Geranyl propionate

Genetic toxicity: in vitro

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 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: Similar to OECD 471

Principles of method if other than guideline:

Gene mutation toxicity study was performed to determine the mutagenic nature of Geranyl acetate

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Geranyl acetate

EC Number:

203-341-5

EC Name:

Geranyl acetate

Cas Number:

105-87-3

Molecular formula:

C12H20O2

IUPAC Name:

(2E)-3,7-dimethylocta-2,6-dien-1-yl acetate

Details on test material:

- Name of test material: Geranyl acetate
- Molecular formula: C14H24O2
- Molecular weight: 224.342 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material (as cited in study report): Geranyl acetate
- Molecular formula: C14H24O2
- Molecular weight: 224.342 g/mol
- Substance type: Organic
- Purity ; 69.6 %

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 metabolic activation system isolated from Aroclor 1254-induced males Sprague Dawley rat and Syrian hamsters

Test concentrations with justification for top dose:

0.0, 1.0, 3.3, 10.0, 33.0, 100.0, 333.0, 1000.0, 3333.0 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hrs
- 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 in duplicate one week after completion of the initial test. At least five dose levels of the chemicals were tested, with three plates per dose level.

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; No data available

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:

1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold;
2) nomutagenic response: when no increase in the number of revertants was elicited by the chemical;
3) questionable response: when there was an absence of a clear-cut dose-related increase in revertants; when the dose-related increases in the number of revertants were not reproducible; or when the response was of insufficient magnitude to support a determination of mutagenicity.

Statistics:

No data

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data

RANGE-FINDING/SCREENING STUDIES: The chemical was tested initially with strain TA100 in the presence and the absence of the metabolic activation systems, over a wide dose range with an upper limit of 10 mg/plate, or less when solubility problems were encountered. 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. Nontoxic chemicals were tested in the initial experiment up to the 10 mg/plate dose level, or to a level determined by their solubility. Toxic chemicals were tested up to a high dose which exhibited some degree of toxicity.

COMPARISON WITH HISTORICAL CONTROL DATA: No data

Remarks on result:

other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:

The Geranyl acetate(105-87-3) failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 in the presence and absence of S9 metabolic activation system and hence is not mutagenic in vitro.

Executive summary:

Geranyl acetate was examined for its ability to cause mutagenic changes when tested in strains of the bacteria Salmonella typhimurium, specifically, TA 1535, TA 1537, TA 98 and TA 100 through the preincubation assay method. Preliminary dose range finding study was performed initially to set the doses for the main study. The test was conducted both in the presence and absence of metabolic activation using male rat and hamster liver derived S-9 mix at dose levels of 0.0, 1.0, 3.3, 10.0, 33.0, 100.0, 333.0, 1000.0, 3333.0 µg/plate. The test was repeated and atleast three plates were used at each dose level. Geranyl acetate failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 in the presence and absence of S9 metabolic activation system and hence is not mutagenic in vitro.