Registration Dossier
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EC number: 235-123-0 | CAS number: 12070-12-1
- 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

Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Non-standard, non GLP study with no data on purity of test substance but provided sufficient details on methods and results.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The delayed lung responses to single and repeated intratracheal administration of pure cobalt and hard metal powder in the rat.
- Author:
- Lasfargues G, Lardot C, Delos M, Lauwerys R and Lison D.
- Year:
- 1 995
- Bibliographic source:
- Environ Res 69, 108-121.
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report for SIAM 21 for Tungsten Carbide (12070-12-1), Washington DC,18-20 October, 2005
- Author:
- OECD-SIDS
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Evaluation of lung effects after 4 month of intratracheal instillation of tungsten carbide.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tungsten carbide
- EC Number:
- 235-123-0
- EC Name:
- Tungsten carbide
- Cas Number:
- 12070-12-1
- Molecular formula:
- CW
- IUPAC Name:
- tungsten carbide
- Details on test material:
- - Name of test material (as cited in study report): tungsten carbide (WC)
- Purity: > 99.9 %
- Impurities: 0.002 % cobalt
- Median particle diameter: 2 um
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 240 g
- Diet: conventional laboratory diet
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
Administration / exposure
- Route of administration:
- other: intratracheal
- Vehicle:
- other: saline
- Details on exposure:
- The animals were anesthetized with Hypernorm (Janssen, Beerse, Belgium, 50 uL im) and instillation was performed by the transoral route in order to avoid repetitive surgical procedures.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 months
- Frequency of treatment:
- monthly (4 administrations)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 5 or 10 mg/kg body weight
- No. of animals per sex per dose:
- 15 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Selected to allow direct comparison with WC-Co.
- Post-exposure period: 1 month
Examinations
- Observations and examinations performed and frequency:
- no data
- Statistics:
- The data were analyzed with the aid of the Statistical Analysis Software package. Differences between treatments were evaluated using a one- or two-way ANOVA complemented by Duncan multiple comparison test. When the variances were significantly different, means of ranks were compared. Statistical significance was considered at P < 0.05.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No mortality or complication occurred following the repeated administration.
BIOCHEMICAL PARAMETERS: There were no increases in animals treated with WC.
CELLUAR PARAMETERS: No significant differences were detected in WC animals.
LUNG HYDROXYPROLINE CONTENT:
No significant differences were found between controls and WC animals.
HISTOPATHOLOGY:
Revealed no difference to sections of controls except for the presence of fine black particles deposited in alveolar macrophages. Trichrome staining did not reveal the presence of an excess of collagen in WC animals.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 other: mg/kg-bw monthly over a 4 month period
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No alterations of biochemical or cellular parameters or lung hydroxyproline content could be observed. Histopathology of the lung revealed no difference to sections of controls except for the presence of fine black particles deposited in alveolar macrophages.
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