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Diss Factsheets

Administrative data

Description of key information

The test article was found to be non sensitizing in the guinea pig maximization test. The study was performed according to OECD testing guideline 406 and under GLP. For intradermal induction, 5% in arachis oil was applied which was the highest obtainable concentration. For epicutaneous induction, the irritating concentration of 50% in petrolatum was applied. In the challenge application, the highest non irritating concentration of 30% was used. None of the animals showed skin reactions at the first and second reading after challenge.

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:
May 21, 1992 - July 29, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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.
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
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
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
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 .
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.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not sensitizing in the Guinea Pig Maximization test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For the assessment of skin sensitization, one study is available that is adequately performed and reported to serve as key study.The study was performed according to OECD testing guideline 406 and under GLP with a well-characterized sample of 95% purity. Pirbright White guinea pigs were used. For intradermal induction, 5% in arachis oil was applied which was the highest obtainable concentration. For epidermal induction, the irritating concentration of 50% in petrolatum was applied. Induction treatments were done with FCA/saline; test item/vehicle; test item/FCA/saline (intradermal induction); test item/vaseline (epidermal induction). For the challenge application, the highest non irritating concentration of 30% was used. None of the animals showed skin reactions at the first and second reading after challenge. No reactions were observed in the animals of the control group. The sensitivity of the guinea pig strain was confirmed by an experiment using potassium dichromate, in which after 48 h challenge, 7 out of 10 animals were positive. After 72 hours 6 out of 10 animals were still positive.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No experimental data is available.

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 classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.