ABSTRACT

Short-term and long-term animal-model tests are available for determining reproductive effects. Since skin is a penetrable barrier that allows many compounds to enter the body, the reproductive hazard from chemicals in contact with skin is a growing area of concern. Developmental toxicity tests, i.e., short-term tests, are used to ascertain the effects of a substance on a developing fetus; the test compound is administered to pregnant animals at least from implantation to the end of gestation. Specific procedures for tests depend upon several factors, of which two are critical: the nature of the substance and the expected length of exposure. Standardized developmental toxicity studies have been set up to maximize exposure to an agent during the period of greatest sensitivity of the developing organism. The considerations of the route of administration found in the section on developmental toxicity study design are equally applicable to the conduct of reproduction studies.