Carbonic acid, ethyl methyl ester

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no official guideline method, GLP without certificate, good documentation, identity of substance clear and with details on its purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Principles of method if other than guideline:

guideline that is proposed by the JMHW (Japanese Ministry of Health and Welfare) and JMOL

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-480-9

EC Name:

-

Cas Number:

623-53-0

Molecular formula:

C4H8O3

IUPAC Name:

ethyl methyl carbonate

Details on test material:

Test material as stated in study report ("Name"): Ethylmethyl carbonate
Purity: 99.8 %
Molecular weight: 104
Melting point: -14.5 °C
Boiling point: 109.2 °C
Appearance at ambient temperature: colorless and transparent liquid
Stability: stable at normal temperature
Solubility: soluble in dimethylsulfoxide and acetone more than 5 wt%
Lot No.: MEC-27452

Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 1537

Species / strain 5

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Solvent control, 10, 50, 100, 500, 1000, 5000 µg per plate

Vehicle / solvent:

The test substance was dissolved in dimethylsulfoxide.

Controls

Untreated negative controls:

yes

Remarks:

Dimethylsulfoxide (= solvent control)

Positive controls:

yes

Positive control substance:

furylfuramide

Remarks:

Migrated to IUCLID6: and: sodium azide, 9-Aminoacridine, Benzo[a]-pyrene, 2-Aminoanthracene

Details on test system and experimental conditions:

The following procedure was carried out with each bacterial strain:
A portion (0.1 mL) of the test substance was placed in a glass tube. Then 0.1 mL of the subculture, and 0.5 mL of S9 mix or 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) was added to the test substance and incubated at 37 °C for 20 minutes with shaking. The suspension was then thoroughly mixed with 2.0 mL of the top agar and overlaid onto the minimum glucose agar plate. After 48 hours' incubation at 37 °C, revertant colonies were counted. Negative and positive controls were simultaneously studied. Preliminary reverse mutation test and reverse mutation test were conducted in duplicate. Toxicity of the test substance was observed with a stereoscopic microscope.

Results and discussion

Test results

Test results 1

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

valid

Test results 2

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

Positive controls validity:

valid

Additional information on results:

With the test substance, increase in the number of revertant colonies was not observed in any bacterial strain used. The number of revertant colonies in positive controls increased markedly as compared with the negative control. This result indicated that this test was carried out properly. The environmental factor that might influence reliability of this test was not detected.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
other: negative mutagenic potential of the test substance

It is concluded from the foregoing results that the test substance is considered as negative for mutagenic potential under the test conditions employed (bacteria mutagenicity).