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EC number: 291-639-6 | CAS number: 90432-09-0
In order to evaluate the potential of the test item to evoke eye irritation in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study, the EpiOcularTMEye Irritation Test was performed, according to the OECD Guideline 492 (2015). The test item was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours. The solid test item was applied to each tissue. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution. Demineralised water was used as negative control and methyl acetate was used as positive control. As the test item colour is very dark, additional tests for data correction were performed to exclude colour interference during the photometric measurement. After treatment with the test item, the mean value of tissue viability was 3.0 %. All the validity criteria were met.
This value is below the threshold for eye irritation potential (≤ 60 %). Under the conditions of the test, the test item is considered as either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.
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