Analysis of Mode of Action of Carcinogenesis in Animal Models. S. M. Cohen, University of Nebraska Medical Center
Experiments performed in animal models evaluating potential human carcinogenic hazard are based on two fundamental assumptions: 1) What happens in the animal model is relevant to the human situation; and 2) what happens at the doses used in the animal model are relevant to human exposures. A rational basis for extrapolation to humans can only be made with an understanding of the mode of action of the chemical in the animal model. In this International Life Sciences Risk Risk Science Institute project, several case studies were evaluated of chemicals with well to poorly delineated modes of action reflecting a broad spectrum of biological processes. The US EPA and IPCS frameworks were used, and in some cases modified, in evaluating the modes of action in animals. It is apparent that identification of key events in animal models is critical for the extrapolation to humans and involves a range of qualitative and quantitative considerations.
U.S. Environmental Protection Agency, Health Canada, ILSI Risk Science Institute.
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