National Institute of Public Health, Srobárova 48, Prague 10, Czech Republic.
Contact Dermatitis. 2010 Feb;62(2):109-16. doi: 10.1111/j.1600-0536.2009.01640.x.
Efforts to replace the rabbit skin irritation test have been underway for many years, encouraged by the EU Cosmetics Directive and REACH. Recently various in vitro tests have been developed, evaluated and validated.
A key difficulty in confirming the validity of in vitro methods is that animal data are scarce and of limited utility for prediction of human effects, which adversely impacts their acceptance. This study examines whether in vivo or in vitro data most accurately predicted human effects.
Using the 4-hr human patch test (HPT) we examined a number of chemicals whose EU classification of skin irritancy is known to be borderline, or where in vitro methods provided conflicting results.
Of the 16 chemicals classified as irritants in the rabbit, only five substances were found to be significantly irritating to human skin. Concordance of the rabbit test with the 4-hr HPT was only 56%, whereas concordance of human epidermis models with human data was 76% (EpiDerm) and 70% (EPISKIN).
The results confirm observations that rabbits overpredict skin effects in humans. Therefore, when validating in vitro methods, all available information, including human data, should be taken into account before making conclusions about their predictive capacity.
欧盟化妆品指令和 REACH 的鼓励下，多年来人们一直在努力寻找替代兔皮肤刺激试验的方法。最近已经开发、评估和验证了各种体外测试方法。
确认体外方法有效性的一个关键难题是动物数据稀缺且对人类效应的预测作用有限，这对其接受度产生了不利影响。本研究检验了体内或体外数据在预测人类效应方面的准确性。
我们使用 4 小时人体斑贴试验（HPT）来研究了一些化学物质，这些物质的皮肤刺激性欧盟分类被认为是边界值，或者体外方法的结果存在冲突。
在被归类为兔皮肤刺激性的 16 种化学物质中，只有 5 种物质被发现对人类皮肤具有明显的刺激性。兔子试验与 4 小时 HPT 的一致性仅为 56%，而人体表皮模型与人体数据的一致性分别为 76%（EpiDerm）和 70%（EPISKIN）。
这些结果证实了兔子过度预测人类皮肤效应的观察结果。因此，在验证体外方法时，在得出其预测能力的结论之前，应考虑所有可用信息，包括人体数据。
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