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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-551-3 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
Long-term s.c. dosing of human insulin has resulted in increased incidences of mammary tumors in female Sprague Dawley rats. As human insulin can act as a growth factor 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 a plausible epidemiological link with cancer to humans (Novo Nordisk 1998).
Same type of response would be expected for Human insulin methylester as the substance has the same potential for binding to the insulin receptor as human insulin.
See read-across template and justification attached in section 13
Key value for chemical safety assessment
Justification for classification or non-classification
Long-term s.c. dosing of human insulin has resulted in increased incidences of mammary tumors in female Sprague Dawley rats. As human insulin can act as a growth factor 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 a plausible epidemiological link with cancer to humans (Novo Nordisk 1998).
Same type of response would be expected for Human insulin methylester 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.
Additional information
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.
