Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance was negative for mutagenicity in vitro in the Ames test with S. typhimurian strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli strain WP2 unrA at plate incorporation levels up to 5000 microg/plate, either with or without rat liver S9 metabolic activation. It was also negative in an in vitro mammalian cell mutagenicity test with mouse lymphoma cells L5178 TK +/- either with or without rat liver S9 metabolic activation at concentrations up to 1042 microg/mL, equivalent to approximately 10 mM. The test substance failed to induce statistically significant increases in the frequency of chromosome aberrations in human lymphocyte cells in vitro at concentations up to 1042 microg/mL, equivalent to approximately 10 mM, either with or with rat liver S9 metabolic activation.


Short description of key information:
The test substance was negative for mutagenicity in an Ames bacterial mutagenicity test; in an in vitro mammalian mutagenicity test; and in an in vitro mammalian cell chromosme aberration test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance was negative when tested in vitro in the Ames bacterial mutagenicity assay and in the mouse lymphoma L5178Y TK +/- mutagenicity assay. It also failed to produce a positive response in the human lymphocyte chromosomal aberration test. Based on the results of these in vitro studies, the test substance would not be rated as a mutagen under either the EU DSD classification system (EU Directive 67/548/EEC) or the EU CLP classification system (EU Regulation 1272/2008).