Steiling W, Basketter D, Berthold K, Butler M, Garrigue J L, Kimber I, Lea L, Newsome C, Roggeband R, Stropp G, Waterman S, Wiemann C
Henkel KGaA, Henkelstrasse 67, D-40191, Düsseldorf, Germany.
Food Chem Toxicol. 2001 Apr;39(4):293-301. doi: 10.1016/s0278-6915(00)00147-2.
Various methodological aspects of skin sensitisation testing have been explored, particularly in the context of animal welfare considerations and reliability and sensitivity of test methods. Recommendations are made for the conduct of current and proposed OECD skin sensitisation tests with respect to appropriate test configurations for the purposes of hazard identification and labelling, and the requirement for positive controls. Specifically, the following aspects of guinea pig sensitisation test methods have been addressed: (1) the number of test and control animals required; (2) the option of using joint positive controls between independent laboratories; (3) the choice of positive control chemicals; (4) the optimal conduct and interpretation of rechallenge; and (5) the requirement for pretreatment with sodium lauryl sulfate. In addition, the use of the murine local lymph node assay (LLNA) has been considered. A number of conclusions have been drawn and recommendations made as follows: In many instances, particularly with the conduct of the guinea pig maximisation test, it is acceptable to halve the number of test and control animals used. An optional scheme for the conduct of joint positive control studies within a co-ordinated group of laboratories is appropriate. Only one positive control chemical (alpha-hexyl cinnamic aldehyde) is necessary for the routine assessment of assay sensitivity. The proper conduct and interpretation of rechallenge can provide valuable information and confirmation of results in guinea pig sensitisation tests. Sodium lauryl sulfate should no longer be used as a pretreatment in the guinea pig maximisation test. The LLNA is a viable and complete alternative to traditional guinea pig test methods for the purposes of skin sensitisation hazard identification. These recommendations provide the opportunity for both animal welfare benefits and improved hazard identification.
皮肤致敏试验的各种方法学方面已得到探讨，特别是在动物福利考量以及试验方法的可靠性和敏感性背景下。针对经合组织现行和拟议的皮肤致敏试验的实施，就用于危害识别和标签目的的适当试验配置以及阳性对照的要求提出了建议。具体而言，已讨论了豚鼠致敏试验方法的以下方面：(1)所需试验动物和对照动物的数量；(2)在独立实验室之间使用联合阳性对照的选择；(3)阳性对照化学品的选择；(4)再激发的最佳实施和解释；(5)用十二烷基硫酸钠进行预处理的要求。此外，还考虑了小鼠局部淋巴结试验(LLNA)的使用。得出了一些结论并提出了如下建议：在许多情况下，特别是在进行豚鼠最大化试验时，将所用试验动物和对照动物的数量减半是可以接受的。在一组协调的实验室中进行联合阳性对照研究的可选方案是合适的。在常规评估试验敏感性时，仅需一种阳性对照化学品(α-己基肉桂醛)。再激发的正确实施和解释可为豚鼠致敏试验的结果提供有价值的信息和确认。在豚鼠最大化试验中，不应再使用十二烷基硫酸钠进行预处理。就皮肤致敏危害识别而言，LLNA是传统豚鼠试验方法的一种可行且完整的替代方法。这些建议为动物福利改善和危害识别改进提供了机会。
