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Diss Factsheets

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:
other: Guideline study conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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:
study from 1998; relevant test system then

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): X-E-OXIMETHER
- Analytical purity: 98.4%
- Batch No.: 26249/176
- Substance No.: 96/288

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Pirbright White, Dunkin Hartley Crl: (HA) BR [SPF]
- Source: Charles River GmbH - Wiga, Kisslegg, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 291 - 342 g
- Housing: 5 animals per cage
- Diet (ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (ad libitum): Tap water (about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: 7 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1% Tylose CB 30.000 (cleaned sodiumcarboxymethylcellulose) in aqua bidest
Concentration / amount:
The intradermal and percutaneous inductions were performed with a 5% and a 50% test substance preparation in 1% Tylose (cleaned sodiumcarboxymethylcellulose in aqua bidest.) respectively, whereas for the challenge a 25% test substance preparation in the same vehicle was chosen.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1% Tylose CB 30.000 (cleaned sodiumcarboxymethylcellulose) in aqua bidest
Concentration / amount:
The intradermal and percutaneous inductions were performed with a 5% and a 50% test substance preparation in 1% Tylose (cleaned sodiumcarboxymethylcellulose in aqua bidest.) respectively, whereas for the challenge a 25% test substance preparation in the same vehicle was chosen.
No. of animals per dose:
10
Details on study design:
Pretest:
2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flanks under an occlusive dressing. Test sites were visually evaluated 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.


Main study

- Intradermal induction:
Intradermal induction using adjuvant technique has been recommended to enhance immune response so that weak sensitizing compounds can be detected. 6 intradermal injections were conducted. 4 animals were administered 100 µl of the test substance formulation and the 2 other served as control. Skin readings were performed 24 h after application.

- Percutaneous induction:
Percutaneous induction was carried out one week after intradermal induction. 2 x 4 cm filter paper strips containing the test substance formulation were applied to the skin of the shoulder for 48 h under an occlusive dressing. The filter paper strip was coated with an approx. 0.5 mm thick layer of the test substance formulation. The control groups were treated analogously to the test group but only with the solvent without the test substance. Skin readings were performed 48 h after application.

- Challenge:
Fourteen days after percutaneous induction, 2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flank for 24 h under an occlusive dressing. The filter paper strip was soaked in the test substance formulation. Skin reactions were read at 24 and 48 after the removal of the patch.


Evaluation:
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 30 per cent of the test animals exhibit skin reactions.
Positive control substance(s):
no
Remarks:
A positive control with a known sensitizer was not included in this study. However, a separate study was performed twice a year in the same laboratory.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
2
Total no. in group:
8
Clinical observations:
Slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Slight erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
4
Total no. in group:
8
Clinical observations:
Well-defined erythema, slight edema in 2 of them
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 4.0. Total no. in groups: 8.0. Clinical observations: Well-defined erythema, slight edema in 2 of them.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
1
Total no. in group:
8
Clinical observations:
Moderate erythema, slight edema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 1.0. Total no. in groups: 8.0. Clinical observations: Moderate erythema, slight edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
2
Total no. in group:
8
Clinical observations:
Slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
3
Total no. in group:
8
Clinical observations:
Well-defined erythema, scaling in 1 of them
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 3.0. Total no. in groups: 8.0. Clinical observations: Well-defined erythema, scaling in 1 of them.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
No. with + reactions:
1
Total no. in group:
8
Clinical observations:
Moderate erythema, slight edema, scaling
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 1.0. Total no. in groups: 8.0. Clinical observations: Moderate erythema, slight edema, scaling.

Any other information on results incl. tables

Pretest:

The pretest was performed with 4 female animals for percutaneous and with 2 female animals for intradermal induction.

In the intradermal pretest, injection of a 5% test substance preparation caused well-defined erythema and slight edema in all test group animals. For the percutaneous induction, the 5%, 10 and 25% test substance preparations did not cause any skin reactions. After application of the 50% test substance preparation discrete or patchy erythema were observed in 2 out of 4 animals. Therefore the 5 and 50% test substance preparations were used for intradermal and percutaneous inductions respectively, whereas the 25% test substance preparations were applied for challenge.

 

Induction:

After the intradermal induction, well-defined erythema and slight edema were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied. Injections of 5% test substance preparations in Tylose CB 30.000, 1% in aqua bidest. or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) caused well-defined erythema and slight edema in all test group animals. The injection sites of all control group animals at which Tylose CB 30.000, 1% in aqua bidest. was applied, did not show any skin reactions.

 

After the percutaneous induction with a 50% test substance preparation, incrustation, partially open (caused by the intradermal induction), were observed in addition to well-defined erythema and slight edema in all test group animals. The animals of control groups, which were applied with Tylose CB 30.000, 1% in aqua bidest., exhibited the same skin reactions as the animals of the test group.

 

Challenge:

The challenge with a 25% test substance preparation caused very slight erythema in 2 out of 8 test group animals 24 hours after removal of the patches. Well-defined erythema was observed in 4 test group animals, whereas 2 out of these animals additionally showed very slight edema. 1 test group animal exhibited moderate erythema and slight edema.

48 hours after removal of the patches very slight erythema was noted in 2 out of 8 test group animals. In 3 test group animals well-defined erythema was observed, in 1 out of them with scaling. 1 test group animal showed moderate erythema, slight edema and scaling.

The animals of control group did not show any skin reactions. Tylose CB 30.000, l% in aqua bidest., which was applied as a vehicle control to all animals, did not cause any skin reactions.

The number of animals with skin findings after the challenge:

 

24 h

48 h

Control group

0/8

0/8

Test group

7/8

6/8

x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information