Registration Dossier
Registration Dossier
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EC number: 206-108-6 | CAS number: 301-10-0
Carcinogenicity
Administrative data
Description of key information
Tin bis(2 -ethylhexanoate) has not been evaluated for carcinogenic potential in adequate long-term studies in experimental animals. In an older study which reported few details (Roe, 1965), diets containing 0.5% tin bis (2 -ethylhexanoate) (292 mg/kg assuming a daily feed consumption of 25 g/day and an average body weight of 450 g) when fed for 80 weeks did not increase the number of tumors at any site including liver and kidney. Tin bis(2 -ethylhexanoate) was negative in three in vitro genotoxicity assays: Ames, HGPRT and CA. Nor was a target organ of toxicity identified in a 14-day repeated-exposure toxicity study of tin bis(2 -ethylhexanoate) in rats.
In studies of hydrolysis products, lifetime exposure of rats and mice to stannous chloride at daily doses exceeding 100 mg/kg/d for rats and 500 mg/kg/d for mice did not result in increases in tumor incidence. Further, a weight of the evidence indicates that stannous chloride was not genotoxic in studies in bacterial and mammalian cells in vitro and in vivo. It is concluded that stannous chloride is not carcinogenic.
EHA has not been evaluated for chronic toxicity/carcinogenicity in studies in experimental animals. However, a weight of the evidence indicates that EHA was not genotoxic in studies in bacterial and mammalian cells in vitro and in vivo. Nor has EHA been found to cause significant target tissue toxicity or proliferative lesions in 90-day studies in rats and mice. Thus, it is concluded that EHA is not likely to be a carcinogen.
Taken together, available data on carcinogenic and mutagenic potential of the hydrolysis products of tin bis(2 -ethylhexanoate) (stannous chloride and ethylhexanoic acid) as well as supporting information of the carcinogenic potential and mutagenic potential of tin bis(2 -ethylhexanoate) itself permit the conclusion that tin bis(2 -ethylhexanoate) is not carcinogenic. The conduct of a carcinogenesis study on tin bis(2 -ethylhexanoate) is not necessary.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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
Taken together, available data on carcinogenic and mutagenic potential of the hydrolysis products of tin bis(2 -ethylhexanoate) (stannous chloride and ethylhexanoic acid) as well as supporting information of the carcinogenic potential and mutagenic potential of tin bis (2 -ethylhexanoate) itself permit the conclusion that tin bis(2 -ethylhexanoate) is not carcinogenic.
Additional information
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