Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The only study available for the registered substance is a bacterial mutagenicity assay, which gave a negative result. Results are available for the related substance 3-chloropropyltrimethoxysilane CAS number 2530-87-2. Both this substance and the registered substance have rapid hydrolysis rates, producing the same parent substance. The other hydrolysis products are HCl (registered substance) and methanol (read-across substance) Neither of these hydrolysis products is genotoxic. The bacterial studies on both substances do not give the same result, but as it is the read-across substance that is positive, it is considered that read-across is appropriate as it is conservative. A positive result was obtained in an in vitro mammalian mutagenicity study with 3-chloropropyltrimethoxysilane, but this potential for genetic toxicity was not confirmed in an in vivo micronucleus study.


Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in all strains tested (OECD TG 471)
Cytogenicity in mammalian cells: not required as in vivo read-across micronucleus result from analogous substance is available
Mutagenicity in mammalian cells: read-across from analogous substance CAS 2530-87-2 : positive in L5178Y mouse lymphoma cells (similar to OECD TG 476)
In vivo:
read-across from analogous substance CAS 2530-87-2: negative in mouse micronucleus test (similar to OECD TG 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available information indicates that, when tested in vitro, trichloro(3 -chloropropyl)silane (CAS 2550 -06 -3) is not mutagenic to bacteria. The related substance, trimethoxy(3 -chloropropyl)silane (CAS 2530 -87 -2) has been tested in vitro and in vivo. Potential for genetic toxicity was demonstrated in vitro, in both bacterial and mammalian mutagenicity studies, but this was not confirmed in an in vivo micronucleus study. It is concluded that classification for mutagenicity is not required.