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EC number: 278-174-4 | CAS number: 75284-35-4
- 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:
- From 09 March, 1994 to 22 March, 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)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- EC Number:
- 278-174-4
- EC Name:
- Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- Cas Number:
- 75284-35-4
- Molecular formula:
- C39H20Cu2N5O15S3.3Na
- IUPAC Name:
- trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- Histidine auxotrophs
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction)
- Test concentrations with justification for top dose:
- Six concentrations of FAT 11127/C (Solophenyl Marine BL roh trocken) ranging from 20.6 to 5000.0 µg/plate were tested with strain Salmonella typhimurium TA 100 to determine the highest concentration to be used in the mutagenicity assay. The experiments were performed with and without metabolic activation. Normal background growth was observed. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 5000.0 µg/plate with and without metabolic activation.
- Vehicle / solvent:
- Dimethyl Sulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cyclophosphamide
- mitomycin C
- other: 2-Aminoanthracene: TA 100, TA102, TA 98 and TA 1537 with S9
- Details on test system and experimental conditions:
- Agar plate incorporation : 0.1 ml of the overnight cultures were mixed with 2 ml of top agar, either 0.5 ml of 100 mM sodium phosphate buffer (experiments without activation) or 0.5 ml of the activation mixture (experiments with activation) and 0.1 ml of a solution of the test substance, the positive control or the solvent as a negative control and poured on minimal agar in Petri dishes. Each Petri dish contained about 20.0 ml of minimal agar (1.5% agar supplemented with 2% salts of the Vogel-Bonner Medium E and 2% glucose). The top agar was composed of 0.6% agar and 0.6% NaCl and was supplemented with 10% of 0.5 mM L-histidine and 0.5 mM (+) biotin dissolved in water.
Incubation period : 48 hours at 37±1.5°C in darkness. - Evaluation criteria:
- Assay accpetance criteria
A test is considered acceptable if the mean colony counts of the negative control values of all strains are within the acceptable ranges and if the results of the positive controls meet the criteria for a positive response. In either case the final decision is based on the scientific judgement of the Study Director.
Criteria for a positive response
The test substance is considered to be positive if the following condition is met:
• At least a reproducible meaningful increase of the mean number of revertant per plate above that of the negative control at any concentration for one or more of the strains tested. Generally, a concentration-related effect should be demonstrable. - Statistics:
- A statistical analysis of the test data was not performed. At present the use of statistical methods concerning this particular test system is not generally recommended.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA 100, TA 1535, WP2 uvrA, TA 102, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Range finding test :
Six concentrations of FAT 11127/C (Solophenyl Marine BL roh trocken) ranging from 20.6 to 5000.0 µg/plate were tested with strain Salmonella typhimurium TA 100 to determine the highest concentration to be used in the mutagenicity assay. The experiments were performed with and without metabolic activation. Normal background growth was observed. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 5000.0 µg/plate with and without metabolic activation.
Mutagenicity test, original experiment
In the experiments performed with and without metabolic activation, treatment of strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 with FAT 11127/C did not lead to an increase in the incidence of histidine-prototrophic mutants in comparison with the negative control.
Mutagenicity test, confirmatory experiment:
Since the purity of the test material is about 80%, in this experimental part the concentration range of 77.2 to 6250.0 µg/plate was used. In the experiments performed with and without metabolic activation for strains TA 100, TA 102, TA 1535 and TA 1537, no increase in the incidence of either histidine-prototrophic mutants was observed in comparison with the negative control. However, in the experiment with strain TA 98 without metabolic activation, a marginal increase in the number of back-mutants was observed at the concentration of 6250 µg/plate. No effect was seen in the corresponding experiment with microsomal activation.
Mutagenicity test, confirmatory experiment 2 :
To confirm the effect observed in the first confirmatory without metabolic activation on strain TA 98, this experiment was repeated. Again, a marginal increase in the number of back-mutants was registered at the highest concentration.
In the mutagenicity tests normal background growth was observed with all strains at all concentrations. The numbers of revertant colonies were not reduced. The test substance exerted no toxic effect on the growth of the bacteria.
There were no known circumstances or occurrences in this study that were considered to have affected the quality or integrity of the test data.
Applicant's summary and conclusion
- Conclusions:
- FAT 11127/C exerted a marginal mutagenic effect in strain TA 98 without metabolic activation.
- Executive summary:
FAT 11127/C was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimurium viz TA 98, TA 100, TA 102, TA 1535 and TA 1537 according to OECD Guideline 471. The test was performed with and without the addition of rat-liver post mitochondrial supernatant (S9 fraction) as an extrinsic metabolic activation system. The compound was tested as a suspension in DMSO at five concentrations in the range of 312.5 to 5000.0 µg/plate in the presence and absence of a metabolic activation system.
In order to confirm the results, the experiments were repeated with and without metabolic activation at five concentrations in the range of 77.2 to 6250.0 µg/plate. Each strain was additionally tested in the presence and in the absence of a metabolic activation system with a suitable, known mutagen as positive control.
In both experiments, performed with and without metabolic activation, none of the tested concentrations of FAT 11127/C led to an increase in the incidence of histidine-prototrophic mutants by comparison with the negative control with strains TA 100, TA 102, TA 1535 and TA 1537. With strain TA 98, however, a slight increase in the number of histidine-prototrophic mutants was observed in the experiments without metabolic activation at the concentration of 6250.0 µg/plate. No effect was seen in the corresponding experiment with metabolic activation. In order to confirm the effect observed in the first confirmatory without metabolic activation on strain TA 98, this experiment was repeated. Again a marginal increase in the number of back-mutants was registered at the highest concentration.
Hence it can be concluded that, based on the results of these experiments and on standard evaluation criteria, FAT 11127/C (Solophenyl Marine BL roh trocken) exerted a marginal mutagenic effect in strain TA 98 without metabolic activation.
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