Assessment of adult toxicity in developmental versus prechronic toxicology studies.

Abstract

There is no general agreement at the present time regarding the role of maternal toxicity in the manifestation of teratogenic effects or developmental toxicity animal studies designed to identify the teratogenic potential of chemicals. A survey of 90 teratology studies published in the recent literature revealed wide differences in the amount and nature of maternal toxicity data collected in teratology studies. In addition, the use of the maternal toxicity data in the process of interpreting developmental toxicity varied widely between authors. In comparison with teratology studies, there is more uniformity in the collection of toxicity data in prechronic toxicity studies. The guidance provided by various government agencies on the parameters to be observed in prechronic toxicity studies is much more explicit than that provided regarding the collection of maternal toxicity data in teratology studies. Because of the likely importance of maternal toxicity in the conduct and interpretation of teratology studies, it is recommended that more maternal toxicity data be collected in teratology studies and the parameters be standardized between laboratories so that data are comparable. Guidelines should be established for the use of maternal toxicity data in the interpretation of the results of teratology studies.