Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 943-210-6 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 15, 1993 to December 16, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- EC Number:
- 943-210-6
- Molecular formula:
- Not applicable. UVCB Substance
- IUPAC Name:
- tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- RANGE FINDING TEST: 20.58, 61.73, 185.19, 555.56, 1666.67, 5000.00 µg/plateMUTAGENICITY EXPERIMENTS: 61.73, 185.19 ,555.56 ,1666.67, 5000.00 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Bidistilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- other: 2-aminoanthracene
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar0.1 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 substance for the positive control or the solvent for the negative control and poured on minimal agar in Petri dishes. Each Petri dish contained about 20 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. It was supplemented with 10 % of 0.5 mM 1-histidine and 0.5 mM (+)biotin dissolved in water.DURATION- Incubation period: 48 hours at 37 ± 1.5 °C in darkness
- Statistics:
- In deviation to the OECD guideline a statistical analysis was not performed. At present the use of statistical methods concerning this particular test system is not generally recommended. No appropriate statistical method is available.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: yesADDITIONAL INFORMATION ON CYTOTOXICITY: The test material exerted no toxic effect on the growth of the bacteria
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
In the original experiment performed without metabolic activation on strain TA 98, treatment with test substance led to a slight, concentration dependent increase in the number of revertant colonies at the concentrations of 1666.7 and 5000 µg/plate. In the original experiment carried out with activation on strain TA 102 a marginal increase in the number of back-mutants was registered at the concentration of 1666.7 µg/plate only.
In the confirmatory experiment performed without metabolic activation, treatment of strain TA 98 with test item led to a slight, concentration dependent increase in the number of revertant colonies at the concentrations of 555.6 to 5000 µg/plate. With strain TA 1537, a marginal increase in the number of back-mutants was registered at the concentrations of 1666.7 and 5000 µg/plate.
In the confirmatory experiment carried out with activation, a slight increase in the number of back-mutants was registered with strain TA 98 at the concentration of 5000 µg/plate, and a marginal increase in the number of back-mutants was observed with strain TA 102 at the concentrations of 555.6 and 1666.7 µg/plate and with strain TA 1537 at the concentrations of 185.2 and 555.6 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positiveBased on the results of these experiments and on standard evaluation criteria, it is concluded that the test substance exerted a weak mutagenic action on strain S. typhimurium TA 98 and the metabolites of the test substance exerted a marginal mutagenic action on strain S. typhimurium TA 102.
- Executive summary:
This test system permits the detection of gene mutations induced by the test material or its metabolites in histidine-requiring strains of Salmonella typhimurium.
Concentrations tested
The concentration range of test substance to be tested in the mutagenicity test was determined in a preliminary toxicity test. Thus, the substance was tested for mutagenic effects without and with metabolic activation at five concentrations in the range of 61.7 to 5000 µg/plate. An independent repetition of the experiments was performed with the same concentrations.
Toxicity test/Range finding test
In the experiment without and with metabolic activation, test item exerted no toxic effect on the growth of strain TA 100.
Mutagenicity test, original experiment
In the experiment performed without metabolic activation on strain TA 98, treatment with test substance led to a slight, concentration dependent increase in the number of revertant colonies at the concentrations of 1666.7 and 5000 µg/plate. No effects were observed with the other strains. In the experiment carried out with activation on strain TA 102 a marginal increase in the number of back-mutants was registered at the concentration of 1666.7 µg/plate only. No effect occurred on the other strains.
Mutagenicity test, confirmatory experiment
In the experiment performed without metabolic activation, treatment of strain TA 98 with test item led to a slight, concentration dependent increase in the number of revertant colonies at the concentrations of 555.6 µg/plate and above. With strain TA 1537, a marginal increase in the number of back-mutants was registered at the concentrations of 1666.7 and 5000 µg/plate. No effect was seen with the other strains. In the experiment carried out with activation, a slight increase in the number of back-mutants was registered with strain TA 98 at the concentration of 5000 µg/plate, and a marginal increase in the number of back-mutants was observed with strain TA 102 at the concentrations of 555.6 and 1666.7 µg/plate and with strain TA 1537 at the concentrations of 185.2 and 555.6 µg/plate. No effect occurred on the other strains. In the mutagenicity tests with metabolic activation, normal background- growth was observed with all strains. The number of revertant colonies was not reduced. The test material exerted no toxic effect on the growth of the bacteria.
Conclusion
Based on the results of these experiments and on standard evaluation criteria, it is concluded that the test substance exerted a weak mutagenic action on strain S. typhimurium TA 98 and the metabolites of the test substance exerted a marginal mutagenic action on strain S. typhimurium TA 102.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.