Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

All required in vitro tests showed negative results for genetic toxicity. According to Column 2 in Annex VIII (Section 8.4), an in vivo test is not necessary given the consistently negative results in multiple in vitro studies.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Information are available from reliable studies for all the required in vitro endpoints. The results of all studies were in agreement.

Where there was more than one reliable study for an endpoint the most recent studies were selected as key studies.

In vitro key and supporting studies indicate that the test substance is negative in the gene mutation assay (Bacterial reverse mutation assay/ Ames test) and is predicted from the read-across substance Ethyl hexanoate in mammalian cell gene mutation test/ HPRT, with and without metabolic activation. One key and one supporting study is available for in vitro micronucleus (read-across substance) and the in vitro mammalian chromosome aberration, respectively, to determine the genetic toxicity of the substance. The results show that the substance does not induce chromosome aberration or micronuclei in mammalian cells.

Justification for classification or non-classification

Based on the available data, the substance does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.