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EC number: 252-305-5 | CAS number: 34977-63-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Direct Black 51- Molecular formula (if other than submission substance): C27H17N5Na2O7S- Molecular weight (if other than submission substance): 601.5- Substance type: organic- Physical state: solid- Analytical purity: cca 80 % w/w- Impurities (identity and concentrations): cca 20 % NaCl (CAS: 7647-14-5)- Lot/batch No.: 9013- Storage condition of test material: stored in dry room in dark in closed container at the room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: SPF breeding, VELAZ, Únětice, Czech Republic (RČH CZ 21760118)- Age at study initiation: 8 - 10 weeks- Weight at study initiation: 133 - 175 g- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage with sterilized shavings of soft wood- Diet (e.g. ad libitum): pelleted standard diet for experimental animals ad libitum- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 22 ± 3°C (permanently monitored)- Humidity: 30 – 70 % (permanently monitored)- Photoperiod: 12-hour light/12 hour dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLEAqua pro iniectioneBatch No.: 1503130162Expiration: 03/2017Producer: Ardeapharma Ševětín, Czech RepublicDOSINGThe test substance was administered to the stomach by tube. The single volume of administered suspension was 1 mL/100 g of animal body weight. The starting dose was 300 mg/kg of body weight.PREPARATION AND APPLICATION OF THE TEST SUBSTANCEImmediately before application the test substance was weighed and mixed in vehicle. The test substance was administered dissolved in water for injections.
- Doses:
- 300 mg/kg (first step)2000 mg/kg (second step)2000 mg/kg (confirmation)
- No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days- Frequency of observations and weighing: 1st day: twice (30 minutes and 3 hours after application), 2nd day: twice (in the morning and in the afternoon), thereafter days: once a day- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death of animals.
- Clinical signs:
- other: No clinical signs of intoxication were detected during whole study.
- Gross pathology:
- No pathologic macroscopic changes were diagnosed during pathological examination.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight.
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance, Direct Black 51 after a single oral administration to Wistar Han rats. The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test substance was administered dissolved in water for injections as a single dose, given orally via gavage to three groups of three female rats. The dosing was performed sequentially in three groups of three females: group No. 1 - first step using the starting dose of 300 mg/kg of body weight, group No. 2 - second step using higher dose 2000 mg/kg and group No. 3 – third step using the same dose 2000 mg/kg.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were detected during whole study. No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight.
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