Registration Dossier
Registration Dossier
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EC number: 211-780-9 | CAS number: 695-34-1
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Comutagenic Effect Of Norharman With Aminopyridine Derivatives
- Author:
- Wakabayashi, K., Yahagi, T., Nagao, M. and Sugimura, T.
- Year:
- 1 982
- Bibliographic source:
- MUTAT. RES. 105:205-210,1982
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The purpose of the study was to determine the comutagenic effect of norharman with 2-amino-4-methylpyridine with or without metabolic activation in Salmonella typhimurium strains TA98 and TA100.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methyl-2-pyridylamine
- EC Number:
- 211-780-9
- EC Name:
- 4-methyl-2-pyridylamine
- Cas Number:
- 695-34-1
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 4-methylpyridin-2-amine
- Reference substance name:
- 2-Amino-4-methylpyridine
- IUPAC Name:
- 2-Amino-4-methylpyridine
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- No specific details on test material used for the study.
Method
- Target gene:
- His-gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- No other details were provided in the study report.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- No other details were provided in the study report.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Kanechlor 500-induced rat liver S9.
- Test concentrations with justification for top dose:
- Up to 2 mg/plate.
- Vehicle / solvent:
- - Vehicle used: DMSO
Controls
- Negative solvent / vehicle controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- No information on controls were provided in the study report
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Incubation period: 2 days
NUMBER OF REPLICATIONS: Not provided.
NUMBER OF CELLS EVALUATED: Not provided.
DETERMINATION OF CYTOTOXICITY: No data - Evaluation criteria:
- No information is available in the study report.
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No additional details were provided in the study report.
Applicant's summary and conclusion
- Conclusions:
- 2-Amino-4-methylpyridine was non-mutagenic in the Ames test when tested up to 2 mg/plate with and without metabolic activation in Salmonella strains TA98 and TA 100 in the presence of norharman.
- Executive summary:
2-Amino-4-methylpyridine was non-mutagenic in the Ames test when tested up to 2 mg/plate with and without metabolic activation in Salmonella strains TA98 and TA 100 in the presence of norharman.
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