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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-395-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
not skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the skin sensitisation potential of the test material an in vivo test to guinea pigs was performed according to the OECD Guideline 406 (1981).
Based on the results of the sighting studies, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 5% (w/v) in distilled water
Topical Induction: 75% (w/w) in distilled water
Topical Challenge: 25% (w/w) in distilled water
The test material produced a 0% (0/20) sensitisation rate and was considered as a non-sensitiser to guinea pig skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the CLP Regulation (EC) no. 1272/2008, in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.
A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for subcategorisation (1A and 1B) in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).
If in order to evaluate skin sensitisation potential, a Guinea pig maximisation test was performed, a substance is classified as skin sensitizer sub-category 1B if ≥ 30 % responding at > 1 % intradermal induction dose.
Based on the experimental results, the substance induces no reactions after the intradermal induction dose > 1 %. Therefore, the substance is not classified as skin sensitiser, according to the CLP Regulation (EC) no. 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.
