US EPA

The purpose of the workshop, which was held in April 1988, was to review the current state of knowledge on the use of the dermal route of exposure in developmental toxicity studies. n evaluating this area, three major issues were considered: 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. he participants concluded: 1) dermal developmental toxicity studies without any indication of maternal or develop mental 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. eneral 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. reas in which additional research is needed were also identified.

Kimmel, C. AND E. Francis. Proceedings of the Workshop on the Acceptability and Interpretation of Dermal Developmental Toxicity Studies. U.S. Environmental Protection Agency, Washington, D.C., EPA/600/J-90/001 (NTIS PB90242371), 1990.

Fundamental & Applied Toxicology, 14:386-398, 1990