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EC number: 231-411-5 | CAS number: 7538-59-2
- 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
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database.
Data source
Reference
- Reference Type:
- other: authoritative database
- Title:
- Genetic toxicity study for the given test chemical by using Salmonella typhimurium strain.
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 010
- Bibliographic source:
- Japan chemicals collaborative knowledge database (J-check)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- as per Prival modification (MJ Prival, and VD Mitchell, 1982)
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of test chemical in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA by AMES test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-, calcium salt
- Molecular formula (if other than submission substance): C18H14N2O6S.Ca
- Molecular weight (if other than submission substance): 424.445 g/mole
- Smiles notation (if other than submission substance): c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]
- InChl (if other than submission substance): 1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3, (H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;
- Substance type: Organic
- Physical state: Solid
purity: 99%,
Constituent 1
Method
- Target gene:
- Histidine for Salmonella typhimurium and tryptophan Escherichia coli
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
NADH 4 μmol, Magnesium chloride 8 μmol, NADPH 4 μmol, Potassium chloride 33 μmol, 0.2 M phosphate buffer (pH 7.4) 1000 μmol, Glucose · 6-phosphate 5 μmol, FMN 2 μmol
- source of S9 : Kikkoman Corporation
- method of preparation of S9 mix : S9 was prepared from non-induced liver of 8-week-old Syrian Hamster (Std: Syrian) males used.
- concentration or volume of S9 mix and S9 in the final culture medium: 0.3 ml - Test concentrations with justification for top dose:
- 0, 312.5, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test chemical was stable in DMSO solution, and the content of test substance in preparation liquid was within a predetermined value range.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: -S9, AF-2 (TA100, WP2, TA98), +S9, 2-aminoanthracene (all strains), trypane blue (TA100, TA98, azo reduction method)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration - triplicate
- Number of independent experiments - 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): No data
- Test substance added in medium (Standard method of Ames and Azo reduction method)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: The pre-incubation method was used to test by direct method and metabolic activation method.
- Exposure duration/duration of treatment: 48 hours (Standard method of Ames); 20 min (Azo reduction method)
- Harvest time after the end of treatment (sampling/recovery times): No data - Evaluation criteria:
- Among the five test bacteria used, in the direct method or metabolic activation method of one or more test bacteria, the number of revertive mutant colonies on the flat plate containing the test substance is more than twice that of the negative control , and when the increase was found to be reproducible or dose-dependent, it was decided that the test substance had mutagenicity (positive) in this test system.
- Statistics:
- Yes, Mean ±standard deviation was observed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: S. typhimurium TA100, TA1535, TA98, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES (if applicable): When test chemical was tested at a common ratio of approximately 3 in the range of 50 to 5000 μg / plate, no antibacterial activity was observed in either direct method or metabolic activation method of all test bacteria. From the above results, it was decided that the maximum dose in this test was set to 5000 μg / plate in all the test bacteria, in the direct method and the metabolic activation method, and the dose was set to 5 in the common ratio 2.
- Remarks on result:
- other: No mutagenic effects were observed.
Any other information on results incl. tables
Please refer attached background material
Applicant's summary and conclusion
- Conclusions:
- Test chemical was evaluated for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA by AMES test. The test result was considered to be negative in all strain in the presence and absence of metabolic activation S9.
- Executive summary:
Genetic toxicity in vitro study was assessed for the given test chemical according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and as per Prival modification (MJ Prival, and VD Mitchell, 1982). The test chemical was exposed to Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA in the presence and absence of metabolic activation S9 (0.3 ml) prepared from non-induced liver of 8-week-old Syrian Hamster (Std: Syrian) males was used with composition of NADH 4 μmol, Magnesium chloride 8 μmol, NADPH 4 μmol, Potassium chloride 33 μmol, 0.2 M phosphate buffer (pH 7.4) 1000 μmol, Glucose · 6-phosphate 5 μmol, FMN 2 μmol at test concentrations of 0, 312.5, 625, 1250, 2500, 5000 µg/plate. Test chemical was dissolved in DMSO. The positive control substances used are as follows, AF-2 : Frill Furide, SA : Sodium azide, 9-AA : 9-aminoacridine, 2-AA : 2-aminoanthracene and TB : Trypan blue. The study was conducted by Standard method of Ames and Azo reduction method. In Azo reduction method, the pre-incubation method was used to test by direct method and metabolic activation method. 0.1 ml of the test bacterial solution, 0.1 ml of the test substance preparation solution, 0.5 ml of the phosphate buffer solution (0.5 ml of the S9 mixed solution in the metabolic activation method)) were mixed in a small test tube and preincubated at 37 ° C. for 20 minutes After it was done, 2 ml of top agar was added and mixed, and it was poured onto a synthetic medium flat plate. At the same time, a control test was conducted using a solvent or two kinds of positive control substance solutions instead of the test substance preparation solution. When test chemical was tested at a common ratio of approximately 3 in the range of 50 to 5000 μg / plate, no antibacterial activity was observed in either direct method or metabolic activation method of all test bacteria. From the above results, it was decided that the maximum dose in this test was set to 5000 μg / plate in all the test bacteria, in the direct method and the metabolic activation method, and the dose was set to 5 in the common ratio 2. Among the five test bacteria used, in the direct method or metabolic activation method of one or more test bacteria, the number of revertive mutant colonies on the flat plate containing the test substance is more than twice that of the negative control, and when the increase was found to be reproducible or dose-dependent, it was decided that the test substance had mutagenicity (positive) in this test system. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA by Ames test. Hence the substance cannot be classified as gene mutant in vitro.
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