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.

引用

页码：43 / 53

页数：11

共 28 条

[11]

Cotovio J., 2007, AATEX, V14, P343

[12] In vitro assessment of eye irritancy using the Reconstructed Human Corneal Epithelial SkinEthic™ HCE model: Application to 435 substances from consumer products industry [J].

Cotovio, Jose ;

Grandidier, Marie-Helene ;

Lelievre, Damien ;

Bremond, Christelle ;

Amsellem, Carolle ;

Maloug, Saber ;

Ovigne, Jean-Marc ;

Loisel-Joubert, Sophie ;

Van Der Lee, Aline ;

Minondo, Anne-Marie ;

Capallere, Christophe ;

Bertino, Beatrice ;

Alepee, Nathalie ;

Tinois-Tessonneaud, Estelle ;

de Fraissinette, Anne De Brugerolle ;

Meunier, Jean-Roch ;

Leclaire, Jacques .

TOXICOLOGY IN VITRO, 2010, 24 (02) :523-537

[13]

EC EURL ECVAM, 2014, VAL STUD REP EURL EC

[14]

ENV/JM/MONO, 2015, SER TEST ASS, V216, P21

[15]

ESAC, 2009, EVCAM SCI ADV COMM E

[16]

Freeman SJ, 2010, ALTEX, V27, P261

[17] First Alternative Method Validated by a Retrospective Weight-of-Evidence Approach to Replace the Draize Eye Test for the Identification of Non-Irritant Substances for a Defined Applicability Domain [J].

Hartung, Thomas ;

Bruner, Leon ;

Curren, Rodger ;

Eskes, Chantra ;

Goldberg, Alan ;

McNamee, Pauline ;

Scott, Laurie ;

Zuang, Valerie .

ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION, 2010, 27 (01) :43-51

[18]

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), 2010, NIH Publ. No. 10-7553-Publ

[19] The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment [J].

Kaluzhny, Yulia ;

Kandarova, Helena ;

Handa, Yuki ;

DeLuca, Jane ;

Truong, Thoa ;

Hunter, Amy ;

Kearney, Paul ;

d'Argembeau-Thornton, Laurence ;

Klausner, Mitchell .

ATLA-ALTERNATIVES TO LABORATORY ANIMALS, 2015, 43 (02) :101-127

[20] Development of the EpiOcular™ Eye Irritation Test for Hazard Identification and Labelling of Eye Irritating Chemicals in Response to the Requirements of the EU Cosmetics Directive and REACH Legislation [J].

Kaluzhny, Yulia ;

Kandarova, Helena ;

Hayden, Patrick ;

Kubilus, Joseph ;

d'Argembeau-Thornton, Laurence ;

Klausner, Mitchell .

ATLA-ALTERNATIVES TO LABORATORY ANIMALS, 2011, 39 (04) :339-364

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