Registration Dossier
Registration Dossier
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EC number: 203-804-1 | CAS number: 110-80-5
Genetic toxicity: in vivo
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:
- 1 996
- 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:
- 1 983
- 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:
- 1 987
- 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 substance name:
- 2-ethoxyethanol
- EC Number:
- 203-804-1
- EC Name:
- 2-ethoxyethanol
- Cas Number:
- 110-80-5
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-ethoxyethan-1-ol
- 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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
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.
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