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EC number: 620-455-4
CAS number: 524709-74-8
The test item was not mutagenic in bacteria with and without
metabolizing system according to OECD Guideline 471.
The present study was conducted to investigate the test material for its mutagenic potential in a bacterial reverse mutation test 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 coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from rats pretreated with β-Naphthoflavone/Phenobarbital was used. In this study, two experi-mental series were performed. The S9 mix used contained 10% S9 in the 1st and 20% S9 in the 2nd series, respectively.
The test item was dissolved in DMSO and tested at concentrations ranging from 5.0 to 5000 µg/plate.
Precipitation of the test material on the agar plates occurred at concentrations >=500 µg/plate. No toxicity to the bacteria was observed, except for TA 1537, where a reduction in colony count below 0.5 of the concurrent negative control was observed in the first and second experimental series.
Solvent and positive control treatments were included for all strains. 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.
Following treatment of all bacteria tester strains with the test item in the absence and presence of S9 mix, no relevant increases in revertant numbers were observed.
Under the experimental conditions reported, the test item did not induce gene mutations by base-pair or frameshift changes in the genome of the strains used. Therefore, it was concluded that with and without addition of S9 mix as the exogenous metabolizing system, the test item was not mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation test.
Based on the provided information the test item is not classified for
mutagenicity according to the EU Regulation (EC) No 1272/2008 on
Classification, Labelling and Packaging of Substances and Mixtures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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