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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-548-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Data from OECD 406 guideline studies on two structural analogues, MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin aspart ethyl ester, a lack of skin sensitising potential can be concluded for Insulin aspart ethyl ester as well.
See further read-across justification in document attacthed in section 13.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on data from OECD 406 guideline studies on two structural analogues, MI3 and X14DesB30 showing no potenteial for skin sensitisation Insulin aspart ethyl ester is considered without potential for skin sensitisation as well. Thus, Insulin aspart ethyl ester is not to be classificied as skin sensitiser according to the CLP-criteria.
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.
