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EC number: 239-147-2
CAS number: 15096-41-0
Study Acceptance Criteria
After treatment with the negative control
(0.9 % sodium chloride solution) the calculated IVIS was 1.2 and, thus,
within three standard deviations of the current historical mean of the
negative control (IVIS: -1.1 - 5.3). After treatment with the positive
control (N,N-dimethylformamide) the calculated IVIS was 95.2 and, thus,
also within two standard deviations of the current historical mean of
the positive control (IVIS 76.1 - 120.0). Therefore, the study fulfilled
the acceptance criteria. The resulting classification of the test item
in this study is unequivocal and no borderline results were obtained.
Therefore, a single testing run composed of three corneas per group was
per group (mean value)
objective of the present study was to examine the potential of the test
substance to induce serious eye damage in the BCOP assay. To determine
the eye hazard potential the induced opacity and increased permeability
was investigated in isolated bovine corneas after exposure to the test
item according to OECD Guideline 437. As negative control 0.9 % sodium
chloride solution and as positive control N,N-dimethylformamide was
used. Three corneas were used per group (negative control, positive
control or test item group). After a first opacity measurement of the
untreated bovine corneas, 750 µL of the test item, positive or negative
control were applied on the corneas and incubated for 10 minutes. After
the incubation phase the test item, the positive, and the negative
control were rinsed from the corneas and the opacity was measured again.
After the opacity measurements, the permeability of the corneas was
determined by application of a fluorescein solution for 90 minutes. The
amount of fluorescein solution that crossed the cornea was measured
spectrophotometrically. The opacity and permeability assessments were
combined to determine an In Vitro Irritancy Score (IVIS).
treatment with the negative control (0.9 % sodium chloride solution) the
calculated IVIS was 1.2 (study acceptance criteria range: -1.1 - 5.3).
Treatment with the positive control (N,N-dimethylformamide) revealed an
IVIS of 95.2 (study acceptance criteria range: 76.1 - 120.0). Therefore,
the study fulfilled the acceptance criteria.
IVIS obtained after treatment with the test item was 145.0 and, thus,
higher than 55, i.e. according to OECD 437 the test item induced
serious eye damage (UN GHS: Category 1).
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