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Basic toxicokinetics

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basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Test according to state-of-the-art operating procedures for testing of metal bioelution.

Data source

Reference Type:
study report
Report date:

Materials and methods

Objective of study:
bioaccessibility (or bioavailability)
Test guideline
according to guideline
other: ASTM D5517-07: Standard Test Method for determining the extractability of metals from art materials - ASTM, 2007 (American Society for Testing and Materials).
Principles of method if other than guideline:
The release/dissolution of indium from indium in simulated gastric fluid was measured. The resulting value is termed bio-accessibility, and is defined as the fraction of a substance that is soluble under physiological conditions and therefore potentially available for absorption into systemic circulation. The simulated gastric fluid represents an exposure-relevant exposure route (oral exposure). The compound was introduced as powder in a test item / solution ratio of 200 mg/L during 2 hours.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Zinc chloride
EC Number:
EC Name:
Zinc chloride
Cas Number:
Molecular formula:
Zinc dichloride
Test material form:
other: shot
Details on test material:
- Product name: indium shot
- Physical state: solid (powder), silver grey
- Purity: 99.99%
- Lot/batch No.: F10164
- Expiration date of the lot/batch: stable over time
- Storage condition of test material: room temperature, in the dark
- Particle size (typical): <100μm after milling and sieving
- Relative densitiy: 7.31 g/cm³

Test animals

Details on test animals or test system and environmental conditions:
not applicable

Results and discussion

Preliminary studies:
not applicable
Main ADME results
other: bioaccessibility
gastric fluid (2hours): as %In released of total In content: 9.3

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:
gastric fluid (2hours): as %In released of total In content: 9.3

Any other information on results incl. tables

Indium, loading 0.2 g/L              2h gastric at pH 1.5

Analyte                                                              X±σ                        CV

Indium (In)


18667 ± 6807 μg/L



92772 ± 33556 μg/g


% Indium eluted




X= Average of 3 test vessels (0.2µm filtration)

σ = Standard deviation

CV: Coefficient of variation (%)

Applicant's summary and conclusion


Bio-elution test according to state-of-the-art procedures, useful for determining dissolution capacity of In in gastric fluid.
Interpretation of results: Moderate bioaccessibility of In from indium. The dissolution in gastric fluid is used to estimate bioavailability after oral exposure
Executive summary:

During this study on Indium at a loading of 0.2 g/L in simulated gastric fluid (pH 1.5), it was shown that significant amounts of indium were measured. For indium an average value of 18667 μg/L In (CV=36%) or 92772 μg In per g test item was found after 2 hours of extraction. This corresponds with indium release of 9.3%.