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EC number: 700-225-0 | CAS number: 1160806-44-9
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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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:
- 2009-08-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific methods; not a guideline method. Method based on modification of OECD TG 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Ames II
- Deviations:
- yes
- Remarks:
- Ames II
- Principles of method if other than guideline:
- The test method is used to evaluate the mutagenic potential of the test substance a based on the ability to induce point mutations in selected loci of several strains of Salmonella typhimurium in a modified version of the Ames test (OECD 471), designated Ames II Assay (microtiter version), both with and without the addition of a metabolizing system (S9 mix) obtained from induced rat liver. According to the authors, this method shows a good accurancy concerning the prediction of the results in the regular Ames test.
- GLP compliance:
- yes
- Remarks:
- Sceening in GLP-certified Laboratory
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate
- EC Number:
- 700-225-0
- Cas Number:
- 1160806-44-9
- Molecular formula:
- C7 H12 Br2 O2
- IUPAC Name:
- ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate
- Details on test material:
- - Name of test material (as cited in study report): 2-Methyl-3,4-dibrombuttersäureethylester
- Physical state: liquid, colorless, clear
- Analytical purity: 98.1 wt%
- Lot/batch No.: 35684-12-5; date of production: 2009-07-14
- Storage condition of test material: refrigerator, under light exclusion
No further data.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium, other: TA mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced rat liver S9
- Test concentrations with justification for top dose:
- 0, 4, 20, 100, 500, 2500, 5000 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without S9: 4-nitrofluorene (5 µg/ml) + 2-nitrofluorene (100 µg/ml); with S9: 2-aminoanthracene (125 µg/ml)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension; liquid fluctuation test with and without induced rat liver S9 mix
NUMBER OF REPLICATIONS: 48 wells in triplicate plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: clearing of the background lawn, decrease in the number of yellow wells - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- MUTAGENICITY:
A relevant increase in the number of positive wells (his+ revertants) was not observed either without S9 mix or after the addition of a metabolizing system.
TEST-SPECIFIC CONFOUNDING FACTORS:
- Precipitation: No precipitation was observed.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) was observed up to the highest applied concentration.
For details, see attached files. - 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
Under the experimental conditions chosen here, it is concluded that 2-Methyl-3,4-dibrombuttersäureethylester is not a mutagenic substance in the Ames II Assay (Salmonella typhimurium reverse mutation assay) in the absence and the presence of metabolic activation.
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