Registration Dossier

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The substance is negative in the Ames test. The substance showed a positive response in the mouse lymphoma TK assay. The colony sizing indicated clastogenic effects. However, these effects were not confirmed in the in vivo micronucleus assay.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Two in vitro mutagencity assays (Ames test and mouse lymphoma gene mutation test) and an in vivo micronucleus assay are available for the test substance. The substance is negative in the Ames test, with and without metabolic activation. The substance showed a positive response in the mouse lymphoma TK assay, both in the absence and presence of metabolic activation. The colony sizing indicated clastogenic effects. However, these effects were not confirmed in the in vivo micronucleus assay. There is no reason to believe that the negative results would not be relevant to humans.


Justification for selection of genetic toxicity endpoint
Two in vitro mutagenticity tests and one in vivo mutagenicity test are available.

Justification for classification or non-classification

The test substance is negative in the Ames test, in the in vitro HPRT assay and in the in vivo micronucleus assay. Therefore, the substance does not need to be classified and labelled as a mutagen, according to the Regulation 1271/2008 and the Directive 67/548/EEC.