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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
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 resultsopen allclose all
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
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
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
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
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

Applicant's summary and conclusion