The predictive value of animal data in human cancer risk assessment

Carcinogenic effects of chemicals can be investigated in animal experiments and epidemiological studies of exposed humans, mostly in the workplace. In this article epidemiologic evidence is compared with the animal data for 35 chemicals. Risk calculations are compared for 22 chemicals. The chemicals showing no or unclear carcinogenic effects in humans were more likely to show toxic side effects in the animal studies, indicating that the test concentrations were above the maximum tolerated dose. In addition, the animal experiments with these chemicals more often showed neoplastic effects on multiple sites than chemicals for which clear positive epidemiological studies are available. These findings may explain the existence of discrepancies between the outcomes of animal testing and human studies. They suggest that carcinogenic effects in multiple organs in animals could be seen as ultimate manifestations of the side effects of the testing method and that they have limited predictive value for the human situation. (C) 1997 Academic Press.