Registration Dossier
Registration Dossier
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EC number: 430-820-8 | CAS number: 114341-88-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V B12
- GLP compliance:
- yes
- Type of assay:
- other: in vivo mammalian bone marrow cytogenetic test
Test animals
- Species:
- other: CD-1 mice
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Mazola corn oil
- No. of animals per sex per dose:
- Male: 320 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 320 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 160 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 80 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Results and discussion
- Additional information on results:
- Observations:
No statistically or biologically significant increases in
the incidence of micronucleated polychromatic erythrocytes,
over the vehicle control values, were seen at any dose level
or sampling times investigated.
Comparison of the percentage of polychromatic erythrocytes
showed no statistically or biologically important
differences at either of the sampling times between the
vehicle control animals and those treated with BPOX.
The test system positive control, cyclophosphamide, induced
statistically significant and biologically meaningful
increases in micronucleated polychromatic erythrocytes,
compared to the vehicle control values, thus demonstrating
the sensitivity of the test system to a known clastogen.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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