3-[(4-hydroxy-3-methoxyphenyl)methyl]pentane-2,4-dione

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:

August-December 2017

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-[(4-hydroxy-3-methoxyphenyl)methyl]pentane-2,4-dione

EC Number:

820-605-0

Cas Number:

30881-23-3

Molecular formula:

C13H16O4

IUPAC Name:

3-[(4-hydroxy-3-methoxyphenyl)methyl]pentane-2,4-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Target gene:

amino acid histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate

Controls

Untreated negative controls:

yes

Remarks:

dimethyl sulfoxide

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-aminoanthracene

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

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

Reduction in number of revertant colonies was not observed in both presence and absence of metabolic activation in all tester strains up to the tested concentration of 5000 µg/plate.

No increase in the number of revertant colonies was observed both in the absence and presence of the metabolic activation system (10% v/v S9 mix) in all the tester strains.

Results revealed that there was no positive mutagenic effect in tester strains TA1537, TA1535, TA98, TA100 and TA102 at the tested concentrations of 156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate of substance in the absence and presence of metabolic activation system (10% v/v S9 mix), when compared with the concurrent negative control.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

From the results of the study, it is concluded that the substance is non-mutagenic to any of the five strains of Salmonella typhimurium viz. TA1537, TA1535, TA98, TA100 and TA102.

Executive summary:

The study was performed to evaluate mutagenic actvity of the substance by the bacterial reverse mutation test, using five histidine mutant tester strains of Salmonella typhimutium (i.e. TA1537, TA1535, TA98, TA100 and TA102).

The substance did not induce any significant increase in the number of revertants, in both trials, with and without S9 mix, in any of the five tester strains. All the values for the negative control were within historical control ranges of the laboratory and positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system. All criteria for a valid study were met.

From the results of this study, under the specified experimental conditions, the tested substance is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.