Guidelines for reproductive and developmental toxicity testing and risk assessment of chemicals

The intent of federal guidelines for reproductive and developmental toxicity testing is to evaluate chemicals for their potential toxicity to the human reproductive system and to its development. The history of regulations, principles of testing and evaluation, and the use of the data for risk assessment are addressed. Information on the regulations and guidelines used worldwide is also presented. Reproductive and developmental toxicity test data are incorporated into decision making based on the mission and mandates of various regulatory organizations. Use of data for prioritization and screening and areas of concern such as life stages, endpoints, duration of exposure, choice of species, dose selection, mode-of-action, cumulative exposure, interpretation of effects, statistical approaches, and human relevance is also discussed. Overall, the potential benefits of these guidelines and related materials are to refine the risk assessment process through a greater understanding of the mechanisms of reproductive and developmental toxicity.