Dimethyl carbonate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl carbonate

EC Number:

210-478-4

EC Name:

Dimethyl carbonate

Cas Number:

616-38-6

Molecular formula:

C3H6O3

IUPAC Name:

dimethyl carbonate

Details on test material:

- Name of test material (as cited in study report): Dimethyl carbonate
- Physical state: Colorless transparent liquid
- Analytical purity: 99.99
- Impurities (identity and concentrations): < 0.1%
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 80413
- Expiration date of the lot/batch: not stated
- Stability under test conditions:
- Storage condition of test material: room temperature and shielded from the light
- Other:

Method

Species / strain

Species / strain 1

Species / strain / cell type:

E. coli WP2 uvr A

Species / strain 2

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9(see "any other information" section below)

Test concentrations with justification for top dose:

Using the results of a preliminary test the maximum dose of the main test in all bacterial strains in both the presence and the absence of metabolic activation was set at 5000 µg/plate. For the main test in both the presence and absence of S9 mix the test concentrationsof DMC were (in µg/plate); 313, 625, 1250, 2500 and 5000.

Vehicle / solvent:

Vehicle(s)/solvent(s) used: DMSO - chosen because it was a good solvent for DMC (solubility and stability)

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Controls 2

Positive control substance:

sodium azide

Controls 3

Positive control substance:

9-aminoacridine

Controls 4

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Controls 5

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk


DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells):

Evaluation criteria:

The test substance was judged positive for mutagenic activity when:
There was a dose related increase in the number of revertant colonies and;
There was a more than two-fold increase in the number of revertant colonies by comparison with the negative control

Statistics:

No statistics used

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

- Evaporation from medium: because DMC has a low boiling point (and high vapour pressure) pre-incubation and incubation phases took place in sealed vessels

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance did not increase the number of the revertant colonies two-fold or more compared with the negative control in any bacterial strains regardless of the presence or the absence of metabolic activation. On the other hand, each of the positive control increased the number of the revertant colonies two-fold or more compared with the negative control in all bacterial strains, respectively. These results indicate that the test has been properly carried out. It is concluded from the foregoing results that the mutagenic activity of the test substance is negative under the test conditions used.

Tabulated results are in the attachment "Pages from AMES DMC (English translation)"

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation

Dimethyl carbonate is not mutagenic under the test conditons employed.