Interpretation and Extrapolation of Reproductive Data to Establish Human Safety Standards (Current Issues in Toxicology)

This monograph focuses on extrapolating data from animal reproduction studies to assess exposure levels acceptable for human reproduction which are consistent with the maintenance of public health. The interpretation and extrapolation of animal data for predicting human health effects from reproductive toxicants is a complex process with many uncertainties. This document attempts to outline some of the factors involved in the process, taking into account biological responses relevant to the test compound in experimental animals and humans. The guidelines for reproductive toxicity tests in different countries are summarized and a proposal for international harmonization is presented. The strengths and limitations of the test systems employed are also discussed. The monograph is intended for individuals interested or involved in safety assessment of chemicals.