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:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented publication which meets basic scientific principles. No data on replicates. No data on necropsy, slide preparation or clinical observations.

Data source

Reference

Reference Type:

publication

Title:

Aneuploidy inducing chemicals in yeast evaluated by the micronucleus test.

Author:

Basler, A.

Year:

1986

Bibliographic source:

Mutat. Res. 174: 11 - 13

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

Remarks:

, no significant deviations based on the information available

Principles of method if other than guideline:

Method: other: Micronucleus Test according to Schmid (Mut Res, 31, 9-15, 1975).

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

141-76-8

IUPAC Name:

141-76-8

Constituent 2

Reference substance name:

Ethyl acetate

EC Number:

205-500-4

EC Name:

Ethyl acetate

Cas Number:

141-78-6

Molecular formula:

C4H8O2

IUPAC Name:

ethyl acetate

Details on test material:

- Name of test material (as cited in study report): ethyl acetate in corn oil.
- Supplier: Merck.

Test animals

Species:

hamster, Chinese

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10-15 weeks old

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: Corn oil

Duration of treatment / exposure:

Single dose.

Frequency of treatment:

Single dose.

Doses / concentrations

Dose / conc.:

2 500 mg/kg bw/day (actual dose received)

Remarks:

Dose approximately 66% of LD50.

No. of animals per sex per dose:

10 animals/time point group

Control animals:

yes

Positive control(s):

vandesine administered by i.p.

Examinations

Tissues and cell types examined:

The number of micronucleated erythrocytes was counted, scoring 1000 polychromatic erythrocytes per animal.

Details of tissue and slide preparation:

no data

Evaluation criteria:

non data

Statistics:

The differences between the frequencies of erythrocytes with micronuclei in each treated group and the controls were statistically estimated according to Kastenbaum and Bowman with a significance level of p<0.05.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No increase in the number of micronuclei in bone marrow polychromatic erythrocytes at any time relative to negative control. Positive control validated test system.

Any other information on results incl. tables

MICRONUCLEI IN POLYCHROMATIC ERYTHROCYTES IN BONE MARROW CELLS OF CHINESE HAMSTERS

	Dose mg/kg	Time of Preparation	Number of Animals	PCE with micronuclei (%)
Ethyl Acetate p.o.	2500.0	12	10	1.30
		24	10	0.90
		48	10	0.60
		72	10	1.30

PE, polychromatic erythrocytes; *p<0.05; + cytotoxic, bone marrow without PE.

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Ethyl acetate was negative in the hamster micronucleus assay (oral).

Executive summary:

Ethyl acetate did not induce increased frequency of micronucleated polychromatic erythrocytes in the bone marrow of hamsters treated with a single oral dose of 2500 mg/kg, approximately 2/3rds of the LD50 by this route.