Registration Dossier
Registration Dossier
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EC number: 226-733-8 | CAS number: 5459-93-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Range-Finding Toxicity Data List VI
- Author:
- Smyth H.F., Carpenter Ch.P., Well C.S., Pozzani U.C., Striegel J.A.,
- Year:
- 1 962
- Bibliographic source:
- American Industrial Hygiene Association Journal
- Reference Type:
- publication
- Title:
- Chemical burns of the rabbit cornea
- Author:
- Carpenter, Ch.P., Smyth Jr., H.F.
- Year:
- 1 946
- Bibliographic source:
- Am. J. Ophtal.
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no data on method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexyl(ethyl)amine
- EC Number:
- 226-733-8
- EC Name:
- Cyclohexyl(ethyl)amine
- Cas Number:
- 5459-93-8
- Molecular formula:
- C8H17N
- IUPAC Name:
- N-ethylcyclohexanamine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- other: 180 chemical substances
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Citric acid, Sodium Hydroxide, Saline
- Time after start of exposure: 30-minute interval
SCORING SYSTEM:
- Symtomps visible before fluorescein Staining
- cornea dull 2 points
- cornea Cornea opaque, less than half of area 4 points
- Cornea opaque, more than half of area 6 points (max. 6 points)
- Keratoconus (max. 6 points)
- Iritis, slight internal congestion 1 point
- Iritis, marked internal congestion 2 points (max. 2 points)
- Symptom Visible After Fluorescein Staining(If necrosis is diffuse assign points corresponding to half observed area)
- Necrosis on less than 5% of cornea 1 points
- Necrosis on 5 to 12% 2 points
- Necrosis on 13 to 37% 3 points
- Necrosis on 38 to 62% 4 points
- Necrosis on 63 to 87% 5 points
- Necrosis on 88 to 100% 6 points (max. 6 points)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0 - <= 9
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- other: no data
- Time point:
- 48 h
- Reversibility:
- other: no data
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- cornea opacity score
- Basis:
- other: no data
- Time point:
- 72 h
- Reversibility:
- other: no data
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- iris score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Reversibility:
- other: no data
- Remarks on result:
- other: no data
- Irritation parameter:
- conjunctivae score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Reversibility:
- other: no data
- Remarks on result:
- other: no data
- Irritation parameter:
- chemosis score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Reversibility:
- other: no data
- Remarks on result:
- other: no data
Any other information on results incl. tables
severe eye irritation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
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