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EC number: 259-197-9 | CAS number: 54527-65-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 21st 2011 - February 4th 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(benzylmethylamino)ethyl acetoacetate
- EC Number:
- 259-197-9
- EC Name:
- 2-(benzylmethylamino)ethyl acetoacetate
- Cas Number:
- 54527-65-0
- Molecular formula:
- C14H19NO3
- IUPAC Name:
- 2-[benzyl(methyl)amino]ethyl 3-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): 2-(N-benzyl-N-methylamino( ethyl acetoacetate
- Physical state: Liquid
- Purity test date: 95.5%
- Lot/batch No.: 112/2010
- Expiration date of the lot/batch: December 2011
- Stability under test conditions: stable
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Method
- Target gene:
- TA 98: his D 3052
TA 100: his G 46
TA 1535: his G 46
TA 1537: his C 3076
TA 102: G 428
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- EXPERIMENT I: 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 uL/plate
EXPERIMENT II: 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 uL/plate
Controls
- Untreated negative controls:
- yes
- Remarks:
- Aqua dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: strain specific positive controls
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes at 37 °C
- Exposure duration: 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor <0.5 in relation to the solvent control. - Evaluation criteria:
- The mean value of revertant counts is divided by the mean values of the solvent control. The biological relevance of the result is the criterion for the interpretation of results.
- Statistics:
- A statistical evaluation of the results is not regarded as necessary
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- EXP I: at conc. >= 2.5 uL/plate (without metabolic activation) and at a conc. of 5.0 uL/plate (with metabolic activation) ; EXP II: at conc. >= 1.0 uL/plate (without metabolic activation) and at a conc. >= 2.5 uL/plate (with metabolic activation)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- EXP I: at conc. >= 2.5 uL/plate (without metabolic activation) and at a conc. of 5.0 uL/plate (with metabolic activation) ; EXP II: at conc. >= 1.0 uL/plate (without metabolic activation) and at a conc. >= 2.5 uL/plate (with metabolic activation)
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
2 (N-Benzyl-N-methylamino) ethyl acetoacetate is considered to be non-mutagenic in this bacterial reverse mutation assay.
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