Vinyl laurate

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

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Vinyllaurat

IUPAC Name:

Vinyllaurat

Details on test material:

- Name of test material (as cited in study report): Vinyllaurat
- Physical state: colourless liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 959837
- Stability under test conditions: stable

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

Experiment : 25, 50, 250, 500, 2500 and 5000 µg/plate (all strains)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used:dimethyl sulfoxide
- Justification for choice of solvent/vehicle: the solvent was chosen becuase of its solubility properties.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

positive control for TA 98 without S9

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

positive control for TA 100 and TA 1535 without S9

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

positive control for TA 1537 without S9

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthrancene

Remarks:

positive control for all strains with S9 Mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION

- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants, bachground growth

Evaluation criteria:

in accordance with the Guideline

Statistics:

not mentioned in report

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1537

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:

S. typhimurium TA 1535

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 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium 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

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: practically not soluble
- Precipitation: Demixing at 5000 µg/plate was visible

RANGE-FINDING/SCREENING STUDIES: were performed to decide on the level

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):
negative

The test substance is not mutagenic in the Salmonella typhimurium Reverse Mutation Assay for tester strains TA 98, TA 100, TA 1535 and TA 1537 with and without activation.

Executive summary:

The bacterial reverse mutation assay (Ames Test) according to OECD 471 did not produce any positive results with the test substance Vinyl laurate in tester strains TA 98, TA 100, TA 1535 and TA 1537 both with and without metabolic activation up to concentrations of 5000 µg/l. Concentrations of 25, 50, 250, 500, 2500 and 5000 µg/plate were tested based on a dose range finding test. The substance was soluted in dimethyl sulphoxide and was administered via plate incorporation. No precipitation was seen whereas phase separation occured in the highest dose tested because of virtually insolubility of the test substance in water. Signs of toxicity were seen in the highest tested concentration of 500 µg/plate for tester strain TA 98 both with and without metabolic activation. The negative, solvent and positive controls worked as expected.