OECD guidelines and validated methods for in vivo testing of reproductive toxicity

Abstract

This chapter discusses the methods adapted by the OECD and some other protocols, including the general principles of the study, the main aspects of the procedure, the endpoints and the observations, data reporting and criteria for interpreting results, and summarizing the guidelines. OECD 414 provides general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism. OECD 415 is designed to provide general information concerning the effects of the tested substance on male and female reproductive performance. OECD 416 test is designed to provide general information concerning the effects of a tested substance on the integrity and performance of the male and female reproductive systems, including gonadal function, the estrus cycle, mating behavior, conception, gestation, parturition, lactation and weaning, and the growth and development of the offspring. The study also provides information about the effects on the first generation (F1) including neonatal morbidity, mortality and preliminary data on prenatal and postnatal developmental toxicity. OECD 421 offers only limited means of detecting postnatal manifestations of prenatal exposure, or effects that may be induced during postnatal exposure. OECD 422 is intended for identification of possible health hazards likely to arise from repeated exposure over a relatively limited period of time. OECD 426 is designed to provide data, including dose–response characterization, on the potential functional and morphological effects on the developing nervous system of the offspring that may arise from exposure in uterus and during early life.