Registration Dossier
Registration Dossier
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EC number: 231-176-9 | CAS number: 7440-67-7
Endpoint summary
Administrative data
Description of key information
No data is available for skin irritation/corrosion or eye irritation on Zr substance ; read across with ZrO2 data is performed. Due to its inert property, the substance is neither a skin irritant, nor an eye irritant. These results are confirmed by different key studies.
Key value for chemical safety assessment
Additional information
- For skin irritation/corrosion
- For eye irritation
According to the REACh recommendations for the DNEL derivation (Guidance on information requirements and chemical safety assessment Chapter R.8: characterisation of dose (concentration)-response for human health), a read across could be used for substances with similar behaviour and toxic effects in the organism. Regarding the unstable properties of pure zirconium, studies have demonstrated that, outdoor, a stable passivation layer is formed on the zirconium metal: this very thin oxide layer grows rapidly. Actually, the rapid oxidation of zirconium metal into ZrO2 and the high stability of the latter form make the zirconium dioxide the best candidate to assess the toxicity of zirconium. Both compounds are such insoluble and are considered inert. Read across to ZrO2 is considered appropriate.
Two reliable studies, performed with ZrO2, have been identified (Klimisch 2). The study of Magnesium Elecktron Ltd (1986) is a GLP study, performed according to the OECD 404 guideline with minor deviations. The substance was determined not to be irritating to New Zealand White rabbit skin after 4 hours of exposure. These observations were supported by the Tosoh study (2000). This second GLP study followed also the OECD guideline 404 and the result is “not irritating”.
A reliable study was performed (Tosoh, 2000 – Klimisch 2) in New Zealand White rabbit. The test substance was determined to be slightly irritating based on the AFNOR criteria. Observed effects were fully reversible within 72 hours.The slight irritation observed in the study performed with ZrO2, after 48 hours, is due to a mechanical action of the powder applied on the eyes.
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Based on the available data, the substance was not classified under the CLP Regulation 1272/2008 and the directive Classification and Labelling 67/548.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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