3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

(no informations if untreated skin served as control).

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)

Version / remarks:

(adopted May 12, 1981)

Deviations:

yes

Remarks:

(no informations if untreated skin was used as control)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

EC Number:

226-107-4

EC Name:

3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]

Cas Number:

5280-80-8

Molecular formula:

C44H38Cl4N8O6

IUPAC Name:

3,3'-{(2,5-dimethyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(5-chloro-2-methylphenyl)benzamide]

Test material form:

solid: particulate/powder

Details on test material:

Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature

Specific details on test material used for the study:

- Lot/batch No.: 057249.28
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410-2530 g
- Housing: Individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: moistened with water before application

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3 female animals

Details on study design:

TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The gauze patch with the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, Brugg / Switzerland).

REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 48 - 72 h

Remarks on result:

other: see table below for details

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Irritant / corrosive response data:

Due to intensive staining by the test compound scoring after 1 h was not possible. Erythema (score 1) were detected 24 h after treatment in 2 animals. One animal recovered within the next 24 h, whereas the other animal still showed erythema (score 2). This animal recovered 72 h after treatment. No edema were observed.

Other effects:

The body weight development was not affected by the application of the test article.

Any other information on results incl. tables

Table 1: Scoring of erythema and edema formation

Exposition:	4 h, semiocclusive
Animal	Reading	Erythema	Edema
1	1 h	na	0
2	1 h	na	0
3	1 h	na	0
1	24 h	1	0
2	24 h	0	0
3	24 h	1	0
1	48 h	0	0
2	48 h	0	0
3	48 h	2	0
1	72 h	0	0
2	72 h	0	0
3	72 h	0	0
1	7 d	0	0
2	7 d	0	0
3	7 d	0	0
1	24/48/72 hrs	0.3	0
2	24/48/72 hrs	0	0
3	24/48/72 hrs	1	0
mean	24 - 72 h	0.44	0.00

na = not assessable due to staining produced by the test item.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met