3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]-N-phenylnaphthalene-2-carboxamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 30 APR 2007 to 10 MAY 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 405; EU method B5), in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide

EC Number:

235-464-5

EC Name:

N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide

Cas Number:

12236-64-5

IUPAC Name:

N-(4-acetamidophenyl)-4-[(5-carbamoyl-2-chlorophenyl)diazenyl]-3-hydroxy-2-naphthamide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: between 2.63 and 3.04 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet. ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 (air condition)
- Humidity (%): 42-68
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 (female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with isotonic solution
- Time after start of exposure: 1 h

SCORING SYSTEM: according to OECD TG 405, reading at 1, 24, 48 and 72 h after removal of test item

TOOL USED TO ASSESS SCORE: occular examination

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 effects

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not relevant since no effects

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

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 effect

Results 6

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 effect

Irritant / corrosive response data:

Slight reddening of the conjunctivae was noted in the three animals 1 h after treatment and persisted up to 48 h in two animals.
1 h reading: slight swelling (chemosis) in 1 animal, slight occular discharges in all treated animals
24 h and 48 h reading: slight conjunctivae redness in 2 animals.
72 h reading: no abnormal findings observed in any animal.

No coloration of the treated eyes was noted at any of the reading times.

Other effects:

- changes in body weight during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to skin when tested under the conditions of the OECD guideline 405.

Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD guideline no 405. The test item (0.1 g) was applied to the intact eye of three New Zealand White rabbits for 1 h. Redding of the conjunctivae was noted in all three animals 1 h after the tratment and persisited up to 48 h in two animals. Slight swelling was noted in one and slight occular discharge was noted in two animals in the 1 h reading.

The individual mean scores calculated across the three scoring times (24, 48, 72 h) were for corneal opacity 0.0 (three animals), for iris 0.0 (three animals), for conjunctivae redding 0.0, 0.7 and 0.7 and for chemosis 0.0 (three animals).

No abnormal findings were observed in the treated eye of any animal 72 h after treatment.

There was no indication of systemic toxicity.