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Reaction mass of trisodium [m[7-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-8-hydroxynaphthalene-1,6-disulphonato(7-)]]dicuprate(3-) and trisodium [m[4-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-3-hydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
EC number: 947-266-2 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Direct Blue 251
- IUPAC Name:
- Direct Blue 251
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: animals were purchased from KFM, CH-4414 Füllinsdorf, Switzerland.
- Weight at study initiation: weight ranged between 160 - 190 g.
- Fasting period before study: access of food only was prevented approximately 18 hours prior and four hours after the dosing.
- Housing: rats were housed individually in Macrolon cages.
- Diet: standard laboratory pelleted diet (KLIBA no. 24-343-4 fro Klingentalmfihle AG., Basle), ad libitum. The batch of diet used for the study was analysed for chemical and microbiological contaminants.
- Water: ad libitum. The water bottles were with-drawn two hours prior and four hours after dosing.
- Acclimation period: about 5 days prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: the room temperature was maintained within a median of 23 ± 2 °C recorded by a maximum-minimum thermometer.
- Humidity: 30 - 70 %, measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the light/dark cycle was 12 hours.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: the test item was diluted with WEM (33.3 %)
- Details on oral exposure:
- Dosed volumee: 15 ml per kg body weight.
The sample was prepared immediately before dosing. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Details on study design:
- PRELIMINARY STUDY
A preliminary study was carried out to establish a dosing regimen, using groups of two males and two females at one dosage, using 15 ml/kg body weight.
- Duration of observation period following administration: 14 days
MAIN STUDY
- Duration of observation period following administration: 14 days
- Frequency of weighing: individual body weights on day 1, 7 and 14.
- Necropsy of survivors performed: surviving animals were killed after two weeks. All animals which died during the study and those killed after two weeks were subjected to a macroscopic postmortem examination. The macroscopic appearance of the abnormal organs was recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during both the preliminary and main experiments.
- Clinical signs:
- The animals were flaccid, weak and showed a rough coat.
- Gross pathology:
- No special findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 (male and female) > 5000 mg/kg bw
- Executive summary:
Young adult male and female rats were used to evaluated the oral acute toxicity potential of the test item. A group of 5 males and 5 females rats were dosed at 5000 mg/kg bw. The substance was administered at the dose volume of 15 ml/kg bw, by gavage. During the observation period of 14 days, all signs of toxicity were recorded. All rats were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.
No deaths occurred during both the preliminary and main experiments; the animals were flaccid, weak and showed a rough coat. Gross examination did not revealed any special finding.
Conclusion
LD50 (male and female) > 5000 mg/kg bw
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