Ethyl 2-ethylhexanoate

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:

key study

Study period:

from 17th of September to 29th of October, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted May 26, 1983

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-ethylhexanoate

EC Number:

221-043-3

EC Name:

Ethyl 2-ethylhexanoate

Cas Number:

2983-37-1

Molecular formula:

C10H20O2

IUPAC Name:

ethyl 2-ethylhexanoate

Details on test material:

- Name of test material (as cited in study report): Ethyl 2-ethylhexanoate
- Physical state: liquid
- Analytical purity: no data

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Additional strain / cell type characteristics:

other: rfa-, uvrB-

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 mix

Test concentrations with justification for top dose:

1st experiment: 8, 40, 200, 1000 and 5000 pg/plate
2nd experiment: 12.5, 25, 50, 100 and 200 pg/plate - without S9-mix / 62.5, 125, 250, 500 and 1000 pg/plate - with S9-mix

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, with metabolic activation

Controls 2

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylendiamine, without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: n.a.
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: reduced background lawn

Evaluation criteria:

A combination of the following criteria was considered as a positive result:
- The plate background of non-converted bacteria did not show any growth reduction versus the respective negative controls.
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range.
- As a rule, the positive controls showed mutation rates exceeding the control values of TA 100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.0.
- At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA 100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no

ADDITIONAL INFORMATION ON CYTOTOXICITY: cytotoxic at 1000 µg/plate and above with and without metabolic activation

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

2-Ethyl ethyl capronate is considered not to be mutagenic in this reverse gene mutation assay in bacteria.

Executive summary:

In a reverse gene mutation assay in bacteria according to OECD Guideline 471 (adopted May 26, 1983), strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of S. typhimurium  were exposed to 2-Ethyl ethyl capronate in DMSO using the plate incorporation methodat the following concentrations:

1st experiment: 8, 40, 200, 1000 and 5000 pg/plate with and without metabolic activation

2nd experiment:

12.5, 25, 50, 100 and 200 pg/plate - without metabolic activation

62.5, 125, 250, 500 and 1000 pg/plate - with metabolic activation

The substance was tested up to cytotoxic concentrations.The positive controls induced the appropriate responses in the corresponding strains.  

There was no evidence of induced mutant colonies over background. 2-Ethyl ethyl capronate was not mutagenic in this reverse gene mutation assay in bacteria.