Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The chromosomal abberation test was negative with S9 activation and positive without S9 activation. However, all 4 other tests run were negative with and without S9 activation. An in vivo mouse micronucleus study was also conducted. No significant increase in micronucleated polychromatic erythrocytes in test article-treated groups relative to the respective vehicle control group was observed in male or female mice at 24 or 48 hours after dose administration (p>0.05, Kastenbaum-Bowman). Therefore, weight of evidence from these 6 tests indicates that the substance is not a mutagen.

Short description of key information:
Five in vitro genetox studies were run with and without S9 activation. Key studies were the Ames mutagencity test and chromosomal abberation studies. The additional 3 studies (mammalian gene mutation, sister chromatid exchange, and hepatocyte) were supporting studies. An in vivo mouse micronucleus study was also conducted which was negative. The weight of evidence from these six studies indicates that the chemical is not a mutagen.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the weight of evidence, 2 -(3,4 -epoxycyclohexyl)ethyltriethoxy silane is not a mutagen and is not classified for mutagenicity according to EU Directive 67/548/EEC and Regulation 1272/2008.