York M, Griffiths H A, Whittle E, Basketter D A
Unilever Environmental Safety Laboratory, Sharnbrook, Bedford, UK.
Contact Dermatitis. 1996 Mar;34(3):204-12. doi: 10.1111/j.1600-0536.1996.tb02175.x.
Current regulations require that the skin irritation/corrosion potential of new chemicals is assessed in the rabbit Draize test, although there are opportunities to use alternative methods to identify the most aggressive materials. Previously, we have proposed that it is possible to employ a strategy that avoids the use of animals and at the same time delivers a more relevant assessment of skin irritation/corrosion potential. The approach is to identify corrosive materials in vitro and then proceed to human volunteer testing for skin irritation. In this study, the human 4-h patch test, its interpretation, and results with 29 test materials are presented. Using 14 materials not classified as "Irritating to skin" by EU criteria, 13 classified as "Irritating to skin" by suppliers, and 2 as "Corrosive - causes burns", it is demonstrated that, by evaluating these on human skin in vitro and in vivo, a significant proportion are either over-classified or under-classified. In conclusion, we are convinced that by application of the approach described in detail here, it is possible to avoid the use of animals, whilst at the same time obtaining an assessment of skin irritation/corrosion potential that is more relevant to man, and which, if required, may be used directly for classification and labelling of substances and preparations within the European Union.
当前法规要求通过兔眼刺激试验评估新化学品的皮肤刺激/腐蚀潜能，不过也有机会使用替代方法来识别最具侵蚀性的物质。此前，我们曾提出可以采用一种策略，既能避免使用动物，同时又能对皮肤刺激/腐蚀潜能进行更具相关性的评估。该方法是先在体外识别出腐蚀性物质，然后再进行人体志愿者皮肤刺激试验。在本研究中，介绍了人体4小时贴片试验、其解读方法以及29种测试物质的试验结果。通过对14种按欧盟标准未归类为“对皮肤有刺激性”的物质、13种供应商归类为“对皮肤有刺激性”的物质以及2种“腐蚀性——会导致灼伤”的物质进行评估，结果表明，通过在人体皮肤体外和体内对这些物质进行评估，相当一部分物质要么被过度归类，要么被归类不足。总之，我们确信，通过应用此处详细描述的方法，可以避免使用动物，同时获得与人类更相关的皮肤刺激/腐蚀潜能评估结果，并且如果需要，该结果可直接用于欧盟内物质和制剂的分类及标签标注。
