Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 909-715-0 | CAS number: -
- 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
Based on the results of the available in vivo skin irritation studies for praseodymium(III,IV) oxide (Shapiro, 1991a), zirconium dioxide (BIBRA, 1986) and the reaction mass of cerium dioxide and zirconium dioxide (Harlan, 2009; De Jouffrey, 1996b), it could be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide is not a skin irritant and does not need to be classified for skin irritation under the CLP Regulation.
Eye irritation
Based on the results of the available in vivo skin irritation studies for praseodymium(III,IV) oxide (Shapiro, 1991b), yttrium zirconium oxide (Japanese Chemical Evaluation and Research Institute, 2000) and the reaction mass of cerium dioxide and zirconium (De Jouffrey, 1996c), it could be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide does not need to be classified for eye irritation under the CLP Regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: 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
- Justification for type of information:
- Note that no justification was given by the laboratory why an in vivo study was performed with the reaction mass of cerium dioxide and zirconium dioxide (Harlan, 2009) instead of first performing an in vitro test.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 16-OCT-1995 to 08-MAR-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.4 +/- 0.2 kg
- Housing: individually in polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet (e.g. ad libitum): free access to 112 pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From: 15 nov 1995 To: 18 nov 1995 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control on the other untreated flank
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 500 mg of the substance was applied to a 6 cm2 moistened gauze pad which was thus applied to the right flank of the animals.
- Type of wrap if used: The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test item was wiped off by means of a moistened gauze pad.
SCORING SYSTEM: according to EEC Criteria - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating to skin.
The reaction mass of cerium dioxide and zirconium dioxide is not classified according to the criteria of the EU-CLP Regulation 1272/2008. - Executive summary:
In a primary dermal irritation study (CIT, 1996), New Zealand White rabbits (3 males) were dermally exposed to 500 mg of the reaction mass of cerium dioxide and zirconium dioxide onto one flank.
Test sites were covered with semi-occlusive dressing for 4 hours. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score values for erythema and oedema were calculated for 24, 48 and 72 hours.
No cutaneous reactions were observed during the study.
In this study, the reaction mass of cerium dioxide and zirconium dioxide is not classified according to the EU classification criteria.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2008-12-02 to 2009-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No information was provided on the initial test or weight of evidence to waive the need for an initial test.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum, 2030 Taklad Global Rabbit diet
- Water (e.g. ad libitum): mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12 (06:00 - 18:00 light)
IN-LIFE DATES: From: no data To: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank
- Type of wrap if used: Cotton gauze patch was used to apply test substances to shorn skin. The patch was secured in position with a strip of surgical adhesive tape. The trunk of each test animal was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water soaked cotton wool cloth
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize (1959) - The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits and this total was divided by six to give the primary irritation index of the test substance. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72-hour readings
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No evidence of skin irritation was reported under the test conditions.
- Other effects:
- All test animals showed expected gain in body weight during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test substance failed to produce an irritation to the skin of the test animals. Under these test conditions it can be stated that the test substance can be classified as not irritating to rabbit skin according to the Draize classification scheme. No corrosive effects were reported.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 26 December 1990 - 5 February 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. No irritation scores recorded for the 48 hour time point.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Individually housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): ad libitum; pelleted Purina Rabbit Chow
- Water (e.g. ad libitum): Tap water supplied by automatic watering system supplied ad libitum.
- Acclimation period: 20 days
- Source: Davidson’s Mill Farm, S. Brunswick, New Jersey
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 - 75 °F
IN-LIFE DATES: From: 26 December 1990 To: 29 December 1990 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved test sites with both intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- - The rabbits were prepared by clipping the skin free of hair over approximately 10% of the body surface (dorsal and ventral surfaces from scapular to pelvic area). Two test application sites, each approximately 2.5 cm² were delineated. One site was left intact while the other was abraded with a needle, taking special precaution not to penetrate the stratum corneum and not to cause bleeding.
- 0.5 g test material was placed on each site and was immediately covered with a 2 x 2.25 inch adhesive-backed gauze patch. The patches and entire trunk of each rabbit were then wrapped with an elastic cloth to aid in maintaining test-patch position and to minimise evaporation.
- The patches were removed after 24 hours of exposure at which time the test sites were gently wiped clean of any residual test material.
Skin sites were evaluated at approximately 24 and 72 hours after initial exposure and scored as follows:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading: 4
Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (edges raised approximately 1 millimeter): 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure): 4 - Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.09
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: very slight erythema without oedema at both abraded and intact sites at 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- measured at 24 h and 72 h
- Irritant / corrosive response data:
- Very slight erythema without oedema was observed at both abraded and intact sites of one rabbit only at 24 hours post-dosing. By 72 hours, no irritation was observed.
- Other effects:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the CLP criteria.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1986-03-04 to 1986-07-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented, scientifically sound GLP study that was based on the OECD Guideline 404 "Acute Dermal Irritation/Corrosion". The test substance was tested simultaneously on the same animals.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- substances were tested simultaneously on the same animals
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Regal Rabbits, Great Bookham, Surrey
- Housing: individually in metal grid-floored cages
- Diet: ad libitum, Grain Harvester's special rabbit diet 679
- Water: ad libitum tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 43-74 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): spread on a patch previously moistened with 0.5 mL of water to ensure good contact with the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 4 male animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: 2.5 cm square patches were applied to the skin on 6 cm square patches of polythene held in place by adhesive tape and elastic net bandages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize (1959), indices of irritation were calculated for each animal by totalling the scores for oedema and erythema for each animal and dividing by two. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No reaction to the test substances was reported in any of the test animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was determined to be not irritating to the skin of rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The in vivo skin irritation studies on praseodymium(III,IV) oxide, zirconium dioxide, and the reaction mass of cerium dioxide and zirconium dioxide are considered relevant for drawing conclusion on the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide. The read across justification document is attached to IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on the results of the in vivo studies performed with praseodymium(III,IV) oxide, zirconium dioxide, and the reaction mass of cerium dioxide and zirconium dioxide, it can be concluded that no erythema is to be expected in similar studies with the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide. The reaction mass is not expected to cause skin irritation and therefore does not need to be classified for skin irritation or corrosion.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on the results of the in vivo studies performed with praseodymium(III,IV) oxide, zirconium dioxide, and the reaction mass of cerium dioxide and zirconium dioxide, it can be concluded that no edema is to be expected in similar studies with the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide. The reaction mass is not expected to cause skin irritation and therefore does not need to be classified for skin irritation or corrosion.
Referenceopen allclose all
Table 1 Primary Dermal Irritation (PDI) Scores - Individual Results
Rabbit |
24 hours |
72 hours |
||
Abraded |
Intact |
Abraded |
Intact |
|
8058 8059 8060 8061 8062 8063 |
0/0 0/0 0/0 0/0 0/0 1/0 |
0/0 0/0 0/0 0/0 0/0 1/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 0/0 0/0 |
Total |
1/0 |
1/0 |
0/0 |
0/0 |
Mean |
0.17/0 |
0.17/0 |
0/0 |
0/0 |
Key: erythema and eschar / oedema
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- The in vivo eye irritation studies on praseodymium(III,IV) oxide, yttrium zirconium oxide (i.e. zirconium dioxide with a small amount of yttrium oxide added to its crystal lattice), and the reaction mass of cerium dioxide and zirconium dioxide are considered relevant for drawing a conclusion on the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide. The read across justification document is attached to IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Remarks:
- read across conclusion
- Remarks on result:
- no indication of irritation
- Remarks:
- Based on the results of the in vivo studies performed with praseodymium(III,IV) oxide, yttrium zirconium oxide (i.e. zirconium dioxide with a small amount of yttrium oxide added to its crystal lattice), and the reaction mass of cerium dioxide and zirconium dioxide, it can be concluded that no eye irritation requiring classification would be observed in a similar study with the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 16-OCT-1995 to 08-MAR-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.4 kg
- Housing: individually in polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet (e.g. ad libitum): free access to 112 pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From: 22 nov 1995 To: 29 nov 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Observation period (in vivo):
- One hour, 24, 48 and 72 hours after the administration and then daily for 4 days at the latest.
Reversibility of ocular lesions was observed on day 4 (two animals) or 8. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not rinsed
SCORING SYSTEM: according to EEC Criteria
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- Clear ocular discharge was observed in 2 rabbits for 24 or 48 hours after administration of the test substance.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The reaction mass of cerium dioxide and zirconium dioxide was found to be slightly irritating to rabbit eyes, however, the observed effects did not reach the classification limits under the CLP Regulation and therefore the reaction mass is not classified for eye irritation under the CLP Regulation.
- Executive summary:
In a primary eye irritation study (CIT, 1996), 100 mg of the reaction mass of cerium dioxide and zirconium dioxide was instilled into the conjunctival sac of the left eye of New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. The ocular examinations were performed 1, 24, 48 and 72 hours after instillation.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.3 for chemosis, 0.3, 1.0 and 2.3 for redness of the conjunctivae, 0.0, 0.0 and 0.7 for iris lesions and 0.7, 0.3 and 1.3 for corneal opacity. Total reversibility was observed by day 4 (2 animals) or day 8.
In this study, the reaction mass of cerium dioxide and zirconium dioxide is not classified as eye irritant based on the EU classification criteria.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 31 December 1990 - 4 February 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. Irritation effects in animals only observed for 72 hours.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA 16 CFR 1500.42
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Individually housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum tap water supplied by automatic watering system
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71 - 73 °F
IN-LIFE DATES: From: 31 December 1990 To: 3 January 1991 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye of each animal remained untreated and served as control
- Amount / concentration applied:
- Undiluted.
Amount applied: 0.1 g into the conjuctival sac of the left eye - Duration of treatment / exposure:
- 30 seconds for 3 of the treated eyes (washed eyes) and up to 72 hours for the 3 others (the upper and lower lids were gently held together for about 1 second to prevent loss of the test material).
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Three of the treated eyes were rinsed with 30 cc of saline 30 seconds post-instillation. The remaining three eyes were not irrigated.
SCORING SYSTEM: Draize Scale for Ocular Irritation
After instillation of the test material, ocular lesions were evaluated in accordance with Draize et al. at 24, 48 and 72 hours.
Special care was taken to look for and notate any unusual effects, such as pannus, blistering of the conjunctivae, ulceration and other indicators of corrosive action.
Draize Scale for Scoring Ocular Irritation:
1. CONJUNCTIVAE
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3
(B) Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4
(C) Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3
THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20
2. IRIS
(D) Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2
THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10
3. CORNEA
(E) Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4
(F) Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4
THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80
MAXIMUM TOTAL SCORE POSSIBLE = 110 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Washed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Washed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- other: 1 animal still exhibited a hyperaemia score of 1 after 72 hours
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- other: 1 animal still exhibited a hyperaemia score of 1 after 72 hours
- Remarks on result:
- other: Washed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Washed
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Washed
- Irritant / corrosive response data:
- - Conjunctival irritation was observed in all treated eyes, unwashed and washed, at 24 hours post-dosing. By 72 hours, this was observed in only one washed and one unwashed treated eye.
- No corneal opacity or iritis was noted during the test period. - Other effects:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced minimal irritation to both the unwashed and washed eyes; no classification is required.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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.
Referenceopen allclose all
Table 1: Individual Results
Time Point (hours) |
Rabbit Number |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
24 |
8087 8088 8089 8090 8091 8092 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
3 2 1 2 2 1 |
1 1 0 0 1 0 |
1 0 0 0 0 1 |
48 |
8087 8088 8089 8090 8091 8092 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
2 2 0 2 1 1 |
1 0 0 0 0 0 |
0 0 0 0 0 0 |
72 |
8087 8088 8089 8090 8091 8092 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 0 0 1 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
Rabbits 8090, 8091 and 8092 had the treated eye rinsed with 30 cc of saline solution 30 seconds post-installation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
1. Information on the reaction mass of cerium dioxide and zirconium dioxide
In a primary dermal irritation study (De Jouffrey, 1996b; Klimisch 1), 3 male New Zealand White rabbits were dermally exposed to 500 mg of the reaction mass of cerium dioxide and zirconium dioxide onto one flank. Test sites were covered with semi-occlusive dressing for 4 hours. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing. The mean scores for erythema and edema were calculated for 24, 48 and 72 hours. No cutaneous reactions were observed during the study warranting classification.
In addition, a similar acute dermal irritation test in New Zealand White rabbits was performed by Harlan (2009; Klimisch 1). Three rabbits were dermally exposed to 500 mg of the reaction mass of cerium dioxide and zirconium dioxide onto a dorsal flank for 4 hours. Cotton gauze was used to apply the test substance to shorn skin. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing. The mean scores for erythema and edema were calculated for 24, 48 and 72 hours. No evidence of skin irritation was reported under the conditions of the test.
Based on these studies the reaction mass of cerium dioxide and zirconium dioxide was concluded not to be irritating to skin and not classified for this endpoint under the CLP Regulation.
2. Information on praseodymium(III,IV) oxide
In the guideline study performed by Shapiro (1991a; Klimisch 2), 0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours, after which the patches were removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure. With the exception of one rabbit, which exhibited very slight erythema without oedema at both the intact and abraded site at 24 hours (reversible within 72 h), all sites were clear of irritation during the test period (PDII = 0.09). This study was considered reliable with restrictions because no observations were made at 48 hours after exposure. Based on the results of this study, praseodymium(III,IV) oxide is considered not be a dermal irritant and does not require classification.
3. Information on zirconium dioxide
In a guideline study performed by The British Industrial Biological Research Association (1986; Klimisch 2), zirconium dioxide was found not to be irritating to the skin of New Zealand White rabbits. The overall irritation score was calculated to be zero and hence, it can be concluded that zirconium dioxide does not need to be classified for skin irritation.
4. Conclusion on the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide
Based on the studies available for praseodymium(III,IV) oxide, zirconium dioxide and the reaction mass of cerium dioxide and zirconium dioxide, it can safely be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide is not irritant to skin and does not need to be classified for skin irritation under the CLP Regulation.
Eye irritation
1. Information on the reaction mass of cerium dioxide and zirconium dioxide
In a primary eye irritation study (De Jouffrey, 1996c; Klimisch 1), 100 mg of the reaction mass of cerium dioxide and zirconium dioxide was instilled into the conjunctival sac of the left eye of New Zealand White rabbits (3 animals). Eyes were not rinsed and the right eye served as control. The ocular examinations were performed 1, 24, 48 and 72 hours after treatment. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.3 for chemosis, 0.3, 1.0 and 2.3 for redness of the conjunctivae, 0.0, 0.0 and 0.7 for iris lesions and 0.7, 0.3 and 1.3 for corneal opacity. Total reversibility was observed by day 4 (2 animals) or day 8. Based on these observations the reaction mass of cerium dioxide and zirconium dioxide is not classified as eye irritant under the CLP Regulation.
2. Information on praseodymium(III,IV) oxide
In the guideline study performed by Shapiro (1991b; Klimisch 2), 0.1 g of the test material was instilled into the left eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for 72 hours and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize. In this study, the test item produced minimal irritation to both the unwashed and washed eyes but no classification is required under the conditions of this study in accordance with the CLP criteria.
3. Information on zirconium dioxide
In the guideline study performed by the Chemical Evaluation and Research Institute of Japan (2000; Klimisch 2), 0.1 g of yttrium zirconium oxide (test item with a low amount of yttrium oxide incorporated into the crystal lattice of zirconium dioxide) was instilled into the left eye of 3 New Zealand White rabbits. The results were calculated in terms of the Mean ocular irritation index (MOI). The test item was determined to be slightly irritating based on the AFNOR criteria, but the irritation was reversible at 72 h. It does not need to be classified for eye irritation according to the criteria of the CLP regulation. The results of this study were considered relevant for zirconium dioxide. The study was considered reliable with restrictions because no scores for each individual eye irritation endpoint for each individual animal were reported.
4. Conclusion on the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide
Based on the studies available for praseodymium(III,IV) oxide, yttrium zirconium oxide (i.e. zirconium dioxide with a small amount of yttrium oxide added to its crystal lattice) and the reaction mass of cerium dioxide and zirconium dioxide, it can safely be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide does not need to be classified for eye irritation either under the CLP Regulation.
Justification for classification or non-classification
Based on the studies available for praseodymium(III,IV) oxide, zirconium dioxide and the reaction mass of cerium dioxide and zirconium dioxide, it can safely be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide is not irritant to skin and does not need to be classified for skin irritation under the CLP Regulation.
Based on the studies available for praseodymium(III,IV) oxide, yttrium zirconium oxide (i.e. zirconium dioxide with a small amount of yttrium oxide added to its crystal lattice) and the reaction mass of cerium dioxide and zirconium dioxide, it can be concluded that the reaction mass of cerium dioxide, praseodymium(III,IV) oxide and zirconium dioxide does not need to be classified for eye irritation either under the CLP Regulation.
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.