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EC number: 700-235-5 | CAS number: 174899-82-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.09.2007 - 07.11.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane
- EC Number:
- 700-235-5
- Cas Number:
- 174899-82-2
- Molecular formula:
- C8H11F6N3O4S2
- IUPAC Name:
- 1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane
- Test material form:
- liquid
- Details on test material:
- clear liquid, colorless
Constituent 1
- Specific details on test material used for the study:
- Batch 25PI208_12; PA204
stable under normal storage conditions - room temperature, keep away from humidity
expiry date: 05.2019
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix 10 % (v/v): MgCl2-6H2O 8 mM KCl 33 mM Glucose-6-Phosphate Na2 5 mM NADP Na2 4 mM Phosphate buffer ph 7.4 0,1 M
- Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfony)imide is soluble in DMSO
Controls
- Untreated negative controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-anthramine; cis-platinum (II) diammine dichloride
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Preincubation period: 30 min. at 37 °C
- Incubation period: 48 -72 h at 37 C
NUMBER OF REPLICATIONS: 3 plates / strain with and without mutagenic activity - Evaluation criteria:
- Ensure that the criteria of validity of the study are well respected namely:
- the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %,
- the spontaneous reversion rate of the absolute negative controll shall comply with the historical values of the laboratory,
- the spontaneous reversion rate of the solvent shall not be statistically differnet from absolute negative controll,
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
- Negative and positive values should not show significant difference with the historical values of the laboratory (+/- 2 stabdard deviatons).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Doses (5000, 1500, 500, 150 and 50 µg/plate) performed from solutions of the test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide Batch 25PI208_12; PA204 (LEMI code: GOL210817), provided by proionic GmbH, do ot induce any mutagenic change in Salmonell typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA-) (pKM 101) without, or with metabolic activation, according to the OECD Guidelines n°471.
- Executive summary:
Solutions, prepared with 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide, have been tested for their capacity to induce reverse mutation in four Salmonell typhimurium strains and one Escherichia coli WP2(uvr A-)(pkM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out.
For assay n° 1, various concentrations of the prepared solution were put in contact with strains in the absence and presence of a metabolic activation system (S9 -mix 10% (v/v)).
For assay n° 2, various concentrations of the prepared solution were put in contact with strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9 -mix 10% (v/v)).
For the two assays, negative and positive controls were carrid out in paralell. Positive controls induce a significant increase in the number of revertant colonies compared to negative controls. There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponting experimental "historical" values obtained in the labaratory.
These results validate the two tests.
There is no evidence of any increase in the number of revertant colonies in the presence of various concentration of the test item (5000, 1500, 500, 150 and 50 µg/plate), without and with metabolic activation in
Salmonell typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA-)(pkM 101).
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