6-methyloct-5-en-2-one

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:

supporting study

Study period:

21.07. - 25.08.1997

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Comparable to OECD 471, deviations: not in very strain 5 analysable concentrations available

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

not in very strain 5 analysable concentrations available

Principles of method if other than guideline:

No data

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

6-methyloct-5-en-2-one

EC Number:

246-073-4

EC Name:

6-methyloct-5-en-2-one

Cas Number:

24199-46-0

Molecular formula:

C9H16O

IUPAC Name:

6-methyloct-5-en-2-one

Details on test material:

- Name of test material (as cited in study report): Ro 02-8094/000; Ethylheptenone
- Physical state: liquid
- Analytical purity: 99.7%
- Lot/batch No.: LOT 25067
- Expiration date of the lot/batch: 31.Dec 2007

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA1535, TA97, TA98, TA100, TA102

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix

Test concentrations with justification for top dose:

standard plate incorporation assay: 50 to 5000 ug/plate,
preincubation assay: 25 to 2500 ug/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: and 2-Nitrofluorene, ICR 191, 2-Aminoanthracene

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA1535, TA97, TA98, TA100, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

2500 and 5000 mg/L, precipitating concentration

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Thus it can be concluded that neither Ethylheptenone per se, nor any of the
metabolites formed under the described experimental conditions used is mutagenic in the Ames test.

Executive summary:

Ethylheptenone was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a preincubation modification assay were performed in absence and in presence of an exogenous metabolic activation system

(S9). Five Salmonella typhimurium tester strains (TA1535, TA97, TA98, TA100, and

TA102) were employed. The activity of the S9-mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment.

Ethylheptenone was dissolved in DMSO. Toxic effects were observed in a preliminary toxicity experiment at 5000 ug/plate. Therefore the concentration range 50 to 5000 ug/plate, the generally recommended highest test concentration for non toxic

compounds, was evaluated in the standard plate incorporation assay and 25 to 2500 ug/plate in the preincubation assay. Some precipitation in the form of oily droplets were visible on the plates at the top concentrations.

No increase in the number of revertant colonies was apparent in any of the five tester strains after treatment with Ethylheptenone.

Thus it can be concluded that neither Ethylheptenone per se, nor any of the metabolites formed under the described experimental conditions used is mutagenic in the Ames test.