2-methoxyethyl acetoacetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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. No detectable mutagenic activity was found.

Link to relevant study records

Reference

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

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

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

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

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

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'.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).