This Test Guideline is designed to provide an evaluation of reproductive and developmental
effects that may occur as a result of pre- and postnatal chemical exposure as well
as an evaluation of systemic toxicity in pregnant and lactating females and young
and adult offspring. In the assay, sexually-mature males and females rodents (parental
(P) generation) are exposed to graduated doses of the test substance starting 2 weeks
before mating and continuously through mating, gestation and weaning of their pups
(F1 generation). At weaning, pups are selected and assigned to cohorts of animals
for reproductive/developmental toxicity testing (cohort 1), developmental neurotoxicity
testing (cohort 2) and developmental immunotoxicity testing (cohort 3). The F1 offspring
receive further treatment with the test substance from weaning to adulthood. Clinical
observations and pathology examinations are performed on all animals for signs of
toxicity, with special emphasis on the integrity and performance of the male and female
reproductive systems and the health, growth, development and function of the offspring.
Part of cohort 1 (cohort 1B) may be extended to include an F2 generation; in this
case, procedures for F1 animals will be similar to those for the P animals.