Portes P, Grandidier M-H, Cohen C, Roguet R
L'Oreal Recherche, Aulnay sous Bois, France.
Toxicol In Vitro. 2002 Dec;16(6):765-70. doi: 10.1016/s0887-2333(02)00090-5.
The Episkin model took part in the prevalidation study on in vitro tests for acute skin irritation of chemicals, which was carried out during 1999 and 2000. This prevalidation study was co-ordinated and supported by the European Centre for the Validation of Alternative Methods (ECVAM). During Phase 1 and Phase 2 of this study, reproducibility and transferability of the method were verified. Unfortunately, the performance of the method in terms of predictive ability was considered insufficient, due to a low specificity. In order to improve the performance of the Episkin method, the existing protocol was refined. This refinement consisted in reducing the exposure time of epidermis with chemicals. Sensitivity, specificity and accuracy of the new method were 70, 80 and 75%, respectively, thus meeting the acceptance criteria as defined by the Management Team. The Episkin method is now ready to enter a validation study of in vitro tests for acute skin irritation.
Episkin模型参与了1999年至2000年期间开展的化学品急性皮肤刺激性体外试验的预验证研究。该预验证研究由欧洲替代方法验证中心（ECVAM）协调并提供支持。在本研究的第1阶段和第2阶段，对该方法的重现性和转移性进行了验证。遗憾的是，由于特异性较低，该方法在预测能力方面的表现被认为不足。为了提高Episkin方法的性能，对现有方案进行了改进。这种改进包括缩短表皮与化学品的接触时间。新方法的敏感性、特异性和准确性分别为70%、80%和75%，从而达到了管理团队规定的验收标准。Episkin方法现已准备好进入化学品急性皮肤刺激性体外试验的验证研究。
