Standard Historical Last Updated: Dec 31, 2010 Track Document
ASTM F2147-01(2006)

Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens F2147-01R06 ASTM|F2147-01R06|en-US Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens Standard new BOS Vol. 13.01 Committee F04
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Abstract

This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. It 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. The split adjuvant method is used when topical application is considered relevant, and the dosage form is a solid, liquid, extract, paste, or gel. The method includes four induction doses applied over a period of time to the same shaved or depilated site on guinea pigs, followed by occlusive patching. Freund's Complete Adjuvant (FCA) is injected near the dose site on a specific time, (second induction dose). Following a rest period, animals are challenged at a previously unexposed site, and the reaction evaluated at regular intervals. The closed patch method is used when topical application is relevant, but the preferred dosage form does not permit injection under the skin or intradermally, and the discomfort involved with extended occlusive patching and adjuvant use is to be avoided. It involves repeated induction doses over a period of time at the same shaved/depilated site, followed each time by occlusive wrapping. After a rest period, animals are challenged at previously untreated sites, and their reactions evaluated after a period of time.

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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.16
Pages: 5
DOI: 10.1520/F2147-01R06
ICS Code: 11.100