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EC number: 701-026-1 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Bioaccessibility study in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-03-12 to 2019-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- 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:
- not specified
- Principles of method if other than guideline:
- An internationally agreed guideline does not exist yet for this test (e.g. OECD). Therefore, the test was performed on the basis of the guidance for OECD-Series on testing and assessment Number 29 and bioaccessibility methods applied in published studies [Midander K. et al. 2007. Enviromental Pollution 145: 51-59.; ASTM 2003. ASTM D5517-03]
Test conditions: Two artificial physiological media GST and PBS composition, one single loading of the test substance, i.e. 100 mg/L, measurements of dissolved TC and NPOC concentrations after 2 and 24 hours of agitation at 37 °C. - GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Batch No: 2399606
- Expiration date of the lot/batch: 08 December 2026
- Appearcane of test material: black powder - Radiolabelling:
- no
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on species / strain selection:
- not applicable
- Sex:
- not specified
- Route of administration:
- other: in vitro study
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
- Dose / conc.:
- 100 other: mg/L
- Remarks:
- Loading
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- other: Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Please refer to box "Any other information on materials and method incl. tables".
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
- Preliminary studies:
- Not applicable
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
- Bioaccessibility (or Bioavailability) testing results:
- The concentrations of non-purgeable organic carbon (NPOC) in the test media GST and PBS for all method blanks and samples were below the LOQ (0.712 mg/L) but above the LOD (0.186 mg/L). To calculate the dissolution of the non-purgeable organic carbon in the test media, a standardisation for values below the LOQ was performed. Therefore, individual sample values below the LOQ were set to LOQ/2 (0.356 mg/L) and these calculated concentrations were used for evaluation. The calculated concentrations in method blanks as well as the calculated concentrations in the samples were in the same order of magnitude and therefore a dissolution of the test item in GST or PBS medium is not distinguishable from the method blanks. The concentrations of total carbon (TC) in the method blank and test samples for the test medium PBS were all above the LOQ and for the test medium GST mainly all method blank and sample concentrations were above the LOQ. The concentrations in sample vessels were in the same order of magnitude as the method blank concentrations and therefore a dissolution of the test item in PBS or GST medium is not distinguishable. This observation is confirmed by the background corrected concentrations from the method blank.
For detailed results please refer to the tables in the box "Any other information on results incl. tables". - Conclusions:
- To determine the dissolution of carbon in the arteficial body fluids GST and PBS the soluble amount of the test item was specified by measuring the total carbon content as TC as well as the dissolved organic carbon as non-purgeable organic carbon (NPOC) in the test media. In the NPOC measurement, the calculated concentrations in method blanks as well as the calculated concentrations in the samples were in the same order of magnitude and therefore a dissolution of the test item in GST or PBS medium is not distinguishable from the method blank. In the TC measurement, the concentrations in sample vessels were in the same order of magnitude as the method blank concentrations and therefore a dissolution of the test item in PBS or GST medium is not distinguishable. This observation is confirmed by the background corrected concentrations from the method blank.
The release of niobium ions from Niobium oxide is very low in artifical body fluids. Based on the results, the bioavailability of Niobium oxide can be considered to be very low for all routes of administration. - Executive summary:
A study was conducted to estimate the bioaccessibility of non-graphitic carbon fibre in different artificial media. 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. Furthermore, only artificial gastric fluid (GST) and PBS (phosphate buffered saline that mimics the ionic strength of human blood serum) were chosen for testing due to the fact that in all other media a carbon source is used for the media. The soluble amount of the test item was specified by measuring the total carbon content as TC as well as the dissolved organic carbon (DOC) as non-purgeable organic carbon (NPOC) in the test media under the applied test conditions after separation of undissolved test item by filtration (filtration through a 0.45 µm PET membrane syringe filter; Polyester filter). For the experimental setup, the test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium (loading of 100 mg/L) and agitated at 100 rpm at 37 °C ± 1 °C. Samples of GST and PBS medium were taken after 2 h and 24 h. The TC concentrations were determined as TC and the DOC as NPOC by a SHIMADZU TOC- V CPH Analyzer.
In the NPOC measurement, the calculated concentrations in method blanks as well as the calculated concentrations in the samples were in the same order of magnitude and therefore a dissolution of the test item in GST or PBS medium is not distinguishable from the method blank. In the TC measurement, the concentrations in sample vessels were in the same order of magnitude as the method blank concentrations and therefore a dissolution of the test item in PBS or GST medium is not distinguishable. This observation is confirmed by the background corrected concentrations from the method blank.
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: literature review
- Adequacy of study:
- supporting study
- Study period:
- 2012-06-12
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Literature review to assess basic toxicokinetics of non-graphitic carbon fibres within the scope of this registration. For this review literature data from official authorities, peer reviewed journals, IARC monographs and other sources were used.
- Conclusions:
- A bioaccumulation is not expected based on a literature review.
Referenceopen allclose all
Table 1: NPOC concentrations of artificial physiological media (filtrated through a 0.45 µm membrane)
Medium & time |
LOD/LOQ of NPOC measurement series [mg/L] |
Mean NPOC ± SD of method blanks [mg/L] |
Without background correction |
With background correction |
Mean NPOC ± SD of test item[mg/L] |
Mean NPOC of test item[mg/L] |
|||
GST 2h |
LOD: 0.186 |
= 0.457± 0.142 (three samples below, one sample above LOQ) |
= 0.356 (all samples below LOQ) |
Negative value |
GST 24h |
= 0.624± 0.107 (two samples below and two samples above LOQ) |
= 0.510± 0.268(samples of one vessel above, other samples all below LOQ) |
Negative value |
|
PBS 2h |
LOD: 0.186 |
= 0.356 (all samples below LOQ) |
= 0.438± 0.142(one sample above, all other samples below LOQ) |
0.08 mg/L |
PBS 24h |
= 0.480± 0.176(three samples below, one sample above LOQ) |
= 0.356 (all samples below LOQ) |
Negative value |
Samples below LOQ were used for calculation of mean by LOQ/2 (Commission Directive 2009/90/EC of 31 July 2009].
Table 2: TC concentrations of artificial physiologocal media (filtered through a 0.45 µm membrane)
Medium & time |
LOD/LOQ of TC measurement series [mg/L] |
Mean TC ± SD of method blanks [mg/L] |
Without background correction |
With background correction |
Mean TC ± SD of test item[mg/L] |
Mean TC of test item[mg/L] |
|||
GST 2h |
LOD: 0.186 |
0.832± 0.059 |
0.755± 0.399 (two samples below LOQ) |
Negative value |
GST 24h |
1.07± 0.035 |
1.01± 0.266 |
Negative value |
|
PBS 2h |
LOD: 0.186 |
2.91± 0.07 |
2.87± 0.08 |
Negative value |
PBS 24h |
3.36± 0.27 |
3.26± 0.14 |
Negative value |
Samples below LOQ were used for calculation of mean by LOQ/2 (Commission Directive 2009/90/EC of 31 July 2009].
Description of key information
In vitro bioaccessibility studies in artificial body fluids were conducted with the target substance. In addition the toxicokinetic behaviour of the target substance was assessed based on a literature review.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
In vitro bioaccessibility study:
To determine the dissolution of carbon in the artificial body fluids GST and PBS the soluble amount of the test item was specified by measuring the total carbon content as TC as well as the dissolved organic carbon as non-purgeable organic carbon (NPOC) in the test media. In the NPOC measurement, the calculated concentrations in method blanks as well as the calculated concentrations in the samples were in the same order of magnitude and therefore a dissolution of the test item in GST or PBS medium is not distinguishable from the method blank. In the TC measurement, the concentrations in sample vessels were in the same order of magnitude as the method blank concentrations and therefore a dissolution of the test item in PBS or GST medium is not distinguishable. This observation is confirmed by the background corrected concentrations from the method blank.
Toxicokinetic Behavior of Non-graphitic Carbon Fibres within the Scope of this Registration
Based on the specifications of the non-graphitic carbon fibres within the scope of this registration several conclusions on the aerodynamic behaviour can be drawn:
WHO fibres are present in concentrations of well below 0.1%. Consequently, the amount of carbon fibres that could possibly reach the deep lung is negligible.
Following the specifications for the aerodynamic diameter, 99% of the fibre mass have an aerodynamic diameter of > 10 µm. Therefore, this material has no significant fraction which is lung respirable. After inhalation these carbon fibres will be deposited only in the nasal cavity and in the upper part of the tracheo-bronchial tree. In these parts of the respiratory tract fibres will be cleared very fast (half-time < 1 day) by mucociliary clearance. Therefore, no accumulation of fibres will be possible in these regions [9]. Consequently, biopersistence is negligible and adverse effects after inhalation of non-graphitic carbon fibres within the scope of this registration are not to be expected.
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