Registration Dossier
Registration Dossier
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EC number: 215-251-3 | CAS number: 1314-98-3
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- 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. Worst case (gastric fluid) taken for checking dissolution of cobalt.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Type of study / information:
- The test was conducted based on ASTM D5517-07: Standard Test Method for determining the extractability of metals from art materials - ASTM, 2007 (American Society for Testing and Materials).
The release/dissolution of cobalt from zinc sulfide in simulated gastric juice 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 (e.g. dissolution in sweat is used to estimate bioavailability after dermal exposure, etc.). The compound was introduced as powder in a test item / solution ratio of 2 g/L during 2 hours.
Test guideline
- Qualifier:
- according to guideline
- Principles of method if other than guideline:
- The test was conducted based on ASTM D5517-07: Standard Test Method for determining the extractability of metals from art materials - ASTM, 2007 (American Society for Testing and Materials).
The release/dissolution of cobalt from zinc sulfide in simulated gastric juice 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 (e.g. dissolution in sweat is used to estimate bioavailability after dermal exposure, etc.). The compound was introduced as powder in a test item / solution ratio of 2 g/L during 2 hours. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc sulphide
- EC Number:
- 215-251-3
- EC Name:
- Zinc sulphide
- Cas Number:
- 1314-98-3
- Molecular formula:
- SZn
- IUPAC Name:
- thioxozinc
- Details on test material:
- ZnS with about 0.3% CoxSy was used (Sachtolith L, from Sachtleben Chemie GmbH, Duisburg, DE. (powder form)
Constituent 1
Results and discussion
Any other information on results incl. tables
Absolute release of cobalt from zinc sulfide in simulated gastric fluid extraction
22.6 µg±0.1 µgCo/gZnS |
average of 3 test vessels± standard deviation
Applicant's summary and conclusion
- Conclusions:
- Bio-elution test according to state-of-the-art procedures, useful for determining dissolution capacity of Co in gastric fluid.
- Executive summary:
The results of the bio-elution test (worst case: gastric fluid) demonstrate that CoS present in the ZnS at 0.3% concentration, is insoluble.
as a consequence, the Co-content in ZnS is not a reason for classification of ZnS for human toxicity effects.
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