Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment

This document is intended to provide guidance on methodological aspects, interpretation of data and an overall approach for testing of chemicals for potential human and other mammalian reproductive toxicity. The document constitutes an essential supplement to existing OECD Test Guidelines that can be used to obtain information on the potential reproductive toxicity of chemicals. Specific OECD Test Guidelines include the one- and two-generation toxicity study (TG 415 and 416), prenatal developmental toxicity study (TG 414), developmental neurotoxicity study (TG 426) and the reproduction/developmental toxicity screening tests (TG 421 and 422). However, data from other toxicity studies e.g., repeated dose toxicity studies for systemic toxicity (TG 407, 408 and 409) may indicate potential reproductive toxicity and should be considered in the assessment as well as existing human data.