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EC number: 271-559-8 | CAS number: 68585-53-5
Table 5: Summary of the test item results
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
Overall ICE Class1
Table 6: Summary of the positive control results
Cornea opacity score 4 was observed in two eyes at30 minutes after the post-treatment rinse.
The positive control Imidazole was classed as corrosive/severely irritating, UN GHS Classification: Category 1.
Table 7: Summary of the negative control results
The negative control NaCl (9 g/L saline) had no significant effects on the chicken eye in this study.
The purpose of this Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular corrosivity or irritancy of the test item by its ability to induce toxicity in enucleated chicken eyes. The study was performed according to the OECD guideline 438. The test compound was applied in a single dose (30 mg/eye) onto the cornea of isolated chicken eyes. Tested corneas were evaluated pre-treatment and at approximately 30, 75, 120, 180, and 240 minutes after the post-treatment rinse. The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological effects. All of the endpoints, with the exception of fluorescein retention (which was determined only at pre-treatment and 30 minutes after test substance exposure) were determined at each of the above time points.
The test item and Imidazole (positive control) was ground before use in the study. The test item and positive control applied in an amount of 0.03 g/eye by powdering the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance or positive control. Three test item treated eyes and three positive control eyes were used in this study. One negative control eye was treated with 30 µL saline solution (9 g/L). After an exposure period of 10 seconds the cornea surface was rinsed thoroughly with ca. 20 mL saline solution at ambient temperature. Positive and negative controls showed the expected results. The experiment was considered to be valid. In this in vitro eye corrosive and severe irritant study, using the Isolated Chicken Eye model with Leuco Sulfur Red 14, no ocular corrosion or severe irritation potential was observed. The overall ICE score was 1xI, 2xII.
According to the overall in vitro evaluation criteria classification is neither UN GHS Classification Category I (an ocular corrosive or severe eye irritant) nor No Category. Thus, according to the guideline OECD 438, test item has been categorized as “No prediction can be made”.
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