Registration Dossier
Registration Dossier
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EC number: 425-400-6 | CAS number: 179986-09-5
Endpoint summary
Administrative data
Description of key information
Skin: In vivo, Rabbit, 4 h, semiocclusive: not irritating (EU method B.4/OECD guideline 404)
Eye: In vivo, Rabbit: not irritating (EU Method B.5/OECD Guideline 405)
Respiratory system: No data available
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin: In a primary skin irritation study of the RCC (635005, 1995), performed according to EU method B.4/OECD guideline 404, three New Zealand rabbits (1 male, 2 females) were dermally exposed to 0.5 ml of the unchanged test substance for 4 hours on an area of 6 cm2 under semiocclusive dressing conditions. Animals were observed for 3 days. The mean score for the 24, 48 and 72 h reading for erythema and edema was 0. Therefore, the test substance is not skin irritating to the rabbit skin.
Eye: In a primary eye irritation study of the RCC (635016, 1995), performed according to EU Method B.5/OECD Guideline 405, 0.1 ml of the unchanged test substance was instilled into the conjunctival sac of New Zealand White rabbits (1 male, 2 females) and the animals were observed for 7 days. The mean scores for the 24, 48 and 72 h reading for irritation parameters were as follows: cornea opacity 0 (max. 4), iritis 0 (max. 2), conjunctivae redness 0.7 (max. 3), chemosis 0 (max. 4). Conjunctivae redness was reversible within 7 days. Therefore, the test substance is not eye irritating.
Respiratory system
No data available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive EC 286/2011.
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