Registration Dossier
Registration Dossier
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EC number: 205-175-9 | CAS number: 135-11-5
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 stell 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g per animal
- Observation period (in vivo):
- 72 hours after administration
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The eyes of each animal were examined 1, 24, 48 and 72 hours after treatment
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris 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:
- cornea opacity 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:
- chemosis 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:
- conjunctivae score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A moderate orange discoloration of the cornea was observed in all rabbits within 1 hour after substance instillation.
No acute toxicological signs were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not eye irritant
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