Methyl 3-methyl-2-butenoate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, L 383 A, Annex B14

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-Methylcrotonsäuremethylester

IUPAC Name:

3-Methylcrotonsäuremethylester

Constituent 2

Reference substance name:

Methyl 3-methyl-2-butenoate

EC Number:

213-107-4

EC Name:

Methyl 3-methyl-2-butenoate

Cas Number:

924-50-5

Molecular formula:

C6H10O2

IUPAC Name:

methyl 3-methylbut-2-enoate

Test material form:

other: Clear colourless to yellowish liquid

Details on test material:

Purity: 98.7 %, Storage: Darkness at approximately 20°C in a fume cupboard

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

Formulation of the test compounds: Dissolved in DMSO at appropriate concentrations immediately before use.
4,20,100,500,2500, 5000 µg/plate with and without metabolic acivation system. control groups: with and without metabolic activation,

Vehicle / solvent:

DMSO to dissolve the test substance.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2- Aminoanthracene

Details on test system and experimental conditions:

Sterility of S9-mix and the test compound were indicated by the absence of contamination on the test material and S9-mix sterility check plates.
Experimental conditions in vitro: 37°C in the incubator.

Evaluation criteria:

A test compound is evaluated as mutagenic if it has:
a) A 2 fold increase in number of the revertants per plate of at least one of the test strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
b) A test compound induces a dose-relevant increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of appropriate vehicle control in at least two or three concentrations of the test compound at complete bacterial lawns.

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:

cytotoxicity

Additional information on results:

See attachment (Attached background material)

Applicant's summary and conclusion

Conclusions:

The test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation.

Executive summary:

Dimethylacrylsäuremethylester was tested for mutagenicity with the strains TA 100, TA 1535,TA 1537 and TA 98 of Salmonella Typhimurium.

In the toxicity test using histidine enriched agar plates and a dilution of the tester strain TA 100, which was performed with the secound experiment, toxicity was found at concentrations of 2500 µg/plate and above in the absence.

Mutagenicity: In the absence and in the presence of the metabolic activiation system Diemethylacrylsäuremethylester did not result in any relevant increases in the number of revertants in any of the bacterial strains.

Summarizing it can be stated that Dimethylacrylsäuremethylester is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose level investigated.