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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Sept - October 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable deviations (no analytical purity reported)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity not reported
Principles of method if other than guideline:
- no observations after 3 days
- no initial and confirmatory test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sulfate d'aluminium en solution
- Physical state: viscous colorless liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: composition does not add up to 100%: see Confidential details on test material.
- Lot/batch No.: ref. 10-13-14-7-87, received on August 11, 1987
- Storage condition of test material: minimum 19°C
- Other: pH 2.3

Test animals / tissue source

Species:
rabbit
Strain:
other: Hybrid Albino New-Zealand rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Cleon, France
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: Individual housing, with perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 1 week before the beginning of treatment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: September 1, 1987 To: September 4, 1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
3 days
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:

SCORING SYSTEM: Draize score system


TOOL USED TO ASSESS SCORE: direct ophthalmoscopy
- cornea, iris and pupil: Heine's ophthalmoscope
- iris: direct lighting (using an electric torch)
- cornea: 2% fluorescein (excess rinsed away with approximately 20 ml tap water) and ultra-violet lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritant / corrosive response data:
The application of the test material to the right eye of the rabbit produced redness of the conjunctivae. Furthermore, moderate chemosis and iridial congestion were observed amongst all three animals during the first 48 to 72 hours. Translucency of the cornea up to one-quarter was also apparent in one rabbit at the onehourexamination.

Any other information on results incl. tables

Summary of ocular lesions

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

 

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

14

37688

Cornea

Iris

Redness

Chemosis

0

1

2

2

0

1

2

2

0

1

2

1

0

1

1

1

-

-

-

-

-

-

-

-

0

 

1

 

 

1.67

 

 

 

1.33

37851

Cornea

Iris

Redness

Chemosis

2

1

2

1

0

1

2

1

0

1

1

1

0

1

0

1

-

-

-

-

-

-

-

-

0

 

1

 

 

1

 

 

 

1

37884

Cornea

Iris

Redness

Chemosis

0

1

2

2

0

1

2

2

0

1

2

2

0

1

2

2

-

-

-

-

-

-

-

-

0

 

1

 

 

2

 

 

 

2

Mean all anim.

 

 

 

 

 

 

 

 

0

 

1

 

1.56

 

1.44

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye irrit 2, H319
DSD: Xi, R36
Executive summary:

A study was conducted to assess the irritancy potential of a solution of aluminium sulfate to the eye of three New Zealand Albino rabbits. The study was performed according to OECD Guideline 405 (Acute Eye Irritation/Corrosion) and also according to Good Laboratory Practice Standards.

A single application of 0.1 mL of the test material to the right eye of the rabbit produced redness of the conjunctivae. Furthermore, moderate chemosis and iridial congestion were observed amongst all three animals during the first 48 to 72 hours. Translucency of the cornea up to one-quarter was also apparent in one rabbit at the onehourexamination.

Based on the results of the present study, it was concluded that the test compound, Aluminium sulphate as a solution, induced a moderate eye irritation. It is not known whether reversibility of the eye effects would occur, as the observation period is only up to 3 days after application. Practically no decrease of the effects is seen after 3 days. It seems, however, that reversibility will occur within 21 days so the test material is classified as irritant (Eye ) to the skin according to OECD-GHS.