Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-583-7 | CAS number: 64366-79-6
Endpoint summary
Administrative data
Description of key information
In GLP guideline studies for skin and eye irritation in rabbits the test item showed no skin or eye irritation properties.
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The key study was performed according to OECD guideline 404 in compliance with GLP (BASF AG, 1998). In this study, the potential of the test material to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semiocclusive dressing.
The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. The skin finding observed in 1 animal was reversible 24 hours after removal of the patch. Thus the study was terminated after 72 hours.
Under the test conditions chosen the test material did not give indication of an irritant property to the skin.
Eye irritation
The key study was performed according to OECD guideline 405 in compliance with GLP (BASF AG, 1998). In this study, the potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 white New Zealand rabbits subjected to a single ocular application of 0.1 mL bulk volume (about 27 mg) of the test substance on day 0 (BASF AG, 1998).
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. Thus the study was terminated. The observed symptoms do not indicate an irritant property of the test substance to the eye.
Under the test conditions chosen the test substance did not give indication of an irritant property to the eye.
Justification for selection of skin irritation / corrosion endpoint:
only available reliable study
Justification for selection of eye irritation endpoint:
only available reliable study
Justification for classification or non-classification
Based on the results of the skin and eye irritation studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
