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EC number: 247-269-2 | CAS number: 25797-81-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-Anthracenesulfonic acid, 1-amino-9,10-dihydro-4-[[3-[[(2-hydroxyethyl)amino]sulfonyl]-4,5-dimethylphenyl]amino]-9,10-dioxo-, sodium salt (1:1)
- IUPAC Name:
- 2-Anthracenesulfonic acid, 1-amino-9,10-dihydro-4-[[3-[[(2-hydroxyethyl)amino]sulfonyl]-4,5-dimethylphenyl]amino]-9,10-dioxo-, sodium salt (1:1)
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 247-269-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 25797-81-3
- Molecular formula:
- C24H23N3O8S2.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Name: FAT 20033/L
Common Name: TECTILON BLUE 4R CRUDE MOIST (LAB DRIED) Acid Blue 277
Batch No.: AT-PD13-359A1
CAS No.: 25797-81-3
Physical State / Colour: solid / dark blue
Storage Conditions: room temperature, protected from light
Active Components: >95 %
Analysation Date: 07 January 2014
Expiry Date: 07 January 2019
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and ß-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation: 7.8, 15.6, 31.3, 62.5, 125, 250, 500, 1000, 2500 and 5000 µg/mL
Experiment I:
without metabolic activation: 25, 50, and 100 µg/mL
with metabolic activation: 200, 400 and 500 µg/mL
Experiment II:
without metabolic activation: 25, 50, and 100 µg/mL
with metabolic activation: 75, 150 and 350 µg/mL - Vehicle / solvent:
- - Vehicle (s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: A solubility test was performed with different solvents and vehicles up to the maximum recommended concentration of 5 mg/mL. DMSO was used as solvent (1 % DMSO). Different test item stock solutions were prepared and added to the samples. The solvent was compatible with the survival of the cells and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation (400 and 900 µg/mL)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation (1.11 µg/mL)
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation, experiment II with metabolic activation)
20 hours (Experiment II without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I and II with and without metabolic activation)
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS SEEDED: 1 x 10E4 - 5 x 10E4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture)
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell count - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (up to 4 % aberrant cells without and 4.3 % with metabolic activation). - Statistics:
- A statistical evaluation was used as an aid for interpretation of the results. Statistical significance at the 5 % level (p <0.05) was evaluated by The Fischer´s exact test. The p value was used as a limit in judging for significance levels in comparison with the corresponding negative/solvent control.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- According to the guidelines the highest recommended concentration was 5000 μg/mL. The test item was suspended in an appropriate solvent (DMSO) or in cell culture medium. Precipitation of the test item was noted at concentrations of 2500 μg/mL and higher. The highest dose group evaluated in the pre-experiment was 5000 μg/mL. The relative mitotic index and cell count were used as parameters for toxicity. The concentrations evaluated in the main experiment were chosen on the basis of the results from the pre-experiment. The mitotic index and/or cell count could not be determined at concentrations of 1000 μg/mL and higher due to the high toxicity of the test item.
Any other information on results incl. tables
| Dose Group | Concentration [µg/mL] | Relative Mitotic Index [%] | Relative Cell Count | Mean % Aberrant Cells | Historical Laboratory Negative Control Range | Precipitationa | Statistical Significanceb | |
incl. Gaps | excl. Gaps |
| |||||||
Experiment I 4 h treatment, 20 h preparation interval | C | 0 | 111 | 116 | 8.0 | 4.0 | 0.0 % - 4.0 % aberrant cells | - | - |
S | 0 | 100 | 100 | 2.0 | 0.5 | - | - | ||
3 | 25 | 106 | 80 | 2.5 | 1.0 | - | - | ||
4 | 50 | 101 | 74 | 2.5 | 1.0 | - | - | ||
5 | 100 | 107 | 54 | 1.0 | 0.0 | - | - | ||
EMS | 900 | 94 | 87 | 12.5 | 8.5 | - | + | ||
|
|
| |||||||
Experiment II 20 h treatment, 20 h preparation interval | C | 0 | 86 | 96 | 1.5 | 0.0 | 0.0 % - 4.0 % aberrant cells | - | - |
S | 0 | 100 | 100 | 2.0 | 1.5 | - | - | ||
4 | 25 | 100 | 86 | 5.0 | 1.5 | - | - | ||
5 | 50 | 90 | 82 | 4.5 | 2.0 | - | - | ||
6 | 100 | 121 | 73 | 2.0 | 0.0 | - | - | ||
EMS | 400 | 54 | 72 | 18.5 | 16.0 | - | + |
| Dose Group | Concentration [µg/mL] | Relative Mitotic Index | Relative Cell Count | Mean % Aberrant Cells | Historical Laboratory Negative Control Range | Precipitationa | Statistical Significanceb | |
incl. Gaps | excl. Gaps |
| |||||||
Experiment I 4 h treatment, 20 h preparation interval | C | 0 | 91 | 108 | 2.5 | 1.0 | 0.0 % - 4.3 % aberrant cells | - | - |
S | 0 | 100 | 100 | 7.0 | 3.0 | - | - | ||
3 | 200 | 84 | 102 | 3.0 | 1.5 | - | - | ||
5 | 400 | 75 | 68 | 2.0 | 1.5 | - | - | ||
6 | 500 | 61 | 38 | 5.0 | 2.0 | - | - | ||
| CPA | 1.1 | 85 | 94 | 10.0 | 7.0 | - | - | |
| |||||||||
Experiment II 4 h treatment, 20 h preparation interval | C | 0 | 100 | 97 | 2.5 | 1.0 | 0.0 % - 4.3 % aberrant cells | - | - |
S | 0 | 100 | 100 | 3.0 | 2.5 | - | - | ||
1 | 75 | 94 | 81 | 5.0 | 2.5 | - | - | ||
2 | 150 | 93 | 78 | 6.0 | 3.0 | - | - | ||
4 | 350 | 88 | 46 | 7.0 | 3.5 | - | - | ||
CPA | 1.11 | 80 | 73 | 12.0 | 8.5 | - | + |
Applicant's summary and conclusion
- Conclusions:
- FAT 20033/L is considered to be non-clastogenic in this chromosome aberration test.
- Executive summary:
To investigate the potential of FAT 20033/L to induce structural chromosome aberrations in Chinese hamster V79 cells,an in vitro chromosome aberration assay was carried out according to OECD TG 473. The metaphases were prepared around 20 h after start of treatment with the test item. The treatment interval was 4 h without and with metabolic activation in experiment I. In experiment II, the treatment interval was around 20 h without and 4 h with metabolic activation. Duplicate cultures were treated at each concentration. 100 metaphases per culture were scored for structural chromosomal aberrations. DMSO was used as solvent (1 % DMSO). Different test item stock solutions were prepared and added to the samples. The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
Experiment I:
without metabolic activation: 25, 50 and 100 µg/mL
with metabolic activation: 200, 400 and 500 µg/mL
Experiment II:
without metabolic activation: 25, 50 and 100 µg/mL
with metabolic activation: 75, 150 and 350 µg/mL
No precipitation of the test item was observed without and with metabolic activation in all dose groups evaluated in experiment I and II. In experiment I (short-term treatment) without metabolic activation, cytotoxicity of the test item was determined at the highest concentration of 100 µg/mL considering the relative cell count. However, considering the relative mitotic index no cytotoxic effects were observed. With metabolic activation cytotoxic effects of the test item were determined at a concentration of 400 µg/mL and higher considering the relative cell count. However, considering the relative mitotic index cytotoxicity was observed at the highest concentration of 500 µg/mL. In experiment II (long-term treatment) without metabolic activation, cytotoxic effects of the test item were not observed up to a concentration of 100 µg/mL considering the relative mitotic index and cell count. Above this concentration of the test item a very high and steep toxicity was observed considering the relative mitotic index. With metabolic activation, no cytotoxic effects of the test item considering the relative mitotic index were observed up to the highest evaluated concentration. However, considering the relative cell count cytotoxicity was observed at the highest concentration of 350 µg/mL. In both experiments, no biologically relevant increase of the aberration rates was determined after treatment with the test item without and with metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control. In the experiments I and II without and with metabolic activation no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the negative / solvent controls. The distinct increase in the number of structural chromosome aberrations induced by the positive controls (EMS, CPA) clearly demonstrated the sensitivity of the test system. There was no evidence of chromosome aberration induced over background. Based on the above findings, it can be concluded that the test item FAT 20033/L did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line. Therefore, FAT 20033/L is considered to be non-clastogenic in this chromosome aberration test.
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