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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically valid publication with limited documentation.

Data source

Reference
Reference Type:
publication
Title:
The genetic toxicology of some hydrocarbon and oxygenated solvents
Author:
Brooks TM, Meyer AL and Hutson DA
Year:
1988
Bibliographic source:
Mutagenesis 3, 227-232

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
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): Methy Ethyl Ketone
- Analytical purity: > 99 %

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
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:
E. coli WP2
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 microsomal fraction from liver homogenate from rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
doses of 2-fold intervalls up to 4000 µg/plate
Vehicle / solvent:
DMSO or water (no further information is given)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sodium azide, benzo[a]pyrene, 4-nitroquinoline-N-oxide, neutral red, potassium dichromate
Details on test system and experimental conditions:
The plate incorporation assay was used. In the assays with S9 mix, a final concentration of 10% S9 in the S9 mix was used.
In each assay control plates were set up with the solvent alone and with an appropriate positive control. All tests were carried out in triplicate. Two replicate assays were carried out on differnt days.
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
E. coli, other: WP2, WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
MEK showed no mutagenic response in any strain. (No further details reported.)
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

In a reverse gene mutation assay the bacteria strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 of S. typhimurium as well as the E.coli strains WP2 and WP2 uvrA were exposed to methyl ethyl ketone up to concentrations of 4000 µg/plate (3 plates/dose) in the presence and absence of mammalian metabolic activation applying the plate incorporation method (Brooks et al., 1988). Two independend assays were performed. The positive ans solvent controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all strains with and without metabolic activation.