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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.