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EC number: 274-700-1 | CAS number: 70616-89-6
- 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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- EC Number:
- 233-311-7
- EC Name:
- Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
- Cas Number:
- 10114-47-3
- Molecular formula:
- C28H20N4O6S4.2Na
- IUPAC Name:
- disodium 2,2'-(diazene-1,2-diyldi-4,1-phenylene)bis(6-methyl-1,3-benzothiazole-7-sulfonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: orange powder- Batch No.: 31/94- Prevailing particle size: 2 - 4 µm
Constituent 1
Method
- Target gene:
- gene for histidine synthesis
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 supernatant of rat liver and a mixture of cofactors
- Test concentrations with justification for top dose:
- 10, 100, 500, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle used: water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-1,2-phenylenediamine (CAS: 99-56-9); 2-aminofluorene (CAS: 153-78-6); 2-aminoanthracene (CAS: 613-13-8)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)NUMBER OF REPLICATIONS: 3PREPARATION OF S9 METABOLIC ACTIVATORThe metabolic activation was performed by S9 fraction of rat liver homogenate and mixture of cofactors. The liver homogenate was prepared from Wistar male rats, previously induced with Delor 106 (mixture of PCBs). Cofactors (NADP and glucoso-6-phosphate) were dissolved in buffer. Each plate in all experiments with metabolic activation contained 0.5 mL of buffer with NADP and glucoso-6-phosphate and 20 µL S9. In experiments without metabolic activation only buffer was added to the top agar.DETERMINATION OF CYTOTOXICITY- Any supplementary information relevant to cytotoxicity: no cytotoxicity observed
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 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 98
- 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 97
- 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
Any other information on results incl. tables
Table No. 1: Bacteria reverse mutation test results
Dose (µg/plate) | S9 (μL) | Rt/Rc | S9 (μL) | Rt/Rc | ||
Salmonella typhimurium TA 97 | ||||||
water | 0 | 1.0 | 1.0 | 20 | 1.0 | 1.0 |
10 | 0 | 1.1 | 1.0 | 20 | 1.1 | 1.0 |
100 | 0 | 1.0 | 1.0 | 20 | 0.9 | 1.0 |
500 | 0 | - | 0.9 | 20 | 1.0 | - |
1000 | 0 | 1.1 | 0.9 | 20 | 1.0 | 1.0 |
2500 | 0 | 1.1 | 0.9 | 20 | 0.9 | 1.0 |
5000 | 0 | 0.9 | - | 20 | - | 0.9 |
NPD | 0 | 7.7 | 6.0 | 20 | 16.3 | 12.8 |
2-AF | 0 | - | - | 20 | - | - |
Salmonella typhimurium TA 98 | ||||||
water | 0 | 1.0 | 1.0 | 20 | 1.0 | 1.0 |
10 | 0 | 0.8 | 1.0 | 20 | 1.1 | 1.2 |
100 | 0 | 0.9 | 1.1 | 20 | 0.9 | 1.1 |
500 | 0 | - | 1.0 | 20 | - | 1.3 |
1000 | 0 | 1.1 | 1.0 | 20 | 0.8 | 1.5 |
2500 | 0 | 0.9 | 1.0 | 20 | 0.9 | 1.1 |
5000 | 0 | 0.7 | - | 20 | 0.7 | - |
NPD | 0 | 56.2 | 106.6 | - | - | - |
2-AF | - | - | - | 20 | 101.2 | 92.9 |
Salmonella typhimurium TA 100 | ||||||
water | 0 | 1.0 | 1.0 | 20 | 1.0 | 1.0 |
10 | 0 | 1.0 | 0.9 | 20 | 1.0 | 0.9 |
100 | 0 | 1.1 | 0.9 | 20 | 0.9 | 1.0 |
1000 | 0 | 1.0 | 1.0 | 20 | 1.0 | 1.1 |
2500 | 0 | 1.1 | 1.0 | 20 | 1.0 | 1.1 |
5000 | 0 | 1.1 | 1.0 | 20 | 1.0 | 1.0 |
AS | 0 | 8.2 | 6.5 | - | - | - |
2-AF | - | - | - | 20 | 14.4 | 16.1 |
Salmonella typhimurium TA 1535 | ||||||
water | 0 | 1.0 | 1.0 | 20 | 1.0 | 1.0 |
10 | 0 | 1.0 | 1.3 | 20 | 1.1 | 1.0 |
100 | 0 | 1.2 | 1.0 | 20 | 1.0 | 0.9 |
500 | 0 | - | 1.2 | - | - | - |
1000 | 0 | 0.7 | 0.9 | 20 | 0.9 | 0.8 |
2500 | 0 | 0.6 | 0.8 | 20 | 1.0 | 0.7 |
5000 | 0 | 0.8 | 0.5 | 20 | 0.9 | 0.6 |
AS | 0 | 51.8 | 52.0 | - | - | - |
2-AA | - | - | - | 20 | 17.0 | 13.2 |
AS sodium azide
NPD 4-nitro-1,2-phenylenediamine
2-AF 2-aminofluorene
2-AA 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Based on results of this test, it is obvious that test substance, Reactive Orange 13, shouldn´t be considered as a mutagen for all the Salmonella typhimurium with as well as without metabolic activation.
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