Registration Dossier
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EC number: 254-413-8 | CAS number: 39318-18-8
- 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:
- 2003-05-13 to 2003-07-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, scientifically sound study that was conducted in accordance to GLP and OECD Guideline 423; limit test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Tungsten oxide blue
- Molecular formula (if other than submission substance): WO
- Physical state: Blue to black powder
- Analytical purity: 99.9%
- Purity test date: 2003-04-15
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature
- Other: Solubility in water- 118 mg/L at 20 degrees C
- pH: 6.9
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: Approximately 8 weeks at the time of administration
- Weight at study initiation: 183-194 g
- Fasting period before study: Yes; the feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Housed singly in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids.
- Diet: Ad libitum (Altromin 1324 forte, gamma irradiated with 25 kGy 60 Co)
- Water: Ad libitum (tap water from an automatic watering system)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 degrees C (continuous control and recording)
- Humidity (%): Average of 59.6% (continuous control and recording)
- Air changes (per hr): 12/hr
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (artificial light from 6 am to 6pm)
IN-LIFE DATES: From: 2003-05-13 To: 2003-05-28
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.1% CMC and 0.1% "Tween 80" (from Merck) in deionised water
- Details on oral exposure:
- DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION: Doses of 2000 mg/kg body weight were prepared as suspensions of the test substance in the vehicle. Suspensions were prepared freshly before administration and were administered within 15 minutes after the preparation.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As requested by the sponsor. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females for each step (6 animals total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations- 0-0.5, 0.5-1, 1-2, 2-4, and 4-6 hours after administration and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
- Body weights: determined before administration, 7 days and 14 days post administration. Body weight gain was calculated for each week of the study, between 0 and 7 days post administration and 7 and 14 days post administration.
- Necropsy of survivors performed: Yes; including gross pathological exmanination. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No severe toxic effects were present after a single dose of 2000 mg/kg of the test substance.
- Mortality:
- None
- Clinical signs:
- All animals were affected. The findings, with an onset shortly after the administration and lasting until a maximum of 6 hours post administration included the piloerection and hunched posture, which was attributed to discomfort.
- Body weight:
- All animals gained weight in both weeks post administration.
- Gross pathology:
- All animals were normal at the necropsy 14 days post administration.
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No severe toxic effects of Tungsten oxide blue were noted by signs in life and post mortem. No mortality occurred. An LD50 of > 2000 mg/kg body weight for rats was established for the test substance.
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