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Regulatory Toxicology and Pharmacology: RTP

Ting Zhang, Wan Hong He, Ling Lin Feng, Hao Guang Huang
The objective of this study was to identify the effect of doxorubicin-induced ovarian toxicity on mouse ovarian granulosa cells. After granulosa cells were treated with doxorubicin at the final concentrations of 0, 0.4, 0.8, and 1.6 μg/ml for 24 h, cell apoptosis was detected by DAPI staining or caspase-3/7 fluorescence probe; ROS was determined by 2', 7'-dichlorodihydrofluorescin diacetate fluorescence probe; mitochondrial membrane potential was detected by rhodamine-123 fluorescence probe; and mRNA expression levels of Bax, Bcl-2, p53, FSHR, StAR, P450scc and P450arom were analyzed by RT-PCR...
February 17, 2017: Regulatory Toxicology and Pharmacology: RTP
Dana Loomis, Kathryn Z Guyton, Kurt Straif, Christopher P Wild
No abstract text is available yet for this article.
February 16, 2017: Regulatory Toxicology and Pharmacology: RTP
(no author information available yet)
No abstract text is available yet for this article.
February 14, 2017: Regulatory Toxicology and Pharmacology: RTP
Shengmin Zhou, Yueqiang Wang, Yuanrong Jiang, Liangli Lucy Yu
A novel medium- and long-chain triacylglycerols (MLCT), with 30% (w/w) medium-chain fatty acids (MCFA) was evaluated for its safety as a dietary fat in mice and rats. The subacute oral toxicity study showed that the maximum tolerated dose exceeded 54.33 g/kg body weight (kg bw)/day. In the 90-day feeding study, no dose-related adverse effects were observed in rats administered diets formulated with different levels of MLCT (2.0, 4.0, and 8.0 g/kg bw/day) as compared to the rapeseed oil control diet. Further safety assessment in pregnant rats did not reveal any significant difference relative to the control at a treatment level up to 8...
February 14, 2017: Regulatory Toxicology and Pharmacology: RTP
Parayil Varghese Christapher, Subramani Parasuraman, Mohd Zaini Asmawi, Vikneswaran Murugaiyah
Medicinal plant preparations may contain high levels of toxic chemical constituents to potentially cause serious harm to animals and/or humans. Thus, toxicity studies are important to assess the toxic effects of plant derived products. Polygonum minus is used traditionally for different ailments in Southeast Asia. This study was conducted to establish the acute and subchronic toxicity profile of the methanol extract of P. minus leaves. The acute toxicity study showed that the methanol extract of P. minus is safe even at the highest dose tested of 2000 mg/kg in female Sprague Dawley rats...
February 13, 2017: Regulatory Toxicology and Pharmacology: RTP
Boris Kolar, Antonio Finizio
The current EU guidelines for the environmental risk assessment of veterinary pharmaceutical products (VMPs) in groundwater (GW) suggest an approach based on the comparison between the calculated concentration in GW (PECgw) and a threshold concentration of 0.1 μg/L. The latter is the upper limit of the concentration for pesticides in groundwater in the EU. If the calculated PECgw does not exceed the threshold, then the risk is considered acceptable. It is assumed that the concentration of 0.1 μg/L is by default safe for both humans and exposed GW organisms...
February 12, 2017: Regulatory Toxicology and Pharmacology: RTP
D Alemán-González-Duhart, F Tamay-Cach, J Correa-Basurto, Padilla-Martínez, S Álvarez-Almazán, J E Mendieta-Wejebe
Peroxisome proliferator-activated receptors (PPARs) are nuclear receptors involved in the metabolism of lipids and carbohydrates. The exogenous ligands of these receptors are thiazolidinediones (TZDs), which are used to treat type 2 diabetes mellitus (DM2). However, drugs from this group produce adverse effects such as hepatic steatosis. Hence, the aim of this work was to design a set of small molecules that can activate the γ isoform of PPARs while minimizing the adverse effects. The derivatives were designed containing the polar head of TZD and an aromatic body, serving simultaneously as the body and tail...
February 12, 2017: Regulatory Toxicology and Pharmacology: RTP
Pingzhe Jiang, Zaizhong Ni, Bin Wang, Baicheng Ma, Huikun Duan, Xiaodan Li, Xiaofeng Ma, Qian Wei, Xiangzhen Ji, Qiqi Liu, Shuguang Xing, Minggang Li
A new trend has been developed using vanadium and organic ligands to form novel compounds in order to improve the beneficial actions and reduce the toxicity of vanadium compounds. In present study, vanadyl trehalose was explored the oral acute toxicity, 28 days repeated dose toxicity and genotoxicity in Kunming mice. The Median Lethal Dose (LD50) of vanadyl trehalose was revealed to be 1000 mg/kg body weight in fasted Kunming mice. Stomach and intestine were demonstrated to be the main target organs of vanadyl trehalose through 28 days repeated dose toxicity study...
February 12, 2017: Regulatory Toxicology and Pharmacology: RTP
Soojin Ha, Il Young Ahn, Da-Eun Kim, Jong Kwon Lee, Soojung Sohn, Mi-Sook Jung, Yong Heo, Takashi Omori, SeungJin Bae, Kyung-Min Lim
Recently UN GHS has introduced the sub-categorization of skin sensitizers for which ECt (concentration estimated to induce stimulation index above threshold) of the murine local lymph node assay (LLNA) is used as criteria. Non-radioisotopic variants of LLNA, LLNA: DA, LLNA: BrdU-ELISA, LNCC and LLNA: BrdU-FCM were developed yet their utilities for potency sub-categorization are not established. Here we assessed the agreement of LLNA variants with LLNA or human data in potency sub-categorization for 22 reference substances of OECD TG429...
February 10, 2017: Regulatory Toxicology and Pharmacology: RTP
Zhilin Zhang, Runzhe Liu, Xiaoping Pu, Yi Sun, Xin Zhao
Carthamus tinctorius L., or safflower, is an annual herbaceous crop belonging to the family Asteraceae, which is cultivated throughout China and used as a traditional Chinese medicine. Our previous study revealed anti-Parkinson's disease effects of an isolated standardized safflower flavonoid extract (SAFE). The purpose of this study is to evaluate the potential sub-chronic toxicity of SAFE. Male and female Sprague Dawley rats received three doses of SAFE (100, 300, and 500 mg/kg) q.d. by gavage for four weeks...
February 10, 2017: Regulatory Toxicology and Pharmacology: RTP
Menk K Prinsen, Coenraad F M Hendriksen, Cyrille A M Krul, Ruud A Woutersen
In 1944, Draize et al., published a paper entitled "Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes". The Organization for Economic Co-operation and Development published their first guideline on eye irritation in 1981, using rabbits. In the early eighties the development of alternative non-animal tests to replace the Draize eye test started. The first attempts to validate alternative tests for eye irritation were considered to be relatively simple by comparing in vitro and in vivo irritation index scores...
February 10, 2017: Regulatory Toxicology and Pharmacology: RTP
N von Goetz, R Pirow, A Hart, E Bradley, F Poças, D Arcella, I T L Lillegard, C Simoneau, J van Engelen, T Husoy, A Theobald, C Leclercq
In the most recent risk assessment for Bisphenol A for the first time a multi-route aggregate exposure assessment was conducted by the European Food Safety Authority. This assessment includes exposure via dietary sources, and also contributions of the most important non-dietary sources. Both average and high aggregate exposure were calculated by source-to-dose modeling (forward calculation) for different age groups and compared with estimates based on urinary biomonitoring data (backward calculation). The aggregate exposure estimates obtained by forward and backward modeling are in the same order of magnitude, with forward modeling yielding higher estimates associated with larger uncertainty...
February 7, 2017: Regulatory Toxicology and Pharmacology: RTP
Michelle Townsend, Connor Peck, Wei Meng, Matthew Heaton, Richard Robison, Kim O'Neill
Glyphosate is a highly used active compound in agriculturally based pesticides. The literature regarding the toxicity of glyphosate to human cells has been highly inconsistent. We studied the resulting DNA damage and cytotoxicity of various glyphosate concentrations on human cells to evaluate DNA damaging potential. Utilizing human Raji cells, DNA damage was quantified using the comet assay, while cytotoxicity was further analyzed using MTT viability assays. Several glyphosate concentrations were assessed, ranging from 15 mM to 0...
February 6, 2017: Regulatory Toxicology and Pharmacology: RTP
Cynthia Van Landingham, William Fuller, Greg Mariano, Kristin Marano, Geoffrey Curtin, Sandra I Sulsky
Though available evidence is relatively consistent in showing no additional health effects among smokers due to menthol in cigarettes, two studies reported conflicting results for stroke risk using different subsets of NHANES data. We investigated reasons for the differences in these reports by analyzing NHANES cycles conducted between 1999 and 2012, combined and in subsets. Adjusted odds ratios (AOR) and 95% confidence intervals (CI) from three different survey logistic regression models compare risk of reported stroke diagnoses among menthol and non-menthol cigarette smokers...
February 3, 2017: Regulatory Toxicology and Pharmacology: RTP
Susanne N Kolle, Andrew Van Cott, Bennard van Ravenzwaay, Robert Landsiedel
In vitro methods have gained regulatory acceptance for the prediction of serious eye damage (UN GHS Cat 1). However, the majority of in vitro methods do not state whether they are applicable to agrochemical formulations. This manuscript presents a study of up to 27 agrochemical formulations tested in three in vitro assays (three versions of the bovine corneal opacity and permeability test (BCOP, OECD TG 437) assay, the isolated chicken eye test (ICE, OECD TG 438) and the EpiOcular™ ET-50 assay). The results were compared with already-available in vivo data...
February 2, 2017: Regulatory Toxicology and Pharmacology: RTP
Makoto Ema, Masashi Gamo, Kazumasa Honda
We summarized the findings of toxicity studies on graphene-based nanomaterials (GNMs) in laboratory mammals. The inhalation of graphene (GP) and graphene oxide (GO) induced only minimal pulmonary toxicity. Bolus airway exposure to GP and GO caused acute and subacute pulmonary inflammation. Large-sized GO (L-GO) was more toxic than small-sized GO (S-GO). Intratracheally administered GP passed through the air-blood barrier into the blood and intravenous GO distributed mainly in the lungs, liver, and spleen. S-GO and L-GO mainly accumulated in the liver and lungs, respectively...
February 1, 2017: Regulatory Toxicology and Pharmacology: RTP
Nico Watzek, Franz Berger, Susanne Noreen Kolle, Tanja Kaufmann, Matthias Becker, Bennard van Ravenzwaay
In the EU, chemicals with a production or import volume in quantities of one metric ton per year or more have to be tested for skin sensitizing properties under the REACH regulation. The murine Local Lymph Node Assay (LLNA) and its modifications are widely used to fulfil the data requirement, as it is currently considered the first-choice method for in vivo testing to cover this endpoint. This manuscript describes a case study highlighting the importance of understanding the chemistry of the test material during testing for 'skin sensitization' of MCDA (mixture of 2,4- and 2,6-diamino-methylcyclohexane) with particular focus on the vehicle used...
January 31, 2017: Regulatory Toxicology and Pharmacology: RTP
Michael J Oldham, Karl A Wagner, I Gene Gilman, James B Beach, Jianmin Liu, Ali A Rostami, Mohamadi A Sarkar
Concerns have been raised about the potential health effects of potential bystander exposure to exhaled aerosols from e-vapor products (EVPs). An exhaled breath collection system (EBS) was developed and analytical methods were verified for collection and analysis of exhaled breath from users of EVPs. Analytical methods were adapted and verified for collection of environmental air samples during EVP use in an exposure chamber. Analysis of constituents in exhaled breath focused on nicotine, propylene glycol, and glycerin (because these are reported as the major constituents in EVPs) and selected carbonyl compounds (acetaldehyde, acrolein, and formaldehyde)...
January 30, 2017: Regulatory Toxicology and Pharmacology: RTP
Laura C Savery, René Viñas, Amber M Nagy, Prachi Pradeep, Stephen J Merrill, Alan M Hood, Subhas G Malghan, Peter L Goering, Ronald P Brown
Silver nanoparticles (AgNP) are incorporated into medical devices for their anti-microbial characteristics. The potential exposure and toxicity of AgNPs is unknown due to varying physicochemical particle properties and lack of toxicological data. The aim of this safety assessment is to derive a provisional tolerable intake (pTI) value for AgNPs released from blood-contacting medical devices. A literature review of in vivo studies investigating critical health effects induced from intravenous (i. v.) exposure to AgNPs was evaluated by the Annapolis Accords principles and Toxicological Data Reliability Assessment Tool (ToxRTool)...
January 27, 2017: Regulatory Toxicology and Pharmacology: RTP
Guangqiu Qin, Pingjing Wen, Yanwu Wang, Lujuan Zhang, Huili Liang, Huiyan Qin, Song Tang, Peng Zhao
Xylans are present naturally in various plants and have important uses in nutrition, food, novel material and biotechnology; however, to date, data regarding their systemic toxicity and safety evaluation is still limited. This study investigated the potential toxicity of xylan from sugarcane bagasse by a subchronic toxicity study in rats. A total of 80 male and female rats were fed with diets containing 10%, 5%, 2.5% and 0% (control) xylan for 90 days. A toxicological assessment was performed including mortality, body and organ weights, food consumption, blood biochemistry, hematology, urinalysis, gross necropsy and histopathological examinations...
January 27, 2017: Regulatory Toxicology and Pharmacology: RTP
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