Registration Dossier
Registration Dossier
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EC number: 205-044-6 | CAS number: 131-92-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-01-17 to 1981-02-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD-Method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- according to internal guideline 1562
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-4,9-diyl)bis(benzamide)
- EC Number:
- 205-044-6
- EC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-4,9-diyl)bis(benzamide)
- Cas Number:
- 131-92-0
- Molecular formula:
- C42H23N3O6
- IUPAC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-4,9-diyl)bis(benzamide)
- Test material form:
- solid
- Details on test material:
- Vat Brown 3
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HACKING & CHURCHILL, Huntingdon England
- Weight at study initiation: 3 - 4kg
- Housing: individually in cages (MEISTER and SCHINDLER)
- Diet (e.g. ad libitum): rabbit feeding Z222 (Höing), ad libitum
- Water (e.g. ad libitum): water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg - Observation period (in vivo):
- 1, 24, 48, 72h and 7d, 14d and 21d
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight conjunctivae redness occurred in 1/6 animals at 1h but was completely reversible within 48 h. No other signs of irritation/corrosion observed.
Any other information on results incl. tables
| endpoint | average score per observation time and endpoint | |||
| 24h | 48h | 72h | ||
| cornea | opacity | 0.0 | 0.0 | 0.0 |
| iris | value | 0.0 | 0.0 | 0.0 |
| conjuctiva | redness | 0.3 | 0.0 | 0.0 |
| chemosis | 0.0 | 0.0 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No significant signs of irritation related to the substance were observed in rabbit eyes. The substance is not classifiable according to CLP criteria.
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