Registration Dossier
Registration Dossier
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EC number: 215-691-6 | CAS number: 1344-28-1
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:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) Draize and Kelly (Drug Cosmet. Industr. 71 (1952) 36)
- Deviations:
- not specified
- 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): aluminium oxide (TBH) coded AK 43/79
- Physical state: reddish-purple coloured solid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals:
Species and strain: New Zealand White albino rabbits
Sex: No information
Source: No information
Age at study initiation: No information
Body weight range at the beginning of the study: No information.
Body weight range at the end of study: No information
Data of receipt: No information
Acclimation: No information
Identification: No information
Environmental/housing and feeding conditions:
Lighting period: No information
Temperature: No information
Relative humidity: No information
Housing/Enrichment: “The animals are caged individually and receive no hay or other extraneous material that might enter the eye.”
Ventilation: No information
Feeding conditions
No information
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as the control.
- Amount / concentration applied:
- 100 mg of the test substance was allowed to “fall on the averted lower lid of one eye.” The eyelids were held together for at least one second to prevent loss of the test material.
- Duration of treatment / exposure:
- The eyes were not washed following instillation. As no examination was conducted at 1 hour after instillation, it is unclear whether the test material was removed from the eye by physiological mechanisms at that time
- Observation period (in vivo):
- Animals were examined 24, 48, 72 hours and 7 days after instillation.
Initial pain reaction was not reported
Clinical signs of toxicity during the study were not reported.
Ocular reactions, read using a binocular magnifying glass, of the individual animals were recorded at each observation time
“The diagnosis of corneal damage is confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers.” [As no animals exhibited signs of cornea damage, this technique, most probably, was not applied] - Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- SCORING SYSTEM: The FDA scoring scale was used
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6/6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6/6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6/6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- other: 5/6 animals redness was reversible after 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Initial pain reaction – no information
1 hour after instillation – no examination was conducted
24 hours after instillation: conjunctival redness (score 1) and chemosis (score 1) was observed in all animals. No cornea or iris lesions in any animal.
48 hours after instillation: conjunctival redness (score 1) was observed in all animals and chemosis (score 1) – in 4 animals. No animals showed signs of cornea or iris lesions
72 hours after instillation: conjunctival redness (score 1) was observed in all animals. No animal showed signs of chemosis, cornea or iris lesions.
7 days after instillation: conjunctival redness (score 1) was observed in one animal, and there were no signs of chemosis, cornea or iris lesions in any animal.
Symptoms in the control eye – no information - Other effects:
- Mortality: no mortality was observed during the study period
Body weight: no information
Clinical observation/General Daily Examination: no information
Any other information on results incl. tables
Individual
scores awarded to the ocular lesions elicited by AK 43/79
--------------------------------------------------------------------------------------------------------------
Conjunctivae
Rabbit
----------------------------------
number cornea iris redness chemosis
------------------------------------------------------------------------------------------------------------------
After 24 hours
1 0 0 1 1
2 0 0 1 1
3 0 0 1 1
4 0 0 1 1
5 0 0 1 1
6 0 0 1 1
After 48 hours
1 0 0 1 0
2 0 0 1 1
3 0 0 1 1
4 0 0 1 0
5 0 0 1 1
6 0 0 1 1
After 72 hours
1 0 0 1 0
2 0 0 1 0
3 0 0 1 0
4 0 0 1 0
5 0 0 1 0
6 0 0 1 0
After 7 days
1 0 0 0 0
2 0 0 0 0
3 0 0 0 0
4 0 0 0 0
5 0 0 0 0
6 0 0 1 0
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:
- No eye irritation/ corrosion effects were observed. According to the FDA standards applied, aluminium oxide is not considered an eye irritant.
- Executive summary:
An eye irritation study of the test item Aluminium oxide (coded AK 43/79) was performed inWhite albino rabbits. Six animals were used in this experiment. The irritation effects of the test item were evaluated according to theFDA criteria. 100 mg of the test item was administered as a single dose. The test item was placed into the conjunctival sac of the eye. The untreated eye served as control. The eyes of the test animals were not washed after the application of the test item. The eyes were examined 24, 48, 72 hours and 7 days after the application. No examination was conducted 1 hour after the application. Initial Pain Reaction was not reported.
At 24 hours after instillation a conjunctival redness (score 1) and chemosis (score 1) was observed in all animals. No cornea or iris lesions in any animal. At 48 hours after instillation,conjunctival redness (score 1) was observed in all animals and chemosis (score 1) in 4 animals. No animals showed signs of cornea or iris lesions. At 72 hours after instillation,conjunctival redness (score 1) was observed in all animals. No animal showed signs of chemosis, cornea or iris lesions. At 7 days after instillation,conjunctival redness (score 1) was observed in one animal, and there were no signs of chemosis, cornea or iris lesions in any animal.
No information was provided on symptoms in the control eye. No information was provided on animal behaviour, clinical signs of toxicity, or body weight changes during the study period. The observed changes of grade 1 were not considered positive according to the FDA standards applied in this study.
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