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

•The China EpiSkin™ Skin Irritation Test was established with 45 chemicals.•This test method showed good within-laboratory reproducibility.•The predictive performance on 45 chemicals met the OECD TG 439 acceptance criteria.•This work provided a solid scientific foundation for future validation in China.•The validity of this method supports the promotion of alternative methods in China.

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.