Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in bacteria (in vitro):

In a GLP guideline study the mutagenicity of the test substance was investigated in Salmonella typhimurium strains TA 1535, 1537, 1538, 98 and 100, with and without metabolic activation (Phenobarbiturate-induced rat liver S9-mix). Doses from 8 -5000 µg/plate were applied in 2 independent assays (one plate incorporation test, one pre-incubation test). Cytotoxicity was observed from 1000 µg/plate upwards. No genotoxicity was observed. Thus, the test substance is not mutagenic in bacteria under the conditions used.

Genetic toxicity, chromosome aberration (in vitro):

A chromosome aberration assay according to OECD TG 473 was performed to assess the clastogenic potential of the test substance. Therefore human peripheral blood lymphocytes were treated with 312.5, 625, 1250, 2500, 5000 µg test substance/mL medium for 4 h with and without metabolic activation (S9 -mix). Cytotoxicity was observed after treatment with 5000 µg/mL. The mean incidence of chromosomal aberrations excluding gaps at concentrations from 625 to 5000 µg/mL with and without metabolic activation was within the control range, and there was no dose related increase in chromosomal aberrations and no polyploidy was noted. All positive and negative controls gave the expected results that were within the historical control ranges of the laboratory and consistent with those reported in the literature. Thus, the test substance showed no clastogenic potential in this chromosome aberration assay in human lymphocytes.

Short description of key information:
Ames Assay (EU Method B.13/14) in Salmonella typhimurium strains TA 1535, 1537, 1538, 98 and, 100 with and without metabolic activation: not mutagenic.
Chromosome aberration assay in peripheral human lymphocytes (OECD TG 473) with and without metabolic activation: no clastogenic effects.

Endpoint Conclusion:

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- Further testing required.

GHS classification (GHS UN rev.3, 2009):

- Further testing required.