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EC number: - | CAS number: -
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
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- Ecotoxicological Summary
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- 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
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- Toxicological Summary
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Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Bioaccessibility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-04-17 to 2015-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Objective of study:
- bioaccessibility (or bioavailability)
- 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 Sn concentrations after filtration by ICP-OES and ICP-MS.
- 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-2018-009 (cobalt magnesium tin spinel) 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 tin concentrations after filtration were performed by ICP-OES and ICP-MS. Samples were taken after 2 and 24 hours agitation (100 rpm) at 37 ± 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., et al. 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)
- Remarks:
- , signed 2016-05-31
- 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 ± 2 °C,
- two method blanks per artificial media were tested; measurement (by ICP-OES and IPC-MS) of dissolved cobalt and tin concentrations after filtration
- the study was performed in triplicate
The aim of this test was to assess the dissolution of IPC-2018-009 (cobalt magnesium tin spinel) 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), Phosphate buffered saline (PBS, pH = 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. - Duration and frequency of treatment / exposure:
- Samples were taken after 2 h and 24h.
- 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: Merck Certipur Cobalt ICP standard 1000 mg/L lot no. HC41722713; Merck Certipur Tin ICP standard 1000 mg/L lot no. HC375770; Darmstadt, Germany).
- Certified reference materials: quality control standards TM-25.4 (lot no. 0914) and TMDA-53.3 (lot no. 0914) obtained from Environment Canada and multielement standards (Merck XVII, lot no. HC382226 – only tin; Merck XXI, lot no. HC42984673 – only cobalt , Darmstadt, Germany) were analyzed for total dissolved tin and cobalt by ICP-MS and 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-MS and 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, 230.786 nm, 231.406 nm, 235.341 nm, 237.863 nm, 238.345 nm, 238.636 nm, 238.892 nm and 258.033 nm;
Sn: 183.113 nm, 189.925 nm, 215.152 nm, 224.606 nm, 242.170 nm, 242.950 nm and 326.233 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 0.999832
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 24h, chromium, 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.
Instrumental and analytical set-up for the ICP-MS instrument:
Agilent 7700ce ICP-MS, Agilent Technologies, Waldbronn Germany
Nebulizer: Conical nebulizer, from Glass Expansion
Spray chamber: Scott Type spray chamber, from Agilent
Carrier gas flow: 0.93 L/min
Dilution Gas flow: 0.1 – 0.16 L/min
RF power: 1500 W
Isotopes: 59Co, 118Sn, 119Sn, 120Sn and 103Rh (internal standard)
The applied LOD/LOQs were calculated as follows:
LOD: 3 x standard deviation of calibration blank divided by the slope of calibration line;
LOQ: 3 x LOD.
The data for the LODs were read directly from the Agilent 7700 ICP-MS instrument output (data calculated by internal algorithms of the instrument software).
Calibration:blank, 0.1 µg/L, 0.25 µg/l, 0.5 µg/L, 0.75 µg/L, 1 µg/L, 2.5 µg/L, 5.0 µg/L, 7.5 µg/L, 10 µg/L, 12.5 µg/L, 15 µg/L, 17.5 µg/L, 20 µg/L, 22.5 µg/L, 25 µg/L, 50 µg/L, 75 µg/l and 100 µg/L
Correlation factors (r): at least 0.999830 - Details on dosing and sampling:
- Loading:
Detailed loadings of the test vessels are given in "Any other information on materials and methods incl. tables". - Toxicokinetic parameters:
- other: bioaccessibility
- Remarks:
- Dissolution of Co at a loading of 0.1 g/L: ALF 24h: 6235 ± 71.3 μg/L. Dissolution of Sn at a loading of 0.1 g/L: ALF 24h: 45205 ± 278 μg/L
- Bioaccessibility (or Bioavailability) testing results:
- Concentration of dissolved cobalt in artificial physiological media
Total Co ± SD in sample vessels
- GST 2h: 151 ± 16.5 μg/L
- GST 24h: 3979 ± 38.4 μg/L
- GMB 2h: 0.485 ± 0.047 μg/L
- GMB 24h: 1.06 ± 0.03 μg/L
- ALF 2h: 501 ± 79.7 μg/L
- ALF 24h: 6235 ± 71.3 μg/L
- ASW 2h: 6.43 ± 0.11 µg/L
- ASW 24h: 123 ± 2.45 µg/L
- PBS 2h: 0.509 ± 0.143 μg/L
- PBS 24h: 6.90 ± 0.73 μg/L
Concentration of dissolved tin in artificial physiological media
Total tin ± SD in sample vessels
- GST 2h: 208 ± 32.6 μg/L
- GST 24h: 10.5 ± 3.61 μg/L
- GMB 2h: 1.42 ± 0.47 μg/L
- GMB 24h: All samples below LOD
- ALF 2h: 3560 ± 567 μg/L
- ALF 24h: 45205 ± 278 μg/L
- ASW 2h: 54.5 ± 5.40 μg/L
- ASW 24h: 626 ± 11.8 μg/L
- PBS 2h*: 3.89 ± 1.21 μg/L
- PBS 24h*: 29.3 ± 7.11 μg/L - 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 magnesium tin spinel 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
Total Co ± SD in sample vessels
- GST 2h: 151 ± 16.5 µg/L
- GMB 2h: 0.485 ± 0.047 µg/L
- ALF 2h: 501 ± 79.7 µg/L
- ASW 2h: 6.43 ± 0.11 µg/L
- PBS 2h: 0.512 ± 0.143 µg/
- GST 24h: 3979 ± 38.4 μg/L
- GMB 24h: 1.06 ± 0.03 μg/L
- ALF 24h: 6235 ± 71.3 μg/L
- ASW 24h: 123 ± 2.45 µg/L
- PBS 24h: 6.90 ± 0.73 μg/L
Concentration of dissolved tin in artificial physiological media
Total tin ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 100 mg/L) without method blank subtraction (all method blanks below LOD(*/LOQ))
- GST 2h: 208 ± 32.6 µg/L
- GMB 2h: 1.42 ± 0.47 µg/L
- ALF 2h: 3560 ± 567 µg/L
- ASW 2h: 54.5 ± 5.40 µg/L
- PBS 2h: 3.89 ± 1.21 µg/L
- GST 24h: 10.5 ± 3.61 μg/L
- GMB 24h: All samples below LOD
- ALF 24h: 45205 ± 278 μg/L
- ASW 24h: 626 ± 11.8 μg/L
- PBS 24h: 29.3 ± 7.11 μg/L
Reference
Method validation summary ICP-MS
validation parameter |
results |
Comment |
Selectivity |
similar data with two different gas modes or two different Isotopes and same gas mode |
- |
Linearity |
applied calibration functions were linear |
correlation coefficient at least 0.999830 |
Limit of detection |
Co: 0.001 – 0.023 µg/L Sn: 0.004 – 0.223 µg/L |
|
Limit of quantification |
Co: 0.004 – 0.070 µg/L Sn: 0.012 – 0.669 µg/L |
|
Accuracy measurement / Reproducibility |
Mean recovery for CRM TM-25.4 (dilution factor 5): Sn: 104 ± 2.9 % (n = 19) |
Low concentration range (certified with 27.5 µg Co/L - diluted 5.50 µg Co/L; 23.8 µg Sn/L – diluted 4.76 µg/L) |
Trueness test samples |
Quality control standard Merck XVII: Sn: 93.6 ± 6.4 % (n = 17) |
Mid concentration range (20 µg/L) |
Trueness test samples |
Quality control standard Merck XXI: Co: 97.7 ± 3.9 % (n = 14) |
High concentration range (20 µg/L) |
Trueness test samples |
Recalibration standard: Co: 96.9 ± 5.6 % (n = 14) Sn: 100 ± 3.0 % (n = 16) |
Low concentration range (5 µg/L) |
Trueness test samples |
Recalibration standard: Sn: 101 ± 1.2 % (n = 3) |
Mid concentration range (10 µg/L) |
Trueness test samples |
Recalibration standard: Sn: 101 ± 1.2 % (n = 3) |
High concentration range (50 µg/L) |
Trueness test samples/mass balance samples |
Fortification of samples: Co: 90.2 – 98.4 % Sn: 91.1 – 101 % |
Cobalt and tin concentration in method blanks
Artificial media | Co | Sn |
GST | All method blanks below LOD |
All method blanks below LOD |
GMB | All method blanks below LOD/LOQ | All method blanks below LOD |
PBS | Two method blanks 2h below LOD, one method blank below LOQ, one method blank above LOQ: 2hà0.004 ± 0.002 µg/L; 2h method blanks at least 147 fold lower than samples; 24h all method blanks below LOD |
All method blanks below LOD/LOQ |
Fortification
For fortified test samples, recoveries were in the range of 90.2 – 98.4 % for Co and 91.1 – 101 % for Sn.
Fortification of Co in test samples
sample |
measured concentration [µg/L] |
calculated level after addition [µg/L] |
recovery |
GMB vessel 1 sample a 2h |
0.520 |
0.430 |
0.423 / 98.3 |
GMB vessel 2 sample a 24h |
1.12 |
2.41 |
2.37 / 98.4 |
PBS vessel a sample a 2h |
0.603 |
0.368 |
0.332 / 90.2 |
PBS vessel a sample a 24h |
7.61 |
3.20 |
2.95 / 92.1 |
Fortification of Sn in test samples
sample |
measured concentration [µg/L] |
calculated level after addition [µg/L] |
recovery |
GST vessel 1 sample a 2h (dilution factor 20) |
11.1 |
12.4 |
12.3 / 98.9 |
GST vessel 1 sample a 24h (dilution factor 2) |
3.88 |
5.08 |
5.03 / 98.9 |
GMB vessel 1 sample a 2h |
1.78 |
1.27 |
1.21 / 95.6 |
GMB vessel 2 sample a 24h |
<LOD# |
1.67 |
1.52 / 91.1 |
PBS vessel a sample a 2h |
5.02 |
1.84 |
1.85 / 101 |
PBS vessel 1 sample b 24h |
37.7 |
50.1 |
50.8 / 101 |
#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.
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 |
coefficient at least 0.999832 |
Limit of detection |
Co: 0.088 – 0.532 µg/L Sn: 2.23 – 3.93 µg/L |
|
Limit of quantification |
Co: 0.265 – 1.59 µg/L Sn: 6.69 – 11.8 µg/L |
|
Method blanks |
Co: in all samples below LOD in ASW and ALF Sn: in all samples below LOD in ASW and ALF |
- |
Accuracy measurement / Reproducibility testsamples |
Mean recovery for CRM TM-25.4 (dilution factor 2): |
Mid concentration range (certified with 27.5 µg Co/L, diluted 13.75 µg Co/L) |
Accuracy measurement / Reproducibility testand mass balance measurements |
Mean recovery for CRM TM-25.4 (dilution factor 5): Sn: 97.1 ± 10 % (n = 7) |
Low concentration range (certified with 27.5 µg Co/L, diluted 5.50 µg Co/L; 23.8 µg Sn/L, diluted 4.76 µg Sn/L) |
Accuracy measurement / Reproducibility testsamples |
Mean recovery for CRM TMDA-53.3 (dilution factor 10): |
Mid concentration range (certified with 252µg Co/L, diluted 25.2 µg Co/L) |
Truenesstest sample measurements |
Quality control standard (Merck XXI): Co: 101 ± 1.4 % (n = 2) |
Mid concentration range (50 µg/L) |
Truenesstestand mass balance measurements |
Quality control standard (Merck XVII): Sn: 96.2 ± 2.5 % (n = 11) |
Mid concentration range (100 µg/L) |
Truenesstestand mass balance measurements |
Quality control standard (Merck XVII): Sn: 101 ± 3.6 % (n = 11) |
High concentration range (500 µg/L) |
Truenesstestand mass balance measurements |
Quality control standard (Merck XXI): Co: 99.0 ± 1.9 % (n = 11) |
Mid concentration range (100 µg/L) |
Truenesstestand mass balance measurements |
Quality control standard (Merck XXI): Co: 97.6 ± 1.3 % (n = 10) |
High concentration range (500 µg/L) |
Truenesstest sample measurements |
Recalibration standard Co: 98.1 ± 0.1 % (n = 2) |
Low concentration range (10 µg/L) |
Truenesstestsample and mass balance measurements |
Recalibration standard Co: 98.5 ± 1.7 % (n = 11) |
Mid concentration range (50 µg/L) |
Truenesstestsample and mass balance measurements |
Recalibration standard Co: 99.9 ± 1.6 % (n = 10) |
High concentration range (250 µg/L) |
Truenesstest sample measurements |
Recalibration standard Co: 99.3 % (n = 1) |
High concentration range (500 µg/L) |
Trueness test samples and mass balancesample measurements |
Fortification of samples: Sn: 97.2 – 101 % |
Fortification
From selected artificial physiological media, samples were fortified with a known amount of cobalt and tin (by standard addition of commercial standards) to determine the standard recovery.
For fortified test samples, recoveries were in the range of 96.5 – 101 % for Co and the recoveries of Sn were in the range of 97.2 – 101 % 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 (dilution factor 10) |
16.6 |
29.9 |
30.3 / 101 |
GST vessel 1 sample a 24h (dilution factor 100) |
40.7 |
54.4 |
54.7 / 101 |
ASW vessel 1 sample b 2h |
6.49 |
33.9 |
33.5 / 98.7 |
ASW vessel 1 sample b 24h (dilution factor 2) |
62.7 |
238 |
235 / 98.7 |
ALF vessel 1 sample a 2h (dilution factor 10) |
41.1 |
54.7 |
53.1 / 97.2 |
ALF vessel 1 sample a 24h (dilution factor 100) |
63.9 |
68.3 |
65.9 / 96.5 |
ALF vessel 1 mass balance (dilution factor 100) |
55.7 |
63.4 |
62.0 / 97.8 |
ASW vessel 3 mass balance (dilution factor 100) |
63.1 |
77.8 |
76.6 / 98.4 |
GMB vessel 3 mass balance (dilution factor 100) |
61.6 |
137 |
133 / 97.3 |
GST vessel 1 mass balance (dilution factor 100) |
57.1 |
74.3 |
73.8 / 99.4 |
PBS vessel 1 mass balance (dilution factor 100) |
33.2 |
39.9 |
39.0 / 97.6 |
Fortification of test samples with tin
sample |
measured concentration of Sn [µg/L] |
calculated level after addition [µg/L] |
recovery |
ASW vessel 1 sample b 2h |
57.1 |
64.2 |
63.8 / 99.3 |
ASW vessel 1 sample b 24h (dilution factor 2) |
323 |
394 |
385 / 97.9 |
ALF vessel 2 sample a 2h (dilution factor 10) |
408 |
445 |
439 / 98.6 |
ALF vessel 1 sample a 24h (dilution factor 100) |
460 |
306 |
298 / 97.2 |
ALF vessel 1 mass balance (dilution factor 100) |
380 |
258 |
259 / 100 |
ASW vessel 3 mass balance (dilution factor 100) |
429 |
297 |
296 / 99.4 |
GMB vessel 3 mass balance (dilution factor 100) |
422 |
353 |
349 / 98.9 |
GST vessel 1 mass balance (dilution factor 100) |
148 |
129 |
130 / 101 |
PBS vessel 1 mass balance (dilution factor 100) |
228 |
157 |
155 / 98.5 |
Solution pH values
During the study, the pH of GST, ALF and PBS media remained stable in the method blank vessels and the test vessels. A low increase of the pH for GST was measurable but this was measurable for the method blanks, too. 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 8.87, 8.88 and 8.96 (test vessels) and 7.40 to 8.88 and 8.94 (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 6.15 and 6.16 (test vessels) and 6.50 to 5.93 and 5.95 (method blank vessels). Therefore, an effect of the test substance can be excluded.
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.
Mass balance calculation
For the mass balance dissolved cobalt and tin concentrations in vessels and filters as measured by ICP-OES indicate mainly a complete dissolution of IPC-2018-009 in the physiological media after addition of aqua regia to the sample vessels. Due to the observations during the mass balance less amount of test item was still visible which could be a result of insoluble parts of the test item.
Amount of cobalt in mass balance samples (vessels, filter/syringes and taken samples) for each media for one vessel each
media |
value for dissolved Co after addition of aqua regia |
In samples [mg] |
Calculated value Co [mg]* |
nominal amount [mg]# |
recovery |
|
Vessels [mg] |
Filters/syringes [mg] |
|||||
GST vessel 1 |
2.86 |
0.002 |
0.168 |
3.03 |
3.28 |
92.4 |
GMB vessel 3 |
3.08 |
0.00004 |
0.0001 |
3.08 |
3.29 |
93.5 |
ALF vessel 1 |
2.79 |
0.001 |
0.270 |
3.06 |
3.27 |
93.6 |
ASW vessel 2 |
3.22 |
0.00004 |
0.005 |
3.23 |
3.31 |
97.3 |
PBS vessel 3 |
1.63 |
0.0003 |
0.00001 |
1.63 |
3.28 |
49.7 |
* Measured dissolved Co includes the amount of tin in test solutions after addition of aqua regia, the amount of tin rinsed of used filters and syringe and the amount of tin removed with samples during the study.
Example ALF: 2.79 mg (amount Co in vessel) + 0.001 mg (amount Co in syringe/filters) + 0.270 mg (Co in samples) = 3.06 mg
# nominal amount Co = 6.50 % in test item (according to CoA) -> 3.25 mg Co in 50 mg test item -> nominal amount 3.25 mg * initial weight mg / 50 mg
Example: 3.25 mg Co * 50.264 mg test item / 50 mg = 3.27 mg Co
Description of key information
In conclusion, since the dissolved Co and Sn concentrations from this pigment under simulated physiological conditions were below 3.6 mg/L even at the highest loading of 0.1g/L, corresponding to a solubility of less than 3.6 % after 2 hours, this pigment may reasonably be considered biologically inert.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The chemical and physiological properties of the pigment cobalt magnesium tin spinel are characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This manufacturing process leads to a very low bioaccessibility of the elements contained in the pigment. This has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral, dermal and inhalation), as follows:
1.) Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,
2.) phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,
3.) artificial sweat (ASW, pH 6.5) which simulates the hypoosmolar fluid, linked to hyponatraemia (loss of Na+ from blood), which is excreted from the body upon sweating,
4.) artificial lysosomal fluid (ALF, pH 4.5), which simulates intracellular conditions in lung cells occurring in conjunction with phagocytosis and represents relatively harsh conditions and
5.) artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.
The dissolution of cobalt from the test item cobalt magnesium tin spinel at a loading of 0.1g/L after 2 hours was between 0.51µg/L (PBS) and 501 µg/L (ALF) and between 1.06 µg/L (GMB) and 6.24 mg/L (ALF) after 24 hours. Further, the dissolution of tin from the test item cobalt magnesium tin spinel was in a range of 3.89 µg/L (PBS) and 3.56 mg/L (ALF) at a loading of 0.1g/L after 2 hours and between 29.3± 7.11 µg/L. (PBS) and 45.21 mg/L (ALF) after 24 hours.
In conclusion, since the dissolved Co and Sn concentrations from this pigment under simulated physiological conditions were below 3.6 mg/L even at the highest loading of 0.1g/L after 2 hours, corresponding to a solubility of less than 3.6 %, this pigment may reasonably be considered biologically inert.
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