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EC number: 616-145-3 | CAS number: 74852-61-2
Due to a high response of the negative control opacity and test item results spread over 2 categories, the first test was rejected and a repeat test was performed. The results reported in this endpoint study record were obtained in the repeat test.
Interpretation (repeat test):
The IVIS of all replicates was within one category.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 109.8 (91.2 to 119.2) and within the laboratory historical positive control data range. Furthermore the opacity and permeability values of the positive control were within two standard deviations of the current historical mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The test item did not induce ocular irritation through both endpoint, resulting in a mean in vitro irritancy score of 0.2 (-0.7 to 0.7) after 240 minutes of treatment.
Since the test item induced an IVIS <=3, no classification is required for eye irritation or serious eye damage.
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