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EC number: 234-282-3
CAS number: 11065-74-0
Table Summary of opacity,
permeability and in vitro scores
Mean In vitro Irritation Score1, 2
using the negative control mean opacity and mean permeability values.
vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490value).
This report describes the ocular
irritation properties of EDTA-MnNa2 on an isolated bovine cornea. The
possible ocular irritancy of EDTA-MnNa2 was tested through topical
application for 240 ± 10 minutes. The study procedures described in this
report were based on the most recent OECD guideline.
Batch CFC 9380 of EDTA-MnNa2 was an
off-white powder.The test substance was applied as a 20% (w/w) solution
(750 µl) directly on top of the corneas. The negative control responses
of the opacity and permeability values were less than the upper limits
of the laboratory historical rangeindicating 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 119 and within the
historical positive controldata range.It was therefore concluded that
the test conditions were adequate and that the test system functioned
properly. EDTA-MnNa2 did not induce ocular irritation through both
endpoints, resulting in a mean in vitro irritancy score of 2.4
after 240 minutes of treatment. It was concluded that this test is valid
and that EDTA-MnNa2 is not a severe irritant or corrosive in the Bovine
Corneal Opacity and Permeability test under the experimental conditions
described in this report.
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