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EC number: 279-365-5 | CAS number: 80010-51-1
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 March 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 79/831, Annex V, Part B, Paragraph 4.3.1
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Disodium 1-amino-4-(4-benzenesulfonamido-3-sulfonatoanilino)anthraquinone-2-sulfonate
- EC Number:
- 400-350-8
- EC Name:
- Disodium 1-amino-4-(4-benzenesulfonamido-3-sulfonatoanilino)anthraquinone-2-sulfonate
- Cas Number:
- 85153-93-4
- Molecular formula:
- C26H17N3Na2O10S3
- IUPAC Name:
- disodium 1-amino-4-(4-benzenesulfonamido-3-sulfonatoanilino)anthraquinone-2-sulfonate
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 20297/C
Purity: 98 %
Test animals
- Species:
- mouse
- Strain:
- other: OF-1 albino
- Details on species / strain selection:
- Recommended by the Guideline
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The experiment was performed using non-consanguinous albino mice originating from an SPF colony (IFFA-CREDO, L'Arbresle, France). Mice of both sexes (25 g) were used after a quarantine period of 2 weeks at Battelle; during the quarantine the animals were allowed ad libitum access to food (Aliment Rats-Souris Charles River, produced by U.A.R., Villemoisson, France) and drinking water. Animals are housed 5 of the same sex by cage in Makrolon type III cages.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- The test substance was dissolved in distilled water.
- Duration of treatment / exposure:
- 1. Control (distilled water): 0.5 mL - sacrificed at 20 hours
2. Positive control (Thio-TEPA): 80 mg/kg bw - sacrificed at 20 hours
3. FAT 20297/C: 1500 mg/kg bw - sacrificed at 20 hours
4. FAT 20297/C: 1500 mg/kg bw - sacrificed at 44 hours
5. FAT 20297/C: 1500 mg/kg bw - sacrificed at 68 hours. - Frequency of treatment:
- Once
Doses / concentrations
- Dose / conc.:
- 1 500 other: mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Thio-TEPA (N,N', N"-triethylenethiophosphoramide)
- Route of administration: oral
- Doses: 80 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow and micronucleated polychromatic erythrocytes
- Details of tissue and slide preparation:
- After sacrifice of the animals the femurs were taken and broken open at one end. Bone marrow cells were suspended in foetal calf serum using a small syringe and the cells were centrifuged at 120 x g for 5 minutes. The supernatant was removed with a Pasteur pipette, cells were spread on a microscope slide and the smears allowed to dry in air. The following day smears were stained with Giemsa (1:6 in water) and mounted with a coverslip after drying.
- Evaluation criteria:
- Statistically significant increase in the number of micronucleated polychromatic erythrocytes
- Statistics:
- using BMPD computer programme 7D
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
GENERAL APPEARANCE OF THE SMEARS:
At low magnification of the microscope no noticeable differences in bone marrow nucleated cells were observed between animals treated with FAT 20297/C and negative control.
In the positive control group (Thio-TEPA) decreased numbers of bone marrow nucleated cells were noted.
NUMBERS OF OBSERVED MICRONUCLEI AND RATIO OF POLYCHROMATIC TO NORMOCHROMATIC ERYTHROCYTES
There was no statistical difference or sex effect between animals exposed to FAT 20297/C and negative control animals. There was no increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 1500 mg/kg bw of FAT 20297/C. In animals treated with Thio-TEPA there is a statistically significant increase number of micronucleated cells.
The ratio of polychromatic to normochromatic erythrocytes in both control and FAT 20297/C treated animals is the same. This ratio is decreased in mice treated with Thio-TEPA.
Applicant's summary and conclusion
- Conclusions:
- FAT 20297/C was considered to be non-clastogenic in the micronucleus assay.
- Executive summary:
FAT 20297/C was assayed for mutagenicity using the micronucleus test. This test was conducted in accordance with EEC Directive 79/831, Annex V, Part B, Paragraph 4.3.1.
The compound was administered orally to mice at a concentration of 1500 mg/kg body weight. No increase in the number of micronucleated polychromatic erythrocytes was observed in the bone marrow smears taken 20, 44 and 68 hours after administration of the test substance. A positive control (Thio-TEPA) administered at a concentration of 80 mg/kg body weight showed pronounced evidence of mutagenicity 20 hours after administration, proving the sensitivity of the testing protocol.
Hence, FAT 20297/C was considered to be non clastogenic in this micronucleus assay.
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