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EC number: 203-940-1 | CAS number: 112-15-2
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:
- supporting study
- Study period:
- 31 Jul 1989 - 31 May 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- limited details on test material
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethanol, 2- (2-Ethoxyethoxy)-, acetate
- Analytical purity: no data
- Other: in the report it is also stated, that a combination aerosol was tested, whoever the combination is not named as the study report is sanitized.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: the animals were housed continously in groups of 2-5 animals in Hazelton H-1000 exposure chambers.
- Diet: was removed during exposure
- Water: was removed during exposure
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- - Vehicle(s)/solvent(s) used: air
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazelton H-1000 exposure chamber
- Method of holding animals in test chamber: whole body exposure
- System of generating aerosols: Laskin nebulizers in each chamber were immersed in water bath at approximately 180 °F (82.2 °C) during each exposure to simulate the temperature under normal conditions of use. The output of the nebulizer went through a glass impactor to remove the larger particles before being diluted by the main air stream entering the exposure chamber.
- Temperature, humidity, pressure in air chamber: recorded every 30 min during exposure; 24.6 °C (mean), 66.5% (mean)
- Air change rate: 12
- Method of particle size determination: at least once daily with a cascade impactor. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.05, 0.15 and 0.5 mg/L
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
50, 150 and 500 mg/m³
Basis:
nominal conc.
- No. of animals per sex per dose:
- 15 (core groups)
10 (additional ancilliary males in each group for specialized endpoints) - Control animals:
- yes, concurrent no treatment
- yes, sham-exposed
Examinations
- Tissues and cell types examined:
- Bone marrow, erythrocytes
- Statistics:
- ANOVA, GLM nodel, SAS, Tukey´s Studentized Range Test, SCheffe´s Test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
Any other information on results incl. tables
Table 1. Result of assay as averaged data.
Treatment |
Sex |
N |
PCE/NCE |
% MNPCE |
%MNN-CE |
Negative control (sham-exposed) |
F |
5 |
0.92(0.37) |
0.04(0.09) |
0(0) |
M |
5 |
0.52(0.11) |
0.02(0.04) |
0(0) |
|
Negative control (not-treated) |
F |
5 |
0.74 (0.23) |
0(0) |
0(0) |
M |
5 |
0.59(0.21) |
0(0) |
0(0) |
|
0.05 |
F |
5 |
0.81(0.29) |
0.04(0.05) |
0(0) |
M |
5 |
0.62(0.24) |
0(0) |
0(0) |
|
0.15
|
F |
5 |
1.17(0.49) |
0(0) |
0(0) |
M |
5 |
0.63(0.24) |
0.02(0.04) |
0(0) |
|
0.5
|
F |
5 |
0.82(0.30) |
0.06(0.09) |
0(0) |
M |
5 |
0.57(0.12) |
0.02(0.04) |
0(0) |
(): SD
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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