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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
February - June 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed in accordance with the corresponding OECD-/EU-testing guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl acetoacetate
EC Number:
203-299-8
EC Name:
Methyl acetoacetate
Cas Number:
105-45-3
Molecular formula:
C5H8O3
IUPAC Name:
methyl 3-oxobutanoate
Test material form:
other: non-viscous clear liquid
Details on test material:
- Physical state: Colourless liquid
- Molecular formula: C5H8O3
- Molecular weight: 116.1
- Storage condition of test material: Room temperature, protected from light

Method

Target gene:
not applicable
Species / strain
Species / strain / cell type:
other: the following five strains were used: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9-liver fractions of Sprague-Dawley rats, induced with Aroclor 1254
Test concentrations with justification for top dose:
Test substance concentrations of 10, 100, 500, 1000 and 5000 microg/plate were used in the main test.
Vehicle / solvent:
- Vehicle: Distilled water
- Justification for choice of solvent/vehicle: high solubility, better than others
Controls
Untreated negative controls:
yes
Remarks:
each strain alone or in presence of the solvent
Negative solvent / vehicle controls:
yes
Remarks:
distilled water
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
further positive control substances were used: 9-Aminoacridine, 2-Nitrofluorene, 2-Aminofluorene
Details on test system and experimental conditions:
The study was performed by the direct plate incorporation method w ith and without metabolic activation.
Evaluation criteria:
A mutagenic effect is significant when, at least in one strain, the number of revertants histidine+ is twice higher than that found in the control.
Statistics:
According to the OECD guideline 471, a statistical analysis of the data is not mandatory.

Results and discussion

Test results
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:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation

COMPARISON WITH HISTORICAL CONTROL DATA:
- not performed

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- no
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations in the five strains tested.
Executive summary:

The assay was performed 1988 in compliance with GLP. The test was performed with and without liver microsomal activation and used strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100. Each concentration and the controls, were tested in triplicate. The test item was tested at the following concentrations: 10; 100; 500; 1000 and 5000 µg/plate (pre-experiment and main test). The plates incubated with the test item showed normal back­ground growth up to 5000 µg/plate with and without S9 mix in all strains used. No toxic effects, evident as a reduction in the number of revertants occurred in the test groups with and without metabolic activation. Precipitation was not observed. MAA was found to be non-mutagenic in this test system.