Li Nan, Liu Yanfeng, Qiu Jie, Zhong Lingyan, Alépée Nathalie, Cotovio José, Cai Zhenzi
L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China.
L'Oréal Research & Innovation France, 1 Avenue Eugène Schueller, 93600 Aulnay-Sous-Bois, France.
Toxicol In Vitro. 2017 Jun;41:159-167. doi: 10.1016/j.tiv.2017.02.009. Epub 2017 Feb 20.
The in vitro EpiSkin™ test method was validated in 2007 by the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) as a full replacement method for the Draize acute skin irritation test and adopted in the OECD Test Guideline 439 in 2009. Based on the EpiSkin™ technology, the production of a reconstructed epidermis model has been established and standardized in China. The evaluation of the in vitro skin irritation test method using this EpiSkin™ model produced in China was performed on a set of 45 chemicals. Good predictive capacity was obtained with 94% (n=17) for sensitivity, 75% (n=28) for specificity and 82% for accuracy. The accuracy of the included 20 OECD reference chemicals also met the OECD acceptance criteria, indicating that this testing method based on the EpiSkin™ model produced in China can be used as a stand-alone test method to predict skin irritation. The availability and validity of in vitro epidermis model and testing method are of great significance for extending the applications of non-animal alternative testing methods in China.
体外EpiSkin™测试方法于2007年被欧盟替代动物测试参考实验室（EURL ECVAM）确认为替代Draize急性皮肤刺激性试验的完全替代方法，并于2009年被采纳为经合组织测试指南439。基于EpiSkin™技术，中国已建立并标准化了重组表皮模型的生产。使用在中国生产的这种EpiSkin™模型对一组45种化学品进行了体外皮肤刺激性测试方法的评估。敏感性为94%（n=17），特异性为75%（n=28），准确性为82%，具有良好的预测能力。所纳入的20种经合组织参考化学品的准确性也符合经合组织的验收标准，表明这种基于在中国生产的EpiSkin™模型的测试方法可作为预测皮肤刺激性的独立测试方法。体外表皮模型和测试方法的可用性和有效性对于在中国扩展非动物替代测试方法的应用具有重要意义。
