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EC number: 228-810-1 | CAS number: 6359-85-9
- 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:
- key study
- Study period:
- 20.01.-20.02.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- A deviation from SOP occurred in the first experiments in E. coli - number of revertants in solvent control was above historical control limits. As number of revertants was within historical control limits for spontaneous reversion we are convinced.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate
- EC Number:
- 228-810-1
- EC Name:
- Sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate
- Cas Number:
- 6359-85-9
- Molecular formula:
- C23H21N5O6S2.Na
- IUPAC Name:
- sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Acid Yellow 25- Physical state: yellow solid, powder- Analytical purity: 95 % (w/w)- Impurities (identity and concentrations): 5%(w/w) NaCl (CAS No. 7647-14-5 - Lot/batch No.: 7003/2007- Expiration date of the lot/batch: 2 years/June 2018- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.
Constituent 1
impurity 1
Method
- Target gene:
- gene for histidine or tryptophan synthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- supernatant of rat liver and a mixture of cofactors.
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 μg30, 100, 300, 1000, 3000 μgSelection of doses/toxicity: : At first, the test substance was tried to dissolve in water for injection. The test substance was insoluble in the highest concentration recommended in guidelines (5000 μg.0.1mL-1). Afterwards, the test substance was dissolved in dimethyl sulfoxide and the maximum recommended concentration was reached.
- Vehicle / solvent:
- Water for injection, Ardeapharma, Lot. No.: 1501210041, exp. 01/2017- Justification for choice of solvent/vehicle: solubility of the substance
Controls
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxid
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylenediamine, 2-aminofluorene, 2-aminoanthracene, N-methyl-N´-nitro-N-nitrosoguanidine, 9-aminoacridine hydrochloride monohydrate
- Details on test system and experimental conditions:
- The bacterial tester strains Salmonella typhimurium TA 1535 (CCM 3814, lot. No. 2101200916917), TA 98 (CCM 3811, lot No. 01022001220053), TA 100 (CCM 3812, lot No. 0102201220054) and TA 1537 (CCM 3815, lot No. 2101200916918) as well as Escherichia coli WP2 uvrA (CCM 4751, lot No. 2104200512732), - were obtained from Czech Collection of Microorganisms (CCM) of Masaryk University, Brno.Strains TA 98 and TA 1537 detect frame shift mutations, strains TA 100 and TA 1535 serve to detectionof base-pair substitution mutations, and strain E.coli WP2 uvrA detects cross-linking mutagensMETHOD OF APPLICATION: in agar (plate incorporation)NUMBER OF REPLICATIONS: two seriesDETERMINATION OF CYTOTOXICITY- Method: relative total growth
- Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule, which is compatible withthe application of statistical methods (2, 3). After this rule the result is positive, if a reproducible doseresponseeffect occurs and/or a doubling of the ratio Rt/Rc is reached.
- Statistics:
- For the evaluation of results, the modified two-fold increase rule was used, which is compatible with theapplication of statistical methods:Dunkel V. C.. Chu K.C. (1980): Evaluation of methods for analysis of microbial mutagenicity assays. inThe Predictive Value of Short-Term Screening Tests in Carcinogenicity Evaluation. Elsevier North-Holland Biomedical Press. 231 - 417Claxton L. D. et al. (1987): Guide for the Salmonella typhimurium/mammalian microsome tests forbacterial mutagenicity. Mutat. Res. 189. 83 - 91
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATAEach experiment included corresponding positive (reference mutagens) and negative controls (untreated control, solvent control). Untreated controls contain no solvent and negative controls contain 0.1 mL of DMSO. All the control numbers were compared with historical ranges of mutant frequencies obtained in our laboratory. The actual numbers were in ranges of the historical numbers. ADDITIONAL INFORMATION ON CYTOTOXICITY:No toxicity was observed in any dose. Precipitation in the top agar occurred from 2500 μg.0.1mL-1. The occurrence of precipitation in top agar was then investigated in the test substance concentration of 1500 μg.0.1mL-1. This concentration of the test substance did not cause precipitation in top agar so concentrations for the first mutagenicity experiments were chosen as 5000, 1500, 500, 150 and 50 μg per plate.
Applicant's summary and conclusion
- Conclusions:
- Under the above-described experimental design, the test substance, Acid Yellow 25, was non mutagenic for all the Salmonella typhimurium as well as Escherichia coli strains with as well as without metabolic activation.
- Executive summary:
The test substance Acid Yellow 25 was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was diluted in dimethyl sulfoxide and assayed in doses of 30 - 5000 µg per plate, which were applied to plates in volume of 0.1 mL.
Experiments were performed without as well as with metabolic activation with a supernatant of rat liver and a mixture of cofactors.
In the arrangement given above, the test substance, Acid Yellow 25, was non-mutagenic for all the used tester strains without as well as with metabolic activation.
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