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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-652-2 | CAS number: 1259300-69-0
Endpoint summary
Administrative data
Description of key information
non-skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance was evaluated for its skin sensitisation potential in the LLNA study according to the OECD guideline 429 and EPA OPPTS 870.2600 in compliance with GLP.
The test substance concentrations used in the main LLNA study (25, 50 and 100 % (v/v)) were chosen such that the maximum concentration tested was the highest achievable solution of the test substance in the vehicle, while avoiding both overt systemic toxicity and excessive local dermal-irritation. Five animals per group were treated by topical application of the test substance concentrations, vehicle or positive control in the same manner as in the screen. A naive group of five animals was sham-treated. DMF was chosen as the vehicle.
Under the test conditions, topical application of the test substances a 25 and 50 %(v/v)in the DMF vehicle, and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0). Therefore, the test substance is not a skin sensitizer in the LLNA.
Justification for classification or non-classification
The substance was assessed for its allergic potential in the in-vivo LLNA study. According to the CLP Regulation a substance is classified in sub-category 1 A if the EC3 is≤ 2 % and in sub-category 1B if the EC3 is > 2. In the present study, the EC3 value could not be determined as the Stimulation Index (S.I) in all the tested concentrations was below 3. Having a S.I. below 3 means that no significant effect and neither a sensitising potential can be identified.
Taking in consideration the above, the substance should not be classified as a 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.
