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Key value for chemical safety assessment

Additional information

In conclusion we are of the opinion that the existing database is conclusive with regard to the genotoxicity.In the Ames assay negative and some positive results were reported and some publications reported primary DNA damage in particular at cytotoxic concentrations, but repair assays and genomic analysis indicate that these are efficiently repaired or the cells are led into apoptosis so that primary DNA damage is not likely to be manifested in a mutagnic event.

The negative results in mammalian gene mutation assays support the view that the substance does not induce gene mutations in mammalian cells and is therefore unlikely to induce gene mutations in vivo. Positive results of in vitro chromosomal aberration assays were not confirmed in the valid in vivo study for this endpoint. It can therefore be concluded that the substance is unlikely to be genotoxic in vivo.

Short description of key information:
Most standard bacterial mutagenicity studies were negative, except one in one strain followinf a fluctuation protocol. The key in vitro mammalian gene mutation study in CHO cells (HPRT test) was negative, supporting the view that the substance does not induce gene mutations in mammalian cells. Positive results in in vitro chromosomal aberration assays were not confirmed in in valid in vivo studies for this endpoint.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance was not genotoxic in mammalian cells in vitro and did not induce chromosomal aberrations in vivo.