Registration Dossier
Registration Dossier
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EC number: 214-463-3 | CAS number: 1131-18-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to determine the mutagenic nature of 5-Amino-3-methyl-l-phenyl-pyrazol
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-methyl-1-phenylpyrazol-5-ylamine
- EC Number:
- 214-463-3
- EC Name:
- 3-methyl-1-phenylpyrazol-5-ylamine
- Cas Number:
- 1131-18-6
- Molecular formula:
- C10H11N3
- IUPAC Name:
- 3-methyl-1-phenylpyrazol-5-ylamine
- Details on test material:
- - Name of the test material: 5-Amino-3-methyl-l-phenyl-pyrazol
- IUPAC name: 3-methyl-1-phenylpyrazol-5-ylamine
- Molecular Formula: C10H11N3
- Molecular weight: 173.2179 g/mol
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: 5-Amino-3-methyl-1-phenyl-pyrazol
- IUPAC name: 3-methyl-1-phenylpyrazol-5-ylamine
- Molecular Formula: C10H11N3
- Molecular weight: 173.2179 g/mol
- Substance type: Organic
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation system
- Test concentrations with justification for top dose:
- 0, 100, 500, 2500 or 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was completely soluble in DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene (with S9 metabolic activation system)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Triplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, bacterial toxicity was determined
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of revertants/plate
- Statistics:
- Mean and Standard deviation
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data
Applicant's summary and conclusion
- Conclusions:
- 5-Amino-3-methyl-1-phenyl-pyrazol induced gene mutation in Salmonella typhimurium strains TA98 (weakly positive) and TA100 in the presence of S9 metabolic activation system. It however did not induce gene mutation in the two strains in the absence of S9 metabolic activation system.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of 5-Amino-3-methyl-1-phenyl-pyrazol. The study was performed as per the standard plate protocol using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose levels of 0, 100, 500, 2500 or 5000 µg/plate. Concurrent solvent and positive controls chemicals were also included in the study. 2- aminoanthracene was used as the positive control chemical. 5-Amino-3-methyl-l-phenyl-pyrazol induced gene mutation in Salmonella typhimurium strains TA98 (weakly positive) and TA100 in the presence of S9 metabolic activation system. It however did not induce gene mutation in the two strains in the absence of S9 metabolic activation system.
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