title: Multi-laboratory validation of SkinEthic HCE test method for testing serious eye damage/eye irritation using liquid chemicals.
abstract: A prospective multicentric study of the reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ 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™ 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™ 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.
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France. Electronic address: nalepee@rd.loreal.com.
authors.forename: N
authors.initials: N
authors.lastname: Alépée
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France.
authors.forename: V
authors.initials: V
authors.lastname: Leblanc
authors.affiliation: Adriaens Consulting, Aalter, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Adriaens
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France.
authors.forename: M H
authors.initials: MH
authors.lastname: Grandidier
authors.affiliation: Episkin SA, Lyon, France.
authors.forename: D
authors.initials: D
authors.lastname: Lelièvre
authors.affiliation: VitroScreen, Milano, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Meloni
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France.
authors.forename: L
authors.initials: L
authors.lastname: Nardelli
authors.affiliation: Charles River Laboratories, Edinburgh, United Kingdom.
authors.forename: C S
authors.initials: CS
authors.lastname: Roper
authors.affiliation: VitroScreen, Milano, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Santirocco
authors.affiliation: Charles River Laboratories, Edinburgh, United Kingdom.
authors.forename: F
authors.initials: F
authors.lastname: Toner
authors.affiliation: VITO NV (Flemish Institute for Technological Research), Mol, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Van Rompay
authors.affiliation: Charles River Laboratories, Edinburgh, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Vinall
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France.
authors.forename: J
authors.initials: J
authors.lastname: Cotovio
mesh_terms: D000826:Animal Testing Alternatives; D001681:Biological Assay; D019573:Epithelium, Corneal / Q000187:drug effects*; D006801:Humans; D007509:Irritants / Q000633:toxicity*; D007753:Laboratories; D015203:Reproducibility of Results
chemical_list: D007509:Irritants
keywords: Inter-laboratory validation; Performance; Reproducibility; Serious eye damage-irritation; SkinEthic HCE; UN GHS Classification and Labelling of Chemicals