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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
in vitro: Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2. (similar to OECD TG 471) (Dow Corning Corporation, 1986).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

[2-(Perfluorobutyl)ethyl]dichloro(methyl)silane has been tested for mutagenicity to bacteria, in a study which was conducted according to a protocol that is similar to OECD 471, and in compliance with GLP (Dow Corning Corporation, 1986). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WP2 in the initial spot test for toxicity or the repeat experiment conducted using the plate incorporation method, when tested up to cytotoxic concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

The key study is supported by an older study in which [2-(perfluorobutyl)ethyl]dichloro(methyl)silane was tested in a study conducted according to a protocol that is similar to OECD 471, not in compliance with GLP (Dow Corning Corporation, 1985). No evidence of a test-substance related increase in the number of revertants was observed in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli WP2 with or without metabolic activation in the initial spot test or the repeat experiment using the plate incorporation method, up to cytotoxic concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.


Justification for classification or non-classification

Based on the available in vitro genotoxicity data, [2-(perfluorobutyl)ethyl]dichloro(methyl)silane does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.