Alternative Approaches for Carcinogenicity and Reproductive Toxicity

Abstract

The regulatory assessment of the complex endpoints, carcinogenicity and reproductive and developmental toxicity, still heavily relies on animal testing. This chapter reviews the alternative approaches that have been developed in these areas in the last decades to waive testing and reduce the number of animals used and summarises the lessons learned. The alternative approaches range from the individual test methods, such as the cell transformation assay for carcinogenicity and the embryotoxicity tests for reproductive toxicity, to reduction approaches, such as the International Conference on Harmonisation strategy for pharmaceuticals and the extended-one-generation assay. Currently, these areas are being revitalised due to the broad recognition of the shortcomings of current in vivo testing requirements and the current regulatory environment (e.g. the European Registration, Evaluation, Authorisation and Restriction of Chemicals and Cosmetics Regulations). More-recent developments aimed at a more human-relevant chemical assessment, which rely on the integration of different sources of information, are also described.