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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:
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:
2008
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

Constituent 1
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)

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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