Acetone

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards, sufficient documentation of methodology and test results

Data source

Reference

Reference 1

Reference Type:

other: data base

Title:

Acetone, CAS Number: 67-64-1, Assay: Micronucleus, Study ID: A71579

Author:

National Toxicology Program (NTP)

Year:

1993

Bibliographic source:

http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

NTP standard protocol

GLP compliance:

not specified

Type of assay:

micronucleus assay

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

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Administration / exposure

Route of administration:

oral: drinking water

Duration of treatment / exposure:

13 wks

Frequency of treatment:

daily

Post exposure period:

24 hrs

Doses / concentrations

Remarks:

Doses / Concentrations:
5,000, 10,000, 20,000 ppm
Basis:
nominal in water

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Positive control(s):

none: because micronuclei were determined in test animals of a subchronic toxicity study

Examinations

Tissues and cell types examined:

Normochromatic erythrocytes in peripheral blood

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: dosages corresponded to dose groups of subchronic toxicity study

TREATMENT AND SAMPLING TIMES: continuously in drinking water, sampling on last day of treatment

DETAILS OF SLIDE PREPARATION: ca. 10,000 - 15,000 normochromatic erythrocytes scored per test animal

METHOD OF ANALYSIS: acridine orange staining

Statistics:

overall increase across all doses: positive trend test: p<=0.025
pairwise comparison of each dose group to the control group: significant increase of micronuclei p<=0.025

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
There was no indication of a clastogenic activity of acetone in normochromatic peripheral blood erythrocytes of B6C3F1 mice after subchronic oral exposure to acetone via drinking water (0.5-2 mg/kg bw/d).

Executive summary:

Groups of 10 B6C3F1 mice, that had continuously been exposed to 0, 0.5, 1 or 2 % acetone in drinking water for 13 weeks, were scored for induction of micronuclei in normochromatic erythrocytes in peripheral blood. Based on actual water consumption these concentrations correspond to dosages of 1,569, 3,023, and 5,481 mg/kg bw/d in male mice and dosages of 2,007, 4,156, and 5,945 mg/kg bw/d in female mice (values reported in NTP, 1991

). No indication of a clastogenic activity of acetone was found.