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Table 1 BCOP Results
Mean opacity value
Mean OD490 value
In vitro score
Positive control (Ethanol)
The Bovine Corneal Opacity and Permeability Assay was used to assess the potential ocular irritancy of the test substance as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas. Based on changes in corneal opacity and permeability (relative to the control corneas), an in vitro score was determined. The in vitro score was 1.7 Since the results of the positive control (ethanol) fell within two standard deviations of the historical mean (within a range of 39.2 to 64.0), the assay was considered valid. Following the classification established by Gautheron et al. (1992) (Sina classification system) based on studies with a wide range of test materials, the test substance, would be considered a mild irritant (in vitro score from 0 to 25). Following the modification of the Sina classification system proposed by Vanparys, et al. (1993) based on an evaluation of 50 pharmaceutical and commercially-available industrial compounds, the test substance would be considered a non-irritant (in vitro score from 0 to 3).
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