4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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:

not specified

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-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide

EC Number:

227-930-1

EC Name:

4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide

Cas Number:

6041-94-7

Molecular formula:

C23H15Cl2N3O2

IUPAC Name:

4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-N-phenyl-2-naphthamide

Test material form:

solid: nanoform, no surface treatment

Details on test material:

Name of test material (as cited in study report): Permanentrot FRR CM 79883
Analytical purity: technically pure

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:

100 mg

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:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effect

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #5, #6 each

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

3

Reversibility:

other: reversibility not relevant since no effects

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Irritant / corrosive response data:

Iris, cornea and chemosis score were 0 for all six animals at all time points (1, 7, 24, 48 and 72 h after removal of the test item). A redness of the conjunctiva was observed at the 7 h -reading in animal #2, 3 and 4 (score1). It persisted up to 24 h (animal 2) and 48 h (animal 3 and 4) with a score of 1.
No discharge was observed in any animal at any time point.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is very slightly irritating to the eyes under the test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. 3/6 animals showed a conjunctiva redness score of one, 7 and 24 h after application, the effect being fully reversible within 72 h. No other effects were observed.
The slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.

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 after start of the exposure. Only slight effects could be observed (conjunctiva redness score of 1 in 3/6 animals after 7 and 24 h, which was fully reversible within 72 h). No other effects could be observed in any animal.