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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:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooel 740
- Physical state: Liquid / yellowish, clear
- Analytical purity: not stated in the report
- Lot/batch No.: TK285_20090716
- Test item No.: 08/0225-2
- Stability under test conditions: According to the sponsor, the stability of the test item is guaranteed throughout the study period.
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage condition of test material: Refrigerator (KS); dry storage

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Kisslegg
- Age at study initiation: 5 – 8 weeks
- Weight at study initiation: 348 g - 447 g
- Housing: 10 animals per container
- Diet: Ssniff Ms-H (Guinea Pig Maintenance Diet V2233), including ascorbic acid (2400 mg/kg), ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before the first test item application

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:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
- all inductions: 100%
- 1st challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
- all inductions: 100%
- 1st challenge: 100%
No. of animals per dose:
- test group: 20;
- negative control group: 10
Details on study design:
RANGE FINDING TESTS:
To obtain the appropriate concentrations of the test item for the definitive study, a pretest was carried out with 3 female guinea pigs. 4 different concentrations of the test item were administered epicutaneously. The mode of application was the same as in the definitive study. The duration of the epicutaneous exposure was 6 hours. The test item was applied as is (100 %) and diluted with acetone (75, 50, and 25%; v/v). For evaluation, skin findings were read 24 and 48 hours after removal of the patch. The following concentrations for induction and challenge were selected on the basis of the pretest: 1st, 2nd and 3rd induction: Test item as is (100%); 1st challenge: Test item as is (100%);

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Amount applied: 0.5 ml of the test item was applied to each animal.
- Occlusive dressing: The test patches (Pur Zellin-Tupfer, Fa. Hartmann, Wiener Neudorf, Austria, ca. 2 cm x 2 cm) were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch (self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, Hamburg, Germany). Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket (Hugo Sachs Elektronik- Harvard Apparatus GmbH, March-Hugstetten, Germany).
- Site: Left flank anterior.
- Frequency of applications: Three times at weekly intervals; on days 0, 7 and 14 on the same application site
- Concentrations: 100%
- Readings: 24 h after the beginning of the induction exposure.
The control group was treated analogously to the test group but only with highly deionized water.

B. CHALLENGE EXPOSURE (14 days after the last induction)
- No. of exposures: 1
- Amount applied: 0.5 mL of the test item was applied to the posterior right flank of each animal of each group. Additionally 0.5 ml of highly deionized water was applied to the anterior right flank as a control.
Occlusive dressing: The test patches (Pur Zellin-Tupfer, Fa. Hartmann, Wiener Neudorf, Austria, ca. 2 cm x 2 cm) were fully loaded with the test item or with highly deionized water, applied to the skin and fixed with a strip of Fixomull stretchm (self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, Hamburg, Germany). Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket (Hugo Sachs Elektronik- Harvard Apparatus GmbH, March-Hugstetten, Germany).
- Day(s) of challenge: 1
- Exposure period: 6 h
- Site: Right posterior (test item) and right anterior (highly deionized water) flank.
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch.

Positive control substance(s):
yes
Remarks:
(see: Results and Discussion)

Results and discussion

Positive control results:
A positive control with a known sensitizer is not included in this study. A separate study is performed twice a year. The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with skin findings.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No animals with skin findings..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No animals with skin findings.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No animals with skin findings..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with skin findings.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No animals with skin findings..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No animals with skin findings.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No animals with skin findings..

Any other information on results incl. tables

The expected body weight gain was generally observed in the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information