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Kola nut extract is used in the food industry as a flavoring ingredient. Kola nut extract is derived from the seeds of primarily two tropical Cola species (Cola nitida (Vent.) Schott et Endl. or Cola acuminata (Beauv.) Schott et Endl.) of the Family, Sterculiaceae. Present day consumption of kola nut extract is 0.69 mg/kg/day. Caffeine and theobromine are two important constituents of kola nuts. Although limited biological data are available for kola nut extract specifically, the published data of the major constituents of kola nuts suggest the pharmacological/toxicological properties of kola nut extract, parallel to those of a roughly equivalent dose of caffeine. Frank developmental/reproductive effects have not been reported and changes in offspring cannot be extrapolated to humans. A NOEL/NOAEL cannot be defined for repeated oral exposure to kola nut extract from available data. Notwithstanding the foregoing, U.S. consumers have a history of safe consumption of cola-type beverages containing kola nut extract that dates at least to the late 19th Century, with a significant global history of exposure to the intact kola nuts that date centuries longer. 相似文献
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M.E. Bette Meek Michael Bolger James S. Bus John Christopher Rory B. Conolly R. Jeffrey Lewis Gregory M. Paolini Rita Schoeny Lynne T. Haber Amy B. Rosenstein Michael L. Dourson 《Regulatory toxicology and pharmacology : RTP》2013
The NRC report Science and Decisions: Advancing Risk Assessment made several recommendations to improve chemical risk assessment, with a focus on in-depth chronic dose–response assessments conducted by the U.S. Environmental Protection Agency. The recommendations addressed two broad elements: improving technical analysis and utility for decision making. To advance the discussions in the NRC report, in three multi-stakeholder workshops organized by the Alliance for Risk Assessment, available and evolving risk assessment methodologies were considered through the development and application of case studies. A key product was a framework (http://www.allianceforrisk.org/Workshop/Framework/ProblemFormulation.html) to guide risk assessors and managers to various dose–response assessment methods relevant to a range of decision contexts ranging from priority setting to full assessment, as illustrated by case studies. It is designed to facilitate selection of appropriate methodology for a variety of problem formulations and includes a variety of methods with supporting case studies, for areas flagged specifically by the NRC committee for consideration – e.g., susceptible sub-populations, population variability and background. The framewok contributes to organization and communication about methodologies for incorporating increasingly biologically informed and chemical specific knowledge into dose–response analysis, which is considered critical in evolving fit-for-purpose assessment to address relevant problem formulations. 相似文献
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Yoichiro Asai Tetsuya Yamada Sohei Tsukita Kei Takahashi Masamitsu Maekawa Midori Honma Masanori Ikeda Keigo Murakami Yuichiro Munakata Yuta Shirai Shinjiro Kodama Takashi Sugisawa Yumiko Chiba Yasuteru Kondo Keizo Kaneko Kenji Uno Shojiro Sawada Junta Imai Hideki Katagiri 《Gastroenterology》2017,152(6):1521-1535.e8
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Antonia Martín-Castillo Maria Teresa Castells Gracia Adánez Maria Teresa Sánchez Polo Bartolomé García Pérez Ignacio Ayala 《Biomedicine & Pharmacotherapy》2010
Non-alcoholic steatohepatitis (NASH) is part of the spectrum of non-alcoholic fatty liver disease (NAFLD), which includes from simple steatosis and steatohepatitis, to the most severe cirrhosis and carcinoma, which develops in the absence of excessive alcohol intake. NAFLD is the most common liver disorder in affluent societies. There is no proven treatment for NAFLD/NASH. One of the most frequent adverse effects of statins is an increase in hepatic aminotransferases. Studies that evaluate if the benefits of statins overcome the risks in NASH are lacking. The present study was conceived to explore the effect of both atorvastatin and diet on regression of steatohepatitis, using a chicken experimental model induced by a hyperlipidemic diet (HD). Plasma lipid levels, liver enzymes and hepatic histopathology, as well as image analysis were performed to determine changes in liver lipid deposits and inflammatory infiltration. Features of steatosis, cell-ballooning, and inflammation were scored to obtain the NAFLD activity score (NAS). A severe level of steatosis was found in animals fed on HD. Atorvastatin treated groups showed smaller size of lipid deposits and a lower level of inflammation than non-treated groups. Atorvastatin therapy induced a significant reduction of hepatocellular damage, even though in the animals which continuously received a hyperlipidemic diet. The combination of atorvastatin therapy and a standard diet produced the lowest decrease of NAS. Our results show that atorvastatin therapy not only decreased plasmatic levels of cholesterol and triglycerides, but also induced a reduction of liver steatosis, inflammation and hepatocellular damage, without increasing plasmatic amynotransferase levels. 相似文献