Registration Dossier
Registration Dossier
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EC number: 211-089-2 | CAS number: 629-40-3
Endpoint summary
Administrative data
Description of key information
Skin irritation (BASF test): not irritating, 1963
Eye irritation (BASF test): irritating, 1963
Key value for chemical safety assessment
Additional information
Skin irritation
In a primary dermal irritation study performed according to a protocol similar to the OECD test guideline 404 (deviations: limited documentation, occlusive treatement, exposure duration, no data on application amount), the test substance (no data on purity) was applied to the intact skin of 2 Vienna White rabbits under occlusive conditions for 1, 5 and 15 min and 20h. No erythema or edema were observed within the observation period of 8 days. As the study conditions were harsher than required by the guideline (20 h and occlusive instead of 4 h and semiocclusive), the test substance is not considered irritating to the skin. The study is suitable for assessment (BASF AG 1963).
Eye irritation
The eye irritation potential of the test substance (no data on purity) was determined according to a protocol similar to the OECD test guideline 405 (deviations: limited documentation, application amount). A single application of 0.05 mL of the undiluted test substance did not cause irritating reactions in the eyes of 2 Vienna White rabbits. Only 1 h after application slight conjunctivae redness and chemosis were seen but were fully reversible within 24 h.
Although the guideline requires an application volume of 0.1 mL, the study is considered suitable for assessment (BASF AG, 1963).
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 and eye irritation is not warranted.
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 and eye irritation is not warranted.
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