ASTM F2147-01(2006)
Historical Standard: ASTM F2147-01(2006) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
SUPERSEDED (see Active link, below)
ASTM F2147
1. Scope
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References.
1.3 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F619 Practice for Extraction of Medical Plastics
F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
ISO Document
ISO10993-10,1995 Tests for Irritation and Sensitization Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.Keywords
acute toxicity; allergenicity; biocompatibility; guinea pigs; immunotoxicity; sensitization; Cement mortars;
ICS Code
ICS Number Code 11.100 (Laboratory medicine)
DOI: 10.1520/F2147-01R06
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