Registration Dossier
Registration Dossier
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EC number: 418-240-3 | CAS number: 74401-04-0 N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
- EC Number:
- 418-240-3
- EC Name:
- N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
- Cas Number:
- 74401-04-0
- Molecular formula:
- C16H17NO5S
- IUPAC Name:
- 4-[2-(4-formylphenyl)ethenyl]-1-methylpyridin-1-ium methyl sulfate
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium: TA1535, TA1537, TA1538, TA98, TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 - 5000 μg/plate
Concentration range in the main test (without metabolic activation): 50 - 5000 μg/plate - Vehicle / solvent:
- Sterile distilled water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium: TA1535, TA1537, TA1538, TA98, TA100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Species / strain:
- other: Salmonella typhimurium: TA1535, TA1537, TA1538, TA98, TA100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Additional information on results:
- The solvent control plates gave counts in the expected ranges. All positive controls produced marked increases in the revertant counts.
Applicant's summary and conclusion
- Conclusions:
- Negative with and without metabolic activation.
- Executive summary:
The genotoxicity potential of the test substance was evaluated in a in vitro bacterial reverse mutation assay according to the EU Method B.14 (92/69/EEC) and in compliance with GLP. The study was performed with and without metabolic activation on the S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 strains at concentrations in the range 50 - 5000 μg/plate. Under the conditions of the study, the test substance did not induce genotoxicity nor with neither without metabolic activation.
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