Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Test was performed in 2000 as common used methode - no LLNA was available at that time.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS (5)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 347 - 424 g
- Housing: singly or in pairs in solid-floor ploypropylen cages furnished with woodflakes.
- Diet: at libitum (Guinea Pig FD1 Diet, Special Diets Services Ltd. Witham, Essex, UK)
- Water: at libitum (tap water)
- Acclimation period: 5 days under test conditions prior to substance application.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air exchange: appr. 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75%
Day(s)/duration:
day 0 (6h) / day 7 (6h) / day 14 (6h)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75% / 50%
Day(s)/duration:
6h
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of applications: 1
- Patch: Occlusive, epidermal administration. Filter paper with leaf aluminium (2 x 2 patch), fastened with elastic bandage
- Exposure period: 15 days
- Test groups: 1
- Control group: 1
- Site: left flank, 2 x 2 cm region shaved prior.
- Concentrations: 75 %
- Duration: 6 hours
- Frequency: 3 days, days 1, 8 and 15
- Control: distilled water

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on day 28
- Exposure period: 6 h
- Test groups: 1
- Control group: destilled water
- Site: right flank for test substance, left flank for control. Flanks were shaved on the 29nd day
- Concentrations: 75% and 50%
- Patch: Occlusive, epidermal administration. Filter paper with leaf aluminium (2 x 2 patch), fastened with elastic bandage
- Evaluation (hr after challenge): 24 and 48 hours after removal of patch.

Challenge controls:
distilled water
Positive control substance(s):
yes
Remarks:
DNCB and 2-Mercaptobenzothiazole
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75% solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75% solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Dose level:
DNCB 0.5% w/v in Ethanol
No. with + reactions:
10
Total no. in group:
10
Reading:
1st reading
Group:
positive control
Dose level:
Induction: 2-Mercaptobenzothiazole 50% in Acetone/PEG 400 (70:30) Challenge: 50% and 25% in Acetone/PEG 400 (70:30)
No. with + reactions:
13
Total no. in group:
20
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification