Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 November 1992 to 12 November 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate

EC Number:

412-540-8

EC Name:

Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate

Cas Number:

22471-55-2

Molecular formula:

C12 H22 O2

IUPAC Name:

ethyl trans-2,2,6-trimethylcyclohexanecarboxylate

Constituent 2

Reference substance name:

Ethyl cis-2,2,6-trimethylcyclohexane-1-carboxylate

Molecular formula:

C12H22O2

IUPAC Name:

Ethyl cis-2,2,6-trimethylcyclohexane-1-carboxylate

impurity 1

Reference substance name:

Unidentified impurities

Molecular formula:

Not specified.

IUPAC Name:

Unidentified impurities

Test material form:

liquid: viscous

Details on test material:

Sample name: ET-344 SP

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Preliminary test +/- S9 mix: 5 / 20 / 78 / 313 / 1250 / 5000 ug/ plateMutation test - S9 mix: 5 / 10 / 20 / 39 / 78 / 156 / 313 ug/ plate + S9 mix: 10 / 20 / 39 / 78 / 156 / 313 ug/ plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-aminoanthracene

Details on test system and experimental conditions:

Bacterial Strains :Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Esherichia coli WP2 uvrA were obtained from Institute for Fermentation,JAPAN.Cultures of each strain were prepared by incubating an aliquot of parent stock culture in nutrient broth a t 37°C for 18 hours. Test Procedures: (Pre-incubation Method)After mixing 0.1mL of test material solution, 0.5mL of phosphate buffer or S9 Mix and 0.1 mL of culture of tester strain in a test tube, the mixture was incubated a t 37°C for 20 minutes.Then 2 mL of top agar was added in the test tube, the mixture of each tube was poured on minimal agar plate. The plates were incubated at 37 °C for 2 days and scored for revertants.The test was performed in tripilcate at each concentration.

Statistics:

No

Results and discussion

Test results

Test results 1

Key result

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

In case of no growth inhibition, there was no significant difference in the number of the colonies between the test compound dosages and the solvent control with any of the bacteria used here.

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

The test results indicated that the compound is not mutagenic under the test system used (with and without metabolic activation).

Executive summary:

According to OECD TG 471, the mutagenic activity of Ethyl 2,2,6-trimethylcyclohexanecarboxylate provided by TAKASAGO International Corporation was tested by the in vitro direct and metabolic activation assays using Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Esherichia coli WP2 uvrA.

The Pre-incubation Method was followed.

Vehicule and positive control were included in the study.

The concentrations of test item were as follows:

Preliminary test

+/- S9 mix: 5 / 20 / 78 / 313 / 1250 / 5000 ug/ plate

Mutation test

- S9 mix: 5 / 10 / 20 / 39 / 78 / 156 / 313 ug/ plate

+ S9 mix: 10 / 20 / 39 / 78 / 156 / 313 ug/ plate

The test was performed in tripilcate at each concentration.

In case of no growth inhibition, there was no significant difference in the number of the colonies between the test compound dosages and the solvent control with any of the bacteria used here.

The test results indicated that the compound is not mutagenic under the test system used.

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