Aluminium oxide

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:

1969

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

Test material information

Constituent 1

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%.

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Results 13

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

Results 14

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

Results 15

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

Results 16

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.