title: In vitro skin irritation assessment becomes a reality in China using a reconstructed human epidermis test method.
abstract: 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.
authors.affiliation: L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.affiliation: L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China.
authors.forename: Yanfeng
authors.initials: Y
authors.lastname: Liu
authors.affiliation: L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qiu
authors.affiliation: L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China.
authors.forename: Lingyan
authors.initials: L
authors.lastname: Zhong
authors.affiliation: L'Oréal Research & Innovation France, 1 Avenue Eugène Schueller, 93600 Aulnay-Sous-Bois, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alépée
authors.affiliation: L'Oréal Research & Innovation France, 1 Avenue Eugène Schueller, 93600 Aulnay-Sous-Bois, France.
authors.forename: José
authors.initials: J
authors.lastname: Cotovio
authors.affiliation: L'Oréal Research & Innovation China, 550 Jinyu Road, 201206 Shanghai, China. Electronic address: ACAI@rd.loreal.com.
authors.forename: Zhenzi
authors.initials: Z
authors.lastname: Cai
mesh_terms: D000826:Animal Testing Alternatives; D002681:China; D004817:Epidermis / Q000187:drug effects*; D006801:Humans; D007509:Irritants / Q000633:toxicity*; D015203:Reproducibility of Results; D023422:Skin Irritancy Tests; D046509:Tissue Culture Techniques
chemical_list: D007509:Irritants
keywords: Alternative testing in China; EpiSkin™; OECD TG439; Reconstructed Chinese human epidermis; Skin irritation; in vitro