Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Feb. 9, 1988 to Apr. 12, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guideline, with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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: Pirbright White Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Age at study initiation: Approximately 10 weeks old.
- Weight at study initiation: 310 to 445 g.
- Housing: Housed individually in Macrolon cages (Type 3).
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 8 days.


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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil or vaseline
Concentration / amount:
Induction:
Intradermal: 1% in sesame oil.
Epidermal: Approximately 0.4 g paste of 30% in vaseline.

Challenge: Approximately 0.2 g paste of 10% in vaseline.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil or vaseline
Concentration / amount:
Induction:
Intradermal: 1% in sesame oil.
Epidermal: Approximately 0.4 g paste of 30% in vaseline.

Challenge: Approximately 0.2 g paste of 10% in vaseline.
No. of animals per dose:
10/sex/group .
Details on study design:
RANGE FINDING TESTS: Separate animals were treated with the test substance for the evaluation of the primary irritation threshold concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2.
- Exposure period: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later for 48 hours.
- Control group: Treated with adjuvant and the vehicle during the induction period.
- Site: The neck region.
- Concentrations:
First induction (Intradermal): 1% in sesame oil and adjuvant mixture.
Second induction (Epidermal): Approximately 0.4 g paste of 30 % in vaseline.


B. CHALLENGE EXPOSURE
- No. of exposures: 1.
- Day(s) of challenge: Two weeks after the epidermal induction application.
- Exposure period: 24 hours.
- Test groups: substance in vaseline.
- Control group: Vehicle and test compound.
- Site: Flank.
- Concentrations: Approximately 0.2 g paste of 10 % in vaseline.
- Evaluation (hr after challenge): Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale (Appendix 1). A second evaluation was made 48 hours after removing the dressings.

The sensitizing potential was classified according to the grading of Magnusson and Kligman (Refer to Table 1).
The body weight was recorded at start and end of the test.
Challenge controls:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
Paraphenylene-diamine or Potassium-dichromate

Results and discussion

Positive control results:
The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.2 g paste of 10% in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2 g paste of 10% in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 g paste of 10% in vaseline
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: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 g paste of 10% in vaseline
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Table 2. Challenge reactions after epicutaneous administration

Animal

Erythema score

Edema score

24 h*

48 h**

24 h

48 h

Test group Male

0

0

0

0

Test group Female

0

0

0

0

Control group Male

0

0

0

0

Control group Female

0

0

0

0

* DRAIZE Score 24 hours after removal of the dressing.

** DRAIZE Score 48 hours after removal of the dressing.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information