Six-month Intravenous Toxicity Study of Amrubicin Hydrochloride(SM-5887) in Rats Followed by 6-month Recovery Study.
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Accession number;99A0241090
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| Title;Six-month Intravenous Toxicity Study of Amrubicin Hydrochloride(SM-5887) in Rats Followed by 6-month Recovery Study. |
| Author;
SHIGENO HITOSHI
(Saf. Res. Inst. for Chem. Compd. Co. Ltd.)
FURUKAWA MASATOSHI
(Saf. Res. Inst. for Chem. Compd. Co. Ltd.)
NAKAJIMA FUMIHARU
(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.307-S.332(1999)
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| Figure&Table&Reference;FIG.13, TBL.12, REF.11 |
| 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 0.02, 0.1 and 0.5mg/kg/day for 6 months, followed by 6-month recovery study. Six-month intravenous administration of SM-5887 in rats resulted in the following effects: decrease in testis weights in males of the 0.1mg/kg group; decrease in thymus weights in females of the 0.1mg/kg group, suppression of body weight gains, suppression of hematopoietic system, mainly of erythrocytic series and lymphocytic series, histopathological changes in the adrenals and harderian glands, and tumorigenesis in the cutaneous or subcutaneous part or external auditory meatus mainly during the recovery period in males and females of the 0.5mg/kg group; decrease in food consumption and spermatogenetic disorder in males of the 0.5mg/kg group; injury at the injection sites(tail) in females of the 0.5mg/kg group. As a results of 6-month withdrawal of SM-5887-treatment, the decreases in testis weights in males and thymus weights of females in the 0.1mg/kg group recovered. In the 0.5mg/kg group, 6/6 of the males and 2/6 of the females were sacrificed because of the masses increased and enlarged during the recovery period. In surviving females, effects on hematopoietic system following the increase and enlargement of the masses were observed. Consequently, evaluation of the recovery was performed on limited items in the 0.5mg/kg group. The injury at the injection sites of females and discoloration of the submandibular glands in males and females recovered, and it was considered that the effects on body weight gains and food consumption in males and females should recover in case a tumor did not develop. The effects on the thymus, harderian glands and adrenals noted in males and females were considered to be in the recovering stage.... (author abst.) |
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