4,4'-ethylidenediphenyl dicyanate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-December 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: no guideline study; not GLP-compliant

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

; deviated from Annex V (observations only at 24 hours and 7 days)

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

other: amber liquid

Details on test material:

- Test Material: C-1054
- Description: Amber liquid
- Date Received: August 7, 19B6
- Storage: Temperature - monitored room (60-85°F)
- Density: 1.2208 g/ml

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml test item was applied

Observation period (in vivo):

Observation at 24 hours and 7 days only

Number of animals or in vitro replicates:

4 animals were used

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.75

Max. score:

1

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: redness

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24. 48 and 72 h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 78 and 72 h

Score:

0.75

Reversibility:

fully reversible

Irritant / corrosive response data:

The test item produced very mild ocular irritation. All four animals exhibited slight conjunctival irritation (redness, chemosis) and iridial changes at 24 hours. By Day 7, two animals were free of ocular irritation; two animals continued to exhibit slight conjunctival irritation.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item showed irreversible conjunctival redness in two animals after seven days.

Executive summary:

The eye irritation test was performed according to EU-testing method B.5, using 4 NZW-rabbits. Deviated from Annex V (observations only at 24 hours and 7 days after initial to administration). At 24 hours mild conjunctival redness (score 1) was observed in all animals. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. Due to the irreversible conjunctival redness observed in two animals, the test item needs to be classified "Eye dam.1, H318".