2-methoxyethyl 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

Study period:

7 January - 4 February 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxyethyl acetoacetate

EC Number:

245-043-8

EC Name:

2-methoxyethyl acetoacetate

Cas Number:

22502-03-0

Molecular formula:

C7H12O4

IUPAC Name:

2-methoxyethyl 3-oxobutanoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): P5098
- Physical state: liquid
- Stability under test conditions: stable at room temperature
- Storage condition of test material: tightly closed at room temperature away from sunlight

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Details on mammalian cell type (if applicable):

- Type and identity of media: The strains were obtained from Professor B.N. Ames, University of California, California, USA
- Properly maintained: yes

Additional strain / cell type characteristics:

DNA polymerase A deficient

Metabolic activation:

with and without

Metabolic activation system:

S9-liver fractions of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

- Pretest: 2,5, 5, 25, 50, 250, 500, 2500, 5000 ug/ml & solvent control
- Main test: 50, 158, 500, 1580, 5000 ug/ml & solvent control

Vehicle / solvent:

A solution of P5098 was prepared in distilled water at 25 mg/ml

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

benzo(a)pyrene

other: 2-Aminoanthracene

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The negative controls, positive controls, and sterility controls all fulfilled requirements for determination of a valid test.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test material, P5098, was devoid of mutagenic activity under the conditions of test.

Executive summary:

This reverse mutation assay was performed in 1991 in accordance with OECD-guidelines without GLP. Five Salm. typh. strains (TA1535, TA1537, TA1538, TA98 and TA100) were tested with and without metabolic activation. Test concentrations ranged from 50 ug/plate up to 5000 ug/plate.

No detectable mutagenic activity was found for the test article when the Salmonella/microsomal assay was performed.