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Diss Factsheets

Administrative data

Description of key information

Skin sensitization (OECD 406, maximization test): not sensitizing (guinea pig, in vivo)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
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
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
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
1 %
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
10 %
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
Positive control results:
No information given in the report.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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 chemical
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

The test substance was investigated for its sensitizing potential in a Maximization test according to OECD guideline 406 performed under GLP-like quality control (CIBA-GEIGY Ltd., 851122, 1986). Pirbright White guinea pigs were induced intradermally with 1% of the test substance in sesame oil (0.1 ml) followed by an epicutaneous induction treatment with 10% in vaseline one week later. During intradermal induction, three pairs (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. The application sites were pretreated the day before epicutaneous induction with 10 % sodium lauryl sulfate to induce a local irritation. Epidermal challenge was performed by occlusive application for 24 h two weeks later (10% in vaseline). A control group was treated with adjuvant and the vehicle during the induction period and with the vehicle as well as with the test compound during challenge. Twenty-four and 48 hours after removal of the dressings the challenge reactions were graded according to the Draize scoring scale. No skin reactions were observed either for control or test group animals. The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate. In conclusion, under the experimental conditions employed 0% of animals have been sensitized and the test substance is therefore not considered to be a skin sensitizer in albino guinea pigs and does not require classification.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Respiratory sensitization

No data

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for sensitization is not warranted under Regulation (EC) No.1272/2008.