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Diss Factsheets
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EC number: 231-975-2 | CAS number: 7783-03-1
- 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
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2009-01-28 To: 2009-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The bioaccessability study described in this report was performed according to the "Draft Guidance for RIP 3.6: Bioavailability and Read-Across for Metals and Minerals". GLP study. The reliability of this study for the substance tested is a K1, but in application of read-across to a different substance, ECHA's guidance specifies that the score can be a maximum of a K2.
- Justification for type of information:
- Tungstic acid (WO3•H2O) is the hydrated form of tungsten trioxide (WO3). Based on Annex V, hydrates and water free forms (anhydrous) of compounds can be regarded as the same substance for registration purposes. Therefore, tungstic acid will be considered equivalent to WO3. For more details on the rationale, refer to the attached description of the read-across approach (Annex 3).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2009
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draft Guidance for RIP 3.6: Bioavailability and Read-Across for Metals and Minerals
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tungsten trioxide
- EC Number:
- 215-231-4
- EC Name:
- Tungsten trioxide
- Cas Number:
- 1314-35-8
- Molecular formula:
- O3W
- IUPAC Name:
- trioxotungsten
- Details on test material:
- - Name of test material (as cited in study report): Tungsten Trioxide
- Substance type: Pure active substance
- Physical state: Solid
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Human simulated fluids
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- other: In vitro study
- Details on exposure:
- Preparation of Testing Fluids: The simulated fluids used in this study were gastric, lung alveolar, lung interstitial, lysosomal and artificial sweat. All salts and reagents used for the simulated fluid preparation were obtained from Sigma-Aldrich (St. Louis, MO).
Extraction Experiments: Extractions of the test substances in the simulated fluids were performed at pre-set time periods (up to 72 hours) while protected from light, using 0.1 g of sample in 50 ml of simulated fluid, at 37 ⁰C and with continuous shaking (for all fluids except sweat, for which only initial shaking was performed). The experiments were carried out as follows:
- Simulated Gastric Fluid: The reactions were sampled for the determination of tungsten at 5 hours.
- Simulated Interstitial, Alveolar and Lysosomal Fluids: 5% CO2 in nitrogen was bubbled into solution at a rate of 50 ml/min. The reactions were sampled for the determination of tungsten at 2, 5, 24, and 72 hours.
- Simulated Sweat: The reactions were sampled for the determination of tungsten after 12 hours. No shaking was performed after the initial set up.
Sample Preparation: The simulated fluid extract samples were filtered immediately after sampling using 50 ml centrifuge tubes equipped with 0.45 microns PVDF filters (Grace Alltech, Deerfield, IL). The filtrates were stored in plastic bottles at 35 ⁰C until analysis.
The extracts were then analyzed for tungsten by inductively coupled plasma-mass spectrometry (ICP-MS). - Duration and frequency of treatment / exposure:
- Single application of tungsten with fluids. Simulated Gastric Fluid was sampled for the determination of tungsten at 5 h. Simulated Interstitial, Alveolar and Lysosomal Fluids were sampled for the determination of tungsten at 2, 5, 24, and 72 h. Simulated Sweat was sampled for the determination of tungsten after 12 h.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1 g of test substance in 50 mL of simulated fluid
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: Simulated gastric fluid, Simulated interstitial fluid, Simulated alveolar fluid, Simulated lysosomal fluid and Simulated sweat
- Time and frequency of sampling: Simulated gastric fluid sampled at 5 hours, Simulated interstitial fluid sampled at 2, 5, 24, and 72 hours, Simulated alveolar fluid sampled at 2, 5, 24, and 72 hours, Simulated lysosomal fluid sampled at 2, 5, 24, and 72 hours and Simulated sweat sampled after 12 hours.
Sample analysis: Samples were diluted (if necessary), spiked with an internal standard [bismuth (Bi) at 1,000 pg/mL, prepared from dilution of a 1,000 ug/mL Certified Standard; Ultra Scientific, North Kingston, RI and analyzed directly on a Perkin Elmer Elan DRC II ICP-MS equipped with a dynamic reaction cell (DRC) and PerkinElmer AS-93 Plus autosampler instrument, according to methods established at IITRI for this study. A standard curve (prepared from dilutions of a 10,000 5%HNO3/6% HF; inorganic Ventures, Lakewood, NJ] was analyzed along with samples on each day of analysis. Instruments calibrators were prepared by diluting Certified Standard with 0.5% nitric acid to concentrations of approximately 200; 400; 800; 1,600; 3,200; 6,400; 13,000; and 25,000 pg/mL. - Statistics:
- Calibration curves, regression coefficients and r-squared values were calculated using PerkinElmer ICP-MS software and Microsoft Excel software. Concentration values of tungsten in the study samples were calculated from linear regression coefficients derived from calibration standards that bracketed the expected concentration levels of tungsten in the study samples.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The fluid extracts were diluted 1:50 to 1:125000 for analysis. The average amount of tungsten found in the extracts was in the 0.0055 to 39% range. The maximum solubility was determined at 72 for the simulated alveolar, lysosomal and interstitial fluids (34, 38 and 39%, respectively). %RSDs ranged from 2.5 to 37%.
Toxicokinetic parameters
- Toxicokinetic parameters:
- other: not applicable
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Gastric Fluid: The mean percent of available tungsten in simulated gastric fluid sampled at 5 hours was 0.0055 +/- 0.00026 % (4.7 % relative standard deviation). Sweat Fluid: The mean percent of available tungsten in simulated sweat fluid sampled at 12 hours was 7.9 +/- 1.3 % (17 % relative standard deviation). Alveolar Fluid: The mean percent of available tungsten in simulated alveolar fluid sampled at 2, 5, 24, and 72 hours was 2.4 +/- 0.18, 7.5 +/- 0.51, 18 +/- 2.5, and 34 +/- 6.1 %, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 7.5, 6.8, 13 and 18 %RSD, respectively. Lysosomal Fluid: The mean percent of available tungsten in simulated lysosomal fluid sampled at 2, 5, 24, and 72 hours was 0.49 +/- 0.014, 1.3 +/- 0.032, 18 +/- 2.6, and 38 +/- 1.3 %, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 2.8, 2.5, 15, and 3.5 %RSD, respectively. Interstitial Fluid: The mean percent of available tungsten in simulated interstitial fluid sampled at 2, 5, 24, and 72 hours was 2.3 +/- 0.83, 11 +/- 2.8, 23 +/- 4.3, and 39 +/- 1.6 %, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 37, 25, 19, and 4.1 %RSD, respectively.
Applicant's summary and conclusion
- Conclusions:
- In a GLP in vitro study conducted according to Draft Guidance for RIP 3.6: Bioavailability and Read-Across for Metals and Minerals, the bioavailability of tungsten trioxide was determine in human gastric, sweat, alveolar, lysosomal, and interstitial fluids. The mean percent of available tungsten in simulated gastric fluid sampled at 5 hours was 0.0055 % (4.7 % relative standard deviation). The mean percent of available tungsten in simulated sweat fluid sampled at 12 hours was 7.9 (17 % relative standard deviation). The mean percent of available tungsten in simulated alveolar fluid sampled at 2, 5, 24, and 72 hours was 2.4, 7.5, 18, and 34, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 7.5, 6.8, 13 and 18 %RSD, respectively. The mean percent of available tungsten in simulated lysosomal fluid sampled at 2, 5, 24, and 72 hours was 0.49, 1.3, 18, and 38%, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 2.8, 2.5, 15, and 3.5 %RSD, respectively. The mean percent of available tungsten in simulated interstitial fluid sampled at 2, 5, 24, and 72 hours was 2.3, 11, 23, and 39%, respectively; the percent relative standard deviation for the 2, 5, 24, and 72 hours was 37, 25, 19, and 4.1 %RSD, respectively. The bioavailability in the fluids ranged from 0.0055% (gastric fluid) to 39% (interstitial fluid). The maximum solubility was determined at 72 hours for the simulated alveolar, lysosomal and interstitial fluids (34, 38 and 39%, respectively). Based on the results, the bioavailability of tungsten trioxide would be expected to be low for the oral route of administration, but moderate for inhalation route.
- Executive summary:
No toxicokinetics data are available for tungstic acid (target substance). However, toxicokinetics data are available for tungsten trioxide (source substance), which were used for read-across. Tungstic acid (WO3•H2O) is the hydrated form of tungsten trioxide (WO3). Based on Annex V, hydrates and water free forms (anhydrous) of compounds can be regarded as the same substance for registration purposes. Therefore, tungstic acid will be considered equivalent to WO3. For more details on the rationale, refer to the attached description of the read-across approach.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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