Registration Dossier
Registration Dossier
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EC number: 812-024-6 | CAS number: 1638534-24-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
- EC Number:
- 812-024-6
- Cas Number:
- 1638534-24-3
- Molecular formula:
- C20H23ClN2
- IUPAC Name:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- Animal 1,2,3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5 days after instillation
- Remarks on result:
- other: Max. score end of observation period 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Remarks:
- Animal 1,2,3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1 - 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days after instillation
- Remarks on result:
- other: Max. score end of observation period 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 1,2,3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1 - 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d after instillation. The intensity increased with time.
- Remarks on result:
- other: Max. score end of observation period 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 1,2,3
- Time point:
- other: 24, 48,72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 d after instillation
- Remarks on result:
- other: Max. score end of observation period 1
Applicant's summary and conclusion
- Interpretation of results:
- other: Risk of serious damage to eyes
- Remarks:
- Criteria used for interpretation of results: EU
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