Registration Dossier

Toxicological information

Carcinogenicity

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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 tumor 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

Additional information

Justification for classification or non-classification

There are no data to suggest that the substance should be classified for this endpoint.