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EC number: 931-384-6 | CAS number: -
The reported historical background frequency of micronucleated cells in the Crl:CD-1(ICR) BR strain at the test laboratory was about 0.0-0.4%, which was stated to be within the range reported in the published data.
The temperature range of the animal housing was reported as 64–79ºF, equivalent to 17.8–26.1ºC. Recommended animal housing conditions were not included in the June 1996 draft EPA guideline, but the final 1998 guideline (and OECD TG 474) recommends maintaining temperatures within the range of 19–25ºC.
The test substance was evaluated for clastogenic potential in a mouse micronucleus test. The GLP study was conducted in accordance with US EPA OPPTS and OECD guidelines. The test substance, in white oil vehicle, was administered by intraperitoneal injection. In the initial dose-range-finding study, doses of 250, 500, 1000 and 2000 mg/kg/day were adminstered to groups of male and female Crl:CD-1(ICR) BR mice causing extensive mortality in the higher dose groups. As there was no indication of sex-dependent effects, doses of 62.5, 125 and 250 mg/kg/day were administered to groups of six males in the main micronucleus study (with two additional males dosed at 250 mg/kg/day in case of mortality in this group). The animals were dosed for three days. 24 hours after the third dose, animals were sacrificed, bone marrow collected and prepared for microscopic analysis of polychromatic erythrocytes (PCEs) and normochromatic erythrocytes (NCEs). Cytotoxicity to the bone marrow was not seen (i.e. there was no decrease in the PCE:NCE ratio) in any of the test substance treatment groups, but clinical signs of toxicity and two deaths occurred at 250 mg/kg/day. A statistically significant increase in micronuclated PCEs was not seen at any dose level. The positive control, cyclophosphamide administered by gavage, confirmed the sensitivity of the test. It is concluded that the test substance was not clastogenic under the conditions of this test.
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