CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labeling of eye irritating chemicals

H. Kandarova, S. Letasiova, E. Adriaens, R. Guest, J.A. Willoughby Sr., A. Drzewiecka, K. Gruszka, Nathalie Alépée, Sandra Verstraelen, An R. Van Rompay

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 labeling. 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.


CON4EI, Ocular irritation, EpiOcular™ Eye Irritation Test (EpiOcular™ EIT), OECD Test Guideline 492

Materials Tested

2–Hydroxy iso–butyric acid ethyl ester, Benzensulphonylchloride, bis–(3–Aminopropyl)–tetramethyldisiloxane, Diethylethanolamine, Ethylhexyl acid phosphate ester, Lactic acid, Domiphen bromide (10%), 2–Benzyl–4–chlorophenol Aryl halide, 2–Hydroxy iso–butyric acid, 4,4’–4,5,6,7–Tetrabromo–3H–2,1–benzoxathiol–3–ylidene)bis[2,6–dibromophenol] S,S–dioxide, 4–(1,1,3,3–Tetramethylbutyl)phenol, alpha–Ketoglutaric acid, Dibenzoyl–L–tartaric acid, Distearyldimethylammonium chloride, Hexadecyltrimethylammonium chloride (25%), Hydroxyethyl acrylate, 1–Chloroctan–8–ol, Cetyltrimethyl ammonium bromide (10%), 1–Naphthalene acetic acid Na salt, Captan 90–concentrate, Lauric acid, m–Phenylene diamine, p–tert–Butylphenol, Sodium perborate, Sodium salicylate, Benzoic acid, (3–Aminopropyl)triethoxy silane, Methoxyethyl acrylate, Methyl thioglycolate, n–Octylamine, Tetrahydrofuran, Tributyltin oxide, 1,2–Benzisothiazol–3(2H)–one Benzothiazole/Benzoisothiazole, Paraformaldehyde, N–(2–Methylphenyl)–iminodicarbonimidic diamide (1–(o–Tolyl)biguanide), N–Acetyl–DL–methionine, Quinacrine, Triethanolamine orthovanadate, 2–Propanl, 1–phenoxy-, Cyclopentanol, Propasol Solvent P, (2R,3R)–3–((R)–1–(Tert–butyldimethylsiloxy)ethyl)–4–oxoazetidin–2–yl acetate, 3,3’–Dithiopropionic acid, 4–Carboxybenzaldehyde, Dibenzyl phosphate, 2–Methyl–1–pentanol, 3–Chloropropionitrile, Butyl Dipropasol, iso–Butanal, n–Butanal, 2,6–Dichloro–5–fluoro–beta–oxo–3–Pyridinepropanoate, iso–Propanol, Methyl cyanoacetate, 1,5–Naphthalenediol, 2–Amino–3–hydroxy pyridine, Ammonium nitrate, Sodium benzoate, 2–Pseudoionone, iso–Propyl acetoacetate, Glycolic acid (10%), 2–Hydroxy–1,4–naphthoquinone, Camphene, m–Dinitrobenzene, p–Nitrobenzoic acid, Sodium monochloroacetate, 1,2,6–Hexanetriol, 1–Ethyl–3–methylimidazolium ethyl sulphate, 2–Ethylhexyl p–dimethylamino benzoate, Dioctyl ether, Dodecane, Glycerol, Propylene glycol, Tween 80, 1–(9H–Carbazol–4–yloxy)–3–[[2–(2–methoxyphenoxy)ethyl]amino]propan–2–ol, 2–Mercaptopyrimidine, Phenothiazine, Potassium tetrafluoroborate, Silicic acid, Tetrabromobisphenol A, Theobromine

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