Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Detailed describtion of the conducted methods and obtained results

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Genotoxic and/or Epigenetic Effects of Some Glycol Ethers: Results of Different Short-Term Tests
Author:
Elias, Z. et al.
Year:
1996
Bibliographic source:
Occup. Hyg. 2, 187-212
Reference Type:
publication
Title:
The induction of micronuclei as a measure of genotoxicity. A report of the U.S. Environmental Protection Agency Gene-Tox Program.
Author:
Heddle et al.
Year:
1983
Bibliographic source:
Heddle, J. A., Hite, M., Kirkhart, B., Mavournin, K., MacGregor, J.T., Newell. G. W. and Salamone, M. F. (1983), Mutat. Res., 123, 61-118.
Reference Type:
publication
Title:
Guidelines for the conduct of micronucleus assay in mammalian bone marrow erythrocytes.
Author:
MacGregor et al.
Year:
1987
Bibliographic source:
MacGregor, J.T., Heddle, J.A., Hite, M., Margolin, B.H., Ramel, C., Salamone, M.F., Tice, R.R. and Wild, D. (1987), Mutat. Res., 189, 103-112.

Materials and methods

Principles of method if other than guideline:
as stated in the publication:
The·assay was conducted according to the recommended standards (Heddle et al. (1983)) and guidelines (MacGregor et al. (1987)).
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance as stated in the publication: ethylene glycol monoethyl ether;
purchased from Merck;
purity according to manufacturer > 99 %, analyzed purity 99.9 % with ~ 10 mg/L peroxide

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal

Results and discussion

Any other information on results incl. tables

No micronucleus induction in mouse PCE was observed at either non toxic or toxic doses of the test substance 2 -ethoxyethanol.

Concentration (mg/kg)         Micronucleated PCE (‰)        PCE/NCE ratio
   24 h  48 h  72 h  24 h  48 h  72 h
 1368  1.06 +/-0.23  --  --  2.50 +/-0.17  --  --
 1710  0.97 +/-0.24  --  --  2.25 +/-0.33  --  --
 2500  1.01 +/-0.22  --  --  1.28 +/-0.11  --  --
 3000  0.34 +/-0.22  --  --  1.41 +/-0.22  --  --
 Hanks'  1.50 +/-0.46  --  --  1.55 +/-0.15  --  --
 Cyclophosphamide 25 mg/kg  14.54 +/-3.81  --  --  1.40 +/-0.09  --  --

Micronucleated PCE (‰) were mean values +/- S.D. for 8 animals with ≥ 1000 PCE scored per animal. PCE/NCE data were mean values +/- S.D. for 8 animals with ≥ 2000 erythrocytes (PCE+NCE) scored per animal. At the highest dose administered (3000 mg/kg) two animals died, values represented are therefore mean +/- S.D. from 6 animals.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The intraperitoneally injection of the test substance 2-ethoxyethanol at different concentrations (single doses) in male and female CD-1 mice did not induce polychromatic erythrocytes in the bone marrow of the animals. The in vivo micronucleus assay was therefore negative.