Oxacycloheptadec-10-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:

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 journal

Data source

Reference

Reference Type:

publication

Title:

Fragrance material review on test chemical

Author:

D. McGinty

Year:

2011

Bibliographic source:

Food and Chemical Toxicology

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Bacterial gene mutation test was performed to evaluate the mutagenic potential of test substance using both plate incorporation and preincubation protocols.

GLP compliance:

no

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Oxacycloheptadec-10-en-2-one

EC Number:

249-120-7

EC Name:

Oxacycloheptadec-10-en-2-one

Cas Number:

28645-51-4

Molecular formula:

C16H28O2

IUPAC Name:

oxacycloheptadec-10-en-2-one

Test material form:

not specified

Details on test material:

- Name of test material: Oxacycloheptadec-10-ene-2- one
- Molecular formula: C16H28O2
- Molecular weight: 252.395 gram/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9

Test concentrations with justification for top dose:

33, 100, 1000, 2500, or 5000 µg/plate

Vehicle / solvent:

Ethanol

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: Plate incorporation and preincubation protocols

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- 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: No data available

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

Rationale for test conditions:

No data

Evaluation criteria:

Increase in revertants/plate was observed

Statistics:

No data available

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

No data available

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

Test substance did not produce reverse mutation up to 5000 µg/plate in Salmonella typhimurium tester strains of TA 1535, TA 1537, TA 98, TA 100 and TA 102 both with and without metabolic activation.

Executive summary:

Bacterial reverse mutation assaywas performed to evaluate the mutagenic potential of test chemicalin Salmonella typhimurium tester strains of TA 1535, TA 1537, TA 98, TA 100 and TA 102. The assay was performed employing both plate incorporation and preincubation protocols.The test chemical was dissolved in ethanol and tested in concentrations of 33, 100, 1000, 2500, or 5000 µg/plate with and without rat liver microsomal activation (S9 mix). No substantial increase in number of mutant colonies compared to vehicle control was observed up to the concentration of 5000µg/plate. Hence,the test chemicalwas regarded non-mutagenic (negative) in bacterial reverse mutation assay under the experimental conditions described.