Methyl acetoacetate

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:

other: GLP guideline study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

(1983) and according to Matsushima et al (1980). Short-Term Test Systems for Detecting Carcinogens. Edited by Norpoth KH and Garner RC, Springer, Berlin-Heidelberg-New York, 273-285.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

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

Details on test material:

- Name of test material (as cited in study report): methyl acetoacetate;
- Analytical purity: according to the authors, purity was 99.4%

Method

Target gene:

For Salmonella typhimurium strains, the amino acid histidine locus is the target gene.

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix prepared from Sprague-Dawley rat liver homogenate, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0.313; 625; 1250; 2500; 5000 µg/plate;

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide

Remarks:

0.01 and 0.1 µg/plate was used without S9 mix in the strains TA100 and TA98, respectively

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

0.5 µg/plate was used without S9 mix in the strain TA1535

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

80 µg/plate was used without S9 mix in the strain TA1537

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

1; 2; 0.5; 2 µg/plate was used with S9 mix in the strains TA100, TA1535; TA98; TA1537, respectively

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation; 3 plates per test

DURATION
- no data

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: no data

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The original data of the study are written in Japanese language; however, an abstract written in English language is included. 
The main information of the study is presented in this abstract and in tables written in english in sufficient detail.