Reproductive and Developmental Toxicology

This chapter provides a brief overview of normal reproduction and development, as well as examples of how toxic agents may impact these processes. It summarizes the types of studies conducted and data collected as part of routine toxicity testing. Assumptions that must be made in the risk assessment process and an evaluation of data from both animal and human studies used in this process are discussed. The integration of hazard data (both animal and human) and dose–response information is described, and exposure estimates in the final characterization of risk are summarized. Advances have been made in our understanding of reproductive and developmental toxicity, particularly as the integration of molecular biology and toxicology has grown. However, there are still many gaps in our knowledge of both normal and abnormal reproductive and developmental processes. Further research will continue to fill these gaps and enhance our ability to identify more specific susceptible events in these processes and ultimately reduce adverse reproductive and developmental outcomes due to chemical exposures. The views expressed in this chapter are those of the authors and do not necessarily reflect the views or policies of the U.S. Environmental Protection Agency. Mention of trade names of commercial products does not constitute endorsement or recommendation for use. Keywords: Reproduction; Overview; Gametagenesis; Fertilization; Development; Testing; Guidelines; Pharmaceuticals; Germ cell toxicity; Risk assessment; Dose-response relationship; Exposure assessment