Registration Dossier
Registration Dossier
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EC number: 610-147-8 | CAS number: 438056-69-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Sep 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- 4-(4-aminophenyl)morpholin-3-one
- EC Number:
- 610-147-8
- Cas Number:
- 438056-69-0
- Molecular formula:
- C10 H12 N2 O2
- IUPAC Name:
- 4-(4-aminophenyl)morpholin-3-one
- Details on test material:
- Anilinomorpholinon, brownish-yellowish powder, batch number BXR3AR1, content 96.2%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- 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 | 0 | 0 | 0 | 0.0 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
| 2 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
| Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
| 3 | Corneal Opacity | 1 | 1 | 0 | 0.7 |
| Iritis | 0 | 0 | 0 | 0.0 | |
| Redness conjunctivae | 3 | 2 | 0 | 1.7 | |
| Chemosis conjunctivae | 2 | 1 | 0 | 1.0 | |
All animals showed reddening of the conjunctivae (grade 2) 1 h after administration.
Applicant's summary and conclusion
- Executive summary:
0.1 g of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 females and after 24 h the treated eyes were rinsed with physiologic saline.
Evaluation of eye irritation was made according to Draize.
According to the classification criteria Anilinomorpholinon is not irritating to eyes.
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