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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test according to state-of-the-art operating procedures for testing of metal bioelution.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
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 from cadmium telluride 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:
Cadmium telluride
EC Number:
215-149-9
EC Name:
Cadmium telluride
Cas Number:
1306-25-8
Molecular formula:
CdTe
IUPAC Name:
telluroxocadmium
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: powder, dark grey
- Purity: 99.999% CdTe
- Lot/batch No.: 166386
- Expiration date of the lot/batch: stable over time
- Storage condition of test material: room temperature, in the dark, under argon atmosphere
- Particle size (typical): 200 mesh (74µm)

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: average : 35.35 ± 8.69

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 bioaccessibility (2hours) as %Cd released of total Cd content: average : 35.35 ± 8.69 (experiment 1: 29.2, experiment 2: 41.5)

Any other information on results incl. tables

Experiment 1

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

Analyte                                                              X±σ                        CV

Cadmium (Cd)

dissolution

27394±3527 µg/L

13%

eluted

136675±17442 µg/g

13%

% Cadmium eluted

 

29.2 %

 

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

σ = Standard deviation

CV: Coefficient of variation (%)

Experiment 2

cadmium sulfoselenide red, loading 0.2 g/L              2h gastric at pH 1.5

Analyte                                                              X±σ                        CV

Cadmium (Cd)

dissolution

38953±3953 µg/L

10%

eluted

194391±19494 µg/g

10%

% Cadmium eluted

 

41.5 %

 

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 (migrated information): other: Moderate bioaccessibility of Cd2+ from CdTe. The data have been incorporated into read-across assessment. 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 gastric fluid.
Executive summary:

During this study on Cadmium telluride at a loading of 0.2 g/L in simulated gastric fluid (pH 1.5), it was shown that significant amounts of cadmium were measured. For cadmium an average value of 27394 μg/L Cd (CV = 13%) and 38953 μg/L Cd (CV = 10%) were found in a first and second experiment, respectively, after 2 hours of extraction. This corresponds with cadmium releases of 29.2% and 41.5%, respectively.