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EC number: 947-377-6
CAS number: -
7.3.2/1: First experiment – Results
Calibration of the opacitometer
Calibrator No. 1
Calibrator No. 2
Calibrator No. 3
cOD 490 nm
7.3.2/2: Second experiment – Results
optical density corrected by mean OD value of vehicle control
corneal opacity corrected by mean opacity value of vehicle control
corneal opacity before treatment
corneal opacity after treatment
correction: all individual values below 0 are set at 0
Vitro Irritation Score
control: Paraffin oil
control: 20% imidazole solution in 0.9% NaCl
An ex vivo eye irritation study was
performed according to the OECD Guideline 437 and in compliance with GLP
to evaluate the possible ocular corrosive or severe irritating effects
of the test item after administration on bovine corneas.
The test item was evaluated in two
experiments. In both experiments, 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. Three
corneas for each treated series (test item formulation, positive control
and vehicle control) were used.
Before treatments, a first opacity
measurement was performed on each cornea using an opacitometer.
The test item, formulated at 20% in paraffin
oil, was evaluated in these two experiments using a treatment time of 4
hours and using the open-chamber method. Vehicle and positive controls
were applied using the same treatment time and 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.
A second opacity measurement was then
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 irregularities.
With one exception during the second
experiment (mean OD490 nm of the vehicle control), all acceptance
criteria were fulfilled during both experiments. The study was therefore
considered as valid.
In first experiment, fluorescein fixation
and/or residual amount of test item were observed on two of the three
test item-treated corneas. No notable opaque spots or irregularities
were observed on the remaining cornea. The mean In Vitro Irritancy Score
(IVIS) of the test item-treated corneas was: 4.
Individual IVIS values of test item-treated
corneas were: 1, 1 and 11. Two of the three corneas gave discordant
predictions from the mean of all three corneas since the third corneas
gave a higher IVIS principally due to the opacity value. As residual
test item was noted over these corneas after the rinsing step, it was
therefore not possible to determine if the high corneal opacity value
noted for these corneas was due to the test item reacting with cell
structures (i.e. protein precipitation, etc.) or only to these residuals
amounts of test item which stuck to the cornea. Moreover, during this
assay, results could be considered as borderline between "no category"
and "no prediction can be made" since the mean IVIS was 4. In this
context, the result in the first testing experiment was considered
borderline and a second experiment was performed.
In the second experiment, fluorescein
fixation and residual test item were observed on all the corneas treated
with the test item. The mean IVIS of the test item-treated corneas was:
1. Individual IVIS values of test item-treated corneas were: 2, 0 and 1.
On the basis of the two experiments
performed as part of this study, five out of the six test item-treated
corneas gave a mean IVIS < 3, and the only IVIS > 3 could be related to
a high corneal opacity value likely due to representative residual
amounts of test item which stuck to the corresponding cornea. Residual
amounts of test item were also noted on each test item-treated cornea in
the second experiment, but amounts were not graded, and no significant
increase in opacity was noted, suggesting only very few amount of test
item remained onto these corneas.
As a consequence, based on the concordant
results obtained on five out of six corneas during these two
experiments, no additional experiment was performed and the test item
was considered as a test chemical not requiring classification for eye
irritation or serious eye damage (UN GHS No Category).
Under the experimental conditions of this
study, the test item, the test item was identified as not requiring
classification for eye irritation or serious eye damage (UN GHS No
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