Reproductive and Developmental Toxicity Studies

In this chapter, we discuss the guideline test protocols designed to identify the potential adverse effects of pharmaceuticals and environmental chemicals. Included is a discussion of the multigenerational tests designed to determine reproductive and developmental effects, as well as protocols specific for identifying adverse effects in the developing organism. Also included is a discussion of the proposed ILSI Health and Environmental Sciences Institute Agricultural Chemical Safety Assessment (HESI ACSA) extended one-generation reproductive and developmental toxicity protocol (Cooper et al. 2006), the proposed United States Environmental Protection Agency (US EPA) Endocrine Disruptor Screening and Testing Program (US EPA 2008a,b), and the European Registration, Evaluation, and Authorisation of Chemicals (REACH) program.