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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
Study period:
1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
0.1mL dose, treated eyes unwashed for 24h, 7d observation period.
Principles of method if other than guideline:
The procedure followed was a modification of that used by Dr. J.H. Draize in Appraisal of The Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration - Department of Health, Education and Welfare.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Neo-DHC, Lot #26-RS-17, received date 8/11/78.
- Purity (HPLC): 98.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Six albino New Zealand rabbits (3 males, 3 females), healthy, without ocular defects; no further details.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
24h.
Observation period (in vivo):
7d.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: water rinsing.
- Time after start of exposure: 24h.

SCORING SYSTEM: Observations of injuries were made on the cornea, iris and the bulbar and palpebral conjunctivae. Numerical scores were assigned to lesions observed according to the Draize standard scoring system. In this system, the injuries to the cornea and iris account for approximately 80% of the total score; these structures are purposely weighted because of their vital role in the vision. The maximum score is the sum of all scores obtained for the cornea, iris, and conjunctivae.

TOOL USED TO ASSESS SCORE: hand-held lenses.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
2.2
Max. score:
110
Reversibility:
fully reversible within: 2d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See table 1.

Any other information on results incl. tables

Table 1. Eye Irritation

Rabbit

Day

Cornea

A x B x 5

Iris

C x 5

Conjunctivae

(D + E + F) x 2

Total Score

1

1

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

2

1

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

3

1

0

0

1

1

1

1

11

2

0

0

0

1

0

0

2

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

 4

1

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

5

1

0

0

0

1

0

0

2

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

6

1

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

-

-

-

-

-

-

-

7

-

-

-

-

-

-

-

Average

1

*total score possible = 110

2.2

2

0.3

3

0.0

4

-

7

-

A: opacity, B: area of cornea involved, C: value, D: redness, E: chemosis, F: discharge.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under test conditions, the test substance is found to be not irritating.
Executive summary:

A study to investigate possible irritation or corrosion of the test substance on the eyes of rabbits was performed according to Draize (1944), similar to OECD Guideline 405 (no GLP). The right eye of 6 New Zealand White rabbits (3 males, 3 females) received single application of 0.1ml test item, while the left eye was used as a control. The treated eyes of all rabbits remained unwashed for 24h, readings were made using hand-held lenses 1, 2, 3 and up to 7 days after. Under test conditions, the test substance was found to be non-irritating to the eyes.