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EC number: 936-897-9 | 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:
- transformation/dissolution in artificial physiological media / bioaccessibility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-09-24 to 2013-02-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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 Al, Cr, Fe and Zn concentrations after filtration by ICP-OES.
- Principles of method if other than guideline:
- 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.
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. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed, 2011-02-07
Test material
- Reference substance name:
- dichromium(3+) diiron(3+) lambda2-iron(2+) trizinc(2+) octaoxidandiide silicate
- EC Number:
- 936-897-9
- Cas Number:
- 1373399-58-6
- Molecular formula:
- (Zn, Fe)(Fe, Cr)2O4-Zn2SiO4
- IUPAC Name:
- dichromium(3+) diiron(3+) lambda2-iron(2+) trizinc(2+) octaoxidandiide silicate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of willemite, white and zinc iron chromite brown spinel
- Substance type: inorganic pigment
- Physical state: solid, light brown powder, odourless
- Storage condition of test material: store separate from food and drinks, dry in closed containers and protected places. Keep containers air-tight.
- Relative density: 4.58
Constituent 1
Test animals
- Species:
- other: in vitro (simulated human body fluids)
Administration / exposure
- Details on exposure:
- 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) of dissolved aluminium, chromium, iron and zinc concentrations after filtration (0.2 µm, Supor membrane)
- the study was performed in duplicates
The aim of this test was to assess the dissolution of IPC-2013-017 (Reaction mass of willemite, white and zinc iron chromite brown 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.
Doses / concentrations
- Dose / conc.:
- 100 other: mg of the test item /L artificial 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 and multielement standards were used as aluminium, iron, chromium and zinc standards (Merck XXl lot no. HC075495, Merck Certipur Aluminium ICP standard 1000 mg/L lot no. HC125228; Merck Certipur Chromium ICP standard 1000 mg/L lot no. HC114885, Merck Certipur Iron ICP standard 1000 mg/L lot no. HC093237, Merck Certipur Zinc ICP standard 1000 mg/L lot no. HC090981; Darmstadt, Germany).
- Certified reference materials: TMDA-70 (lot no. 0310) and TM-15.2 (lot no. 1011) obtained from Environment Canada and a multielement standard (Merck VIII, lot no. HC137073, 19 elements, CPI, Amsterdam, the Netherlands, lot.no. 12A089)
Instrumental and analytical set-up for the ICP-OES instrument (sample measurement series):
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: 1200 W
Wavelengths: Al: 167.019 nm, 236.705 nm, 308.215 nm and 396.152 nm; Cr: 205.560 nm, 206.158 nm, 266.602 nm, 284.325 nm and 357.868 nm; Fe: 234.350 nm, 238.204 nm, 238.863 nm and 258.588 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 * standard deviation of calibration blank/slope of the calibration;
LOQ: 3 * LOD
Instrumental and analytical set-up for the ICP-OES instrument (mass balance series):
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: Fe: 238.204 nm and 239.562 nm; Zn: 202.548 nm, 206.200 nm and 213.856 nm
The applied LOD/LOQ calculations for the IRIS Intrepid ICP-OES 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: blank, 1, 5, 7.5, 10, 25, 50, 75, 100, 200, 250, 300, 400 and 500 µg/L. Calibrations were performed before each measurement.
- Correlation factors (r): at least 0.9988 - Details on dosing and sampling:
- Loading:
The nominal loading in this test was 100 mg/L. However, due to weighing uncertainties the actual loadings range from 100.628 mg/L to 101.96 mg/L in the test vessels.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- other: Bioaccessibility
- Results:
- Higest dissolution at a loading of 0.1g/L in ALF after 24h: Al = 20.7± 0.21 µg/L, Cr = 2.74 ± 0.11 µg/L, Fe = 69.8 ± 1.60 µg/L, Zn = 26761 ± 789 µg/L
- Type:
- other: Bioaccessibility
- Results:
- Higest dissolution at a loading of 0.1g/L in GST after 24h: Al = 32.4 ± 0.72 µg/L, Cr = 3.21 ± 0.05 µg/L, Fe = 92.7 ± 0.54 µg/L, Zn = 26411 ± 1718 µg/L
Any other information on results incl. tables
Method validation summary (ICP-OES)
validation parameter |
results |
Comment |
Selectivity |
similar data with two different wavelengths for ICP-OES method |
No interference observed |
Linearity |
applied calibration functions were linear |
correlation coefficient at least 0.9988 |
Limit of detection |
Al: 0.15 – 0.31 µg/L |
|
Limit of quantification |
Al: 0.46 – 0.92 µg/L |
|
Method blanks |
see table: `Concentration of method blanks in artificial media´ |
Elevated concentrations of Al and Fe in method blanks origin from the applied chemicals for preparation of different media |
Accuracy samples |
mean recovery for CRM TMDA-70: Cr: 102 ± 0.8 % (n = 14) Fe: 100 ± 0.8 % (n = 14) Zn: 103 ± 1.2 % (n = 17) |
high concentration range (415 µg Al/L; 389 µg Cr/L, 368 µg Fe/L, 477 µg Zn/L) |
Accuracy samples |
mean recovery for CRM TM15.2: Cr: 107 ± 1.1 % (n = 14) Fe: 103 ± 1.4 % (n = 14) Zn: 111 ± 1.2 % (n = 17) |
low concentration range (33.9 µg Al/L; 16.4 µg Cr/L, 25.8 µg Fe/L, 35.4 µg Zn/L) |
Accuracy mass balance |
mean recovery for CRM TMDA-70: Fe: 104 ± 10.1 % (n = 9) Zn: 98.5 ± 4.8 % (n = 7) |
high concentration range (368 µg Fe/L, 477 µg Zn/L) |
Trueness measurement series in samples |
mean recovery for recalibration standard : Cr: 97.6 ± 1.0 % (n = 11) Fe: 98.8 ± 0.9 % (n = 11) Zn: 105 ± 1.1 % (n = 11) |
mid concentration range (50 µg/L) |
Trueness measurement series in samples |
mean recovery for recalibration standard : Cr: 96.8 ± 0.8 % (n = 3) Fe: 100 ± 0.8 % (n = 3) Zn: 101 ± 2.1 % (n = 6) |
mid high concentration range (100 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : |
low concentration range (10 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : |
Mid low concentration range (25 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : |
low concentration range (50 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : Zn: 102 ± 3.1 % (n = 7) |
Mid concentration range (100 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : Zn: 98.0 ± 0.7 % (n = 2) |
High concentration range (250 µg/L) |
Trueness |
Fortification of samples: Al: 90.0 – 97.3 % Cr: 88.0 – 99.0 % Fe: 90.3 – 98.4 % Zn: 92.3 – 100 % |
|
Reproducibility sample measurement |
mean recovery for CRM TMDA-70: Cr: 102 ± 0.8 % (n = 14) Fe: 100 ± 0.8 % (n = 14) Zn: 103 ± 1.2 % (n = 17) |
high concentration range (415 µg Al/L; 389 µg Cr/L, 368 µg Fe/L, 477 µg Zn/L) |
Reproducibility sample measurement |
mean recovery for CRM TM15.2: Cr: 107 ± 1.1 % (n = 14) Fe: 103 ± 1.4 % (n = 14) Zn: 111 ± 1.2 % (n = 17) |
low concentration range (33.9 µg Al/L; 16.4 µg Cr/L, 25.8 µg Fe/L, 35.4 µg Zn/L) |
Reproducibility mass balance |
mean recovery for CRM TMDA-70: Fe: 104 ± 10.1 % (n = 9) Zn: 98.5 ± 4.8 % (n = 7) |
high concentration range (368 µg Fe/L, 477 µg Zn/L) |
Concentration of method blanks in artificial media
Artificial media |
Element |
|||
Al |
Cr |
Fe |
Zn |
|
GST |
Method blanks above LOQ but at least 2.81 fold lower than concentrations in samples |
<LOD |
three method blanks 2h below LOQ one above LOQ and 24h blanks above LOQ but at least 25 fold than concentration in samples |
Method blanks above LOQ but at least 11403 fold lower than concentrations in samples |
GMB |
Method blanks above LOQ and mainly the same as the concentration in samples |
One method blank 2h below LOQ three above LOQ and mainly the same concentration as in samples; method blanks 24h below LOQ |
<LOD/LOQ |
<LOD/LOQ |
ALF |
Method blanks above LOQ but at least 6.14 fold lower than concentrations in samples |
Method blanks above LOQ but 1.46 fold lower than concentrations in samples |
Method blanks above LOQ but at least 3.10 fold lower than concentrations in samples |
three method blanks 2h below LOQ one above LOQ; one method blank 24h below LOD and three above LOQ but at least 38939 fold lower than concentration in samples |
ASW |
Method blanks above LOQ but 1.49 fold lower than concentrations in samples |
<LOD |
<LOQ |
Method blanks above LOQ but at least 1246 fold lower than concentrations in samples |
PBS |
Method blanks above LOQ but 1.29 fold lower than concentrations in samples |
Mainly < LOQ except one method blank 2h, nearly the same concentration as in samples |
Method blanks above LOQ and mainly the same as the concentration in samples |
Method blanks above LOQ but at least 98.3 fold lower than concentrations in samples |
Measured pH in method blank and test vessels in ALF medium
sample name |
target pH |
pH prior to the test |
temp. [°C] prior to the test |
pH after 2h |
temp.[°C] |
pH after 24h |
temp.[°C] |
ALF vessel A |
4.5 |
4.5 |
31.5 |
4.5 |
30.7 |
4.5 |
28.4 |
ALF vessel B |
4.5 |
4.5 |
31.6 |
4.5 |
30.8 |
4.5 |
28.5 |
ALF blank vessel A |
4.5 |
4.5 |
31.0 |
4.5 |
33.3 |
4.5 |
31.7 |
ALF blank vessel B |
4.5 |
4.5 |
31.4 |
4.5 |
33.5 |
4.5 |
32.0 |
Measured pH in method blank and test vessels in ASW medium
sample name |
target pH |
pH prior to the test |
temp. [°C] prior to the test |
pH after 2h |
temp.[°C] |
pH after 24h |
temp.[°C] |
ASW vessel A |
6.5 |
6.5 |
33.5 |
7.3 |
32.2 |
6.2 |
30.2 |
ASW vessel B |
6.5 |
6.5 |
33.2 |
7.3 |
32.4 |
6.2 |
30.2 |
ASW blank vessel A |
6.5 |
6.5 |
33.3 |
6.4 |
34.3 |
6.0 |
33.2 |
ASW blank vessel B |
6.5 |
6.5 |
33.5 |
6.4 |
34.5 |
5.9 |
33.6 |
Measured pH in method blank and test vessels in GMB medium
sample name |
target pH |
pH prior to the test |
temp. [°C] prior to the test |
pH after 2h |
temp.[°C] |
pH after 24h |
temp.[°C] |
GMB vessel A |
7.4 |
7.4 |
32.6 |
7.8 |
31.7 |
8.8 |
29.8 |
GMB vessel B |
7.4 |
7.4 |
32.5 |
7.7 |
31.6 |
8.8 |
29.7 |
GMB blank vessel A |
7.4 |
7.4 |
31.8 |
7.7 |
33.9 |
8.8 |
32.7 |
GMB blank vessel B |
7.4 |
7.4 |
32.5 |
7.6 |
34.1 |
8.8 |
33.1 |
Measured pH in method blank and test vessels in GST medium
sample name |
target pH |
pH prior to the test |
temp. [°C] prior to the test |
pH after 2h |
temp.[°C] |
pH after 24h |
temp.[°C] |
GST vessel A |
1.5 – 1.6 |
1.6 |
34.4 |
1.6 |
32.5 |
1.6 |
31.6 |
GST vessel B |
1.5 – 1.6 |
1.6 |
34.4 |
1.6 |
32.5 |
1.6 |
31.6 |
GST blank vessel A |
1.5 – 1.6 |
1.6 |
34.4 |
1.6 |
35.1 |
1.6 |
34.5 |
GST blank vessel B |
1.5 – 1.6 |
1.6 |
34.5 |
1.6 |
34.9 |
1.6 |
33.8 |
Measured pH in method blank and test vessels inPBS medium
sample name |
target pH |
pH prior to the test |
temp. [°C] prior to the test |
pH after 2h |
temp.[°C] |
pH after 24h |
temp.[°C] |
PBS vessel A |
7.2 - 7.4 |
7.4 |
34.4 |
7.4 |
32.9 |
7.4 |
30.7 |
PBS vessel B |
7.2 - 7.4 |
7.4 |
34.2 |
7.4 |
32.5 |
7.4 |
30.2 |
PBS blank vessel A |
7.2 - 7.4 |
7.4 |
34.0 |
7.4 |
34.8 |
7.4 |
33.8 |
PBS blank vessel B |
7.2 - 7.4 |
7.4 |
34.4 |
7.4 |
34.9 |
7.4 |
34.1 |
Concentration of aluminium in artificial media, calculated nominal aluminium concentration and dissolved amount of aluminium
media and sample |
total Al ± SD in method blanks [µg/L] |
total Al ±SD in sample vessels [µg/L] |
Al ± SD in sample vessels with blank subtraction [µg/L] |
calculated nominal Al concentration in [µg/L]# |
dissolved amount Al in artificial media [%] normalized for measured background in method blank |
ALF 2h |
2.40 ± 0.10 |
14.7 ± 2.32 |
12.3 ± 2.32 |
5760 |
0.21 ± 0.04 |
ALF 24h |
2.93 ± 0.01 |
23.6 ± 0.21 |
20.7 ± 0.21 |
5760 |
0.36 ± <0.01 |
ASW 2h |
2.58 ± 0.04 |
4.59 ± 0.28 |
2.01 ± 0.28 |
5729 |
0.04 ± 0.01 |
ASW 24h |
3.23 ± 0.15 |
4.82 ± 0.34 |
1.59 ± 0.34 |
5729 |
0.03 ± 0.01 |
GMB 2h |
5.09 ± 0.12 |
6.53 ± 0.74 |
1.44 ± 0.74 |
5727 |
0.03 ± 0.01 |
GMB 24h |
5.46 ± 0.04 |
5.59 ± 0.06 |
0.42 ± 0.48 |
5727 |
0.01 ± 0.01 |
GST 2h |
7.24 ± 0.47 |
20.3 ± 7.34 |
13.1 ± 7.34 |
5734 |
0.23 ± 0.13 |
GST 24h |
8.94 ± 0.60 |
41.4 ± 0.72 |
32.4 ± 0.72 |
5734 |
0.57 ± 0.01 |
PBS 2h |
3.02 ± 0.10 |
3.89 ± 0.12 |
0.87 ± 0.12 |
5723 |
0.02 ± <0.01 |
PBS 24h |
3.85 ± 0.42 |
4.53 ± 0.78 |
0.80 ± 0.60 |
5723 |
0.01 ± 0.01 |
# (initial weight (e.g. 50 mg)* 5.66§ (percentage aluminium in test item) / 100) *2 (multiplication to calculate aluminium amount in one litre -> 100 mg/L) = nominal aluminium concentration in [mg/L] / 1000 = nominal aluminium concentration in [µg/L]
§ according to CoA 10.70 % Al as Al2O3 -> 52.93 % aluminium in Al2O3 -> (10.70 % * 52.93 %) / 100 % = 5.66 % Al in test item
In five different artificial physiological media, between 0.01 and 0.57 % of aluminium was dissolved from the test item IPC-2013-017 (reaction mass of willemite, white and zinc iron chromite brown spinel) depending on solution parameters and test duration.
Concentration of chromium in artificial media, calculated nominal chromium concentration and dissolved amount of chromium
media and sample |
total Cr ± SD in method blanks [µg/L] |
total Cr ±SD in sample vessels [µg/L] |
Cr ± SD in sample vessels with blank subtraction [µg/L] |
calculated nominal Cr concentration in [µg/L]# |
dissolved amount Cr in artificial media [%] normalized for measured background in method blank |
ALF 2h |
3.80 ± 0.03 |
5.54 ± 0.12 |
1.75 ± 0.12 |
6269 |
0.03 ± <0.01 |
ALF 24h |
3.93 ± 0.02 |
6.67 ± 0.11 |
2.74 ± 0.11 |
6269 |
0.04 ± <0.01 |
ASW 2h |
<LOD |
0.57 |
0.57 |
6235 |
0.01 |
ASW 24h |
<LOD |
1.03 ± 0.08 |
1.03 ± 0.08 |
6235 |
0.02 ± <0.01 |
GMB 2h |
0.63 ± 0.02 |
0.60 ± 0.02 |
- |
6233 |
- |
GMB 24h |
<LOQ |
0.73 ± 0.08 |
0.73 ± 0.08 |
6233 |
0.01 ± <0.01 |
GST 2h |
<LOD |
1.05 ± 0.08 |
1.05 ± 0.08 |
6241 |
0.02 |
GST 24h |
<LOD |
3.21 ± 0.05 |
3.21 ± 0.05 |
6241 |
0.05 ± <0.01 |
PBS 2h |
0.56 |
0.63 ± 0.05 |
0.15 ± 0.07 |
6228 |
0.002 ± 0.001 |
PBS 24h |
<LOQ |
0.66 ± 0.07 |
0.66 ± 0.07 |
6228 |
0.01 ± <0.01 |
# (initial weight (e.g. 50 mg) * 6.16 § (percentage chromium in test item) / 100) * 2 (multiplication to calculate chromium amount in one litre -> 100 mg/L) = nominal chromium concentration in [mg/L]/1000 = nominal chromium concentration in [µg/L]
§ according to CoA 9.01 % Cr as Cr2O3 -> 68.42 % chromium in Cr2O3 -> (9.01 % * 68.42 %) / 100 % = 6.16 % Cr in test item
In five different artificial physiological media, between 0.002 and 0.05 % of chromium was dissolved from the test item IPC-2013-017 (reaction mass of willemite, white and zinc iron chromite brown spinel) depending on solution parameters and test duration.
Concentration of iron in artificial media, calculated nominal iron concentration and dissolved amount of iron
media and sample |
total Fe ± SD in method blanks [µg/L] |
total Fe ±SD in sample vessels [µg/L] |
Fe ± SD in sample vessels with blank subtraction [µg/L] |
calculated nominal Fe concentration in [µg/L]# |
dissolved amount Fe in artificial media [%] normalized for measured background in method blank |
ALF 2h |
19.3 ± 0.15 |
59.7 ± 6.95 |
40.4 ± 6.95 |
9465 |
0.43 ± 0.07 |
ALF 24h |
19.9 ± 0.06 |
89.7 ± 1.60 |
69.8 ± 1.60 |
9465 |
0.74 ± 0.02 |
ASW 2h |
<LOQ |
2.92 ± 0.74 |
2.92 ± 0.74 |
9414 |
0.03 ± 0.01 |
ASW 24h |
<LOQ |
4.40 ± 1.15 |
4.40 ± 1.15 |
9414 |
0.05 ± 0.01 |
GMB 2h |
<LOD/LOQ |
2.24 |
2.42 |
9411 |
0.02 |
GMB 24h |
<LOD/LOQ |
<LOD/LOQ |
<LOD/LOQ |
9411 |
|
GST 2h |
1.42 |
34.8 ± 18.7 |
33.4 ± 18.7 |
9422 |
0.35 ± 0.20 |
GST 24h |
1.24 ± 0.03 |
93.9 ± 0.54 |
92.7 ± 0.54 |
9422 |
0.98 ± 0.01 |
PBS 2h |
3.91 ± 0.02 |
6.71 ± 2.95 |
2.80 ± 2.95 |
9403 |
0.03 ± 0.03 |
PBS 24h |
4.71 ± 0.66 |
4.70 ± 0.10 |
0.37 |
9403 |
0.003 |
# (initial weight (e.g. 50 mg)* 9.30 § (percentage iron in test item)/ 100) *2 (multiplication to calculate iron amount in one litre -> 100 mg/L) = nominal iron concentration in [mg/L]/1000 = nominal iron concentration in [µg/L]
§ according to CoA 13.30 % Fe as Fe2O3 -> 69.94 % iron in Fe2O3 -> (13.30 % * 69.94 %) /100 % = 9.30 % Fe in test item
In five different artificial physiological media, between 0.003 and 0.98 % of iron was dissolved from the test item IPC-2013-017 (reaction mass of willemite, white and zinc iron chromite brown spinel) depending on solution parameters and test duration.
Concentration of zinc in artificial media, calculated nominal zinc concentration and dissolved amount of zinc
media and sample |
total Zn ± SD in method blanks [µg/L] |
total Zn ±SD in sample vessels [µg/L] |
Zn ± SD in sample vessels with blank subtraction [µg/L] |
calculated nominal Zn concentration in [µg/L]# |
dissolved amount Zn in artificial media [%] normalized for measured background in method blank |
ALF 2h |
0.39 |
15014 ± 3480 |
15014 ± 3480 |
43497 |
34.5 ± 8.00 |
ALF 24h |
0.40 ± 0.01 |
26761 ± 789 |
26761 ± 789 |
43497 |
61.5 ± 1.81 |
ASW 2h |
0.71 ± 0.01 |
878 ± 110 |
878 ± 110 |
43263 |
2.03 ± 0.25 |
ASW 24h |
0.77 ± 0.22 |
1678 ± 181 |
1677 ± 181 |
43263 |
3.88 ± 0.42 |
GMB 2h |
<LOD/LOQ |
90.7 ± 3.05 |
90.7 ± 3.05 |
43249 |
0.21 ± 0.01 |
GMB 24h |
<LOD/LOQ |
2.25 |
2.25 |
43249 |
0.01 |
GST 2h |
0.99 ± 0.44 |
12741 ± 6747 |
12740 ± 6747 |
43301 |
29.4 ± 15.6 |
GST 24h |
2.31 ± 0.02 |
26413 ± 1718 |
26411 ± 1718 |
43301 |
61.0 ± 3.97 |
PBS 2h |
1.60 ± 0.10 |
158 ± 38.5 |
156 ± 38.5 |
43214 |
0.36 ± 0.09 |
PBS 24h |
1.62 ± 0.11 |
313 ± 2.77 |
311 ± 2.77 |
43214 |
0.72 ± 0.01 |
# (initial weight (e.g. 50 mg) * 42.74§ (percentage zinc in test item) / 100) * 2 (multiplication to calculate zinc amount in one litre -> 100 mg/L) = nominal zinc concentration in [mg/L] / 1000 = nominal zinc concentration in [µg/L]
§ according to CoA 53.20 % Zn as ZnO -> 80.34 % zinc in ZnO -> (53.20 % * 80.34 %) / 100 % = 42.74 % Zn in test item
In five different artificial physiological media, between 0.21 and 61.5 % of zinc was dissolved from the test item IPC-2013-017 (reaction mass of willemite, white and zinc zinc chromite brown spinel) depending on solution parameters and test duration.
Mass balance calculation
Total dissolved iron and zinc concentrations in vessels, filters and syringes measured by ICP-OES indicate an incomplete dissolution of the test item in all physiological media after addition of aqua regia to the sample vessels.
Calculation of iron mass balance
media |
value for dissolved Fe after addition of aqua regia |
nominal |
recovery |
ALF 24h A |
0.05 |
4.74 |
1.15 |
ALF 24h B |
0.06 |
4.72 |
1.20 |
ASW 24h A |
0.05 |
4.68 |
1.07 |
ASW 24h B |
0.05 |
4.74 |
1.09 |
GMB 24h A |
0.05 |
4.72 |
1.16 |
GMB 24h B |
0.05 |
4.69 |
1.11 |
GST 24 A |
0.05 |
4.73 |
1.09 |
GST 24h B |
0.05 |
4.73 |
1.08 |
PBS 24h A |
0.06 |
4.69 |
1.22 |
PBS 24h B |
0.06 |
4.71 |
1.20 |
# nominal concentration Fe = 13.30 % as Fe2O3in test item = 36.94 % Fe in Fe2O3 => 4.651 mg Fe in 50 mg test item => 4.651 * initial weight / 50 mg
Calculation of zinc mass balance
media |
value for dissolved Zn after addition of aqua regia |
nominal |
recovery |
ALF 24h A |
11.3 |
21.8 |
51.7 |
ALF 24h B |
11.0 |
21.7 |
50.7 |
ASW 24h A |
12.6 |
21.5 |
58.6 |
ASW 24h B |
12.6 |
21.8 |
57.9 |
GMB 24h A |
13.4 |
21.7 |
61.9 |
GMB 24h B |
12.9 |
21.5 |
60.1 |
GST 24 A |
11.2 |
21.7 |
51.7 |
GST 24h B |
11.3 |
21.6 |
52.5 |
PBS 24h A |
13.4 |
21.6 |
61.9 |
PBS 24h B |
13.4 |
21.6 |
62.1 |
# nominal concentration Zn = 53.20 % as ZnO in test item = 80.34 % Zn in ZnO => 21.370 mg Zn in 50 mg test item => 21.370 * initial weight / 50 mg
Applicant's summary and conclusion
- Conclusions:
- Dissolved Cr, Al, Zn and Fe concentrations were below 3.21 µg Cr/L, 32.4 µg Al/L, 26.7 mg Zn/L and 92.7 µg Fe/L respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.003 %, 0.032 %, 26.7 % and 0.093 % respectively.
- Executive summary:
The bioaccessibility of reaction mass of willemite, white and zinc iron chromite brown spinel 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:
- Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,
- Phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,
- 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,
- 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
- Artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.
Under the conditions of this test (flasks with different artificial physiological media; loadings of 100 mg/L, 37 °C, sampling after 2h and 24h), the concentrations of dissolved aluminium, chromium, iron and zinc were as follows:
In five different artificial physiological media dissolved aluminium concentrations were between 0.01 and 0.57 %, dissolved chromium concentrations were between 0.002 and 0.05 %, dissolved iron concentrations were between 0.003 and 0.98 %, and dissolved zinc concentrations were between 0.21 and 61.5 % based on respective element contained in 100 mg pigment.
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