Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-227-2 | CAS number: 1314-23-4
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral
The LD50 value for acute oral toxicity determined via the acute class method in female Sprague-Dawley rats was > 5000 mg/kg.
Acute toxicity: inhalation
The LC50 was higher than 4.3 mg/L (maximal technically achievable mean concentration) in male and female Crl:CD(SD) albino rats via nose-only inhalation exposure (dust aerosol of zirconium dioxide).
Acute toxicity: dermal
No reliable data were available for acute toxicity via the dermal route of exposure.
Key value for chemical safety assessment
Additional information
Acute toxicity: oral
One key study was identified (Klimisch 1). Acute toxicity of zirconium dioxide was determined via the acute class method (OECD Guideline 423 and EU Method B1 tris) in female Sprague-Dawley rats. The LD50 value was > 5000 mg/kg. Two supporting studies were either scored Klimisch 3 or performed using a read across substance (in this case: zirconium basic carbonate, another insoluble zirconium compound).
Acute toxicity: inhalation
One key study (Klimisch 1) was performed by WIL Research Laboratories. Acute inhalation toxicity was tested according to OPPTS Guideline 870.1300 and OECD Guideline 436. Zirconium dioxide was administered to 1 group of 3 male and 3 female Crl:CD(SD) albino rats via nose-only inhalation exposure as a dust aerosol at a concentration of 4.3 mg/L, which was the maximum technically obtainable mean concentration, for 4 hours. The exposure atmosphere was characterized by a mean mass median aerodynamic diameter (± geometric standard deviation) of 2.0 µm ± 1.75 µm. As no mortality occurred during the study, the LC50 of zirconium dioxide was greater than 4.3 mg/L.
Acute toxicity: dermal
No acute toxicity study for the dermal route was identified, however this study can be waived based on Column 2 adaptation (REACH Regulation, Annex VIII, section 8.5).
Justification for classification or non-classification
- Based on the available data and according to the DSD/CLP criteria zirconium dioxide should not be classified for acute toxicity via the oral route of exposure.
- No reliable data were available on the acute toxicity via the dermal route of exposure. Therefore no conclusion can be made on the classification for this exposure route.
- Based on the available data and according to the DSD/CLP criteria zirconium dioxide should not be classified for acute toxicity via the inhalation route of exposure. Although the LC50 of zirconium dioxide dust aerosol is higher than 4.3mg/L, which is lower than the classification cut-off value of 5 mg/L for harmful classification (DSD) or category 4 classification (CLP), further testing would not be considered feasible as the maximum technically obtainable mean concentration for exposure is 4.3 mg/L and no mortality and no overt toxicity occurred at this concentration.Classification for acute inhalation toxicity is therefore deemed unnecessary.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
