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Regulatory Toxicology and Pharmacology: RTP

Satoru Munakata, Kanae Ishimori, Nobumasa Kitamura, Shinkichi Ishikawa, Yuichiro Takanami, Shigeaki Ito
The use of novel tobacco- and nicotine-containing vapor products that do not combust tobacco leaves is on the rise worldwide. The emissions of these products typically contain lower numbers and levels of potentially harmful chemicals compared with conventional cigarette smoke. These vapor products may therefore elicit fewer adverse biological effects. We compared the effects of emissions from different types of such products, i.e., our proprietary novel tobacco vapor product (NTV), a commercially available heat-not-burn tobacco product (HnB), and e-cigarette (E-CIG), and a combustible cigarette in a human bronchial epithelial cell line...
September 15, 2018: Regulatory Toxicology and Pharmacology: RTP
Youngbeom Ahn, Ji Young Jung, Brian T Veach, Sangeeta Khare, Kuppan Gokulan, Silvia A Piñeiro, Carl E Cerniglia
The use of antimicrobials, such as tetracycline, in food-producing animals may result in antimicrobial drug residues (ADR) in edible tissues from treated animals and contribute to the emergence of antibiotic resistant bacteria. The Veterinary International Conference on Harmonization (VICH) document (VICH GL36(R)/FDA-CVM Guidance for Industry#159) provides guidance on evaluating the safety of veterinary ADR in the human foods as related to effects on the human intestinal microbiome. One recognized research gap is a need for additional data and testing requirements to determine the fraction of an oral dose of ADR available to intestinal microorganisms...
September 15, 2018: Regulatory Toxicology and Pharmacology: RTP
Thomas Verron, Rémi Julien, Xavier Cahours, Stéphane Colard
Since it was first required to measure and to report NFDPM and nicotine yields in a limited number of countries, there has been an increasing trend for more testing and reporting requirements. Historically, the ISO 3308 smoking regime has been used to determine NFDPM and nicotine yields. However recommendations from the World Health Organization, now include the use of two smoking regimes such as the ISO 3308 and the WHO TobLabNet Official Method SOP01, the latter being considered as an intense smoking regime...
September 15, 2018: Regulatory Toxicology and Pharmacology: RTP
Gunnar Damgaard Nielsen
In mice, inhalation of formic, acetic, propionic and butyric acid caused a rapid decrease in the respiratory rate, which decreased to a stable level during the remaining part of the 30 min exposure period; this was due to sensory irritation. The concentration decreasing the respiratory rate (RD) by 50% (RD50) was 438, 308, 386 and 285 ppm, respectively, which allowed an adequate prediction of the Threshold Limit Values. In mice inhaling through a tracheal cannula, bypassing the trigeminal nerves, caused a slower decrease in respiratory rate due to pulmonary irritation...
September 14, 2018: Regulatory Toxicology and Pharmacology: RTP
Qing Zhou, Shuhua Xi
Long-term exposure to arsenic (inorganic arsenic) is a world-wide environmental health concern. Arsenic is classified as the Group 1 human carcinogen by the International Agency for Research on Cancer (IARC). Epidemiological studies have established a strong association between inorganic arsenic (iAs) exposure in drinking water and an increased incidence of cancer including bladder, liver, lung, prostate, and skin cancer. iAs also increases the risk of other diseases such as cardiovascular disease, hypertension and diabetes...
September 14, 2018: Regulatory Toxicology and Pharmacology: RTP
Keiichiro Sato, Hidenori Watanabe, Takanori Ikeda, Hiroaki Miida, Kiyoshi Ohtaki, Kazuto Watanabe
The distribution of active pharmaceutical ingredients (APIs) in prescription medicines for human consumption in Japan was estimated using the public database of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). From the latest NDB, 2058 APIs were identified, and the prescription weight exceeded 1 tonne/year for 711 APIs. Of these, 298 APIs were selected for further analysis after removing 413 APIs that were not covered by current environmental risk assessment (ERA) directives or were combination products...
September 14, 2018: Regulatory Toxicology and Pharmacology: RTP
M Sue Marty, Chris Borgert, Katie Coady, Richard Green, Steven L Levine, Ellen Mihaich, Lisa Ortego, James R Wheeler, Kun Don Yi, Leah M Zorrilla
The endocrine system is responsible for growth, development, maintaining homeostasis and for the control of many physiological processes. Due to the integral nature of its signaling pathways, it can be difficult to distinguish endocrine-mediated adverse effects from transient fluctuations, adaptive/compensatory responses, or adverse effects on the endocrine system that are caused by mechanisms outside the endocrine system. This is particularly true in toxicological studies that require generation of effects through the use of Maximum Tolerated Doses (or Concentrations)...
September 11, 2018: Regulatory Toxicology and Pharmacology: RTP
Corie A Ellison
Physiologically based pharmacokinetic (PBPK) models enable simulations of absorption, distribution, metabolism, and elimination of chemicals from the body. Model evaluation is a key step in the PBPK model development processes whereby model predictions are compared to pharmacokinetic (PK) data. A prerequisite for PBPK model evaluation has always been the availability of PK data for the modeled compound, a requirement which has limited the use and acceptance of PBPK models since PK data is often limited or not available...
September 7, 2018: Regulatory Toxicology and Pharmacology: RTP
Ian M Fearon, Alison C Eldridge, Nathan Gale, Mike McEwan, Mitchell F Stiles, Elaine K Round
E-cigarettes are battery-powered electronic devices from which users can inhale nicotine following its aerosolisation from a liquid solution. Some regulators and public health bodies consider e-cigarettes as potentially playing a major role in tobacco harm reduction. Their ability to provide nicotine to smokers in both amount and in a manner and form generally similar to cigarette smoking have been proposed as key components to help smokers reduce or cease the use of combustible cigarettes. Nicotine pharmacokinetic studies of e-cigarettes have been performed for a number of years and are beginning to show how nicotine delivery is evolving as the products themselves evolve...
September 7, 2018: Regulatory Toxicology and Pharmacology: RTP
Cunxi Wang, Wenze Li, Colton R Kessenich, Jay S Petrick, Timothy J Rydel, Eric J Sturman, Thomas C Lee, Kevin C Glenn, Thomas C Edrington
The lepidopteran-active Cry1A.105 protein is a chimeric three-domain insecticidal toxin with distinct structural domains derived from the naturally occurring Cry1Ab, Cry1Ac and Cry1F proteins from the soil bacterium Bacillus thuringiensis (Bt). The X-ray crystal structure of the Cry1A.105 tryptic core at 3.0 Å resolution demonstrates its high structural similarity to the tryptic core of Cry1Ac. Bioinformatics analyses demonstrate that Cry1A.105 has no significant amino acid sequence similarity to known allergens or mammalian toxins, which is the same conclusion reached for its component domains...
September 6, 2018: Regulatory Toxicology and Pharmacology: RTP
Robert E Tarone
No abstract text is available yet for this article.
September 5, 2018: Regulatory Toxicology and Pharmacology: RTP
Charles Laroche, Manoj Aggarwal, Hans Bender, Paul Benndorf, Barbara Birk, Jonathan Crozier, Gianni Dal Negro, Federica De Gaetano, Christian Desaintes, Iain Gardner, Bruno Hubesch, Amaia Irizar, David John, Vikas Kumar, Alfonso Lostia, Irene Manou, Mario Monshouwer, Boris P Müller, Alicia Paini, Kirsty Reid, Timothy Rowan, Magdalini Sachana, Katrin Schutte, Catrina Stirling, Rob Taalman, Leon van Aerts, Renate Weissenhorn, Ursula G Sauer
The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum Toxicokinetics and Read-Across to provide an overview on research activities to develop in vitro toxicokinetics methods and physiologically-based kinetic (PBK) models and to find synergies to enhance use of toxicokinetic data to strengthen read-across. Currently, lacking toxicokinetic data often prevent the application of read-across. Preferably, toxicokinetic data should be generated using in vitro and in silico tools and anchored towards human relevance...
August 23, 2018: Regulatory Toxicology and Pharmacology: RTP
Yong-Jiang Zhou, Hai-Rong Huang, Jing Zhou, Li-Qing Wang
This study aimed to investigate the toxicity mechanism of beta-cypermethrin (beta-CYP) on fertility in female mice. Eighty female mice were randomly assigned to four groups of 20 mice each: one control group and three beta-CYP-treated groups. The control group was administered corn oil only, while the three beta-CYP-treated groups were given corn oil containing 1.38, 2.76, and 5.52 mg/kg bw.d beta-CYP for 180 days through intragastric administration. The results found that the 2.76 and 5.52 mg/kg bw.d beta-CYP significantly decreased the rate of successful pregnancy (p < 0...
August 20, 2018: Regulatory Toxicology and Pharmacology: RTP
Ozge Kose, Pinar Erkekoglu, Suna Sabuncuoglu, Belma Kocer-Gumusel
Human skin is a protective barrier against the toxic effects of cosmetics. Marketing of cosmetic products with ingredients tested on animals was prohibited in 2013. Since then, safety evaluation of cosmetic products is performed by using alternative in vitro toxicity tests. In vitro 3-D reconstructed human epidermis (RhE) tissue models are now used to define skin irritation/corrosion potentials of cosmetic ingredients and end-products. The main aim of this study was to evaluate skin irritation potentials of topically used cosmetic end-products which were marketed in Turkey during 2015-2017, by using the EpiDerm in vitro 3D-human skin model...
August 20, 2018: Regulatory Toxicology and Pharmacology: RTP
Simone Caetani Machado, Isarita Martins
Pesticides occupy a special position among various chemical agents that are present in the environment because of to their toxicity, wide use, mainly in mixtures, and lack of action selectivity. To correlate the toxic effects to the pesticides exposure, biomarkers called endpoints are used and often use highly predictive adverse effects or death; however, there is a constant search for markers that may determine the effects of exposure before the organisms suffer from them, and these markers are the so-called surrogate endpoints...
August 18, 2018: Regulatory Toxicology and Pharmacology: RTP
Helena Ponte, Rui Santos Ivo, Beatriz Silva-Lima, Fernando Ramos
The health benefits of the antimicrobial's use is inherently associated to the risk of antimicrobial resistance (AMR), an ever-increasing multifactorial problem, closely related with injudicious use of antimicrobials, and the lack of new antimicrobial medicines on the market, particularly for veterinary use. Currently, an increasing number of regulatory "One Health" action plans on AMR are running worldwide, already based on monitoring and surveillance systems for resistance and antimicrobials consumption...
August 18, 2018: Regulatory Toxicology and Pharmacology: RTP
Ulrike Bernauer
In response to the concerns of the European Commission about potential absorption and entry of nanoparticles of hydroxyapatite into the cells when used in oral cosmetic products, the Scientific Committee on Consumer Safety (SCCS) was requested to provide a safety assessment of hydroxyapatite (nano). After making a detailed evaluation of the data provided in the submissions and scientific literature, the SCCS considered needle-shaped hydroxyapatite (nano) to be of concern due to its potential toxic effects, and stated that it should not be used in cosmetic products...
August 17, 2018: Regulatory Toxicology and Pharmacology: RTP
Niels Hadrup, Anoop K Sharma, Katrin Loeschner
Silver is used in different applications that result in contact with skin and mucosal surfaces (e.g., jewelry, wound dressings, or eye drops). Intact skin poses an effective barrier against the absorption of silver. Mucosal surfaces are observed to be less effective barriers and compromised skin is often a poor barrier. Silver can deposit as particles in the human body causing a blue-gray discoloration known as argyria. Urine and feces are reported pathways of excretion. Acute human mortality has been observed following an abortion procedure involving the intrauterine administration of 7 g silver nitrate (64 mg silver/kg body weight)...
August 17, 2018: Regulatory Toxicology and Pharmacology: RTP
Michael W J Urquhart, Ben Bardsley, Andrew J Edwards, Amanda Giddings, Emma Griva, Jim Harvey, Stephen Hermitage, Fiona King, Stuart Leach, Claire Lesurf, Clare McKinlay, Paul Oxley, Tran N Pham, Alec Simpson, Elaine Smith, Neil Stevenson, Charles Wade, Angela White, Nick Wooster
The mutagenic-impurity control strategy for a second generation manufacturing route to the non-mutagenic antipneumocystic agent atovaquone (2-((1R,4R)-4-(4-chlorophenyl)cyclohexyl)-3-hydroxynaphthalene-1,4-dione) 1 is described. Preliminary assessment highlighted multiple materials of concern which were largely discharged either through returning a negative bacterial mutagenicity assay or through confidence that the impurity would be purged during the downstream processing from when it was first introduced...
August 15, 2018: Regulatory Toxicology and Pharmacology: RTP
Asghar Ashrafi Hafez, Parvaneh Naserzadeh, Khadijeh Ashtari, Amir Mohammad Mortazavian, Ahmad Salimi
Metal nanoparticles (NPs) have been extensively used in industry as well as in biomedical application. Manganese oxide-nanoparticles (MnO2 -NPs) one of these materials, have many applications. This study was designed to evaluate the protective role of vitamin D against MnO2 -NPs -induced toxicity in the BALB c mice. These mice were randomly assigned to 4 (n = 10). In this study, MnO2 -NPs (10 mg/kg), vitamin D (10 mg/kg) and MnO2 -NPs plus vitamin D were administered interperitoneally once daily for 50 consecutive days...
August 10, 2018: Regulatory Toxicology and Pharmacology: RTP
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