Pentyl phenylacetate

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

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: Similar to OECD 471

Principles of method if other than guideline:

Benzyl Acetate 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:

no

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

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:

- Name of test material: Benzyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.176 g/mol
- Substance type:Organic
- Physical state:Liquid
- Purity: 99.1%
- Impurities (identity and concentrations): No data

Specific details on test material used for the study:

- Name of the test material: benzyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.176 g/mol

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

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

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

Test concentrations with justification for top dose:

0, 33, 100, 333, 1000, 3333 or 10000 ug/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

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.

Rationale for test conditions:

No data

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 information available.

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 mgjplate, 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

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data

Remarks on result:

other: No mutagenic potential

Any other information on results incl. tables

Table: Mutation data for the test chemical Benzyl acetate

Dose (µg/plate)	TA100
	NA		10% HLI		10% RLI
	Mean	SEM	Mean	SEM	Mean	SEM
0	97	5.5	102	7.3	105	14.9
33	102	4.7
100	101	4.0	67	2.7	122	2.9
333	85	5.8	97	9.6	118	12.3
1000	91	14.4	93	2.7	99	12.1
3333	58	11.7	104	15.5	78	4.1
10000			84	9.0	95	6.5
Positive control	481	29.2	1770	34.1	961	89.2

 

Dose (µg/plate)	TA1535
	NA		10% HLI		10% RLI
	Mean	SEM	Mean	SEM	Mean	SEM
0	8	0.3	7	1.5	6	1.3
33	5	0.9
100	4	0.6	6	1.2	6	1.5
333	5	0.6	8	1.2	6	1.2
1000	4	0.6	2	0.9	3	0.3
3333	3	0.3	3	1.2	8	3.0
10000			1	0.7	5	2.3
Positive control	724	63.9	106	2.6	43	3.5

 

Dose (µg/plate)	TA1537
	NA		10% HLI		10% RLI
	Mean	SEM	Mean	SEM	Mean	SEM
0	2	0.0	6	1.2	7	1.3
33
100	2	1.0	8	2.3	6	1.2
333	5	1.3	4	0.9	9	0.3
1000	1	0.7	4	1.2	7	3.2
3333	5		3	0.3	5	1.5
10000	T		6	1.2	9	1.3
Positive control	224	32.4	79	9.2	82	14.2

 

Dose (µg/plate)	TA98
	NA		10% HLI		10% RLI
	Mean	SEM	Mean	SEM	Mean	SEM
0	12	2.8	16	2.6	20	1.2
33
100	11	1.2	20	1.8	23	2.5
333	13	0.3	20	3.8	24	1.9
1000	15	3.5	16	1.9	20	3.2
3333	12	2.3	19	2.3	19	4.8
8	1.0	12	1.3	18	4.1
Positive control	140	3.7	1169	69.6	324	49.4

 

T: Complete clearing of background lawn

 

Applicant's summary and conclusion

Conclusions:

Benzyl Acetate did not induce mutation in the Salmonella typhimurium strain TA98, TA100, TA1535 or TA1537 both in the presence and absence of S9 metabolic actuvation system and hence does not classify for gene mutation under the conditions of this study.

Executive summary:

Benzyl Acetate 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. 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, 33, 100, 333, 1000, 3333 or 10000 ug/plate. The test was repeated and atleast three plates were used at each dose level. Benzyl Acetate did not induce mutation in the Salmonella typhimurium strain TA98, TA100, TA1535 or TA1537 both in the presence and absence of S9 metabolic activation system and hence does not classify for gene mutation under the conditions of this study.