Indium, cake

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

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 cadmium, indium and lead from indium cake 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, cake

EC Number:

273-794-1

EC Name:

Indium, cake

Cas Number:

69029-48-7

IUPAC Name:

Insoluble indium-containing residue after precipitation of indium bearing solutions

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid, powder, dark grey
- Composition of test material, percentage of components: 32.450% Al, 0.005% As, 7.671% Cd, 0.085%Cu, 3.60% Fe, 27.68% In, 3.81% Zn, 26.17% H2O
- Lot/batch No.: BB944
- Expiration date of the lot/batch: stable over time
- Storage condition of test material: room temperature, in the dark
- Relative denistiy: 1-1.5 (water=1)

Test animals

Details on test animals or test system and environmental conditions:

not applicable

Administration / exposure

Details on exposure:

not applicable

Results and discussion

Preliminary studies:

not applicable

Main ADME results

Type:

other: bioaccessibility

Results:

gastric fluid (2hours): as %Cd released of total Cd content: 65; as %In released of total In content: 52; as %Pb of total Pb content: 47

Toxicokinetic / pharmacokinetic studies

Details on absorption:

not applicable

Details on distribution in tissues:

not applicable

Details on excretion:

not applicable

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:

gastric fluid (2hours): as %Cd released of total Cd content: 65; as %In released of total In content: 52; as %Pb of total Pb content: 47

Any other information on results incl. tables

Indium cake, loading 0.2 g/L                 2h gastric at pH 1.5
Analyte                                                                 X±σ                        CV
Cadmium (Cd)	dissolution	9932±115 µg/L	1%
	eluted	49597±528 µg/g	1%
% Cadmium eluted		64.7 %
Indium (In)	dissolution	29000±1000 µg/L	3%
	eluted	144815±4914 µg/g	3%
% Indium eluted		52.3 %
Lead (Pb)	dissolution	934±31 µg/L	3%
	eluted	4666±151 µg/g	3%
% Lead eluted		46.7 %

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

σ = Standard deviation

CV: Coefficient of variation (%)

Applicant's summary and conclusion

Conclusions:

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

Executive summary:

During this study on indium cake at a loading of 0.2 g/L in simulated gastric fluid (pH 1.5), it was shown that significant amounts of cadmium, indium and lead were measured. For cadmium an average value of 9932 μg/L Cd (CV = 1%) was found after 2 hours of extraction. This corresponds with cadmium releases of 65%. For indium an average value of 29000 μg/L In (CV = 3%) was found after 2 hours of extraction. This corresponds with an indium releases of 52%. For lead an average value of 934µg/L Pb (CV=3%) was found at the end of the test. This corresponds to lead release of 47%.