Basketter D A, Whittle E, Chamberlain M
Unilever Environmental Safety Laboratory, Sharnbrook, Bedford, UK.
Food Chem Toxicol. 1994 Jun;32(6):539-42. doi: 10.1016/0278-6915(94)90111-2.
To date the use of in vitro/alternative tests to achieve formal classification in the EEC of the toxic properties of new substances is very limited. An opportunity exists in the area of skin irritation/corrosivity to adopt a strategic approach which will limit the need to use animals. The approach would involve use of human skin in vitro to identify corrosive materials followed by ethically approved human patch testing. In the patch test, the irritation potential of the substance or preparation would be judged against a suitable positive irritant control. In addition to the avoidance of the use of animals, a further benefit would be that use of human skin should lead to a more relevant classification of skin irritation/corrosion hazard for humans.
迄今为止，在欧盟通过体外试验或替代试验对新物质的毒性特性进行正式分类的应用非常有限。在皮肤刺激/腐蚀性领域，存在采用一种策略性方法的机会，这种方法将减少使用动物的需求。该方法将包括使用人体皮肤进行体外试验以识别腐蚀性物质，随后进行经伦理批准的人体斑贴试验。在斑贴试验中，将根据合适的阳性刺激对照来判断该物质或制剂的刺激潜力。除了避免使用动物外，另一个好处是使用人体皮肤应该会对人类皮肤刺激/腐蚀危害进行更相关的分类。
