Registration Dossier
Registration Dossier
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EC number: 944-549-2 | 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 an acceptable epidemiological link with cancer to humans (Novo Nordisk 1998).
A tumorigenic response for insulin aspart precursor may furthermore considered less likely as the substance does not bind to the insulin receptor and act as a growth factor.
Data source
Materials and methods
Test material
- Reference substance name:
- Insulin Aspart Precursor
- EC Number:
- 944-549-2
- Molecular formula:
- C302H446N76O91S7
- IUPAC Name:
- Insulin Aspart Precursor
- Test material form:
- solid: crystalline
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).
A tumorigenic response for insulin aspart precursor may furthermore considered less likely as the substance does not bind to the insulin receptor and act as a growth factor.
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.
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