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reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
EC number: 429-070-4 | CAS number: 214362-06-8 SCARLET DER 8107
- 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:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- February 1998, adopted July 21, 1997
- Deviations:
- yes
- Remarks:
- Regarding positive control sun=bstance final concentration and evaluation of results. These deviations had no detrimental impact on the outcome of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- "Kanpoan No. 287 ~ Environment Protection Agency"
"Eisei No. 127 - Ministry of Health & Welfare"
"Heisei 09/10/31 Kikyoku No. 2 -- Ministry of International Trade & Industry".
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss GLP
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- EC Number:
- 429-070-4
- EC Name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- Cas Number:
- 214362-06-8
- Molecular formula:
- C26H(25-y-x)KyN5NaxO16S5 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO22S7
- IUPAC Name:
- octapotassium octasodium 7-amino-4-hydroxy-3,8-bis(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3,8-bis(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test item name: Reactive Brown 49
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR50
- Expiration date of the lot/batch: September 01, 2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability of the test substance in the solvent/vehicle: 24 h in water, saline, PEG, CMC, vaseline, and FCA
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Cells V79 of Chinese hamster
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from rats treated with phenobarbital and ß-Naphthoflavone.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 25, 50, 100, 200, 300, 400 µg/ml
Concentration range in the main test (without metabolic activation): 187.5, 375.0, 750, 1500, 3000, 4000 µg/ml - Vehicle / solvent:
- deionised water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Concurrent negative (culture medium)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- Choice of the Cell Line V79
Exposure period (with and without metabolic activation): 4 h
Recovery period (with and without metabolic activation): 14 h
Preparation interval (with and without metabolic activation): 18 h
Fixation time:
18 h - Evaluation criteria:
- Breaks, fragments, deletions, exchanges and chromosome disintegrations were recorded as structural chromosome aberrations.
100 well spread metaphases per culture were scored for cytogenetic damage on coded slides.
Mitotic index (% cells in mitosis) was determined.
The number of polyploid cells was determined (% polyploid metaphases; in the case of this aneuploid cell line polyploid means a near tetraploid karyotype). - Statistics:
- Statistical significance was confirmed by means of the Fischer's exact test (10) (p < 0.05).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 312.5 µg/ml in pre-test an at 300 µg/ml in main test)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- only at 4000 µg/ml at cytotoxic conc.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 5000 µg/ml in pre-test and 3000 µg/ml in main test)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article induced structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro.
Therefore, the test substance is considered to be weakly mutagenic in this chromosome aberration test. Since increased aberration frequencies were observed only in the presence of strong toxicity indicated by reduced cell numbers, it can not be excluded that an indirect, non genotoxic DNA damaging mechanism was involved.
Applicant's summary and conclusion
- Conclusions:
- FAT 40'571/A induced structural chromosome aberrations in V79 cells (Chinese hamster cell line) at a high concentration exhibiting strong toxicity.
- Executive summary:
This in-vitro mammalian chromosomal aberration test was carried out with FAT 40'571/A (dissolved in deionised water) was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamsteri n vitro in one experiment. The study was carried out as per OECD 473 and B.10 guideline. Exposure period was 4 h with and without S9 mix.
In each experimental group two parallel cultures were set up. Per culture 100 metaphase plates were scored for structural chromosome aberrations. The highest applied concentration in the pre-test on toxicity (5000 µg/ml) was chosen with regard to current OECD Guideline 473. Using reduced cell numbers as an indicator for toxicity, clear toxic effects were observed after 4 h treatment with 5000 µg/ml in the absence of S9 mix and 312.5 µg/ml and above in the presence of S9 mix.
Dose selection of the cytogenetic experiments was performed considering the toxicity data of the pre-test. The chosen treatment concentrations.
In the main experiment, clear toxic effects indicated by reduced mitotic indices were observed in the presence of S9 mix after treatment with 300 µg/ml. In addition, reduced cell numbers were observed after treatment with 3000 µg/ml and above in the absence of S9 mix and after treatment with 300 µg/ml and above in the presence of S9 mix. In the absence of S9 mix, the test article did induce a significant increase in the number of cells carrying structural chromosome aberrations after treatment with 4000 µg/ml. This increase beyond our historical control data range was regarded as being relevant in this test system. However, it has to be considered, that the increase was observed at a high concentration inducing strong toxic effects indicated by strongly reduced cell numbers.
In addition, no increase in the frequencies of polyploid metaphases was found after treatment with the test article as compared to the frequencies of the controls. Appropriate mutagens were used as positive controls. They induced statistically significant increases (p < 0.05) in cells with structural chromosome aberrations.
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article induced structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro. Therefore, FAT 40571 is considered to be weakly mutagenic in this chromosome aberration test. Since increased aberration frequencies were observed only in the presence of strong toxicity indicated by reduced cell numbers, it can not be excluded that an indirect, none genotoxic DNA damaging mechanism was involved.
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