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ASTM E1163

2010 Edition, November 1, 2010

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Standard Test Method for Estimating Acute Oral Toxicity in Rats

Includes all amendments and changes through Reapproval Notice , 2019

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Product Details:

  • Revision: 2010 Edition, November 1, 2010
  • Published Date: January 2019
  • Status: Active, Most Current
  • Document Language: English
  • Published By: ASTM International (ASTM)
  • Page Count: 3
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

This test method determines the lethality (LD50 value, slope and 95 % confidence interval (CI)) and signs of acute toxicity from a material using a limited number of rats. The technique used in this test method is referred to as the “Stagewise, Adaptive Dose Method.”2 This test method is an alternative to the classical LD50 test and is applicable to both liquids and solids.

This test method is not recommended for test materials which typically produce deaths beyond two days postdosing.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2 Feder, P.I., Statistical Design Considerations for Stagewise, stagewise, adaptive dose allocation in dose responsive studies. In: Peace, Karl E., ed. Biopharmaceutical sequential statistical applications. New York: Marcel Dekker 1992.