Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance showed no mutagenic properties in fully reliable bacterial reverse mutation assays according to OECD TG 471, in mammalian cell gene mutation assays according to OECD TG 476, and in in vitro chromosome aberration assays according to OECD TG 473.

Additionally available is a Mammalian Bone Marrow Micronucleus Test similar to OECD TG 474. In this study 5 mice/sex were treated orally with a single limit dose of 5000 mg/kg prior to bone marrow sampling after 24, 48 and 72 hours. No increase in the frequencies of micronuclei were observed after exposure, therefore it was concluded that the test substance was devoid of mutagenic activity. In this study no substance-related toxic symptoms were observed and also no appreciable suppression of marrow proliferation, as indicated by shifts in the PCE/NCE ratios. The slightly reduced number of PCE recorded in the 48 h samples was taken to indicate that the test compound had reached the target organ. Thus, under the experimental conditions chosen here, no indications were found for a genotoxic potential in vivo.


Justification for selection of genetic toxicity endpoint
No study selected since none of the available studies (several in vitro, one in vivo) conclude a genotoxic potential for the substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for genetic toxicity.