Proceedings of the workshop on the acceptability and interpretation of dermal developmental toxicity studies

Abstract

The workshop on The Acceptability and Interpretation of Dermal Developmental Toxicity Studies, held April 13–14, 1988, was organized by the U.S. EPA's Office of Research and Development and Office of Toxic Substances and was supported by the Agency's Risk Assessment Forum. The purpose of the workshop was to review the current state of knowledge on the use of the dermal route of exposure in developmental toxicity studies. In evaluating this area, three major issues were considered by the participants: (1) the evaluation of maternal toxicity in dermal developmental toxicity studies, (2) what types of pharmacokinetic data are necessary or desirable for the appropriate design and interpretation of these studies, and (3) what factors are important to consider in the design of dermal developmental toxicity studies. The participants concluded: (1) dermal developmental toxicity studies without any indication of maternal or developmental toxicity are inadequate for risk assessment unless accompanied by absorption data, (2) absorption data and limited pharmacokinetic data should be collected in every dermal developmental toxicity study, and (3) dermal developmental toxicity studies in which skin irritation is too marked should be considered inadequate for risk assessment. General recommendations made for all developmental toxicity studies regardless of the route of exposure were: signs of local irritation should be examined, and absorption/pharmacokinetic data should be developed. Areas in which additional research is needed to permit more complete assessment of dermal developmental toxicity studies were also identified.