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EC number: 688-489-2 | CAS number: 1024700-50-2
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
The condition of the cornea immediately after rinsing and at the final opacity measurement is given in Table 2.
The corneas treated with the test item were clear post treatment and slightly cloudy post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
The results are summarised as follows:
In Vitro Irritancy Score
The positive control In Vitro irritancy Score was within the range of 30.9 to 67.7. The positive control acceptance criterion was therefore satisfied.
In vitroIrritancy Score
OD= Optical density * = Mean of the post treatment-pre‑treatment values # = Mean permeability · = Mean corrected value
A study was performed to assess the ocular irritancy potential of the test material to the isolated bovine cornea. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 437 (2009) “Bovine Corneal Opacity and Permeability Assay”
The undiluted test material was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control materials were tested concurrently. 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 scores are summarised as follows:
The corneas treated with the test item were clear post treatment and slightly cloudy post incubation.
The test item was considered not to be an ocular corrosive or severe irritant.
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