Registration Dossier

Administrative data

Endpoint:
skin 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal 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

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
pulverized solid moistened with water to ensure good contact with the skin
Controls:
other: The test site surrounding untreated skin served as a control
Duration of treatment / exposure:
Expsoure time 4 hours
Observation period:
60 minutes, 24,48 and 72 hours after patch removal
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Erythema, eschar, oedema formation
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema, eschar, oedema formation
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema, eschar, oedema formation
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema, eschar, oedema formation
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU