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Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-01-18 to 2012-03-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Objective of study:
bioaccessibility (or bioavailability)
Qualifier:
no guideline available
Principles of method if other than guideline:
This report measured bioaccessibility of Titanium carbide in body fluid simulants as a surrogate for bioavailability.
GLP compliance:
no
Radiolabelling:
no
Species:
other: not applicable
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
Not applicable
Route of administration:
other: In vitro study
Vehicle:
other: not applicable
Details on exposure:
Not applicable
Duration and frequency of treatment / exposure:
Not applicable
Remarks:
Doses / Concentrations:
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:
Titanium Carbide was extracted in leaching fluids for different time periods: 2 hrs and 24 hrs in simulated gastric and lysosomal fluid, 24 hrs in simulated interstitial fluid and 12 hrs in artifical perspiration. The extractions were performed using 0.1 gram of sample in 50 ml of simulated fluid. A shaker water bath at a temperature of 37°C was used. All extractions were performed in triplicate. The extracts were analyzed for soluble Titanium using EPA Method #200.7 (ICP). Results were reported as ug Ti/g sample, % Ti/g sample and as % of total available Ti released.
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

Table 1: Soluble Titanium in gastric fluid

Extraction time in h

Weight used

µg Titanium/g Sample

% Titanium release/Titanium content

2

0.1008

1,637

0.20

(dup)

0.1058

1,749

0.22

(trip)

0.1034

1,644

0.21

24

0.1021

4,603

0.58

(dup)

0.1024

4,395

0.55

(trip)

0.1042

4,319

0.54

 

Table 2: Soluble Titanium in simulated interstitial fluid

Extraction time in h

Weight used

µg Titanium/g Sample

% Titanium release/Titanium content

24

0.1027

< 50.0

-

(dup)

0.1004

< 50.0

-

(trip)

0.1024

< 50.0

-

 

Table 3: Soluble Titanium in lysosomal fluid

Extraction time in h

Weight used

µg Titanium/g Sample

% Titanium release/Titanium content

2

0.0992

151

0.02

(dup)

0.0995

151

0.02

(trip)

0.1015

148

0.02

24

0.1029

656

0.08

(dup)

0.0995

678

0.08

(trip)

0.1005

662

0.08

 

Table 4: Soluble Titanium in artificial perspiration

Extraction time in h

Weight used

µg Titanium/g Sample

% Titanium release/Titanium content

12

0.0996

< 50.0

-

(dup)

0.1052

< 50.0

-

(trip)

0.1006

< 50.0

-

 

Conclusions:
The release of Ti ions from TiC is very low in artifical body fluids. More Ti ions are released at acidic pH with up to 0.56 % in simulated gastric acid solution (pH 1.5) and 0.08 % in lysosomal fluid (pH 4.5).
Executive summary:

This report measured bioaccessibility of Titanium Carbide as a surrogate for bioavailability.To do this the soluble Titanium was measured using the EPA method #200.7 (ICP) after incubation of Titanium Carbide in simulated body fluids (simulated gastric fluid, simulated interstitial fluid, simulated lysosomal fluid, and artifical perspiration). Results were reported as ug Ti/g sample, % Ti/g sample and as % of total available Ti released.

Overview of Ti released in the different simulated body fluids:

Medium

t in h

% Ti-release

Simulated gastric fluid

2

0,21 %

24

0,56 %

Simulated interstitial fluid

24

BDL

Simulated lysosomal fluid

2

0,02%

24

0,08 %

Artifical perspiration

12

BDL

BDL: Below detection limit. In summary, release of Titanium ions from TiC is higher at acidic pH, even though at a very low degree. The bioavailability in the fluids ranged from BDL (interstitial fluid and artifical perspiration) to 0,56 % (simulated gastric fluid). Thus, the maximum solubility was determined at acidic pH. Based on the results, the bioavailability of Titanium carbide would be expected to be low for all routes of administration.

Description of key information

Bioelution results of titanium carbide in four artificial body fluids which served as a surrogate for bioavailability in different tissues, demonstrated very low release of titanium ions in general.

The amount of soluble titanium was below detection limit in artificial perspiration fluid and simulated interstitial fluid, representing sweat/dermal and interstitial milieus in the deep lung, respectively.

Very limited amounts of soluble titanium could be detected in artificial lysosomal fluid (0.08% titanium release after 24 hours) and simulated gastric fluid (0.56% titanium release after 24 hours).

Key value for chemical safety assessment

Additional information

Bioelution results of titanium carbide in four artificial body fluids have been conducted (Kirby Memorial Health Center, 2012).

Titanium carbide was incubated for up to 24 hours in the different fluids (simulated gastric fluid, simulated interstitial fluid, simulated lysosomal fluid and artificial perspiration fluid) and analysed by Inductively Coupled Plasma-Atomic Emission Spectrometry (EPA Method 200.7).

The results after incubation in the different body fluids demonstrated that the release of titanium ions from titanium carbide is very low.

The amount of soluble titanium was below detection limit in artificial perspiration fluid and simulated interstitial fluid, representing sweat/dermal and interstitial milieus, respectively.

Very limited amounts of soluble titanium could be detected in artificial lysosomal fluid (up to 0.08% titanium release after 24 hours) and simulated gastric fluid (up to 0.56% titanium release after 24 hours).

In summary, release of titanium ions from titanium carbide is higher at acidic pH, even though at a very low degree. Based on the results, the bioavailability of titanium carbide would be expected to be low for all routes of administration.