Ethyl butyrate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

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:

Gene mutation toxicity study for the test chemical

Author:

Ishidate et al

Year:

1984

Bibliographic source:

Food and chemical toxicology

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

A salmonella/microsome test (Ames tests) was performed on the test substance to evaluate its mutagenic effect.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl butyrate

EC Number:

203-306-4

EC Name:

Ethyl butyrate

Cas Number:

105-54-4

Molecular formula:

C6H12O2

IUPAC Name:

ethyl butanoate

Details on test material:

- Name of test material: Ethyl butyrate
- IUPAC name: Ethyl butyrate
- Molecular formula: C6H12O2
- Molecular weight: 116.16 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 99.8%
- Impurities (identity and concentrations): 0.2%

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA92, TA1535,TA100, TA1537, TA94 and TA98

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data available

Metabolic activation:

with and without

Metabolic activation system:

The liver microsome fraction (S-9) was prepared from the liver of Fischer rats

Test concentrations with justification for top dose:

Six different concentrations were used with 10 mg/plate as the maximum concentration.

Vehicle / solvent:

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

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: Preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- 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: Duplicate

NUMBER OF CELLS EVALUATED: No data available

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

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

OTHER: No data available

Rationale for test conditions:

No data available

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).

Statistics:

No data available

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA92, TA1535,TA100, TA1537, TA94 and TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

The maximum dose for negative results represents the highest non-cytotoxic dose used in the experiment.

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

The test chemical did not induce a doubling of His + revertant colonies over the control using S. typhimurium TA92, TA1535, TA100, TA1537, TA94, TA98 strains in the presence and absence of metabolic activation system. Hence, Ethyl butyrate is considered as Non-mutagenic (negative) in vitro in the test system used under the certain experimental conditions.

Executive summary:

A bacterial reverse mutation test was performed to determine the mutagenic nature of the test substance. The study was performed using Salmonella typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 with and without S9 metabolic activation system. The test was performed as a preincubation assay at six different concentration with 10 mg/plate being the maximum concentration.Cells were pre-incubated with both the test chemical and S9-mix for 20 min. The number of revertant (His⁺) colonies was scored after 48 hours of incubation. The result was considered positive if the number of revertant colonies was found twice the number of the controls(exposed to the appropriate solvent or untreated). The test chemical did not induce a doubling of revertant colonies over the control using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 in the presence and absence of S9 metabolic activation system. Hence, Ethyl butyrate is considered as Non-mutagenic (negative)in vitro in the test system used under the certain experimental conditions.