Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Bacterial cell gene mutation assay:

A reverse gene mutation assay (Ames test) has been conducted using the pre-incubation method with strains TA100, TA1535, TA98, TA1537 of S. typhimurium and Escherichia coli Wp2 uvrA. These were exposed to concentrations up to 5000 ug/plate in the presence and absence of a mammalian metabolic activation system. The substance did not induce mutations in the S. typhimurium and E. coli strains examined.

 

Cytogenicity:

A chromosome aberration assay in V79 cells has been conducted using OECD test methods. There were no biologically significant increases in the number of cells showing structural chromosome aberrations, either in the absence or in the presence of metabolic activation, up to and including cytotoxic concentrations. There were no statistical differences between treatment and control groups and no dose-response relationships were noted.There were no biologically relevant increases in the rate of polyploid or endoreduplicated metaphases. The substance was therefore considered as not clastogenic in this test system

 

Mammalian cell gene mutation assay:

An in vitro mammalian cell assay has been performed in Chinese hamster ovary (CHO) cells to test the potential for gene mutation and/or chromosome damage. Treatments were carried out for 5 hours with and without metabolic activation (S9 Mix) and for 24 hours without metabolic activation following OECD/EU test methods. Mutation frequencies did not show any statistical or biological significant differences from controls.


Short description of key information:
Genotoxicity in-vitro:
Bacterial reverse mutation - Negative
Mammalian cell gene mutation - Negative
Cytotoxicity - Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on results of three different in vitro genetic toxicity studies the substance need not be classified and labelled as genotoxic according to Directive 67/548/EEC (DSD) and to Regulation 1272/2008/EC (CLP).