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EC number: 256-062-6
CAS number: 43048-08-4
The objective of this study was to
evaluate the potential irritant and corrosive properties of the
test item to the eye. The Bovine Corneal Opacity and Permeability (BCOP)
test method can identify chemicals inducing serious eye damage and
chemicals not requiring classification for eye irritation or serious eye
The design of this study was based on
the OECD Guideline 437 and the study was performed in compliance with
Charles River Laboratories Evreux’s standard operating procedures and
with the OECD Principles of Good Laboratory Practice.
Corneas obtained from freshly
slaughtered calves were mounted in corneal holders. Both chambers of the
corneal holder were filled with complemented MEM culture media (cMEM)
and pre-incubated for 1 hour and 5 minutes at +32°C. A single experiment
was performed using three corneas for each treated series (test item,
positive control and negative control). Before the treatment, a first
opacity measurement was performed on each cornea using an opacitometer.
The test item and both negative and positive controls were applied
undiluted using a treatment time of 10 minutes and the closed-chamber
treatment method. At completion of the treatment period, all items were
removed from the front opening of the anterior chamber and the epithelia
were rinsed. The corneas were then incubated for 2 hours at +32°C before
a second opacity measurement was performed. After the second opacity
measurement, the medium of the anterior chamber was removed and filled
with a fluoresce in solution. The holders were then incubated vertically
for 90 minutes at +32°C. At the end of the incubation period, the
Optical Density of the solution from the posterior chamber of each
holder was measured in order to determine the permeability of the
cornea. Each cornea was then observed for opaque spots and other
No notable opaque spots or
irregularities were observed on the three test item-treated corneas.
In Vitro Irritancy
All acceptance criteria were
fulfilled. The study was therefore considered as valid.
The mean In Vitro Irritancy
Score (IVIS) of the test item-treated corneas was: 1.
As the test item induced a mean IVIS <
3, the test item was considered as a test chemical not requiring
classification for eye irritation or serious eye damage (UN GHS No
Under the experimental conditions of
this study, the test item was identified as not requiring classification
for eye irritation or serious eye damage (UN GHS No Category).
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