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EC number: 701-300-0 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 17, 2010 - January 19, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Although since 1 June 2008 it has been mandatory to first consider and use whenever possible in vitro testing when generating new data for the eye irritation endpoint, an in vitro test was not performed before generating in vivo data because the registrant was incorrectly informed by the testing facility that "No validated in vitro method is available for assessing acute eye irritation/corrosion". As reported in their study report on page 14 as justification for the selection of the test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cerium terbium magnesium undecaaluminum nonadecaoxide
- Molecular formula:
- Ce0.5Tb0.5MgAl11O19 -Ce0.7Tb0.3MgAl11O19
- IUPAC Name:
- Cerium terbium magnesium undecaaluminum nonadecaoxide
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- Cas Number:
- 1344-28-1
- Molecular formula:
- Al2O3
- IUPAC Name:
- aluminium trioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): CAT
- Physical state: colourless solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 23 weeks old
- Weight at study initiation: >2 kg
- Housing: individually housed in ABS - plastic rabbit cages, floor 4200 cm^2
- Diet: autoclaved hay and Altromin 2123 maintenance diet (lot no. 0955), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: November 28, 2010 To: December 20, 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Not applicable (the treated eyes were not rinsed)
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing. To determine the reversibility of the observed effects in animal no. 1, the observation period was extended to the maximum of 21 days after dosing.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Not applicable
SCORING SYSTEM: in accordance with OECD 405
TOOL USED TO ASSESS SCORE: fluorescein (only 72 hours after installation)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- - In animal #1, effects on the cornea (score: 1) were observed starting from 24 hours after installation up to the end of the observation period (21 days)
- In none of the animals, any effects on the iris were observed
- In animal #1, conjunctival redness (score: 1) was observed starting from 1 hour after installation up to day 6. In the other 2 animals, conjunctival redness (score: 1) was observed starting from 1 hour after installation up to 48 hours after installation.
- In animal #1, chemosis (score: 1) was observed starting from 1 hour after installation up to 72 hours after installation. In the other 2 animals, chemosis (score: 2) was observed 1 hour after installation and chemosis (score: 1) was observed at 24 and 48 hours after installation. - Other effects:
- - All 3 animals had a slight discharge after 1 hour
Any other information on results incl. tables
- No mortalities nor significant clinical signs of toxicity were observed
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on GHS and CLP criteria
- Conclusions:
- In an acute eye irritation study in 3 rabbits, conducted in accordance with OECD 405 (2002), EU Method B.5 (2008), EPA OPPTS 870.2400 (1998) and according to GLP principles, irritant effects were observed which were not all fully reversible. Based on the results of this study, the substance needs to be classified as causing irreversible effects on the eye (Category 1).
- Executive summary:
An acute eye irritation study was conducted in 3 rabbits in accordance with OECD 405 (2002), EU Method B.5 (2008), EPA OPPTS 870.2400 (1998) and according to GLP principles. In none of the animals, any effects on the iris were observed. In one animal, effects on the cornea (score: 1) were observed starting from 24 hours after installation up to the end of the observation period (21 days). In the same animal also conjunctival redness (score: 1) was observed starting from 1 hour after installation up to day 6 and chemosis (score: 1) starting from 1 hour after installation up to 72 hours after installation. In the other 2 animals, conjunctival redness (score: 1) was observed starting from 1 hour after installation up to 48 hours after installation and chemosis (score: 2) was observed 1 hour after installation and chemosis (score: 1) was observed at 24 and 48 hours after installation. Based on the results of this study, the substance needs to be classified as causing irreversible effects on the eye (Category 1).
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