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EC number: 807-889-1
CAS number: 1255203-42-9
Summary of opacity, permeability and in vitro scores
Mean In vitro Irritation Score*
* Calculated using the negative control mean opacity and mean
permeability values. In vitro irritancy score (IVIS) = mean opacity
value + (15 x mean OD490 value).
Evaluation of the eye hazard potential of D-C16 was performed
using the Bovine Corneal Opacity and Permeability test (BCOP test, OECD
429). The report describes the potency of chemicals to induce serious
eye damage using isolated bovine corneas. The eye damage of D-C16 was
tested through topical application for approximately 240 minutes.
Batch 14-002 of D-C16 was a white crystal with a purity of 99.3%.
Since no workable suspension in physiological saline could be obtained,
the test substance was used as delivered and added pure on top of the
corneas (321.7 to 358.4 mg).
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 135 and within the historical positive control data
range. It was therefore concluded that the test conditions were adequate
and that the test system functioned properly.
D-C16 did not induce ocular irritation through both endpoints,
resulting in a mean in vitro irritancy score of -0.5 after 240 minutes
of treatment. Since D-C16 induced an IVIS ≤ 3, no classification is
required for eye irritation or serious eye damage.
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