2-(2-ethoxyethoxy)ethyl acetate

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:

1991

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

Test material information

Constituent 1

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.

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 / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.05, 0.15 and 0.5 mg/L
Basis:
nominal conc.

Doses / concentrations 2

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