4-hydroxybutan-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxybutan-2-one

EC Number:

209-693-6

EC Name:

4-hydroxybutan-2-one

Cas Number:

590-90-9

Molecular formula:

C4H8O2

IUPAC Name:

4-hydroxybutan-2-one

Details on test material:

Name of the test substance used in the study report: Ketobutanol (= 4-Hydroxybutan-2-on)
Physical state: liquid
Substance No. 81/0093

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Acclimatization in the animal care unit for at least one week.
Age of animals at beginning of study: about 12 weeks
Type of cage: type DK-III stainless steel wire mesh cages
Animal identification: identification of groups (5 animals) using cage cards
Room temperature: 20 - 26°C; relative humidity: 45 - 75%; day/night rhythm: 12 h/12 h (6 .00 - 18 .00 hours/18 .00 - 6 .00 hours)
Drinking water: Fully demineralized water each workday, ad libitum; tap water on public holidays, ad libitum
The animals are given no feed for 16 hours before administration, but water is available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test concentrations: 21.5, 31.6 and 46.4% (g/v).
Application volume: 10 ml/kg

Doses:

2150, 3160 and 4640 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Weight check: Animals of comparable weights (± 10 g) in one cage. Weighing of groups before administration, 2nd weighing 2 d, 2nd weighing 3 d, 3rd weighing 7 d and 4th weighing 13 d after administration.
Cageside observation: Recording of signs and symptoms < 15, 15, 30 min, 1 h, 2 h, 4 h, and 5 h after administration of test substance and then once each workday. Check for moribund and dead animals twice each workday and once daily at weekends and on public holidays.
Pathology: Withdrawal of feed 16 hours before sacrifice with C02, followed by necropsy and grosspathological examination. All animals that die are necropsied as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 - < 4 640 mg/kg bw

Mortality:

male rats: 2150 and 3160 mg/kg: 0/5 after 14 days; 4640 mg/kg: 5/5 after 14 dys
female rats: 2150 mg/kg: 0/5 after 14 days; 3160 mg/kg: 2/5 after 14 days; 4640 mg/kg: 3/5 after 14 days

Clinical signs:

other: dyspnea, apathy, staggering, trembling, spastic gait, ruffled fur, poor general state

Gross pathology:

animals that died: acute congestive hyperemia; lung: intensified hyperemia; intestine: partly reddenisch-mucoid content.
sacrified animals - 2150 mg/kg: nothing abnormal detected; 3160 mg/kg: multiple thickening of the top of the forestomach and concrescence with liver, spleen and peritoneum