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Carcinogenicity

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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