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reaction mass of mono to tetra(lithium and/or sodium)3-amino-10-[4-(4-amino-3-sulfonatoanilino)-6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to tetra(lithium and/or sodium)3-amino-10-[4,6-bis(4-amino-3-sulfonatoanilino)-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to penta(lithium and/or sodium)10,10´-diamino-6,6',13,13´-tetrachloro-3,3'-[6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10-amino-6,6',13,13'-tetrachloro-10´[4-(4-amino-3-sulfonatoanilino)-[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10,10'-diamino-6,6',3,3'[(2-sulfonato)-1,4-phenylenediiminobis[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate
EC number: 430-200-7 | 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Registered substance
- IUPAC Name:
- Registered substance
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background:
yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver, phénobarbital/ß-naphthoflavone.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 15.6 ... 500 µg/ml
Concentration range in the main test (without metabolic activation): 9.4 ... 300 µg/ml
Concentration range in the main test (without metabolic activation): 18.75 ... 600 µg/ml - Vehicle / solvent:
- distd. water
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
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
Experimental Scheme:
Experiment I and II:
Segment a): Procedure for determination of toxicity
Segment b): Procedure for determination of mutation rates
day 1
Subculturing of a log-phase culture which showed an initial spontaneous mutation rate at the beginning of the experiment of 1.9 mutant colonies per 10^6 cells
(Experiment I) and 6.5 mutant colonies per 10^6 cells (Experiment II).
a) About 500 cells in 5 ml medium/25 cm2-plastic-flask for cloning efficiency; in duplicate per experimental point
b) About 1 5x10^6 cells in 30 ml medium/175 cm2-plastic-flask for the mutagenicity test, 1 flask per experimental point
day 2 Treatment of a) and b)
day 5 Subculturing of b) in 175 cm 2-plastic-flasks 1 5x10^6 cells in 30 ml medium/175 cm2-plastic-flasks
day 8/10 Fixation and staining of colonies in the flasks used to determine toxicity (a) determination of concentration-related cloning efficiency
day 9 Subcultivation of (b) in five 80 cm 2-plastic-flasks containing selective medium to select mutant colonies (about 3-5 x10^5 cells/flask) and in two 25 cm 2-
flasks without selective medium to determine the cloning efficiency (about 500 cells/flask)
day 16/17 Fixation and staining of the colonies to determine the cloning efficiency and the number of mutant colonies.
The cultures were incubated at 37° C in a humidified atmosphere with 4.5 % CO2. The colonies were stained with 10 % methylene blue in 0.01 % KOH solution.
The stained colonies with more than 50 cells were counted. In doubt the colony size was checked with a preparation microscope.
SELECTION AGENT (mutation assays): 6-Thioguanine
STAIN: 10 % methylene blue in 0.01 % KOH solution
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: >1.5x10^ 6
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- Acceptability of the Assay
The gene mutation assay is considered acceptable if it meets the following criteria:
a) the numbers of mutant colonies per 10^6 cells found in the negative and/or solvent controls fall within the laboratory historical control data range of 1996 - 1997.
b) the positive control substances must produce a significant increase in mutant colony frequencies.
c) the cloning efficiency (absolute value) of the negative and/or solvent controls must exceed 50 % . - Statistics:
- Since the distribution of mutant cells does not follow known statistical models, an adequate statistical method is not
available
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
not subject for clasification;
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