Case Study on the Use of Integrated Approaches for Testing and Assessment (IATA) for Chronic Toxicity and Carcinogenicity of Agrichemicals with Exemplar Case Studies ‑ Ninth Review Cycle (2023)

The objective of the Integrated Approaches for Testing and Assessment (IATA) Case Studies Project is to increase experience with the use of IATA by developing case studies which constitute examples of predictions that are fit for regulatory use. The aim of this project is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies. This case study was developed by the International Council on Animal Protection in OECD Programmes (ICAPO) to illustrate practical uses of IATA, and was submitted to the 2023 review cycle of the IATA Case Studies Project. The case study provides a framework to fulfil an IATA for chronic toxicity and carcinogenicity assessment through a weight of evidence (WoE)-based approach, in the absence of rodent cancer bioassays. The purpose of this IATA is to illustrate the use of the Rethinking Carcinogenicity Assessment for Agrichemicals Project (ReCAAP) framework, which is a scientific, WoE-based approach that allows the estimation of a Point of Departure (POD) for use in agrochemical risk assessment. To illustrate the use of the ReCAAP framework, two examples are presented in this IATA.