title: Evaluation of general toxicity and genotoxicity of the silkworm extract powder.
abstract: The silkworm extract powder contain 1-deoxynojirimycin (DNJ), a potent α-glycosidase inhibitor, has therapeutic potency against diabetes mellitus. Therefore, natural products containing DNJ from mulberry leaves and silkworm are consumed as health functional food. The present study was performed to evaluate the safety of the silkworm extract powder, a health food which containing the DNJ. The repeated toxicity studies and gentic toxicity studies of the silkworm extract powder were performed to obtain the data for new functional food approval in MFDS. The safety was evaluated by a single-dose oral toxicity study and a 90 day repeated-dose oral toxicity study in Sprague-Dawley rats. The silkworm extract powder was also evaluated for its mutagenic potential in a battery of genetic toxicity test: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus assay. The results of the genetic toxicology assays were negative in all of the assays. The approximate lethal dose in single oral dose toxicity study was considered to be higher than 5000 mg/kg in rats. In the 90 day study, the dose levels were wet at 0, 500, 1000, 2000 mg/kg/day, and 10 animals/sex/dose were treated with oral gavage. The parameters that were monitored were clinical signs, body weights, food and water consumptions, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological examination. No adverse effects were observed after the 90 day administration of the silkworm extract powder. The No-Observed-Adverse-Effect-Level (NOAEL) of silkworm extract powder in the 90 day study was 2000 mg/kg/day in both sexes, and no target organ was identified.
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea ; College of Veterinary Medicine, Konkuk University, Seoul, Korea.
authors.forename: Hyun-Suk
authors.initials: HS
authors.lastname: Heo
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Jae-Hun
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Jung-Ja
authors.initials: JJ
authors.lastname: Oh
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Woo-Joo
authors.initials: WJ
authors.lastname: Lee
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Seong-Sook
authors.initials: SS
authors.lastname: Kim
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Do-Hoon
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Hyun-Kul
authors.initials: HK
authors.lastname: Lee
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Si-Whan
authors.initials: SW
authors.lastname: Song
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Kap-Ho
authors.initials: KH
authors.lastname: Kim
authors.affiliation: College of Veterinary Medicine, Konkuk University, Seoul, Korea.
authors.forename: Yang-Kyu
authors.initials: YK
authors.lastname: Choi
authors.affiliation: Department of Agricultural Biology, National Academy of Agricultural Science, Rural Development Administration, Suwon, Korea.
authors.forename: Kang-Sun
authors.initials: KS
authors.lastname: Ryu
authors.affiliation: Nonclinical Research Center, Chemon Inc., Yongin, Korea.
authors.forename: Boo-Hyon
authors.initials: BH
authors.lastname: Kang
keywords: 90 day repeated dose toxicity; Genotoxicity; Silkworm extract powder; Single oral dose toxicity