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EC number: 215-691-6 | CAS number: 1344-28-1
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : observations ought to be made at 1 hour post-application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- Cas Number:
- 1344-28-1
- Molecular formula:
- Al2O3
- IUPAC Name:
- oxo[(oxoalumanyl)oxy]alumane
- Details on test material:
- - Name of test material (as cited in study report): ALON (aluminium oxide, fumed alumina)
- Physical state: white powder with faint odour
- Analytical purity: The test material was a gamma-phase, high surface area alumina made by the hydrolysis of aluminium chloride. Purity is close to 100%.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Sex: not reported
Age: not reported
Weight: 2.2 – 2.6 kg
Environmental/Housing conditions
No information provided.
Feeding conditions
No information provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eyes of the animals were used as controls.
- Amount / concentration applied:
- Single application of 100mg solid ALON
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- Observations were made at 24, 48, 72 hours and also on days 4 and 7.
- Number of animals or in vitro replicates:
- 9 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In three animals, the compound was washed out after 2 seconds, in three animals it was washed out after 4 seconds and in 3 animals the substance was not washed out. Tap water was used for washing the animals’ eyes.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein (2% on day 7)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- unwashed
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- unwashed
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- unwashed
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 4 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals; unwashed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 4 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals; unwashed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 4 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals; unwashed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 2 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals; washed after 4 sec
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- The authors reported no principal toxic effects.
Any other information on results incl. tables
Individual results were provided in the report for each rabbit.
The total scores are provided in the table below for the different observation times:
Rabbit # | Washing | 24 hrs
| 48 hrs | 72 hrs | 4 days | 7 days | Fluor-escein (t=0) | Fluor-escein (t=7d) |
68-2816 | unwashed | 2 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2817 | unwashed | 2 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2818 | unwashed | 2 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2819 | washed-2s | 0 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2820 | washed-2s | 2 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2821 | washed-2s | 2 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2822 | washed-4s | 0 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2823 | washed-4s | 0 | 0 | 0 | 0 | 0 | Neg. | Neg. |
69-2824 | washed-4s | 0 | 0 | 0 | 0 | 0 | Neg. | Neg. |
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The total scores of 2 at 24 hours in all unwashed eyes and in treated eyes of two animals with washing after 2 seconds result from slight conjunctival erythema (scored as 1). The slight erythema had resolved by 48 hours in all animals. No other effects were observed. There was no evidence of corneal damage using fluorescein stain at baseline or at 7 days in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The results from this study were negative and would not support classification of ALON for eye irritation.
- Executive summary:
ALON, a high surface area fumed alumina, was tested for acute eye irritation in 9white rabbits (weights 2.2-2.6 kg) (Cabot, 1969). A single application of 100mg of the powdered substance was applied to the conjunctival sac of the left eye of each animal. In three animals, tap water was used to wash the eye after 2 seconds, in three animals washing occurred after 4 seconds, and in the remaining 3 animals, the test substances was not washed from the eyes. This deviates from OECD TG#405 which recommends washing of a solid substance from the eye if it has not been removed by physiological mechanisms 1 hour after administration. Observations were made at 24 hours, 28 hours, 72 hours, 4 days and 7 days post-application. The untreated eyes of the animals served as controls. The animals’ corneas were also examined using fluorescein stain prior to application and at 7 days to assess corneal damage. Eye irritative effects were scored and graded according to Draize (1959). The only effects reported were at 24 hours post-application: slight erythema (score=1) in all unwashed eyes and two eyes washed after 2 seconds. The erythema had resolved by the 48 hour observation time. Examination of the cornea using the fluorescein stain produced no evidence of damage. The results from this study are negative and a Klimisch Score of 2 is considered appropriate.
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