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EC number: 944-870-8
CAS number: -
Table 1: Results
objective of the present study was to investigate the potential of the
test item to induce eye irritation in an in
cornea model according to OECD TG 492. The
test item was applied topically to a reconstructed human cornea-like
epithelium model (EpiOcular™) followed by determination of the cell
viability. Cell viability was determined by enzymatic conversion of
vital dye MTT into a blue formazan salt and measurement of the formazan
salt after extraction from tissues. The percent reduction of cell
viability in comparison to untreated negative controls was used to
predict the eye irritation potential. Duplicates of the EpiOcular™-model
were treated with the test item, the negative or the positive control
for 6 hours (± 15 minutes). 50 mg of the test item and 50 µL of either
the negative control (sterile deionized water) or the positive control
(methyl acetate) were applied to the tissues.
treatment with the negative control (sterile deionized water) the mean
OD was 2.034 (study acceptance criterion: >0.8 and <2.5). Treatment with
the positive control (methyl acetate) revealed a mean viability value of
29.6% (study acceptance criterion: <50%). Thus, the acceptance criteria
were met. Following
treatment with the test item, the tissue viability was 1.1% and, thus,
lower than 60%,i.e.according
to OECD 492 no prediction can be made regarding the eye hazard potential
of the test item.
the conditions of the present study, the eye hazard potential of the
test item cannot be predicted and further testing is necessary.
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