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EC number: 606-948-7
CAS number: 2217-02-9
Appendix No. 4: Selected eyes for the performance of the ICE test
Corneal thickness (e)
N.t.R: Nothing to report
Table 9: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS
Corneal swelling (%)
Combination of the 3 Endpoints
1 x VI, 1 x III, 1 x II
No prediction can be made
Note: No morphological effects were noted, whatever the examination time.
Table 8: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS
3 x IV
Category 1 : Corrosive/Severe irritant
(-): evaluation of corneal swelling not possible (Corneal opacity = 4 at
each examination time, leading to a marked refraction
of the light preventing from the evaluation of the corneal swelling with
Table 7: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS
3 x I
An in vitro (ex vivo) study was conducted in order to determine the
potential severe eye damaging effects of the test item according to the
OECD guideline 438 under GLP conditions. Eyeballs were isolated from
chickens killed for human consumption and after the appropriate
preparation were exposed to either 30 mg of the test item, 30 mg of
sodium hydroxide (positive control) or 30μL of physiological saline
(negative control). Three eyeballs were used in test item and positive
groups, and one for the negative control group. Fluorescein retention,
corneal opacity and corneal swelling were evaluated, then the results of
each endpoint were assigned to ICE classes according to OECD guideline
438. Under experimental conditions, no prediction can be made for the
test item in the ICE test since the combinations of the 3 endpoints were
1 x VI, 1 x III, 1 x II.
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