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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-784-2 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No bacterial tester strain to detect cross-linking mutagens included (e.g. E.coli wp2/uvra)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- other: OFFICIAL JOURNAL OF THE EUROPEAN COMMUNITIES, No. L 383 A, Volume 35, 160-162, Annex to Commission Directive 92/69/EEC of July 31, 1992: Salmonella typhimurium - Reverse Mutation Assay, December 29, 1992.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate
- EC Number:
- 941-784-2
- Molecular formula:
- C38H26N2O10S2.2Na
- IUPAC Name:
- Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): FAT 21030/D (Irganol Grün BLS roh trocken).
- Batch N°: 16.36.
- Purity: 67 %.
- Appearance: Greenblack fragments
- Expiry date: December 31, 1998.
- Storage: Room temperature.
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 21030/D (Irganol Grün BLS roh trocken)
Batch No.: 16.36
Purity: 67 %
Appearance: Green black fragments.
Expiry date: December 31, 1998
Storage: Room temperature
Method
- Target gene:
- Salmonella typhimurium histidine auxotrophs
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction: Rat-liver post mitochondrial supernatant.
- Test concentrations with justification for top dose:
- Concentrations tested in the range finding test: 20.58, 61.73, 185.19, 555.56, 1666.67 and 5000 µg/plate
Concentration range in the mutagenicity test:
- Original experiment: 92.13, 276.40, 829.19, 2487.56 and 7462.69 µg/plate
-Confirmatory experiment: 92.13, 276.40, 829.19, 2487.56 and 7462.69 µg/plate
In preliminary test conducted at test concentration of 5000 µg/plate, normal background growth was observed. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 7462.7 µg/plate with and without metabolic activation. (The purity of the tested batch is 67%, hence 7462.7 µg/plate correspond to 5000 µg/plate of pure substance). - Vehicle / solvent:
- Bidistilled water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cyclophosphamide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; in agar (plate incorporation);
Agar plate incorporation : 0.1 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 positive control or the solvent as a 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 and was supplemented with 10% of 0.5 mM L-histidine and 0.5 mM (+)biotin dissolved in water. - Evaluation criteria:
- A test is considered acceptable if the mean colony counts of the negative control values of all strains are within the acceptable ranges and if the results of the positive controls meet the criteria for a positive response. In either case the final decision is based on the scientific judgement of the Study Director.
Criteria for a positive response
The test substance will be considered positive in the test system if the following condition is met:
- At least a reproducible meaningful increase of the mean number of revertant per plate above that of the negative control at any concentration for one or more of the strains tested. Generally a concentration-related effect should be demonstrable. - Statistics:
- A statistical analysis of the test data was not performed. At present the use of statistical methods concerning this particular test system is not generally recommended.
Results and discussion
Test results
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Range finding test
Normal background growth was observed. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 7462.7 ug/plate with and without metabolic activation. (The purity of the tested batch is 67 %, hence 7462.7 µg/plate correspond to 5000 µg/plate of pure substance).
Mutagenicity test, original experiment
In the experiments performed with and without metabolic activation, treatment of strains TA 98, TA 100, TA 1535 and TA 1537 with FAT 21030/D (Irganol Grün BLS roh trocken) did not lead to an increase in the incidence of histidine-prototrophic mutants in comparison with the negative control.
Mutagenicity test, confirmatory experiment
In the experiments performed with and without metabolic activation, again after treatment of strains TA 98, TA 100, TA 1535 and TA 1537 with FAT 21030/D (Irganol Grün BLS roh trocken) no increase in the incidence of histidine-prototrophic mutants was observed in comparison with the negative control.
In the mutagenicity tests normal background growth was observed with all strains at all concentrations. The numbers of revertant colonies were not reduced with increasing concentration. Therefore, the test substance exerted no toxic effect on the growth of the bacteria.
There were no known circumstances or occurrences in this study that were considered to have affected the quality or integrity of the test data.
Applicant's summary and conclusion
- Conclusions:
- FAT 21030/D and its metabolites did not induce gene mutations in the strains Salmonella typhimurium used (S. typhimurium TA 1535, TA 1537, TA 98 and TA 100).
- Executive summary:
The purpose of this study is to evaluate the test compound for mutagenic activity in bacterial test systems in the presence and absence of a rat liver metabolic activation system. This experiment was performed in compliance with GLP and according to the OECD Guideline 471 (Bacterial Reverse Mutation Assay).
FAT 21030/D, purity 67%, batch no. 16.36, was tested for mutagenic effects in vitro in histidinerequiring strains of Salmonella typhimurium. The following strains of Salmonella typhimurium were used: TA 98, TA 100, TA 1535 and TA 1537. The test was performed with and without the addition of rat-liver post mitochondrial supernatant (S9 fraction) as an extrinsic metabolic activation system. The compound was dissolved in bidistilled water and tested at five concentrations in the range of 92.1 to 7462.7 µg/plate in the presence and absence of a metabolic activation system. In order to confirm the results, the experiments were repeated with and without metabolic activation at five concentrations in the range of 92.1 to 7462.7 µg/plate. (The purity of the tested batch is 67%, hence 7462.7 µg/plate correspond to 5000 µg/plate of pure substance.) Each strain was additionally tested in the presence and in the absence of a metabolic activation system with a suitable, known mutagen as positive control.
In both experiments, performed with and without metabolic activation, none of the tested concentrations of FAT 21030/D led to an increase in the incidence of histidine-prototrophic mutants by comparison with the negative control. Hence, it was concluded that FAT 21030/D and its metabolites did not induce gene mutations in the strains Salmonella typhimurium used (S. typhimurium TA 1535, TA 1537, TA 98 and TA 100).
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.