Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Objective of study:
bioaccessibility (or bioavailability)
Test guideline
Qualifier:
according to guideline
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(III) chloride 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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Indium trichloride
EC Number:
233-043-0
EC Name:
Indium trichloride
Cas Number:
10025-82-8
Molecular formula:
Cl3In
IUPAC Name:
indium trichloride
Test material form:
other: solution
Details on test material:
- Product name: Indium(III) chloride
- Physical state: solution, Clear, colourless
- Lot/batch No.: UP566
- Expiration date of the lot/batch: stable over time
- Storage condition of test material: room temperature, in the dark

Results and discussion

Preliminary studies:
not applicable
Main ADME results
Type:
other: bioaccessibility
Results:
gastric fluid (2hours): as %In released of total In content: 102

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: 102

Any other information on results incl. tables

Indium(III) chloride, loading 0.2 g/L              2h gastric at pH 1.5

Analyte                                                              X±σ                        CV

Indium (In)

dissolution

28333 ± 577 μg/L

2%

eluted

137755 ± 1873 μg/g

1%

% Indium eluted

 

102%

 

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

σ = Standard deviation

CV: Coefficient of variation (%)

Applicant's summary and conclusion

Conclusions:
Bio-elution test according to state-of-the-art procedures, useful for determining dissolution capacity of In in gastric fluid.
Interpretation of results: other: High bioaccessibility of In from Indium(III) chloride. The dissolution in gastric fluid is used to estimate bioavailability after oral exposure
Executive summary:

During this study on Indium(III) chloride 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 28333 μg/L In

(CV=2%) or 137755 μg In per g test item was found after 2 hours of extraction. This corresponds with

indium release of 102% (based on the available amount of indium (169 g/L), the density (1.25 kg/L)).