5-acetyl-1,3-phenylene diacetate

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:

11 January 1999 - 13 January 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and according to an OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

The study procedures described in this report were based on the guideline no. 471: (the study was performed only with strain T A98 and strain TA 100, with the omission of the independent repeat):

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,5-DIACETOXYACETOPHENON

IUPAC Name:

3,5-DIACETOXYACETOPHENON

Test material form:

other: solid

Details on test material:

- Physical state: Brownish solid
- Analytical purity: Not indicated by sponsor; treated as 100% pure
- Lot/batch No.: 286
- Expiration date of the lot/batch: 16 December 1999
- - Stability under test conditions: Dimethylsulphoxide: not indicated
- Storage condition of test material: At room temperature in the dark
- Other:

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate

Vehicle / solvent:

dimethylsulphoxide

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

other: daunomycine, 2-aminoanthracene

Evaluation criteria:

No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
-) The total number of revertants in any tester strain at any concentration is not greater than two
times the solvent control value, with or without metabolic activation.
A test substance is considered positive (mutagenic) in the test if:
-) lt induces at least a 2-fold, dose related increase in the number of revertants with respect to the
number induced by the solvent control in any of the tester strains, either with or without
metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
The preceding criteria were not absolute and other modifying factors might enter into the final
evaluation decision.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: strain/cell type:

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Precipitate: 3,5-DIACETOXYACETOPHENON did not precipitate in the top agar. Precipitation of 3,5- DIACETOXYACETOPHENON was not observed on the plates at the start or at the end of the incubation period in both tester strains.

Toxicity of the test substance: To determine the toxicity of 3,5-DIACETOXYACETOPHENON, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the His+ revertant colanies were observed. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.

Number of revertants:

Both bacterial strains showed negative responses over the entire dose range, i.e. no dose-related,

two-fold, increase in the number of revertants.

The negative and strain-specific positive control values were within our labaratory background

historical control data ranges indicating that the test conditions were adequate and that the

metabolic activation system functioned properly.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Basedon the results of this study it is concluded that 3,5-DIACETOXYACETOPHENON is not
mutagenic in the Salmonella typhimurium reverse mutation assay.