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EC number: 204-254-5 | CAS number: 118-47-8
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: Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of Some Commonly Used Dyes
- Author:
- King-Thom Chung, T George E. Fulk, And A. W. Andrews
- Year:
- 1 981
- Bibliographic source:
- Applied And Environmental Microbiology, Oct. 1981, P. 641-648 Vol. 42, No. 4
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The results of mutagenicity testing of some dyes and their metabolites are determined by using the Salmonella-microsome mutagenicity test ()Plate incorporation method developed by Ames et al.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid
- EC Number:
- 204-254-5
- EC Name:
- 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid
- Cas Number:
- 118-47-8
- Molecular formula:
- C10H8N2O6S
- IUPAC Name:
- 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid
- Reference substance name:
- Pyrazolone T
- IUPAC Name:
- Pyrazolone T
- Details on test material:
- - Name of test material (as cited in study report): Pyrazolone T
- Molecular formula (if other than submission substance): C10H8N2O6S
- Molecular weight (if other than submission substance): 284.26 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity ±96%
Constituent 1
Constituent 2
Method
- Target gene:
- No data avaialble
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 of male Sprague-Dawley rats stimulated with Aroclor 1254
- Test concentrations with justification for top dose:
- 5 to 5000 µg.
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation
DURATION(for liquid preincubation assays)
- Preincubation period:
- Exposure duration: 30min at 37’c
- Expression time (cells in growth medium):No data
- Selection time (if incubation with a selection agent): No details
- Fixation time (start of exposure up to fixation or harvest of cells): No details
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available - Evaluation criteria:
- A compound was considered mutagenic when the number of revertants above background was at least twice the value of the historical control mean or twice the value of the current control mean, whichever was greater, and a dose-response curve could be demonstrated
- Statistics:
- No data available
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Additional information on results
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: No data available
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available - 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):
negative withand without
The test compound Pyrazolone T failed to induce mutation in the Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system and hence is negative for gene mutation in vitro. - Executive summary:
Bacterial gene mutation assay was performed to evaluate the mutagenic nature of the test compound Pyrazolone T by the plate incorporation method. The test was performed using Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system. After the treatment , the revertant colonies were counted by using a hand-held tally.
The test compound Pyrazolone T failed to induce mutation in theSalmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system and hence is negative for gene mutation in vitro.
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