2,4-Pentanedione, 3-[(3,4,5-trimethoxyphenyl)methylene]-

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-[(3,4,5-trimethoxyphenyl)methylidene]pentane-2,4-dione

EC Number:

807-059-9

Cas Number:

945558-97-4

Molecular formula:

C15H18O5

IUPAC Name:

3-[(3,4,5-trimethoxyphenyl)methylidene]pentane-2,4-dione

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535

Metabolic activation:

with and without

Metabolic activation system:

S-9 activation system

Test concentrations with justification for top dose:

5 mg, 1.6 mg, 0.5 mg, 0.16 mg, 0.05 mg, 0.016 mg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

mitomycin C

other: 4-nitro-o- phenylenediamine(NPD), 2-aminofluorene(2-AF), 2- aminoanthracene(2-AA)

Remarks:

NPD and 2-AF for TA97a, sodium azide and 2-AF for TA98, TA100, mitomycin C and 2-AA for TA102, sodium azide and 2-AA for TA1535

Details on test system and experimental conditions:

Three replicates for each test article or control.

Evaluation criteria:

Criteria for a Mutaqen: 1) A greater than two-fold increase in the number of revertants in strains TA97a, TA100 and TA102 or a greater than three-fold increase in strains T A98 and T A 1535 when compared to the solvent control (percent of control >200% or >300%).
2) Demonstration of a clear dose related response when dilutions are tested.
Criteria for a Non-Mutaqen 1) A less than two-fold increase in strains TA97a, TA100 and TA102 or a less than three-fold increase in strains T A98 and T A 1535 when compared to the solvent control (percent of control <200% or <300%)
2) No dose related response when dilutions are tested .

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

The test article did show some cytotoxicity in all five strains in the higher concentrations, which decreased with the decreasing concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

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

The test article concentrations did not produce a two-fold or three-fold increase in the number of revertants or produce a clear dose related response in any of the 5 tester strains. The spot tests showed no zone of increased reversion or of toxicity. In summary, the test article concentrations tested against the five strains did not meet the criteria for a potential mutagen.