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Registration Dossier
Diss Factsheets
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EC number: 264-885-7 | CAS number: 64417-98-7
- 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
Skin irritation / corrosion:
Based on the test results (in vivo study performed according to OECD guideline 404), yttrium zirconium oxide (a form of zirconium oxide stabilised with yttrium oxide) was determined not to be irritating to the skin of New Zealand White rabbit (Chemical Evaluation and Research Institute, 2000).
Eye irritation:
Based on the test results obtained with New Zealand White rabbit (in vivo study performed according to OECD guideline 405), yttrium zirconium oxide (a form of zirconium oxide stabilised with yttrium oxide) does not need to be classified as irritating to eyes (Chemical Evaluation and Research Institute, 2000).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-02-08 to 2000-03-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, scientifically sound study with methods similar to OECD guidline 404 with the following deviations: not GLP, no information on environmental conditions, and no mention of untreated areas used as controls.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Not GLP, no information on environmental conditions, and no mention of untreated areas used as controls.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Biotech Co., Ltd
- Age at study initiation: 3 months
- Weight at study initiation: 2.91-3.28 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: no data To: no data - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g; moistened with distilled water for injection
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24 and 48 hours after the lint removal.
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- % coverage: no data
- Type of wrap if used: 0.5 g of the test agent was applied to a 2.5 cm square lint (Nankai Sangyou Inc.), and was secured with a piece of White Tape (Nichiban Co., Ltd.). Two application areas were established per animal. Each area was covered with a piece of oilpaper (Amadin Inc.), and the torso was covered by Silkytex (Alcare Co., Ltd.) to protect and secure the lint.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area was wiped off with distilled water for injection to remove the test agent
- Time after start of exposure: 4 hours
SCORING SYSTEM: Grades were given based on the Draize scoring method. The skin irritation of the test agent was evaluated according to skin primary irritation evaluation standard of the AFNOR (1982) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24 and 48 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed after 48 hours.
- Other effects:
- There were no abnormalities in the general condition or the weight changes to any of the 3 animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritative reaction was observed during the observation period.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-02-08 to 2000-03-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well documented, scientifically sound study according to a method similar to OECD guideline 405 with a few deviations. However, not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) not reported in the results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) were not reported in the results
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Biotech Co., Ltd
- Age at study initiation: 4 months old
- Weight at study initiation: 3.22-3.59 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: no data To: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eyes were kept as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3 animals (administered to the left eye of each animal)
- Details on study design:
- SCORING SYSTEM: According to Draize's standard (1959). Cornea, iris and conjunctiva were observed, and acknowledged damages were recorded. After calculating the total scores of each observation of each animal (Individual ocular irritation index, IOI) and the average score of each observation of each group (Mean ocular irritation index, MOI), the evaluation was made according to the AFNOR (1982) evaluation criteria. The acute ocular irritation index (AOI) was defined as the maximum of the MOI.
Accident Value Test of Corneal Epithelium: After the accident value test of anterior ocular segment done 24 hours after the application, corneal epithelium were dyed with fluorescein, and the stainability was evaluated.
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- other: MOI
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 1 hour
- Score:
- 4.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: MOI
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24 h
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: MOI
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: MOI
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: AOI
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24 h
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The AOI was determined to be 6.0 at 24 hours and the MOI after 48 hours was 2.0, therefore, this test agent was determined to be slightly irritating based on the AFNOR (1982) criteria. No irritation was observed after 72 hours.
The Accident Value Test of Corneal Epithelium 24 hours after application was zero in all three animals. - Other effects:
- There were no abnormalities in the general condition or the weight changes to any of the 3 animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test agent was determined to be slightly irritating based on the AFNOR criteria. It does however not need to be classified for eye irritation according to the CLP criteria.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation / corrosion:
One reliable studiy was identified (Klimisch 2). The study performed by Chemical Evaluation and Research Institute (2000) is a non-GLP study performed according to the OECD 404 guideline with minor deviations. Yttrium zirconium oxide (a form of zirconium oxide stabilised with yttrium oxide) was determined not to be irritating to New Zealand White rabbit skin after 4 hours of exposure.
Eye irritation:
A reliable study was performed with yttrium zirconium oxide (Chemical Evaluation and Research Institute, 2000) in New Zealand White rabbit according to OECD guideline 405 with minor deviations. The test substance was determined to be slightly irritating based on the AFNOR criteria but the observed effects were fully reversible within 72 hours. Therefore, it does not need to be classified for eye irritation according to the rules of the CLP Regulation.
Justification for classification or non-classification
Skin irritation / corrosion:
Based on to the available data and according to the criteria of the CLP Regulation, this substance should not be classified for skin corrosion / irritation or for eye irritation.
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