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EC number: 604-776-7 | CAS number: 151213-15-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- EC Number:
- 604-776-7
- Cas Number:
- 151213-15-9
- Molecular formula:
- C20 H21 F2 N3 O3
- IUPAC Name:
- 7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid
- Details on test material:
- Bay Z 7906, white to yellow powder, batch 501779, purity 99.8%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- eyes were not rinsed after exposure
- Observation period (in vivo):
- 12 days
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.22
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 1
- Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Results of the study
| Irritant Effects (Score) | |||||
| Animal | 24 h | 48 h | 72 h | Mean scores | |
| 1 | Corneal Opacity | 1 | 1 | 1 | 1.0 |
| Iritis | 1 | 1 | 1 | 1.0 | |
| Redness conjunctivae | 0 | 0 | 0 | 0.0 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
| Fluorescein | corneal staining (whole surface) | ||||
| 2 | Corneal Opacity | 1 | 1 | 1 | 1.0 |
| Iritis | 1 | 1 | 1 | 1.0 | |
| Redness conjunctivae | 1 | 1 | 0 | 0.67 | |
| Chemosis conjunctivae | 1 | 1 | 0 | 0.67 | |
| Fluorescein | corneal staining (whole surface) | ||||
| 3 | Corneal Opacity | 1 | 1 | 1 | 1.0 |
| Iritis | 1 | 1 | 1 | 1.0 | |
| Redness conjunctivae | 0 | 0 | 0 | 0.0 | |
| Chemosis conjunctivae | 1 | 0 | 0 | 0.33 | |
| Fluorescein | corneal staining (3/4 of the surface) | ||||
7 days fluorescein test: animal nos. 1 and 3: corneal staining (1/4 of the surface) and animal no. 2: corneal staining (3/4 of the surface)
Applicant's summary and conclusion
- Executive summary:
100 mg of the test substance was administered into the conjunctival sac of the right eye of male rabbits with no rinsing after instillation.
Evaluation of eye irritation was made according to Draize.
According to the classification criteria Bay Z 7906 is irritating to eyes.
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