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EC number: 418-200-5 | CAS number: 69227-51-6
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:
- October-December 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- under GLP requirenents
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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 forward mutation assay
Test material
- Reference substance name:
- 1-ethyl-1-methylpyrrolidinium bromide
- EC Number:
- 418-200-5
- EC Name:
- 1-ethyl-1-methylpyrrolidinium bromide
- Cas Number:
- 69227-51-6
- Molecular formula:
- C7H16NBr
- IUPAC Name:
- 1-ethyl-1-methylpyrrolidin-1-ium bromide
Constituent 1
- Specific details on test material used for the study:
- Cas # 69227-51-6
Batch # 0691
pH: 6-9
Storage: 5°C in the dark
Supplier: Chemson, Polymer-Additive Gesellschaft m.b.H. A-9601 Arnoldstein.
Characterization:
Appearance: Colorless liquid.
pH 6.84
Content 52.2% (estimation of bromide)
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- Mutation D6610, rfa,uvrB, pkM101
- Additional strain / cell type characteristics:
- other: D6610 is a frameshift mutation, rfa leads to reduced lipopolysaccharide barriere in the cell wall . uvrB results in a loss of the DNA excision repair system. pkM101 increases the sensitivity to mutagens as well.
- Species / strain / cell type:
- S. typhimurium TA 98
- Remarks:
- Mutation D3052, rfa, uvrB, pkM101
- Additional strain / cell type characteristics:
- other: D3052 is a frameshift mutation, rfa, uvrB, pkM101 as in TA 97
- Species / strain / cell type:
- S. typhimurium TA 100
- Remarks:
- Mutation G46 , rfa, uvrB, pkM101
- Additional strain / cell type characteristics:
- other:
- Remarks:
- G46 is a base pair mutation, rfa, uvrB, pkM101 as in TA97
- Species / strain / cell type:
- S. typhimurium TA 102
- Remarks:
- Mutation G428, rfa, pkM101
- Additional strain / cell type characteristics:
- other: G428 is an ochre mutation with sensitivity to hydroperoxides and crosslinking substances, rfa and pkM101 as in TA97
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal fraction of homogenized livers of rats treated once with 500 mg/kg arcolor 1240
- Test concentrations with justification for top dose:
- high concentration 1: 5000 µg/plate 3 samples
concentration 2: 1667 µg/plate 3 samples
concentration 3: 555 µg/plate 3 samples
concentration 4: 185 µg/plate 3 samples
low concentration 5: 62 µg/plate 3 samples
control (water): 6 samples
Postive control: Aflatoxine B1, 1µg/plate, for strains TA97 and TA100 at samples with S9-mix. - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: water
- Positive controls:
- yes
- Positive control substance:
- other: Aflaxotine B1
- Details on test system and experimental conditions:
- see attached document on test system (1-3)
- Rationale for test conditions:
- The study was conducted according to OECD 471. according to Ames (1983) mutationRes. 113, 173-215 the strains TA97 and TA 102 are recommended instead of TA1535 and TA1537 and they give better response to the mutagen spectrum. theses are the strain used in this test.
- Statistics:
- see attached document on test system (1-3)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- tested only with metabolic activation
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- tested without metabolic activation
- Remarks on result:
- other: not mutagenic
Applicant's summary and conclusion
- Conclusions:
- All positive control groups showed significantly increased mutation frequencies which demonstrates the sensitivity of the test system.
the test substance was not toxic up to 5 mg/plate. all used concentrations could be evaluated.
In none of the tested concentrations and with none of the used strains a statistically significant increase of the mutation frequency was obtained. Metabolic activation did not change these results.
The test substance is therefore non mutagenic in Ames test. - Executive summary:
MEP was tested for mutagenic action with the salmonella thyphimurium reverse mutation assay (Ames test). The study was conducted according to OECD 471.
The test substance was tested at concentrations ranging from 62 µg to 5 mg per plate. with and without external metabolizing system S9 -mix.
The following bacterial strains were used: TA 97, TA 98, TA 100 and TA 102, as well as negative (vehicle) and positive control.
All positive control groups showed significantly increased mutation frequencies which demonstrates the sensitivity of the test system.
the test substance was not toxic up to 5 mg/plate. all used concentrations could be evaluated.
In none of the tested concentrations and with none of the used strains a statistically significant increase of the mutation frequency was obtained. Metabolic activation did not change these results.
The test substance is therefore non mutagenic in Ames test.
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