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Regulatory toxicology

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https://www.readbyqxmd.com/read/28714573/assessment-of-the-dna-damaging-potential-of-environmental-chemicals-using-a-quantitative-high-throughput-screening-approach-to-measure-p53-activation
#1
Kristine L Witt, Jui-Hua Hsieh, Stephanie L Smith-Roe, Menghang Xia, Ruili Huang, Jinghua Zhao, Scott S Auerbach, Junguk Hur, Raymond R Tice
Genotoxicity potential is a critical component of any comprehensive toxicological profile. Compounds that induce DNA or chromosomal damage often activate p53, a transcription factor essential to cell cycle regulation. Thus, within the US Tox21 Program, we screened a library of ∼10,000 (∼8,300 unique) environmental compounds and drugs for activation of the p53-signaling pathway using a quantitative high-throughput screening assay employing HCT-116 cells (p53(+/+) ) containing a stably integrated β-lactamase reporter gene under control of the p53 response element (p53RE)...
July 17, 2017: Environmental and Molecular Mutagenesis
https://www.readbyqxmd.com/read/28699487/mixed-matrix-method-provides-a-reliable-metabolite-exposure-comparison-for-assessment-of-metabolite-in-safety-testing-mist
#2
Ryan Takahashi, Cyrus Khojasteh, Matthew Wright, Cornelis Hop, Shuguang Ma
The regulatory guidances on metabolites in safety testing (MIST) by US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) describe the necessity to assess exposures of circulating metabolites in humans at steady state relative to exposures achieved in nonclinical safety studies prior to the initiation of large scale clinical trials. This comparison can be accomplished by measuring metabolite concentrations in animals and humans with validated bioanalytical methods. However, bioanalysis of metabolites in multiple species and multiple studies is resource intensive and may impact the timelines of clinical studies...
July 10, 2017: Drug Metabolism Letters
https://www.readbyqxmd.com/read/28699400/regulatory-forum-opinion-piece-effective-sectioning-of-spinal-cord-during-regulatory-type-nonclinical-toxicity-studies
#3
Brad Bolon
Regulatory guidelines for nonclinical neurotoxicity testing require spinal cord evaluation but do not specify a trimming scheme. The Society of Toxicologic Pathology (STP) "best practices" for nervous system sampling during nonclinical general toxicity studies recommend that spinal cord be assessed in both longitudinal/oblique and transverse sections. This article defines possible longitudinal/oblique orientations, describes their benefits and challenges, and provides an expert recommendation regarding suitable trimming planes...
January 1, 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28695774/regulatory-risk-assessments-is-there-a-need-to-reduce-uncertainty-and-enhance-robustness-update-on-propylparaben-in-relation-to-its-eu-regulatory-status
#4
D Snodin
Over 10 years ago, propylparaben (propyl- p-hydroxybenzoate; PP) was withdrawn as a permitted food preservative in the EU based entirely on findings reported in a single dietary study in juvenile rats claiming to show adverse effects on male reproductive parameters [Oishi S. Effects of propyl paraben on the male reproductive system. Food Chem Toxicol 2002; 40(12): 1807 -1813]. Subsequent data reviews have cast serious doubt on the validity of the Oishi results, mainly in relation to aberrant concurrent-control values, and in two further comprehensive studies using neonatal and juvenile rats there were no adverse effects in males at oral doses up to 1000 mg/kg/day...
January 1, 2017: Human & Experimental Toxicology
https://www.readbyqxmd.com/read/28692439/lipid-emulsion-in-local-anesthetic-toxicity
#5
Martyn Harvey, Grant Cave
PURPOSE OF REVIEW: Enthusiasm for regional anesthesia has been driven by multimodal benefits to patient outcomes. Despite widespread awareness and improved techniques (including the increasing use of ultrasound guidance for block placement), intravascular sequestration and the attendant risk of local anesthetic systemic toxicity (LAST) remains. Intravenous lipid emulsion (ILE) for the treatment of LAST has been endorsed by anesthetic regulatory societies on the basis of animal study and human case report data...
July 7, 2017: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/28689746/steps-towards-the-international-regulatory-acceptance-of-non-animal-methodology-in-safety-assessment
#6
Fiona Sewell, John Doe, Nichola Gellatly, Ian Ragan, Natalie Burden
The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies...
July 6, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28684318/the-juvenile-toxicity-study-as-a-tool-for-a-science-based-risk-assessment-in-the-children-population-group
#7
REVIEW
Laura Narciso, Tiziana Catone, Gabriele Aquilina, Leonello Attias, Isabella De Angelis, Maria Grazia Iuliano, Roberta Tassinari, Alberto Mantovani, Francesca Maranghi
Children show unique features concerning chemical hazards and risks, due to different exposure scenarios, age-related metabolic capacity and biological susceptibility linked to post-natal development. Chemical Regulatory frameworks state the need of children risk characterization. Current testing guidelines covering post-natal development are not routinely required by regulatory applications other than pesticides and biocides. Juvenile toxicity studies are foreseen for paediatric drugs: the toxicological repeated-dose tests don't allow accurate evaluations of effects upon direct exposure of immature organism...
July 3, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28681657/fatal-poisoning-by-terbufos-following-occupational-exposure
#8
Yue Liang, Fang Tong, Lin Zhang, Wenhe Li, Weisheng Huang, Yiwu Zhou
CONTEXT: Terbufos (TBF) is a class Ia (extremely hazardous) organophosphate pesticide (OP) and its distribution in industrialized countries has been severely restricted. Thus, acute occupational poisoning is rather uncommon. However, it still occurs in rural areas of some developing countries, where the sale of TBF is not controlled and its use is thus not properly regulated. We report a case of a 43-year-old female farmer who died after applying TBF granules. CASE: The patient died within 3 h after applying 20 bags of 5% TBF granules (900 g per bag)...
July 6, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28677675/probabilistic-dietary-risk-assessment-of-pesticide-residues-in-foods-for-the-german-population-based-on-food-monitoring-data-from-2009-to-2014
#9
Christian Sieke, Britta Michalski, Thomas Kuhl
Dietary risks for the German population owing to pesticide residues in foods were assessed based on food monitoring data, consumption surveys for children and adults and compound specific toxicological reference values or general thresholds of toxicological concern. A tiered probabilistic modelling was conducted to screen 700 pesticides for significant long- and short-term dietary exposures. Especially for the short-term dietary exposure, the probabilistic methodology used allows simultaneous consideration of the complete daily consumption, whereas most regulatory bodies still rely on single commodity approaches...
July 5, 2017: Journal of Exposure Science & Environmental Epidemiology
https://www.readbyqxmd.com/read/28668334/a-retrospective-analysis-of-in-vivo-eye-irritation-skin-irritation-and-skin-sensitisation-studies-with-agrochemical-formulations-setting-the-scene-for-development-of-alternative-strategies
#10
M Corvaro, S Gehen, K Andrews, R Chatfield, F Macleod, J Mehta
Analysis of the prevalence of health effects in large scale databases is key in defining testing strategies within the context of Integrated Approaches on Testing and Assessment (IATA), and is relevant to drive policy changes in existing regulatory toxicology frameworks towards non-animal approaches. A retrospective analysis of existing results from in vivo skin irritation, eye irritation, and skin sensitisation studies on a database of 223 agrochemical formulations is herein published. For skin or eye effects, high prevalence of mild to non-irritant formulations (i...
June 28, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28654780/development-and-validation-of-an-icp-ms-method-for-the-determination-of-elemental-impurities-in-tp-6076-active-pharmaceutical-ingredient-api-according-to-usp-%C3%A2-232%C3%A2-%C2%AA-%C3%A2-233%C3%A2-%C2%AA
#11
Osama Chahrour, John Malone, Mark Collins, Vrushali Salmon, Catherine Greenan, Amy Bombardier, Zhongze Ma, Nick Dunwoody
The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and concentration/limits of elemental impurities in pharmaceutical final products, active pharmaceutical ingredients (API) and excipients. In chapter USP 〈233〉 method implementation, validation and quality control during the analytical process are described...
June 20, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28645863/toxicology-of-octamethylcyclotetrasiloxane-d4
#12
Allison Franzen, Tracy Greene, Cynthia Van Landingham, Robinan Gentry
Octamethylcyclotetrasiloxane (D4) is a volatile cyclic siloxane used primarily as a monomer or intermediate in the production of some silicon-based polymers widely used in industrial and consumer applications and may be present as a residual impurity in a variety of consumer products. A robust toxicological data set exists for D4. Treatment-related results from a chronic inhalation study conducted in rats are limited to mild effects on the respiratory tract, increases in liver weight, increases in the incidence of uterine endometrial epithelial hyperplasia, and a dose-related trend in the incidence of endometrial adenomas...
June 20, 2017: Toxicology Letters
https://www.readbyqxmd.com/read/28641506/regulatory-forum-opinion-piece-imaging-applications-in-toxicologic-pathology-recommendations-for-use-in-regulated-nonclinical-toxicity-studies
#13
Robert R Maronpot, Abraham Nyska, Sean P Troth, Kathleen Gabrielson, Polina Sysa-Shah, Vyacheslav Kalchenko, Yuri Kuznetsov, Alon Harmelin, Yael S Schiffenbauer, David Bonnel, Jonathan Stauber, Yuval Ramot
Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist's armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such as organ and lesion volume not obtained by conventional toxicology study parameters. Representative examples of practical imaging applications in toxicology research and preclinical studies are presented for ultrasound, positron emission tomography/single-photon emission computed tomography, optical, magnetic resonance imaging, and matrix-assisted laser desorption ionization-imaging mass spectrometry imaging...
June 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28627759/vibrational-biospectroscopy-characterises-biochemical-differences-between-cell-types-used-for-toxicological-investigations-and-identifies-alterations-induced-by-environmental-contaminants
#14
Kelly A Heys, Richard F Shore, M Glória Pereira, Francis L Martin
The use of cell-based assays is essential in reducing the number of vertebrates used in the investigation of chemical toxicities and in regulatory toxicology assessment. An important factor in obtaining meaningful results which can be accurately extrapolated is the use of biologically appropriate cell lines. In this preliminary study, ATR-FTIR spectroscopy with multivariate analysis was used to assess the fundamental biomolecular differences between a commonly used cell line, MCF-7 cells, and an environmentally relevant cell line derived from Mallard (Anas platyrhynchos) dermal fibroblasts...
June 19, 2017: Environmental Toxicology and Chemistry
https://www.readbyqxmd.com/read/28627468/a-novel-chalcone-derivative-lqfm064-induces-breast-cancer-cells-death-via-p53-p21-kit-and-pdgfra
#15
Bruna Lannuce Silva Cabral, Artur Christian Garcia da Silva, Renato Ivan de Ávila, Alane Pereira Cortez, Rangel Magalhães Luzin, Luciano Morais Lião, Eric de Souza Gil, Gérman Sanz, Boniek G Vaz, José R Sabino, Ricardo Menegatti, Marize Campos Valadares
This study shows the design, synthesis and antitumoral potential evaluation of a novel chalcone-like compound, (E)-3- (3, 5-di-ter-butyl-4-hydroxyphenyl)-1- (4-hydroxy-3-methoxyphenyl) prop-2-en-1-one [LQFM064) (4)], against human breast adenocarcinoma MCF7 cells. Some toxicological parameters were also investigated. LQFM064) (4) exhibited cytotoxic activity against MCF7 cells (IC50=21μM), in a concentration dependent-manner, and triggered significant changes in cell morphology and biochemical/molecular parameters, which are suggestive of an apoptosis inductor...
June 13, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28625566/advances-in-bioremediation-of-1-4-dioxane-contaminated-waters
#16
Shu Zhang, Phillip B Gedalanga, Shaily Mahendra
1,4-Dioxane is a contaminant of emerging concern that has been found widespread in groundwater, surface water, and drinking water environments. Many states are implementing lower regulatory advisory levels based on the toxicological profile of 1,4-dioxane and the potential public health risks. However, the unique chemical properties of 1,4-dioxane, such as high water solubility, low Henry's law constant, and importantly, the co-occurrence with chlorinated solvents and other contaminants, increase the challenges to efficiently cleanup 1,4-dioxane...
June 15, 2017: Journal of Environmental Management
https://www.readbyqxmd.com/read/28625099/toxicology-in-clinical-laboratories-challenging-times
#17
N W Brown
In recent years, there have been a number of significant developments in toxicology within clinical laboratories, both with the available instrumentation and in the range of compounds abused by the drug using communities. There have also been developments in the regulation of forensic science in the UK which may in time impact clinical toxicology. This review is designed to provide an update of these changes within toxicology to the more general pathology laboratory audience. For detailed information in specific areas, the reader is referred to the references in the text...
July 2017: British Journal of Biomedical Science
https://www.readbyqxmd.com/read/28618056/improving-substance-information-in-usetox%C3%A2-part-1-discussion-on-data-and-approaches-for-estimating-freshwater-ecotoxicity-effect-factors
#18
Erwan Saouter, Karin Aschberger, Peter Fantke, Michael Z Hauschild, Stephanie K Bopp, Aude Kienzler, Alicia Paini, Rana Pant, Michela Secchi, Serenella Sala
The scientific consensus model USEtox® is recommended by the European Commission as the reference model to characterize life cycle chemical emissions in terms of their potential human toxicity and freshwater aquatic ecotoxicity impacts in the context of the International Reference Life Cycle Data System (ILCD) Handbook and the Environmental Footprint pilot phase looking at products (PEF) and organisations (OEF). Consequently, this model has been systematically used within the PEF/OEF pilot phase by 25 EU industry sectors, which manufacture a wide variety of consumer products...
June 15, 2017: Environmental Toxicology and Chemistry
https://www.readbyqxmd.com/read/28599657/comparison-of-methods-for-calculating-the-health-costs-of-endocrine-disrupters-a-case-study-on-triclosan
#19
Radka Prichystalova, Jean-Baptiste Fini, Leonardo Trasande, Martine Bellanger, Barbara Demeneix, Laura Maxim
BACKGROUND: Socioeconomic analysis is currently used in the Europe Union as part of the regulatory process in Regulation Registration, Evaluation and Authorisation of Chemicals (REACH), with the aim of assessing and managing risks from dangerous chemicals. The political impact of the socio-economic analysis is potentially high in the authorisation and restriction procedures, however, current socio-economic analysis dossiers submitted under REACH are very heterogeneous in terms of methodology used and quality...
June 9, 2017: Environmental Health: a Global Access Science Source
https://www.readbyqxmd.com/read/28596090/liposomes-containing-monophosphoryl-lipid-a-and-qs-21-serve-as-an-effective-adjuvant-for-soluble-circumsporozoite-protein-malaria-vaccine-fmp013
#20
Christopher J Genito, Zoltan Beck, Timothy W Phares, Fanta Kalle, Keith J Limbach, Maureen E Stefaniak, Noelle B Patterson, Elke S Bergmann-Leitner, Norman C Waters, Gary R Matyas, Carl R Alving, Sheetij Dutta
Malaria caused by Plasmodium falciparum continues to threaten millions of people living in the tropical parts of the world. A vaccine that confers sterile and life-long protection remains elusive despite more than 30years of effort and resources invested in solving this problem. Antibodies to a malaria vaccine candidate circumsporozoite protein (CSP) can block invasion and can protect humans against malaria. We have manufactured the Falciparum Malaria Protein-013 (FMP013) vaccine based on the nearly full-length P...
June 5, 2017: Vaccine
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