(2S)-pentan-2-ol

Skin sensitisation

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)

Results

Results 1

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.

Results 2

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.