N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide

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 08 NOV 1988 to 15 NOV 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

EC Number:

219-730-8

EC Name:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

Cas Number:

2512-29-0

Molecular formula:

C17H16N4O4

IUPAC Name:

2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, breeding colony, Germany
- Age at study initiation: abour 3-5 months
- Weight at study initiation: 2.1 - 3.6 kg
- Housing: single
- Diet: mixed feed (Altromin 2123), ad libitum, and about 15 g hay daily
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM:
Scores were read 1, 24, 48 and 72 h after test substance application as well as after 7 days.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 and 72 h reading

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2 and #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

iris score

Basis:

mean

Remarks:

animals #2 and #3

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not relevant since no effect

Results 8

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Irritant / corrosive response data:

- no corneal effects were observed.
- iris scores for animal #1,2,3 after 1h: (0,1,0), after 24 h: (1,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
- conjunctivae redness scores for animal #1,2,3 after 1 h: (2,2,1), 24 h: (2,1,1), 48 h: (2,2,1), 72 h: (1,0,0) and 7 days: (0,0,0)
- chemosis scores for animals #1,2,3 after 1 h: (2,2,2), 24 h: (2,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
All effects were completely reversible within 7 days.

Other effects:

No other effects reported

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 slightly irritating to the eyes when tested under the conditions of the OECD guideline 405. Chemosis was seen at 1 (all animals) and 24 h (one animal), being reversible within 48 h. Redness of the conjunctivae was also seen in all animals in the 1 h reading, being fully reversibly after 7 days. Animal #2 had an iris score of 1 in the 1 h reading, animal #1 in the 24 h reading. These effects were fully reversible within 48 h. No corneal effects were observed.

The effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.

Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405.

Chemosis was observed in all three animals 1 h after application. The effect was fully reversible within 48 h. Conjunctival redness was observed in all three animals up to 72 h after application , reversible by seven days. Iridial effects were noted in one animal up to 24 h. Corneal opacity was not oberved in any animal.