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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1H-benzo[10,5]anthra[2,1,9-def]isoquinoline-1,3(2H)-dione
EC Number:
608-929-9
Cas Number:
33955-44-1
Molecular formula:
C22H11NO2
IUPAC Name:
1H-benzo[10,5]anthra[2,1,9-def]isoquinoline-1,3(2H)-dione
Details on test material:
- Physical state: Powder / red-brown
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
other: White New Zealand HsdIf: NZW (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, GER
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.72 - 3.97 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day).
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4h
Observation period:
14 days
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol(R)** and Lutrol(R)/water (1:1).
- Time after start of exposure: 4h

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 14 d
Score:
0
Remarks on result:
other: erythema scores at other time points could not be read because of staining due to the color of the test substance
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Remarks on result:
other: erythema scores at other time points could not be read because of staining due to the color of the test substance
Irritant / corrosive response data:
All edema scores in all animals at any time point were zero. Erythema scores could not be read due to coloring of the test site. The only readable time points are listed above (score = zero)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Considering the non-observed cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant
property to the skin under the test conditions chosen.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after removal of the patch and then in weekly intervals until day 14. Index for erythema could not be read in all animals because of staining due to the color of the test substance. No edema was observed in all animals over the observation period. In two animals evaluation of erythema was applicable 72 hours respectively 14 days after removal of the patch. No erythema was noted. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for edema. Considering the non-observed cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.

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