4,4'-ethylidenediphenyl dicyanate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-December 1986

Reliability:

2 (reliable with restrictions)

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.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

; deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period).

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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

Observation only at 72 hours

Number of animals:

4 animals were used

Details on study design:

Observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

The test item produced very mild dermal irritation. Only one of the four animals exhibited very slight (barely perceptible) erythema at 72 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was found to be non-irritant to rabbit skin.

Executive summary:

The skin irritation test was performed according to EU-testing method B.4, using 4 NZW-rabbits. Deviated from Annex V (observations only at 72 hours after initial to administration) but with procedures more severe than Annex V (skin abraded prior to administration, occlusive dressing and 24-hour exposure period). Very slight erythema (grade I) was observed in one animal at 72 hours. The test item was found to be non-irritant to rabbit skin.