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EC number: 249-951-5 | CAS number: 29911-28-2
Groups of CD-1 (ICR) BR mice (5/sex/dose/sacrifice time) were administered single doses (by gavage) of 0, 250, 833, or 2500 mg DPnB/kg body weight. The positive control chemical was cyclophosphamide (120 mg/kg). The negative control chemical (i.e., the diluent for DPnB) was 1% methocel (10 ml/kg). Groups of animals were sacrificed by cervical dislocation at three time intervals: 24, 48, and 72 hours after treatment. Bone marrow was collected from the femur of each animal. Cells from the bone marrow were transferred to slides, fixed in methanol, and stained in 5% Giemsa. One thousand polychromatic erythrocytes were evaluated from each animal and the frequencies of micronucleated polychromatic erythrocytes were recorded.
There were no significant increases in the frequencies of micronucleated polychromatic erythrocytes (MN-PCE) in any of the groups treated with the test chemical compared to negative controls at any dose or time point. The positive control mice showed significant increases in MN-PCE.
In conclusion, under the experimental conditions used, the test chemical was negative in the mouse bone marrow micronucleus test.
Other metabolism studies show that DPnB reaches the bone marrow of mice. This in vivo assay confirms that that DPnB is not clastogenic to chromosomal material. This study was identified as key for this toxicity endpoint because of the methods followed (which were well documented in the report). The report included GLP and Quality Assurance statements, signed by the Study Director and Head of the QA Unit, respectively. The cell line used, test substance concentrations and dose spacing (4 dose levels including negative control, with highest being 2500 mg/kg), positive control agent used, the number of cells scored, and scoring criteria all followed or exceeded guidance as specified in OECD Guideline 475 "Mammalian Erythrocyte Micronucleus Test." The positive control agents gave the expected results showing that the animals were responsive to clastogenic insult.
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