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EC number: 275-170-4 | CAS number: 71077-14-0
- 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
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. 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 revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro.
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- without
- Metabolic activation system:
- not specified
- Test concentrations with justification for top dose:
- 1.10, 100, 250, 500 or 1000 μg /plate
2.50 and 250 µg/plate - Vehicle / solvent:
- 1.Sterile double distilled water
2.water or DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- .Sterile double distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other:
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Ethylmethanesulfonate (5 µl) Methylmethanesulfonate (1 µl) 9-Aminoaeridine (50µl) Nitroquinoline-N-oxide (0.22 pg) Anthragallol ( 50 µ g ) 2-Anthramine (1 µg) Negative control Dithionite
- Details on test system and experimental conditions:
- 1.Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data available
- Exposure duration: 48⁰C
- Expression time (cells in growth medium): 48⁰C
- 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: triplicate
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
2.METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:16 hour
- Exposure duration:3 days
- Expression time (cells in growth medium): 3days
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: Liquid test was also performed . - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- 1.Increase in the number of mutagenic revertants
2.The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. - Statistics:
- 1,ANOVA test was performed at 0.05 level
2.Mean was observed. - Species / strain:
- S. typhimurium, other: TA97a, TA98 and TA100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Gene mutation toxicity study for 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
- Executive summary:
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. 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 revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro.
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.
The data available for the target chemical based on its read across substance and applying weight of evidence 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. 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 revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.
The data available for the target chemical based on its read across substance and applying weight of evidence 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for target substance 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
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