Registration Dossier
Registration Dossier
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EC number: 227-877-4 | CAS number: 6022-22-6
Skin irritation / corrosion
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:
- 1 989
- 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
- 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
Constituent 1
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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