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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (occlusive, no washing, area of exposure: 12 - 16 cm2 instead of 6 cm2).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981)
Deviations:
yes
Remarks:
(occlusive dressing, no washing conducted, area of exposure: 12 - 16 cm2 instead of 6 cm2)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
EC Number:
227-877-4
EC Name:
Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
Cas Number:
6022-22-6
Molecular formula:
C28H16N2O10S2.2Na
IUPAC Name:
disodium 4,4'-diamino-9,9',10,10'-tetraoxo-9,9',10,10'-tetrahydro-1,1'-bianthracene-3,3'-disulfonate
Details on test material:
- Physical state: solid
- Contents of active ingredient: 82.9 %
- Lot/batch No.: EN 901700.99
- Stability under test conditions: not determined
- 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: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: between 2350 to 2500 g
- Housing: individually
- Diet: ad libitum, standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: moistened with distilled water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 female animals
Details on study design:
TEST SITE
- Area of exposure: 12-16 cm2
- Type of wrap if used: The patches were loosely covered with an aluminium foil (approx. 36 cm2) and held in place by an adhesive tape (Isoplast, Isoplast AG, Brugg, Switzerland).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was done

SCORING SYSTEM: OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
no effects observed
Other effects:
The application site was red-stained (substance-related) one hour after the application, therefore the evaluation of a possible erythema formation was impeded.

Any other information on results incl. tables

Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

Exposition:  4 h, occlusive Comment
Animal  Reading  Erythema Edema
1 1 h na 0 red-staining (substance-related)
2 1 h na 0 red-staining (substance-related)
3 1 h na 0 red-staining (substance-related)
1 24 h 0 0  
2 24 h 0 0  
3 24 h 0 0  
1 48 h 0 0  
2 48 h 0 0  
3 48 h 0 0  
1 72 h 0 0  
2 72 h 0 0  
3 72 h 0 0  
1 24/48/72 hrs 0 0  
2 24/48/72 hrs 0 0  
3 24/48/72 hrs 0 0  
mean 24 - 72 h 0.00 0.00  
na = not assessable due to staining produced by the test item.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information

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