Basketter D A, Gerberick G F, Kimber I, Loveless S E
Unilever Environmental Safety Laboratory, Sharnbrook, Bedford, UK.
Food Chem Toxicol. 1996 Oct;34(10):985-97. doi: 10.1016/s0278-6915(96)00059-2.
The prospective identification of skin sensitizing chemicals is a vital prerequisite for their proper risk management. Traditionally this has been achieved largely by the conduct of guinea pig assays such as the maximization and Buehler tests. These methods are recommended by the Organisation for Economic Cooperation and Development (OECD) and are required by the European Union (EU) for the evaluation of new substances. However, a novel mechanistically based method, the local lymph node assay (LLNA), has been the focus of substantial validation activity in recent years. This material is reviewed in this paper. It is shown that the LLNA has been validated successfully by five interlaboratory assessments as well as by comparisons with guinea pig tests and human data. The method also offers clear advantages to the user in terms of objectivity, time and cost, and delivers important animal welfare benefits. In consequence, it is recommended that the LLNA be formally adopted by the OECD in Guideline 406 and accepted by the EU and US EPA as a method suitable for the classification of the skin sensitizing potential of chemicals.
前瞻性识别皮肤致敏化学物质是对其进行适当风险管理的重要前提。传统上，这主要通过进行豚鼠试验来实现，如最大化试验和布勒试验。这些方法得到经济合作与发展组织（OECD）的推荐，并且欧盟（EU）要求用其来评估新物质。然而，一种基于新机制的方法——局部淋巴结试验（LLNA），近年来一直是大量验证活动的焦点。本文对该方法进行综述。结果表明，LLNA已通过五次实验室间评估以及与豚鼠试验和人体数据的比较而成功得到验证。该方法在客观性、时间和成本方面也为用户提供了明显优势，并带来了重要的动物福利益处。因此，建议OECD在第406号指南中正式采用LLNA，并被欧盟和美国环境保护局（US EPA）认可为一种适用于化学品皮肤致敏潜力分类的方法。
