11-oxahexadecan-16-olide

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:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

11-oxahexadecan-16-olide

EC Number:

222-225-5

EC Name:

11-oxahexadecan-16-olide

Cas Number:

3391-83-1

Molecular formula:

C15H28O3

IUPAC Name:

1,7-dioxacycloheptadecan-8-one

Test material form:

liquid

Specific details on test material used for the study:

Musk R1, T-02437, No. 148983

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

CELLS USED
- Source of cells: Dr Bruce Ames
- Suitability of cells: Yes

MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
- Properly maintained:: yes

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

CELLS USED
- Source of cells: Dr Bruce Ames
- Suitability of cells: Yes

MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
- Properly maintained:: yes

Additional strain / cell type characteristics:

not applicable

Cytokinesis block (if used):

NA

Metabolic activation:

with and without

Metabolic activation system:

Single ip injection of 500 mg Aroclor

Test concentrations with justification for top dose:

Bactericidal affect at the higher test concentrations.
Test concentrations 5 - 25 mg/plate.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

methylmethanesulfonate

other: Hycanthone Methanesulfonate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation);

DURATION
- Exposure duration: 3 days treatment

NUMBER OF REPLICATIONS: 3 per concentration


DETERMINATION OF CYTOTOXICITY
- Background lawn on the agar plates.

Rationale for test conditions:

Standard conditions for the OECD 471 guidance.

Evaluation criteria:

Not required as the number of revertants for each tester strain were comparable between the solvent control at all concentrations.

Statistics:

Not required.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

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:

S. typhimurium TA 1537

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 3

Key result

Species / strain:

S. typhimurium TA 98

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 4

Key result

Species / strain:

S. typhimurium 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 5

Key result

Species / strain:

S. typhimurium TA 1538

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

Applicant's summary and conclusion

Conclusions:

Incorporation of Musk R1 up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or absence of the liver microsome activation system.

Executive summary:

Negative in TA1535, TA1537, TA98, TA100 and TA1538 in the absence and presence of S9-mix.