OECD 443 Regulatory Recommendations

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015. In July 2021, an evaluation of 12 test cases of the Organisation for Economic Cooperation and Development (OECD) 443 study led by the European Chemicals Agency (ECHA) revealed critical issues with study designs that had the potential to compromise data analysis and interpretation. This infographic outlines the resulting regulatory recommendations and the subsequent potential impact of these recommendations upon study design that can be taken into account to improve ongoing and future EOGRT studies.