2-(tetrahydro-5-methyl-5-vinyl-2-furyl)propan-2-ol

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:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted according to OECD Guidelines, with no or minor deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(tetrahydro-5-methyl-5-vinyl-2-furyl)propan-2-ol

EC Number:

262-038-6

EC Name:

2-(tetrahydro-5-methyl-5-vinyl-2-furyl)propan-2-ol

Cas Number:

60047-17-8

Molecular formula:

C10H18O2

IUPAC Name:

2-(5-methyl-5-vinyltetrahydrofuran-2-yl)propan-2-ol

Test material form:

other: liquid

Details on test material:

Batch 9000504271
Purity 97.1%
Expiry date February 13, 2005

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

33; 100; 133; 1000; 2500 and 5000 micrograms/plate

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA1535, TA100 without metabolic activation

Controls 2

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylene-diamine

Remarks:

TA1537, TA98 without metabolic activation

Controls 3

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

TA100 without metabolic activation

Controls 4

Untreated negative controls:

yes

Remarks:

Concurrent untreated and solvent controls were performed

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

TA1535, TA1537, TA98, TA100 and TA102 with metabolic activation

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:

cytotoxicity

Remarks:

Slight toxic effect

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Slight toxic effect, evident as a reduction in the number of revertants, were observed in experiment I (TA1537 at 1000 micrograms/plate with S9 mix) and in experiment II (TA102 at 5000 micrograms/plate with and without S9 mix).

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

In conclusion it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair of changes or frameshifts in the genome of the strains used.
Therefore, LINALOOL OXIDE is considered to be non-mutagenic in this Salmonella Typhimurium reverse mutation assay.