Registration Dossier
Registration Dossier
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EC number: 257-158-0 | CAS number: 51368-55-9
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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Isopropyl 2-bromo-2-methylpropionate
- EC Number:
- 257-158-0
- EC Name:
- Isopropyl 2-bromo-2-methylpropionate
- Cas Number:
- 51368-55-9
- Molecular formula:
- C7H13BrO2
- IUPAC Name:
- isopropyl 2-bromo-2-methylpropionate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Duration of treatment / exposure:
- Single administration of the substance
- Frequency of treatment:
- Single administration of the substance
- Post exposure period:
- 2 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500, 750, 1000, 1250, 1500, 1750, 2000 mg/kg
Basis:
nominal in diet
Range-finder experiment
- Remarks:
- Doses / Concentrations:
125, 250, 500 mg/kg
Basis:
nominal in diet
Main study experiment
- No. of animals per sex per dose:
- 64 male/female
- Control animals:
- yes
- Positive control(s):
- Mitomycin (MMC) and Cyclophosphamide (CPA) used as positive control for the spermatogonial and micronucleus assays respectively.
Examinations
- Tissues and cell types examined:
- Spermatogonial cells
Polychromatic / normochromatic erythrocytes
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- 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 Isopropyl 2-bromoisobutyrate induced chromosome aberrations in the spermatogonial cells and micronuclei in the bone marrow erythrocytes of B6C3F1 mice after oral administration.
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