PRACTICAL GUIDANCE FOR EVALUATING AND INTERPRETING DEVELOPMENTAL TOXICITY TESTS

The complex physiological interactions among a pregnant mammal, her em bryos, and their placentae pose considerable challenges to investigato rs who conduct safety tests for the assessment of potential developmen tal toxicity. Many individuals who review developmental toxicity safet y tests are not trained in this specialized area of toxicology. This p aper presents a concise introduction to the science that underlies dev elopmental toxicology for those individuals. The purpose of the paper is to educate the reader about appropriate test procedures, the types of data that are collected, and evaluation of studies. To these ends, the paper explains important terminology and study designs' makes comm ents concerning what should be considered acceptable developmental tox icity data; and provides insights and rules of thumb regarding the eva luation and interpretation of the data.