This test method covers a long-term study to determine the oncogenicity potential of a substance in mammalian species such as the rat and mouse. The objective is to observe the test animals for a major portion of their life span for neoplastic lesions during exposure to various doses of a test substance by oral administration.

Formerly under the jurisdiction of Committee E47 on Biological Effects and Environmental Fate, this test method was withdrawn in February 2010, because other guidelines currently exist.

This test method should generate data to determine the presence, incidence, and severity of abnormalities (including behavioral and clinical abnormalities) and whether significant tumor production has occurred. In addition, the test should allow for the detection of general toxic effects.

This test method provides information on potential health hazards likely to arise from repeated exposure over a long period of time.

1.1 This test method covers a long-term study to determine the oncogenicity potential of a substance in mammalian species such as the rat and mouse. the objective is to observe the test animals for a major portion of their life span for neoplastic lesions during exposure to various doses of a test substance by oral administration.

1.2 This test may also provide some information on long-term general toxicity.

1.3 This test method assumes that the user is knowledgeable in mammalian toxicology and related pertinent areas, and it relies heavily on the judgment of the evaluator.

1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific hazards statements are given in Section 6.