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EC number: 454-450-1 | CAS number: 429659-01-8 BIBR 1048 MANAMIDE
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October November 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- EC Number:
- 454-450-1
- EC Name:
- Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
- Cas Number:
- 429659-01-8
- Molecular formula:
- C18 H20 N4 O5
- IUPAC Name:
- ethyl 3-{1-[4-(methylamino)-3-nitrophenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium strains TA1535, TA 1537, TA 98, TA 100 and TA 102.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Additional information on results:
- Observations:
The test item induced gene mutations by frameshifts in the
genome of strain TA98 with and witout metabolic activation
Applicant's summary and conclusion
- Conclusions:
- It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations frameshifts in the genome of strain TA 98 with and without metabolic activiation.
Therefore, BIBR 1048 Manamide is considered to be mutagenic in this Salmonelia typhimurium reverse mutation assay.
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