5.5.4 Reproductive and Developmental Toxicity

Segment I reproductive toxicity testing (OECD 415, ICH S5(R3)) evaluates fertility and early embryonic development in both male and female animals through...

Segment I reproductive toxicity testing (OECD 415, ICH S5(R3)) evaluates fertility and early embryonic development in both male and female animals through mating, implantation, litter size, and fetal weight endpoints. Segment II teratology testing (OECD 414, ICH S5) evaluates embryo-fetal development with dosing spanning gestational days 6–17 in the rat or 6–18 in the rabbit, assessing both maternal toxicity and fetal malformation through combined skeletal and visceral examination. Segment III perinatal/postnatal toxicity testing (OECD 416, ICH S5) evaluates pre- and post-natal development, with dosing continuing from gestational day 6 through postnatal day 21, monitoring pup development, behaviour, and the reproductive performance of the resulting F1 generation.