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

Endpoint summary

Description of key information

In vitro skin irritation/corrosion: Data waiving. An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

In vitro eye irritation/damage: Data waiving. An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.

Skin irritation/corrosion: Key study. Test method according to OECD 404, GLP study. The test material is not irritating to skin under these test conditions.

Eye irritation/damage: Key study. Test method according to OECD 405, GLP study. The test item showed slightly irritating effects to the eyes of rabbits under the test conditions. But the test item has not to be classified for eye irritation according to the classification criteria of Regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 12 MAY 1998 to 15 MAY 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 404) GLP compliant

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Weight at study initiation: 2.7-2.9 kg
- Housing: individually
- Diet: ssniff, K-H (V2333), ad libitum plus hay approx. 15 g daily
- Water: ad libitum
- Acclimation period: 1 week

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

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: sesame oil

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g pasted with 0.8 ml sesame oil DAB 10

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch on a piece of surgical plaster (Beiersdorf AG)
- Type of wrap: semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No edema were observed during the study. All animals showed very slight erythema (score 1) 30-60 minutes after removal of the plaster but not at later timepoints.

Other effects:

Yellow discolouration of treated skin sites.

Interpretation of results:

other: Not irritating

Conclusions:

The test material is not irritating to skin under these test conditions.

Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No edema were observed during the study. Very slight erythema were observed in 3/3 animals one hour after exposure. No effects were observed 24, 48 and 72 h after exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 19 MAY 1998 to 02 JUN 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 405) GLP compliant

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH (Kißlegg, Germany)
- Weight at study initiation: 3.02 - 3.95 kg
- Housing: individually
- Diet: ssniff K_H (V2333) ad libitum, plus hay ca. 15 g per day
- Water: ad libitum

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

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: with ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light

TIME POINTS OF EXAMINATION: 1, 24, 48, 72 hours and 7 days after administration of the test substance

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2 each

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2 each

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

- No iridial effects were observed during the study in animal #1 and #2. Animal #3 only showed slight effects (score 1) one hour after application but not at later points in time.
- Slight cornea opacity (score 1) was only detected in animal #3 1, 24 and 48 hours after application but not at later points in time.
- Conjunctivae redness was observed in all animals (score 1 or 2) which lasted 3 days in animals #1 and #2 and 2 days in animal #3.
- Conjunctivae swelling (chemosis) was obvious in all animals, score 2 in animals #1 and #2 at 1 and 24 hours after application of the test substance and sore 1 in animal #3 at 1 hour after application of the test substance. No chemosis was detected at later points in time.
- No effects were noted 7 d after application.

Other effects:

Substance coloured discharge was observed in all animals one hour after application of the test substance.

Interpretation of results:

other: Not irritating

Conclusions:

The test item showed slightly irritating effects to the eyes of rabbits under the test conditions. But the test item has not to be classified for eye irritation according to the classification criteria of Regulation (EC) No 1272/2008.

Executive summary:

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. Iridial responses were only observed in one animal 1 h after application. Slight opacity of the cornea was only detected in one animal at 1, 24 and 48 hours after application but not at later points in time. All animals showed conjunctivae redness which lasted 3 days in two animals and 2 days in the third animal. Conjunctivae swelling (chemosis) was obvious in all animals at the early time points of examination but was fully reversible within 48 hours. All effects were fully reversible at day seven after application of the test material.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin irritation according to CLP Regulation (EC) no. 1272/2008.

Based on the available data, the substance is not classified for eye irritation according to CLP Regulation (EC) no. 1272/2008.