Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

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
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually in suspended solid-floor polypropylene cages with softwood wood flakes
- Diet (e.g. ad libitum): ad lib Certified Rat & Mouse diet
- Water (e.g. ad libitum): ad lib mains tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 5 June 2008 To: 19 June 2008

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50%, and 100% (undiluted)
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: not applicable, used undiluted
- Irritation: none recorded

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: at least 3-fold greater increase in 3H thymidine incorporation compared to control
- Lymph node proliferation response: lymph nodes were pooled from all animals in each group prior to the preparation of the cell suspension

TREATMENT PREPARATION AND ADMINISTRATION: mice were administered the test material (25 µl) on the dorsal surface of the ear for three consecutive days, test material formulation was applied with a micropipette and spread over the dorsal surface of the ear using the tip of the pipette
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Historical control data indicate suitable sensitivity and reproducibility of the study as conducted at the laboratory

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 25%: 7.43 50%: 10.78 100%: 18.52
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: control: 3061.39 25%: 22732.31 50%: 33009.29 100%: 56693.54

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test material was positive (greater than 3 -fold response above control) at all concentrations tested.