Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test: positive

HPRT test: negative

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

Micronucleus test: negative

DNA damage and/or repair test: 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 of test substance was based on: positive outcomes in bacterial reverse mutation assays (AMES test), negative outcome in HPRT assay and negative results in mammalian erythrocyte micronucleus tests and unscheduled DNA synthesis test with rat liver cells in vivo.

Overall, these studies represent a weight of evidence and allow to exclude a genotoxic potential. Therefore, the substance is not classified within the CLP Regulation (EC 1272/2008).