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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-08-08 to 2006-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD test guideline 429

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
April 24th 2002
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 26-33 g
- Housing: single-housed in type II cages
- Diet: PROVIMI KLIBA SA 3883 ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 70
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12 h/12 h, with artificial illumination

Study design: in vivo (LLNA)

Vehicle:
other: corn oil
Concentration:
2, 10 or 50%
No. of animals per dose:
6
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: IMDS
- Criteria used to consider a positive response: increase in the stimulation indices for cell counts (> 1.4) and for weights of the draining lymph nodes

TREATMENT PREPARATION AND ADMINISTRATION:
The registered substance (in corn oil) or the vehicle were applied epicutaneously onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days (d1, d2 and d3).
The volume administered was 25 mL/ear.
Based on experiences with this test system and the known properties of the test item the following concentrations were used: 0 (vehicle control), 2, 10 and 50%.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The last reliability test using Alpha Hexyl Cinnamic Aldehyde formulated in Acetone/Olive Oil (4:1) at concentrations of 3%, 10% and 30% showed clearly the sensitizing potential of the test item.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
At the dose of 2% a cell count index of 1.20 and a ear swelling index of 0.98 were detected. At 10% a cell count index of 1.26 and an ear swelling index of 1.00 was revealed. The 50% dosage showed a cell count index of 1.11 and an ear swelling index of 1.00.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not applicable

Any other information on results incl. tables

The body weights of the animals were not affected by any treatment.

Applicant's summary and conclusion