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. (August 2016)

• Record Type: Journal Article
• Authors: Alépée, N.; Adriaens, E.; Grandidier, M.H.; Meloni, M.; Nardelli, L.; Vinall, C.J.; Toner, F.; Roper, C.S.; Van Rompay, A.R.; Leblanc, V.; Cotovio, J.
• Is Part Of: Toxicology in vitro. Volume 34(2016)
• Page Start: 55
• Page End: 70
• Publication Date: 2016-08
• Subjects: BCOP Bovine Corneal Opacity and Permeability -- BLR between laboratory reproducibility -- C classified -- CAS RN Chemical Abstracts Service Registry Number -- Cat 1 UN GHS classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat 2 UN GHS classification for chemicals causing reversible effects on the eye/eye irritation, sub-categorised in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mildly irritant to eyes, eye effects fully reversible within 7 days of observation) -- CC Conjunctival Chemosis -- CI confidence interval -- CM Cytosensor Microphysiometer -- CO Corneal Opacity -- Conj CR and/or CC -- CR Conjunctival Redness -- CRL Charles River Laboratories -- DRD Draize eye test Reference Database -- EIT Eye Irritation Test -- EITL Eye Irritation Testing of Liquids -- EITS Eye Irritation Testing of Solids -- EURL ECVAM European Union Reference Laboratory for Alternatives to Animal Testing -- HCE Human Corneal Epithelium -- HPLC/UPLC High/Ultra Performance Liquid Chromatography -- ICCVAM Interagency Coordinating Committee on the Validation of Alternative Methods -- ICE Isolated Chicken Eye -- IR Iritis -- LO L'Oréal -- MTT 3-[4, 5-dimethylthiazole-2-yl]-2, 5-diphenyltetrazolium bromide -- NgC negative control -- NC not classified -- No Cat chemicals not classified for serious eye damage/eye irritation under UN GHS/EU CLP -- NSC non-specific colour -- NSCkilled non-specific colour on killed tissues -- NSMTT non-specific reduction of MTT -- OD optical density -- OECD Organisation for Economic Co-operation and Development -- PC positive control -- PBS phosphate-buffered saline -- pers persistence -- RhCE Reconstructed human Cornea-like Epithelium -- RhT Reconstructed human Tissue -- SCNM study criteria not met -- STE short-time exposure -- S.O.P. Standard Operating Procedure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals -- VITO Flemish Institute for Technological Research -- VMG Validation Management Group -- VRM validation reference method -- WLR within laboratory reproducibility; Ocular toxicity -- SkinEthic HCE -- Reconstructed human corneal tissue -- Validation -- Reproducibility -- Predictive capacity; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2016.02.014
• Languages: English
• ISSNs: 0887-2333

Abstract

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. Highlights: SkinEthic™ HCE method has been developed for the Eye Irritation Testing of Solids. A validation study has been conducted with three laboratories on 60 substances. Good within- and between laboratory reproducibility was achieved of ≥ 95.0% and. 96.8%, respectively. The accuracy was 81.0% with a sensitivity of 90.5% and specificity of 73.6% on 95 chemicals. Overall, 200 chemicals were tested resulting in an accuracy of 83.7% meeting all acceptance criteria for predictive capacity.