Registration Dossier
Registration Dossier
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EC number: 306-479-5 | CAS number: 97280-83-6
Endpoint summary
Administrative data
Description of key information
Skin irritation: test substance is irritating to skin (OECD404, BASF AG, 1989)
Eye irritation: test substance it not irritating to eyes (OECD405, BASF AG, 1989)
Key value for chemical safety assessment
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The potential of the test substance to induce skin irritation was tested in a study similar to OECD test guideline 404 (BASF AG, 1989). Two male and one female rabbit were treated with 0.5 ml of the undiluted test substance under semi-occlusive dressing for 4 hours, after which the test substance was removed with lutrol/water; rabbits were the observed for 15 days and the skin irritation scores recorded according to the Draize scheme 30-60 min following application, 24, 48 and 72 h later as well as 8 and 15 days following the initial application. The mean erythema and edema scores for the individual animals were as follows: erythema 2.7, 3.3 and 3 (mean for all three animals: 3), edema: 2.3, 3 and 0.7 (mean: 2). While irritation was still present after 8 days (mean erythema: 1.67, edema: 0.67), the lesions were fully reversible within 15 days. Hence, the test substance is classified as irritating to the skin.
Eye Irritation:
The potential of the test substance to induce eye irritation was analyzed according to OECD test guideline 405 (BASF AG, 1989). The right eyes of one male and two female rabbit was instilled with 0.1 ml of the undiluted test item; the test substance was not washed out. The left eyes served as controls. Scores were recorded according to the Draize scheme following 1, 24, 48 and 72 h. The mean scores for chemosis, cornea and iris were 0; the individual scores for conjunctivae were 1, 0 and 0.3, resulting in a mean score of 0.4 for all three animals for the mean 24/48/72 h readings. Based on these findings, the test substance is not classified for eye irritation.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The test item does not warrant classification with respect to eye irritation. However, according to Diercetive 67/548/EEC the test item is classified with R38, Xn and according to EC1272/2008 as irritating to skin, category 2, H315, Warning.
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