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Toxicological information

Genetic toxicity: in vivo

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.