Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

3-[3-(Triethoxysilyl)propyl]oxolane-2,5-dione has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, in compliance with GLP (Notox, 2002). 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 uvrA in the initial or the repeat experiments up to cytotoxic or limit 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 selection of genetic toxicity endpoint
Conclusion based on the following assay: Bacterial reverse mutation assay (Ames test). The selected study is the only available study for the registered substance. It was conducted according to OECD 471 (1997) and in compliance with GLP.

Short 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 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA (OECD 471) (Notox, 2002).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available in vitro bacterial mutagenicity data, 3-[3-(triethoxysilyl)propyl]oxolane-2,5-dione does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.