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EC number: 270-208-6 | CAS number: 68412-74-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77366.
- 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, other
- Remarks:
- Bioaccessibility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-07-07 to 2015-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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: loading of 100 mg/L; five artificial physiological media agitated at 100 rpm, at 37 °C ± 2 °C; sampling after 2 h and 24 h; determination of Co and Zn concentrations after filtration by ICP-OES.
- Principles of method if other than guideline:
- The test was performed on the basis of OECD Series on Testing and Assessment No. 29 as well as according to the bioaccessibility test protocol provided by the monitor. The bioaccessibility protocol has been developed on the basis of relevant published methods ([1], [2], [3], [4] and [5]).
The aim of this test was to assess the dissolution of the pigment IPC-2018-006 (cobalt zinc silicate blue phenacite) in the artificial physiological media GST, GMB, ALF, ASW and PBS. 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 or by inhalation.
Five different artificial physiological media with a single loading of test substance of 100 mg/Lwere used. The measurement of dissolved cobalt and zinc concentrations after filtrationwere performed by ICP-OES. Samples were taken after 2 and 24 hours agitation (100 rpm) at 37 °C ± 2 °C. The study was performed in triplicate with two additional method blanks per medium.
[1] Hanawa T. 2004. Metal ion release from metal implants. Materials Science and Engineering C 24: 745-752.
[2] Stopford W., Turner J., Cappelini D., Brock T. 2004. Bioaccessibility testing of cobalt compounds. Journal of Environmental Monitoring 5: 675-680.
[3] Midander K., Odnevall Walinder I., Leygraf C. 2007. In vitro studies of copper release from powder particles in synthetic biological media. Environmental Pollution 145: 51-59.
[4] European standard 1998. Test method for release of nickel from products intended to come into direct and prolonged contact with the skin (EN 1811)
[5] ASTM 2003. Standard test method for determining extractability of metals from art materials. ASTM D5517-03. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cobalt zinc silicate blue phenacite
- EC Number:
- 270-208-6
- EC Name:
- Cobalt zinc silicate blue phenacite
- Cas Number:
- 68412-74-8
- Molecular formula:
- Zn(2-x)Co(x)SiO4 0,7≤x≤1,1
- IUPAC Name:
- cobalt zinc silicate blue phenacite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: cobalt zinc silicate blue phenacite (Pigment Blue 74)
- Physical state: intense blue powder, odourless
Constituent 1
Test animals
- Species:
- other: in vitro (simulated human body fluids)
- Details on test animals or test system and environmental conditions:
- Test principle in brief:
- five different artificial physiological media,
- single loading of test substance of 100 mg/L,
- samples taken after 2 and 24 hours agitation (100 rpm) at 37 °C ± 2 °C,
- two method blanks per artificial media were tested; measurement (by ICP-OES) of dissolved cobalt and zinc concentrations after filtration
- the study was performed in triplicate
The aim of this test was to assess the dissolution of IPC-2018-006 (cobalt zinc silicate blue phenacite) in five artificial physiological media: Artificial lysosomal fluid (ALF, pH = 4.5), Artificial sweat solution (ASW, pH = 6.5), Gamble´s solution (GMB, pH = 7.4), Artificial gastric fluid (GST, pH = 1.5-1.6), Phosphate buffered saline (PBS, pH = 7.2- 7.4). 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 gastrointestinal tract and by inhalation.
Administration / exposure
- Duration and frequency of treatment / exposure:
- Samples were taken after 2 h and 24h.
Doses / concentrations
- Dose / conc.:
- 100 other: mg of the test item /L artifical 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).
- Sodiumhydroxide – pro Analysis quality (Chemsolute, Th. Geyer, Renningen, Germany)
Metal analysis
- Standards: single element standards were used to prepare an appropriate stock solution and subsequently calibration solutions for ICP-OES measurements as cobalt and zinc standards (Merck Certipur Cobalt ICP standard 1000 mg/L lot no. HC41722713; Merck Certipur Zinc ICP standard 1000 mg/L lot no. HC388620; Darmstadt, Germany).
- Certified reference materials: quality control standards TM-25.4 (lot no. 0914) and TMDA-53.3 (lot no. 0914, Environment Canada) and a multielement standard (Merck XXI, lot no. HC42984673 and HC55190098, Darmstadt, Germany) were analysed for total dissolved cobalt and zinc by ICP-OES along with the samples to determine the accuracy of the applied analytical method. 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: 201.151 nm, 228.615 nm, 230.786 nm, 231.160 nm, 231.497 nm, 235.341 nm, 236.379 nm, 237.863 nm, 238.345 nm, 238.892 nm and 241.765 nm
Zn: 202.548 nm, 206.200 nm and 213.857 nm
The applied LOD/LOQ calculations for the Agilent 720 ICP-OES are (according to DIN 32645):
LOD: 3 x standard deviation of calibration blank/slope of the calibration
LOQ: 3 x LOD
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.
Correlation coefficients (r): at least 0.999851
Determination of mass balance
To the residual, undissolved test item in the vessels, 80 mL aqua regia (3 : 1 mixture of concentrated hydrochloric and nitric acid) were added to the flasks after the test. The filters used for sampling were extensively rinsed with aqua regia. Solutions were sampled after at least 24 h, cobalt and zinc concentration were measured in at least one mass balance sample (vessel and filter/syringes) for each medium by ICP-OES, and the mass balance was calculated. - Details on dosing and sampling:
- Loading:
Detailed loadings of the test vessels are given in "Any other information on materials and methods incl. tables".
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parameters
- Toxicokinetic parameters:
- other: bioaccessibility
- Remarks:
- Dissolution of Co at a loading of 0.1 g/L: ALF 24h: 25097 ± 437 µg/L. Dissolution of Zn at a loading of 0.1 g/L: ALF 24h: 34781 ± 645 µg/L.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Concentration of dissolved cobalt in artificial physiological media:
Total Co ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 100 mg/L) with mean method blank subtraction (mean of 2 h and/or 24 h)
- GST 2h: 17389 ± 3552 µg/L (no subtraction, all method blanks below LOD)
- GST 24h: 24288 ± 1267 µg/L (no subtraction, all method blanks below LOD)
- GMB 2h: 29.9 ± 11.5 µg/L (no subtraction, all method blanks below LOD)
- GMB 24h: 34.6 ± 2.23 µg/L (no subtraction, all method blanks below LOD)
- ALF 2h: 11174 ± 7648 µg/L (no subtraction, all method blanks below LOD)
- ALF 24h: 25097 ± 437 µg/L (no subtraction, all method blanks below LOD)
- ASW 2h: 106 ± 42.8 µg/L (no subtraction, all method blanks below LOD)
- ASW 24h: 936 ± 46.8 µg/L (no subtraction, all method blanks below LOD)
- PBS 2h: 55.1 ± 6.78 µg/L (no subtraction, all method blanks below LOD)
- PBS 24h: 181 ± 2.76 µg/L (no subtraction, all method blanks below LOD)
Concentration of dissolved zinc in artificial physiological media
Total Zn ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 100 mg/L) with mean method blank subtraction (mean of 2 h and/or 24 h)
- GST 2h: 24474 ± 4850 µg/L (method blanks: 4.26 ± 2.95 µg/L)
- GST 24h: 33612 ± 2460 µg/L (method blanks: 5.47 ± 3.57 µg/L)
- GMB 2h: 21.7 ± 8.27 µg/L (no subtraction, all method blanks below LOD)
- GMB 24h: All samples below LOD, all method blanks below LOD
- ALF 2h: 17628 ± 10974 µg/L (no subtraction, all method blanks below LOD/LOQ)
- ALF 24h: 34781 ± 645 µg/L (no subtraction, all method blanks below LOD/LOQ)
- ASW 2h: 216 ± 97.0 µg/L (method blanks: 1.47 ± 0.52 µg/L)
- ASW 24h: 1537 ± 76.0 µg/L (method blanks: 2.20 ± 0.58 µg/L)
- PBS 2h: 67.9 ± 8.72 µg/L (no subtraction, all method blanks below LOD)
- PBS 24h: 220 ± 7.87 µg/L (no subtraction, all method blanks below LOD)
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 |
at least 0.999618 |
Limit of detection |
Co: 0.209 – 2.21 µg/L Zn: 0.054 – 1.45 µg/L |
|
Limit of quantification |
Co: 0.628 – 6.64 µg/L Zn: 0.163 – 4.35 µg/L |
|
Method blanks |
Co: < LOD Zn: - GST 2h: 4.26 ± 2.95 µg/L; 24 h: 5.47 ± 3.57 µg/L - ALF: < LOD/LOQ - GMB and PBS: < LOD - ASW 2h: 1.47 ± 0.52 µg/L; 24 h: 2.20 ± 0.58 µg/L |
- |
Accuracy measurement / Reproducibility testsample and mass balance measurements |
Mean recovery for CRM TM-25.4 (dilution factor 10): Zn: 105 ± 8.5 (n = 20) |
Low concentration range (certified with 27.5 µg Co/L, diluted 2.75 µg Co/L; 44.5 µg Zn/L, diluted 4.45 µg Zn/L) |
Accuracy measurement / Reproducibility testsample and mass balance measurements |
Mean recovery for CRM TMDA-53.3 (dilution factor 10): Zn: 99.4 ± 4.6 (n = 30) |
Low to mid concentration range (certified with 251 µg Co/L, diluted 25.1 µg Co/L; 386 µg Zn/L, diluted 38.6 µg Zn/L) |
Truenesstest sample measurements |
Quality control standard (Merck XXI): Co: 98.0 ± 2.8 (n = 4) |
Low to mid concentration range (20 µg/L) |
Truenesstestsample and mass balance measurements |
Quality control standard (Merck XXI): Co: 97.7 ± 2.6 (n = 26) |
Mid to high concentration range (100 µg/L) |
Truenesstestsample and mass balance measurements |
Quality control standard (Merck XXI): Co: 97.9 ± 3.0 (n = 11) |
High concentration range |
Truenesstest sample measurements |
Quality control standard (Merck XXI): Co: 96.6 ± 0.8 (n = 5) |
High concentration range |
Truenesstestsample and mass balance measurements |
Recalibration standard Co: 100 (n = 1) |
Low to Mid concentration range (25 µg/L) |
Truenesstestsample and mass balance measurements |
Recalibration standard Co: 97.5 ± 1.7 (n = 21) |
Mid concentration range |
Truenesstest sample measurements |
Recalibration standard Co: 98.5 ± 2.0 (n = 9) |
Mid to high concentration range (100 µg/L) |
Truenesstestsample and mass balance measurements |
Recalibration standard Co: 99.5 ± 2.4 (n = 15) |
High concentration range |
Trueness test samples |
Fortification of samples: Zn: 95.8 – 107 % |
|
Truenessmass balancesample measurements |
Fortification of samples: Zn: 99.2 – 101 % |
Solution pH values
After preparation of the artificial physiological media, solution pH was adjusted to their respective target pH, which was in the nominal range in all media before addition of test substance.
During the study, the pH of GST (low increase from 1.55 and 1.56 to 1.58 to 1.61), ALF and PBS media remained stable in the method blank vessels and the test vessels. Therefore, a possible effect of the test substance can be excluded.
In GMB medium, the pH in all vessels (including method blanks) increased during the time of the test from 7.40 to 8.73, 8.74 and 8.67 (test vessels) and 7.40 to 8.79 and 8.81 (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.
In ASW medium, the pH in all vessels (including method blanks) decreased during the time of the test from 6.50 to 6.36 and 6.37 (test vessels) and 6.50 to 5.96 and 5.99 (method blank vessels). Therefore, an effect of the test substance can be excluded.
Temperature control
The test was performed in an incubated laboratory shaker (Shaking incubation cabinet, Minitron, INFORS AG, Bottmingen, Switzerland) at 100 rpm. The temperature was adjusted to 37.5 °C in a thermostatically controlled shaking cabinet to reach a temperature of 37 °C ± 2 °C in the media. The temperature remained stable during the test in all media.
Fortification
From selected artificial physiological media, samples were fortified with a known amount of cobalt and zinc (by standard addition of commercial standards) to determine the standard recovery. For fortified test samples, recoveries were in the range of 98.2 – 102 % for Co and the recoveries of Zn were in the range of 95.8 – 107 % in test samples.
Fortification of test samples with cobalt
sample |
measured concentration of Co [µg/L] |
calculated level after addition [µg/L] |
recovery |
GST vessel 1 sample a 2h |
186 |
117 |
118 / 101 |
GST vessel 1 sample a 24h |
244 |
129 |
130 / 101 |
GST vessel 3 sample b 24h (remeasurement series) |
261 |
452 |
459 / 102 |
GMB vessel 1 sample a 2h |
33.5 |
45.8 |
45.0 / 98.4 |
GMB vessel 2 sample a 24h |
33.1 |
43.2 |
42.4 / 98.2 |
ASW vessel 3 sample b 2h (dilution factor 2) |
32.1 |
27.0 |
26.6 / 98.3 |
ASW vessel 1 sample a 24h (dilution factor 10) |
99.1 |
39.8 |
39.5 / 99.1 |
ALF vessel 1 sample b 2h (dilution factor 100) |
192 |
118 |
117 / 99.0 |
ALF vessel 1 sample a 24h (dilution factor 100) |
249 |
130 |
129 / 99.6 |
PBS vessel 1 sample a 2h |
62.3 |
84.9 |
84.6 / 99.6 |
PBS vessel 1 sample a 24h |
188 |
225 |
222 / 98.7 |
Fortification of test samples with zinc
sample |
measured concentration of Zn [µg/L] |
calculated level after addition [µg/L] |
recovery |
GST Vessel 1 sample a 2h |
261 |
132 |
131 / 99.1 |
GST Vessel 1 sample a 24h |
338 |
148 |
145 / 98.3 |
GST vessel 3 sample b 24h (remeasurement series) |
370 |
474 |
478 / 101 |
GMB Vessel 1 sample a 2h |
27.2 |
40.9 |
42.9 / 105 |
GMB vessel 2 sample a 24h |
<LOD |
29.8 # |
29.8 / 100 |
ASW vessel 3 sample b 2h (dilution factor 2) |
68.4 |
33.7 |
36.0 / 107 |
ASW vessel 1 sample a 24h (dilution factor 10) |
163 |
52.6 |
52.0 / 98.8 |
ALF vessel 1 sample b 2h (dilution factor 100) |
294 |
139 |
133 / 95.8 |
ALF vessel 1 sample a 24h (dilution factor 100) |
347 |
149 |
146 / 97.8 |
PBS vessel 1 sample a 2h |
76.0 |
90.4 |
91.3 / 101 |
PBS vessel 1 sample a 24h |
223 |
239 |
239 / 99.8 |
# Solutions with concentrations below the LOD/LOQ were also fortified. However, a recovery of ± 15 % may not be realistic as concentrations in the original (unfortified) sample below the LOD may be lower than the noise ratio and concentrations below the LOQ are between the noise ratio and a real (quantifiable) signal. For solutions with concentrations below the LOD/LOQ, a recovery of ± 25 % - 30 % is more realistic.
Determination of mass balance
Furthermore from the mass balance selected samples were fortified with a known amount of cobalt and zinc (by standard addition of commercial standards) to determine the standard recovery. For fortified test samples, recoveries were in the range of 93.2 – 96.0 % for Co and 99.2 – 101 % for Zn in mass balance samples.
Fortification of mass balance samples with cobalt
sample |
measured concentration of Co [µg/L] |
calculated level after addition [µg/L] |
recovery |
ALF vessel 1 (dilution factor 100) |
193 |
316 |
302 / 95.8 |
ASW vessel 1 (dilution factor 100) |
227 |
336 |
313 / 93.2 |
GMB vessel 1 (dilution factor 100) |
220 |
332 |
315 / 94.7 |
GST vessel 1 (dilution factor 100) |
200 |
320 |
307 / 96.0 |
PBS vessel 1 (dilution factor 100) |
224 |
335 |
316 7 94.4 |
Fortification of mass balance samples with zinc.
sample |
measured concentration of Zn [µg/L] |
calculated level after addition [µg/L] |
recovery |
ALF vessel 1 (dilution factor 100) |
284 |
370 |
370 / 99.9 |
ASW vessel 1 (dilution factor 100) |
325 |
395 |
398 / 101 |
GMB vessel 1 (dilution factor 100) |
324 |
394 |
395 / 100 |
GST vessel 1 (dilution factor 100) |
273 |
364 |
363 / 99.7 |
PBS vessel 1 (dilution factor 100) |
333 |
400 |
397 / 99.2 |
Applicant's summary and conclusion
- Conclusions:
- On the basis of OECD Series on Testing and Assessment No. 29 as well as according to a bioaccessibility test protocol, which has been developed on the basis of relevant published methods, the dissolution of the pigment cobalt zinc silicate blue phenacite in artificial physiological media with a single loading of 100 mg/L at 37 °C ± 2 °C was determined.
Concentration of dissolved cobalt in artificial physiological media:
- GST 2h: 17389 ± 3552 µg/L
- GST 24h: 24288 ± 1267 µg/L
- GMB 2h: 29.9 ± 11.5 µg/L
- GMB 24h: 34.6 ± 2.23 µg/L
- ALF 2h: 11174 ± 7648 µg/L
- ALF 24h: 25097 ± 437 µg/L
- ASW 2h: 106 ± 42.8 µg/L
- ASW 24h: 936 ± 46.8 µg/L
- PBS 2h: 55.1 ± 6.78 µg/L
- PBS 24h: 181 ± 2.76 µg/L
Concentration of dissolved zinc in artificial physiological media
Total Zn ± SD in sample vessels
- GST 2h: 24474 ± 4850 µg/L
- GST 24h: 33612 ± 2460 µg/L
- GMB 2h: 21.7 ± 8.27 µg/L
- GMB 24h: All samples below LOD
- ALF 2h: 17628 ± 10974 µg/L
- ALF 24h: 34781 ± 645 µg/L
- ASW 2h: 216 ± 97.0 µg/L
- ASW 24h: 1537 ± 76.0 µg/L
- PBS 2h: 67.9 ± 8.72 µg/L
- PBS 24h: 220 ± 7.87 µg/L
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