Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

3 in vitro genetic toxicity studies were performed to assess the genotoxic potential of FR-370.

All 3 studies were concluded to be negative in the presence and absence of metabolic activation. FR-370 was not mutagenic to E. coli or to S. typhimarium and did not induce forward mutations at the TK locus in L5178Y mouse lymphoma cells. FR-370 was negative in the induction of structural aberrations and equivocal in the induction of numerical aberrations in the in vitro mammalian cytogenetic assay using Chinese hamster ovary cells.

Short description of key information:
Reverse mutation assay Ämes test using Salmonella Typhimurium and Escherichia coli.
Chromosome aberration test in CHL cells.
Mouse Lymphoma forward Mutation Assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance in not mutagenic.