Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals

被引：33
作者：
Alepee, N. [1 ]
Leblanc, V. [1 ]
Adriaens, E. [2 ]
Grandidier, M. H. [1 ]
Lelievre, D. [3 ]
Meloni, M. [4 ]
Nardelli, L. [1 ]
Roper, C. S. [5 ]
Santirocco, E. [4 ]
Toner, F. [5 ]
Van Rompay, A. [6 ]
Vinall, J. [5 ]
Cotovio, J. [1 ]
机构：
[1] LOreal Res & Innovat, F-93600 Aulnay Sous Bois, France
[2] Adriaens Consulting, Aalter, Belgium
[3] Episkin SA, Lyon, France
[4] VitroScreen, Milan, Italy
[5] Charles River Labs, Edinburgh, Midlothian, Scotland
[6] VITO NV Flemish Inst Technol Res, Mol, Belgium
来源：
TOXICOLOGY IN VITRO | 2016年 / 31卷
关键词：
Inter-laboratory validation; SkinEthic HCE; Reproducibility; Performance; Serious eye damage-irritation; UN GHS Classification and Labelling of Chemicals; HAZARD IDENTIFICATION; PRE-VALIDATION; PREDICTION; SUBSTANCES; MODEL;
D O I：
10.1016/j.tiv.2015.11.012
中图分类号：
R99 [毒物学（毒理学）];
学科分类号：
100405 ;
摘要：
A prospective multicentric study of the reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic (TM) HCE) was conducted to evaluate its usefulness to identify chemicals as either not classified for serious eye damage/eye irritation (No Cat.) or as classified (Cat. 1/Cat. 2) within UN GHS. The aim of this study was to demonstrate the transferability and reproducibility of the SkinEthic (TM) HCE EITL protocol for liquids and define its predictive capacity. Briefly, 60 chemicals were three times tested (double blinded) in 3 laboratories and 45 additional chemicals were tested three times in one laboratory. Good within laboratory reproducibility was achieved of at least 88.3% (53/60) and 92.4% (97/105) for the extended data set. Furthermore, the overall concordance between the laboratories was 93.3% (56/60). The accuracy of the SkinEthic (TM) HCE EITL for the extended dataset, based on bootstrap resampling, was 84.4% (95% CI: 81.9% to 87.6%) with a sensitivity of 99.0% (95% CI: 96.4% to 100%) and specificity of 68.5% (95% CI: 64.0% to 74.0%), thereby meeting all acceptance criteria for predictive capacity. This efficient transferable and reproducible assay is a promising tool to be integrated within a battery of assays to perform an eye irritation risk assessment. (C) 2015 Elsevier Ltd. All rights reserved.
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页码：43 / 53
页数：11
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