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Diss Factsheets
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EC number: 234-808-1 | CAS number: 12034-57-0
- 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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Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-09-29 to 2017-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Objective of study:
- bioaccessibility (or bioavailability)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- This report measured bioaccessibility of Niobium(II) oxide in body fluid simulants as a surrogate for bioavailability.
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
- Route of administration:
- other: in vitro study
- Vehicle:
- other: not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
- Dose / conc.:
- 0.2 other: g/L
- Remarks:
- Loading (Gastric bio-elution test)
- Dose / conc.:
- 2 other: g/L
- Remarks:
- Loading (Sweat bio-elution test)
- Dose / conc.:
- 2 other: g/L
- Remarks:
- Loading (Alveolar bio-elution test)
- Dose / conc.:
- 2 other: g/L
- Remarks:
- Loading (Lyosomal bio-elution test)
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- other: Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Please see box "Any other information on materials and method incl. tables"
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
- Preliminary studies:
- Not applicable
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
- Bioaccessibility (or Bioavailability) testing results:
- The results of the bio-elution tests (see tables 1-5 in box "Any other information on results incl. tables") showed a consistent very low metal release in all the arteficial media tested. The highest metal release concentration was found in lysosomal fluid with < 0.2 % after 72 hours of incubation.
- Conclusions:
- The release of niobium ions from Niobium oxide is very low in artifical body fluids. Based on the results, the bioavailability of Niobium oxide can be considered to be very low for all routes of administration.
- Executive summary:
A study to estimate the bioaccessibility of Niobium(II) oxide 80K in different artificial media: gastric juice, lysosomal, alveolar and perspiration fluids; representing ingestion, inhalation and dermal contact routes of exposure in humans, was performed. The rate and extend of the metal released in these in vitro simulations of biological compartments can be used for human health hazard classification of this substance.
The results showed a consistent very low metal release in all the arteficial media tested. The highest niobium release concentration was found in lysosomal fluid with ca. 0.2% after 72 hours of incubation. Metal release (μg/L) and solubility results (percentage) are summarized in the Table below.
Simulated Body Fluid pH Extraction Time (h) µg Nb/L sample % Nb release Gastric fluid 1.5 2 5.13 0.0031 Lyosomal fluid 4.5 - 5.0 24 1348.7 - 72 3298.1 0.198 Alveolar fluid 7.4 24 251.7 - 72 1149.4 0.069 Perspiration fluid 6.5 24 399.5 - 168 689.8 0.041
Reference
Table 1: Summary of Results
Metal release in Gastric test (µg/L) | % Solubility (0.2 g/L loading) | ||||
2 h | CV, % | 2 h | CV, % | ||
5.13 | 2 | 0.0031 | 2 | ||
Metal release in Lyosomal fluid (µg/L) | % Solubility (2 g/L loading) | ||||
24 h | CV, % | 72 h | CV, % | 72 h | CV, % |
1348.7 | 1 | 3298.1 | 15 | 0.198 | 15 |
Metal release in Alveolar fluid (µg/L) | % Solubility (2 g/L loading) | ||||
24 h | CV,% | 72 h | CV, % | 72 h | CV, % |
251.7 | 3 | 1149.4 | 6 | 0.069 | 6 |
Metal release in Perspiration fluid (µg/L) | % Solubility (2 g/L loading) | ||||
24 h | CV, % | 168 h | CV, % | 168 h | CV, % |
399.5 | 7 | 689.8 | 1 | 0.041 | 1 |
Table 2: Results of the Gastric bio-elution test
Gastric test parameters | Niobium, µg/L | |||||
Time [h] | T [° C] | pH | Mean | SD | CV [%] | |
Blanks | 0 | 37 | 1.51 | BDL | - | - |
2 | 37 | 1.51 | BDL | - | - | |
Nb(II)O 80K | 0 | 37 | 1.51 | BDL | - | - |
2 | 37 | 1.49 | 5.13 | 0.11 | 2 |
CV corresponds to the coefficient of variation between vessels. BDL: Below detection limit.
Table 3: Results of the Lyosomal bio-elution test
Lyosomal test parameters | Niobium, µg/L | |||||
Time [h] | T [° C] | pH | Mean | SD | CV [%] | |
Blanks | 0 | 37 | 4.45 | BDL | - | - |
2 | 37 | 4.48 | BDL | - | - | |
24 | 37 | 4.49 | BDL | - | - | |
72 | 37 | 4.52 | BDL | - | - | |
Nb(II)O 80K | 0 | 37 | 4.45 | BDL | - | - |
2 | 37 | 4.47 | 383.6 | 7 | 2 | |
24 | 37 | 4.47 | 1348.7 | 10.6 | 1 | |
72 | 37 | 4.47 | 3298.1 | 484.2 | 16 |
CV corresponds to the coefficient of variation between vessels. BDL: Below detection limit.
Table 4: Results of the Alveolar bio-elution test
Alveolar test parameters | Niobium, µg/L | |||||
Time [h] | T [°C] | pH | Mean | SD | CV [%] | |
Blanks | 0 | 37 | 7.39 | BDL | - | - |
2 | 37 | 7.47 | 0.7 | 0.2 | 22 | |
24 | 37 | 7.37 | 0.8 | 0.2 | 28 | |
72 | 37 | 7.42 | 0.9 | 0.2 | 25 | |
Nb(II)O 80K | 0 | 37 | 7.39 | BDL | - | - |
2 | 37 | 7.47 | 197.1 | 0.6 | 0 | |
24 | 37 | 7.44 | 251.7 | 7 | 3 | |
72 | 37 | 7.43 | 1149.4 | 66.9 | 6 |
CV corresponds to the coefficient of variation between vessels. BDL: Below detection limit. Nb values reported in the Blanks were equal to or below the practical quantitation level for the Alveolar media (PQL = 1.0 μg/L).
Table 5: Results of the Sweat bio-elution test
Alveolar test parameters | Niobium, µg/L | |||||
Time [h] | T [° C] | pH | Mean | SD | CV [%] | |
Blanks | 0 | 30 | 6.67 | BDL | - | - |
24 | 30 | 6.30 | BDL | - | - | |
168 | 30 | 6.07 | BDL | - | - | |
Nb(II)O 80K | 0 | 30 | 6.67 | BDL | - | - |
24 | 30 | 6.36 | 399.5 | 28 | 7 | |
168 | 30 | 5.82 | 689.8 | 8.75 | 1 |
CV corresponds to the coefficient of variation between vessels. BDL: Below detection limit.
Description of key information
A study to estimate the bioaccessibility of Niobium oxide as a surrogate for bioavailability in different artificial body fluids were conducted. Based on the results, the bioavailability of Niobium oxide can be considered to be very low for all routes of administration.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
A study to estimate the bioaccessibility of Niobium(II) oxide 80K as a surrogate for bioavailability in different artificial media: gastric juice, lysosomal, alveolar and perspiration fluids; representing ingestion, inhalation and dermal contact routes of exposure in humans, was performed. The rate and extend of the metal released in these in vitro simulations of biological compartments can be used for human health hazard classification of this substance. The results showed that the release of niobium ions is very low, with a maximum release of ca. 0.2% in lysosomal fluid. Based on the results, the bioavailability of Niobium oxide can be considered to be very low for all routes of administration.
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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