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EC number: 251-410-3 | CAS number: 33229-34-4
- 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:
- key study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 474 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- EC Number:
- 251-410-3
- EC Name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- Cas Number:
- 33229-34-4
- Molecular formula:
- C12H19N3O5
- IUPAC Name:
- 2-({4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl}amino)ethan-1-ol
- Details on test material:
- Test item : HC Blue 2 No 2
EC number : 251-410-3
Batch number : 114B5
Content : 98.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5% aqueous carboxymethylcellulose
- Duration of treatment / exposure:
- The animals in the positive control, 500 and 1000 mg/kg groups were killed 24 hours after treatment.
5 males and 5 females were killed 24 hours after administration of the vehicle and 2000 mg/kg groups.
The remaining 5 males and 5 females were killed 48 hours after treatment. - Frequency of treatment:
- Single dose
- Post exposure period:
- The animals in the positive control, 500 and 1000 mg/kg groups were killed 24 hours after treatment.
5 males and 5 females were killed 24 hours after administration of the vehicle and 2000 mg/kg groups.
The remaining 5 males and 5 females were killed 48 hours after treatment.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females for the positive control, 500, 1000 mg/kg groups
10 males and 10 females for the control, 2000 mg/kg groups - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control : cyclophosphamide
Route of administration : Oral
Dose/concentration : 60 mg/kg administered once
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- For each animal, bone marrow smears were prepared and the micronucleated polychromatic erythrocytes were counted in 2000 polychromatic erythrocytes. The polychromatic/normochromatic erythrocyte ratio was established by scoring a total of 500 erythrocytes per animal.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No mortality occurred during the study. All animals in all dose groups showed purple urine and purple staining of one or more areas of the body on day 1 and day 2. This finding was not considered to be a sign of toxicity but was attributed to the colour of the test item. The maximum tolerated dose of 2000 mg/kg bw was achieved.
Statistically significant increases in micronucleus frequencies were observed in male rats at 500 and 2000 mg/kg bw. The increases were found to be within the laboratory historical control range and the micronucleus frequency in the vehicle control males was relatively low. The increased micronucleus frequency was not considered to be biologically relevant. No statistically significant differences were observed in the PCE/NCE ratio at any dose level. Analysis showed mean plasma levels of 18.9 ug/mL and 10.7 ug/mL 1 hour and 4 hours after oral administration at 2000 mg/kg bw respectively and confirmed the systemic exposure of the animals to the test item. Positive controls yielded significant increases in micronucleus frequencies in PCEs.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the experimental conditions reported, HC Blue No 2 did not induce biologically relevant micronucleus formation in the bone marrow cells of Sprague-Dawley rats treated orally up to the maximum recommended dose of 2000 mg/kg. The test substance was considered to be non-mutagenic in this micronucleus assay.
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