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Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)
EC number: 953-115-1 | CAS number: -
- 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 April 1994 to 12 August 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:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)
- Molecular formula:
- C17H10ClCrN2Na2O10S2.C17H11ClCrN2Na3O11S2
- IUPAC Name:
- Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 20044/B (Neolan Blau 3R roh trocken SFO)
Batch No.: 96
Purity: about 80 %
Stability: July 1999
Appearance: Blue mass
Expiry date: July 1999
Storage: Room temperature
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation system:
- With and without metabolic activation
- Test concentrations with justification for top dose:
- Range finding test: ranging from 20.6 to 5000 µg/plate
From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 5000 µg/plate with and without metabolic activation.
Main study: 61.7 to 5000 µg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation: TA 98, TA100, TA1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation: TA1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation: TA100, TA1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA 1537
- Details on test system and experimental conditions:
- The histidine-auxotrophic strains of Salmonella typhimurium (TA 98, TA 1535, TA 1537) were obtained from Prof. B. Ames, Berkeley, USA. Strain TA 100 was obtained from Dr. M. Schüpbach, Hoffmann-La Roche Limited, Basel, Switzerland.
- Evaluation criteria:
- Assay acceptance 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 will be considered to be positive in the test system if the following condition is met:
• At least a reproducible meaningful increase of the mean number of revertants 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
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 100, TA 1535 and TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Four salmonella strains were used
Any other information on results incl. tables
Range finding test
Six concentrations of FAT 20044/B (Neolan Blau 3R roh trocken SFO) ranging from 20.6 to 5000.0 ug/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 µg/plate with and without metabolic activation.
Mutagenicity test, original experiment
In the experiment performed without metabolic activation, treatment of strain TA 98 with FAT 20044/B (Neolan Blau 3R roh trocken SFO) led to a slight increase in the number of histidineprototrophic mutants at the concentration of 5000 µg/plate. No effect was seen in the experiment with activation conducted on this strain and in the experiments with and without activation conducted on strains TA 100, TA 1535 and TA 1537.
Mutagenicity test, confirmatory experiment
In the experiment performed without metabolic activation, again, treatment of strain TA 98 with FAT 20044/B (Neolan Blau 3R roh trocken SFO) led to a slight increase in the number of revertant counts at the concentration of 5000.0 µg/plate. No effects occurred in the experiment with activation conducted on this strain and in the experiments with and without activation conducted on strains TA 100, TA 1535 and TA 1537. In the mutagenicity tests normal background growth was observed with all strains at all concentrations. The numbers of revertant colonies were not reduced with increasing concentration. Therefore, 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.
SUMMARY OF THE MUTAGENICITY EXPERIMENTS: ORIGINAL EXPERIMENT with metabolic activation
Strain | Treatment | Mean Counts | Strain | Treatment | Mean Counts |
TA 100 | Negative control | 121.67 | TA 1535 | Negative control | 11.33 |
| 61.73 µg/plate | 145.00 |
| 61.73 µg/plate | 16.67 |
| 185.19 µg/plate | 143.67 |
| 185.19 µg/plate | 8.33 |
| 555.56 µg/plate | 147.00 |
| 555.56 µg/plate | 12.67 |
| 1666.67 µg/plate | 147.00 |
| 1666.67 µg/plate | 10.67 |
| 5000.00 µg/plate | 158.33 |
| 5000.00 µg/plate | 11.67 |
| Positive Control | 1893.67 |
| Positive Control | 358.00 |
|
|
|
|
|
|
|
|
| TA 98 | Negative control | 27.67 |
|
|
|
| 61.73 µg/plate | 33.33 |
|
|
|
| 185.19 µg/plate | 32.0 |
|
|
|
| 555.56 µg/plate | 35.33 |
|
|
|
| 1666.67 µg/plate | 38.67 |
|
|
|
| 5000.00 µg/plate | 39.33 |
|
|
|
| Positive Control | 1972.33 |
TA1537 | Negative control | 7.67 |
|
|
|
| 61.73 µg/plate | 5.33 |
|
|
|
| 185.19 µg/plate | 7.33 |
|
|
|
| 555.56 µg/plate | 9.67 |
|
|
|
| 1666.67 µg/plate | 9.33 |
|
|
|
| 5000.00 µg/plate | 9.33 |
|
|
|
| Positive Control | 143.33 |
|
|
|
SUMMARY OF THE MUTAGENICITY EXPERIMENTS: ORIGINAL EXPERIMENT without metabolic activation
Strain | Treatment | Mean Counts | Strain | Treatment | Mean Counts |
TA 100 | Negative control | 126.33 | TA 1535 | Negative control | 14.00 |
| 61.73 µg/plate | 126.67 |
| 61.73 µg/plate | 8.33 |
| 185.19 µg/plate | 136.67 |
| 185.19 µg/plate | 12.00 |
| 555.56 µg/plate | 121.67 |
| 555.56 µg/plate | 12.00 |
| 1666.67 µg/plate | 142.00 |
| 1666.67 µg/plate | 11.33 |
| 5000.00 µg/plate | 158.67 |
| 5000.00 µg/plate | 10.00 |
| Positive Control | 1292.67 |
| Positive Control | 1015.00 |
|
|
|
|
|
|
|
|
| TA 98 | Negative control | 16.00 |
|
|
|
| 61.73 µg/plate | 17.33 |
|
|
|
| 185.19 µg/plate | 16.00 |
|
|
|
| 555.56 µg/plate | 21.33 |
|
|
|
| 1666.67 µg/plate | 29.33 |
|
|
|
| 5000.00 µg/plate | 51.00 |
|
|
|
| Positive Control | 1750.33 |
TA1537 | Negative control | 9.67 |
|
|
|
| 61.73 µg/plate | 5.00 |
|
|
|
| 185.19 µg/plate | 8.00 |
|
|
|
| 555.56 µg/plate | 9.33 |
|
|
|
| 1666.67 µg/plate | 12.00 |
|
|
|
| 5000.00 µg/plate | 11.00 |
|
|
|
| Positive Control | 2050.33 |
|
|
|
SUMMARY OF THE MUTAGENICITY EXPERIMENTS: CONFIRMATORY EXPERIMENT with metabolic activation
Strain | Treatment | Mean Counts | Strain | Treatment | Mean Counts |
TA 100 | Negative control | 115.67 | TA 1535 | Negative control | 8.00 |
| 61.73 µg/plate | 121.00 |
| 61.73 µg/plate | 10.33 |
| 185.19 µg/plate | 111.67 |
| 185.19 µg/plate | 10.33 |
| 555.56 µg/plate | 128.33 |
| 555.56 µg/plate | 10.67 |
| 1666.67 µg/plate | 138.67 |
| 1666.67 µg/plate | 10.67 |
| 5000.00 µg/plate | 158.67 |
| 5000.00 µg/plate | 9.00 |
| Positive Control | 1758.00 |
| Positive Control | 357.00 |
|
|
|
|
|
|
|
|
| TA 98 | Negative control | 33.00 |
|
|
|
| 61.73 µg/plate | 30.00 |
|
|
|
| 185.19 µg/plate | 39.33 |
|
|
|
| 555.56 µg/plate | 36.33 |
|
|
|
| 1666.67 µg/plate | 34.00 |
|
|
|
| 5000.00 µg/plate | 41.00 |
|
|
|
| Positive Control | 1743.33 |
TA1537 | Negative control | 9.33 |
|
|
|
| 61.73 µg/plate | 5.33 |
|
|
|
| 185.19 µg/plate | 7.00 |
|
|
|
| 555.56 µg/plate | 10.33 |
|
|
|
| 1666.67 µg/plate | 8.67 |
|
|
|
| 5000.00 µg/plate | 16.33 |
|
|
|
| Positive Control | 176.33 |
|
|
|
SUMMARY OF THE MUTAGENICITY EXPERIMENTS: CONFIRMATORY EXPERIMENT without metabolic activation
Strain | Treatment | Mean Counts | Strain | Treatment | Mean Counts |
TA 100 | Negative control | 120.33 | TA 1535 | Negative control | 8.67 |
| 61.73 µg/plate | 108.33 |
| 61.73 µg/plate | 11.33 |
| 185.19 µg/plate | 113.00 |
| 185.19 µg/plate | 11.33 |
| 555.56 µg/plate | 124.00 |
| 555.56 µg/plate | 9.33 |
| 1666.67 µg/plate | 139.00 |
| 1666.67 µg/plate | 9.67 |
| 5000.00 µg/plate | 172.00 |
| 5000.00 µg/plate | 11.67 |
| Positive Control | 1260.33 |
| Positive Control | 1137.00 |
|
|
|
|
|
|
|
|
| TA 98 | Negative control | 18.33 |
|
|
|
| 61.73 µg/plate | 18.67 |
|
|
|
| 185.19 µg/plate | 15.67 |
|
|
|
| 555.56 µg/plate | 16.00 |
|
|
|
| 1666.67 µg/plate | 24.67 |
|
|
|
| 5000.00 µg/plate | 51.67 |
|
|
|
| Positive Control | 1792.67 |
TA1537 | Negative control | 8.33 |
|
|
|
| 61.73 µg/plate | 9.33 |
|
|
|
| 185.19 µg/plate | 7.00 |
|
|
|
| 555.56 µg/plate | 9.33 |
|
|
|
| 1666.67 µg/plate | 12.67 |
|
|
|
| 5000.00 µg/plate | 13.67 |
|
|
|
| Positive Control | 2029.67 |
|
|
|
Applicant's summary and conclusion
- Conclusions:
- In the experiments performed without metabolic activation, treatment of strain TA 98 with FAT 20044/B led to a slight increase in the number of back-mutant colonies at the highest concentration only. No effect occurred in the experiments with activation conducted on this strain and on the other strains.
- Executive summary:
In a GLP-compliant study, FAT 20044/B, was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimurium according to OECD guideline 471. The strains of Salmonella typhimurium used were TA 98, TA 100, TA 1535 and TA 1537. 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 dissolved in bi-distilled water and tested at five concentrations in the range of 61.7 to 5000.0 µg/plate. In order to confirm the results, the experiments were repeated with and without metabolic activation in the same concentration range. 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 the experiments performed without metabolic activation, treatment of strain TA 98 with FAT 20044/B led to a slight increase in the number of back-mutant colonies at the highest concentration only. No effect occurred in the experiments with activation conducted on this strain and on the other strains.
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