Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran

EC Number:

240-457-5

EC Name:

Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran

Cas Number:

16409-43-1

Molecular formula:

C10H18O

IUPAC Name:

tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran

Method

Target gene:

his

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 97a, TA 98, TA 100, and TA 102

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital and beta-naphtoflavone induced rat liver S9 mix

Test concentrations with justification for top dose:

Two independent studies were conducted.
Test material concentrations were 0.016, 0.05, 0.16, 0.5, and 1.6 mg/plate in strains TA97a, TA100, and TA1535 with and without S9 and TA98 and TA102 without S9 in the first study. Test material concentrations were 0.05, 0.16, 0.5, 1.6 and 5.0 mg/plate in strains TA98 and TA102 with S9 in the second study.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (TA98, TA100, TA97a, and TA1535), and danthron (TA102)

Remarks:

with metabolic activation

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: ICR 191 (TA97a), 4-nitro-o-phenylendiamine (TA98), nitrofurantoine (TA100), sodium azide (TA1535), and cumene hydroperoxide (TA102)

Remarks:

without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Expression time (cells in growth medium): 48 hours

NUMBER OF REPLICATIONS: triplicates tested


DETERMINATION OF CYTOTOXICITY
- Method: background lawn

Evaluation criteria:

Mutagenic if there is a concentration effect relationship and the induction rate is >= 2.

Statistics:

Arithmetic mean values and standard deviations were calculated from colonies per plate of three replicates.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 97a, TA 98, TA 100, and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

The test material was cytotoxic at 1.6 mg/plate with and without S9 in strains TA97a, TA100 and TA1535. The test material was cytotoxic at 1.6 mg/plate without S9 and at 5.0 mg/plate with S9 in strains TA98 and TA102.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.