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Diss Factsheets

Administrative data

Description of key information

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:
1988-03-15 to 1988-05-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
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
- Weight at study initiation: 336 to 430 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets NAFAG No. 846, Gossau SG
- Water: tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 to 70%
- Photoperiod: 12 hrs light cycle
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline (epicutaneous), sesame oil (intradermal)
Concentration / amount:
Intradermal Induction: test substance in sesame oil and adjuvant mixture: 1%
Epidermal Induction: test substance 30 % in vaseline
Epidermal Challenge: test substance 3 % in vaseline
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline (epicutaneous), sesame oil (intradermal)
Concentration / amount:
Intradermal Induction: test substance in sesame oil and adjuvant mixture: 1%
Epidermal Induction: test substance 30 % in vaseline
Epidermal Challenge: test substance 3 % in vaseline
No. of animals per dose:
10 male and 10 female guinea pigs
Details on study design:
INDUCTION (weeks 1 and 2)
The induction was a two-stage operation. First, intradermal injections (into the neck region), secondly, 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 and saline (1:1)
- test compound in sesame oil
- test compound in the adjuvant saline mixture
One week later the test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm - occluded administration for 48 hours). Dose of application: approx. 0.4 g paste of 30 % test substance in vaseline

CHALLENGE
Two weeks after the epidermal induction application the animals were tested on the flank with the test substance in vaseline and the vehicle alone (patch 2 x 2 cm,- occluded administration for 24 hours). Dose of application: approx. 0.2 g paste of 3 % test article in vaseline. The concentrations of the test compound for the induction and challenge periods were determined on separate animals.

OTHER
Separate animals were treated with the test substance for the evaluation of the primary irritation threshold concentration. Concentrations of 1, 3, 10 and 30 % in vaseline were tested. Erythema reactions were observed at 10 and 30 %. No erythema was induced at the lower concentrations. Therefore, 3 % was used as the maximum subirritant concentration for the challenge application.
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 article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3% test substance in vaseline
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% test substance in vaseline. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3% test substance 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: 3% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3% test substance in vaseline
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% test substance in vaseline. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3% test substance 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: 3% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Executive summary:

A skin sensitisation test in Pirbright White guinea pigs was performed according to OECD 406 (Maximisation test according to Magnusson and Kligman). The test was performed on 10 male and 10 female guinea pigs in the test group and 10 males and 10 females in the control group. The induction was a two-stage operation. First, three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:

- adjuvant and saline (1:1)

- test compound in sesame oil

- test compound in the adjuvant saline mixture

One week later the test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm - occluded administration for 48 hours; 0.4 g paste of 30 % test substance in Vaseline). Two weeks after the epidermal induction application the animals were tested on the flank with the test substance in vaseline and the vehicle alone (patch 2 x 2 cm,- occluded administration for 24 hours; approx. 0.2 g paste of 3 % test article in vaseline). 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 article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals. The concentrations of the test compound for the induction and challenge periods were determined on separate animals. 15 % of the animals were sensitized in this guinea pig maximization test (according to Magnusson and Kligman). The substance is therefore considered to have little or no skin sensitizing potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
A GLP-compliant skin sensitisation study in Pirbright White guinea pigs was performed according to OECD 406 (Maximization test according to Magnusson and Kligman). The test was performed on 10 male and 10 female guinea pigs in the test group and 10 males and 10 females in the control group. For induction, the animals received three pairs of intradermal injections (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) with 1% of the test article and one epicutaneous induction treatment one week later with 30% test substance in vaseline. Control animals were treated equally with test substance replaced by the vehicle. Epidermal challenge was performed by occlusive application for 24 h two weeks later (30% in vaseline). 15 % of the animals were sensitized in this guinea pig maximization test (according to Magnusson and Kligman). The substance is therefore considered to have little or no skin sensitizing potential (Ciba-Geigy, 1988).

Migrated from Short description of key information:
The test substance did not cause sensitization in a Guinea Pig Maximization Study.

Justification for selection of skin sensitisation endpoint:
GLP-compliant guideline study

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for sensitization is not warranted under Directive 67/548/EEC.

 

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.