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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
-Purity: 96.8%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckshire Corporation, Perkasie, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2514 to 3229 g
- Housing: housed
singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow® #5322
- Water (e.g. ad libitum): No data on the source of the water
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): No data are available
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test material and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 90 mg
Duration of treatment / exposure:
Approximately 10 seconds; after the test material was administered, both eyes of 3 rabbits were rinsed with water for approximately 1 minute with room temperature water. The eyes of the other 6 rabbits were not washed with water
Observation period (in vivo):
Approximately 24, 48, and 72 hours after the test substance administered, the rabbits were examined for evidence of eye irritation. Six rabbits were further examined at 7 days, 2 at 10 days, and 1 at 13, 16, 20, and 21 days
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 rabbits were washed with water for 1 minute
- Time after start of exposure: 10 seconds

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.34
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.28
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Post Treatment

Evaluation Time

Conjunctival

Chemosis

Conjunctival Redness

Iridic Congestion

Corneal

Opacity

24 hours

1

0.83

0

1

48 hours

0

0

0

0.67

72 hours

0

0

0

0.67

Overall Average (24h + 48h + 72h/3)

0.33

0.28

0

1.34

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of testing, the test substance produced ocular irritation in the form of corneal opacity, conjunctiva! redness, and chemosis. Epithelial sloughing of the cornea was observed in 3 of the unwashed eyes and in 1 of the washed eyes. The substance is considered to be irritating to the eyes.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 9 young adult New Zealand White rabbits. Approximately 90 mg (a weight corresponding to a 0.1 mL volume of test material) was administered to one eye of each test animal. The eyes of 6 rabbits remained unwashed following treatment, and the eyes of 3 rabbits were washed (OECD Guideline 405)

 

The conjunctiva, iris and cornea of each treated eye were evaluated and scored according to a numerical scale, 24, 48, and 72 hours following administration of the test material. Animals were also assessed for reversibility of ocular effects for up to 21 days following treatment.

 

Mean values were calculated from the quantitative evaluation of ocular lesions observed in rabbits with unwashed eyes at 24, 48, and 72 hours following treatment. Since the substance produced corneal opacity in 5/6 animals at 24 hours with a mean cornea opacity score of ≥1, the substance is considered an eye irritant. These effects were reversible within 10 days. The substance would therefore be considered a Cat 2 eye irritant.