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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd/Win: DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH
- Age at study initiation: males 9 weeks; females 9 weeks
- Weight at study initiation: males 493-533 g; females 419-469 g
- Housing: individually in Macrolon cages type IV
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 - 19.5
- Humidity (%): 52-70
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 1%
epicutaneous induction: 50%
epicutaneous challenge: 30%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 1%
epicutaneous induction: 50%
epicutaneous challenge: 30%
No. of animals per dose:
control group: 6 animals
treatment group: 10 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE

intracutaneous application
- No. of exposures: 1
- Test groups: 2 x FCA/physiological saline solution (1:1); 2 x test substance solution; 2 x test substance solution/ FCA (1:1)
- Control group: 2 x FCA/physiological saline solution (1:1); 2 x 0.9% phyiological saline solution; 2 x 0.9% phyiological saline solution/ FCA (1:1)
- Site: area of 4 x 6 cm of the scapular region
- Concentrations: 1%

epicutaneous application
- No. of exposures: 1
- Test group: test substance in 0.9 % physiological saline solution
- Control group: 0.9 % physiological saline solution
- Site: vehicle => right flank; test substance => left flank
- Duration: 48 hours
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 48 h
- Test group: test substance in 0.9 % physiological saline solution
- Control group: test substance in 0.9 % physiological saline solution
- Site: vehicle => right flank; test substance => left flank
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hrs
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
under the conditions used in this study the test substance showed no sensitizing potential