Registration Dossier
Registration Dossier
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EC number: 224-460-9 | CAS number: 4368-56-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 26 to August 15, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 224-460-9
- EC Name:
- Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 4368-56-3
- Molecular formula:
- C20H219N2O5S.Na
- IUPAC Name:
- sodium 4-(4-acetamidophenyl-1-amino)-1-amino-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Association of Breeders of Hradec Kralove.
- Weight at study initiation: above 2.5 Kg.
- Housing: rabbits were housed invidually in metal cages commercially produced without bedding, with automatic air-condition.
- Diet: rabbits were fed standard commercially manufacturing feed mixture TM-rabbit, ad libitum.
- Water: drinking water according to CSN 757111 ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 15%
- Photoperiod:12 hrs cycle dark/light
- Other: fluorescent light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: an area of 6 cm x 6 cm was depilated.
- Type of wrap if used: the sample was covered with gauze, above which aluminum film and cellulose wadding was applied. Technical tape was used so that the test substance was in contact with the depilated skin.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The mean erythema and edema score for the three rabbits is 0.
Any other information on results incl. tables
At 4, 24, 48 and 72 hours after removal of patch no rmacroscopic or pathomorphological changes were identified on the intact or scarified skin. The present sample after epicutaneous application to the skin of rabbits did not induce contact dermatitis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not irritant to the rabbits
- Executive summary:
The substance was evaluated for Skin irritation/Corossion according to the OECD Guideline 404. The test substance (0.5 g) after the treatment with water was applied as a paste on the intact (left lateral depilated area) and scarified skin (right lateral depilated area) of Three New Zealand white rabbits. Depilated area of skin outside the application zone was used to control the assessment.
After 4 - 24 - 48 - 72 hours of the removal of the patch the animals were examined for signs of erythema and oedema. No edema or erythema signs were identified on the intact skin and neither on the scarified skin.
Based on erythema and edema scores, the test substance is not considered to be irritating to the skin.
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