4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 03 May 1976 to 06 MAY 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

Deviations:

no

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted)

Test material

Test material information

Constituent 1

Reference substance name:

4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

EC Number:

220-509-3

EC Name:

4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

Cas Number:

2786-76-7

Molecular formula:

C26H22N4O4

IUPAC Name:

4-[(4-carbamoylphenyl)diazenyl]-N-(2-ethoxyphenyl)-3-hydroxy-2-naphthamide

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: individually
- Weight at study initiation: 1.5-2.0 kg
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

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

Reversibility:

other: reversibility not relevant since no effect

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effects

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Remarks:

The test item is intensly red colored,. remaining traces might appear as "erythema"

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #2, #4, #5, #6 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not relevant since no effects

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Irritant / corrosive response data:

Animals #3 showed redness of the conjunctivae 7 h after application, this effect persisted up to 48 h. Animal #2 and #6 showed discharge after 1 h (score 1). This effect was completely reversible within 7 h. No other effects could be observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was not irritating to eyes under test conditions which are basically in accordance with todays standard methods regarding dosing, exposureduration, scoring system and reading time points. One animal showed a conjunctiva redness score of 1 in the 7 h and 24 h reading. This effect was completely reversible within 48 h. Two animals showed a discharge score of 1 in the 1 h reading. No other effects were observed.
Therefore, it is concluded that the submission substance is not irritating to eyes.

Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h. One animal showed a conjunctiva redness score of 1 in the 7 h and 24 h reading. This effect was completely reversible within 48 h. Two animals showed a discharge score of 1 in the 1 h reading. No other effects were observed. Therefore, it is concluded that the submission substance is not irritating to eyes.