Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In Vitro (Mutagenic effects - bacterial): OECD 471; Bacterial reverse mutation assay. Negative. Reliability = 1.

In Vitro (Clastogenic effects - mammalian): OECD 473; Chromosome aberrations in human lymphocytes. Negative. Reliability = 1

In Vitro (Mutagenic effects - mammalian): OECD 476; Mammalian Cell Gene Mutation. Negative. Reliability = 1

Genetic toxicity in vivo

Description of key information

In Vivo (Clastogenic effects - mammalian): OECD 474; in vivo rat micronucleus study; Negative at concentrations up to 500 ppm. Reliability = 1.

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

Additional information

The substance was negative in a battery of in vitro and in vivo studies. 

In vitro: The substance exhibited no mutagenic responses in either the presence or absence of metabolic activation in bacterial cells (Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and Escherichia coli strain WP-2 uvrA) (OECD 471). 

The substance was not clastogenic in either the presence or absence of metabolic activation in human peripheral blood lymphocytes (OECD 473).

The substance was negative for the induction of forward mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus (hprt) of Chinese hamster ovary (CHO) cells, in the presence and absence of an exogenous metabolic activation system (OECD 476).

In vivo: The substance was negative in a peripheral blood micronucleus test in rats following a 90-day inhalation exposure up to exposure concentrations of 7500 ppm (50322 mg/m3) (OECD 474).

Based on the results of this battery of genetic toxicity studies, it is concluded that the substance is not genotoxic in mammalian systems.

Justification for selection of genetic toxicity endpoint
Multiple OECD guideline, GLP studies have been identified as key for this endpoint. In addition the study selected above an Ames assay and in vitro chromosome aberration plus cell forward mutations at the (HPRT) locus of Chinese hamster ovary (CHO) cells assays are pertinent to the hazard conclusion for this endpoint.

Justification for classification or non-classification

The substance was not mutagenic or clastogenic when evaluated in a variety of guideline in vitro and in vivo test designs conducted in accordance to GLP standards. The substance does not need to be classified for mutagenicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.