Butanone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

S. typhimurium strain TA102 or E. coli strain WP2 not used and 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Butanone

EC Number:

201-159-0

EC Name:

Butanone

Cas Number:

78-93-3

Molecular formula:

C4H8O

IUPAC Name:

butan-2-one

Details on test material:

- Name of test material (as cited in study report): Methyl ethyl ketone
- Physical state: Clear liquid
- Lot/batch No.: 5-82
- Storage condition of test material: Room temperature under nitrogen

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver microsomes (S9)

Test concentrations with justification for top dose:

Preliminary toxicity determination: 0.015, 0.05, 0.15, 0.5, 1.7, 5.2, 17, 50, 100, or 150 µL/plate
Ames assay: 0.1, 0.5, 2, 16, or 32 µL/plate (- S9) and 0.05, 0.1, 0.5, 2, or 16 µL/plate (+ S9)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: See Table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Exposure duration: Incubated at 37 ºC for 48 hours.

NUMBER OF REPLICATIONS: triplicate

Evaluation criteria:

For a test article to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain. This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test article. In those cases where the observed dose-responsive increase in TA1537 or TA1538 revertants per plate is less than three-fold, the response must be reproducible.

Statistics:

Not required (revertant colonies were counted)

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Moderately to extremely reduced background lawn at 32 µL/plate (+S9)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Moderately to extremely reduced background lawn at 32 µL/plate (+S9)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Moderately to extremely reduced background lawn at 32 µL/plate (+S9)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Moderately to extremely reduced background lawn at 32 µL/plate (+S9)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Moderately to extremely reduced background lawn at 32 µL/plate (+S9)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested