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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

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%.