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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000-05-26 until 2000-08-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Testing done in 2000, LLNA was not available then.

Test material

Constituent 1
Reference substance name:
3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
IUPAC Name:
3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
Details on test material:
- Name of test material (as cited in study report): 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester)
- Physical state: brown liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 1/99
- Expiration date of the lot/batch: 2000-07-31
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan strain
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL ltd. Füllinsdorf, Switzerland
- Weight at study initiation: 397-544 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Concentrations: 100% , 50%, 20%, 10%, 5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Concentrations: 100% , 50%, 20%, 10%, 5%
No. of animals per dose:
10 in main study, 5 in the control
Details on study design:
RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main study. The selection of concentrations was based on the following criteria:
- The concentrations are well tolerated by the animals.
-For the induction exposures: the highest possible concentration that produced mild to moderate irritation (grades 2-3)
_for challenge exposure: The maximum non-irritant concentration.

Series of test substance concentrations were tested. Practical feasibility of administration determined the highest starting concentration for each route. The stating and subsequent concentrations were taken from the series: 100% , 50%, 20%, 10%, 5%, 2% 1% and if neded further lower concentrations using the same steps.

Intradermal injections: Initially, a series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The resulting dermal reactions were assessed 24 and 48 hours after treatment. Based on the results in the initially treated animals two other animals were treated in a similar manner with four concentrations at a later stage.

Epidermals application: A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) pera nimal to the clipped flank. The initially used animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water.
The results were assessed for irritation 24 and 48 hours after exposure. Based on the results in the initially treated animals two other animals were treated in a similar manner with four concentrations at a later stage.


MAIN STUDY
A. INDUCTION EXPOSURE
Day 1: The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
a) A 1:1 mixture of Freuds' Complete Adjuvant with water for injections
b) The test substance at a 10 % concentration
c) A 1:1 mixture of the stest substance at twice the concentration used in B) and Freud' Complete Adjuvant.
Day 3: The dermal reactions caused by the intradermal injections were assessed for irritation
Day 8: The scapular area between the injection sites was clipped and subsequently treated with0.5 ml of a 50% test substance concentration. The dressing was removed after 48 hours exposure the skin cleaned of residual test substance using water and the dermal rections caused by the epidermal exposure were assessed for irritation.

The control animals were treated as described for the experimental animals except that instead of the test substance vehicle alone was administered.


B. CHALLENGE EXPOSURE
Day 22 One flank of all animals was clipped and treated by epidermal application of a 50% test substance concentration and the vehicle (0.15 ml each).The dressing was removed after 24 hours exposure the skin cleaned of residual test substance using water. The trated sites were assessed for challenge rections 24 and 48 hours after removel of the dressing.
Positive control substance(s):
yes
Remarks:
alpha Hexylcinnamicaldehyde

Results and discussion

Positive control results:
The reliability control worked as expected. The test was prepared separately in October/November 1999 with 10% .alpha.-Hexylcinnamicaldehyde.0/10 animal showed score 3 reactions, 3 showed score 2 reactions and 3 showed score 1 reactions after 24 h. 4 animals showed no reaction.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The substance is sensitizing to the skin in a OECD 406 Guinea Pig Maximation Test under the conditions used.
Executive summary:

A guinea pig maximization test on 3-Chlorpropionsäure-(4'Chlorbutyl)ester (Clp-Ester) according to OECD 406 did show clearly sensitizing effects when applied. The controls worked as expected.