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EC number: 204-254-5 | CAS number: 118-47-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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
- 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
- Target gene:
- No data avaialble
- 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
- 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
- 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'.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Gene mutation in vitro:
Data from peer reviewed publication for the target chemical and its read across was assessed to determine the mutagenic nature of he test compound Pyrazolone T. The summary is as mentioned below:
Bacterial gene mutation assay was performed by Chung (1981) to evaluate the mutagenic nature of the test compound Pyrazolone T (CAS no 118 -47 -8) by the liquid preincubation assay and by plate incorporation method. The test was performed using Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system. Preincubation was perfomed for 30mins at 37⁰C in a Dri-block. The revertant colonies were counted by using a hand-held tally. 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.
Ames mutagenicity assay was performed by Das et al (2004) to evaluate the mutagenic nature of the test compound tartrazine (RA CAS no 1934 -21 -0) in plate incorporation assay. The test material was tested at a concentration of 10,100,250,500 and 1000 μg /plate without metabolic activation system. The plates were inverted within an hour and placed in a dark vented incubator at 37⁰C for 48 hours. Positive controls (for TA97a and TA98, 20 μg/plate nitro phenylene diamine and for TA100, 1.5 μg/plate sodium azide) and negative controls were maintained concurrently for all the experiments. Three plates were used for each set. After 48 hours of incubation, the revertant colonies were counted. The test compound tartrazine is not mutagenic in the study conducted using Salmonella typhimurium TA97a, TA98 and TA100 without metabolic activation system.
Tartrazine (RA CAS no 1934 -21 -0) was tested by Tonogai et al (1979) for gene mutation in vitro in the bacterium Bacillus subtilis H17 (Rec+) and M45 (Rec-) in the repair test rec assay performed. Agar plates were streaked with inocula of two strains and paper disk 8 mm of diameter, immersed with 10 µM of dye in DMSO solution, was placed on the surface so as to cover the beginning of the bacterial streaks. After incubation for 24 hrs at 37◦C, the length of growth inhibition of the bacterial streak was measured. No length of growth inhibition was found in Rec+and Rec-strains. Tartrazine failed to induce gene mutation inBacillus subtilisH17 (Rec+) and M45 (Rec-) in the rec assay.
Bacterial gene mutation assay was also performed by Chung (1981) to evaluate the mutagenic nature of the test compound tartrazine (CAS no 1934 -21 -0) by the liquid preincubation assay and by plate incorporation method. The test was performed using Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 with and without S9 activation system. Preincubation was perfomed for 30mins at 37⁰C in a Dri-block. The revertant colonies were counted by using a hand-held tally. The test compound tartrazine 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.
Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed bu Zeiger et al (1987) to evaluate the mutagenic nature of the test compound Phenyl Methyl Pyrazolone (RA CAS no 89 -25 -8). The test compound was used at a dosage level of 0, 100, 333, 1000, 3333.0, 6666.0, 10000 µg/plate in the preincubation assay of 48 hrs. Phenyl Methyl Pyrazolonefailed to induce mutation in the S. typhimurium tester strains TA 1535, TA 1537, TA 98 and TA 100 and hence is negative for mutation in vitro.
The key study and its supporting data suggests that the chemical is not mutagenic in vitro.Justification for selection of genetic toxicity endpoint
Data is from peer reviewed publication
Justification for classification or non-classification
Based on the data presented, the test compound Pyrazolone T (118 -47 -8) is found to be negative for gene mutation in vitro.
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