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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-054-3 | CAS number: 10519-11-6
Endpoint summary
Administrative data
Description of key information
The skin sensitisation potential of the test item was determined in a local lymph node assay (LLNA) in female CBA/JcrHSD mice (2016).
The test item did not produce a stimulation index ≥3 at concentrations up to and including 100%.Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the test item was determined in a local lymph node assay (LLNA) in female CBA/JcrHSD mice (2016). Doses of 25, 50 and 100% test item was applied to the dorsum of both ears on Days 1, 2 and 3, alongside a vehicle control and positive control. All animals were given a two-day rest period on Days 4 and 5 and animals were injected with tritiated methyl-thymidine and sacrificed on Day 6. The test item produced a stimulation index <3 in all groups of test animals. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 429 and EPA OCSPP 870.2600.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
One key study (Klimisch 1) is available for skin sensitisation classification (2016). The test item at 25, 50 and 100% concentration did not produce a stimulation index ≥3 in a LLNA study. Therefore, according to "Guidance on the Application of the CLP Criteria" (ECHA 2015), the test item is not classified as a skin sensitiser.
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.
