want to find out more about our services.

Further related wca blogs:

Conducting and interpreting vitellogenin measurements in fish for regulatory purposes

Detection of anti-androgenic activity of chemicals in fish studies: a data review

New EU hazard classifications for ED, PBT/vPvB and PMT/vPvM

Not Just Another NAMs meeting – NAMs from Aspiration to Implementation

Image credit: iStock.com/GlobalP