Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test


Importancia y uso:

4.1 In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. This practice provides recommendations for evaluating the potential for chemicals to leach out of a material or device and elicit an allergic reaction by applying the test article to the skin of guinea pigs. The rationale for this practice is based on the fact that the guinea pig has been shown to be a sensitive animal model for predicting human allergic contact dermatitis.4 The use of FCA and SLS tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is one of the sensitive animal tests in common use today.

Subcomité:

F04.16

Referida por:

F0748-16, F2147-01R25, F2148-18, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

11.220 (Veterinary medicine)

Palabras clave:

acute toxicity tests; allergenicity; biocompatibility; guinea pigs; sensitization; test animals;

$ 1,056

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Norma
F720

Versión
24

Estatus
Active

Clasificación
Test Method

Fecha aprobación
2024-12-01