Registration Dossier
Registration Dossier
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EC number: 202-980-7 | CAS number: 101-83-7
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
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 965
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 0.5 ml undiluted TS into the conjunctival sac of the eye.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dicyclohexylamine
- EC Number:
- 202-980-7
- EC Name:
- Dicyclohexylamine
- Cas Number:
- 101-83-7
- Molecular formula:
- C12H23N
- IUPAC Name:
- N-cyclohexylcyclohexanamine
- Details on test material:
- DCHA undiluted
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- Unspecified
- Observation period (in vivo):
- 1h, 24h, 8d
- Number of animals or in vitro replicates:
- No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Time point:
- 24 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal:
- Time point:
- other: 1h
- Reversibility:
- not specified
- Remarks on result:
- other: silght redness, strong edema, slight cloudiness
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal:
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal:
- Time point:
- other: 8d
- Reversibility:
- not specified
- Remarks on result:
- other: marked redness
Any other information on results incl. tables
NaCl (control substance) caused no adverse reactions in the eye.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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