Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Bacterial mutation assay (Ames test): FR-513 showed no evidence of mutagenic activity in the absence or presence of rat S-9 mix. FR-513 showed clear evidence of mutagenic activity between 500 and 15 µg/plate with strains TA 1535 and TA 100 in the presence of hamster S-9 mix.

Mouse lymphoma: FR-513 is mutagenic in the TK mutation test system under the experimental conditions described in the report. The mutagenicity was confirmed only to incubations in the presence of metabolic activation.

Chromosome aberration: FR-513 was found to be clastogenic in the presence of metabolic activation and at the highest test substance concentration (1000 microgram/ml) in the absence of metabolic activation. FR-513 has the potential to disturb mitotic processes and cell cycle progression.

Micronucleus assay:FR-513 did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore FR-513 can be considered to be non - mutagenic in this test.

UDS assay: FR-513 did not induce any marked or toxicologically significant increases in the incidence of cells undergoing unscheduled DNA synthesis in isolated rat hepatocytes following in vivo exposure for 2 or 16 hr. Therefore, the test material was considered to be non-genotoxic under the conditions of the study.


Short description of key information:
The following studies are available:
In vitro Bacterial mutation assay (Ames test)
In vitro Mammalian cell gene mutation assay with Mouse lymphoma cells
In vitro Chromosome aberration study
In vivo Micronucleus assay
In vivo UDS assay

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the in vivo studies which were negative FR-513 .

Based on the information gained, the test substance Dibromoneopentyl glycol can be considered non mutagenic ans does not need to be classified according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.