Registration Dossier
Registration Dossier
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EC number: 413-860-0 | CAS number: 1187-74-2 ACETONYLBERNSTEINSÄUREESTER; ASE
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study primarily conducted in accordance with internaltional test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- EC Number:
- 413-860-0
- EC Name:
- Diethyl 4-oxopentane-1,2-dicarboxylate
- Cas Number:
- 1187-74-2
- Molecular formula:
- C11H18O5
- IUPAC Name:
- 1,4-diethyl 2-(2-oxopropyl)butanedioate
- Details on test material:
- - Name of test material (as cited in study report): acetonyl succinic acid diethyl ester
- Physical state: Liquid
- Analytical purity: 96.1%
- Lot/batch No.: A548702
- Storage condition of test material: Room temperature, protected from humidity
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from Aroclor 1254 treated rats
- Test concentrations with justification for top dose:
- 10.0, 100.0, 333.3, 1000.0 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Suitable to solubilise the test substance
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Strains TA 1535 and TA 100; without metabolic activation
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- Strains TA 1537, TA 1538 and TA 98; without metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All tester strains; with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); 2 independent experiments
DURATION
- Preincubation period:
- Exposure duration: at least 48 hours
SELECTION AGENT (mutation assays): Histidine requirement
NUMBER OF REPLICATIONS: 3
- Evaluation criteria:
- Revertant rate
- Statistics:
- Significance (in response) considered as:
- number of revertants is 2x (strain TA 100) or 3x (strains TA 1535, TA 1537, TA 1538 and TA 98) higher than spontaneous reversion rate
- dose dependent increase in revertant rate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance does not induce point mutations by base pair changes or frameshifts in the genome of the tester strains used - Executive summary:
The substance does not induce point mutations by base pair changes or frameshifts in the genome of the tester strains used
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