Registration Dossier
Registration Dossier
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EC number: 226-323-9 | CAS number: 5351-04-2
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating; reliability score = 1 (BASF AG 1998)
Eye irritation (OECD 405): irritating; reliability score = 1 (BASF AG 1998)
Key value for chemical safety assessment
Additional information
Skin irritation
In a primary dermal irritation study performed according to the OECD test guideline 404, the test substance (99.6% pure) was applied to the intact skin of 3 rabbits (HSDIF:NZW) under semiocclusive conditions for 4 h. 1 h after application, erythema (score = 2 in all animals) and edema (score = 2, 1 and 2) were observed that were extending beyond the area of exposure. The mean score for erythema and edema over 24, 48 and 72 h was 0.33 and 0.00, respectively, as the observed effects were fully reversible within 48 h and 24 h. As the study was performed according to the guideline under GLP conditions, it is considered suitable for assessment (BASF AG 1998).
Eye irritation
The eye irritation potential of the test substance (99.6% pure) was determined according to the OECD test guideline 405. A single application of 0.1 mL of the undiluted test substance caused irritating reactions in the eyes of 3 rabbits (HSDIF:NZW). The effects observed at the relevant readings 24, 48 and 72 h after application on corneal opacity (mean score = 1.00), iritis (mean score = 1.00, 0.67 and 0.67), conjunctival redness (mean score: 2.33, 3.00 and 2.67) and conjunctival swelling (mean score = 1.67, 2.00 and 2.00) were fully reversible within 8 d. Furthermore, contracted pupils, suppuration and loss of corneal tissue were observed in all animals, whereas bloody discharge was observed only in one animal. All symptoms were reversible within 72 h.
The study is considered suitable for assessment as it was performed according to the OECD guideline under GLP conditions (BASF AG, 1998).
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Dangerous substance Directive (67/548/EEC)
The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of skin and eye irritants of Directive 67/548/EEC, as amended for the 28thtime in Directive 2001/59/EC, classification for skin irritation is not warranted and classification for eye irritation is warranted as "R 36".
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the 2ndtime in Directive EC 286/2011, classification for skin irritation is not warranted and classification for eye irritation is warranted as "category 2".
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