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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:
October 1, 1990 - November 2, 19 90
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12, 1981
GLP compliance:
yes
Remarks:
CIBA-GEIGY Limited Toxicology Services Dermatotoxicology 4002 Basel / Switzerland
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
EC Number:
407-000-3
EC Name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
Cas Number:
127519-17-9
Molecular formula:
C27 H37 N3 O3
IUPAC Name:
heptyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; nonyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; octyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
Details on test material:
- Physical state: liquid, viscouse
- Analytical purity: 98%
- 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
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 368 t o 448 g
- Housing: individual in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 84 5, Gossau SG
- Water: ad libitum
- Acclimation period: 6 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:
other: sesame oil, vaseline
Concentration / amount:
Intradermal induction: 5%
Epidermal induction: 100%
Epidermal challenge: 30%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil, vaseline
Concentration / amount:
Intradermal induction: 5%
Epidermal induction: 100%
Epidermal challenge: 30%
No. of animals per dose:
20 animals in test group
10 animals in control group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea
pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- 5% test article in sesame oil (w/v)
- 5% test article in the adjuvant saline mixture (w/v)
In the second week of induction the test material was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours). The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application). During weeks 3 and 4 no treatments were performed. A control group was treated with adjuvant and the vehicle during the induction period.

B. CHALLENGE EXPOSURE
In the fifth week the animals were tested on the flank with 30% test material in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours). During the challenge period the control group was treated with the vehicle as well as with the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.

OTHER:
The following concentrations have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration: 100; 30 and 10% of test material in vaseline. The tested concentrations did not induce erythema reactions, under the area of exposure, but on the border when applied as 100 %. 100% was, therefore, selected for the epidermal induction application. 30% was used as subirritant concentration for the challenge application, to omitt all possible nonspecific reactions under the area of exposure and on the borders.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No animal of the test group was sensitised by the test article under the experimental condition employed. The test article is therefore classified as not sensitizing in albino guinea pigs.
Executive summary:

In a guinea pig maximization test according to OECD guideline No. 406, 10 male and 10 female animals were first induced and then challenged with the test article to investigate its sensitization potential. Induction was a two-stage operation: First, three pairs of intradermal injections (5 % test substance in sesame oil) were made into the neck of the animals with a 1:1 mixture (v/v) of FCA/ physiological saline, the test substance in sesame oil, and the test substance in a 1:1 mixture (v/v) of FCA/ physiological saline. One week later, the test article was incorporated in vaseline at a concentration of 100% and applied on a filter paper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with 30% test substance 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. A second evaluation was made 48 hours after removing the dressings. A control group (10 m/10 f) 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. No animal of the test group was sensitized by the test substance, all skin reactions at 24 and 48 hour time points were scored 0. Therefore, under the experimental conditions of this study, the test material is non-sensitizing when topically applied to albino guinea pigs.