The definition of mitogenic activity of insulin is controversial. Under physiological conditions, mitogenic refers to cell proliferation and tissue repair. In pathological conditions, it may refer to stimulation of tumour cells in pre-existing (undiagnosed) tumours. The in vitro investigations using benign and malignant cell lines compare proliferative activity of insulin molecules (animal, human and analogues). In these studies, inclusion of [B10-Asp] insulin would be a valuable link to the existing evidence on proliferation of mammary tissue in rodents. Animal and human insulin have growth promoting activity on spontaneously arising tumours (e.g. mammary tumours in rodents). They have no carcinogenic activity (cell transformation), and moreover insulin is not a co-carcinogen when evaluated in special toxicology. Mitogenicity (growth promoting activity) of insulin may be a problem in people with undiagnosed tumours, and may require definition of patient groups who would benefit from targeted monitoring.