Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No data is available for the carcinogenicity of potassium methylsilanetriolate. However, further testing is not considered necessary because:
- The substance is not classified for mutagenicity based on a negative bacterial mutagenicity with the substance and negative in vitro chromosome aberration and in vivo micronucleus assays with the related substance trimethoxy(methyl)silane;
- Testing with the substance itself would have to be performed at a very low, non-irritant/corrosive doses, where no relevant systemic toxicity is expected;
- A 90-day subchronic inhalation toxicity study of methyltrimethoxysilane 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, 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

Additional information