Standard Article

Reproductive Toxicology

Genetic Toxicology, Oncogenesis, Developmental and Reproductive Toxicology

  1. Norbert Makori MSc, DVM, PhD1,
  2. Satoru Oneda DVM, PhD2,
  3. Patricia R. McElhatton MSc, PhD, CBiol, FIBiol3,
  4. Jennifer M. Ratcliffe BSc, MSc, PhD4,
  5. Frank Sullivan BSc3

Published Online: 15 DEC 2009

DOI: 10.1002/9780470744307.gat083

General, Applied and Systems Toxicology

General, Applied and Systems Toxicology

How to Cite

Makori, N., Oneda, S., McElhatton, P. R., Ratcliffe, J. M. and Sullivan, F. 2009. Reproductive Toxicology. General, Applied and Systems Toxicology. .

Author Information

  1. 1

    SNBL USA, Ltd, Senior Scientist/Manager, Developmental and Reproductive Toxicology, Everett, Washington, USA

  2. 2

    SNBL USA, Ltd, Everett, Washington, USA

  3. 3

    National Teratology Information Service, Regional Drug and Therapeutics Centre, Newcastle-uopn-Tyne, UK

  4. 4

    Analytical Sciences Inc, Statistics and Public Health Research Division, Durham, North Carolina, USA

Publication History

  1. Published Online: 15 DEC 2009


This article introduces some of the newer approaches for biopharmaceuticals reproductive toxicity testing, and includes the classical small molecules testing paradigms. The scientific basis for concern about exposure to agents that cause reproductive toxicity is discussed in various contexts, including aspects of adult male or female sexual function and fertility, embryology and teratology, and the F1 offspring and lactation in the context of interfere with the production or development of normal offspring which could be reared to sexual maturity, capable in turn of reproducing the species. Reproductive toxicology is divided into two major classes: (i) adverse effects on reproductive ability or capacity in adult males and females, i.e. effects on sexual behavior and fertility and (ii) adverse effects on maintenance of pregnancy (embryo-fetal loss) and developmental outcome of the offspring, i.e. developmental toxicity. The former is assessed in both males and females as exposure of a toxicant applies to both, while the latter is assessed in only female and their concepti/offsprings as exposure only occurs during pregnancy where the male is used only for mating purposes and is not exposed to the reproductive toxicant.


  • Fertility;
  • teratology;
  • postnatal development;
  • reproductive toxicity;
  • ICH guidelines