Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-10-08 until 2007-12-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (S)-Pentan-2-ol
- Substance type: intermediate
- Physical state: liquid
- Stability under test conditions: pure: stable until 2008-09-30,
in Water: stable under test conditions
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 19-21 g
- Housing: semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate (at least 5 days)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Remarks:
3+1 (v/v)
Concentration:
25%, 50 % and 100 %
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: fully soluble
- Irritation: none


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: as stated in the Guideline


TREATMENT PREPARATION AND ADMINISTRATION:
1) topical Application of 25 µl of the selected solution
2) after 5 days: 20 µCi 3H-methyl thymidine are injected intravenuously
3) after 5 hours: lymph nodes excised out of sacrificed animals

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The stimulation index at a concentration of 25% is 1.2. The stimulation index at a concentration of 50% is 1.1. The stimulation index at a concentration of 100% is 0.8.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 0%: 943.8 (mean) 25% : 1154.6 (mean) 50%: 994.8 (mean) 100%: 740.0 (mean)

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitizing to the skin.
Executive summary:

A LLNA test on the test substance according to OECD 429 did not show any sensitizing effects when applied.