2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 JAN 1985 to 05 FEB 1985.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

EC Number:

228-787-8

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]

Cas Number:

6358-85-6

Molecular formula:

C32H26Cl2N6O4

IUPAC Name:

2-[2-(3,3'-dichloro-4'-{2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl}-[1,1'-biphenyl]-4-yl)diazen-1-yl]-3-oxo-N-phenylbutanamide

Test material form:

solid: nanoform

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 3.0-3.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- 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 0.65 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen)

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Baiersdorf)
- Type of wrap if used: semiocclusive bandage

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

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks:

7 days after exposure.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible

Remarks:

7 days after exposure.

Irritant / corrosive response data:

No edema was observed during the study. 30-60 min and 24 h after exposure 2/3 animals showed erythema score 1, 48 h and 72 h after exposure erythema scores 1 and 2 were observed in these two animals. Animal #2 didn't show any skin response. Seven days after exposure no effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the classification criteria of Regulation (EC) No 1272/2008 the test item 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 item was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Slight erythema were observed in two of three animals, which were fully reversible within seven days. No edema were observed at any time points. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.