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. 1998 Apr;106(Suppl 2):467–471. doi: 10.1289/ehp.98106467

Alternative tests: carcinogenesis as an example.

B Schwetz 1, D Gaylor 1
PMCID: PMC1533376  PMID: 9599693

Abstract

Acceptance of new tests that are alternatives to currently used toxicology tests is a topic of considerable importance in the field of toxicology. Carcinogenicity testing today normally includes 2-year studies in rats and mice of both sexes, following widely accepted procedures for husbandry; selection of dose levels; pathology and toxicity observations; and statistical interpretation of tumor data. These studies are usually preceded by tests for genetic toxicity and subchronic toxicity studies to select dose levels for the 2-year studies. Although these data are used for quantitative risk assessment, the mechanistic basis for effects is usually unknown. The series of studies is very expensive and requires 5 years or more to conduct. Alternative approaches are being developed that would provide more mechanistic information and hopefully would permit decisions to be made about carcinogenic potential without the need to conduct 2-year studies in rats and mice of both sexes. Decisions could be based on a profile of data rather than on the result of one test. Procedures for regulatory acceptance of new approaches for carcinogenicity testing are critical to future progress.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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