Registration Dossier
Registration Dossier
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EC number: 211-190-1 | CAS number: 633-03-4
Carcinogenicity
Administrative data
Description of key information
There is no evidence of carcinogenic activity of MG chloride in mice exposed to 100, 225, or 450 ppm.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- other: Rats and mice
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Basic Green 1 is not classified as carcinogen
Additional information
In the female rats there was a small, but statistically significant, increase in the incidence of hepatocellular adenoma, but is not clear if the increase is biologically significant; is not clear if the tested substance increase incidence of adenoma and incidence of pituitary gland adenoma (Culp, 2006).
Other effects attributed to similar substances and that seems linked to tumour promotion were reported in literature.
MG appears to be able to produce transformation SHE cells, developing aneuploid pattern; this cells can be tumorigenic, as they could produce tumours (Rao, 2001). Carcinogenesis involves an imbalance between the regulation of cell proliferation and apoptotic death, either by inhibition of apoptosis or by stimulation of cell division, or by affecting both. The Rao study (2001) suggests also that transformed cells are much less sensitive to apoptosis than normal cells. Nevertheless the exact mechanisms by which transformed SHE cells could develop resistance to MG-induced apoptosis are not clear and further studies are required to see the link between the abrogation of G2/M checkpoint control and the development of resistance to apoptosis observed (Rao, 2001).
Furthermore static protein tyrosine specific phosphatases associated with enhanced protein tyrosine and/or serine-threonine phosphorylation seems to be linked to abnormal expression of G1/S cyclins and PCNA during rat liver tumour promotion by MG (Sundarrajan, 2000), but also in this case further studies are required.
Mechanisms behind the induction of these tumours are uncertain and also are not entirely clear the relevance of these findings.
The NTP report (Cilp, 2005) explain that under the conditions of these 2-year feed studies, there was equivocal evidence of carcinogenic activity of MG Chloride in female F344/N rats based on the occurrence of thyroid gland follicular cell adenoma or carcinoma (combined) and marginal increases in hepatocellular adenoma and mammary gland carcinoma in exposed rats. Furthermore it was concluded that there was no evidence of carcinogenic activity of MG chloride in female B6C3F1 mice exposed to 100, 225, or 450 ppm.
Studies available on similar substances don't show a clearly result, so Basic Green 1 can't be classified ad a carcinogenic substance.
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