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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 guidelineopen allclose all
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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
Version / remarks:
(June 1996)
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

Constituent 1
Chemical structure
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 / strainopen allclose all
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 / 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
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
other: 2-aminoanthracene
Remarks:
TA 100
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 resultsopen allclose all
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
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.

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