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EC number: 907-728-6 | CAS number: -
Skin corrosion: Not corrosive in view of absence of skin and eye irritation.
Skin irritation (OECD TG 439): Not irritating Eye irritation (OECD TG 438): Not irritating
Mean OD570 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item:
Relative SD (%)
Positive Control Item
OD = Optical Density
SD = Standard deviation
∗ = The mean viability of the negative control tissues is set at 100%
The possible skin irritation potential of the substance was tested in an in vitro using a human skin model through topical application for 15 minutes. The study procedures described in this report were according to OECD TG 439 guideline and GLP principles. Skin tissue was treated by topical application of 10 μL undiluted test substance. After 42 hours post incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) MTT at the end of treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. Reliable negative and positive controls were included. The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 8.1%. The relative mean tissue viability obtained after 15 minutes treatment with the substance compared to the negative control tissue was 56.1%. Since the mean relative tissue viability for the substance was above 50% after 15 minutes treatment, the substance is considered to be not irritating to skin.
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 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) 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 very slight or slight corneal swelling (mean of 4%), no or slight opacity (mean of 0.3) and no or very slight fluorescein retention (mean of 0.3). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with the test substance did not reveal any abnormalities. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. Microscopic examination of the corneas treated with the positive control BAC 5% revealed slight or severe erosion and very slight or slight vacuolation of the epithelium and endothelial necrosis (two corneas). Based on these results, the test substance is considered to be not eye irritating.
Not corrosive in view of absence of skin irritation.
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