Registration Dossier
Registration Dossier
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EC number: 205-175-9 | CAS number: 135-11-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 3rd to 10th, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(p-aminoanilino)-3-nitrobenzenesulphonic acid
- EC Number:
- 205-175-9
- EC Name:
- 4-(p-aminoanilino)-3-nitrobenzenesulphonic acid
- Cas Number:
- 135-11-5
- Molecular formula:
- C12H11N3O5S
- IUPAC Name:
- 4-[(4-aminophenyl)amino]-3-nitrobenzene-1-sulfonic acid
- Test material form:
- solid
- Details on test material:
- Sample name: 4-amino-2'-nitro-4'-sulfo-1,1'-diphenylamin (ANSD)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoering AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Kliba 341
- Water (e.g. ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Light cycle: 12 h/d
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- intact skin
- Amount / concentration applied:
- 0.5 g of test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after application of the test article
- Number of animals:
- 3 males
- Details on study design:
- OBSERVATION TIME POINTS
:
1, 24, 48 and 72 hours after the removal of bandages and patch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Local signs consisted of grade 0 erythema and grade 0 edema
In the area of the application, a slight orange discoloration of the skin was observed within 1 hour after removing of the bandage
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect occurred on the skin.
No acute toxicologica signs were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-skin irritant
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