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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD testing guideline compliant study with well characterized test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-920-6
EC Name:
-
Cas Number:
88949-33-1
Molecular formula:
C30 H20 N2 O2
IUPAC Name:
3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione
Details on test material:
- Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2287 - 2600 grams
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days before start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-11-24 To: 1992-11-27

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral flanks of the trated aninals
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4h
Observation period:
4 days
Number of animals:
6
Details on study design:
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was shaved with
electric clippers

- Area of exposure: approximately 150 square centimeters (10 cm X 15 cm).
- % coverage:
- Type of wrap if used: moistened Scotchpak-non-woven patch, mounted on Micropore tape. The dressing was wrapped around the abdomen
and secured with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU