Registration Dossier
Registration Dossier
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EC number: 209-980-6 | CAS number: 600-00-0
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
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
- 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
Constituent 1
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.
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