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EC number: 255-940-6 | CAS number: 42783-06-2
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
- EC Number:
- 255-940-6
- EC Name:
- 2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
- Cas Number:
- 42783-06-2
- Molecular formula:
- C18H19N5O8S
- IUPAC Name:
- 2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- CI Disperse Blue 284
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Details on species / strain selection:
- C57BL/6JfBL10/Alpk male and female mice
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Bone marrow samples were taken 24 hours after dosing at 3130 mg/kg and 24, 48 and 72 hours after dosing at 5000 mg/kg.
- Frequency of treatment:
- Twice at an interval of 24 h
- Post exposure period:
- Bone marrow samples were taken 24 hours after dosing at 3130 mg/kg and 24, 48 and 72 hours after dosing at 5000 mg/kg.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3 130 mg/kg bw (total dose)
- Dose / conc.:
- 5 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 5/sex/dose and killing time
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: oral, gavage
- Doses / concentrations: 65 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on patterns of lethalities or severe toxicity observed over a 4-d observation period following a single oral dose in a maximum tolerated dose (MTD)-Phase I
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Bone marrow smears were prepared 24 and 48 h after dosing for the vehicle control and treated animals and 24 h after dosing for the cyclophosphamide treated animals.
DETAILS OF SLIDE PREPARATION: The preparations were stained with polychrome methylene blue and eosin to visualise the various cell types.
METHOD OF ANALYSIS: Prior to microscopic assessment, all slides were furnished with code numbers, so that the counting was blind. The following counts were made:
Number of polychromatic erythrocytes (PCE) per slide: 1000 PCE
Percentage of polychromatic erythrocytes in the total erythrocyte population: 1000 Erythrocytes - Evaluation criteria:
- A substance is considered positive if there is a significant increase in the number of micronucleated polychromatic erythrocytes compared with the concurrent negative control group
- Statistics:
- - The incidence of micronucleated PCE and percentage PCE in the erythrocyte sample, were considered by ANOVA.
- All analyses were carried out using the GLM procedure in SAS.
- One-sided Student's t-test:
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance is not clastogenic in the mouse micronucleus assay.
- Executive summary:
Disperse Blue 284 was tested in C57BL/6JfBL10/Alpk male and female mice at dose levels of 3130 and 5000 mg/kg, the higher dose level being the limit dose for this assay. Bone marrow samples were taken 24 hours after dosing at 3130 mg/kg and 24, 48 and 72 hours after dosing at 5000 mg/kg.
No statistically or biologically significant increases in the incidence of micronucleated polychromatic erythrocytes, over vehicle control values, were seen at either dose level in the females at any of the sampling times investigated. A small but statistically significant increase in the incidence of micronucleated polychromatic erythrocytes was noted in male mice 24 hours after being dosed at 5000 mg/kg. Extended analysis of a further 2000 polychromatic erythrocytes from all males at the 24 hour sampling time was conducted. No statistically or biologically significant increases were observed in the extended analyses or when the original andextended analyses were combined prior to statistical analysis. The original increase observed in the males is therefore considered not to be of any biological significance.
The test system positive control, cyclophosphamide, induced statistically significant and biologically meaningful increases in micronucleated polychromatic erythrocytes, compared to the vehicle control values, thus demonstrating the sensitivity of the test system to a known clastogen.
It is therefore concluded Disperse Blue 284, under the conditions of test, is not clastogenic in the mouse micronucleus test.
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