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https://www.readbyqxmd.com/read/28462146/comparative-toxicity-study-on-classical-and-modified-version-of-jawarish-jalinoos-a-traditional-unani-formulation-in-rats
#1
Gulam Mohammed Husain, Syed Shoeb Ahmed, Misbahuddin Azhar, Javed Inam Siddiqui, Mohammad Abdul Waheed, Munawwar Husain Kazmi
BACKGROUND: Jawarish Jalinoos (JJ) is a classical semisolid traditional Unani formulation clinically used for the treatment of weakness of vital organs, liver, and stomach. Although JJ has been widely used clinically for several decades, no scientific report is available for its safety. METHODS: JJ and its sugar-free tablet version (SFJJ; formulated to target diabetic population) were assessed for safety in rats. Ninety-day repeated dose oral toxicity study was performed as per the Organisation for Economic Co-operation and Development Guideline 408...
March 2017: Integr Med Res
https://www.readbyqxmd.com/read/28454766/mixture-effects-of-azole-fungicides-on-the-adrenal-gland-in-a-broad-dose-range
#2
S Rieke, T Heise, F Schmidt, W Haider, H Bednarz, K Niehaus, A Mentz, J Kalinowski, K I Hirsch-Ernst, P Steinberg, L Niemann, P Marx-Stoelting
Consumers are exposed to low concentrations of a variety of pesticide residues in or on food. Some of them might interfere with the endocrine system. While each individual active substance has been extensively tested for toxicity and safety, potential combination effects possibly resulting from combined exposure to different pesticides have seldomly been tested so far, especially in vivo. Since the adrenal gland is a key endocrine organ, we investigated if and how substances of a group of fungicides presumed to interfere with the biosynthesis of steroid hormones affect this organ when applied individually and in combination in a broad dose range...
April 25, 2017: Toxicology
https://www.readbyqxmd.com/read/28433587/pharmacokinetic-and-toxicology-comparator-testing-of-biosimilar-drugs-assessing-need
#3
Paul Baldrick
A key element in the development of a biosimilar molecule is the comparability of the biological activity/nonclinical similarity to the innovator drug. Although some regulatory guidelines are encouraging little or no in vivo testing, currently a common practice is to perform at least one toxicology and/or one pharmacokinetic (PK) study to assess if any different findings occur for in-life, clinical pathology and histopathological parameters or in exposure. An exercise was performed in which the results of such testing were evaluated...
April 20, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28421968/chronic-toxicology-studies-of-basal-insulin-peglispro-in-rats-and-dogs-a-novel-pegylated-insulin-lispro-analog-with-a-prolonged-duration-of-action
#4
Richard A Byrd, Jamie L Blackbourne, Mary Pat Knadler, Albert E Schultze, John L Vahle
Basal insulin peglispro (BIL) consists of insulin lispro with a 20-kDa polyethylene glycol (PEG) moiety covalently attached to lysine B28. Because chronic parenteral administration of PEGylated proteins to animals has sometimes resulted in PEG vacuolation of tissue macrophages, renal tubular cells, and choroid plexus ependymal cells, we investigated whether chronic subcutaneous (sc) injection of BIL in rats (52 weeks) and dogs (39 weeks) was associated with systemic toxicities or other changes, including vacuolation of tissue macrophages, renal tubular cells, and ependymal cells...
April 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28416568/pharmacological-and-toxicological-properties-of-the-potent-oral-%C3%AE-secretase-modulator-bpn-15606
#5
Steven L Wagner, Kevin D Rynearson, Steven K Duddy, Can Zhang, Phuong D Nguyen, Ann Becker, Uyen Vo, Deborah Masliah, Louise Monte, Justin B Klee, Corinne M Echmalian, Weiming Xia, Luisa Quinti, Graham Johnson, Jiunn H Lin, Doo Y Kim, William C Mobley, Robert A Rissman, Rudolph E Tanzi
Alzheimer's disease is characterized neuropathologically by an abundance of 1) neuritic plaques, which are primarily composed of a fibrillar 42 amino acid amyloid β peptide, as well as 2) neurofibrillary tangles composed of aggregates of hyperphosporylated tau. Elevations in the concentrations of the Aβ42 peptide in the brain, as a result of either increased production or decreased clearance are postulated to initiate and drive the AD pathological process. We initially introduced a novel class of bridged aromatics referred to as γ-secretase modulators that inhibited the production of the Aβ42 peptide and to a lesser degree the Aβ40 peptide while concomitantly increasing the production of the carboxyl-truncated Aβ38 and Aβ37 peptides...
April 17, 2017: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/28345450/erratum
#6
(no author information available yet)
Weber, K. (2017). Differences in Types and Incidence of Neoplasms in Wistar Han and Sprague-Dawley Rats. J Toxicol Pathol45, 64-75. (Original DOI: 10.1177/0192623316672075) In the January 2017 issue of Toxicologic Pathology, a number of in text Table citations were incorrectly labeled. The following are the sentences with corrected Table number (this has also been corrected in the online version): Many fewer neoplasms are recorded for the endocrine pancreas compared with islet cell tumor incidences (Table 3)...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28341569/oral-exposure-of-pregnant-rats-to-toxic-doses-of-methylmercury-alters-fetal-accumulation
#7
Cláudia Oliveira, Lucy Joshee, Hannah George, Sanya Nijhara, Christy Bridges
Methylmercury (CH3Hg(+)) is an environmental toxicant that may lead to significant pathologies in exposed individuals. The current study assessed the disposition and toxicological effects of 2.5 or 7.5mgkg(-1) CH3Hg(+), conjugated to cysteine (Cys; Cys-S-CH3Hg) and administered orally to pregnant and non-pregnant Wistar and TR(-) rats. Rats were euthanized on gestational day 20 and the content of mercury in each fetus, amniotic sac, and placenta was determined. The brain, liver, and kidneys were removed from each fetus for estimation of mercury content...
March 21, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28341247/toxicological-evaluation-of-oviductus-ranae-acute-sub-acute-and-genotoxicity-studies-in-mice-and-rats
#8
Yang Zhang, Kun Zhu, Hao Cui, Yang Liu, Ye-Fang Lu, Hong-Wei Pan, He-Peng Zhao, Ling Qi, Xiu-Dong Yang, Hong-Li Zhou
ETHNOPHARMACOLOGICAL RELEVANCE: Oviductus ranae (OR) is a traditional animal-based Chinese medicine, which has been listed in the Chinese Pharmacopoeia since 1985 edition. Although its medicinal application has been widely acknowledged, there is little available information on its potential toxicity. AIM OF THE STUDY: The aim of this study was to investigate the acute, sub-acute, and genetic toxicities of OR. MATERIALS AND METHODS: In acute toxicity evaluation, OR was administered orally to mice at doses of 2...
May 5, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/28249224/a-moderate-metal-binding-hydrazone-meets-the-criteria-for-a-bioinorganic-approach-towards-parkinson-s-disease-therapeutic-potential-blood-brain-barrier-crossing-evaluation-and-preliminary-toxicological-studies
#9
Daphne Schneider Cukierman, Ana Beatriz Pinheiro, Sergio L P Castiñeiras-Filho, Anastácia Sá P da Silva, Marco C Miotto, Anna De Falco, Thales de P Ribeiro, Silvia Maisonette, Alessandra L M C da Cunha, Rachel A Hauser-Davis, J Landeira-Fernandez, Ricardo Q Aucélio, Tiago F Outeiro, Marcos D Pereira, Claudio O Fernández, Nicolás A Rey
Alzheimer's and Parkinson's diseases share similar amyloidogenic mechanisms, in which metal ions might play an important role. In this last neuropathy, misfolding and aggregation of α-synuclein (α-Syn) are crucial pathological events. A moderate metal-binding compound, namely, 8-hydroxyquinoline-2-carboxaldehyde isonicotinoyl hydrazone (INHHQ), which was previously reported as a potential 'Metal-Protein Attenuating Compound' for Alzheimer's treatment, is well-tolerated by healthy Wistar rats and does not alter their major organ weights, as well as the tissues' reduced glutathione and biometal levels, at a concentration of 200mgkg(-1)...
February 22, 2017: Journal of Inorganic Biochemistry
https://www.readbyqxmd.com/read/28239534/transcriptome-and-metabolome-analysis-of-liver-and-kidneys-of-rats-chronically-fed-nk603-roundup-tolerant-genetically-modified-maize
#10
Robin Mesnage, Matthew Arno, Gilles-Eric Séralini, Michael N Antoniou
BACKGROUND: A previous 2-year rat feeding trial assessing potential toxicity of NK603 Roundup-tolerant genetically modified maize revealed blood and urine biochemical changes indicative of liver and kidney pathology. In an effort to obtain deeper insight into these findings, molecular profiling of the liver and kidneys from the same animals was undertaken. RESULTS: Transcriptomics showed no segregation of NK603 maize and control feed groups with false discovery rates ranging from 43 to 83% at a cut-off p value of 1%...
2017: Environmental Sciences Europe
https://www.readbyqxmd.com/read/28185575/integration-of-metabolomics-lipidomics-and-clinical-data-using-a-machine-learning-method
#11
Animesh Acharjee, Zsuzsanna Ament, James A West, Elizabeth Stanley, Julian L Griffin
BACKGROUND: The recent pandemic of obesity and the metabolic syndrome (MetS) has led to the realisation that new drug targets are needed to either reduce obesity or the subsequent pathophysiological consequences associated with excess weight gain. Certain nuclear hormone receptors (NRs) play a pivotal role in lipid and carbohydrate metabolism and have been highlighted as potential treatments for obesity. This realisation started a search for NR agonists in order to understand and successfully treat MetS and associated conditions such as insulin resistance, dyslipidaemia, hypertension, hypertriglyceridemia, obesity and cardiovascular disease...
November 22, 2016: BMC Bioinformatics
https://www.readbyqxmd.com/read/28058783/characterization-of-phase-i-and-phase-ii-hepatic-metabolism-and-reactive-intermediates-of-larrea-nitida-cav-and-its-lignan-compounds
#12
Hyesoo Jeong, Soolin Kim, Jimin Lee, Jin Young Park, Wenmei Zhou, Xiyuan Liu, So Dam Kim, Yun Seon Song, Chang-Young Jang, Sei-Ryang Oh, Sangho Choi, Minsun Chang
Larrea nitida Cav. (LNC), which belongs to the family Zygophyllaceae, is widely indigenous and used in South America to treat various pathological conditions. It contains the antioxidant and antiinflammatory but toxic nordihydroguaiaretic acid (NDGA) as well as O-methylated metabolite of NDGA (MNDGA) as bioactive compounds. The hepatic metabolism-based toxicological potential of extracts of LNC (LNE), NDGA, and MNDGA has not previously been reported. The present study aimed to characterize the phase I and phase II hepatic metabolism and reactive intermediates of LNE, NDGA, and MNDGA and their effects on the major drug-metabolizing enzymes in vitro and ex vivo...
January 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/27879439/interpreting-and-integrating-clinical-and-anatomic-pathology-results-pulling-it-all-together
#13
Lila Ramaiah, Mary Jane Hinrichs, Elizabeth V Skuba, William O Iverson, Daniela Ennulat
The continuing education course on integrating clinical and anatomical pathology data was designed to communicate the importance of using a weight of evidence approach to interpret safety findings in toxicology studies. This approach is necessary, as neither clinical nor anatomic pathology data can be relied upon in isolation to fully understand the relationship between study findings and the test article. Basic principles for correlating anatomic pathology and clinical pathology findings and for integrating these with other study end points were reviewed...
November 13, 2016: Toxicologic Pathology
https://www.readbyqxmd.com/read/27825753/in-vitro-and-in-vivo-anti-coagulant-activity-and-toxicological-studies-of-marine-sulfated-glycosaminoglycans
#14
Fatma Krichen, Zohra Ghlissi, Ikram Ben Amor, Nadhem Sayari, Rim Kallel, Jalel Gargouri, Zouheir Sahnoun, Tahia Boudawara, Ali Bougatef
The present study aimed to characterize and evaluate the in vitro and in vivo anticoagulant activity of sulfated glycosaminoglycans from the skins of smooth hound (SHSG) and grey triggerfish (GTSG). The analysis of SHSG and GTSG with acetate cellulose electrophoresis in Zn-acetate revealed the presence of hyaluronic acid (HA), chondroitin sulfate (CS) and dermatan sulfate (DS). Both glycosaminoglycans were evaluated for their in vitro anticoagulant activities using activated partial thromboplastin time (aPTT), thrombin time (TT) and prothrombine time (PT) tests...
January 2017: Experimental and Toxicologic Pathology: Official Journal of the Gesellschaft Für Toxikologische Pathologie
https://www.readbyqxmd.com/read/27821915/histopathological-localization-of-cadmium-in-rat-placenta-by-la-icp-ms-analysis
#15
Yoshikazu Yamagishi, Satoshi Furukawa, Ayano Tanaka, Yoshiyuki Kobayashi, Akihiko Sugiyama
In order to clarify the histological localization of cadmium (Cd) in the placenta, we analyzed paraffin sections of placentas from rats with a single Cd exposure on gestation day 18 by the LA-ICP-MS imaging method compared with the histopathological changes. The placentas were sampled at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours after treatment. Histopathologically, the trophoblasts in the labyrinth zone of the Cd group showed swelling at 1 hour. At 2 and 3 hours, the trophoblasts showed swelling and vacuolar degeneration...
October 2016: Journal of Toxicologic Pathology
https://www.readbyqxmd.com/read/27821709/proceedings-of-the-2016-national-toxicology-program-satellite-symposium
#16
Susan A Elmore, Vivian S Chen, Schantel Hayes-Bouknight, Jessica S Hoane, Kyathanahalli Janardhan, Linda H Kooistra, Thomas Nolte, Kathleen A Szabo, Gabrielle A Willson, Jeffrey C Wolf, David E Malarkey
The 2016 annual National Toxicology Program Satellite Symposium, entitled "Pathology Potpourri" was held in San Diego, CA, at the Society of Toxicologic Pathology's (STP) 35th annual meeting. The goal of this symposium was to present and discuss challenging diagnostic pathology and/or nomenclature issues. This article presents summaries of the speakers' talks, along with select images that were used by the audience for voting and discussion. Some lesions and topics covered during the symposium included malignant glioma and histiocytic sarcoma in the rodent brain; a new statistical method designed for histopathology data evaluation; uterine stromal/glandular polyp in a rat; malignant plasma cell tumor in a mouse brain; Schwann cell proliferative lesions in rat hearts; axillary schwannoma in a cat; necrosis and granulomatous inflammation in a rat brain; adenoma/carcinoma in a rat adrenal gland; hepatocyte maturation defect and liver/spleen hematopoietic defects in an embryonic mouse; distinguishing malignant glioma, malignant mixed glioma, and malignant oligodendroglioma in the rat; comparison of mammary gland whole mounts and histopathology from mice; and discussion of the International Harmonization of Nomenclature and Diagnostic Criteria collaborations...
January 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/27753636/regulatory-forum
#17
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])...
December 2016: Toxicologic Pathology
https://www.readbyqxmd.com/read/27733446/a-28-day-repeated-dose-toxicological-study-of-an-aqueous-extract-of-morus-alba-l
#18
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...
November 2016: International Journal of Toxicology
https://www.readbyqxmd.com/read/27695630/general-and-genetic-toxicology-of-enzyme-treated-ginseng-extract-toxicology-of-ginseng-rh2
#19
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
https://www.readbyqxmd.com/read/27693245/ninety-day-toxicity-and-single-dose-toxicokinetics-study-of-alpha-glycosyl-isoquercitrin-in-sprague-dawley-rats
#20
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...
November 2016: Food and Chemical Toxicology
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