Registration Dossier
Registration Dossier
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EC number: 605-830-2 | CAS number: 178671-69-7
Endpoint summary
Administrative data
Description of key information
The test substance was found to be not irritating to the skin and not irritating to eyes in two GLP compliant tests following OECD guidelines.
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 irritation
In an in vivo skin irritation study performed according to OECD guideline no. 404 and in compliance with GLP, the potential of the test substance to cause acute dermal irritation or corrosion was assessed. A single topical application of 0.5 g of the test substance was administered to the intact skin of 3 New Zealand White rabbits for 4 hours under semi-occlusive dressing. Following removal of the test substance, consecutive readings of the application sites were performed over a period of 72 hours. Untreated skin regions of the same animals served as control. As no skin findings were observed in all animals within 72 hours after removal of the patches, the study was terminated. Under the test conditions chosen and considering the described findings the test compound does not give indication of an irritant property to the skin.
Eye Irritation
In an acute eye irritation study performed according to OECD guideline no. 405 and in compliance with GLP, the potential of the test compound to cause damage to the conjunctiva, iris and cornea was assessed in 3 New Zealand White rabbits, subjected to a single ocular application of the test substance. About 36 mg (0.1 ml volume) of the comminuted test substance was applied to the conjunctival sac of the right eye; the left eye remained untreated and served as control. Following removal of the test substance, consecutive readings were performed over a period of 72 hours. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application. Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC.
Based on the data, the test subtance has not to be classified as skin or eye irritatant.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.
Based on the data, the test subtance has not to be classified as skin or eye irritatant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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