Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro-

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981 version

Deviations:

yes

Remarks:

occlusive instead of semi-occlusive conditions as recommended by the Guideline; due to the solubility of the test article the vehicle was changed, which did not affect the validity of the results.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

401-540-3

EC Name:

-

Cas Number:

84632-65-5

Molecular formula:

C18H10Cl2N2O2

IUPAC Name:

3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Test material form:

solid: particulate/powder

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: 15 - 16 weeks
- Weight at study initiation: 2400 - 2600 g
- Diet (ad libitum): pelleted standard Kliba 341, rabbit maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol 400

Controls:

other: untreated skin area served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g of moistened test article was applied to the skin.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 animals (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: approximately 3.0 cm x 3.0 cm
- Type of wrap if used: occlusive dressing

REMOVAL OF TEST SUBSTANCE
Four hours after application, skin was flushed with luke warm tap water.

SCORING SYSTEM:
Skin reaction was assessed according to the OECD Guidelines 404 (1981) as follows:

ERYTHEMA AND ESCHAR FORMATION
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema reading) 4

EDEMA FORMATION
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (edges raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No signs of skin irritation or skin corrosion were observed.

Other effects:

No signs of systemic toxicity and no mortality were observed. A red discoloration of the skin was observed in all animals during the whole observation period. No information was reported on the potential interference of the scoring through the severe red discoloration of the skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After dermal application of 0.5 g of the substance to rabbits for 4 h according to OECD 404 (1981) no erythema or edema were observed. Therefore, the test item is considered to be not irritating to rabbit skin.

Executive summary:

In a primary dermal irritation GLP-compliant study according to guideline OECD 404, threee New Zealand White rabbits (15 -16 weeks old, approx. 2.5 kg) were dermally exposed to 0.5 mL of substance. Test sites were shaved and covered with a occlusive dressing for 4 hours.

Neither erythema, nor edema were observed in any rabbits at any timepoint (24, 48 and 72h). Therefore, the substance was not irritating when applied to rabbit skin.