title: Multi-laboratory evaluation of SkinEthic HCE test method for testing serious eye damage/eye irritation using solid chemicals and overall performance of the test method with regard to solid and liquid chemicals testing.
abstract: A prospective multicentre 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 EITS protocol for solids and define its predictive capacity. Briefly, 60 chemicals were three times tested (double blinded) in 3 laboratories and 35 additional chemicals were tested three times in one laboratory. Good within laboratory reproducibility was achieved of at least 95% (57/60) and 96.8% (92/95) for the extended data set. Furthermore, the overall concordance between the laboratories was 96.7% (58/60). The accuracy of the SkinEthic™ HCE EITS for the extended dataset, based on bootstrap resampling, was 81.0% (95% CI: 78.9% to 83.2%) with a sensitivity of 90.5% (95% CI: 88.1% to 92.9%) and specificity of 73.6% (95% CI: 71.7% to 75.5%). Overall, 200 chemicals were tested (105 liquids (EITL protocol) and 95 solids (EITS protocol)) resulting in a sensitivity of 95.2%, specificity of 72.1% and accuracy of 83.7%, thereby meeting all acceptance criteria for predictive capacity.
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: 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: 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, EH33 2NE, United Kingdom.
authors.forename: C J
authors.initials: CJ
authors.lastname: Vinall
authors.affiliation: Charles River Laboratories Edinburgh, EH33 2NE, United Kingdom.
authors.forename: F
authors.initials: F
authors.lastname: Toner
authors.affiliation: Charles River Laboratories Edinburgh, EH33 2NE, United Kingdom.
authors.forename: C S
authors.initials: CS
authors.lastname: Roper
authors.affiliation: VITO NV (Flemish Institute for Technological Research), Mol, Belgium.
authors.forename: A R
authors.initials: AR
authors.lastname: Van Rompay
authors.affiliation: L'Oréal Research & Innovation, Aulnay Sous Bois, France.
authors.forename: V
authors.initials: V
authors.lastname: Leblanc
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; D019573:Epithelium, Corneal / Q000187:drug effects*; D006801:Humans; D066298:In Vitro Techniques; D007509:Irritants / Q000633:toxicity*; D007753:Laboratories; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods
chemical_list: D007509:Irritants
keywords: Ocular toxicity; Predictive capacity; Reconstructed human corneal tissue; Reproducibility; SkinEthic HCE; Validation