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EC number: 300-723-4
CAS number: 127823-21-6
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 performedin compliance with
Citoxlab France 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 (± 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 was applied undiluted in
a single experiment using a treatment time of 10 minutes and using the
closed-chamber treatment method. Negative and positive controls were
applied using the same treatment time and through the closed-chamber
treatment method. At the 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 (± 10 minutes) at +32°C before a second opacity measurement was
After the second opacity measurement,
the medium of the anterior chamber was removed and filled with a
fluorescein solution. The holders were then incubated vertically for 90
minutes (± 5 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
Fluorescein fixation was observed on
all corneas treated with the test item.
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: 0.
As the mean IVIS was < 3, the test
item was considered as a test chemical not requiring classification for
eye irritation or serious eye damage (UN GHS No Category).
the test item was identified as not
requiring classification for eye irritation or serious eye damage (UN
GHS No Category).
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