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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: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The study is performed based on the method of Magnusson, B. and Kligman, A.M.: The
Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J.
Invest. Dermatol. 52, 268 - 276 (1969).
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: MGDN
Test-substance No.: 06/0116-1
Batch identification: Betriebsware C404
Purity: 99.5 area-%
Physical state: solid
Homogeneity: The test substance was homogeneous by visual inspection.
Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc: DH
Sex:
female
Details on test animals and environmental conditions:
Age at day 0: 6-7 weeks.
Supplier: Harlan Winkelmann GmbH, Gartenstr. 27, 33178 Borchen, Germany
Acclimatization period: 7 days.
Identification: Ear tattoo
Body weight at day 0: 305 g – 358 g
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature and of 30 – 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.
Day / night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Stainless steel wire mesh cages with plastic-coated grating, minimum floor area: 2,000 cm2
Number of animals per cage: 5
Feeding: Kliba Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland ad libitum
Drinking water: Tap water ad libitum.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
Intradermal induction: test substance 2.5% in 1% aqueous CMC-solution or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1).
Epicutaneous induction: test substance 50% in 1% aqueous CMC-solution.
Challenge: test substance 50% in 1% aqueous CMC-solution.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
Intradermal induction: test substance 2.5% in 1% aqueous CMC-solution or in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1:1).
Epicutaneous induction: test substance 50% in 1% aqueous CMC-solution.
Challenge: test substance 50% in 1% aqueous CMC-solution.
No. of animals per dose:
Test group: 10
Control group: 5
Details on study design:
The study consists of pretests and a main test. The concentrations for the test substance suitable for use in the main experiment were determined in the pretests.
Clipping of the fur: At least 2 hours before each test-substance application at the appropriate application sites. If necessary, additionally at least 2 hours before evaluation of the skin reactions.
Body weight determination: Individual body weights on day 0 and at the last day of observation.
Mortality: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany).
Main test: Induction
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test substance emulsified with Freund’s complete adjuvant* / 0.9% aqueous NaCl-solution (1 : 1)
Injections for the test group: Analogously to the intradermal pretest.
Application site: neck region.
Readings: 24 h after the beginning of application

Epicutaneous induction: Epicutaneous induction was carried out one week after intradermal induction.
Amount applied: 1 mL of the test-substance preparation was applied to each animal.
Occlusive dressing: 2 x 4 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test-substance preparations were applied to the skin of the neck region under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka), and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 48 hours
Application site: Neck region, same area as in the case of the previous intradermal application
Readings: Directly after removal of the patch
The control animals were not treated since the 1% aqueous CMC-solution used as formulating agent was not expected to influence the result of the study.

The challenge was carried out 14 days after the epicutaneous induction.
Amount applied: 0.5 mL of the test-substance preparation was applied to each animal. The test group and control group were treated with the testsubstance preparation.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test-substance preparation were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 24 hours
Application site: Intact flank
Readings: 24 and 48 h after the removal of the patch

Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
not applicable

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% in the challenge
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% in the challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in the challenge
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% in the challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% in the challenge
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% in the challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in the challenge
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% in the challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information