Toxicity study: Fertility and early embryonic
The objective of the fertility and early embryonic toxicity study is to assess the maturation of gametes, mating behavior, fertility, preimplantation development of the embryo and implantation.
For females, this assessment includes effects on estrous cycles, tubal transport, implantation and embryonic development. For males, this study design will detect functional effects (i.e., libido, sperm maturation). Sperm assessments (concentration, motility and morphology) can be conducted as needed. Fresh semen collection can be used for longitudinal assessment of test article exposure.