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Last Updated: Dec 31, 2024
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ASTM F720-24
Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F0720-24
ASTM|F0720-24|en-US
Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
Standard
F720 Standard Test Method for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test>
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BOS Vol. 13.01 Committee F04
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Significance and Use
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.
Scope
1.1 This test method is intended to determine the potential for a test article to elicit contact dermal allergenicity. This is a semi-quantitative method. There are no known limitations to this method.
1.2 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.