Maurer T, Hess R, Weirich E G
Derm Beruf Umwelt. 1985;33(1):6-11.
In the first part of this article a historical note is given on the development of predictive contact allergenicity tests in guinea pigs starting with the Draize test, including epidermal methods and at least induction procedures using Freund complete adjuvant as a nonspecific enhancer of immunoreactivity. The tests of the OECD and EEC guidelines are listed and classified according to their predictive sensitivity. It is recommended to test reference allergens by different test methods in one's own laboratory to obtain personal experience with the various methods. Comparisons of the different methods based only on the literature are difficult, because there are so many influences on the performance of sensitization tests and because one is often not sure how the animals were termed positive, i.e. the threshold of a positive erythema score is often not clearly defined. Correlations between test results obtained in guinea pigs and man are presented for the Draize test, the maximization and the optimization test. It is emphasized that guinea pig tests are performed to assess the contact allergenic potential of a compound or formulation, but that the risk assessment is dependent on many other factors and should, therefore, be evaluated separately.
在本文的第一部分,给出了关于豚鼠预测性接触变应原性试验发展的历史记录,从德莱兹试验开始,包括表皮方法以及至少使用弗氏完全佐剂作为免疫反应性非特异性增强剂的诱导程序。列出了经合组织和欧盟委员会指南中的试验,并根据其预测敏感性进行了分类。建议在自己的实验室中用不同的试验方法检测参考变应原,以获得对各种方法的个人经验。仅基于文献对不同方法进行比较很困难,因为致敏试验的性能受到诸多影响,而且人们常常不确定动物是如何被判定为阳性的,即阳性红斑评分的阈值往往没有明确界定。文中给出了德莱兹试验、最大化试验和优化试验在豚鼠和人体中获得的试验结果之间的相关性。需要强调的是,进行豚鼠试验是为了评估化合物或制剂的接触变应原性潜力,但风险评估取决于许多其他因素,因此应单独进行评估。