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EC number: 279-131-2 | CAS number: 79295-99-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From September 17 to October 03, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Disperse Blue 291 - Similar Substance 01
- IUPAC Name:
- Disperse Blue 291 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd:Sprague Dawley (SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH Gartenstrasse 27 D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation (mean): 188.3 g
- Housing: in transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: ssniff R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
- Randomization procedure: Computer generated algorithm (archived with raw data) Randomization schemes 2002.0512
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C (except short lasting deviations due to disturbances of air condition)
- Humidity (%): 50 ± 20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Tylose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension in tylose
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The acute oral toxicity of the test substance was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- The following clinical signs were observed in the animals starting 30 – 60 minutes hour after the administration of the test substance:
uncoordinated gait, squatting posture, and irregular respiration.
Urine was discolored red on day 1 and later on up to day 3 discolored dark as well as feces.
From day 4 until the end of the study no symptoms were observed. - Body weight:
- One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopically visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method
The test substance was tested for its Acute Oral Toxicity according to a the OECD guideline 423.
Observations
No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific symptoms the animals showed impairments of motility and respiration starting 30 – 60 minutes after application. Additionally urine was discolored reddish on day one. Later on up to day 3 urine was
discolored dark as well as feces. From day 4 until the end of the study no symptoms were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.
Conclusion
LD50 > 2000 mg/kg bw.
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