Registration Dossier

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:
other: see 'Remark'
Remarks:
Guidline study conducted according to GLP. A deviation from protocol was mentioned in the report (page 6), indicating that due to the solubility of the test article the vehicle was changed. This remark was given as first amendment without further details. The deviation however, did not affect the validity of the results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
occlusive instead of semi-occlusive conditions as recommended by the Guideline
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione
- Physical state: solid
- Purity: commercial grade
- Lot/batch No.: Op. 11 006
- Expiration date of the lot/batch: 1995-12-31
- Stability of test article: stable
- Stability of test article dilution: stable for at least two hours.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(three animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: since no erythema was observed, not applicable
Remarks on result:
other: None of the animals showed erythema. Due to the red color of the test compound, a red discoloration of the skin was observed in all animals during the whole observation period.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(three animals)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: since no edema was observed, not applicable
Remarks on result:
other: None of the animals showed edema
Irritant / corrosive response data:
No signs of skin irritation or skin corrosion were seen.
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. There was no comment on the potential interference of the scoring through the severe red discoloration of the skin.

Applicant's summary and conclusion