Registration Dossier

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:
1998

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

Constituent 1
Chemical structure
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

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