Registration Dossier
Registration Dossier
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EC number: 215-227-2 | CAS number: 1314-23-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No reliable information was available on pure zirconium dioxide. One reliable (Klimisch 2) read across study was available for the skin sensitisation endpoint and was selected as the key study (TOSOH Corporation, 1999). This study was performed with yttrium stabilised zirconium oxide. The traditional skin sensitisation test was performed according to OECD guideline 406 and the Maximization Test of the Guideline for Toxicity Studies of Drugs (Notification No. 1-24 of Pharmaceuticals and Cosmetics Division dated September 11, 1989). Female Guinea pigs of the Hartley strain received following treatment:
Intradermal sensitisation
1) Test agent group - E-FCA (equal volume (v/v) of "distilled injection water" and Freund's complete adjuvant (FCA) were mixed and emulsified in water-in-oil style - 2.5% test agent - 2.5% test agent/FCA emulsion
2) Control group - E-FCA
3) Positive control group - E-FCA - 0.1% DNCB/olive oil - 0.1% DNCB/FCA emulsion
Patch sensitisation
1) Test agent group - 25% test agent
2) Control group - distilled injection water
3) Positive control group - 0.5% DNCB
Elicitation Treatment
1) Test group and control group - 25% test agent - 2.5% test agent
2) Positive control group - 0.1% DNCB
The test substance was found to be not sensitising to the skin at levels up to 25% whilst the positive control substance, DNCB, was found to have an extreme skin sensitising potential.
Migrated from Short description of key information:
In a traditional skin sensitisation test in guinea pigs (Hartley strain) zirconium dioxide (intercrystallised with yttrium oxide) was observed to be not sensitising to the skin. This information is considered relevant for pure zirconium dioxide too.
Justification for classification or non-classification
Based on the read across test results and according to the criteria of the CLP Regulation, zirconium dioxide should not be classified as a skin sensitiser.
No reliable data are available for respiratory sensitisation, therefore no conclusion can be drawn on the classification of this endpoint.
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