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局部淋巴结试验:用于监管目的的验证评估

Local lymph node assay: validation assessment for regulatory purposes.

作者信息

Gerberick G F, Ryan C A, Kimber I, Dearman R J, Lea L J, Basketter D A

机构信息

Miami Valley Laboratory, Procter & Gamble Company, the Zeneca Central Toxicology Laboratory, Alderley Park, Cincinnati, OH 45253-8707, USA.

出版信息

Am J Contact Dermat. 2000 Mar;11(1):3-18. doi: 10.1053/ajcd.2000.0003.

DOI:10.1053/ajcd.2000.0003
PMID:10684384
Abstract

For the prediction of skin sensitization potential of substances, the murine local lymph node assay (LLNA) is an alternative to the widely used guinea pig tests. For more than 10 years, this method has undergone extensive development, evaluation, and validation. In this review, the validation status of the LLNA is considered, specifically with regard to its use for regulatory identification of skin sensitization hazards. The LLNA is a method for the predictive identification of chemicals that have a potential to cause skin sensitization. Activity is measured as a function of lymph node cell proliferative responses stimulated by topical application of test chemicals. The LLNA has successfully passed all reasonable validation stages. It provides a reliable and relevant source of predictive skin sensitization data, which unlike results from guinea pig tests, are reproducible from laboratory to laboratory. In summary, the LLNA is now ready for acceptance as a viable and complete alternative to traditional methods, offering a substantial reduction in animal numbers and refinement opportunities without compromising the standards for the identification of important skin sensitizers.

摘要

对于物质皮肤致敏潜力的预测,小鼠局部淋巴结试验(LLNA)是广泛使用的豚鼠试验的一种替代方法。十多年来,该方法经历了广泛的发展、评估和验证。在本综述中,考虑了LLNA的验证状态,特别是关于其用于皮肤致敏危害的监管识别方面。LLNA是一种预测性识别有潜在皮肤致敏作用化学物质的方法。活性通过局部应用受试化学物质刺激的淋巴结细胞增殖反应来衡量。LLNA已成功通过所有合理的验证阶段。它提供了可靠且相关的预测性皮肤致敏数据来源,与豚鼠试验结果不同,这些数据在不同实验室之间具有可重复性。总之,LLNA现在已准备好被接受为传统方法的可行且完整的替代方法,在不影响识别重要皮肤致敏剂标准的情况下,可大幅减少动物数量并提供优化机会。

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