ASTM F2147-01(2025)

Detail information

Designation: ASTM F2147-01(2025)

Publication date: 01/01/2025

Pages: 5

Country: American technical standard

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Anotation

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.


Keywords:
acute toxicity, allergenicity, biocompatibility, guinea pigs, immunotoxicity, sensitization,, ICS Number Code 11.100 (Laboratory medicine)