Guidelines for Reproductive Toxicity Tests in Different Countries With a Proposal for International Harmonization

  • K. S. Khera
  • H. C. Grice
  • D. J. Clegg
Part of the Current Issues in Toxicology book series (CI TOXICOLOGY)


Guidelines proposed by several countries for testing chemicals to determine their safety for human reproduction are essentially based on guidelines of the U.S. Food and Drug Administration (FDA) for pharmaceutical drugs (Goldenthal, 1966). The requirements for the type of tests to be conducted and the endpoints to be examined in these guidelines are shown in Table 10–1. Regulatory agencies of the United States, Europe, Canada, and Japan generally require studies on fertility and reproduction (Segment 1), embryo-toxicity (including teratogenicity; Segment 2), and perinatal and postnatal effects (Segment 3) for safety assessment of pharmaceutical drugs. Embryo-toxicity or teratogenicity studies (Segment 2) and multigeneration reproduction studies are required for agricultural and environmental chemicals and food additives.


Reproduction Study Pharmaceutical Drug Developmental Toxicity Reproductive Toxicity Methyl Isocyanate 
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Copyright information

© Springer-Verlag New York Inc. 1989

Authors and Affiliations

  • K. S. Khera
    • 1
  • H. C. Grice
    • 2
  • D. J. Clegg
    • 1
  1. 1.Health Protection BranchHealth and Welfare CanadaOttawaCanada
  2. 2.NepeanCanada

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