2-methoxy-2-methylheptane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 5,20 17 - February 9,20 17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2017

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:

2-methoxy-2-methylheptane

EC Number:

816-311-7

Cas Number:

76589-16-7

Molecular formula:

C9H20O

IUPAC Name:

2-methoxy-2-methylheptane

Test material form:

liquid

Specific details on test material used for the study:

Name: 2-Methoxy-2-methylheptane
CAS NO.: 76589-16-7
Appearance: Colorless liquid
Storage condition: Stable at room temperature

Method

Target gene:

histidine

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 9.77, 19.5, 39.1, 78.1, 156, 313 µg/plate

Vehicle / solvent:

Dimethylsulfoxide (DMSO)

Controls

Untreated negative controls:

yes

Remarks:

vehicle

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-Aminoanthracene, 2-(2-Furyl)-3 -(5-nitro-2-furyl)acrylamide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar
- Cell density at seeding: 0.1 mL

DURATION
- Preincubation period: 48 h

Evaluation criteria:

When the test substance induces a dose-dependent increase in the number of revertant colonies to at least twice as many as that of the negative control and the increase is reproducible, the test substance is judged positive in this test system.

Statistics:

None

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

not specified

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

See attachment.
Cytotoxicity to bacteria by the test substance was observed at and above dose levels of 313 pg/plate in TA100, TA1535, WP2uvrA, TA98 and TA1537 strains with or without metabolic activation in the dose-determination test. In the mutagenicity test 1 and the mutagenicity test 2, cytotoxicity to bacteria by the test substance was observed at and above dose levels of 156 &plate in TA100, TA1535, TA98 and TA1537 strains without metabolic activation, and at 313 pglplate in WP2uvrA strain without metabolic activation, and in TA100, TA1535, WP2uvrA, TA98 and TA1537 strains with metabolic activation.
Precipitation of the test substance was not observed at any dose levels with or without metabolic activation in the dose-determination test, the mutagenicity test 1 and the mutagenicity test 2.

Applicant's summary and conclusion

Conclusions:

Throughout the tests, the test substance did not induce any increases in the number of revertant colonies to at least twice as many as that of the negative control for any of the bacterial strains at any dose levels either with or without metabolic activation; therefore, the test substance was concluded to be non-mutagenic under the conditions of this test.