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EC number: 620-455-4
CAS number: 524709-74-8
The objective of the present study was to investigate the potential of the test item to induce eye irritation in an in vitro human cornea model.
The test item was applied topically to a reconstructed human cornea-like epithelium model (EpiOcular) followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the eye irritation potential. Duplicates of the EpiOcular-model were treated with the test item, the negative or the positive control for6 hours (± 15 minutes). 50 mg of the test item and 50 µL of either the negative control (sterile deionized water) or the positive control (methyl acetate) were applied to the tissues.
After treatment with the negative control (sterile deionized water) the mean OD was 1.571 (study acceptance criterion: >0.8 and <2.5). Treatment with the positive control (methyl acetate) revealed a mean viability value of 48.8% (study acceptance criterion: <50%). Thus, the acceptance criteria were met.
Following treatment with the test item, the tissue viability was 90.7% and, thus, higher than 60%, i.e.according to OECD 492 the test item is labeled non-irritant (UN GHS: No Category).
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