Registration Dossier
Registration Dossier
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 4 to November 6, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Analytical purity: 99%
- Lot No.: 08-018
- Storage condition of test material: room temperature (permissible range: 10-30°C, actual values: 18.1-25.3°C ) in light-shielded and air-tight container)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 19.6-23.2g (av.21.3g)
- Housing: polycarbonate cages (W220*D325*H130)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3-22.0
- Humidity (%): 55.5-61.3
- Air changes (per hr): 6-20 times
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: September 10, 2008 To: September 22, 2008
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 5 and 20 w/v%
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximum 20 w/v% suspension
- Irritation: not observed
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: Stimulation Index Value (Sample group Mean Value/Vehicle group Mean Value) >3
TREATMENT PREPARATION AND ADMINISTRATION:
Auricular application
-Dose volume: 25μL per ear (total 50 μL)/day
-Treatment: application to dorsum of each ear with a micropipette
-Frequency: once daily for 3 consecutive days
Radioisotope
-Dose volume: 250 μL/body (radioactivity level: 0.74MBq)
-Treatment: injection into the caudal vein at a rate of approx. 100 μL/sec. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI = 7.38
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.94
- Test group / Remarks:
- 1% (w/v)
- Parameter:
- SI
- Value:
- 1.05
- Test group / Remarks:
- 5% (w/v)
- Parameter:
- SI
- Value:
- 0.77
- Test group / Remarks:
- 20% (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Negative control (vehicle): 968.2 Test substance 1 w/v %: 911.0 Test substance 5 w/v %: 1013.3 Test substance 20 w/v %: 750.0 Positive control (HCA): 7148.0
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the conditions of the test, the test substance was not considered to be sensitising
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