Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Positive in vitro gen mutation, OECD 471, Thompson (2011)

Positive in vitro gene mutation study in bacteria, OECD 473, Bohnenberger (2011)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

Non-genotoxic, UDS Assay, OECD 486, Merker (2011)
Non-mutagenic, Mammalian Micronucleous Assay, OECD 474, Roth (2012)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

The in-vivo studies were performed for a chemical registration scheme outside of the European Economic Area.

The test substance has been assessed for genotoxic activity, in a tiered manner, in two in vitro and two in vivo assays.  The test substance was mutagenic in an in vitro bacterial mutation (Ames) assay, this activity was shown to be absent in vivo in an unscheduled DNA synthesis assay and the test substance is considered non-mutagenic.  The test substance was clastogenic in an in vitro chromosome aberration assay, this activity was shown to be absent in vivo in a mammalian erythrocyte micronucleus assay and the test substance is considered non-clastogenic. On the basis of two in vivo assays the test substance has been shown to be non-genotoxic in vivo.

The available studies are considered to be reliable, adequate and conclusive for the purposes of risk assessment and classification.

Justification for classification or non-classification

The potential for the test item to cause genotoxicity has been fully evaluated in vitro and in vivo. Although the in vitro studies were positive, there was no indication of clastogenicity or mutagenicity in the in vivo studies leading to a clear conclusion that the test item is not genotoxic in vivo in accordance with the Globally Harmonized System of classification (2013) and Labelling Regulation (EC) No 1272/2008 (CLP Regulation) .