Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study in Chinese (brief english summary incl. different 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:
OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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
Basis:

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
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
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.