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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".

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
LOQ: 0.712

= 0.457± 0.142 (three samples below, one sample above LOQ)

= 0.356

(all samples below LOQ)

Negative value
(-0.10)

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
(-0.11)

PBS 2h

LOD: 0.186
LOQ: 0.712

= 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
(-0.12)

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
LOQ: 0.712

0.832± 0.059

0.755± 0.399 (two samples below LOQ)

Negative value
(-0.08)

GST 24h

1.07± 0.035

1.01± 0.266

Negative value
(-0.06)

PBS 2h

LOD: 0.186
LOQ: 0.712

2.91± 0.07

2.87± 0.08

Negative value
(-0.05)

PBS 24h

3.36± 0.27

3.26± 0.14

Negative value
(-0.10)

Samples below LOQ were used for calculation of mean by LOQ/2 (Commission Directive 2009/90/EC of 31 July 2009].

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.

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.