Registration Dossier
Registration Dossier
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EC number: 944-550-8 | 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 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 Insulin DesB30 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 DesB30
- EC Number:
- 944-550-8
- Molecular formula:
- C253H376N64O75S6
- IUPAC Name:
- Insulin DesB30
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- No data is available for the target substance. 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 Insulin DesB30 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. - Executive summary:
No data is available for the target substance. 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 Insulin DesB30 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.
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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