Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation assay in bacteria (AMES test): positive.

Gene mutation assays in mammalian cells (HPRT test): negative.

Genetic toxicity in vivo

Description of key information

Micronucleus assay in bone marrow cells of mouse: negative.

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

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans are classified in Category 2. This classification is based on positive evidence obtained in:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Note: substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.

In vitro mutagenicity tests are the following:

in vitro mammalian chromosome aberration test;

in vitro mammalian cell gene mutation test;

— bacterial reverse mutation tests.

The overall assessement on the genotoxic potential was based on: positive outcome in bacterial reverse mutation assay (AMES test), negative outcomes in in vitro HPRT assays and negative result in in vivo micronucleus test in bone marrow cells of mouse.

All studies were conducted according to OECD guidelines and have a high reliability.

Based on these results, target susbstance was considered as non genotoxic and it was not classified within the CLP Regulation (EC 1272/2008).