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EC number: 701-439-7 | CAS number: -
- 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
- Remarks:
- Bioaccessibility - transformation/dissolution in artificial physiological media
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-09-25 to 2015-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
- Reference Type:
- other: Amendment
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Objective of study:
- bioaccessibility (or bioavailability)
Test guideline
- Qualifier:
- equivalent or similar 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
- Deviations:
- yes
- Remarks:
- Bioaccessibility testing: single loading 2 g/L, measurement after filtration, sampling after 2 and 24 hours agitation (100 rpm) at 37 ± 2 °C, three replicates, two method blanks / artificial media (ALF, GMB, GST)
- Principles of method if other than guideline:
- The test was performed on the basis of the guidance for OECD-Series on testing and assessment Number 29 and according to the bioaccessibility test protocol provided by the study monitor.
An internationally agreed guideline does not exist for this test (e.g. OECD). However, similar tests have been conducted with several metal compounds, including steels, in previous risk assessments (completed under Regulation (EEC) No 793/93) and in recent preparation for REACH regulation (EC) No 1907/2006. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2011-02-07
Test material
- Reference substance name:
- Reaction mass of cobalt olivine and crystalline silicon dioxide
- EC Number:
- 701-439-7
- Molecular formula:
- Co2SiO4∙xSiO2 (0,7≤x≤1,5)
- IUPAC Name:
- Reaction mass of cobalt olivine and crystalline silicon dioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Test item identification: Olivine, cobalt silicate blue (Pigment blue 73)
- new chemical name: Reaction mass of cobalt olivine and crystalline silicon dioxide
- Substance type: inorganic pigment
- Storage conditions: Keep dry and container tightly closed. Keep container in an adequately ventilated storage
Constituent 1
- Specific details on test material used for the study:
- Appearance: light violet powder, odourless
Storage conditions: Store in a dry place
Test animals
- Species:
- other: in vitro (simulated human body fluids)
Administration / exposure
- Details on exposure:
- Test principle in brief:
- three different artificial physiological media,
- single loading of test substance of ~ 2 g/L,
- samples taken after 2 and 24 hours agitation (100 rpm) at 37 ± 2 °C,
- two method blanks per artificial media were tested; measurement (by ICP-OES) of total dissolved cobalt concentrations after filtration
- the study was performed in triplicate
The aim of this test was to assess the dissolution of Olivine, cobalt silicate blue (IPC-2013-006-01) in three artificial physiological media: Artificial lysosomal fluid (ALF, pH= 4.5), Gamble´s solution (GMB, pH= 7.4), Artificial gastric fluid (GST, pH= 1.5). The test media were selected to simulate relevant human-chemical interactions (as far as practical), i.e. a substance entering the human body by ingestion into the gastro-intestinal tract and by inhalation. - Duration and frequency of treatment / exposure:
- Samples were taken after 2h and 24h.
Doses / concentrations
- Dose / conc.:
- 2 other: g of the test item /L artificial physiological media
- Details on study design:
- Reagents
The water (resistivity >18 MΩ·cm.) used for this test was purified with a Pure Lab Ultra water purification system from ELGA LabWater, Celle, Germany.
- Nitric acid - “Supra” quality (ROTIPURAN® supplied by Roth, Karlsruhe, Germany).
- Hydrochloric acid – “instra-analyzed plus” quality (J.T. Baker, Griesheim, Germany).
Metal analysis
- Standards: single element standards were used as cobalt standard (Merck Certipur Cobalt ICP standard 1000 mg/L lot no. HC41722713; Darmstadt, Germany; Merck).
- Certified reference materials: quality control standards TM-25.4 (lot no. 0914), TMDA-53.3 (lot no. 0914) and TMDA-54.5 (lot no. 0815) obtained from Environment Canada and multielement standards (CPI 19 Elements, lot no. 15C267, Netherlands; Merck XXI, lot no. HC55190098, Germany) were analysed for total dissolved cobalt by ICP-OES along with the samples to determine the accuracy of the applied analytical method. To meet quality assurance requirements recovery needs to be in the range of ± 15 % of the respective certified value. Furthermore the calibration solutions were measured along with the ICP-OES measurements as recalibration standards.
Instrumental and analytical set-up for the ICP-OES instrument:
- Agilent 720, Agilent Technologies, Waldbronn, Germany
- Nebulizer: Sea spray nebulizer from Agilent
- Spray chamber: Glass cyclonic spray chamber from Agilent
- Carrier gas flow: 0.75 L/min
- RF power: 1200W
- Wavelengths: Co 230.786 nm and 231.406 nm
The applied LOD/LOQ calculations for the Agilent 720 ICP-OES are (according to DIN 32645):
LOD: 3 * standard deviation of calibration blank/slope of the calibration
LOQ: 3 * LOD
Thermo IRIS Intrepid II from Thermo Electron Corporation, Germany
- Nebulizer: Concentric glass nebulizer, from Thermo
- Spray chamber: Glass cyclonic spray chamber, from Thermo
- Nebulizer gas flow: 0.68 L/min
- Make-up gas flow: 0.5 L/min
- RF power: 1150 W
- Wavelengths: Co 228.616 nm, 230.786 nm and 231.160 nm
The applied LOD/LOQ calculations for the Thermo IRIS Intrepid are:
LOD: 3 * method standard deviation from calibration line
LOQ: 10 * method standard deviation from calibration line
These data were read directly from the Thermo IRIS Intrepid II ICP-OES instrument output (data calculated by internal algorithms of the instrument software).
Calibration:
- high calibration: blank, 0.5 mg/L, 1.5 mg/L, 2.5 mg/L, 3.5 mg/L, 4.5 mg/L, 5.5 mg/L, 6.5 mg/L and 7.5 mg/L;
- medium calibration: blank, 100 μg/L, 250 μg/L, 500 μg/L, 750 μg/L, 1000 μg/L, 1250 μg/L, 1500 μg/L, 1750 μg/L and 2000 μg/L
- low calibration: blank, 1 μg/L, 2.5 μg/L, 5 μg/L, 7.5 μg/L, 10 μg/L, 25 μg/L 50 μg/L, 75 μg/L, 100 μg/L, 250 μg/L, 500 μg/L, 750 μg/L and 1000 μg/L
Deviations:
Due to a mistake two vessels of the vessel mass balance for ALF medium were disposed before a sample was taken. According to the results of the vessel mass balance for the media GMB, GST and the remaining ALF medium (one vessel) a total dissolution in aqua regia was measured. After discussion with the study monitor it was decided that the ALF test will not be repeated, because the remaining two vessels are sufficient and this deviation was considered as not critical. - Details on dosing and sampling:
- Loading:
The nominal loading in this test was 2 g/L. However, due to weighing uncertainties the actual loadings range from 2.0000 g/L to 2.0016 g/L in the test vessels.
Results and discussion
Main ADME results
- Type:
- other: Bioaccessibility
- Results:
- Highest dissolution of Cobalt (loading: 0.1g/L, after 24h) in GST: 808 ± 32.3 mg/L, GMB: 197 ± 17.2 μg/L, ALF: 529 ± 20.2 mg/L
Any other information on results incl. tables
Method validation summary ICP-OES.
validation parameter |
results |
Comment |
Selectivity |
similar data with different wavelengths for ICP-OES method |
- |
Linearity |
applied calibration functions were linear |
correlation coefficient at least 0.999648 |
Limit of detection |
Co: 0.48 µg/L (Agilent 720) |
|
Limit of quantification |
Co: 1.45 µg/L (Agilent 720) |
|
Method blanks |
In all samples below LOD |
- |
Accuracy measurement / Reproducibility GMB medium sample measurements |
TM-25.4 (dilution factor 2; 13.8 µg Co/L) Co: 111 ± 2.2 % (n = 6) |
Low concentration range (undiluted 27.5 µg Co/L – diluted 13.8 µg Co/L) |
Accuracy measurement / Reproducibility ALF method blank sample measurements |
TM-25.4 (dilution factor 10; 2.75 µg Co/L) |
Low concentration range (undiluted 27.5 µg Co/L – diluted 2.75 µg Co/L) |
Accuracy measurement / Reproducibility ALF method blank sample measurements |
TMDA-53.3 (dilution factor 10; 25.1 µg Co/L) |
Mid concentration range (undiluted 251 µg Co/L – diluted 25.1 µg Co/L) |
Accuracy measurement / Reproducibility GMB medium sample measurements |
TMDA-53.3 (dilution factor 4; 62.8 µg Co/L) |
Mid concentration range (undiluted 251 µg Co/L – diluted 62.8 µg Co/L) |
Accuracy measurement / Reproducibility ALF sample measurements and GMB mass balance samples (both adapted calibrations) |
TMDA-54.5 (318 µg Co/L) |
Low concentration range |
Trueness ALF method blank sample measurements |
Quality control standard (Merck XXI 200 µg Co/L |
High concentration range |
Trueness ALF sample and GMB mass balance samples (both adapted calibrations) measurements |
Quality control standard (CPI 500 µg Co/L) |
Mid concentration range |
Trueness GST medium sample and mass balance sample measurements |
Quality control standard (CPI 2.5 mg Co/L) |
High concentration range |
Trueness GMB medium sample measurements |
Recalibration standard (50 µg Co/L) |
Mid concentration range |
Trueness ALF method blank measurements |
Recalibration standard (100 µg Co/L) |
Mid concentration range |
Trueness GST medium sample and mass balance sample measurements; mass balance vessel samples GMB and ALF samples and mass balance measurements |
Recalibration standard (1000 μg Co/L) Co: 102 ± 2.1 % (n = 20) |
Low concentration range for GST medium, High concentration range for GMB and ALF samples |
Trueness test samples and mass balance |
Fortification of samples: |
Solution pH values
After preparation of the artificial physiological media, solution pH was adjusted to their respective target pH. The target pH in all media before addition of test substance was in the nominal range.
During the study, the pH of GST solutions remained mainly stable in the method blank vessels but in the test vessels the pH increased from 1.51 – 1.52 up to 2.31 – 2.52. Therefore, an effect of the test substance cannot be excluded.
The pH of ALF solutions remained mainly stable. In the method blanks the pH was between 4.50 – 4.52 (start of the test to end of the test), a low increase of the pH in test vessel was measurable (4.50 to 4.59). Therefore, as in the GST medium, a low effect of the test substance cannot be excluded.
In GMB medium, the pH in all vessels (including method blanks) increased during the time of the test from 7.40 to 8.88 (test vessels) and 7.4 to 8.69 and 8.76 (method blank vessels). Therefore, an effect of the test substance can be excluded. In fact, the pH of the GMB media does not seem to be stable under the conditions of the test.
Temperature control
The temperature was adjusted to 37.5 in a thermostatically controlled shaking cabinet to reach a temperature of 37 ± 2 °C in the media. The temperature in thermostatically controlled shaking cabinet was confirmed by a certified thermometer and a thermo data logger. In all test vessels, the temperature was constant at 37 ± 2 °C.
Analytical measurements
The nominal loading in this test was 1000 mg/ 500mL. However, due to weighing uncertainties the actual loadings range from 2.0000 g/L to 2.0016 g/L in the 9 test vessels.
Concentration of dissolved cobalt in artificial physiological media.
media and sample | LOD/LOQ of Co measurement series [μg/L] / [mg/L] | total Co ± SD in method blanks [μg/L] / [mg/L] | total Co ± SD in sample vessels [μg/L] / [mg/L] | total Co ± SD in sample vessels [μg/L] / [mg/L] (corrected concentrations, corresponding to a loading of exactly 2 g/L) |
GST 2h |
LOD: 0.07 mg/L LOQ: 0.23 mg/L |
all method blanks below LOD |
88.1 ± 39.3 mg/L |
88.0 ± 39.3 mg/L |
GST 24h |
LOD: 0.07 mg/L LOQ: 0.23 mg/L |
all method blanks below LOD |
808 ± 32.5 mg/L |
808 ± 32.3 mg/L |
GMB 2h |
LOD: 0.98 μg/L LOQ: 3.25 μg/L |
all method blanks below LOD |
110 ± 37.4 μg/L |
110 ± 37.4 μg/L |
GMB 24h |
LOD: 0.98 μg/L LOQ: 3.25 μg/L |
all method blanks below LOD |
197 ± 17.2 μg/L |
197 ± 17.2 μg/L |
ALF 2h |
ALF method blanks: LOD: 0.48 μg/L LOQ: 1.45 μg/L ALF test samples LOD: 27.9 μg/L LOQ: 92.8 μg/L |
all method blanks below LOD |
106 ± 16.5 mg/L |
106 ± 16.4 mg/L |
ALF 24h |
ALF method blanks: LOD: 0.48 μg/L LOQ: 1.45 μg/L ALF test samples LOD: 27.9 μg/L LOQ: 92.8 μg/L |
all method blanks below LOD |
530 ± 20.3 mg/L |
529 ± 20.2 mg/L |
Mass balance calculation
The mass balance dissolved cobalt concentrations in vessels and filters as measured by ICP-OES indicate a complete dissolution of IPC-2013-006-01 in the physiological media after addition of aqua regia to the sample vessels. Due to the observations during the mass balance a small amount of particles were still visible which could be a result of insoluble parts of the test item (for example according to CoA 45.2 % SiO2 in test item).
Amount of cobalt in mass balance samples (vessels, filter/syringes and taken samples) for each media
Media |
Value for dissolved Co after addition of aqua regia |
In samples [mg] |
Calculated value Co [mg]* |
Nominal amount [mg] # |
Recovery [%] |
|
Vessels [mg/L] |
Filters/ syringes [mg] |
|||||
GST vessel 1 |
394 |
0.17 |
38.4 |
433 |
415 |
104 |
GST vessel 2 |
391 |
0.12 |
36.4 |
428 |
415 |
103 |
GST vessel 3 |
349 |
0.13 |
32.8 |
381 |
414 |
92.0 |
GMB vessel 1 |
427 |
0.18 |
0.01 |
427 |
415 |
103 |
GMB vessel 2 |
433 |
0.28 |
0.01 |
433 |
415 |
104 |
GMB vessel 3 |
442 |
0.28 |
0.01 |
442 |
415 |
107 |
ALF vessel 1 |
369 |
1.70 |
23.9 |
395 |
415 |
95.2 |
ALF vessel 2 |
Due to a mistake vessel of mass balance was disposed before sample was taken |
|||||
ALF vessel 3 |
369 |
1.98 |
26.8 |
398 |
415 |
95.9 |
* Measured dissolved Co includes the amount of cobalt in test solutions after addition of aqua regia, the amount of cobalt rinsed of used filters and syringe and the amount of cobalt removed with samples during the study.
Example: 394 mg (amount Co in vessels) + 0.17 mg (amount Co in filters/syringes) + 38.4 mg (amount Co in samples) = 433 mg
# nominal amount CoO = 52.70 % in test item (according to CoA) -> 78.6483 % Co in CoO -> 414 mg Co in 1 g test item -> nominal amount 414 mg * initial weight / 1 g
Example: 414 mg Co * 1000.3 mg test item / 1000 mg = 415 mg Co
Applicant's summary and conclusion
- Conclusions:
- The bioaccessibility of Cobalt silicate olivine and silca polymorphs has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral and inhalation). At a loading of 2 g test item /L dissolved Co concentrations after 24 h in GST, GMB and ALF were 808 mg/L (88 mg/L after 2 h), 0.197 mg/L and 529 mg/L, respectively, referring to a solubility of ~ 40.4 % (4.41 % after 2h), 0.01 % and ~ 26.45 %, respectively.
The dissolved Co concentrations (according to the CoRC bioaccessibility protocol) were 88 mg/L at a 2 g loading, corresponding to a solubility of 4.41 % in the most effective surrogate physiological medium (GST, 2 hours).
Total Co ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 2 g/L)
- GST 2h: 88.0 ± 39.3 mg/L
- GST 24h: 808 ± 32.3 mg/L
- GMB 2h: 110 ± 37.4 μg/L
- GMB 24h: 197 ± 17.2 μg/L
- ALF 2h: 106 ± 16.4 mg/L
- ALF 24h: 529 ± 20.2 mg/L
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