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What criteria should be used in determining if the results of acute toxicity studies in animals constitute information that reasonably supports a conclusion of substantial risk?

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What criteria should be used in determining if the results of acute toxicity studies in animals constitute information that reasonably supports a conclusion of substantial risk?

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A.22. Criteria used to determine TSCA ยง8(e) reporting in the case of acute toxicity findings in animals depends on the nature of the effects observed and the dose at which the effects occurred. For example, data showing a tested chemical to be extremely toxic (e.g., lethality at very low doses) by inhalation, dermal or oral administration should be reported. On the other hand, the need to report data indicating that a chemical has a moderate degree of acute toxicity depends on the degree of actual or potential exposure to the tested chemical. Information showing a chemical to be slightly or minimally toxic on an acute basis is not typically considered to be reportable.

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