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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
Study period:
21st October 1986 - 5th December 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Valid data from a guinea pig maximation test are available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 11638/1
- Substance type: Organotin
- Physical state: Liquid
- Analytical purity: commercial grade
- Main component: dibutyltinbis(2-ethylhexylthioglycolate)
- Impurities (identity and concentrations): NDA
- Composition of test material, percentage of components: NDA
- Storage condition of test material: room temperature
- Batch no.: 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Giegy LTD. Tierfarm, 4344 Sisseln, Switzerland
- Age at study initiation: ca. 10 weeks old
- Weight at study initiation: 266 - 450 g
- Housing: Invividually in Macrolon type 3 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13th October - 21st October 1986


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 13th October 1986 To: 5th December 1986

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
30 % solution in Vaseline vehicle for induction procedure
10 % solution in Vaseline vehicle for 1st challenge procedure
3 % solution in Vaseline vehicle for 2nd challenge procedure
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
30 % solution in Vaseline vehicle for induction procedure
10 % solution in Vaseline vehicle for 1st challenge procedure
3 % solution in Vaseline vehicle for 2nd challenge procedure
No. of animals per dose:
20 (10 male, 10 female)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal adjuvant injections and epidermal closed patch exposure to the test compound in the neck region; second, closed patch exposure over the injection sites one week later.

- First Induction:
0.1 ml of a freshly prepared adjuvant saline mixture (1:1) was injected intracutaneously at 4 sites into the animals neck skin. TK 11638/1 was incorporated in vaseline and applied on a filterpaper patch over the adjuvant injection sites (patch 2x4 cm; occluded administration for 24 hours).
Dose of application: approx. 0.4 g of 30 % TK 11638/1 in vaseiine

- Second Induction:
One week later TK 11638/1 was again incorporated in vaseline and applied on the adjuvant injection sites of the first week. The filterpaper patches were administered occlusively for 48 hours.
Dose of application: approx. 0.4 g paste of 30 % TK 11638/1 in vaseline


B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with TK 11638/1 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 10% TK 11638/1 in vaseline. The concentration of the test compound for the induction and challenge periods were determined on separate animals. A second challenge of 3% TK 11638/1 was later performed.


- Control group:
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 compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
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 compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
No statistical analysis performed.

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.2 g paste at 10 % test substance conc.
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Erythema and Edema formation
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g paste at 10 % test substance conc.. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema and Edema formation.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 g paste at 10 % test substance conc.
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Erythema and Edema formation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g paste at 10 % test substance conc.. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Erythema and Edema formation.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.2 g paste at 3 % test substance conc.
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Erythema and Edema formation
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g paste at 3 % test substance conc.. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Erythema and Edema formation.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
0.2 g paste at 3 % test substance conc.
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Erythema and Edema formation
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g paste at 3 % test substance conc.. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Erythema and Edema formation.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
control (0% test material)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: control (0% test material). No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
55% of the animals were sensitized by TK 11638/1 under the experimental conditions employed.
According to the maximization grading TK 11638/1 showed a moderate grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.
Executive summary:

In a dermal sensitisation study according to OECD 406, 10 week old male and female Pirbright White Guinea Pigs were exposed to TK 11638/1 in a maximisation test. The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact.