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Diss Factsheets

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Qualifier:
according to guideline
Guideline:
other: ICH tripartite harmonised guideline on genotoxicity : specific aspects of regulatory tests
Qualifier:
according to guideline
Guideline:
other: Japonese MHW
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS-42193 Mammalian Erythrocyte Micronucleus Test
GLP compliance:
yes (incl. QA statement)
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 2-bromo-2-methylpropionate
EC Number:
209-980-6
EC Name:
Ethyl 2-bromo-2-methylpropionate
Cas Number:
600-00-0
Molecular formula:
C6H11BrO2
IUPAC Name:
ethyl 2-bromo-2-methylpropionate

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil
Duration of treatment / exposure:
Once daily
Frequency of treatment:
Two consecutive days
Post exposure period:
2 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
500, 750, 900, 1000, 2000 mg/kg
Basis:
nominal conc.
Range-finder experiment
Remarks:
Doses / Concentrations:
225, 450, 900 mg/kg : males ; 500, 1000, 2000 mg/kg : femals
Basis:
nominal conc.
main study experiment 1
Remarks:
Doses / Concentrations:
450 mg/kg
Basis:
nominal conc.
main study experiment 2
No. of animals per sex per dose:
3 males / 3 females per dose : range-finder experiment
6 males / 6 femals per dose : main study experiment 1
7 males : main study experiment 2
Control animals:
yes
Positive control(s):
Cyclophosphamide (CPA) used as positive control

Examinations

Tissues and cell types examined:
Polychromatic / normochromatic erythrocytes

Results and discussion

Test resultsopen allclose all
Sex:
male/female
Genotoxicity:
positive
Remarks:
450 & 900 mg/kg/day
Toxicity:
no effects
Vehicle controls validity:
not valid
Negative controls validity:
valid
Positive controls validity:
valid
Sex:
male
Genotoxicity:
positive
Remarks:
450 mg/kg/day
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
It is concluded that Ethyl 2-bromoisobutyrate induced micronuclei in the polychromatic erythrocytes of the bone marrow of mice.