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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: II. Results from the Testing of 270 Chemicals
Author:
Mortelmans K., Haworth S., Lawlor T., Speck W., Tainer B., Zeiger E
Year:
1986
Bibliographic source:
Environmental Mutagenesis Volume 8, Supplement 7: 1-119 ,1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Test chemical was examined alongside 269 other chemicals for its ability to induce mutagenic changes when tested in Salmonella typhimurium bacterial strains in the presence and absence of metabolic activation with rat and hamster S-9 mix using the preincubation assay method.
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl acetate
EC Number:
205-399-7
EC Name:
Benzyl acetate
Cas Number:
140-11-4
Molecular formula:
C9H10O2
IUPAC Name:
benzyl acetate
Test material form:
other: Liquid
Details on test material:
Details on test material
- Name of test material (as cited in study report): Benzyl acetate
- Molecular formula (if other than submission substance): C9-H10-O2
- Molecular weight (if other than submission substance): 150.176
- Substance type:Organic
- Physical state:Liquid

Method

Target gene:
S. typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 98,TA 97 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat and hamster
Test concentrations with justification for top dose:
0, 10, 100, 1000 and 10000ug/plate.
Vehicle / solvent:
Distilled water. For chemicals that were not soluble or had low solubility in water, dimethyl sulfoxide (DMSO) was used. Ethanol (95%) or acetone was used for chemicals insoluble in water or DMSO.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide-Used with metabolic activation for strains TA 1535 and TA 100
Remarks:
4-nitro-o-phenylenediamine-Used with metabolic activation for strain TA 98 9-aminoacridine- Used with metabolic activation for strains TA 97 and TA 1537 2-aminoanthracene-Used with all strains with rat and hamster liver metabolic activation systems
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium):No data available
- Selection time (if incubation with a selection agent): :No data available
- Fixation time (start of exposure up to fixation or harvest of cells): :No data available

SELECTION AGENT (mutation assays): :No data available
SPINDLE INHIBITOR (cytogenetic assays): :No data available
STAIN (for cytogenetic assays): :No data available

NUMBER OF REPLICATIONS: : All assays were repeated no less than one week after completion of the initial test.

NUMBER OF CELLS EVALUATED: :No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Toxicity was evidenced by one or more of the following phenomena: appearance of his- pinpoint colonies, reduced numbers of revertant colonies per plate or thinning or absence of the bacterial lawn.

OTHER EXAMINATIONS:
- Determination of polyploidy: :No data available
- Determination of endoreplication: :No data available
- Other: :No data available

OTHER: At least one toxic dose was incorporated into the first mutagenicity test, the repeat test(s) occasionally had the doses adjusted so that an apparent toxic dose was not reached.
Evaluation criteria:
Mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold.
Nonmutagenic response: when no increase in the number of revertants was elicited
Questionable response: when there was an absence of a clear cut dose related increase in revertants, when the dose related increase in revertants was not reproducible or when the response was of insufficient magnitude to support a determination of mutagenicity.
Statistics:
No information available.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 98,TA 97 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data available
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
Based on the results of the study, the test substance can be considered to be non-mutagenic under the conditions of this study.
Executive summary:

In the study conducted by Mortelmans et al in 1986,test chemical was examined for its ability to cause mutagenic changes when tested in five strains of the bacteria Salmonella typhimurium, specifically, TA 1535, TA 1537, TA97, TA 98 and TA 100 through the preincubation assay method. The test was conducted both in the presence and absence of metabolic activation using rat and hamster liver derived S-9 mix, over a range of doses, from 0 to 10000 ug/plate. Based on the results of this study, the test substance was not considered to be mutagenic under the conditions of this test.