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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
GLP compliance:
yes
Remarks:
Experimental Toxicology, CIBA-GEIGY Ltd., Basle, Switzerland
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
400-820-2
EC Name:
-
Cas Number:
84268-33-7
Molecular formula:
C20 H23 N3 O3
IUPAC Name:
methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
Details on test material:
- Physical state: solid
- Analytical purity: purified
- Lot/batch No.: Z 288/1U
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White (Tif:DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: bred on premises
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: between 305 and 4 05 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum, standard diet supplemented with fresh carrots
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
1% for intradermal application
20% for epidermal application (Induction)
10% for epidermal application (Challenge)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: vaseline
Concentration / amount:
1% for intradermal application
20% for epidermal application (Induction)
10% for epidermal application (Challenge)
No. of animals per dose:
10 for control group
20 for test group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Induction, intradermal application: Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound TK 13'116 in sesame oil and with the test compound in the adjuvant saline mixture.
Induction, epidermal application: One week later the substance was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).

B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with 10% in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination. A second evaluation is made 48 hours after removing the dressings.
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 to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
p - phenylenediamine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

The test item, at the concentration of 10% in vaseline, did neither induce edema nor erythema reactions after epidermal challenge application.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information