Indium trichloride

Basic toxicokinetics

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

Test material information

Constituent 1

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)).