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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports

Data source

Reference
Reference Type:
secondary source
Title:
The effects of test chemical on the eye mucosa of New Zealand Albino Rabbits
Author:
NTRL report
Year:
1974
Bibliographic source:
NTRL report, last updated 1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: A modification of the method as described in the Code of Federal Regulations, section 1500.42 was used in this experiment
Principles of method if other than guideline:
The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of the test chemical: (1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl prop-2-enoate
Common Name: Isobornyl acrylate
Molecular Formula: C13H20O2
Molecular Weigth: 208.299 g/mol
Substance Type: Organic
Physical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Housing: The animals were housed individually
Diet: The animals were housed and fed individually and maintained in accordance with standard laboratory procedure.
Water: Water was available at all times

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
Details on study design
TEST SITE
- Area of exposure: left eye conjunctival sac

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

Observation duration: The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material.

SCORING SYSTEM:
SCALE FOR INTERPRETATION OF EYE SCORES FOR OCULAR LESIONS (DRAIZE)

1. Cornea
Total Maximum = 80
2. Iris
Total Maximum = 10
3. Conjunctivae
Total Maximum = 20
Total Eye Score = 110

Classification of ocular reactions based on the scores
1-15 – Slight Irritation
16-30 – Mild Irritation
31-75 – Moderate Irritation
76-110 – Severe Irritation

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four.

Any other information on results incl. tables

 

Table Eye Irritation in rabbits

Animal number

Cornea

A*B*6

Iris

A*5

Conjunctivae

(A+B+C)*2

Total score per animal

A

B

A

A

B

C

24 hours – No wash

1

1

1

0

1

0

0

7

2

1

1

0

1

1

0

9

3

0

0

0

0

0

0

0

4

1

1

0

1

1

1

11

5

1

1

0

1

1

0

9

6

1

1

0

1

0

0

7

48 hours – No wash

1

1

1

0

1

0

0

7

2

1

1

0

1

0

0

7

3

0

0

0

0

0

0

0

4

1

1

0

1

1

0

9

5

1

1

0

1

0

0

7

6

0

0

0

0

0

0

0

72 hours – No wash

1

1

1

0

1

0

0

7

2

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

4

1

1

0

1

0

0

7

5

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

4 days – No wash

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

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

7 days – No wash

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

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four.
The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits.
Based on the scores and observations,the test substance was considered to be not irritating to rabbit eyes.
Executive summary:

The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines.

6 New Zealand albino rabbits were used for the study.0.1ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material.

Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four.

The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits.

Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.