Carcinogen decision point approach

For the mutagenicity analysis a decision-point approach to testing for carcinogenicity is used(From Casarett and Doull, Toxicology 3rd Edition)... 

The decision point approach takes these two categories or types of carcinogens into account in... 

Table I. Decision Point Approach to Carcinogen Evaluation ...

Other elements of the decision point approach are the use of a battery of short term tests that either may eliminate the need for further testing of the chemical or may enable the verification of carcinogenic potential in one of four limited in vivo bioassays for carcinogenicity. The battery also adds essential information for data evaluation when an already completed chronic test series has yielded ambiguous results. 

The decision point approach therefore is a systematic approach to the reliable evaluation of the potential carcinogenicity of chemicals which provides a framework in which to minimize the necessary testing in chemical evaluation, and at the same time develop an understanding of the mechanism of action of a test chemical. 

If the decision point approach has led to chronic bioassays, then fairly definitive data on carcinogenicity would be obtained. Nevertheless, the results of the in vitro short-term tests are considered for evaluation of possible mechanisms of action and risk extrapolation to humans. Convincing positive results in the in vitro tests coupled with documented in vivo carcinogenicity permits classification of the chemical as a genotoxic carcinogen. It would, therefore, be antici-... 

Weisburger, J.H., Williams, G.M. 1978. Decision point approach to carcinogen testing. In Structural Correlates of Carcinogenesis and Mutagenesis, ed. I.M. Asher C. Zervos, pp. 45-52. Rockville, Md. FDA Office of Health Affairs. 

Williams, G.M. and Weisburger, J.H. Systematic carcinogen testing through the decision point approach. Annual Review of Pharmacology and Toxicology, in press. 

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