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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-328-3 | 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:
The key study was conducted to evaluate the potential of the test article to induce hypersensitivity in guinea pigs using the Maximization test (Research & Consulting Company AG, 1990).
For the intradermal induction phase of the study, the test article was diluted to 5% with oleum arachidis. One week later, the epidermal induction started. The test and control group were challenged two weeks after the epidermal induction application. A second challenge was performed two weeks after the first challenge. The challenge site was evaluated 24 and 48 hours after removal of the patch.
The test result of the first challenge in test group showed positive erythema reactions at 24 h and 48 h when treated with 25% test article in vaseline. The test result of the second challenge in test group showed positive erythema reactions at 24 h and 48 h when treated with 25% test article dilution in oleum arachidis.
Therefore, it can be concluded that test article can be classified as a sensitizer (category 1) to the skin of rabbit in accordance with CLP (Regulation EC No. 1272/2008).
Migrated from Short description of key information:
Experimental results indicated that test substance is a sensitizer to the skin of rabbits.
Justification for selection of skin sensitisation endpoint:
well performed with OECD guideline and GLP principle
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
There are no specific data on respiratory sensitisation.
Justification for selection of respiratory sensitisation endpoint:
Since the most likely route is considered to be via dermal and inhalative exposure is not of concern due to low vapour pressure and the substance is not used in aerosol or spray applications, a DNEL for inhalation route is required and not being proposed.
Justification for classification or non-classification
Based on the present condition, it can be concluded that test article can be classified as a sensitizer (category 1) to the skin of rabbit under 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.
