Development of a Defined Approach for Eye hazard identification of chemicals having surfactant properties according to the three UN GHS categories. (June 2023)

• Record Type: Journal Article
• Authors: Alépée, N.; Adriaens, E.; Abo, T.; Magby, J.; Mewes, K.R.; Giusti, A.
• Is Part Of: Toxicology in vitro. Volume 89(2023)
• Publication Date: 2023-06
• Subjects: Serious eye damage and eye irritation -- Defined approach -- Draize eye reference database -- NAM -- Surfactant -- OECD 467; BCOP Bovine Corneal Opacity and Permeability -- CASRN 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-categorized in 2A (irritant to eyes, eye effects are not fully reversible within 7 days of observation) and 2B (mild irritant to eyes, eye effects fully reversible within 7 days of observation) -- CO Corneal Opacity -- CON4EI CONsortium for in vitro Eye Irritation testing strategy -- DA Defined Approach -- DASF Defined Approach for Surfactants -- DRD Draize eye test Reference Database -- EIT Eye Irritation Test -- EIVS Eye Irritation Validation Study -- HCE Human Corneal Epithelium -- IATA Integrated Approach on Testing and Assessment -- LLBO Laser Light-Based Opacitometer -- NAM New Approach Methodologies -- No Cat. Chemicals not classified for serious eye damage or eye irritation under GHS/EU CLP -- OECD Organisation for Economic Co-operation and Development -- RhCE Reconstructed human Cornea-like Epithelium -- STE Short Time Exposure -- TG Test Guideline -- UN GHS United Nations Globally Harmonized System of Classification and Labelling of Chemicals; Toxicity testing -- In vitro -- Periodicals; Toxicology -- Periodicals; 615.9
• DOI: 10.1016/j.tiv.2023.105576
• Languages: English
• ISSNs: 0887-2333

Abstract

Abstract: The purpose of this study was to develop a defined approach (DA) for eye hazard identification according to the three UN GHS categories for surfactants (DASF). The DASF is based on a combination of Reconstructed human Cornea-like Epithelium test methods (OECD TG 492; EpiOcular™ EIT and SkinEthic™ HCE EIT) and the modified Short Time Exposure (STE) test method (0.5% concentration of the test substance after a 5-min exposure). DASF performance was assessed by comparing the prediction results with the historical in vivo data classification and against the criteria established by the OECD expert group on eye/skin. The DASF yielded a balanced accuracy of 80.5% and 90.9% of Cat. 1 ( N = 22), 75.0% of Cat. 2 ( N = 8), and 75.5% of No Cat. ( N = 17) surfactants were correctly predicted. The percentage of mispredictions was below the established maximum values except for in vivo No Cat. surfactants that were over-predicted as Cat. 1 (5.6%, N = 17), with a maximum value set at 5%. The percentage of correct predictions did meet the minimum performance values of 75% Cat. 1, 50% Cat. 2, and 70% No Cat. established by the OECD experts. The DASF has shown to be successful for eye hazard identification of surfactants. Highlights: develop defined approach (DA) for eye hazard assessment of surfactants (DASF). proposed DA: combination of OECD TG 492 with the modified STE test method. The DASF can distinguish between the three UN GHS categories.