Guidelines for developmental toxicity testing of chemicals in Japan

With the definition of teratogenicity expanded in terms of the developmental stages when an agent acts and the types of developmental anomalies induced, the concept of developmental toxicity has been established. The examination of functional developmental disorders including behavior has become one of the most important items for the evaluation of developmental toxicity of chemicals, especially pharmaceutical drugs. The guidelines for developmental toxicity testing of drugs in Japan stress the need for examination of growth and development including behavior and fertility on the postweaning offspring. The outline of the Japanese guidelines is presented and it is emphasized that studies should be done as research and include self evaluation of the scientific truth of the experiment and extrapolation to humans. In addition, the activities of the Behavioral Teratology Meeting, a satellite meeting to the Japanese Teratology Society, are introduced and enquête surveys of the Japan Pharmaceutical Manufacturers Association and collaborative studies for the standardization of learning tests in Japan are briefly presented.