A way forward of alternative methods in China: Implementation of skin corrosivity potential using in vitro reconstructed human epidermis. (October 2018)

• Record Type: Journal Article
• Authors: Liu, Yanfeng; Li, Nan; Chen, Lizao; Zhong, Lingyan; Zhou, Ming; Pan, Li; Chen, Dan; Gu, Wei; Li, Yifeng; Wang, Wei; Guo, Yuanji; Cotovio, José; Qiu, Jie; Alépée, Nathalie; Cai, Zhenzi
• Is Part Of: Toxicology in vitro. Volume 52(2018)
• Page Start: 321
• Page End: 331
• Publication Date: 2018-10
• Subjects: CASRN Chemical Abstract Service Registry Number -- d-PBS Dulbecco's Phosphate Buffered Saline -- EURL ECVAM European Union Reference Laboratory for European Centre for the Validation of Alternative Methods -- GHS Globally harmonized system of classification and labelling of chemicals -- HCl Hydrochloric Acid -- HPLC High Performance Liquid Chromatography -- MTT 3-(4, 5-Dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide -- NaCl Sodium Chloride -- NC Non-corrosive -- NgC Negative Control -- OECD Organization for Economic Co-operation and Development -- OD Optical Density -- PC Positive Control -- PM Prediction Model -- RHE Reconstructed Human Epidermis -- SCT Skin Corrosion Test -- SD Standard deviations -- TER Transcutaneous Electrical Resistance -- TDG Transport of Dangerous Goods -- TG Test guideline -- UN United Nations -- WLR Within-laboratory Reproducibility; Reconstructed Chinese human epidermis model -- EpiSkin™ skin corrosion test -- in vitro -- OECD test guideline 431 -- sub-categorization 1A 1B/1C -- alternative testing in China; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2018.07.013
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: The purpose of present study was to investigate the applicability of reconstructed human epidermis model to identify skin corrosive UN GHS Categories 1A, 1B/1C and non-corrosive chemicals in China. By using a commercialized reconstructed human epidermis model, China EpiSkin™ which had been proven to be applicable as a stand-alone test method to predict skin irritation in previous study, the predictive capacity of corrosion was assessed with 76 chemicals that included 30 reference chemicals recommended by OECD TG 431 in this study. The latter reference chemicals were tested in three runs, the within-laboratory reproducibility reached 100%, the accuracy was 90% for distinguishing corrosive and non-corrosive chemicals and 80% for sub-categorization (Cat. 1A vs Cat. 1B/1C vs non corrosive). Additional 46 chemicals were also tested, and the overall accuracy for sub-categorization of all 76 tested chemicals was 80.3% with 91.7% sensitivity for Category 1A, 82.1% sensitivity for category 1B/1C and 75% specificity which met all required predictive capacity by OECD. The present study results show that China EpiSkin™ model can be applied to predict sub-categorization 1A and 1B/1C of corrosive chemicals. The availability of skin corrosion in vitro test method provides the applicability of in vitro non-animal testing method for chemicals widely used in various industries, and will further support the implementation and promotion of alternative methods in China. Highlight: The China EpiSkin™ Skin Corrosion Test method was assessed by 76 chemicals. This test method showed good within-laboratory reproducibility. The predictive performance on 76 chemicals met the OECD TG 431 acceptance criteria. The first reliable in vitro test system in China for corrosion sub-categorization A solid scientific foundation to support alternative method promotion in China.