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EC number: 237-354-2 | CAS number: 13760-80-0
Table1: Individual and Mean Corneal Opacity and Permeability Measurements
In Vitro Irritancy Score
OD= Optical density
* = Mean of the post-treatment - pre-treatment values
** = Mean permeability
*** = Mean corrected value
The potential of the test material to cause eye irritation was investigated under the standardised guidelines OECD 437 and EU method B.47 under GLP conditions using the Bovine Corneal Opacity and Permeability (BCOP) test method.
The Bovine Corneal Opacity and Permeability (BCOP) test method is an organotypic model that provides short term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test material is assessed by quantitative measurements of changes in corneal opacity and permeability.
The test material was applied to the corneas at a concentration of 20 % w/v in 0.9 % w/v sodium chloride solution for 240 minutes, the study was performed in triplicate. Negative and positive control materials were tested concurrently, in triplicate also. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
The in vitro irritancy score for the test material was 9.3 and as a result it falls into the band of IVIS > 3 - ≤55 in the classification system and so no prediction of eye irritation can be made.
The positive control In Vitro Irritancy Score was within the range of 66.9 to 101.4. The positive control acceptance criterion was therefore satisfied. The negative control gave opacity of ≤ 4.1 and permeability ≤ 0.105. The negative control acceptance criteria were therefore satisfied.
Under the conditions of this study, as the test material induced an IVIS score of 9.3, no prediction on eye irritation can be made.
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