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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1991, when the GPMT was the internationally accepted and recommended study type in order to assess sensitizing potential of a substance.

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
EC Number:
406-750-9
EC Name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
Cas Number:
129757-67-1
Molecular formula:
C44 H84 N2 O6 + C80 H150 N4 O12 737.16 g/mol + 1360.1 g/mol
IUPAC Name:
2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-1-{[8-({2,2,6,6-tetramethyl-4-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-1-yl}oxy)octyl]oxy}piperidin-4-yl decanedioate 2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-4-{[8-({2,2,6,6-tetramethyl-1-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-4-yl}oxy)octyl]oxy}piperidin-1-yl decanedioate bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate
Details on test material:
- State of aggregation: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Tierfarm, Stein / Switzerland
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 322 to 449 g
- Housing: individually
- Diet (e.g. ad libitum): guinea pig pellets (NAFAG No. 84 5, Gossau SG) ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
5 %
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
30 %
Day(s)/duration:
48h
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10 %
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
RANGE FINDING TESTS:
The following concentrations have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration of the test article:
30 and 10 % in vaseline. The tested concentrations did not induce erythema reactions. 30 % was, therefore, selected for the epidermal induction application.
10 % was used as subirritant concentration for the challenge application, because highest concentrations may lead to nonspecific reactions in adjuvant treated animals (Magnusson B., Contact Dermatitis 6, 46-50, 1980).
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles. Concentration: 5 %
Vehicle: sesame oil.

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.
First Induction, intradermal application:
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 in sesame oil (w/v)
- test article in the adjuvant saline mixture (w/v)
Second Induction, epidermal application:
One week later the test article 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).

B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with the test item in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).

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):
yes
Remarks:
2,4-dinitrochlorobenzene, paraphenylene- diamine or potassium-dichromate

Results and discussion

In vivo (non-LLNA)

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met