荧光素漏出试验替代整体兔眼刺激试验的初步研究

Study on fluorescein leakage test as an alternative method of draize eye irritation test

目的:探讨荧光素漏出试验(FLT)替代整体动物眼刺激试验(Draize eye irritation test,Draize test)的可能性。方法:用FLT对26种阳性参考物和20种化妆品产品进行检测并分级,化妆品产品同步进行Draize test,比较分析两种方法受试物刺激性分级结果的等级和分级一致性。结果:对于所检测26种阳性参考物和20种化妆品的刺激性分级,FLT与Draize test之间具有较高的一致性(kappa值分别为0.827和0.571,P均<0.001)。结论:FLT是一种有效的Draize test体外替代方法,具有良好的应用价值。

Objective ：To study the possibility of the fluorescein leakage test （FLT） as an alternative method for in vivo draize eye irritation test（ Draize test）. Methods：In this study, 26 positive referent chemicals with known eye irritant potentiality and 20 cosmetic products with unknown eye irritant assessment were tested by FLT. Meanwhile, the cosmetics were tested by Draize test. In vivo/in vitro comparisons of the positive chemicals and the cosmetics were conducted according to ranking concordance analysis, respectively. Results： FLT was concordant with draize test in the ocular irritant classification of chemicals and cosmetics （ kappa = 0. 827, P 〈 0. 001 ; kappa = 0. 571, P = 0. 002 ）. Conclusion： The FLT is a valuable alternative test of draize test that may he applied in the evaluation of the eye irritation properties of cosmetics and ingredients and even other industrial products.