(2S)-pentan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-10-08 until 2007-12-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Good laboratory practice guideline study (OECD).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: female: 172 - 175 g
- Fasting period before study: yes
- 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 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/10 ml vehicle
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: non-toxic characteristics


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Assuming substance is non-toxic

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: three times in first four hours, weighting on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: none

Mortality:

none

Clinical signs:

none

Body weight:

weight gain within expected range

Gross pathology:

no changes found

Other findings:

- Other observations:
Animal 1 of step 1: reduced spontaneous activity, ataxia and abdominal position during the first day post dose, after 1 day: no signs of toxicity
Animal 2 of step 1: reduced spontaneous activity, comatose condition and piloerection during the first four hours post dose, after 4 hours: no signs of toxicity
Animal 3 of step 1: reduced spontaneous activity, ataxia and unstedy gait during the first hours post dose, after 4,5 hours: no signs of toxicity

Animal 1 of step 2: reduced spontaneous activity, unsteady gait during the first hours post dose, after 2,5 h: no signs of toxicity
Animal 2 of step 2: reduced spontaneous activity, unsteady gait during the first hours post dose, after 2,5 h: no signs of toxicity
Animal 3 of step 2: reduced spontaneous activity post dose, after 1,25 hours: no signs of toxicity

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be > 2000 mg/kg bw.

Executive summary:

An acute toxicity test according the acute toxic class method (OECD 423) was performed. The test item was given at a dose of 2000 mg/kg bw to two group of 3 female rats (HsdBrlHan:WIST) in a single dose via gavage. No mortality nor any other clinical sign were observed within these two groups. The LD50 of the substance was determined to be > 2000 mg/kg bw.