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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study in Chinese (brief english summary incl. several tables)

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of Methyl Tertiary-Butyl Ether, Anhydrous Ethanol and Dimethyl Carbonate
Author:
Song C, Gao X, Cheng C, Liu K, Zhou L & Zhao C (2004)
Year:
2004
Bibliographic source:
J Tianjin University 37, 678 - 681

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Chemical structure
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
Test material form:
other: liquid
Details on test material:
not further specified

Test animals

Species:
mouse
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Weight at study initiation: 25-30 g

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 18-22
-Humidity (%): 43-70

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not further specified
Details on exposure:
not further specified
Duration of treatment / exposure:
not further specified
Frequency of treatment:
single oral dosing
Post exposure period:
not further specified
Doses / concentrations
Remarks:
Doses / Concentrations: 0, 0.99, 1.99 or 3.97 g/kg bw
No. of animals per sex per dose:
5 m
Control animals:
yes
Positive control(s):
yes

Examinations

Tissues and cell types examined:
500 metaphases per group
Details of tissue and slide preparation:
not further specified
Evaluation criteria:
according to Guideline
Statistics:
yes

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In this in vivo cytogenetic test for detection of chromosome aberrations in spermatogonial mitoses, 5 male mice were dosed once orally with 0, 0.99, 1.99 or 3.97 g/kg bw of dimethyl carbonate. The results of this study gave no indications for an increase in chromosome aberrations.
Executive summary:

In this in vivo cytogenetic test for detection of chromosome aberrations in spermatogonial mitoses, 5 male mice were dosed once orally with 0, 0.99, 1.99 or 3.97 g/kg bw of dimethyl carbonate. The results of this study gave no indications for an increase in chromosome aberrations.