Ninety-day Intravenous Toxicity Study of Amrubicin Hydrochloride(SM-5887) in Rats Followed by 90-day Recovery Study.
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Accession number;99A0241086
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| Title;Ninety-day Intravenous Toxicity Study of Amrubicin Hydrochloride(SM-5887) in Rats Followed by 90-day Recovery Study. |
| Author;
KIGUCHI MASAO
(Saf. Res. Inst. for Chem. Compd. Co. Ltd.)
SHIGENO HITOSHI
(Saf. Res. Inst. for Chem. Compd. Co. Ltd.)
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Journal Title;Japanese Pharmacology & Therapeutics
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Journal Code:Z0947A
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ISSN:0386-3603
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VOL.27;NO.Suppl.1;PAGE.S.91-S.107,S.109-S.110(1999)
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| Figure&Table&Reference;FIG.9, TBL.12, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Amrubicin hydrochloride(SM-5887), anthracycline antitumor antibiotic, was investigated for its intravenous toxicity by intravenous administration in Slc:SD rats at the doses of 0.015, 0.05, 0.15 and 0.5mg/kg/day for 90 days, followed by 90-day recovery study. Ninety-day intravenous administration of SM-5887 in rats resulted in the following effects: decrease in testis weights in males of the 0.15mg/kg group; decreases in hematocrit and hemoglobin in females of the 0.15mg/kg group; suppression of hematopoietic system, mainly of erythrocytic series and lymphocytic series, and histopathological changes in the adrenals and harderian glands in males and females of the 0.5mg/kg group; suppression of body weight gains and spermatogenetic disorder in males of the 0.5mg/kg group. After 90-day withdrawal of SM-5887-treatment, the spermatogenetic disorder in males of the 0.5mg/kg group did not recover. The histopathological changes in the adrenals and harderian glands in males and females of the 0.5mg/kg group reduced or disappeared, so these changes were considered to be in the recovering stage. All of the other changes recovered. On the basis of these results, non-observed-effect level was estimated to be 0.05mg/kg/day for males and females in the present study. (author abst.) |
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