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EC number: 701-281-9
CAS number: -
permeability and IVIS values
Opacity, permeability (1 x value
measured and 15 x values for IVIS calculation) and IVIS values of test
substance, negative and positive controls. Individual
data, means and standard deviations (SD).
1 % Sodium hydroxide(PC)
The temperature of the incubator was
29.3 °C – 33.7 °C instead of 31 °C – 33 °C. This deviation is considered
to be of no relevance for the outcome of this study.
The Bovine Corneal Opacity and
Permeability Study (BCOP Test Method) was performed to reveal possible
ocular corrosivity and severe irritation of the test substance,
according to the OECD Guideline 437 for the testing of chemicals “Bovine
Corneal Opacity and Permeability Test Method for Identifying Ocular
Corrosives and Severe Irritants”,.
Fresh isolated and quality checked
corneas were mounted in cornea holders and the initial opacity was
determined. After equilibration 750 µl of the test substance (as is)
were topicallyadministered to 3 isolated bovine corneas to the
epithelial surfaces for 10 minutes. After a post-incubation period of 2
hours, the final opacity was measured. Then 1 ml of a fluorescein
solution was added on the epithelial site and permeability was measured
after 90 minutes.
Two groups of 3 corneas each served as
positive and negative controls. Both control substances were
administered under identical conditions as the test substance. The
following solutions served as control substances:
IVIS (In Vitro Irritancy Score) was calculated as follows:
IVIS = mean opacity value + (15 x mean
The opacity and mean permeability
values were corrected for background opacity and the negative control
permeability values. The mean opacity value results from subtraction of
final opacity from initial opacity. A substance that induces an
IVIS≥55.1 is defined as ocular corrosive or severe irritant.
The IVIS for the test substance was
IVIS of the negative control was -1.0
and for the positive control 123.5, thus demonstrating the validity of
According to the results of this study
and the OECD Guideline 437, the test substance is considered to be not
an ocular corrosive or severe irritant.
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