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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: -
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Long-term s.c. dosing of human insulin has resulted in increased incidences of mammary tumors in female Sprague Dawley rats. As both human insulin and insulin aspart are connected with growth factor properties it is not unexpected that both substances after long term treatment at dose levels of about 200 times above human dose levels may cause this type of response. Furthermore, human insulin products have been in clinical use for more than 50 years without showing an epidemiological link with cancer to humans (Novo Nordisk 1998).
Same type of response would be expected for Insulin aspart ethyl ester as the substance has the same potential for binding to the insulin receptor as human insulin.
Overall, the data is not considered sufficient for a cancer classification, partly due to the human experience and partly due to difficulties by making extrapolation from s.c. administation to exposure routes relevant in terms of CLP classification.
Data source
Materials and methods
Test material
- Reference substance name:
- Insulin Aspart Ethyl Ester
- EC Number:
- 944-548-7
- Molecular formula:
- C258H385N65O79S6
- IUPAC Name:
- Insulin Aspart Ethyl Ester
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Long-term s.c. dosing of human insulin has resulted in increased incidences of mammary tumors in female Sprague Dawley rats. As both human insulin and insulin aspart are connected with growth factor properties it is not unexpected that both substances after long term treatment at dose levels of about 200 times above human dose levels may cause this type of response. Furthermore, human insulin products have been in clinical use for more than 50 years without an acceptable epidemiological link with cancer to humans (Novo Nordisk 1998).
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.
