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:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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%.

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.

 

 

 

 

 

 

 

 

 

 

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.