Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 19 January 1996 to 12 February 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to international guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: maximization method of Magnusson and Kligman

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: SR 48941
Batch no. 5ARL002
Description: beige powder
Quantity and container: 60 g in one glass flask and 10 g in one glass flask
Date of receipt: 29 November 1995
Storage conditions: at room temperature

Preparation
The test substance was prepared at appropriate concentrations in the vehicule or Freund's complete adjuvant.
It was finely pulverised before being incorporated in the vehicle of adjuvant.
All preparations were made freshly on the morning of administration and any unused material was discarded that same day.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Number: 30 animals ( 15 males and 15 nulliparous and non-pregnant females)
Allocation of the animals to the groups on day-1, the animals were weighted and randomly allocated to two groups; a control group 1 consisting of ten animals (five males and five females) and a treated group 2 consisting of 20 animals (ten males and ten females).
- Source: Centre d'Elevage Lebeau, 78950 Gambais, France
- Age at study initiation: approximately three months old
- Weight at study initiation: 413 +/- 26 g for the males and 402 +/- 32 g for the females.
- Housing: housed individually in polycarbonate cages ( 48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle. The housing conditions (temperature, relative humidity and ventilation) were checked monthly.
- Diet (e.g. ad libitum): free access to "106 diet".
- Water (e.g. ad libitum): Drinking water filtered by a F.G. Millipore membrane (0.22 micron)
Bacteriological and chemical analysis of the water and diet and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically. It was verified that no contaminants in the diet or water at levels likely to influence the outcome of the study were present.
- Acclimation period: at least five days before the beginning of the study.
- Identification of the animals: ear-tattoo

ENVIRONMENTAL CONDITIONS
- temperature: 21 +/- 2 °C
- relative humidity: 30 to 70 %
- light/dark cycle: 12h/12h
- ventilation: about 12 cycles/hour of filtered, non-recycled air.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
5 or 10 % in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
5 or 10 % in paraffin oil
No. of animals per dose:
5 (control group) or 10 (treated group) animals per group per sex
Details on study design:
INDUCTION PHASE
D1
Intradermal injections (0.1 ml) with or without complete Freund's adjuvant
Control: Paraffin oil
Treated: SR 48941 at 5 % in paraffin oil

D8
Occlusive bandage (48h) (0.5 ml)
Control: Paraffin oil
Treated: SR 48941 at 10 % in paraffin oil

CHALLENGE PHASE
D22
Two occlusive bandages (24h)
- Left flank (0.5 ml)
Control: Paraffin oil
Treated: Paraffin oil
- Right flank (0.5 ml)
Control: SR 48941 at 10 % in paraffin oil
Treated: SR 48941 at 10 % in paraffin oil
Positive control substance(s):
yes
Remarks:
2,4-dinitro chlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 % in paraffin oil
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % in paraffin oil. No with. + reactions: 20.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10 % in paraffin oil
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % in paraffin oil. No with. + reactions: 20.0. Total no. in groups: 20.0.

Any other information on results incl. tables

No other data

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these experimental conditions and according to the maximization method of Magnusson and Kligman, cutaneous reactions attributable to the sensitization potential of the test substance SR 48941 at a concentration of 10 % (w/w) were observed in all guinea-pigs.