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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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 408 in compliance to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
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 substance : HC Blue No2
Batch number : 114B5
Purity : 98.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% carboxymethylcellulose in water
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Ten males and ten females per dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Details on results:
- Mortality
No unscheduled deaths occurred during the study.
Clinical Observations
All treated animals produced ptyalism, purple colour of urine, coat, tail and urogenital area with a dose related incidence. These findings were no longer observed during the treatment free period and were considered related to treatment, but not to represent adverse effects.
Functional Observation Battery
There were no perturbations of the autonomic or physiological functions in any treated group compared to controls.
Body Weight
No treatment related efects were noted on body weight in both sexes.
Food Consumption
No treatment related effects were noted on food consumption for either males or females.
Ophthalmology
There were no treatment related ophthalmic findings at the end of the treatment period.
Hematology and Blood Biochemistry
No treatment related changes were noted for any hematological or blood biochemical parameters.
Urinalysis
Due to the urine colouration, the only urinary parameter that could be evaluated was the urine volume which was similar in all treated groups compared to controls.
Toxicokinetics
The test item was well absorbed following oral administration. In the test item dose groups and in weeks 1 and 13 plasma levels of the test item were quantifiable at the first time-point and reached maximum levels between 0.5 and 4 hours post dosing. The test item was no longer detectable 24 hours after dosing at any dose level. There were minimal sex related differences. Except in the low dose treated group, no evidence of time effects was observed. The systemic exposure increased with dose levels in a dose proportional manner.
Organ Weights
No significant changes were observed at 100 and 300 mg/kg bw/day. Slightly higher absolute and/or relative liver and kidney weights were noted in males and females given 1000 mg/kg bw/day at the end of the dosing period and were still recorded in females at the end of the recovery period. As the concurrent individual data for relative organ weight changes in males and relative kidney weight increases in females given 1000 mg/kg bw/day fell within historical control ranges and were not associated with relevant histopathological or blood biochemical abnormalities, they were not considered to be adverse effects. In contrast, a relationship to treatment of relative liver weight elevations in females given 1000 mg/kg bw/day could not be excluded as some individual values exceeded or were close to historical control changes, though no histopathological or blood biochemical abnormalities were noted.
Macroscopic Findings
At the end of both treatment and treatment free periods, purple colourations of the hair and extremities and some intestinal parts were observed. These findings were due to the physical property of the test item and consequently of no toxicological importance.
Microscopic Findings
No treatment related findings were observed at any dose level.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: higher liver/kidney weights and biochemistry parameters observed at the highest dose
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test item, HC Blue No 2, when administered daily by gavage to Sprague-Dawley rats at the dose level of 100, 300 or 1000 mg/kg bw/day for 13 weeks was well absorbed and caused purple colouration of urine and, as a consequence, of extremities and excessive salivation in all the treated animals. At 1000 mg/kg bw/day, higher absolute and relative liver and kidney weights were observed in both sexes at the end of the dosing period and the recovery period (except for kidneys in males) while no changes were noted on hematology or biochemistry parameters. Only relative liver increases in females given 1000 mg/kg bw/day were considered to be test item related adverse effects. No treatment related findings were noted at histopathological examination. After a 4 week treatment free period, coloured urine and excessive salivation were no longer observed while the slight increase in liver weights were still observed in females given 1000 mg/kg bw/day. Under the experimental conditions of the study the NOAEL of the test item was considered to be 300 mg/kg bw/day.
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