Registration Dossier
Registration Dossier
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EC number: 203-309-0 | CAS number: 105-56-6
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP testing report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl cyanoacetate
- EC Number:
- 203-309-0
- EC Name:
- Ethyl cyanoacetate
- Cas Number:
- 105-56-6
- Molecular formula:
- C5H7NO2
- IUPAC Name:
- ethyl 2-cyanoacetate
- Details on test material:
- Tank 434 colorless liquid 99.7%(GC-analysis)
Constituent 1
Method
- Target gene:
- Not available
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA1537, TA 1538, TA98 and TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbiturate S9 fraction treated from rat liver
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000, 5000 μg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- There were two tests:
1. Main test with and without the use of an induced with phenobarbiturant metabolic system.
2. Preincubation with and without use of an induced phenobarbiturat metabolic system(pre-incubation 30 minutes at 30±1℃
The incubation conditions were:
about 96 hours incubation;
Incubation temperature about 37℃
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA1537, TA 1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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