In vitro skin irritation assessment becomes a reality in China using a reconstructed human epidermis test method

摘要

The in vitro EpiSkin (TM) 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 (TM) 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 (TM) 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 (TM) 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. (C) 2017 Elsevier Ltd. All rights reserved.