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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
An LLNA test was performed according to OECD 429 guideline and GLP principles.The majority of nodes were considered normal in size, except for one or both nodes of one animal at 10%, two animals at 25% and two animals at 50% which were considered enlarged in size. Median DPM/animal values were reported due to possible outlier responses for individual animals within groups. Median DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 797, 1674 and 1299 respectively. The median DPM/animal value for the vehicle control group was 300. The SI values calculated for the substance concentrations 10, 25 and 50% were 2.7, 5.5 and 4.3 respectively. An EC3 value of 11.6% was calculated.
Based on these results, the test substance should be classified as a skin sensitizer (category 1B) according to Regulation EC 1272/2008.
Migrated from Short description of key information:
The in vivo LLNA study was performed according to OECD Guideline 429 and GLP principles.
Justification for selection of skin sensitisation endpoint:
One key study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above results, the test substance should be classified as a skin sensitizer (category 1B) and labelled with H317 (may cause an allergic skin reaction) according to Regulation EC 1272/2008.
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.
