Etocrilene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Dermal Toxicity - J. H. Draize, Ph. D. , Chief, Skin Toxicity Branch. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of the Food and Drug Officials of the United States. pp. 46-59, 1959.

Principles of method if other than guideline:

One hundred milligrams of undiluted test material was instilled into the conjunctival sac of the right eye of each of six test animals. The right eyes were not washed; the left eyes served as a controls. At 24 hour consecutive intervals examinations were made of the cornea, the iris and the conjunctiva and grades were recorded according to a standard Draize scoring system.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Etocrilene

EC Number:

226-029-0

EC Name:

Etocrilene

Cas Number:

5232-99-5

Molecular formula:

C18H15NO2

IUPAC Name:

ethyl 2-cyano-3,3-diphenylprop-2-enoate

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Instillation of the test article into the conjunctival sac of the right eye of each animal, no further washing.

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize Scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

Instillation of the test material produced no discernible effects in the eyes of the rabbits tested.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article is not an ocular irritant.

Executive summary:

In an in vivo study performed in the pre-GLP and pre-OECD guideline era, the test substance was instilled into the conjunctival sac of the right eye of six albino rabbits to assess its irritating potential. The eyes were not rinsed and the animals were examined for occular reactions at 24 hour consecutive intervals for three days. Cornea, the iris and the conjunctiva of each animal were examined for irritation and grades were recorded according to a standard Draize scoring system. No discernible effects in the eyes of the rabbits tested could be observed. Therefore, the test substance is considered to be not irritating to the rabbit eye under the conditions presented.