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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.

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