Tetrahydro-2-isobutyl-4-methyl-2H-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: Study according to current guideline, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-2-isobutyl-4-methyl-2H-pyran

EC Number:

236-770-1

EC Name:

Tetrahydro-2-isobutyl-4-methyl-2H-pyran

Cas Number:

13477-62-8

Molecular formula:

C10H20O

IUPAC Name:

4-methyl-2-(2-methylpropyl)oxane

Details on test material:

Name of the test substance used in the study report: Dihydrorosenoxid

Method

Target gene:

his and trp

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 mix

Test concentrations with justification for top dose:

4 µg - 5000 µg/plate (Standard Plate Test = SPT)
1 µg - 2500 µg/plate (Preincubation Test = PIT)

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Remarks:

+S9: 2-aminoanthracene; -S9: N-methyl-N'-nitro-.N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate, N-ethyl-N'-nitro-N-nitrosoguanidin

Details on test system and experimental conditions:

Standard Plate Test and Preincubation Test
METHOD OF APPLICATION: in agar (SPT); preincubation (PIT)

DURATION
- Preincubation period: 20 min (PIT)
- Exposure duration: 48h

DETERMINATION OF CYTOTOXICITY
- Method: reduced background growth, decrease in the number of his+ or trp+ revertants

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: Complete solubility of the test substance in DMSO.

ADDITIONAL INFORMATION ON CYTOTOXICITY: A bacteriotoxic effect was observed using the Salmonella strains at doses > 100 µg/plate (PIT) or from about 2500 µg/plate onward (SPT) and with E. coli WP2 uvrA at doses > 500 µg/plate (PIT) or at 5000 µg/plate (SPT)

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.