CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labelling of eye irritating chemicals. (June 2018)

• Record Type: Journal Article
• Authors: Kandarova, H.; Letasiova, S.; Adriaens, E.; Guest, R.; Willoughby, J.A.; Drzewiecka, A.; Gruszka, K.; Alépée, Nathalie; Verstraelen, Sandra; Van Rompay, An R.
• Is Part Of: Toxicology in vitro. Volume 49(2018)
• Page Start: 21
• Page End: 33
• Publication Date: 2018-06
• Subjects: DBALM Database of Alternative Methods at the European Commission's Joint Research Centre -- Cat 1 UN GHS/EU CLP classification for chemicals causing irreversible effects on the eye/serious damage to the eye -- Cat 2 UN GHS/EU CLP classification for chemicals causing reversible effects on the eye/eye irritation -- CI confidence interval -- CCIs cell culture inserts -- CO corneal opacity -- Conj conjunctival redness -- CON4EI Consortium for Eye Irritation Testing -- EURL ECVAM European Union Reference Laboratory for Alternative Methods to Animal testing -- EU CLP European Union Regulation on Classification, Labelling and Packaging of chemicals -- EIT eye irritation test -- FN false negative -- FP false positive -- I Irritant (Cat1/Cat2) -- JoVE Journal of Visualized Experiments -- MTT 3-[4, 5-dimethyl-thiazol-2-yl]-2, 5-diphenyl tetrazolium bromide -- NC negative control -- NI Non-Irritant (No Cat) -- No Cat chemicals not classified for serious eye damage/eye irritation under UN GHS/EU CLP -- NQ not qualified -- OD optical density -- OECD Organisation for Economic Co-operation and Development -- PC positive control -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals -- STE Short Time Exposure Assay -- ICE Isolated Chicken Eye Test -- BCOP Bovine Corneal Opacity and Permeability Test -- SMI Slug Mucosal Irritation Test -- GMP Good Laboratory Practice -- NHEK Normal Human Epidermal Keratinocytes -- CCIs cell culture inserts -- SCCs Standard Cell Culture Conditions -- DPBS Dulbecco's Phosphate Buffered Solution; CON4EI -- Ocular irritation -- EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) -- OECD Test Guideline 492; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2017.07.002
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: Assessment of the acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI project was to develop tiered testing strategies for eye irritation assessment. A set of 80 reference chemicals (38 liquids and 42 solids) was tested with eight different methods. Here, the results obtained with the EpiOcular™ Eye Irritation Test (EIT), adopted as OECD TG 492, are shown. The primary aim of this study was to evaluate of the performance of the test method to discriminate between chemicals not requiring classification for serious eye damage/eye irritancy (No Category) and chemicals requiring classification and labelling. In addition, the predictive capacity in terms of in vivo drivers of classification ( i.e. corneal opacity, conjunctival redness and persistence at day 21) was investigated. EpiOcular™ EIT achieved a sensitivity of 97%, a specificity of 87% and accuracy of 95% and also confirmed its excellent reproducibility (100%) from the original validation. The assay was applicable to all chemical categories tested in this project and its performance was not limited to the particular driver of the classification. In addition to the existing prediction model for dichotomous categorization, a new prediction model for Cat 1 is suggested. Highlights: EpiOcular achieved a sensitivity of 97%, a specificity of 87% and accuracy of 95%. Excellent reproducibility (100%) obtained in 2 runs. EpiOcular™ EIT was applicable to all chemical categories tested in this project. Excellent performance not limited to the particular driver of the classification A new prediction model for Cat 1 is suggested for liquids and solids.