Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF-bred guinea pigs, strain Hsd Poc:DH
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: polyethylene glycol 400 to yield a suspension
Concentration / amount:
Intradermal induction: 1 % (= 4 mg test item/animal)
Topical induction: 25 % (=125 mg test item/animal)
Challenge: 25 % (125 mg test item/animal)
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: polyethylene glycol 400 to yield a suspension
Concentration / amount:
Intradermal induction: 1 % (= 4 mg test item/animal)
Topical induction: 25 % (=125 mg test item/animal)
Challenge: 25 % (125 mg test item/animal)
No. of animals per dose:
Test group: 10
Control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

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