Registration Dossier
Registration Dossier
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EC number: 945-888-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The release of ytterbium, zirconium or hafnium from the target substance zirconium oxide, hafnium and ytterbium doped in simulated body fluids indicated that the bio-accessibility is very low for all routes (see section 7.1.1). The hafnium release was below the detection limit, the zirconium release was 0.02 µg/mL and the ytterbium release was 3.24 µg/mL from the target substance within 24 hours in artificial perspiration fluid. Thus, the bioavailability of hafnium, zirconium and/or ytterbium after administration to the skin can expected to be very low. No information was found in the public domain, which would have indicated any skin sensitising properties of hafnium, zirconium and/or ytterbium. Based on the results and in line with the 3R principles, the study is scientifically unjustified.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The release of ytterbium, zirconium or hafnium from the target substance zirconium oxide, hafnium and ytterbium doped in simulated body fluids indicated that the bio-accessibility is very low for all routes (see section 7.1.1). The hafnium release was below the detection limit, the zirconium release was 0.02 µg/mL and the ytterbium release was 3.24 µg/mL from the target substance within 24 hours in artificial perspiration fluid. Thus, the bioavailability of hafnium, zirconium and/or ytterbium after administration to the skin can expected to be very low. No information was found in the public domain, which would have indicated any skin sensitising properties of hafnium, zirconium and/or ytterbium. Based on the results and in line with the 3R principles, the study is scientifically unjustified. Based on the low release of test item components to the skin, skin sensitising properties are not expected and therefore no classification is warranted.
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