m-acetylphenyl acetate

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:

1999-11-16 to 2000-01-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

(21 July, 1997)

Deviations:

yes

Remarks:

E.coli WP2 or S.thyphimurium TA102 were not tested; no historical control data are reported; no cytotoxicity or solubility criteria discussed for the chosen maximum test concentration

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Version / remarks:

(June 1996)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EU Method B.14

Version / remarks:

(29 December, 1992)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

m-acetylphenyl acetate

EC Number:

219-524-8

EC Name:

m-acetylphenyl acetate

Cas Number:

2454-35-5

Molecular formula:

C10H10O3

IUPAC Name:

3-acetylphenyl acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): 3-Acetoxyacetophenon ( synonymous to 3-Acetoxyacetophenon lose Ware )
- Physical state: solid
- Analytical purity: 99.0 %
- Purity test date: October 19 , 1999
- Lot/batch No.: 489
- Storage condition of test material: room temperature , light protection

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Details on mammalian cell type (if applicable):

his D 3052; rfa-; uvrB-; R-factor frame shift mutations

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

his G46; rfa-; uvrB-; R-factor base paired subst.

Metabolic activation:

with and without

Metabolic activation system:

Mammalian microsomal fraction S9 mix

Test concentrations with justification for top dose:

31.6, 100.0, 316.2, 1000.0, 2500.0 and 5000.0 µg/plate

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

other: 2-aminoanthracene

Remarks:

TA 100

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene

Remarks:

TA 98

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): approx. 10E9 cells/mL

DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

A test item is considered as mutagenic if:
- a dose-related increase in the number of revertant occurs and/or
- a reproducible biologically relevant positive response for at least one of the test points occurs
in at least one strain with or without metabolic activation.

A biologically relevant increase is described as follows :
- if in strain TA 100 the numbers of reversions is at least twice as high
- if in strain TA 98 the number of reversions is at least three times higher
as compared to the spontaneous rate.

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 nor precipitates, but tested up to recommended limit concentrations

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 nor precipitates, but tested up to recommended limit concentrations

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that during the described mutagenicity test under the experimental conditions reported, the test item did not cause
gene mutations by base pair changes or frameshifts in the genome of the tester strains used.

Executive summary:

In order to investigate the potential of 3-Acetoxyacetophenon for its ability to induce gene mutations the plate incorporation test and the pre-incubation test were performed with the Salmonella typhimurium strains TA 98 and TA 100 .

No substantial increase in revertant colony numbers of any of the two tester strains were detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments.

The reported data of this mutagenicity test show that the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Therefore, 3-Acetoxyacetophenon is considered to be non-mutagenic in this bacterial reverse mutation assay.