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EC number: 215-213-6 | CAS number: 1313-96-8
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Aug 2013 - 18 Dec 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study supporting the assessment on toxicokinetic behaviour of niobium pentoxide.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Objective of study:
- bioaccessibility (or bioavailability)
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- artificial sweat solution (ASW) and gastric fluid (GST) used instead of water
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium fuer Arbeit, Integration und Soziales des Landes Nordrhein-Westfalen, Germany
Test material
- Reference substance name:
- Diniobium pentaoxide
- EC Number:
- 215-213-6
- EC Name:
- Diniobium pentaoxide
- Cas Number:
- 1313-96-8
- Molecular formula:
- Nb2O5
- IUPAC Name:
- diniobium(5+) pentaoxidandiide
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
Administration / exposure
- Route of administration:
- other: not applicable
- Vehicle:
- other: Artificial sweat solution (ASW) and Artificial gastric fluid (GST) were used as media
- Details on exposure:
- The objective of the present test was to investigate the dissolution of niobium pentoxide in artificial sweat solution (ASW) and artificial gastric fluid (GST). Thus, each test medium was selected to simulate relevant human-chemical interactions (as far as practical), i.e. contact of a test substance with skin and a substance entering the human body by ingestion. Attention was given to establish conditions similar as for human body regarding pH and temperature.
The dissolved amount of test item was specified by the mass concentration of the substance in the test media under the applied test conditions. The total dissolved amount was determined by measuring the total concentrations of dissolved test item in solution.
For the experimental setup the test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium (loading of 100 mg/L) and agitated at 100 rpm at 37±2 °C. The test was performed in triplicates and two blanks per media were added. Samples were collected after 2 and 24 hours. The total concentrations of niobium of sampled solutions were determined after filtration (0.2 µm, Supor membrane) by inductively-coupled-plasma mass-spectrometry (ICP-MS). Mass balance was based on inductively-coupled-plasma optical emission spectrometry (ICP-OES).
o the residual, undissolved test item in the vessels, 80 mLaqua regia (3:1 mixture of concentrated hydrochloric andnitric acid) were added
to the flasks after the test. The filter used for sampling were extensively rinsed with aqua regia. Solutions weresampled after at least 24h
and the samples were filtered (0.2 µm polyethersulfon membrane, DIA Nielsen, Dueren, Germany). Nb concentrations were measured in
mass balance samples (vessels) for each medium by ICP-OES and the mass balance was calculated. It was observed that aqua regia is not
sufficient to dissolve the test item and the recovery for the mass balance is not within 100 ± 15 %. Therefore, an additional measurement of
the very low concentrations of solution samples from rinsed syringes was regarded not to be reasonable.
For niobium analysis, a commercially available single element standard was used as standard substance (Nb single element standard, lot no. HC264839, expiry date 2015-06-30, Merck, Darmstadt, Germany). This standard solution was used to prepare appropriate stock solutions and subsequently calibration solutions for measurements. - Duration and frequency of treatment / exposure:
- The objective of the present test was to investigate the dissolution of niobium pentoxide in artificial sweat solution (ASW) and artificial gastric fluid (GST). Thus, each test medium was selected to simulate relevant human-chemical interactions (as far as practical), i.e. contact of a test substance with skin and a substance entering the human body by ingestion. Attention was given to establish conditions similar as for human body regarding pH and temperature.
The dissolved amount of test item was specified by the mass concentration of the substance in the test media under the applied test conditions. The total dissolved amount was determined by measuring the total concentrations of dissolved test item in solution.
For the experimental setup the test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium (loading of 100 mg/L) and agitated at 100 rpm at 37±2 °C. The test was performed in triplicates and two blanks per media were added. Samples were collected after 2 and 24 hours. The total concentrations of niobium of sampled solutions were determined after filtration (0.2 µm, Supor membrane) by inductively-coupled-plasma mass-spectrometry (ICP-MS). Mass balance was based on inductively-coupled-plasma optical emission spectrometry (ICP-OES).
For niobium analysis, a commercially available single element standard was used as standard substance (Nb single element standard, lot no. HC264839, expiry date 2015-06-30, Merck, Darmstadt, Germany). This standard solution was used to prepare appropriate stock solutions and subsequently calibration solutions for measurements.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Each test flask was loaded with 100 mg/L of test item.
- No. of animals per sex per dose / concentration:
- not applicable
- Control animals:
- other: control blanks were added
Results and discussion
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- ICP-MS measurements:
Under the conditions of the test, the results of the ICP-MS measurements of total dissolved niobium in test item loaded samples were as follows:
sample / mean Nb conc. ± SD [µg/L] for all vessels (n=3)
ASW 2h (duplicate samples, a and b) / 1.889 ± 0.174
ASW 24h (duplicate samples, a and b) / 6.992 ± 0.457
GST 2h (duplicate samples, a and b) / 0.356 ± 0.047
GST 24h (duplicate samples, a and b) / 1.059 ± 0.088
The niobium concentrations in the control blanks were all below the limit of detection (LOD) and limit of quantification (LOQ). LOD was set at 0.039 µg Nb/L for the ASW medium and 0.0033 µgNb/L for the GST medium. LOQ was set at 0.118 µg Nb/L for the ASW medium and 0.0099 µgNb/L for the GST medium.
ICP-OES measurements:
Recoveries of Nb were <1% in ASW and in GST medium, respectively. This clearly shows, that aqua regia is not sufficient to dissolve the test item.
Any other information on results incl. tables
Nb concentrations in test item loaded samples (1, 2, 3 – triplicate vessels; a, b – duplicate samples):
sample |
Nb conc. [µg/L] |
mean Nb |
Nb conc. [µg/L] |
mean Nb conc. |
Nb conc. [µg/L] |
mean Nb |
mean Nb conc. all vessels ± SD |
ASW2h a |
1.683 |
1.690 ± 0.010 |
2.044 |
2.074 ± 0.043 |
1.894 |
1.904 ± 0.014 |
1.889 ± 0.174 |
ASW2h b |
1.697 |
2.104 |
1.914 |
||||
ASW24h a |
6.685 |
6.822 ± 0.193 |
7.157 |
7.150 ± 0.010 |
6.335 |
7.005 ± 0.948 |
6.992 ± 0.457 |
ASW24h b |
6.958 |
7.144 |
7.675 |
||||
|
|
|
|
|
|
|
|
GST 2h a |
0.305 |
0.307 ± 0.003 |
0.409 |
0.412 ± 0.005 |
0.357 |
0.349 ± 0.011 |
0.356 ± 0.047 |
GST 2h b |
0.309 |
0.415 |
0.342 |
||||
GST 24h a |
1.159 |
1.114 ± 0.064 |
1.108 |
1.112 ± 0.006 |
0.936 |
0.952 ± 0.023 |
1.059 ± 0.088 |
GST 24h b |
1.069 |
1.116 |
0.969 |
Nb concentrations in method blanks:
medium & sample time |
sample |
Nb conc. [µg/L] |
Nb conc. [µg/L] |
LOD |
LOQ |
ASW2h |
a |
<LOD |
<LOD |
0.039 |
0.118 |
b |
<LOD |
<LOD |
|||
ASW24h |
a |
<LOD |
<LOD |
||
b |
<LOD |
<LOD |
|||
|
|
|
|
|
|
GST 2h |
a |
<LOD |
<LOD |
0.0033 |
0.0099 |
b |
<LOD |
<LOD |
|||
GST 24h |
a |
<LOQ (0.006) |
<LOD |
||
b |
<LOQ (0.007) |
<LOD |
Amount of niobium in mass balance samples for each media:
medium |
Nb concentration after addition of aqua regia |
loading |
loading in relation to Nb |
recovery |
ASW vessel 1 |
7.81 |
100.69 |
70.38 |
< 1 |
ASW vessel 2 |
8.01 |
101.01 |
70.61 |
< 1 |
ASW vessel 3 |
12.0 |
101.14 |
70.70 |
< 1 |
|
|
|
|
|
GST vessel 1 |
4.68 |
100.52 |
70.26 |
< 1 |
GST vessel 2 |
3.73 |
101.81 |
71.17 |
< 1 |
GST vessel 3 |
3.92 |
100.32 |
70.12 |
< 1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: Niobium was hardly soluble in artificial sweat solution (ASW) nor in artificial gastric fluid (GST).
The objective of the present test was to investigate the dissolution of niobium pentoxide in artificial sweat solution (ASW) and artificial gastric fluid (GST). Thus, each test medium was selected to simulate relevant human-chemical interactions (as far as practical), i.e. contact of a test substance with skin and a substance entering the human body by ingestion. Niobium was hardly soluble in artificial sweat solution (ASW) nor in artificial gastric fluid (GST) under pH and temperature mimicking human body conditions.
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