Maurer T, Arthur A, Bentley P
Ciba-Geigy Ltd., Pharmaceuticals Division, Preclinical Safety PH 2.812, Basel, Switzerland.
Toxicology. 1994 Sep 22;93(1):47-54. doi: 10.1016/0300-483x(94)90195-3.
After reviewing general aspects and the historical development of predictive animal skin sensitization tests, the recommended tests of the OECD and EC are discussed. Background information is given on the changes which occurred in the last 2 years. From the many factors known to influence induction and challenge of contact allergy in animals, the discussion is focused on the choice of induction concentration and the vehicle. The difference of general screening strategies in Europe and the USA is presented and discussed. The paper closes with a discussion on the importance of inhouse validation of the methods used for proper prediction of the sensitizing potential of chemicals and with remarks on predictive in vitro tests.
在回顾了预测性动物皮肤致敏试验的一般情况和历史发展之后,讨论了经合组织(OECD)和欧盟委员会(EC)推荐的试验。介绍了过去两年中发生的变化的背景信息。从已知影响动物接触性过敏诱导和激发的诸多因素中,讨论聚焦于诱导浓度的选择和赋形剂。介绍并讨论了欧洲和美国一般筛选策略的差异。本文最后讨论了对用于正确预测化学品致敏潜力的方法进行内部验证的重要性,并对预测性体外试验进行了评述。