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EC number: -
CAS number: -
Test Results (10 Minute Treatment time)
This in vitro study
was performed to assess the corneal
damage potential of the test substance
by means of the BCOP assay using fresh
bovine corneae. The test was designed
to meet the requirements of OECD
Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and
Permeability Test Method for Identifying i) Chemicals Inducing Serious
Eye Damage and ii) Chemicals Not Requiring Classification for Eye
Irritation or Serious Eye Damage (July, 2013).
a first opacity measurement of the fresh bovine corneae (t0),
the neat test item, the positive, and the negative controls were applied
to corneae fixed in an incubation chamber in horizontal position for 10
minutes at 32 ± 1 °C.
The posterior chamber contained incubation
medium. After the incubation phase the test item, the positive, and the
negative controls were each rinsed from the corneae.
Further, the corneae were incubated
for another 120 minutes at 32 ± 1 °C in a vertical position, while the
anterior chamber contain incubation medium as well. Afterwards,opacity
was measured a second time (t130).
opacity measurements permeability of the corneae was determined by
measuring spectrophotometrically the transfer of sodium fluorescein
after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative
control (0.9% (w/v) NaCl solution in deionised water) neither an
increase of opacity nor permeability of the corneae could be observed. The
positive control (2-Ethoxyethanol) showed clear opacity and distinctive
corneae corresponding to a classification as serious eye damaging
to the negative control, the test substance caused an increase of the
corneal opacity. The calculated mean in vitro irritancy score was
15.89 which is below the threshold for classification for serious eye
damage (IVIS > 55) according to CLP/EPA/GHS.
conclusion, under the experimental conditions reported, the test
substance does not cause serious eye damaging (i.e. it is not classified
CLP/EPA/GHS Category 1 for eye effects).
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