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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:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported as such

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2596, 2820, 2889 g
- Housing: Singly in suspended stainless steel caging with mesh floors. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 or 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 63-71%. The humidity was above the targeted upper limit for one day during the study. A portable dehumidifier was used to decrease the humidity levels during this time.
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test substance and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated and control eyes of all rabbits remained unwashed.

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: High-intensity white light source and fluorescein stain (24-hour evaluation).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-, 48-, and 72-hr
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-, 48-, and 72-hr
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of the 24-, 48, and 72-hr scores for redness
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of the 24-, 48-, and 72-hr scores
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of the 24-, 48-, and 72-hr scores for redness
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of the 24-, 48-, and 72-hr scores
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of the 24-, 48-, and 72-hr scores for redness
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of the 24-, 48-, and 72-hr scores
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours. Individual eye irritation scores are presented in Table 1. A summary of mean scores are presented in Table 2.
Other effects:
All animals appeared active and healthy during the study. No biologically significant weight loss occurred in any of the rabbits. Apart from the eye irritation, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Any other information on results incl. tables

Table 1

Individual Scores for Ocular Irritation

 

Rabbit No. 3401 (Male)

Rabbit No. 3402 (Female)

Rabbit No. 3403 (Female)

 

Hours

 

1

24

48

72

1

24

48

72

1

24

48

72

I. Cornea

 

A. Opacity

0

01

0

0

0

01

0

0

0

01

0

0

B. Area

4

4

4

4

4

4

4

4

4

4

4

4

II Iris

 

A. Values

0

0

0

0

1

0

0

0

1

0

0

0

III. Conjunctivae

 

A. Redness

1

1

0

0

2

1

0

0

2

1

1

0

B. Chemosis

0

0

0

0

1

0

0

0

1

0

0

0

C.Discharge

1

0

0

0

1

0

0

0

1

1

0

0

12% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.

 

Table 2

Mean Scores for Individual Rabbits

Rabbit Number

Corneal Opacity

Iritis

Conjunctival Redness

Conjunctival Chemosis

3401

3402

3403

0.00

0.00

0.00

0.00

0.00

0.00

0.33

0.33

0.67

0.00

0.00

0.00

a Calculated from the 24-, 48-, and 72-hour scores.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Irritation was observed in all treated eyes. The treated eye was normal in 2 rabbits by 48 hours and in 1 rabbit by 72 hours.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. There was no corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours.