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Issues in Risk Assessment (1993) / Chapter Skim
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DEFINITIONS AND BACKGROUND
Pages 21-23

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From page 21...
... is based on a 90 day or other subchronic test, and its determination involves scientific judgment applied to the information available at the end of the test period. How well the EMTD approximates the true MTD can be evaluated only after the bioassay.
From page 22...
... The MTD, by definition, is an inverse measure of the potency of an agent in causing chronic toxic effects, specifically those manifested as premature death, weight loss, or histopathologic changes after near-lifetime exposure. Potency refers to the range of doses over which a chemical produces increasing responses.
From page 23...
... , • Test agent was administered alone, rather than in combination with other chemicals, • Exposure was chronic, with not more than 7 days between administrations, • Duration of exposure was at least one-fourth the standard lifespan of the test species, • Duration of experiment was at least half the standard lifespan of the test species, • Research design included a control group, • Research design included at least five animals per group, • Surgical intervention was not performed, • Pathology data were reported as the number of animals with tumors, rather than the total number of tumors, • Results reported were original data, rather than secondary analyses of experiments already reported by other authors. Bioassays of particulate or fibrous matter and of mixtures of chemicals were not included (except some commercial preparations to which humans are often exposed)


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