title: The toxicological evaluation of repetitive 2- and 4-week intravenous injection of Activin A/BMP-2 chimera (AB204) into rats.
abstract: The subchronic (28-days) toxicity of an Activin A/BMP-2 chimera (AB204) was assessed in rats. Sprague-Dawley rats received repetitive intravenous injection of AB204 in doses of 0, 0.25 and 0.5 mg/kg for two weeks and in doses of 0, 0.08, 0.16 and 0.32 mg/kg/day for four weeks. No animal was dead and no change caused by the AB204 was observed in general symptoms, weight variation, and food and water intake as well as blood test and autopsy findings. In conclusion, the no observed adverse effects level (NOAEL) of the AB204 on rats was determined to be 0.32 mg/kg/day.
authors.affiliation: Protein Engineering Laboratory, Joint Center for Biosciences at Songdo Smart Valley, Incheon 406-840, Republic of Korea; Department of Basic Science, Hongik Univesity, 94 Wausan-ro, Mapo-Gu, Seoul 121-791, Repulic of Korea.
authors.forename: Byung-Hak
authors.initials: BH
authors.lastname: Yoon
authors.affiliation: Department of Orthopedic Surgery, College of Medicine, Seoul National University, SMG-SNU Boramae Medical Center, Seoul 156-707, Republic of Korea. Electronic address: spinelee@snu.ac.kr.
authors.forename: Jae Hyup
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Dong-A Socio Holdings Research Institute. Giheung-gu, Yongin, Gyeonggi 446-905, Republic of Korea.
authors.forename: Kyuheum
authors.initials: K
authors.lastname: Na
authors.affiliation: Dong-A Socio Holdings Research Institute. Giheung-gu, Yongin, Gyeonggi 446-905, Republic of Korea.
authors.forename: Jongho
authors.initials: J
authors.lastname: Cho
authors.affiliation: Protein Engineering Laboratory, Joint Center for Biosciences at Songdo Smart Valley, Incheon 406-840, Republic of Korea; Structural Biology Laboratory, The Salk Institute for Biological Studies, La Jolla, CA 92037, USA.
authors.forename: Senyon
authors.initials: S
authors.lastname: Choe
mesh_terms: D028341:Activins / Q000008:administration & dosage* / Q000009:adverse effects*; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004326:Drinking / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D007275:Injections, Intravenous / Q000379:methods; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: C000597022:AB204; D011993:Recombinant Fusion Proteins; C422405:activin A; D028341:Activins
keywords: Activin A; BMP-2; Intravenous administration; Rat; Repetitive administration; Toxicity