Registration Dossier
Registration Dossier
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EC number: 214-685-0 | CAS number: 1185-55-3
Carcinogenicity
Administrative data
Description of key information
No data are available for the carcinogenicity of trimethoxy(methyl)silane. However, further testing is not considered to be necessary. A 90-day subchronic inhalation toxicity study of trimethoxy(methyl)silane with a 28-day recovery period in Sprague-Dawley Rats was conducted. There were no test article-related adverse effects on organs subject to gross and histopathological examination other than minimal to moderate bladder hyperplasia at 400 ppm (2200 mg/m3). It is concluded that the bladder hyperplasia were due to the formation of calculi causing constant irritation of the epithelium. The relevance of this finding to humans is not clear. Similar effects observed in animals with other types of substance have been recently reviewed by a panel of experts; the panel came to the conclusion that bladder calculi, hyperplasia and tumour formation were not of concern for humans because this was typical with these types of materials. In addition, it is not likely that humans will be exposed to a constant concentration high enough to cause the calculi. Based on these findings, as well as the lack of structural alerts indicating that the material may possess carcinogenicity potential in humans, the fact that the substance is not classified for mutagenicity, and in the spirit of REACH to minimise use of animals, it is proposed that the carcinogenicity study can be waived.
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
There are no data to suggest that the substance should be classified for this endpoint.
Additional information
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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