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EC number: 936-120-3 | CAS number: -
OECD 471: negative
The present study was conducted to investigate the test material for mutagenic potential in a bacterial reverse gene mutation assay in the absence and presence of a rat liver metabolizing system (S9 mix).
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coil WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from rats pre-treated with beta-Naphthoflavone/Phenobarbital was used. In this study, two independent experimental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series. The test item was dissolved in acetone and tested at concentrations ranging from 1.58 to 889 µg/plate.
Precipitation of the test material on the agar plates occurred at concentrations >=158 µg/plate. No toxicity to the bacteria was observed, with the exception of TA 1537, where a reduction in colony count below 0.5 of the concurrent negative control was observed in the first experimental series.
The mean numbers of revertant colonies were all within acceptable ranges for solvent control treatments, or were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Under the conditions described, there were no relevant increases in revertant numbers observed after exposure to the test item in the absence and presence of S9 mix.
According to the predetermined criteria for negative and positive results, the test item was not mutagenic under the experimental conditions described.
With and without addition of S9 mix as the external metabolizing system, the test item was not mutagenic under the experimental conditions described.
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.
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