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EC number: 946-103-2 | CAS number: -
Celitement is considered to be eye irritant.
In accordance to OECD guideline 431, 439 and GLP the test substance was examined for its in vitro skin corrosion and irritation potential using EpiDerm™ reconstructed skin membranes. In the in vitro skin corrosion test, the skin membranes were topically exposed to the undiluted test substance for 3 min and 60 min. Per test group, test was performed in duplicate. Immediately after exposure the viability of the epidermal cells was assessed using the MTT test. In the in vitro skin irritation test, the skin membranes were topically exposed to the undiluted test substance for and 60 min. Per test group, tests was performed in triplicate. Viability of the epidermal cells was assessed using the MTT test after 42 h of culture. In both tests negative and positive controls were run in parallel. Optical density of the test groups was expressed as percentage of the concurrent negative control. Both tests included one test group (group B) for which the skin surface was moistened prior to application (to improve tissue surface contact with the test substance) and one test group (group A) in which the skin surface was not moistened prior to application (because it was known that the test substance reacts with an aqueous solution). In the in vitro skin corrosion test, after 3 min exposure the mean viability of the skin membranes was 92 ± 10% for group A and 89 ± 5% for group B, compared to the concurrent negative control group, respectively. After 60 min exposure, the mean viability of the skin membranes was 53 ± 52% for group A and 95 ± 5 for group B, compared to the concurrent negative control group, respectively. In the in vitro skin irritation test, the mean viability was 88 ± 7% for group A and 98 ± 6% for group B, compared to the concurrent negative control group. Based on the results obtained in the present study, the test substance was classified as non-corrosive and non-irritant
In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 mg test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 mg imidazole) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused slight corneal swelling (7%), slight to moderate or moderate corneal opactiy (1.8) and moderate or moderate to severe fluorescein retention (2.2). In addition, spots with erosion of epithelium was observed in one eye. The negative control eye did not show any corneal effect while the positive control eyes showed severe corneal effects. Microscopic examination of the corneas treated with the test substance revealed very slight erosion of the epithelium. Microscopic examination of the cornea treated with the negative control did not reveal any abnormalities. The positive control caused severe erosion and necrosis of the epithelium. Based on the results obtained in the present study, the test substance is considered to be irritating to eyes. Based on GHS and CLP, the test substance can be classified as category 2A and category 2 substance, respectively.
Based on the result from an experimental Klimesch 1 in vitro study Celitement is non-corrosive and non-irritant. "
Based on the result from an experimental Klimesch 1 in vitro study Celitement requires classification as "Irritating to eye", Category 2, H319 - Causes serious eye irritation
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