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EC number: 274-402-1 | CAS number: 70210-05-8
- 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
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
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- EC Number:
- 274-402-1
- EC Name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-05-8
- Molecular formula:
- C37H31N3O11S3.2Na
- IUPAC Name:
- sodium (E)-3-((2,4-bis(o-tolyloxy)phenyl)diazenyl)-4-hydroxy-5-(4-methylphenylsulfonamido)naphthalene-2,7-disulfonate
- Test material form:
- other: solid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- experiment 1: 3; 10; 33; 100; 333; 1000; 2500; 5000 um/plateexperiment 2: 33; 100; 333; 1000; 25000; 5000 um/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent untreated and solvent controls were performed
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-Nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- PreculturesFrom the thawed ampoules of the strains 0.5 ml bacterial suspension were transferred into 250 ml Erlenmeyer flasks containing 20 ml nutrient medium. A solution of 20 pl ampicillin (25 pg/ml) was added to the strains TA 98 and TA 100. This nutrient medium contains per litre: 8 g Merck Nutrient Broth (MERCK, D-64293 Darmstadt) 5 g NaCI (MERCK, D-64293 Darmstadt) The bacterial cultures were incubated in a shaking water bath for 4 hours at 37° C.The overlay agar contains per litre: for Salmonella strains:6.0 g MERCK Agar Agar6.0 g NaCI10.5mg L-Histidine• HCI. H2012.2 mg Biotinfor Escherichia coli: 6.0 g MERCK Agar Agar6.0 g NaCl2.5 mg Tryptophan Sterilisation was performed at 121° C in an autoclaveRat Liver S9 (Preparation by RCC Cytotest Cell Research) Phenobarbital/I3-Naphthoflavone induced rat liver S9 is used as the metabolic activation system. The S9 is prepared from 8 - 12 weeks old male VVistar Hanlbm rats, weight approx. 220 - 320 g induced by applications of 80 mg/kg b.w. Phenobarbital i.p. (Desitin; D-22335 Hamburg) and 13-Naphthoflavone p.o. (Aldrich, 0-89555 Steinheim) each on three consecutive days. The livers are prepared 24 hours after the last treatment. The S9 fractions are produced by dilution of the liver homogenate with a KCI solution (1+3) followed by centrifugation at 9000 g. Aliquots of the supernatant are frozen and stored in ampoules at -80° C. Small numbers of the ampoules can be kept at -20°C for up to one week. Each batch of S9 mix is routinely tested with 2-aminoanthracene as well as benzo(a)pyrene. The protein content was determined using an analysis kit of Bio-Rad Laboratories, 0-80939 München (Bio-Rad protein assay, Catalogue No. 5000006). The protein concentration in the S9 preparation was 30.6 mg/mL. Hamster Liver S9 (Preparation by RCC Cytotest Cell Research) The S9 liver microsomal fraction was prepared from the liver of 7 - 8 weeks old male Syrian golden hamsters. After decapitation of the anaesthetised animals the livers of the animals was removed, washed in 0.1 M sodium phosphate buffer pH 7.4, 0.25 M sucrose and 1 mM disodium EDTA in deionised water and homogenised. The homogenate, diluted 1+3 in sodium phosphate buffer was centrifuged at 9,000 g for 25 minutes at 4° C. Aliquots of the supernatant were frozen and stored in ampoules at -80° C. Small numbers of the ampoules can be kept at -20°C for up to one week. Each batch of S9 mix is routinely tested with 2-aminoanthracene as well as congo red. The protein content was determined using an analysis kit of Bio-Rad Laboratories, 0-80939 München (Bio-Rad protein assay, Catalogue No. 5000006). The protein concentration in the S9 preparation was 42.2 mg/mL.Rat S9 Mix Before the experiment an appropriate quantity of S9 supernatant was thawed and mixed with S9 cofactor solution. The amount of S9 supernatant was 15% v/v. Cofactors were added to the S9 mix to reach the following concentrations in the S9 mix: 8 mM MgC12 33 mM KCI 5 mM glucose-6-phosphate 5 mM NADP in 100 mM sodium-ortho-phosphate-buffer, pH 7.4. During the experiment the S9 mix was stored in an ice bath. The S9 mix preparation was performed according to Ames et al.(2).Hamster S9 Mix Before the experiment an appropriate quantity of S9 supernatant was thawed and mixed with S9 cofactor solution. The amount of S9 supernatant was 30% v/v. The concentrated cofactor solution yields the following concentrations in the S9 mix: 8.0 mM MgCl2 33.0 mM KCI 20.0 mM Glucose-6-phosphate 2.8 units/ml Glucose-6-phosphate-dehydrogenase 4.0 mM NADP 2.0 mM NADH 2.0 mM FMN in 100 mM Sodium-Ortho-Phosphate-buffer, pH 7.4. During the experiment the S9 mix was stored in an ice bath. The S9 mix preparation was performed according to Ames et al.(2) and Prival and Mitchell (1).Pre-Experiment for Toxicity To evaluate the toxicity of the test item a pre-experiment was performed with all strains. Eight concentrations were tested for toxicity and mutation induction with 3 plates each. Toxicity of the test item results in a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. Experimental Performance For each strain and dose level, including the controls three plates were used. The following materials were mixed in a test tube and poured onto the selective agar plates (first experiment): 100 ul Test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control), 500 ul S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation), 100 ul Bacteria suspension (cf. test system, pre-culture of the strains), 2000 ul Overlay agar According to the pre-incubation method (second experiment) 100 ul test solution, 500 ul S9 mix / S9 mix substitution buffer, and 100 ul bacteria suspension were mixed in a test tube and incubated at 30°C for 30 minutes. After pre-incubation 2.0 ml overlay agar (45°C) was added to each tube. The mixture was poured on selective agar plates. After solidification the plates were incubated upside down for at least 48 hours at 37° C in the dark.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant
- Statistics:
- No statistical evaluation of the data is required
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxic effects, evident as a reduction in the number of revertants, were observed without metabolic activation in strain TA 1535 at 5000 pg/plate and with metabolic activation in strain TA 1535 at 2500 and 5000 pg/plate, and in strains TA 1537 at 5000 pg/plate and TA 98 at 2500 pg/plate in experiment I.
- 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):negativeThe tested substance is not mutagenic.
- Executive summary:
This study was performed to investigate the potential of the substance to induce gene mutations according to the plate incorporation assay with rat liver S9 (experiment l), and the pre-incubation test with hamster liver S9 (experiment II) using the Salmonella typhimuriunn strains TA 1535, TA 1537, TA 98, TA 100 and the Escherichia coli strain VVP2 uvrA.
The assay was performed in two independent experiments with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Experiment I: 3; 10;33; 100; 333; 1000; 2500; and 5000 pg/plate.
Experiment II: 33; 100; 333; 1000; 2500; and 5000 pg/plate
The plates incubated with the test item showed normal background growth up to 5000 ug/plate with and without metabolic activation in both independent experiments.
Toxic effects, evident as a reduction in the number of revertants, were observed without metabolic activation in strain TA 1535 at 5000 ug/plate and with metabolic activation in strain TA 1535 at 2500 and 5000 ug/plate, and in strains TA 1537 at 5000 ug/plate and TA 98 at 2500 ug/plate in experiment I.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Sanolin-Red N-6B at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
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