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EC number: 244-168-5
CAS number: 21041-95-2
The mean values of the treated eyes for maximum corneal thickness
change, corneal opacity and fluorescein retention are given below. The
conclusion on eye irritancy was based on the OECD guideline quantitative
Mean maximum corneal swelling at up to 75 min
Mean maximum corneal swelling at up to 240 min
Mean maximum corneal opacity
Mean fluorescein retention
Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.
Overall ICE Class
Based on the performed in vitro eye irritation assay in
isolated chicken eyes with Cadmium hydroxide, the test item is not
classified as a severe irritant and not classified as non-irritant. It
is concluded that further information is required for classification.The
results were very close to the borderline for non-irritant, but as it
was just over the limit, the test item can not be classified. If a REACH
classification is required, it is recommended that another in vitro test
(for example the Epiocular test) is performed.
Imidazole was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were not cleared at 240 minutes after the post-treatment rinse.
The positive control Imidazole was classified as severely
irritating, UN GHS Classification: Category 1.
The negative control Physiological saline was classified as
non-irritating, UN GHS Classification: No Category.
Semi-quantitative microscopic evaluation was performed on the cornea in
the ICET. The classification of histopathology findings was performed
based on the publications: M.K. Prinsen et al./Toxicology in Vitro 25
(2011), 1475-1479), Elodie Cazelle et al./ Toxicology in Vitro 28
(2014), 657-666 and Atlas of histopathological lesions of Isolated
Chicken Eyes, M.V.W. Wijnands and M.K. Prinsen, June 2015. The negative
control, 30 μL of 0.9 % Sodium chloride (Salsol solution) cornea showed
no abnormalities. Positive control, 30 mg Imidazole caused severe
epithelial erosion of corneal epithelium in 3/3 cases and detachment
form the basement membrane in 2/3 cases. No compromised Bowman’s or
basement membrane as well as no endothelial changes were recorded.
Cadmium hydroxide produced very slight erosion of the corneal epithelium
in 6/6 sections. Very slight and/or slight vacuolation of the top of the
epithelium was seen in 6/6 sections. No stromal or endothelial changes
were observed as well as no effects on integrity on basement, Bowman's
and Descemet's membranes. Based on the published criteria for
histopathological changes, no predictions can be made for Cadmium
Disorder of fibers
outer region (adjacent to epithelium)
inner region (adjacent to endothelium)
Physiological saline solution (Salsol solution,NaCl 0.9% (w/v)
- = not observed; P = present; ½ = very slight; 1 = slight; 2 =
moderate; 3 = severe;
x- detachment from basement membrane
An in vitro eye irritation study of the test item was
performed in isolated chicken’s eyes. The irritation effects of the test
item were evaluated according to the OECD No. 438 guideline (25 June
After the zero reference measurements, the eye was held in
horizontal position and 30 mg test itemwas applied onto the centre of
the cornea in such a way that the entire surface of the cornea was
covered. After 10 seconds exposure time, the surface was rinsed with
physiological saline. Positive control eyes were treated with 30 mg
powdered Imidazole. The negative control eye was treated with 30 µL
ofphysiological saline(0.9% (w/v) NaCl solution). Three test item
treated eyes, three positive control treated eyes and one negative
control treated eye were examined.
The results from all eyes used in the study met the quality
control standards. The negative control and positive control results
were within the historical control data range in this experiment. Thus,
the study was considered to be valid.
No significant cornea swelling (mean swelling ≤5%) was observed
during the four-hour observation period on test item treated eyes.
Slight cornea opacity change (severity 1) was observed on any eyes.
Slight fluorescein retention change (severity 1) was observed on any
eyes.Test item was stuck on all cornea
surfaces after the post-treatment rinse. The cornea surfaces were not
cleared at 240 minutes after the post-treatment rinse.
The results were very close to the borderline for non-irritant, but as
it was just over the limit, the test item can not be classified. If a
REACH classification is required, it is recommended that another in
vitro test (for example the Epiocular test) is performed.
Based on the performed in vitro eye irritation assay in isolated chicken
eyes with Cadmium hydroxide, the test item is not classified as a severe
irritant and not classified as non-irritant. It is concluded that
further information is required for classification.
Histopathological observations were made on two sections of each
of the 3 corneas treated with test item (6 sections). Microscopic
evaluation showed very slight erosion of the corneal epithelium in 6/6
sections. Very slight and/or slight vacuolation of the top epithelium
were seen in 6/6 cases. No stromal or endothelial changes were observed
as well as no effects on integrity of basement, Bowman’s and Descemet’s
membranes. Based on the published criteria for histopathological
changes, no prediction can be made for Cadmium hydroxide.
SUMMARY TABLE FOR UN GHS CLASSIFICATION
Criteria for “No category” (all true)
3 endpoints classed as I or 2 endpoints classed as I and 1 endpoint classed as II or 1 endpoint classed as I and 2 endpoints classed as II:
No severe corneal morphological changes:
Test item was not stuck to the cornea at 240 minutes after the post-treatment rinse:
Criteria for “Category 1” (one or more true)
2 or more endpoints classed as IV:
Corneal opacity ≥ 3 at 30 min (in at least 2 eyes):
Corneal opacity = 4 at any time point (in at least 2 eyes):
Severe loosening of epithelium (in at least 1 eye):
Criteria for “No prediction can be made” (one or two true)
Based on the endpoints not classifiable for No Category, or for Category 1:
Particles of test item were stuck to the cornea and could not be washed off during the study:
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