Acetone

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: Study meets generally accepted scientific principles, minor restriction: only data for female rats; sufficient documentation of test conditions, less detailed documentation of test results; publication acceptable as a key study for acute toxicity

Data source

Reference

Reference Type:

publication

Title:

Acetone potentiation of acute acetonitrile toxicity

Author:

Freeman JJ, Hayes EP

Year:

1985

Bibliographic source:

J Toxicol Environ Health 15: 609-621

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Undiluted acetone applied to female rats by gavage, dose range 5370 - 6980 mg/kg bw, post-observation 14 days for mortality, clinical signs, body weights, necropsy performed

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Acetone

EC Number:

200-662-2

EC Name:

Acetone

Cas Number:

67-64-1

Molecular formula:

C3H6O

IUPAC Name:

propan-2-one

Details on test material:

- Purity: at least 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Mass., USA
- Age at study initiation: not specified
- Weight at study initiation: 174-260 g
- Fasting period before study: overnight fast
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 d

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5370 to 6980 mg/kg

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: signs of toxicity observed frequently on day of dosing, daily thereafter for 14 days; body weights prior to dosing, at 24, 48, 72 hrs and 7 and 14 days after dosing
- Necropsy performed on rats dying and on survivors: yes
- Other examinations performed: clinical signs, body weight, necropsy (not further specified)

Statistics:

LGD50 values according to method of Litchfield and Wilcoxon (1948)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

5 800 mg/kg bw

Mortality:

death within 48 to 72 hrs

Clinical signs:

other: initial signs: decreased activity and ataxia appeared within 3 hrs; animals appeared recovered after 24 hrs at 32-36 hrs: severe toxicity including tremors, tonus, convulsions signs preceeding death: were a state of prostration, usually without convulsion

Gross pathology:

no remarkable differences between dosage groups (no further details)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acetone was practically nontoxic based on an oral LD50 value of 5800 mg/kg bw in female rats.

Executive summary:

Female Sprague-Dawley rats (N=5/group) were orally exposed to doses of 5370 to 6980 mg/kg for determination of LD50. Acetone was practically nontoxic based on an oral LD50 value of 5800 mg/kg bw in rats. Initial signs of intoxication, such as decreased activity and ataxia, appeared within 3 hrs of dosing. Rats appeared to be recovered after 24 hrs. At 32 to 36 hrs severe toxicity was indicated by tremors, tonus, and convulsions, and gradually progressed to death within 48 to 72 hrs. Clinical signs preceeding death were a state of prostration, usually without convulsions. Loss of weight up to 15% occured until 48 hrs after dosing, but started to be reversible at 72 hrs.