Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The analyses of the test substance were carried out at the GKA Competence Center Analytics, BASF SE, Ludwigshafen, Germany.
Name of test substance: (S)-1-(3-Methoxyphenyl)ethylamine
Test-substance No.: 07/0571-1
Batch identification: 76584075L0
Purity: 99.8 area-% (analytical report No.: 07L00237)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
peanut oil
Remarks:
Ph.Eur. 5.5
Concentration / amount:
Intradermal induction: test substance 0.5% in peanut oil Ph.Eur. 5.5 or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1)
Epicutaneous induction: test substance 1% in peanut oil Ph.Eur. 5.5
Challenge: test substance 0.5% in peanut oil Ph.Eur. 5.5
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Remarks:
Ph.Eur. 5.5
Concentration / amount:
Intradermal induction: test substance 0.5% in peanut oil Ph.Eur. 5.5 or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1)
Epicutaneous induction: test substance 1% in peanut oil Ph.Eur. 5.5
Challenge: test substance 0.5% in peanut oil Ph.Eur. 5.5
No. of animals per dose:
control: 5 animals
test group: 10 animals

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle control
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: vehicle control. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle control. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
swelling (1/10) and scaling (1/10)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: swelling (1/10) and scaling (1/10).

Applicant's summary and conclusion

Conclusions:
The results of this study show that (S)-1-(3-Methoxyphenyl)ethylamine has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions.
Executive summary:

(S)-1-(3-Methoxyphenyl)ethylamine was tested for its sensitizing effect on the skin of the guinea pig in the Maximization Test based on the method of Magnusson and Kligman. The test-substance concentrations for the main test were selected based on the results of the pretests. The intradermal induction was performed with a 0.5% test-substance preparation in peanut oil Ph.Eur. 5.5 or 0.5% test substance preparation in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1) and the epicutaneous induction with a 1% test-substance preparation in peanut oil Ph.Eur. 5.5. For the challenge, a 0.5% test-substance preparation in peanut oil Ph.Eur. 5.5 was chosen. The study was performed using 1 control group and 1 test group. The intradermal induction was performed on day 0 and the epicutaneous induction on day 7. A challenge was carried out 14 days after the epicutaneous induction. The intradermal induction caused intense erythema and swelling at the injection sites of the test-substance preparations in all test group animals. After the epicutaneous induction, incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema and swelling in all test group animals. After the challenge discrete or patchy to moderate and confluent erythema, swelling and scaling were observed in the test group animals.