Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 310-193-6 | CAS number: 1345-16-0 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77346
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- 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:
- 2012-0813 to 2013-02-06
- 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 2h and 24h; determination of Co and Al concentrations after filtration by ICP-OES and ICP-MS.
- 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
- Species:
- other: in vitro (simulated human body fluids)
- 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 and ICP-MS) of dissolved aluminium and cobalt 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-2013-011 (Cobalt aluminate blue 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 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: Merck XXI (lot no. HC075495); Merck VIII (lot no. HC137073); Merck Certipur Cobalt ICP standard 1000 mg/L (lot no. HC242065); Merck Certipur Aluminium ICP standard 1000 mg/L (lot no. HC125228, Darmstadt, Germany).
- Certified reference materials: TMDA-70 (lot no. 0310, Environment Canada) and a multielement standard: Merck VIII (lot no. HC137073); Merck XXI (lot no. HC075495, Darmstadt, Germany)
Instrumental and analytical set-up for the ICP-OES instrument (Al 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: Aluminium: 176.502 nm, 172.438 nm, 257.509 nm, 308.215 nm and 394.401 nm
Calibration: blank, 5 µg/L, 10 µg/L, 50 µg/L, 100 µg/L, 200 µg/L and 300 µg/L
Correlation coefficients (r): at least 0.9999
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: Cobalt: 228.616 nm and 230.786 nm.
Calibration: blank, 1 µg/L, 5 µg/L, 7.5 µg/L, 10 µg/L, 25 µg/L, 50 µg/L, 100 µg/L, 200 µg/L, 300 µg/L and 400 µg/L
Correlation coefficients (r): at least 0.9999
Four measurement series were performed for the determination of aluminium and cobalt concentrations in the test item samples, method blanks, mass balance samples and filter samples.
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).
Instrumental and analytical set-up for the ICP-MS instrument:
Agilent 7700 ICP-MS, Agilent Technologies, Waldbronn, Germany
Nebulizer: Concentric glass nebulizer, from GlassExpansion
Spray chamber: Scott Type spray chamber, from Agilent
Carrier gas flow: 0.91 L/min
Dilution/Make-up gas flow: 0.13 L/min
RF power: 1500 W
Isotopes: 90Zr, 91Zr, 103Rh (internal standard)
calibrations: blank, 0.1 µg/L, 0.25 µg/L, 0.5 µg/L, 0.75 µg/L, 1.0 µg/L, 2.5 µg/L, 5.0 µg/L, 7.5 µg/L, 10.0 µg/L, 25.0 µg/L, 50.0 µg/L, 75.0 µg/L, 100 µg/L, 250 µg/L and 500 µg/L.
Correlation factors (r) were at least 0.9997
In sum, five series of measurements were performed for the determination of total dissolved cobalt and aluminium concentrations in samples including the test vessels as well as blanks to determine background levels of elements and fortified samples.
The LOD and LOQ for zirconium were calculated using the internal instrument algorithm. This calculation is according to DIN 32645. For this the standard deviation of calibration blanks is multiplied by 3 and divided by the slope of the calibration line. In Table 10 the LODs and LOQs for cobalt and aluminium are shown. - 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 100.422 mg/L to 101.986 mg/L in the test vessels. - Type:
- other: Bioaccessibility
- Results:
- Higest dissolution at a loading of 0.1g/L after 24h in ALF: Co: 12.9 ± 0.37 µg/L, Al: 181 ± 1.54 µg/L; in GST: Co: 9.18 ± 0.08 µg/L, Al: 223 ± 4.81 µg/L
- Conclusions:
- The bioaccessibility of cobalt aluminate blue 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 dissolved Co and Al concentrations were below 12.9 µg/L and 223 µg/L, respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.013 % and 0.223 %, respectively, the pigment is considered biologically inert. - Executive summary:
The bioaccessibility of Co, and Al 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.
In total dissolved Co and Al concentrations were below 12.9 µg/L and 223 µg/L, respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.013 % and 0.223 %, respectively, the pigment is considered biologically inert.
Reference
Method validation summary (ICP-OES)
validation parameter |
results |
Comment |
Selectivity |
Nearly similar data with two different wavelengths for ICP-OES method |
interference observed on the wavelength 176.502 nm, for this reason wavelength 394.401 nm was used for evaluation of date -> no interference was observed on this wavelength |
Linearity |
applied calibration functions were linear |
correlation coefficient at least 0.9999 |
Limit of detection |
Al: 3.45 – 4.08 µg/L |
|
Limit of quantification |
Al: 10.3 – 12.2 µg/L |
|
Method blanks |
ASW <LOQ; ALF: Method blanks above LOQ but at least 5.63 fold lower than concentrations in samples |
Elevated concentrations of Al in method blanks origin from the applied chemicals for preparation of different media |
Accuracy |
mean recovery for CRM TMDA-70: Co: 100 ± 2.8 % (n = 9) |
high concentration range (415 µg Al/L; 285 µg Co/L) |
Trueness measurement series Al in samples |
mean recovery for recalibration standard : |
low concentration range (100 µg/L) |
Trueness measurement series Al in samples |
mean recovery for recalibration standard : |
mid concentration range (250 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 : |
Mid concentration range (100 µg/L) |
Trueness mass balance samples |
mean recovery for recalibration standard : |
High concentration range (250 µg/L) |
Trueness |
Fortification of samples: Al: 86.5 – 96.8 % |
|
Accuracy |
mean recovery for CRM TMDA-70: Co: 100 ± 2.8 % (n = 9) |
high concentration range (415 µg Al/L; 285 µg Co/L) |
Method validation summary (ICP-MS)
validation parameter |
results |
Comment |
Selectivity |
Co: similar in Helium and HiHelium mode Al: similar in Helium and HiHelium mode |
appropriate gas mode were selected for interference free measurements |
Linearity |
applied calibration functions were linear |
correlation coefficients ≥ 0.9997 |
Limit of detection |
Co: 0.0004 – 0.45 µg/L Al: 0.32 – 0.39 µg/L |
|
Limit of quantification |
Co: 0.001 – 1.38 µg/L Al: 0.96 – 1.17 µg/L |
|
Method blanks |
Co: ASW, PBS and GST below LOD; GMB above LOQ but at least 3.4 fold lower than concentrations in samples; ALF above LOQ but at least 91 fold lower than concentrations in samples Al: Method blanks GMB and PBS above LOQ, mainly same concentrations as in samples |
Elevated concentrations of Co and Al in method blanks origin from the applied chemicals for preparation of different media |
Accuracy |
mean recovery for CRM TMDA-70: Al: 94.0 ± 8.2 % (n = 8) |
high concentration range (285 µg Co/L, 415 µg Al/L) |
Trueness Co |
mean recovery for recalibration standard: |
low concentration range (10 µg/L) |
Trueness Co |
mean recovery for recalibration standard: |
mid concentration range (100 µg/L) |
Trueness Al |
mean recovery for recalibration standard: |
low concentration range (10 µg/L) |
Trueness Al |
mean recovery for recalibration standard: |
mid concentration range (100 µg/L) |
Trueness |
Fortification of samples: Co: 91.8– 109 % Al: 87.2– 111 % |
|
Reproducibility |
mean recovery for CRM TMDA-70: Co: 104 ± 6.5 % (n = 20) Al: 94.0 ± 8.2 % (n = 8) |
high concentration range (285 µg Co/L, 415 µg Al/L) |
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 |
27.9 ± 0.12 |
157 ± 1.30 |
129 ± 1.30 |
31225 |
0.41 ± <0.01 |
ALF 24h |
24.8 ± 0.37 |
206 ± 1.54 |
181 ± 1.54 |
31225 |
0.58 ± 0.01 |
ASW 2h |
<LOQ |
15.7 ± 0.13 |
15.7 ± 0.13 |
31106 |
0.05 ± <0.01 |
ASW 24h |
<LOQ |
22.5 ± 1.52 |
22.5 ± 1.52 |
31106 |
0.07 ± 0.01 |
GMB 2h |
37.7 ± 5.30 |
31.7 ± 3.49 |
1.51 |
31153 |
0.005 |
GMB 24h |
27.9 ± 4.83 |
34.7 ± 1.52 |
6.80 ± 1.52 |
31153 |
0.02 ± 0.01 |
GST 2h |
18.3 ± 0.26 |
182 ± 3.59 |
163 ± 3.59 |
31273 |
0.52 ± 0.01 |
GST 24h |
15.3 ± 1.52 |
238 ± 4.81 |
223 ± 4.81 |
31273 |
0.71 ± 0.02 |
PBS 2h |
14.6 ± 0.78 |
9.38 ± 0.75 |
- |
31156 |
- |
PBS 24h |
10.0 ± 0.16 |
10.4 ± 1.35 |
- |
31156 |
- |
# (initial weight (e.g. 50 mg) * 30.75 § (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 58.10 % Al as Al2O3 => 52.93 % aluminium in Al2O3 => (58.10 % * 52.93 %) / 100 % = 30.75 % Al in test item
In five different artificial physiological media, dissolved Al levels ranged from 0.005 and 0.71 % of nominal aluminium contained in the respective loading of 100 mg/L cobalt aluminate blue spinel (IPC-2013 -011) depending on solution parameters and test duration.
Concentration of cobalt in artificial media, calculated nominal cobalt concentration and dissolved amount of cobalt.
media and sample |
total Co ± SD in method blanks [µg/L] |
total Co ±SD in sample vessels [µg/L] |
Co ± SD in sample vessels with blank subtraction [µg/L] |
calculated nominal Co concentration in [µg/L]# |
dissolved amount Co in artificial media [%] normalized for measured background in method blank |
ALF 2h |
0.07 ± 0.01 |
6.78 ± 0.22 |
6.70 ± 0.22 |
31469 |
0.02 ± <0.01 |
ALF 24h |
0.08 ± 0.01 |
12.9 ± 0.37 |
12.9 ± 0.37 |
31469 |
0.04 ± <0.01 |
ASW 2h |
<LOD |
<LOD |
<LOD |
31123 |
- |
ASW 24h |
<LOD |
1.56 ± 0.08 |
1.56 ± 0.08 |
31123 |
0.01 ± <0.01 |
GMB 2h |
0.02 ± <0.01 |
0.08 ± 0.01 |
0.06 ± 0.01 |
31396 |
<0.001 |
GMB 24h |
0.03 ± 0.01 |
0.40 ± 0.02 |
0.37 ± 0.02 |
31396 |
0.001 ± <0.001 |
GST 2h |
<LOD |
4.96 ± 0.16 |
4.96 ± 0.16 |
31517 |
0.02 ± <0.01 |
GST 24h |
<LOD |
9.15 ± 0.08 |
9.15 ± 0.08 |
31517 |
0.03 ± <0.01 |
PBS 2h |
<LOD |
0.05 ± 0.02 |
0.05 ± 0.02 |
31399 |
<0.001 |
PBS 24h |
<LOD |
0.46 ± 0.14 |
0.46 ± 0.14 |
31399 |
0.002 ± <0.001 |
# (initial weight (e.g. 50 mg) * 30.99 § (percentage cobalt in test item) / 100) * 2 (multiplication to calculate cobalt amount in one litre -> 100 mg/L) = nominal cobalt concentration in [mg/L]/1000 = nominal cobalt concentration in [µg/L]
§according to CoA 39.40 % Co as CoO => 78.65 % cobalt in CoO => (39.40 % * 78.65 %) / 100 % = 30.99 % Co in test item
In five different artificial physiological media, dissolved Co levels ranged from 0.001 to 0.04 % of nominal cobalt contained in the respective loading of 100 mg/L cobalt aluminate blue spinel (IPC-2013-011) depending on solution parameters and test duration.
Mass balance calculation
Total dissolved cobalt 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 cobalt mass balance
media |
value for dissolved Co after addition of aqua regia[mg] |
nominal concentration |
recovery |
ALF 24h A |
0.005 |
15.7 |
0.03 |
ALF 24h B |
0.005 |
15.8 |
0.03 |
ASW 24h A |
- |
- |
- |
ASW 24h B |
0.02 |
15.6 |
0.14 |
GMB 24h A |
0.005 |
15.7 |
0.03 |
GMB 24h B |
0.005 |
15.7 |
0.03 |
GST 24 A |
0.01 |
15.8 |
0.04 |
GST 24h B |
0.01 |
15.8 |
0.04 |
PBS 24h A |
0.01 |
15.6 |
0.03 |
PBS 24h B |
0.01 |
15.8 |
0.03 |
# nominal concentration Co = 39.40 % as CoO in test item = 78.65 % Co in CoO => 15.4937 mg Co in 50 mg test item => 15.4937 * initial weight / 50 mg
Description of key information
As dissolved Co and Al concentrations were below 12.9 µg/L and 223 µg/L, respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.013 % and 0.223 %, respectively, the pigment is considered biologically inert.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Discussion on bioaccumulation potential result:
The chemical and physiological properties of the pigment cobalt aluminate blue spinelare dominated by inertness due to the characteristics of the production process (calcination at high temperatures, approximately 1000 °C), rendering the substance to be of a unique, stable crystalline structure. This fundamental process leads to a very low bioaccessibility for the elements contained in the pigment. By simulating the typical physiological conditions of the presumed exposure routes (oral, dermal and inhalation) with
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.
An oral, dermal or inhalative uptake of the substance for humans exposed to the pigment is negligible.
The dissolution of Co of the test item is between 0.06 µg/L /0.37 µg/L (GMB) and 6.70 µg/L/ 12.9 µg/L (ALF) at a loading of 0.1 g/L after 2 and 24 hours.
The dissolution of Al of the test item is in a range of below LoD/ 1.28 µg/L, (PBS) and 163 µg/L/ 223 µg/L (GST) at a loading of 0.1 g/L after 2 and 24 hours.
A pH dependent dissolution can be observed.In conclusion, since the dissolved Co and Al concentrations were below 12.9 and 223 µg/L respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.013 and 0.223 %, respectively, this pigment may reasonably be considered biologically inert.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.