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EC number: 215-609-9 | CAS number: 1333-86-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- distribution
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Carbon black (Association of Powder Process Industry and Engineering, Kyoto, Japan).
Fraction of CB particles below 100 nm was approximately 3% and 40% of the nominal concentrations of CB particles by weight and number. - Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- inhalation
- Details on exposure:
- Median particle diameter 116.4 nm
- Duration and frequency of treatment / exposure:
- 6 hours per day, 5 days per week for a total of 4 weeks; mean CB particle size (nm) ± SD determined at 1, 8, 15, 22 and 29 days after exposure was 118.1 ± 2.4, 119.1 ± 2.7, 122.2 ± 2.0, 122.4 ± 2.5, and
121.9 ± 3.6, respectively. Concentration of CB particles below 100 nm was approximately 3% and 40% of the nominal concentrations of CB particles by weight and by number, respectively - Dose / conc.:
- 15.6 mg/m³ air
- Control animals:
- yes
- Details on study design:
- Rats were exposed to nominal concentrations of 15.6±3.5 mg/m3 (1.57±0.4×1010 particle number/m3) for 6 h/day, 5 days per week for a total of 4 weeks. The control rats were exposed to clean, filtered air containing no CB for the same period. The concentrations of CB were monitored twice weekly by measuring the gross weight with a PTFE binder glass filter
Mean size (nm)±SD determined at 1, 8, 15, 22 and 29 days after exposure was 118.1±2.4, 119.1±2.7, 122.2±2.0, 122.4±2.5, and 121.9±3.6, respectively. Concentration of CB particles below 100 nm was approximately 3% and 40% of the nominal concentrations of CB particles by weight and number - Type:
- absorption
- Results:
- no evidence of systemic absorption
- Type:
- distribution
- Results:
- no evidence of translocation of inhaled carbon black
- Type:
- metabolism
- Results:
- not measured
- Executive summary:
Evidence of translocation of inhaled carbon black (median diameter of 116 nm) was not obtained. It is likely that inhaled nano-sized carbon black particles form aggregations in the lung and do not exert direct adverse effects on extrapulmonary tissues.
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- MPPD Modelling
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- exposure-related information
- Objective of study:
- toxicokinetics
- other: deposition kinetics in lungs
- Principles of method if other than guideline:
- Dustiness of the test substance was investigated in accordance with rotating drum method and the results expressed in mg/g. The fraction of material that becomes airborne under the conditions of this test is described as “total dustiness, which is a reflection of that fraction of material capable to become airborne under moderate agitation as comparable to conditions at the workplace (e.g. during packaging operations). Particle size distribution and aerodynamic diameters of the airborne fraction is characterised. The MMAD and GSD of the particles are calculated for with the aid of non-linear regression algorithms. Derived particles distribution parameters are used to quantify the deposited fractions of the airborne dust in the human respiratory tract. This is performed using the Multiple-Path Particle Dosimetry Model (MPPD, v3.04; ARA, 2015) based on morphological data on the human respiratory tract and the aerodynamic diameter of a particle under scrutiny. This model predicts the fraction of inhaled material that is deposited in the extra-thoracic (Head), tracheo-bronchial (TB) and alveolar (PU) regions. The MPPD model algorithms calculate the deposition (and clearance) of mono-disperse and polydisperse aerosols in the respiratory tract for particles ranging from ultra-fine (0.01 microns) to coarse (20 microns) sizes. Within each airway, deposition is calculated using theoretically derived efficiencies for deposition by diffusion, sedimentation and impaction within the airway or airway bifurcation. Filtration of aerosols by the head is determined using empirical efficiency functions.
- GLP compliance:
- no
- Species:
- other: humans
- Route of administration:
- inhalation: aerosol
- Details on distribution in tissues:
- Based on the MPPD model the following conclusions can be drawn for risk characterisation purposes for all of the tested substances:
(i) the tested Carbon black sample has a limited deposition ability in the human respiratory tract: Only 42.86 % of airborne material is estimated to deposit in the human lung. The rest of the airborne material is not inhaled due to physical phenomena related to air streams and turbulences close to the mouth or simply exhaled (i.e. not deposited).
(ii) about 0.56 % or less of inhaled material are predicted to deposit in the pulmonary region (PU) of the human lung whereas the material deposited in the tracheobronchial (TB) (0.35 %) and the extrathoracic region (Head) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing). - Conclusions:
- Based on the MPPD model the following conclusions can be drawn for risk characterisation purposes for all of the tested substances:
(i) the tested Carbon black sample has a limited deposition ability in the human respiratory tract: Only 42.86 % of airborne material is estimated to deposit in the human lung. The rest of the airborne material is not inhaled due to physical phenomena related to air streams and turbulences close to the mouth or simply exhaled (i.e. not deposited).
(ii) about 0.56 % or less of inhaled material are predicted to deposit in the pulmonary region (PU) of the human lung whereas the material deposited in the tracheobronchial (TB) (0.35 %) and the extrathoracic region (Head) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing). - Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Remarks:
- Bioaccessibility
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- September - October 2020
- 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
- Version / remarks:
- test medium, loading and test duration adopted for toxicokinetics assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: the Standard Operating Procedure for Bioelution Testing of Metals, Inorganic Metal Compounds, and Complex Metal-Containing Materials: Simulated Gastric Fluid
- Version / remarks:
- Version 09.11.2018; submitted by Eurometaux to ECVAM as part of the OECD validation process in November 2018, validated by ECVAM in December 2019
- Principles of method if other than guideline:
- An internationally agreed guideline does not exist for this test (e.g. OECD). The test was conducted on the basis of the guidance for OECD-Series on testing and assessment Number 29 and according to the bioaccessibility test protocol validated by EURL ECVAM.
The test was performed on the basis of OECD Series on Testing and Assessment No. 29 (2001; ENV/JM/ MONO(2001)9) and the Standard Operating Procedure for Bioelution Testing of Metals, Inorganic Metal Compounds, and Complex Metal-Containing Materials: Simulated Gastric Fluid (version 09.11.2018; submitted by Eurometaux to ECVAM as part of the OECD validation process in November 2018) and was in principle followed. The test media were artificial physiological media: Gamble's solution (GMB) and Artificial gastric fluid (GST). - GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: in vitro (simulated human body fluids)
- Details on test animals or test system and environmental conditions:
- The objective of this test was to assess the dissolution of carbon black in two artificial physiological media: Artificial gastric fluid (GST, pH 1.5) and Gamble’s solution (GMB, pH 7.4). The test media were selected to simulate relevant human-chemical interactions (as far as practical), e.g. a substance entering the human body by ingestion into the gastro-intestinal tract (GST) or via the respiratory system (GMB).
Test principle in brief:
- two different artificial physiological media: GMB and GST,
- one loading of test substance of 2 g/L,
- the test was performed in triplicates with blanks in quadruplicates
- solutions were sampled after 2 and 24h of agitation (100 rpm) at 37 ± 1 °C; one replicate of GMB was additionally sampled after 168h. Further, the test was performed in a 5 % CO2 atmosphere.
- measurement of dissolved/dispersed carbon concentrations (inorganic carbon and total carbon) after filtration (0.2 µm)
- four additional method blanks per medium - Duration and frequency of treatment / exposure:
- Dissolved total carbon (TC), inorganic carbon (IC) and based on indirect determination organic carbon concentrations in GMB and GST media were assessed after 2 and 24 hours of incubation with the test substance. One replicate of GMB solution was analysed after 168 hours to confirm the absence of carbon dissolution.
- Dose / conc.:
- 2 other: g of test item/L artificial media
- Details on study design:
- Test setup
Four replicate flasks (500 mL glass flasks, one for pH measurement only) per test medium (GMB and GST) were prepared with a loading of 2 g/L. The test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium and agitated at 100 rpm at 37°C ± 1°C. Four control blank replicates (same procedure) per test medium were also prepared.
Four replicates containing the test item (one for pH measurement only) and four method blanks per artificial medium were tested. All solutions were sampled after 2 and 24 h (one replicate of GMB after 168 h.
Dissolved total carbon (TC) and inorganic carbon (IC) were measured by a TOC analyser after 0.2 µm filtration (0.2 µm, Syringe Filter, PET, Chromafil, Macherey-Nagel, Düren, Germany). In addition, temperature, pH and observations, including the appearance of the solution (including colour, turbidity and particle film on the surface) were recorded.
Sample fortification:
In addition, samples of the artificial physiological media were fortified with a known amount of TC and IC (by standard addition of commercial standards) to determine the standard recovery. For detailed information please refer to "Any other information on materials and methods incl. tables".
Reagents:
Purified water (resistivity > 18 MΩ·cm, Pure Lab Ultra water purification system from ELGA LabWater, Celle, Germany)
MgCl2 x 6H2O (extra pure AppliChem, Darmstadt, Germany)
NaCl (p.A., Merck, Darmstadt, Germany)
KCl (p.A., Merck, Darmstadt, Germany)
Na2HPO4 (p.A., Merck, Darmstadt, Germany)
Na2SO4 (p.A., Merck, Darmstadt, Germany)
CaCl2 x 2H2O (p.A., Merck, Darmstadt, Germany)
NaAcetate anhydrous (p.A., Merck, Darmstadt, Germany)
NaHCO3 (p.A., Merck, Darmstadt, Germany)
Na3Citrate x 2H2O (p.A., Merck, Darmstadt, Germany)
HCl 30% (instra-analyzed, plus J.T. Baker, Griesheim, Germany)
HNO3 (Supra, Roth, Karlsruhe, Germany)
NaOH (p.A., Merck, Darmstadt, Germany)
DISSOLVED TOTAL CARBON AND INORGANIC CARBON ANALYSIS
Chemical analysis:
For the measurement of TC and IC a pre-performed and validated calibration was used. Based on the calibration the LOD and LOQ was calculated and reported.
The TC and IC concentrations were determined after 0.2 µm filtration of the samples, whereas the TOC (DOC) was calculated by subtraction of IC from TC.
The measurements were performed according to internal Fraunhofer IME SOPs (Standard Operating Procedures) with a SHIMADZU TOC- V CPH Analyzer.
Analysis by SHIMADZU TOC- V CPH Analyzer
A calculation of the LOD and LOQ according to DIN 32645 by the indirect method (calibration method) was performed with the program SQS (SQS 2013, version 1.00, Software zur statistischen Qualitätskontrolle analytischer Daten; validated software).
Recovery rates of the quality control standards (for TC = Potassium hydrogen phthalate standard solution lot. No. 20029253 and for IC = Sodium hydrogen carbonate standard solution lot. No. 20031922, Bernd Kraft, Duisburg, Germany) and the TC and IC concentrations of ultra-pure water (used a quality control sample to check possible contaminations; measurement of NPOC – standard program for ultra-pure water) were determined. - Details on dosing and sampling:
- Total carbon (TC), inorganic carbon (IC) and based on indirect determination organic carbon concentrations in GMB and GST media were assessed after 2 and 24 hours of incubation with 2 g/L test substance. One replicate of GMB solution was analysed after 168 hours to confirm the absence of carbon dissolution.
- Type:
- other: Bioaccessibility GMB, 2, 24 and 168 h @ 37°C (2 g/L loading, 0.2 µm filtration for phase separation)
- Results:
- TC, IC & OC concentrations are similar to respective TC, IC & OC background concentrations
- Type:
- other: Bioaccessibility GST, 2 and 24 h @ 37°C (2 g/L loading, 0.2 µm filtration for phase separation)
- Results:
- TC, IC & OC concentrations are similar to respective TC, IC & OC background concentrations
- Bioaccessibility (or Bioavailability) testing results:
- The bioaccessibility of Carbon Black (N990) was determined in vitro by simulating dissolution under physiological conditions in body fluids with a loading of 2 g test item/L.
Total carbon (TC):
Total carbon concentrations of GST method blanks and after 2 and 24h sampling were below the LOQ (LOQ: 1.01 mg TC/L).
Total carbon concentrations of GMB test solutions were above the LOQ (LOQ: 4.27 mg/L) but results were within the calculated range for total carbon background concentration. Hence, concentrations are not distinguishable from background concentrations (i.e. 503 - 525 mg/L).
Inorganic carbon (IC):
Inorganic carbon concentrations of method blanks and GST test solutions were above the LOQ (LOQ: 0.114 mg/L). The concentrations of the test solutions were in the same order of magnitude as concentrations of method blanks and are not distinguishable from background concentrations (i.e. 0.140 - 0.164 mg/L).
Inorganic carbon concentrations of GMB test solutions were above the LOQ (LOQ: 3.90 mg/L) but results were within the calculated range for total carbon background concentration. Hence, concentrations are not distinguishable from background concentrations (i.e. 304 - 325 mg/L).
Organic carbon (OC):
Organic carbon concentrations of GST method blanks and after 2 and 24h sampling were below the LOD/LOQ (same LOD/LOQ as TC).
Inorganic carbon concentration of GMB test solution were determined the LOQ (same LOQ as TC) but results were within the calculated range for organic carbon background concentrations. Hence, concentrations are not distinguishable from background concentrations (i.e. 196 - 200 mg/L). - Conclusions:
- Measured total carbon, inorganic carbon concentrations and indirectly determined organic carbon concentrations of artificial lung fluid and artificial gastric fluid exposed to 2 g/L Carbon Black (N990) for 2 and 24 h were not different from respective carbon background concentrations of the artificial body fluids. Hence, Carbon Black (N990) is considered non-soluble in artificial lung fluid and artificial gastric fluid.
- Executive summary:
The objective of this bioaccessibility study is to investigate the dissolution/dispersion of Carbon Black (N990) (EC 215-609-9; CAS 1333-86-4) in artificial lung fluid and gastric fluid.
The test was performed on the basis of the OECD Series on Testing and Assessment No. 29 (2001; ENV/JM/ MONO(2001)9). The Standard Operating Procedure for Bioelution Testing of Metals, Inorganic Metal Compounds, and Complex Metal-Containing Materials: Simulated Gastric Fluid (validated by ECVAM in December 2019) was followed in principle .
The test media were selected to simulate relevant human-chemical interactions of the substance by entering the human body by ingestion into the gastro-intestinal tract (GST) or by inhalation via the respiratory system (GMB).
The test solutions with a loading of 2g/L (triplicates and one additional flask for pH measurements) were agitated at 100 rpm at 37°C ± 1°C. Test solutions were sampled for analysis after 2 h, 24 h and one GMB replicate after 168 h.
Dissolved total carbon concentrations (TC) and inorganic carbon concentrations (IC) were measured with a SHIMADZU TOC- V CPH Analyzer after filtration (0.2 µm, Syringe Filter, PET, Chromafil, Macherey-Nagel, Düren, Germany). Organic carbon concentrations were determined indirectly by subtraction (OC=TC-IC). In addition, temperature, pH and observations, including the appearance of the solution (including colour, turbidity and particle film on the surface) were recorded.
Measured total carbon, inorganic carbon concentrations and indirectly determined organic carbon concentrations of artificial lung fluid and artificial gastric fluid exposed to 2 g/L Carbon Black (N990) for 2 and 24 h were not different from respective carbon background concentrations of the artificial body fluids. Hence, Carbon Black (N990) is considered insoluble in artificial lung fluid and artificial gastric fluid.
Referenceopen allclose all
Dustiness. Particles size distribution, MMAD and GSD
Full description of dustiness testing and results are displayed in section IUCLID 4.28.8. Value for dustiness for Corax N990 is 64.42 mg/g. This represents the fraction of the material that is likely to become airborne upon agitation. The cumulated fractions of the airborne material which deposited at certain stages of the cascade impactor (cut-off points) are given below (Table 2)
Table 2: Cumulated fractions smaller than specific cut-off particle sizes
Cut off point [µm], AD |
0.473 |
0.989 |
2.04 |
4.06 |
8.13 |
15.8 |
32.4 |
CORAX N 990 BDS |
0.18% |
0.78% |
4.16% |
6.67% |
17.53% |
23.04% |
41.45% |
Table 3 gives the results for the estimated MMADs and GSDs for different model assumptions and regression methods. The results show that approximately 100 % of Carbon black tend to have an MMAD of 49.31 μm.
Test material |
p1 |
MMAD 1 |
GSD 1 |
CORAX N 990 BDS |
1 |
49.31 |
5.72 |
Prediction of respiratory deposition patterns using the MPPD model
The total deposited fraction of the material that would become airborne under simulated workplace conditions is estimated at 42.86 % for the human worker. The rest of the airborne material would not get inhaled due to physical phenomena related to air streams and turbulences close to the mouth or simply exhaled (i.e. not deposited). When assessing the exposure of specific regions of the respiratory tract, the data indicate that almost all (ca. 42 %) of the deposited material would actually impact the pharynx and is subsequently most likely swallowed. Thus, almost all of the deposited material would contribute to oral and not to inhalation exposure. The deposited fraction in the “TB” region (0.35 %) is also assumed to be discharged into the gastro-intestinal (G) tract by mucociliary escalation and subsequent swallowing. Therefore, the proportion of the airborne material, which may lead to local effects deep in the human lung, reduces to 0,56 % (Table 4, column “PU”) for the tested material.
Table 4: MPPD model outputs using specific input parameters MMAD and GSD estimators
Test material |
Head [%] |
TB [%] |
PU [%] |
Total [%] |
CORAX N 990 BDS |
41.95 |
0.35 |
0.56 |
42.86 |
Table 3: Measured pH of GST method blanks and test solutions.
sample name |
target pH |
pH prior to the test |
pH after 2h |
pH after 24h |
GST 1 |
1.5 |
1.502 |
Not measured |
1.490 |
GST 2 |
1.5 |
1.507 |
1.481 |
|
GST 3 |
1.5 |
1.508 |
1.479 |
|
GST 4 (pH measurement vessel) |
1.5 |
1.508 |
1.480 |
1.458 |
GST blank vessel 1 |
1.5 |
1.508 |
1.513 |
1.520 |
GST blank vessel 2 |
1.5 |
1.507 |
1.513 |
1.516 |
GST blank vessel 3 |
1.5 |
1.512 |
1.521 |
1.524 |
GST blank vessel 4 |
1.5 |
1.504 |
1.513 |
1.512 |
Table 4: Measured pH of GMB method blanks and test solutions.
sample name |
target pH |
pH prior to the test |
pH after 2h |
pH after 24h |
pH after 7d |
GMB 1 |
7.4 |
7.397 |
Not measured |
7.484 |
7.502 |
GMB 2 |
7.4 |
7.413 |
7.495 |
7.451 |
|
GMB 3 |
7.4 |
7.412 |
7.501 |
7.473 |
|
GMB 4(pH measurement vessel) |
7.4 |
7.396 |
7.440 |
7.482 |
7.456 |
GMB blank vessel 1 |
7.4 |
7.424 |
7.497 |
7.487 |
7.461 |
GMB blank vessel 2 |
7.4 |
7.415 |
7.491 |
7.484 |
7.457 |
GMB blank vessel 3 |
7.4 |
7.420 |
7.443 |
7.481 |
7.460 |
GMB blank vessel 4 |
7.4 |
7.405 |
7.404 |
7.483 |
7.457 |
Test temperature:
With 37 °C ± 1 °C, the temperature was stable during the test for all solutions
LOQ/LOD:
Calibration range 0-10 mg/L:
For the total carbon concentration, the LOD is 0.267 mg/L and the LOQ is calculated to 1.01 mg/L. For the inorganic carbon concentration the LOD is 0.029 mg/L and the LOQ is 0.114 mg/L, respectively.
Calibration range 10 – 100 mg/L: For the total carbon concentration, the LOD is 1.15 mg/L and the LOQ 4.27 mg/L. For the inorganic carbon concentration the LOD is 1.05 mg/L and the LOQ is 3.90 mg/L, respectively.
Recovery:
Table 5: TOC Analyzer measurement series: LOD/LOQ, QA samples and recovery.
Date |
Calibration range [mg/L] |
Carbon fraction |
LOD [mg/L] |
LOQ [mg/L] |
Quality control standards – after subtraction of mean background concentration ultra-pure water |
Ultra-pure water – blank quality control standard; mean concentration measured as NPOC (standard procedure) |
|
September 03, 2020; TC and IC measurements of GST samples 2h |
0 - 10 mg/L for all samples |
TC |
0.267 |
1.01 |
1 mg/L: 121 ± 3 (n = 4) |
10 mg/L: 108 ± 2 |
0.131 ± 0.017 mg/L (n = 8); all concentration below the LOD (LOD of TC used for TOC) |
IC |
0.029 |
0.114 |
1 mg/L: 129 ± 3 (n = 4) |
10 mg/L: 122 ± 11 |
|||
September 04, 2020; TC and IC measurements of GST samples 24h |
0 - 10 mg/L for all samples |
TC |
0.267 |
1.01 |
1 mg/L: 123 ± 3 (n = 4) |
10 mg/L: 108 ± 2 |
0.122 ± 0.012 mg/L (n = 8); all concentration below the LOD (LOD of TC used for TOC) |
IC |
0.029 |
0.114 |
1 mg/L: 122 ± 14 (n = 4) |
10 mg/L: 114 ± 19 |
|||
September 28, 2020; TC and IC measurements of GMB samples 2h |
10 - 100 mg/L for all samples |
TC |
1.15 |
4.27 |
50 mg/L: 99.9 ± 3.0 |
100 mg/L: 104 ± 3 |
0.217 ± 0.062 mg/L (n = 8); all concentration below the LOD (LOD of TC used for TOC) |
IC |
1.05 |
3.90 |
50 mg/L: 112 ± 12 |
100 mg/L: 107 ± 8 |
|||
September 29, 2020; TC and IC measurements of GMB samples 24h |
10 - 100 mg/L for all samples |
TC |
1.15 |
4.27 |
50 mg/L: 102 ± 6 |
100 mg/L: 106 ± 4 |
0.130 ± 0.023 mg/L (n = 8); all concentration below the LOD (LOD of TC used for TOC) |
IC |
1.05 |
3.90 |
50 mg/L: 124 ± 10 |
100 mg/L: 108 ± 13 |
|||
October 05, 2020; TC and IC measurements of GMB samples 7d |
10 - 100 mg/L for all samples |
TC |
1.15 |
4.27 |
25 mg/L: 92.1 ± 2.8 |
50 mg/L: 106 ± 9 |
0.199 ± 0.073 mg/L (n = 4); all concentration below the LOD (LOD of TC used for TOC) |
IC |
1.05 |
3.90 |
25 mg/L: 88.7 ± 1.6 |
50 mg/L: 98.8 ± 6.6 |
The recoveries should be in a range of 100 ± 25% in the lower concentration range (1 mg/L) due to the higher influence of the carbon contamination in ultra-pure water. For higher concentrations (e.g. 10 mg/L) the recoveries should be in the range of 100 ± 20%.
Description of key information
See discussion under key information for set_not treated
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 0
- Absorption rate - dermal (%):
- 0
- Absorption rate - inhalation (%):
- 0
Additional information
Results from bioelution/solubility testing in artificial biological fluids [Artificial gastric fluid (GST, pH 1.5) mimicking the very harsh digestion milieu of high acidity in the stomach (ASTM D5517; (Stopford et al. 2003)], performed on the basis of the OECD Series on Testing and Assessment No. 29 (2001; ENV/JM/ MONO(2001)9) and following the Standard Operating Procedure for Bioelution Testing of Metals, Inorganic Metal Compounds, and Complex Metal-Containing Materials: Simulated Gastric Fluid (validated by ECVAM in December 2019) show that untreated nanoforms of carbon black are insoluble in GST. CORAX N990 was insoluble after a 2 and 24-hour incubation in GST. Similarly, no solubility, measured as total carbon, inorganic carbon concentrations and indirectly determined organic carbon concentrations was recorded for the same grades in artificial interstitial fluid (Gamble’s solution (GMB, pH 7.4) mimicking conditions within the deep lung under normal health conditions (Midander et al. 2007). After 2 hours, 24 hours and 7 days incubation in the GMB, values for total and inorganic carbon were not different from the background concentrations.
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