Registration Dossier
Registration Dossier
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EC number: 700-224-5 | CAS number: 1647-12-7
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:
- no guideline available
- Guideline:
- other: according to 471
- 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 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 accuracy concerning the prediction of the results in the regular Ames test.
- GLP compliance:
- yes
- Remarks:
- comparable to GLP -Screening test, GLP certif. laboratory
- Type of assay:
- other: Ames II
Test material
- Reference substance name:
- ethyl (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate
- EC Number:
- 700-224-5
- Cas Number:
- 1647-12-7
- Molecular formula:
- C7 H12 O2
- IUPAC Name:
- ethyl (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate
- Details on test material:
- - Name of test material (as cited in study report): 2-Methylbuten-3-saureethylester
- Physical state: liquid, colorless, clear
- Analytical purity: 99.2 wt%
- Lot/batch No.: 34649/199/Fr.3; date of production: 2009-05-29
- Storage condition of test material: at room temperature
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: good solubility of the test substance in DMSO
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 occurred.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) was observed. - 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, the test substance is not a mutagenic substance in the Ames II Assay (Salmonella typhimurium reverse mutation assay) in the absence and presence of metabolic activation.
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