Registration Dossier
Registration Dossier
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: 227-877-4 | CAS number: 6022-22-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (no data on test substance purity).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 21st July, 1997)
- Deviations:
- yes
- Remarks:
- (2-Aminoanthracene was used as the sole indicator of the efficacy of the S9-mix)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
- EC Number:
- 227-877-4
- EC Name:
- Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
- Cas Number:
- 6022-22-6
- Molecular formula:
- C28H16N2O10S2.2Na
- IUPAC Name:
- disodium 4,4'-diamino-9,9',10,10'-tetraoxo-9,9',10,10'-tetrahydro-1,1'-bianthracene-3,3'-disulfonate
- Details on test material:
- - Physical state: solid, red
- Analytical purity: no data
- Lot/batch No.: 00584CL6
- Expiration date of the lot/batch: April 01, 2011
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his- and trp-gene
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:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9 liver microsomal fraction (induced with Phenobarbital and beta-Naphtoflavone)
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see: Details on test system and conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
For the plate incorporation method (experiment I) the following materials were mixed in a test tube and poured over the surface of a minimal agar plate:
100 µL Test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control),
500 µL S9 mix (for testing with metabolic activation) or S9 mix substitution buffer (for testing without metabolic activation),
100 µL Bacteria suspension,
2000 µL Overlay agar.
For the pre-incubation method (experiment II) 100 µL of the test item-preparation is preincubated with the tester strains (100 µL) and sterile buffer or the metabolic activation system (500 µL) for 60 minutes at 37°C prior to adding the overlay agar (2000 µL) and pouring onto the surface of a minimal agar plate.
After solidification the plates were inverted and incubated at 37 °C for at least 48 h in the dark.
The colonies were counted using a ProtoCOL counter (Meintrup DWS Laborgeraete GmbH). If precipitation of the test item precluded automatic counting the revertant colonies were counted by hand. In addition, tester strains with a low spontaneous mutation frequency like TA 1535 and TA 1537 were counted manually.
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately < 0.5 in relation to the solvent control
Positive Control Substances:
- Without metabolic activation:
- S. typhimurium: TA 100, TA 1535: Sodium azide, NaN3 (at least 99%) in aqua dest., 10 µg/plate;
- S. typhimurium: TA 98, TA 1537: 4-nitro-o-phenylene-diamine, 4-NOPD (> 97%) in DMSO, 10 µg/plate for TA98, 40 µg/plate for TA 1537
- E. coli: WP2 uvrA: Methyl methane sulfonate, MMS (99.0%) in Aqua dest., 1 µL/plate
- With metabolic activation:
- S. typhimurium: TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA: 2-aminoanthracene, 2-AA (97.5%) in DMSO, 2.5 µg/plate - Evaluation criteria:
- Evaluation of Results:
The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to crystal violet and ampicillin
- the preculture shows a number of 10^9 cells/mL (quantified by optical density)
- the control plates without S9 mix are within the following ranges (mean values of the spontaneous reversion frequency are within the historical control data range):
S. typhimurium:
- TA98: 18-63
- TA 100: 79-197
- TA 1535: 5-30
- TA1537: 4-32
E. coli:
- WP2uvrA: 38-122
- corresponding background growth on both negative control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate.
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 100 and WP2 uvrA the number of reversions is at least twice as high
- if in tester strains TA 1535, TA 1537 and TA 98 the number of reversions is at least three times higher as compared to the spontaneous reversion rate.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
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:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- , but tested up to limit dose (= 5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- ( 5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determined with tester strains TA 98 and TA 100 in a pre-experiment. Eight concentrations were tested for toxicity and induction of mutations with 3 plates each. The experimental conditions in this pre-experiment were the same as described for the main experiment I (plate incorporation test). Toxicity may be detected by a clearing or rather diminution of the background
lawn or a reduction in the number of revertants down to a mutation factor of approximately < 0.5 in relation to the solvent control. The test item was tested in the pre-experiment at the following concentrations: 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate. The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 5000 µg/plate was selected as the maximum concentration. Two independent experiments were performed at the following concentrations: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate. As the results of the pre-experiment were in accordance with the criteria described above, these were reported as a part of the main experiment I.
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects ofthe test item were noted in any of the five tester strains used up to the highest dose group evaluated (with and without metabolic activation) in experiment I and II. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
1st experiment: Standard plate test (31.6 - 5000 µg/plate) | ||||||
Strain | Metabolic activation system | mean his+/trp+revertant colonies (negative control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) |
TA 98 | no | 24 | 1.0 (31.6/100/1000/2500/5000) | no | negative | 18.1 (4-NOPD) |
yes | 34 | 1.2 (31.6) | no | negative | 56.4 (2-AA) | |
TA 100 | no | 120 | 1.0 (2500) | no | negative | 18.7 (NaN3) |
yes | 109 | 1.2 (2500) | no | negative | 8.9 (2-AA) | |
TA 1537 | no | 15 | 1.3 (2500) | no | negative | 13.6 (4-NOPD) |
yes | 22 | 1.1 (2500) | no | negative | 16.5 (2-AA) | |
TA 1535 | no | 19 | 0.9 (100/2500) | no | negative | 49.1 (NaN3) |
yes | 11 | 1.8 (31.6) | no | negative | 12.9 (2-AA) | |
E. coli WP2 uvrA | no | 45 | 1.3 (1000) | no | negative | 12.6 (MMS) |
yes | 74 | 0.8 (316/1000/2500) | no | negative | 2.8 (2-AA) | |
2nd experiment: Preincubation test (31.6 - 5000 µg/plate) | ||||||
Strain | Metabolic activation system | mean his+/trp+revertant colonies (negative control) | maximum revertant factor (conc. (µg/plate)) | dose dependency | Assessment | maximum revertant factor (positive control) |
TA 98 | no | 30 | 1.1 (31.6/316/5000) | no | negative | 24.2 (4-NOPD) |
yes | 54 | 1.1 (31.6) | no | negative | 36.1 (2-AA) | |
TA 100 | no | 80 | 1.3 (31.6/100) | no | negative | 4.7 (NaN3) |
yes | 117 | 1.1 (316) | no | negative | 16.1 (2-AA) | |
TA 1537 | no | 17 | 0.9 (316) | no | negative | 10.9 (4-NOPD) |
yes | 37 | 1.0 (31.6) | no | negative | 7.4 (2-AA) | |
TA 1535 | no | 9 | 1.1 (31.6) | no | negative | 54.0 (NaN3) |
yes | 27 | 1.1 (31.6/1000) | no | negative | 3.6 (2-AA) | |
E. coli WP2 uvrA | no | 51 | 1.0 (31.6/100/5000) | no | negative | 12.6 (MMS) |
yes | 67 | 1.1 (1000) | no | negative | 2.6 (2-AA) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
