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W Michael Peden
Revision of the International Council for Harmonization (ICH) S1 guidance for rat carcinogenicity studies to be more selective of compounds requiring a 2-year rat carcinogenicity study has been proposed following extensive evaluation of rat carcinogenicity and chronic toxicity studies by industry and drug regulatory authorities. To inform the ICH S1 expert working group in their potential revision of ICH S1, a prospective evaluation study was initiated in 2013, in which sponsors would assess the pharmacologic and toxicologic findings present in the chronic toxicity studies and predict a positive or negative carcinogenicity outcome using a weight of evidence argument (a carcinogenicity assessment document [CAD])...
October 17, 2016: Toxicologic Pathology
Tennille K Marx, Róbert Glávits, John R Endres, Philip A Palmer, Amy E Clewell, Timothy S Murbach, Gábor Hirka, Ilona Pasics
Morus alba L. (white mulberry) leaves are one of the oldest recognized traditional Chinese medicines. More recently, M alba leaves and their constituents, particularly iminosugars (or azasugars), have garnered attention for their ability to maintain normal blood glucose concentrations, an effect identified in both animal studies and human clinical trials. Reducose (Phynova Group Limited) is a commercial water-soluble extract of M alba leaves standardized to 5% 1-deoxynojirimycin (DNJ), an iminosugar with α-glucosidase inhibition properties...
October 12, 2016: International Journal of Toxicology
Mi-Kyung Jeong, Chong-Kwan Cho, Hwa-Seung Yoo
OBJECTIVES: Ginseng Rh2+ is enzyme-treated ginseng extract containing high amounts of converted ginsenosides, such as compound k, Rh2, Rg3, which have potent anticancer activity. We conducted general and genetic toxicity tests to evaluate the safety of ginseng Rh2+. METHODS: An acute oral toxicity test was performed at a high-level dose of 4,000 mg/kg/day in Sprague-Dawley (SD) rats. A 14-day range-finding study was also conducted to set dose levels for the 90-day study...
September 2016: Journal of Pharmacopuncture
Abraham Nyska, Shim-Mo Hayashi, Mihoko Koyanagi, Jeffrey P Davis, Micheal P Jokinen, Yuval Ramot, Robert R Maronpot
alpha-Glycosyl isoquercitrin (AGIQ) is highly absorbable and has been shown to possess antioxidative properties. Based on a favorable safety profile, it has been confirmed as generally recognized as safe (GRAS) compound by the FDA. Nevertheless, safety and toxicity information for AGIQ is still sparse. Therefore, the aim of this study was to test the safety and toxicokinetics of AGIQ in a 90-day study in 60 male and 60 female Sprague-Dawley rats at dietary doses up to 5%. All animals survived until scheduled euthanasia with no clinical signs of toxicity in any animal...
September 28, 2016: Food and Chemical Toxicology
Adrian P L Smith, Michael Marino, Jeanette Roberts, Janell M Crowder, Jason Castle, Lisa Lowery, Christine Morton, Mark G Hibberd, Paul M Evans
Purpose To measure the levels of gadolinium present in the rat brain 1 and 20 weeks after dosing with contrast agent and to determine if there are any histopathologic sequelae. Materials and Methods The study was approved by the GE Global Research Center Institutional Animal Care and Use Committee. Absolute gadolinium levels were quantified in the blood and brains of rats 1 week after dosing and 20 weeks after dosing with up to 20 repeat doses of gadodiamide (cumulative dose, 12 mmol per kilogram of body weight) by using inductively coupled plasma-mass spectrometry...
September 27, 2016: Radiology
Stacey Fossey, John Vahle, Philip Long, Scott Schelling, Heinrich Ernst, Rogely Waite Boyce, Jacquelin Jolette, Brad Bolon, Alison Bendele, Matthias Rinke, Laura Healy, Wanda High, Daniel Robert Roth, Michael Boyle, Joel Leininger
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) Project ( is an initiative of the Societies of Toxicological Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP) and North America (STP) to develop an internationally accepted nomenclature for proliferative and nonproliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature for classifying microscopic lesions observed in the skeletal tissues and teeth of laboratory rats and mice, with color photomicrographs illustrating examples of many common lesions...
2016: Journal of Toxicologic Pathology
Brian R Berridge, Vasanthi Mowat, Hirofumi Nagai, Abraham Nyska, Yoshimasa Okazaki, Peter J Clements, Matthias Rinke, Paul W Snyder, Michael C Boyle, Monique Y Wells
The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of the Societies of Toxicologic Pathology from Japan (JSTP), Europe (ESTP), Great Britain (BSTP) and North America (STP) to develop an internationally-accepted nomenclature for proliferative and non-proliferative lesions in laboratory animals. The primary purpose of this publication is to provide a standardized nomenclature for characterizing lesions observed in the cardiovascular (CV) system of rats and mice commonly used in drug or chemical safety assessment...
2016: Journal of Toxicologic Pathology
Michael R Batzloff, Anne Fane, Davina Gorton, Manisha Pandey, Tania Rivera-Hernandez, Ainslie Calcutt, Grace Yeung, Jon Hartas, Linda Johnson, Catherine M Rush, James McCarthy, Natkunam Ketheesan, Michael F Good
Streptococcus pyogenes (group A streptococcus, GAS) causes a wide range of clinical manifestations ranging from mild self-limiting pyoderma to invasive diseases such as sepsis. Also of concern are the post-infectious immune-mediated diseases including rheumatic heart disease. The development of a vaccine against GAS would have a large health impact on populations at risk of these diseases. However, there is a lack of suitable models for the safety evaluation of vaccines with respect to post-infectious complications...
August 19, 2016: Human Vaccines & Immunotherapeutics
Jay S Petrick, Gregory E Frierdich, Stephanie M Carleton, Colton R Kessenich, Andre Silvanovich, Yuanji Zhang, Michael S Koch
Genetically modified (GM) crops have been developed and commercialized that utilize double stranded RNAs (dsRNA) to suppress a target gene(s), producing virus resistance, nutritional and quality traits. MON 87411 is a GM maize variety that leverages dsRNAs to selectively control corn rootworm through production of a 240 base pair (bp) dsRNA fragment targeting for suppression the western corn rootworm (Diabrotica virgifera virgifera) Snf7 gene (DvSnf7). A bioinformatics assessment found that endogenous corn small RNAs matched ∼450 to 2300 unique RNA transcripts that likely code for proteins in rat, mouse, and human, demonstrating safe dsRNA consumption by mammals...
July 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Palma Ann Marone, Jan Trampota, Steven Weisman
l-(+) Ergothioneine is a naturally occurring thiol amino acid with antioxidant properties and potential benefits as a dietary supplement. Despite its century-old identification and wide distribution in human food, little is known of its mechanism of action and safety. The nature-identical biomimetic of l-(+) ergothioneine, produced by Mironova Labs and supplied as Mironova (EGT+), has been investigated in the present studies for its mutagenic and toxicologic potential. In a plate incorporation and preincubation assay with Salmonella typhimurium strains TA98, 100, 1,535, and 1,537 and Escherichia coli WP2uvrA strain, at dose concentrations of 1...
September 2016: International Journal of Toxicology
Shruti B Patel, Nirav J Rao, Lal L Hingorani
BACKGROUND: The use of Withania somnifera is increasing due to a number of its chemical constituents found useful for health. OBJECTIVE: The present study was carried out to investigate the potential adverse effects (if any) of a standardized Withania somnifera extract (WSE) in rats following acute and sub chronic administration. MATERIALS AND METHODS: The toxicity study was performed in Wistar rats by oral administration. An acute toxicity study was done at the dose of 2000 mg/kg...
March 2016: Journal of Ayurveda and Integrative Medicine
F Schmidt, P Marx-Stoelting, W Haider, T Heise, C Kneuer, M Ladwig, S Banneke, S Rieke, L Niemann
Two 28-day feeding studies were performed in male rats to investigate combination effects of azole fungicides in a broad dose range. Following separate administration of cyproconazole, epoxiconazole, prochloraz, propiconazole, and tebuconazole at five dose levels, the first three compounds were selected to be administered in two different mixtures at three dose levels including very low doses. Here we present the data obtained by clinical observations, pathology, histopathology, clinical chemistry and haematology...
April 29, 2016: Toxicology
Ahmad Nassar, Yael Sharon-Granit, Abed N Azab
Recent evidence suggests that inflammation may contribute to the pathophysiology of mental disorders and that psychotropic drugs exert various effects on brain inflammation. The administration of bacterial endotoxin (lipopolysaccharide, LPS) to mammals is associated with robust production of inflammatory mediators and pathological changes in body temperature. The objective of the present study was to examine the effects of four different psychotropic drugs on LPS-induced hypothermia and production of prostaglandin (PG) E2, tumor necrosis factor (TNF)-α and phosphorylated-p65 (P-p65) levels in hypothalamus of LPS-treated rats...
July 28, 2016: Neuroscience Letters
Yin Duan, Xuxu Yan, Lihui Wei, Corinne Bensimon, Pasan Fernando, Terrence D Ruddy
PURPOSE: Extensive acute and subacute toxicities studies are required to evaluate the toxicological profile of the novel cardiac perfusion imaging tracer (123)I-CMICE-013 to support applications for clinical trials. METHODS: Sprague-Dawley rats and Gottingen minipigs received injections of non-radioactive 127I-CMICE-013 at two dosage levels of 1 and 5 μg/kg, and vehicle buffer as control. In the acute toxicity studies, each animal was injected on two occasions 24 h apart and then underwent a 14-day recovery period; in the subacute study, animals received daily injections for 14 days continuously...
October 2016: Regulatory Toxicology and Pharmacology: RTP
Jeff R Fowles, Marcy I Banton, Peter J Boogaard, Hans B Ketelslegers, Arlean M Rohde
The thyroid gland, and its associated endocrine hormones, is a growing area of interest in regulatory toxicology due to its important role in metabolism, growth and development. This report presents a review of the toxicology data on chemically complex petroleum streams for thyroid hormone effects. Toxicological summaries and studies from all available published and un-published sources were considered, drawing upon the European REACH regulatory submissions for 19 petroleum streams, with in depth review of 11 individual study reports and 31 published papers on related products or environmental settings...
July 8, 2016: Toxicology Letters
Susan A Elmore, Cindy A Farman, James R Hailey, Ramesh C Kovi, David E Malarkey, James P Morrison, Jennifer Neel, Patricia A Pesavento, Brian F Porter, Kathleen A Szabo, Leandro B C Teixeira, Erin M Quist
The 2015 Annual National Toxicology Program Satellite Symposium, entitled "Pathology Potpourri" was held in Minneapolis, Minnesota, at the American College of Veterinary Pathologists/American Society for Veterinary Clinical Pathology/Society of Toxicologic Pathology combined meeting. The goal of this symposium is to present and discuss diagnostic pathology challenges or nomenclature issues. Because of the combined meeting, both laboratory and domestic animal cases were presented. This article presents summaries of the speakers' talks, including challenging diagnostic cases or nomenclature issues that were presented, along with select images that were used for audience voting and discussion...
June 2016: Toxicologic Pathology
Adriana de Siqueira, Karina Borges Almeida Rodrigues, Vagner Gonçalves-Júnior, Atilio Sersun Calefi, André Rinaldi Fukushima, Silvia Elena Campusano Cuevas, Helenice de Souza Spinosa, Paulo César Maiorka
Exhumation is required for the investigation of suspicions deaths when a body is buried and is usually performed under court order. Exhumation of animals is not a routine practice in forensic pathology. In this study, 30 male 70-day-old Wistar rats were experimentally exposed to the carbamate pesticides aldicarb and carbofuran. Toxicological, macroscopic and microscopic examinations were performed. Groups of 3 animals (2 exposed and 1 control) were evaluated at 24h, 3days, 5days, 7days and 10days post-mortem...
June 2016: Experimental and Toxicologic Pathology: Official Journal of the Gesellschaft Für Toxikologische Pathologie
Thomas Nolte, Patricia Brander-Weber, Charles Dangler, Ulrich Deschl, Michael R Elwell, Peter Greaves, Richard Hailey, Michael W Leach, Arun R Pandiri, Arlin Rogers, Cynthia C Shackelford, Andrew Spencer, Takuji Tanaka, Jerrold M Ward
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) project is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature and diagnostic criteria for nonproliferative and proliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature and diagnostic criteria for classifying lesions in the digestive system including the salivary glands and the exocrine pancreas of laboratory rats and mice...
2016: Journal of Toxicologic Pathology
Paul Baldrick
Potential new human vaccines undergo toxicology testing to evaluate local reactogenicity and systemic toxicity. A review of 30 recently published and in-house repeat dose toxicity studies with a variety of vaccines was performed. Species tested were generally rat or rabbit, usually by intramuscular (although occasionally subcutaneous) injection. Results showed no unexpected findings indicating vaccine toxicity, but classic signs of enhanced acute and/or chronic inflammation at the dose site compared with that seen in injected control animals, often accompanied by changes in draining lymph nodes and the spleen (lymphoid hyperplasia and/or increased weight)...
August 2016: Journal of Applied Toxicology: JAT
Chenlin Yu, Ziteng Zhang, Yangang Liu, Ying Zong, Yongchun Chen, Xiuming Du, Jikuai Chen, Shijie Feng, Jinlian Hu, Shufang Cui, Guocai Lu
The use of smokeless tobacco (ST) is growing rapidly and globally. The consumption of ST is associated with an increased risk for developing chronic diseases, such as diabetes, hypercholesterolemia, and myocardial infarction, and has led to many public health problems. It is very important to access the toxicity of ST. This experiment presents data from 184-day toxicology studies in Sprague-Dawley (SD) rats designed to characterize the chronic effects of a smokeless tobacco extract (STE). The control group and treatment groups were matched for a range of nicotine levels...
March 2016: International Journal of Environmental Research and Public Health
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