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EC number: 269-102-2 | CAS number: 68187-50-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77498.
- 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:
- 12 June 2017 - 12 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 guidelineopen allclose all
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: ASTM 2003. Standard test method for determining extractability of metals from art materials. ASTM D5517-03
- Version / remarks:
- bioaccessibility test protocol
- Qualifier:
- according to guideline
- Guideline:
- other: Stopford W, Turner J, Cappelini D, Brock T 2004. Bioaccessibility testing of cobalt compounds. Journal of Environmental Monitoring 5: 675-680.
- Version / remarks:
- bioaccessibility test protocol
- Qualifier:
- according to guideline
- Guideline:
- other: 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.
- Version / remarks:
- bioaccessibility test protocol
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Fraunhofer Institute for Molecular Biology and Applied Ecology IME
Test material
- Reference substance name:
- Iron cobalt black spinel
- EC Number:
- 269-102-2
- EC Name:
- Iron cobalt black spinel
- Cas Number:
- 68187-50-8
- Molecular formula:
- CoFe2O4
- IUPAC Name:
- Iron cobalt spinel
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (RT), Keep container dry, tightly closed at a cool place
- Stability under test conditions: Stable under storage conditions - Radiolabelling:
- no
Administration / exposure
- Details on study design:
- A study was conducted with the objective to investigate the dissolution of the test item in the artificial physiological media GST and ASW. The test media were selected to simulate relevant human-chemical interactions, i.e. a substance entering the human body by ingestion or by inhalation.
The test followed the experimental conditions of the OECD 29 guidance: 24 h agitation at 100 rpm inside an incubated laboratory shaker (Shaking incubation cabinet, INFORS AG, Bottmingen, Switzerland). The temperature in the thermostatically controlled incubation cabinet was adjusted to 37.5°C to obtain a temperature of 37 ± 2°C in the media to simulate the temperature of the human body.
Artificial media:
ASW= Artificial sweat solution (pH = 6.5) simulates an exposure scenario in contact with human skin, i.e. the hypo-osmolar fluid, linked to hyponatraemia (loss of Na+ from
blood), that is excreted from the body when sweating.
Composition: 5 g/L NaCl, 1 g/L Urea, 1g/L Lactic acid
GST =Artificial gastric fluid (pH = 1.5) mimics the very harsh digestion milieu of high acidity in the stomach.
Composition: 0.07 N HCl
For the experimental setup the test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium (loading of approx. 100 mg/L) and agitated at 100 rpm at 37°C ± 2°C. Samples were taken after 2 h and 24 h. The total dissolved iron and cobalt concentrations of sampled solutions were determined after filtration by ICP-OES.
Solution pH during the sampling was measured using a Multi 9430 equipped with a Sentix 940-3 electrode from WTW (Weilheim, Germany) directly in the test vessel.
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, iron and cobalt concentration were measured in at least one mass balance sample (vessel and filter/syringes) for each medium by ICP-OES (see section 6.3), and the mass balance was calculated.
ICP-OES analysis
The ICP-OES measurements were performed with an Agilent 720 ICP-OES (Agilent Technologies, Waldbronn, Germany). Iron was detected at the wavelengths 238.204 nm, 259.837 nm and 259.940 nm; cobalt was detected at the wavelengths 230.786 nm, 237.863 nm and 258.033 nm. The following solutions were used to calibrate the instrument: 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. Calibrations were performed before the measurement. The calibration formula was calculated using the linear regression algorithm of the ICP-OES instrument (correlation coefficient has to be at least 0.995). Concentrations of the respective wavelength data for interference-free measurement with recoveries in the range of the quality control parameters for the validation samples (certified reference material, quality control standards, recalibration standards, fortifications, digested certified reference material) in the measurement series were used. Correlation coefficients (r) for the wavelengths used for evaluation of data were at least 0.999942. For each sample, at least three internal measurements were performed and the mean was calculated and printed by the instrument software.
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
Standards for metal analysis:
Commercially available single element standards were used as iron and cobalt standards (Merck Certipur Iron ICP standard 1000 mg/L lot no. HC55531826; Merck Certipur Cobalt ICP standard 1000 mg/L lot no. HC55211813; Darmstadt, Germany). These standard solutions were used to prepare an appropriate stock solution and subsequently calibration solutions for ICP-OES measurements.
Certified reference materials:
As quality control standards certified aqueous reference material TMDA-52.4 (lot no. 0615) and TMDA-70.2 (lot no. 0916) obtained from Environment Canada and a multielement standard (Roth, lot no. E65304, Karlsruhe, Germany) were analysed for total dissolved iron and cobalt 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.
The certified reference material TMDA-52.4 and TMDA-70.2 as well as quality control standards and recalibration standards were analyzed as quality assurance samples along with the test samples. To meet quality assurance requirements recovery needs to be in the range of ± 15 % of the respective certified value.
As further quality assurance measurement, routine analyses of method blank samples were performed with the same pretreatment as the test samples - Details on dosing and sampling:
- Preparation, treatment and storage of samples for chemical analysis:
Solutions were sampled for measuring total dissolved iron and cobalt by ICP-OES. All samples were filtered through 0.2 μm filter (Syringe Filter w / 0.2 μm, polyethersulfon membrane, DIA Nielsen, Dueren, Germany) prior to the measurements. Aqueous samples of approx. 20 mL for sample a and 20 mL for sample b were taken at each sampling point and each vessel for Fe and Co analysis and transferred into disposable scintillation vials (20 mL scintillation tubes, Sarstedt, Nuembrecht, Germany) after filtration. Afterwards the samples were acidified with HNO3. Of sample b of vessel 2 (2h and 24h) only 10 mL sample was taken during the sampling, this has no influence on the test/concentration only in the end in the mass balance. The maximum storage time until measurement of the samples was less than one month.
Results and discussion
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Under the conditions of this test (flasks with different artificial physiological media; inorganic Pigment loadings of approx. 50 mg per 500 mL (i.e. 100 mg/L), at 37°C, sampling after 2h and 24h), the measured concentrations of dissolved iron and cobalt were presented in the table 1 and 2 below.
The mass balance dissolved iron and cobalt concentrations in vessels and filters as measured by ICP-OES indicate no complete dissolution of the test item in the physiological medium GST and a complete dissolution in ASW medium after addition of aqua regia to the sample vessels. Due to the observations during the mass balance test item was still visible which could be a result of insoluble parts of the test item.
During the study, the pH of GST medium remained stable in the method blank vessels and the test vessels. Therefore, a possible effect of the test substance can be excluded. In ASW medium, the pH in all vessels (including method blank vessels) decreased from the start of the study to the 2h sampling point (6.25 and 6.32 in test sample vessels, 6.26 and 6.32 in method blank vessels). During the measurement of the pH at sampling point 24h a further decrease of the pH in the method blank vessels was observable (6.01 and 6.17) and in the test vessels a decrease in two vessels in the same range as the method blank vessels was observable (5.99 and 6.02) as well as one increase (6.88). Due to the mainly same pH in test and method blank vessels an effect of the test substance can be excluded.
Any other information on results incl. tables
Table 1: Concentration of dissolved iron in artificial physiological media
media and sample |
LOD/LOQ of Fe measurement series |
total Fe ± SD in method blanks |
Without method blank subtraction |
With mean method blank subtraction |
||
total Fe ± SD in sample vessels without method blank |
total Fe ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L) |
total Fe ± SD in sample vessels |
total Fe ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L) |
|||
GST 2h |
LOD: 0.068 µg/L LOQ: 0.204 µg/L |
One method blank below LOD, three method blanks above LOQ; 0.545 ± 0.004 µg/L |
94.7 ± 6.67 µg/L |
94.7 ± 6.68 µg/L |
94.2 ± 6.67 µg/L |
94.1 ± 6.68 µg/L |
GST 24h |
LOD: 0.068 µg/L LOQ: 0.204 µg/L |
One method blank below LOD, one method blank below LOQ (one vessel – first vessel), two method blanks above LOQ; 4.33 ± 5.78 µg/L |
644 ± 166 µg/L |
644 ± 166 µg/L |
640 ± 166 µg/L |
639 ± 166 µg/L |
ASW 2h |
LOD: 0.239 µg/L LOQ: 0.718 µg/L |
One method blank below LOD, two method blanks below LOQ, one method blank above LOQ; 0.890 µg/L |
Four samples below LOD, two samples above LOQ; 2.11 ± 1.86 µg/L |
2.11 ± 1.86 µg/L |
After subtraction of mean method blank concentration one sample concentration negative and one concentration at 2.54 µg/L |
After subtraction of mean method blank concentration one sample concentration negative and one concentration at 2.54 µg/L |
ASW 24h |
LOD: 0.239 µg/L LOQ: 0.718 µg/L |
Two method blanks below LOD, one method blank below LOQ; one method blank above LOQ; 1.29 µg/L |
Three samples below LOD, one sample below LOQ, two samples above LOQ; 0.810 ± 0.069 µg/L |
0.810 ± 0.069 µg/L |
After subtraction of mean method blank concentration of both sample concentrations negative |
After subtraction of mean method blank concentration of both sample concentrations negative |
Table 2: Concentration of dissolved cobalt in artificial physiological media
media and sample |
LOD/LOQ of Co measurement series |
total Co ± SD in method blanks |
Without method blank subtraction |
With mean method blank subtraction |
||
total Co ± SD in sample vessels without method blank |
total Co ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L) |
total Co ± SD in sample vessels |
total Co ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L) |
|||
GST 2h |
LOD: 0.387 µg/L LOQ: 1.16 µg/L |
All method blanks below LOD |
94.4 ± 4.18 µg/L |
94.4 ± 4.16 µg/L |
No subtraction |
No subtraction |
GST 24h |
LOD: 0.387 µg/L LOQ: 1.16 µg/L |
All method blanks below LOD |
362 ± 89.7 µg/L |
362 ± 89.6 µg/L |
No subtraction |
No subtraction |
ASW 2h |
LOD: 0.301 µg/L LOQ: 0.904 µg/L |
All method blanks below LOD |
31.3 ± 1.26 µg/L |
31.3 ± 1.25 µg/L |
No subtraction |
No subtraction |
ASW 24h |
LOD: 0.301 µg/L LOQ: 0.904 µg/L |
All method blanks below LOD |
66.1 ± 6.66 µg/L |
66.1 ± 6.65 µg/L |
No subtraction |
No subtraction |
Applicant's summary and conclusion
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