US EPA

4609263 

Book/Book Chapter 

Chapter 64 –Toxicologic pathology of the reproductive system 

Woldemeskel, M 

2017 

Yes 

Academic Press 

San Diego, CA 

Reproductive and Developmental Toxicology (Second Edition) 

745-763 

English 

10.1016/B978-0-12-804239-7.00064-0 

is a chapter of 4779372 Reproductive and developmental toxicology (Second edition)

Colossal industrial developments, excessive use of pesticides, and chemicals in various uses on humans and animals have severely polluted our environment. The adverse effects of chemical pollutants including drugs and pathogens on the reproductive systems are the major causes of infertility in humans. Reproductive toxicity can result in fetal organ deformities in pregnant women and have a detrimental impact on male fertility. Histopathological examination of reproductive organs in repeated dose toxicity studies in rodents and nonrodents is the only assessment of male and female reproductive organs performed prior to the first administration of a novel pharmaceutical to humans. An overview of potential mechanisms, toxicity end points evaluation, and histopathological lesions of reproductive tracts in laboratory animals along with toxicokinetics are given in this chapter. The regulatory and nonregulatory studies that need to be carried out during drug development are described. Some examples of toxicants affecting the reproductive systems are also provided. Current concepts that underlie mechanisms of teratogenesis with thalidomide as an example are discussed. In summary, meticulous use of different methods of pathology can generate sufficient information to evaluate the reproductive system during repeated dose toxicity studies and help to develop safer drugs, agrochemicals, and cosmetics for human use. 

Female; Male; Pathology; Reproductive toxicity; Teratogenesis 

2nd 

Gupta, RC 

9780128042397