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Regulatory Toxicology and Pharmacology: RTP

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https://read.qxmd.com/read/30779931/28-day-somatic-gene-mutation-study-of-1-bromopropane-in-female-big-blue-%C3%A2-b6c3f1-mice-via-whole-body-inhalation-support-for-a-carcinogenic-threshold
#1
Mark Stelljes, Robert Young, Jeff Weinberg
A 2-year inhalation rat and mouse cancer study by the National Toxicology Program (NTP) on 1-bromopropane, a brominated solvent most commonly used as a vapor degreaser, showed significant increase in tumors in the lung of female mice and in the large intestine of male and female rats. The most sensitive endpoint was lung tumors in female mice. Mice of both sexes had hyperplasia and inflammation of the nose and showed regeneration of lung tissue. The NTP assumed that these tumors were due to genotoxic effects and that a linear dose-response relationship was appropriate...
February 16, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30771368/toxicological-assessment-compilation-of-selected-examples-of-raw-materials-for-homeopathic-medicinal-products
#2
REVIEW
Marie-Luise Buchholzer, Marion Kirch, Christiane Kirchner, Werner Knoess
The considerable number of homeopathic medicinal products (HMP) on the German market and the staggering breadth of active substances of various origin along with the specific legal requirements of adequate safety principles posed the need to compile data on toxicologically evaluated raw materials. In line with the European regulatory framework, HMP applications must consider appropriate safety standards in analogy to conventional human medicinal products. This review presents an option for a systematic and scientifically substantiated approach for regulatory use...
February 13, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30753850/evaluation-of-developmental-toxicity-of-methyl-chloride-chloromethane-in-rats-mice-and-rabbits
#3
REVIEW
Josje Arts, Marco Kellert, Lynn Pottenger, Josianne Theuns-van Vliet
Methyl Chloride (MeCl; Chloromethane) is a high production volume chemical (>1000 t/a) and is used as an industrial solvent. Based on cardiac lesions reported in developmental toxicity studies in mice, but not in rats, manufacturers decided to classify MeCl as a developmental toxicant, cat. 2. Recently, the European Chemical Agency required a developmental toxicity study in a non-rodent species. No developmental toxicity was observed in rabbits in the recently completed, GLP, OECD 414 guideline study. In view of the absence of cardiac effects in rats and rabbits, the purpose of this review is to consider whether the cardiac effects reported in mice should be considered real effects and, if so, their potential for relevance to humans...
February 9, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30742876/acute-toxicity-and-genotoxicity-evaluations-of-nattokinase-a-promising-agent-for-cardiovascular-diseases-prevention
#4
Hao Wu, Huan Wang, Feng Xu, Jiepeng Chen, Lili Duan, Fengjiao Zhang
Cardiovascular diseases (CVDs) are the leading cause of death in the world; however, current agents for CVDs prevention are still limited. Owing to the serious bleeding risk of Aspirin, FDA recently recommended against it from preventing first heart attacks. Nattokinase (NK), a serine protease possessing many key beneficial effects on cardiovascular system, is being pursued as a promising alternative agent. In light of this, the safety profile of NK, in particular its potential genotoxicity, need to be characterized...
February 8, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30742875/regulatory-effect-of-decreasing-therapeutic-duplication-of-respiratory-drugs-using-a-prescription-database-between-2012-and-2015
#5
Hyesung Lee, Inmyung Song, Sun Mi Shin, Han Eol Jeong, Eui-Kyung Lee, Ju-Young Shin
Duplicative drug use increases the risk of adverse drug reactions and expends healthcare resources unnecessarily. No epidemiological evidence of the prevalence of therapeutic duplication (TD) involving respiratory system drugs exists. Therefore, we describe the prescription patterns of these drugs and estimate changes in TD rates following implementation of a new regulation in 2013. A time-series analysis using national healthcare data was conducted, involving eight classes, and patients prescribed any of these drugs between 2012 and 2015...
February 8, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30738882/a-90-day-subchronic-toxicology-screen-of-genetically-modified-rice-lac-3-and-its-effects-on-the-gut-microbiota-in-sprague-dawley-rats
#6
Xueqin Zhang, Tongtong Zhang, Jingni Shi, Shiying Zou, Mingzhang Guo, Xiaoyun He, Daichang Yang, Xiaohong Mei
A 90-day subchronic toxicology screen of genetically modified (GM) rice Lac-3 expressing human lactoferrin (hLF) and its effects on the gut microbiota were studied in comparison to non-GM rice fed to Sprague-Dawley (SD) rats. Three different dietary concentrations (17.5%, 35% and 70%, w/w) of the GM rice or its corresponding non-GM rice were used. Additionally, the phylotypes of gut microbiota in the control group, the 70% GM rice diet group and the 70% non-GM rice diet group on day 90 were determined by 16S rRNA sequencing...
February 7, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30738088/subacute-toxicity-and-toxicokinetics-study-of-dhp107-an-oral-paclitaxel-formulation-with-once-weekly-dosing-in-mice
#7
Ji-Young Kim, Sunyeong Lee, Yongbum Kim, Eun Ju Jeong, In-Hyun Lee, Min-Hee Son, Jae Young Lee, Sang Kyum Kim, Kyoung-Sik Moon
DHP107, an oral formulation of paclitaxel, is effectively and systemically absorbed in intestinal endothelial cells. Although the in vivo efficacy of DHP107 has been reported, the potential toxicity of DHP107 has not been evaluated. Therefore, this study was conducted to evaluate the toxicity and toxicokinetics of DHP107 orally administered to ICR mice at 25, 50, and 100 mg/kg via once-weekly dosing for six weeks. DHP107-related clinical signs were observed in both sexes at 100 mg/kg. There were significant increases in the number of platelets and percentages of reticulocytes and basophils in male mice...
February 6, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30735698/toxicology-study-of-long-term-administration-of-rhkgf-2-eye-drops-on-rabbit-corneas
#8
JianQiu Cai, Wenqing Li, Jinghang Li, Qingde Zhou, Yadong Huang, Xiaokun Li, Qi Hui, Xiaojie Wang
Keratinocyte growth factor -2 promotes corneal repair. Its mechanism of action involves regulating regeneration and migration of corneal cells, as well as activating corneal limbal stem cells. However, KGF-2 being a carcinogenic growth factor and its potential adverse effect in over dosage long-term treatment had not yet been reported. In this study, we used New Zealand white rabbits to study possible toxic effects of ocular administration of recombinant human keratinocyte growth factor-2 eye drops. Animals in the medium- and high-dose groups had some ocular irritant reactions during the course of drug administration; however this reaction was harmless to the cornea and it ended up when administration was stopped...
February 5, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30721718/toxicological-comparison-of-cigarette-smoke-and-e-cigarette-aerosol-using-a-3d-in-vitro-human-respiratory-model
#9
Lukasz Czekala, Liam Simms, Matthew Stevenson, Nicole Tschierske, Anna G Maione, Tanvir Walele
With the growing prevalence of e-cigarettes as an alternative to conventional cigarettes amongst smokers worldwide, there is a need for new methods to evaluate their relative toxicological profile as part of a safety assessment. Initiatives to replace, reduce and refine animal testing have led to developments of new methodologies utilizing organotypic, in vitro tissue models. Here we use a respiratory epithelial model, EpiAirway, to examine the biological effects of nicotine-containing blu PLUS + e-cigarettes, with or without blueberry flavoring, in comparison to conventional cigarette smoke...
February 2, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30716379/evaluation-of-aspartame-cancer-epidemiology-studies-based-on-quality-appraisal-criteria
#10
REVIEW
Lois Haighton, Ashley Roberts, Tomas Jonaitis, Barry Lynch
Given the widespread use of the low-calorie sweetener aspartame over the last 30 years, the current work was undertaken to evaluate aspartame epidemiology studies looking at cancer endpoints against quality appraisal criteria. The quality appraisal tool used was from the National Heart, Lung and Blood Institute (NHLBI) of the National Institute of Health. Studies identified included nine case-control studies and five prospective cohort studies. Most studies assessed low-calorie or diet beverages rather than aspartame intake specifically; however, common use of aspartame in diet sodas does allow for some general extrapolation of results...
February 1, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30711621/approval-of-modified-release-products-by-fda-without-clinical-efficacy-safety-studies-a-retrospective-survey-from-2008-to-2017
#11
Yi-Lin Wang, Yi-Ting Chang, Shih-Ying Yang, Ya-Wen Chang, Mei-Hsien Kuan, Chien-Lung Tu, Hui-Chun Hong, I-Chun Lai, Churn-Shiouh Gau, Li-Feng Hsu
In principle, approval of a modified-release (MR) drug product is based on evidence from pharmacokinetic (PK) and/or pharmacodynamic studies and clinical efficacy/safety studies. The purpose of this survey is (i) to explore the number of new drug applications (NDAs) of MR drug products, approved by the FDA, employ the PK study as a bridge to already-approved immediate-release drug products without conducting their own clinical efficacy/safety studies; and (ii) to understand the type of PK studies are required for such NDAs...
January 31, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30710578/emission-level-of-seven-mainstream-smoke-toxicants-from-cigarette-with-variable-tobacco-leaf-constituents
#12
Bin Cai, Zhitao Li, Rengang Wang, Zhaoliang Geng, Yuewei Shi, Shengdong Xie, Zhihong Wang, Zhixiao Yang, Xueliang Ren
[Introduction] Seven smoke constituents, including hydrogen cyanide (HCN), ammonia (NH3 ), phenol, benzo[α]pyrene (B[a]P), carbon monoxide (CO)¸ crotonaldehyde, and 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanone (NNK), are proposed be the most relevant constituents for smoking-related diseases. [Methods] Different combinations of leaf stalk positions, varieties and locations were used to create variable chemistry of cigarette filler and smoke. Experimental cigarettes were measured for emission level of seven smoke toxicants and content of seventy-three filler components...
January 30, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30707931/an-evaluation-of-the-usepa-proposed-approaches-for-applying-a-biologically-based-dose-response-model-in-a-risk-assessment-for-perchlorate-in-drinking-water
#13
Harvey H Clewell, P Robinan Gentry, C Eric Hack, Tracy Greene, Rebecca A Clewell
The United States Environmental Protection Agency's (USEPA) 2017 report, "Draft Report: Proposed Approaches to Inform the Derivation of a Maximum Contaminant Level Goal for Perchlorate in Drinking Water", proposes novel approaches for deriving a Maximum Contaminant Level Goal (MCLG) for perchlorate using a biologically-based dose-response (BBDR) model. The USEPA (2017) BBDR model extends previously peer-reviewed perchlorate models to describe the relationship between perchlorate exposure and thyroid hormone levels during early pregnancy...
January 29, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30703409/acute-and-sub-chronic-90-day-oral-toxicity-study-of-perilla-seed-oil-in-rodents-and-beagle-dogs
#14
Hui-Xing Zhang, Jian Guan, Yi-Hong Tian, Guang-Yue Su, Yu-Qing Zhao
Perilla seeds are used as food and traditional medicine in China. This study aimed to investigate the toxicity profile of Perilla seed oil (PSO), which is the main constituent of Perilla seeds in rodents and Beagle dogs. No significant treatment-associated toxicity or mortality was observed at PSO dosages of up to 50 g/kg and 20 g/kg in KM mice and Wistar rats, respectively, suggesting that PSO was well tolerated by the experimental rodents. Sub-chronic oral toxicity of PSO was studied in dogs at doses of 3, 6 and 12 g/kg/d for 90 days followed by a 30 day recovery period...
January 28, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30703408/improving-risk-assessment-approaches-for-chemicals-with-both-endogenous-and-exogenous-exposures
#15
William H Farland, Angela Lynch, Neeraja K Erraguntla, Lynn H Pottenger
To conduct risk assessments of exogenous chemicals for which there are also endogenous exposures, knowledge of the chemistry and biology of both types of exposures need to be integrated into problem formulation and carried through to risk characterization. This issue is framed in a risk assessment context, highlighting the importance of quantifying increments of dose from all sources of the same or similar chemicals interacting with biological targets; understanding the influence of endogenous chemical concentrations on disease risk; and assessing total dose to targets in evaluating risk from incremental environmental exposures...
January 28, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30685222/a-study-in-a-rat-initiation-promotion-bladder-tumour-model-demonstrated-no-promoter-progressor-potential-of-dapagliflozin
#16
Martin Billger, Jason Kirk, Jane Chang, Agathe Bedard, Bassem Attalla, Solomon Haile, Magnus Söderberg
Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is indicated to improve glycaemic control in adults of type 2 diabetes. In nonclinical studies, dapagliflozin was neither genotoxic nor carcinogenic. However, in some clinical studies, an increased incidence of bladder cancer was observed in the dapagliflozin group vs. the placebo. Therefore, this study was undertaken to determine if dapagliflozin can act as a promoter in a 2-stage bladder cancer model in rats induced with N-butyl-N-(4-hydroxybutyl)-nitrosamine (BBN)...
January 24, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30684565/a-comprehensive-toxicological-safety-assessment-of-an-extract-of-ageratum-conyzoides
#17
Philip A Palmer, Bryson A Jessica, Amy E Clewell, John R Endres, Gábor Hirka, Adél Vértesi, Erzsébet Béres, Róbert Glávits, Ilona Pasics Szakonyiné
A battery of toxicological studies was conducted to aid in the safety assessment of an ethanolic extract of Ageratum conyzoides for use as an ingredient in food. In accordance with internationally accepted standards, a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, an in vivo mammalian micronucleus test, and a 90-day repeated-dose oral toxicity study in rats were performed. In the first three applied test systems, no evidence of mutagenicity, clastogenicity or genotoxicity was revealed...
January 23, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30682377/toxicologic-evaluation-of-repetitive-4-week-intravenous-injections-of-midkine-antisense-oligonucleotide-nanoliposomes-in-rats
#18
Jing Chen, Jing Zhong, Pingping Niu, Limin Xu, Linfu Zhou, Honghai Wu, Chao Chen, Licheng Dai
Midkine antisense oligonucleotide (MK-ASODN) nanoliposomes have previously been shown to have inhibitory activity against hepatocellular carcinoma growth. Herein we report the 4-week sub-chronic toxicity of MK-ASODN nanoliposomes in SD rats. The adverse effects included loss of body weight gain and food consumption, peri-rhinal bleeding, piloerection, peri-anal filth, and kidney, liver, spleen, thymus, lung, and injection site lesions at high doses. Macroscopic changes were observed in the kidneys of the high-dose group, accompanied by a variation in urine protein and white blood cells, blood urea nitrogen, and serum creatinine...
January 22, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30664901/human-health-safety-studies-of-a-new-insecticide-dissipation-kinetics-and-dietary-risk-assessment-of-afidopyropen-and-one-of-its-metabolites-in-cucumber-and-nectarine
#19
Jun Xie, Yunxi Zheng, Xingang Liu, Fengshou Dong, Jun Xu, Xiaohu Wu, Mingshan Ji, Yongquan Zheng
To preliminarily study the law of natural dissipation and the relation to human health of a new insecticide (afidopyropen), the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method and a UHPLC-MS/MS system were used to extract and detect the afidopyropen and its metabolite (M440I007) from cucumber and nectarine. The limits of quantitation (LOQs) of both target compounds in two matrixes were reduced to 0.0001 mg/kg. Dissipative dynamics experiments indicated that afidopyropen residue dissipation is more consistent with a two-compartment kinetic model than a first-order kinetic model whether in cucumber or nectarine...
January 18, 2019: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/30664900/effective-tool-for-assessment-of-the-quality-of-barrier-creams-relationships-between-rheological-textural-and-sensory-properties
#20
Agnieszka Kulawik-Pióro, Anna Ptaszek, Joanna Kruk
The efficiency of barier creams (BC) in the prevention of occupational skin diseases is closely related to their mechanical, rheological but also sensory properties. The measurement procedure we elaborated, which simulates the spreadability conditions on the skin and evaluation whether the structure reconstruction occurs (hysteresis loop test, shear rate dependence of normal force), allows the assessment of the effectivness of the BC in terms of mechanical resistance and its adhesion to the skin surface. In this thesis an effort was made to define the impact of the human factor - the product application on skin - on the efficiency of medical devices for cutaneous use...
January 18, 2019: Regulatory Toxicology and Pharmacology: RTP
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