Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Silica-Zirkonia Filler was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone). Silica-Zirkonia Filler was tested in the first mutation assay at a concentration range of 33 to 3330 µg/plate in the absence and presence of 5% (v/v) S9-mix and at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9-mix in the second mutation assay. The bacterial background lawn was not reduced at any of the concentrations tested. Silica-Zirkonia Filler did not induce a significant dose-related increase in the number of revertant colonies in each of the tester strains In this study, the negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of this study it is concluded that Silica-Zirkonia Filler is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Short description of key information:

In bacteria no mutagenic potential was observed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.