Registration Dossier
Registration Dossier
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EC number: 231-445-0 | CAS number: 7554-65-6
Toxicological information
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, restriction in design (only one positive control used to test efficacy of the S9-mix), but adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , only one positive control used to test efficacy of the S9-mix
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- , only one positive control used to test efficacy of the S9-mix
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methylpyrazole
- EC Number:
- 231-445-0
- EC Name:
- 4-methylpyrazole
- Cas Number:
- 7554-65-6
- Molecular formula:
- C4H6N2
- IUPAC Name:
- 4-methyl-1H-pyrazole
- Details on test material:
- - Name of test material (as cited in study report): 4-Methylpyrazol
- Appearance: yellowish liquid
- Storage: room temperature
Constituent 1
Method
- Target gene:
- - S. typhimurium: His-locus
- E. coli: Trp-locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- - Experiment 1: 20, 100, 500, 2500 and 5000 µg/plate (E.coli)
- Experiment 2: 20, 100, 500, 2500 and 5000 µg/plate (S. typhimurium)
- Experiment 3: 500, 1000, 2000, 4000 and 6000 µg/plate (E.coli) - Vehicle / solvent:
- Water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA: 2.5 µg/plate, E.coli: 60 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- TA 100, TA 1535; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- TA 98; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg/plate
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- E.coli; without metabolic activation
- Details on test system and experimental conditions:
- EXPERIMENT 1
- METHOD OF APPLICATION: in agar (plate incorporation)
- DURATION: Exposure duration: 48 - 72 hours
- NUMBER OF REPLICATIONS: 3 test plates per dose or control
- DETERMINATION OF CYTOTOXICITY: reduced trp- background growth, decrease in the number of trp+ revertants
EXPERIMENT 2
- METHOD OF APPLICATION: in agar (plate incorporation)
- DURATION: Exposure duration: 48 - 72 hours
- NUMBER OF REPLICATIONS: 3 test plates per dose or control
- DETERMINATION OF CYTOTOXICITY: reduced his- background growth, decrease in the number of his+ revertants
EXPERIMENT 3
- METHOD OF APPLICATION: in agar (plate incorporation)
- DURATION: Exposure duration: 48 - 72 hours
- NUMBER OF REPLICATIONS: 3 test plates per dose or control
- DETERMINATION OF CYTOTOXICITY: reduced trp- background growth, decrease in the number of trp+ revertants - Evaluation criteria:
- In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- Slightly elevated figures at 2500 and 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Remarks:
- Weakly positive reaction from about 2000 - 2500 µg/plate (factor 1.9 - 2.2) onward with an increase in the number of trp+ revertants by a factor 4.6 at 6000 µg/plate.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Remarks:
- Weakly positive effects at dosed 2500 - 6000 µg/plate (factor 1.8 - 2.7)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS: Precipitation: No test substance precipitation was found.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous
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