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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 1535, TA 1537, TA 98 and 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
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
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion