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Administrative data

Endpoint:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 2.1- 2.3 kg
- 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): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12h dark, 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated but shaved other side served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: gauze patch held with an non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: any
Score:
0
Max. score:
0
Remarks on result:
other: no irritant effects in any animal

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritating to the skin of rabbits
Executive summary:

The irritation study on three New Zealand White Rabbits dosed semiocclusively with 0.5 ml of the test substance did not show any signs of irritating effects within the observation period. No other signs of toxicity were found.

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