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EC number: 607-674-0 | CAS number: 25260-60-0
Table 1 Summary of results of BCOP assay
per group(mean value)
0.9% sodiumchloride solution
This in vitro study was performed to evaluate the eye hazard potential of the test item by means of the BCOP (Bovine Corneal Opacity and Permeability Assay). Therefore, the induced opacity and increased permeability was investigated in isolated bovine corneas after exposure to the test item. As negative control 0.9% sodium chloride solution and as positive control N,N-dimethylformamide was used. Three corneas were used per group (negative control, positive control or test item group).
After a first opacity measurement of the untreated bovine corneas, 750 µL of the test item, positive or negative control were applied on the corneas and incubated for 10 minutes. After the incubation phase the test item, the positive, and the negative control were rinsed from the corneas and the opacity was measured again. After the opacity measurements, the permeability of the corneas was determined by application of a fluorescein solution for 90 minutes. The amount of fluorescein solution that crossed the cornea was measured spectrophotometrically. The opacity and permeability assessments were combined to determine an In Vitro Irritancy Score (IVIS). After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 2.8. Treatment with the positive control (N,N-dimethylformamide) revealed an IVIS of 105.0. Therefore, the study fulfilled the validity criteria. The IVIS obtained after treatment with the test item was 12.2 and, thus, according to OECD 437 no prediction can be made regarding the eye hazard potential.
In conclusion, under the conditions of the present study, no prediction can be made for the test item with regard to the eye hazard potential.
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