Table 1181 Criteria For Evaluating Carcinogen Experiments On Animals

Criteria

Recommendations

Experimental design

Choice of animal model

Number of animals

Route of administration

Identity of the substance tested

Dose levels Age of treatment Conduct and duration of bioassays

Two species of rats, and both sexes of each; adequate controls; sufficient animals to resolve any carcinogenic effect; treatment and observation throughout animal lifetimes at range of doses likely to yield maximum cancer rates; detailed pathological examination; statistical analyses of results for significance

Genetic homogenity in test animals, especially between exposed and controls; selection of species with low natural-tumor incidence when testing that type of tumor Sufficient to allow for normal irrelevant attrition along the way and to demonstrate an effect beyond the level of cancer in the control group Were tumors found remote from the site of administration? No tumors observed should demonstrate that absorption occurred Exposure to chemicals frequently involves mixtures of impurities. What effect did this have on results? What is the significance of pure compound results? Also, consider the carrier used in administration Sufficient to evoke maximum tumor incidence Should be started early

Refer to NCI's "Guidelines for Carcinogen in Small Rodents"

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