title: A 28-day oral gavage toxicity study of 3-monochloropropane-1,2-diol (3-MCPD) in CB6F1-non-Tg rasH2 mice.
abstract: 3-Monochloro-1,2-propanediol (3-MCPD) is a well-known contaminant of foods containing hydrolyzed vegetable protein. However, limited toxicity data are available for the risk assessment of 3-MCPD and its carcinogenic potential is controversial. To evaluate the potential toxicity and determine the dose levels for a 26-week carcinogenicity test using Tg rasH2 mice, 3-MCPD was administered once daily by oral gavage at doses of 0, 25, 50, and 100 mg/kg body weight (b.w.)/day for 28 days to male and female CB6F1-non-Tg rasH2 mice (N = 5 males and females per dose). The standard toxicological evaluations were conducted during the in-life and post-mortem phase. In the 100 mg/kg b.w./day group, 3 males and 1 female died during the study and showed clinical signs such as thin appearance and subdued behavior accompanied by significant decreases in mean b.w. Microscopy revealed tubular basophilia in the kidneys, exfoliated degenerative germ cells in the lumen of the seminiferous tubule of the testes, vacuolation in the brain, axonal degeneration of the sciatic nerve, and cardiomyopathy in the 100, ≥25, ≥50, 100, and 100 mg/kg b.w./day groups, respectively. In conclusion, 3-MCPD's target organs were the kidneys, testes, brain, sciatic nerve, and heart. The "no-observed-adverse-effect level" (NOAEL) of 3-MCPD was ≤25 and 25 mg/kg b.w./day in males and females, respectively.
authors.affiliation: College of Veterinary Medicine, Chungnam National University, Daejeon 305-764, South Korea; Research Center for Toxicologic Pathology, Korea Institute of Toxicology (KIT), Daejeon 305-343, South Korea.
authors.forename: Byoung-Seok
authors.initials: BS
authors.lastname: Lee
authors.affiliation: Research Center for General and Applied Toxicology, Korea Institute Toxicology (KIT), Daejeon 305-343, South Korea.
authors.forename: Sang-Jin
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Research Center for Toxicologic Pathology, Korea Institute of Toxicology (KIT), Daejeon 305-343, South Korea.
authors.forename: Yong-Bum
authors.initials: YB
authors.lastname: Kim
authors.affiliation: Research Center for Toxicologic Pathology, Korea Institute of Toxicology (KIT), Daejeon 305-343, South Korea.
authors.forename: Ji-Seok
authors.initials: JS
authors.lastname: Han
authors.affiliation: Research Center for General and Applied Toxicology, Korea Institute Toxicology (KIT), Daejeon 305-343, South Korea.
authors.forename: Eun-Ju
authors.initials: EJ
authors.lastname: Jeong
authors.affiliation: Research Center for General and Applied Toxicology, Korea Institute Toxicology (KIT), Daejeon 305-343, South Korea. Electronic address: ksmoon@kitox.re.kr.
authors.forename: Kyoung-Sik
authors.initials: KS
authors.lastname: Moon
authors.affiliation: College of Veterinary Medicine, Chungnam National University, Daejeon 305-764, South Korea. Electronic address: hyson@cnu.ac.kr.
authors.forename: Hwa-Young
authors.initials: HY
authors.lastname: Son
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D001681:Biological Assay; D015197:Carcinogenicity Tests; D004305:Dose-Response Relationship, Drug; D005260:Female; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D009374:Neoplasms, Experimental / Q000139:chemically induced; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D013047:Specific Pathogen-Free Organisms; D000517:alpha-Chlorohydrin / Q000633:toxicity*
chemical_list: D000517:alpha-Chlorohydrin
keywords: 3-MCPD; CB6F1-non-Tg rasH2 Mice; Risk assessment; Toxicological pathology