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.
Keywords: Defined approach; Draize eye reference database; NAM; OECD 467; Serious eye damage and eye irritation; Surfactant.
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