Registration Dossier

Toxicological information

Eye irritation

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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:
1979

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
6/6
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6/6
Time point:
other: 24 h, 48 h, 72 h
Score:
1
Max. score:
3
Reversibility:
other: 5/6 animals redness was reversible after 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6/6
Time point:
other: 24 h, 48 h, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: According to the FDA standards the test material AK 43/79 is not considered an eye irritating agent.
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.