Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 22, 1992 - October 10, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Remarks:
CIBA-GEIGY Limited, Toxicology Services, Short-term Toxicology
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid; white
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 353 to 428 g
- Housing: individually in Macrolon cages
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 845
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
5 % test substance for intradermal induction
50% test substance for cutaneous induction
50% test substance for cutaneous challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
5 % test substance for intradermal induction
50% test substance for cutaneous induction
50% test substance for cutaneous challenge
No. of animals per dose:
20 for test group (10 male, 10 female)
10 for control group (10 male, 10 female)
Details on study design:
RANGE FINDING TESTS:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. Since 5% in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction. The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, 20, 30, and 50% in vaseline. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% was selected for the epidermal applications in the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week each
- Test groups: - adjuvant/saline mixture 1:1 (v/v)
- test article in Oleum arachidis (w/v)
- test article in the adjuvant/saline mixture (w/v)
- Control group: - adjuvant/saline mixture 1:1 (v/v)
- Oleum arachidis (w/v)
- adjuvant/saline mixture (w/v)
- Site: neck region
- Frequency of applications:
- Duration: 2 weeks induction, 2 weeks rest period
- Concentrations: 5% for intradermal injection, 50% for epidermal induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: d15
- Exposure period: 24hours
- Test groups: test article in vaseline, and vaseline alone
- Control group: test article in vaseline, and vaseline alone
- Site: flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours after challenge
Positive control substance(s):
yes
Remarks:
The sensitivity of the strain is checked every six months with a known sensitiser. The results of the latest positive control test are presented in the report (Potassiomdichromate)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

One female animal showed an erythema score of 1 (very slight erythema (barely perceptible)) after 24 hours of challenge. Therefore, under the experimental conditions employed, 5% of the animals of the test group showed skin reactions 24 hours after removing the dressings.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
5% of the animals were sensitised by the test item under the experimental conditions employed. The test item is therefore considered to be not sensitizing.