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Diss Factsheets
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EC number: 215-227-2 | CAS number: 1314-23-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
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