Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

FBC Ashes showed negative results in two studies for the induction of gene mutations (bacterial reverse mutation assays) by frameshift or base-pair substitutions with and without metabolic activation. Studies were performed with the test strains S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A. Test concentrations up to the limit concentration of 5000 µg/plate were tested in all experiments.

FBC Ash also yielded negative results in an in vitro gene mutation studies in mammalian cells (mouse lymphoma assay) in concentration up to 5000 µg/ml in the presence and absence of metabolic activation.

FBC Ash did not induce micronuclei in V79 cells (Chinese hamster cell line) in vitro in the absence and the presence of metabolic activation.

In conclusion, FBC Ash is not mutagenic in the bacterial reverse mutation assay, in the mouse lymphoma assay and in the in vitro micronucleus assay in the presence and absence of metabolic activation up to the tested concentrations.


Short description of key information:
Mutagenic properties of FBC Ashes were investigated in bacterial reverse mutation assays (Ames test; test strains used: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, E. coli WP2 uvr A), in an in vitro gene mutation study in mammalian cells (Mouse lymphoma assay) and in an in vitro micronucleus assay. Negative results were obtained in all tests with and without metabolic activation.

All tests have been performed in accordance with GLP principles.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

FBC Ash does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because FBC Ash did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation at concentrations up to 5000 µg/plate, in the mouse lymphoma assay in the presence or absence of metabolic activation at concentrations up to 5000 µg/ml and in the in vitro micronucleus test in V79 cells in the presence or absence of metabolic activation at concentrations up to 5000 µg/ml.