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Significance and Use
This test method should generate data to identify the majority of chronic effects and shall serve to define long-term dose response relationships. In addition the test should allow for the detection of general toxic effects including neurological, physiological, biochemical, and hematological effects and exposure-related morphological (pathology) effects.
This test method should provide information on target organs, the possibilities of accumulation, and may be used for establishing safety criteria for human exposure. It 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 effects of a substance in a mammalian species such as the rat following prolonged and repeated oral exposure. Under the conditions of the chronic toxicity test, effects that require a long latency period or that are cumulative should become manifest.
1.2 This test method assumes that the user is knowledgeable in mammalian toxicology and related pertinent areas, and relies heavily on the judgment of the evaluator.
1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.4 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. For specific hazard statements, see Section 6.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E943 Terminology Relating to Biological Effects and Environmental Fate
Federal StandardsTitle 21, Code of Federal Regulations (CFR). Food and Drug Administration, Part 58, Good Laboratory Practice for Nonclinical Studies Title 40, CFR, Environmental Protection Agency, Part 798, Health Effects Testing Guidelines, Subpart D, Chronic Exposure, Chronic Toxicity Title 40, CFR, Toxic Substance Control Act, Part 792, Good Laboratory Practice Standards Title 40, Code of Federal Regulations (CFR), Environmental Protection Agency, Subchapter E, Pesticide Programs: Part 160, Good Laboratory Practice Standards
UNSPSC Code 77101501(Risk or hazard assessment); 10101505(Rats)
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ASTM E1619-11, Standard Test Method for Chronic Oral Toxicity Study in Rats, ASTM International, West Conshohocken, PA, 2011, www.astm.orgBack to Top