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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 and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Heptadecanol, branched and linear
EC Number:
291-378-8
EC Name:
Heptadecanol, branched and linear
Cas Number:
90388-00-4
Molecular formula:
C17H36O
IUPAC Name:
2-methylhexadecan-1-ol; heptadecan-1-ol
Details on test material:
Name of test substance used in the study report: Heptadecanol N
Purity: 99.8 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
5 - 8 weeks old female guinea pigs were used (body weight on day 0: 403 - 450 g).
5 animals per cage (type: stainless steel wire cages with floor grating, floor area: 3000 cm2).
Animal identification via ear tattoo.
The animals were offered a standardized laboratory diet as well as tap water ad libitum.
They were housed in fully air-conditioned rooms with a temperature in the range of 20 - 24°C and a relative humdity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
(all inductions)
Concentration / amount:
1st, 2nd and 3rd induction: undiluted test substance
1st challenge: 25% in acetone
2nd challenge. 10% in acetone
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
(all inductions)
Concentration / amount:
1st, 2nd and 3rd induction: undiluted test substance
1st challenge: 25% in acetone
2nd challenge. 10% in acetone
No. of animals per dose:
test group: 20; control group 10
Details on study design:
Clipping of the fur: At least 15 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 on the last day of observation.
Mortality: Twice each workday (beginning and end) and once on weekends and on public holidays.
Assessment of the skin reactions: The evaluation of the skin reactions was performed according to the following grading scale 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).

PRETEST:
Amount applied: 0.5 mL of the test substance / test-substance preparation was applied to each animal.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance / test-substance preparations were applied to the skin of the flanks 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: 6 hours
Application site: Right and left flank
Application frequency: One application
Number of test animals: 3 per test-substance concentration
Concentrations: Undiluted test substance, 50% and 25% in acetone
Readings: 1, 24 and 48 h after removal of the patch

MAIN TEST:
Amount applied: 0.5 mL of the test substance was applied to each animal.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test substance 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: 6 hours
Application site: Intact flank
Application frequency: Three times at weekly intervals; days 0, 7 and 14 on the same
Readings: 24 h after the removal of the patch
The control group was not treated, since the test substance was applied undiluted and thus no vehicle was used.

CHALLENGE:
The 1st challenge was carried out 14 days after the third induction. A 2nd challenge was performed one week after the 1st challenge.
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 test substance preparation. Additionally, acetone was applied as a vehicle control.
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: 6 hours
Application site: Intact flank
Readings: 24 and 48 h after the removal of the patch

Positive control
A positive control (reliability check) with a known sensitizer is not included in this study.
However, a separate study is performed twice a year in the laboratory.

EVALUATION OF RESULTS: 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 15 per cent of the test animals exhibit skin reactions.
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 12.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information