Registration Dossier
Registration Dossier
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EC number: 235-125-1 | CAS number: 12070-14-3
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-08 to 2014-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Objective of study:
- bioaccessibility (or bioavailability)
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This report measured bioaccessibility of Zirconium carbide in body fluid simulants as a surrogate for bioavailability.
- GLP compliance:
- no
Test material
- Reference substance name:
- Zirconium carbide
- EC Number:
- 235-125-1
- EC Name:
- Zirconium carbide
- Cas Number:
- 12070-14-3
- Molecular formula:
- CZr
- IUPAC Name:
- zirconium carbide
- Details on test material:
- Batch No.: 25051/13
Purity: > 97 %
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Route of administration:
- other: not applicable
- Vehicle:
- other: not applicable
- Details on exposure:
- not applicable
- Duration and frequency of treatment / exposure:
- not applicable
Doses / concentrations
- Remarks:
- 0.1 g of test substance in 50 mL of simulated fluid
- 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 see box "Any other information on materials and method incl. tables"
- Details on dosing and sampling:
- not applicable
- Statistics:
- not applicable
Results and discussion
- Preliminary studies:
- not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not applicable
- Details on distribution in tissues:
- not applicable
- Details on excretion:
- not applicable
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- not applicable
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- The results of the bio-elution tests (see Table 1 in box "Any other information on results incl. tables") of Zirconium carbide in general showed a very low solubility in the set of fluids assayed.
Any other information on results incl. tables
Table 1: Results of bio-elution tests
Extraction Time |
Weight Used (g) |
µg Zirconium / g Sample |
% Zirconium Release/ Zirconium Content |
Simulated Gastric Fluid |
|||
2 hours |
0.1004 |
<25.0 |
--- |
(dup) |
0.1008 |
<25.0 |
--- |
24 hours |
0.1001 |
<25.0 |
--- |
(dup) |
0.1006 |
<25.0 |
--- |
Simulated Interstitial Fluid |
|||
2 hours |
0.1016 |
<25.0 |
--- |
(dup) |
0.1016 |
<25.0 |
--- |
24 hours |
0.1005 |
<25.0 |
--- |
(dup) |
0.1016 |
<25.0 |
--- |
Simulated Lysosomal Fluid |
|||
2 hours |
0.1002 |
35.0 |
0.004 |
(dup) |
0.1008 |
<25.0 |
--- |
24 hours |
0.1012 |
40.0 |
0.005 |
(dup) |
0.1028 |
39.0 |
0.005 |
Artificial Perspiration |
|||
2 hours |
0.1001 |
<25.0 |
--- |
(dup) |
0.1008 |
<25.0 |
--- |
24 hours |
0.1009 |
<25.0 |
--- |
(dup) |
0.1005 |
<25.0 |
--- |
PBS |
|||
2 hours |
0.1006 |
<25.0 |
--- |
(dup) |
0.1009 |
<25.0 |
--- |
24 hours |
0.1003 |
<25.0 |
--- |
(dup) |
0.1004 |
<25.0 |
--- |
Applicant's summary and conclusion
- Conclusions:
- The release of zirconium ions from Zirconium carbide was very low in artificial body fluids. For simulated gastric fluid, simulated interstitial fluid and arteficial perspiration no release of zirconium ions was observed as the results were below the detection limit of the method. Only in simulated lysosomal fluid 0.005% zirconium ions were released within 24 hours from Zirconium carbide.
- Executive summary:
This report measured bioaccessibility of Zirconium carbide as a surrogate for bioavailability. Thus, the soluble zirconium was measured by using EPA Method #200.8 (ICP/MS) after incubation of Zirconium carbide in different simulated body fluids (simulated gastric fluid, simulated interstitial fluid, simulated lysosomal fluid, and artificial perspiration). Results were reported as µg Zr/g sample, % Zr release/Zr content. The release of zirconium ions from Zirconium carbide was very low in artificial body fluids. The results of the study are summarized in the table below:
Extraction Time
Weight Used (g)
µg Zirconium /
g Sample
% Zirconium Release/ Zirconium Content
Simulated Gastric Fluid
2 Hours
0.1004
<25.0
---
(dup)
0.1008
<25.0
---
24 Hours
0.1001
<25.0
---
(dup)
0.1006
<25.0
---
Simulated Interstitial Fluid
2 Hours
0.1016
<25.0
---
(dup)
0.1016
<25.0
---
24 Hours
0.1005
<25.0
---
(dup)
0.1016
<25.0
---
Simulated Lysosomal Fluid
2 Hours
0.1002
35.0
0.004
(dup)
0.1008
<25.0
---
24 Hours
0.1012
40.0
0.005
(dup)
0.1028
39.0
0.005
Artificial Perspiration
2 Hours
0.1001
<25.0
---
(dup)
0.1008
<25.0
---
24 Hours
0.1009
<25.0
---
(dup)
0.1005
<25.0
---
PBS
2 Hours
0.1006
<25.0
---
(dup)
0.1009
<25.0
---
24 Hours
0.1003
<25.0
---
(dup)
0.1004
<25.0
---
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