1.1 本规程旨在确定物质或材料提取物引起接触性皮肤过敏性的可能性。 1.2 鉴于与豚鼠最大化试验（GPMT）相关的剂型限制和假阳性倾向，本实践旨在作为豚鼠最大化试验（GPMT）的替代方法。参见基本原理和参考资料。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 5.1 在医疗应用中选择人体接触材料时，重要的是确保材料不会刺激免疫系统在相关暴露条件下产生过敏反应。皮肤接触或生理暴露过程中产生的可提取化学物质可能会引起过敏反应。 因此，本规程规定使用材料提取物或直接评估供试品来评估固体或半固体剂型。该动物模型的基本原理是，豚鼠已被证明是预测人类接触性皮炎的合适动物模型。其易处理性、从信誉良好的供应商处获得的信息、使用该物种获得的信息的历史数据库以及这些结果与已知人类过敏原数据的相关性，都有助于其广泛用于过敏性研究 ( 1- 5. ) . 4. 5.2 除最大化测试外，还需要敏化程序（实践 F720 )基于:( 1. )需要更类似于使用条件的暴露途径；( 2. )关注佐剂的使用，因为其将细胞类型招募到试验部位，而这些细胞类型通常不涉及免疫反应，并且因为这会导致动物不适；( 3. )在传统的最大化设计中缺乏适当的FCA刺激性对照组；和( 4. )GPMT经常遇到的误报频率。 这两种测试都是国际公认的 ( 1. ) .

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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. ====== Significance And Use ====== 5.1 In selecting a 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 under relevant exposure conditions. Extractable chemicals produced by skin contact or during physiological exposures may cause allergic reactions. Therefore, this practice provides for evaluations of solid or semisolid dosage forms using material extracts or direct evaluation of the test article. The rationale for this animal model is based on the fact that the guinea pig has been shown to be an appropriate animal model for predicting human contact dermatitis. Its tractable nature, its availability from reputable suppliers, the historical database of information already acquired using this species, and the correlation of such results to data on known human allergens, all contribute to its widespread use for allergenicity studies ( 1- 5 ) . 4 5.2 The need for sensitization procedures other than the maximization test (Practice F720 ) is based on: ( 1 ) the need for a route of exposure more similar to use conditions; ( 2 ) concern over the use of adjuvant because of its recruitment of cell types to the test site which are not typically involved in immunologic reactions, and because of the discomfort this causes in the animals; ( 3 ) absence of a proper FCA-irritant control group in the traditional maximization design; and ( 4 ) the frequency of false positives often encountered with the GPMT. Both of these tests are internationally accepted ( 1 ) .