Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 21, 1992 - July 29, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
84/449/EEC B.6 (1984)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The conduction of an LLNA is not required since valid information from a GPMT are available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctadecyl 3,3'-thiodipropionate
EC Number:
211-750-5
EC Name:
Dioctadecyl 3,3'-thiodipropionate
Cas Number:
693-36-7
Molecular formula:
C42H82O4S
IUPAC Name:
dioctadecyl 3,3'-thiodipropionate
Details on test material:
- Substance type: Organic
- Physical state: Solid, white
- 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 Ltd., Animal Production, Stein, Switzerland
- Weight at study initiation: 318 - 430 g
- Housing: Individually in Macrolon cages (Type 3)
- Diet: Ad libitum, standard guinea pig pellets (NAFAG No. 845, Gossau SG)
- Water: Ad libitum
- Acclimation period: 1 week

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Arachis oil (first induction); vaseline (second induction)
Concentration / amount:
5 % in arachis oil for intradermal injection
50 % (w/w) in vaseline for epicutaneous induction
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
30% in vaseline
No. of animals per dose:
10 males an 10 females in dose groups
5 males and 5 males in control group
Details on study design:
RANGE FINDING TESTS
determination of the maximum subirritant concentration: 1, 5, 10, 30, and 50 % in vaseline. Erythema reactions were observed with 50 % TK 10594 in vaseline.
The highest dose for intradermal injection was chosen based on solubility and systemic tolerance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (one intradermal and one epicutaneous)
- Exposure period: 48 h for epicutaneous induction
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant (FCA)/saline mixture 1:1 (v/v)
- test article in Oleum arachidis (w/v)
- test article in the adjuvant (FCA)/saline mixture (w/v)
In the second week of induction the test item was incorporated in vaseline 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).
- Control group: FCA and vehicle
- Site: Neck
- Frequency of applications: Weekly
- Duration: 0-14 d
During weeks 3 and 4 no treatments were performed.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: test item in vaseline or vaseline alone
- Control group: test item in vaseline or vaseline alone
- Site: Flank
- Concentrations: 30 %
- Evaluation (hr after challenge): 24 and 48 after removing the dressing
Challenge controls:
No re-challenge performed.
Positive control substance(s):
yes
Remarks:
The results of the latest positive control test with Potassiumdichrcxnate are included

Results and discussion

Positive control results:
After 48 h challenge, 7 out of 10 animals were positive. After 72 hours 6 out of 10 animals were still positive .

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 % . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
Vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
Vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not sensitizing in the Guinea Pig Maximization test.