2-ethylcyclopentane-1,3-dione

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylcyclopentane-1,3-dione

EC Number:

212-512-3

EC Name:

2-ethylcyclopentane-1,3-dione

Cas Number:

823-36-9

Molecular formula:

C7H10O2

IUPAC Name:

2-ethylcyclopentane-1,3-dione

Test material form:

solid: crystalline

Details on test material:

Test item: Ethyl-cyclopentanedioneCAS number: 823-36-9Batch number: S41196NPhysical state: Solid, crystalline substanceColuor: Almost whiteActive ingredient content (Calculated): 93.7%Storage: At a temperature of 15 to 30 °C

Method

Target gene:

S. typhimurium TA98: hisD3052; TA100: hisG46; TA1535: hisG46; TA1537: hisC3076E. coli WP2 uvr A: trpE

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:

The following concentrations of the test item were prepared and used in the Initial and Confirmatory Mutation Tests: 5000, 1581, 500, 158, 50 and 15.8 μg/plate.

Vehicle / solvent:

Dimethyl sulfoxide (DMSO)Ultrapure water (UPW)

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO, UPW

Controls 2

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

other: 4-nitro-1,2-phenylenediamine

Remarks:

Dose: 4 µg/plate; Vehicle: DMSO ; Strain: Salmonella TA98

Controls 3

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

sodium azide

Remarks:

Dose: 2 µg/plate; Vehicle: UPW ; Strain: Salmonella TA100 and TA1535

Controls 4

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

9-aminoacridine

Remarks:

Dose: 50 µg/plate; Vehicle: DMSO ; Strain: Salomella TA1537

Controls 5

Positive controls:

yes

Remarks:

without metabolic activation

Positive control substance:

methylmethanesulfonate

Remarks:

Dose: 2 µL/plate; Vehicle: UPW ; Strain: E. coli WP2 uvrA

Controls 6

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-aminoanthracene

Remarks:

Dose: 2 µg/plate; Vehicle: DMSO ; Strain: all of Salmonella strains

Controls 7

Positive controls:

yes

Remarks:

with metabolic activation

Positive control substance:

other: 2-aminoanthracene

Remarks:

Dose: 50 µg/plate; Vehicle: DMSO ; Strain: E. coli strain

Details on test system and experimental conditions:

The study included a Preliminary Solubility Test, a Preliminary Range Finding Test (Informatory Toxicity Test) an Initial Mutation Test (Plate Incorporation Test) and a Confirmatory Mutation Test (Pre-Incubation Test).In the preliminary Range Finding Test as well as in the Initial Mutation Test the plate incorporation method was used.

Evaluation criteria:

A test item is considered mutagenic if:- a dose–related increase in the number of revertants occurs and/or;- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.An increase is considered biologically relevant if:- in strain Salmonella typhimurium TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control;- in strain TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.

Results and discussion

Test results

Test results 1

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The highest revertant colony number increase over the spontaneous rate of the vehicle control plates was observed in the Initial Mutation Test (Plate Incorporation Test) in Salmonella typhimurium TA1535 at 15.8 μg/plate, without metabolic activation (-S9 Mix). The mutation rate was: 2.05. This value remained far below the genotoxicological threshold for being positive.

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):negativeIn conclusion, the test item Ethyl-cyclopentanedione (CAS 823-36-9) has no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.