tert-butyl methyl ether

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 compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl methyl ether

EC Number:

216-653-1

EC Name:

tert-butyl methyl ether

Cas Number:

1634-04-4

Molecular formula:

C5H12O

IUPAC Name:

2-methoxy-2-methylpropane

Details on test material:

- Name of test material (as cited in study report): DRIVERON, MTBE
- Analytical purity: 99.0%
- Lot/batch No.: 3630/81297

Method

Target gene:

his

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

liver S9 fraction from rats

Test concentrations with justification for top dose:

8, 40, 200, 1000 and 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Migrated to IUCLID6: and sodium azide and aminoacridin

Details on test system and experimental conditions:

METHOD OF APPLICATION:
plate incorporation and preincubation assay; samples were tested in triplicate

DURATION:
- Preincubation period: 30 minutes at 30 oC
- Exposure duration: 96 hours at 37 oC

Evaluation criteria:

As specified in EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Statistics:

After completion of scoring, mean of revertant colonies and standard deviation for each dose are determined.

Results and discussion

Test results

Species / strain:

other: TA98, TA100, TA1535, TA1537, TA1538

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.