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Administrative data

Description of key information

This in vitrostudy was performed to assess the eye irritation potential of FRET 11-0571 by means of the Human Cornea Model Test. The test item did not prove to be an MTT reducer in the MTT pre-test. And it did not prove to dye water or isopropanol in the colour interference pre-test. Therefore, additional tests with freeze-killed or viable tissues did not have to be performed. Each 50 mg of the test item were applied to each of duplicate tissue for 6 hours. Each 50 µL of the negative control (deionised water) and of the positive control (methyl acetate) were also applied to duplicate tissues each. After treatment with the negative control, the absorbance values were well within the required acceptability criterion of mean OD > 0.8 and < 2.5, thus showing the quality of the tissues. Treatment with the positive control induced a decrease below 50% compared with thenegative control value in the relative absorbance, thus ensuring the validity of the test system. The difference of viability between the two relating tissues was < 20% in the same run (for test item tissues, positive and negative control tissues). Irritating effects were observed following incubation with FRET 11-0571. Compared with the value of the negative control, the relative mean absorption value corresponding to the viability of the tissues decreased below 60% (4.2%). In conclusion, it can be stated that in this study and under the experimental conditions reported, FRET 11-0571 possesses an eye irritating potential

Key value for chemical safety assessment

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In this in vitro study and under the experimental conditions reported, FRET 11-0571 possesses an eye irritating potential.

Justification for classification or non-classification