Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-07-09 to 2007-09-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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 - 31 g
- Housing: during adaption phase. up to 8 animals in Type II Makrolon cages; during the study period animals were single-housed in Type II cages; cages were changed at least twice a week;
- Diet: PROVIMI KLIBA SA 3883 maintenance diet for rats and mice (Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland), ad libitum;
- Water: tap water ad libitum
- Acclimation period: for at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 40 - 70 %
- Air changes: abt. 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs, with artificial illumination

IN-LIFE DATES: From: 2007-07-10 To: 2007-07-13

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
0, 2, 10 50 %
No. of animals per dose:
six animals per dose group
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: soluble
- Irritation: none
- Lymph node proliferation response: none

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: grouping
- Criteria used to consider a positive response: ear swelling

TREATMENT PREPARATION AND ADMINISTRATION: The test item in the formulation 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, d3).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
The stimulation index of 1.4 was never reached in one of the test groups. The values for the cell count index, ear swelling, direct LLNA and ear weight were not elevated in any of these parameters. Therefore, a skin sensitization potential could be excluded for the test item.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
The test was performed as an IMDS assay. The IMDS assay (IMDS = Integrated Model for Differentiation of Skin Reactions) does not use radioactive labelling for assaying the lymph node response. By comparing the specific immune reaction induced by the test item in the draining lymph nodes (LN, cell counts/LN weights) with the immediate unspecific acute skin reaction (ear swelling/ear weight) it is possible to discriminate the irritant potential from the sensitizing potential of the compound tested.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions the test item did not induce sensitization.
Executive summary:

The test item was investigated by dermal application in accordance with OECD guideline 429 in female NMRI mice. It had no sensitization potential up to and including the test concentration of 50%.