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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.01. - 03.03.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no
Remarks:
but performed under GLP like quality control with QAU statement included.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Since a valid guinea pig study is avaliable no LLNA is required

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: yellow liquid
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd., Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: males and females: 304-461 g
- Housing: individually in Macrolon cages
- Diet: standard guinea pig pellets NAFAG No.846, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: 9 days

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

IN-LIFE DATES: from 14-January to 13-February 1986

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
1 %
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
10 %
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: vaseline
Concentration / amount:
10 %
No. of animals per dose:
10 males /10 females in the test group,
5 males / 5 females in the control group;
Details on study design:
RANGE FINDING TEST
- no information provided

A. INDUCTION EXPOSURE
First induction, intradermal injection:
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)
- test article (1 %) in sesame oil
- test article (1 %) in the adjuvant saline mixture (w/v)

Second induction (one week later), epidermal application:
The test item (10 %) in vaseline (w/w) was applied on a filterpaper patch to the neck of the animals (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).

Control group animals were treated identically in the absence of test item.

B. CHALLENGE EXPOSURE
Test and control group animals were treated (week 5) on the flank with the test item (10 %) in vaseline (w/w) and the vehicle alone (approx. 0.2 g paste per patch; occluded administration for 24 hours).
Skin reactions were scored 24 and 48 hrs after patch removal.
Positive control substance(s):
no

Results and discussion

Positive control results:
No information given in the report.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No animal of the test group was sensitized under the experimental condition employed and therefore the test substance is regarded as not sonsitizing.
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 (1 % test substance in sesame oil) were made into the neck of the animals with a 1:1 mixture (v/v) of adjuvant and saline, the test compound in sesame oil, and the test compound in the adjuvant saline mixture. One week later, the test article was incorporated in vaseline at a concentration of 10% 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 10% 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 is made 48 hours after removing the dressings. A control group (10 males, 10 females) 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. 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.