Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 MAR 1983 to 01 APR 1983.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study (OECD TG 404).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

EC Number:

271-878-2

EC Name:

Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

Cas Number:

68610-86-6

Molecular formula:

C36H34Cl2N6O4 // C35H32Cl2N6O4 // C34H30Cl2N6O6

IUPAC Name:

2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2,4-dimethylphenyl)-3-oxobutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-breeding
- Weight at study initiation: 1.6-1.8 kg
- Housing: individually
- Diet: feed for breeding rabbits ERKA Z 6000 (Robert Koch, Hamm), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.72 ml polyethylene glycol 400

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 of an adhesive tape in contact with skin site
- Type of wrap: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks:

48 h after exposure.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks:

72 h after exposure.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks:

48 h after exposure.

Irritant / corrosive response data:

One hour and 24 h after exposure 2/3 animals showed very slight up to well defined erythema. 48 h after exposure 1/3 animals showed erythema score 1. No erythema were observed 72 h after exposure. Edema was observed in 1/3 animals one hour (edema score 2) and 24 h (edema score 1) after exposure. No edema were observed 48 and 72 h after exposure.

Other effects:

Yellow discolouration of treated skin sites.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Very slight up to well defined erythema were observed in two of three animals, which were fully reversible 72 h after exposure. Slight edema was observed in one of three animals, which was fully reversible 48 h after exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.