TOX/2025/42 - Annex A

Lessons learnt from case studies

Annex A to TOX/2025/42

Last updated: 08 October 2025

This is a paper for discussion. It does not reflect the views of the Committee and should not be cited.

20.               These case studies illustrate diverse approaches to Steps 3 and 4 of the read-across framework.

21.               Case studies 1 and 2 primarily applied cheminformatics methods, leveraging the fact that their general MoAs are known. In contrast, case studies 4 to 6 addressed more specific MoAs and therefore focused on AOP communality between target and source substances. This communality was supported by various NAMs. Additionally, the OECD IATA case studies included a standardised uncertainty table. Case study 3 explored multiple combinations of chemical similarity, biological NAMs, and physiologically based kinetic modelling to support the read-across.

22.               EFSA concluded that the selection of case studies demonstrates how read-across strategies can be tailored to address specific scientific questions. The importance of systematically analysing uncertainty was emphasised.

Secretariat

September 2025