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Key value for chemical safety assessment

Additional information

Ames (according to OECD 471 and EC B.13/14):

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments with and without metabolic activation. Based on the results of this study it is concluded that Biomass residue (liquid) obtained after B2 production is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Chromosome aberration test (according to OECD 473 and EC B.10):

No effects of Biomass residue (liquid) obtained after B2 production on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that Biomass residue (liquid) obtained after B2 production does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations.

Mouse lymphoma test (according to OECD 476 and EC B.17): In the absence of S9-mix, Biomass residue (liquid) obtained after B2 production did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the duration of treatment time.

In the presence of S9-mix, Biomass residue (liquid) obtained after B2 production did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the concentration of the S9 for metabolic activation.

Based on the above mentioned results it is concluded that Biomass residue (liquid) obtained after B2 production is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions tested.


Short description of key information:
Reliable in vitro studies according to OECD and GLP are available to cover the genetic toxicity endpoint: Ames test, chromosome aberration assay and mouse lymphoma test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the genotoxicity studies, the substance does not need to be classified according to the CLP Regulation (EC) 1272/2008 and Council Directive 67/548/EEC (DSD).

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