Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Not mutagenic

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

Genetic toxicity in vivo

Description of key information

Not mutagenic

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

Additional information

Justification for classification or non-classification

A mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). According to the CLP Regulation (EC 1272/2008), substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans are considered. The classification (Category 2) is based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from: 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. Moreover, 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 this classification category.

Based on the results of the in vitro salmonella and in vivo micronucleus mutagenicity tests, it is concluded that the substance did not induce gene mutations in the strains of Salmonella typhimurium and in mouse respectively used.

Therefore, the substance does not meet the criteria to be classified for genetic toxicity according to the CLP Regulation (EC 1272/2008).