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Regulatory Toxicology and Pharmacology: RTP

Jia Du, Junhong Tang, Shaodan Xu, Jingyuan Ge, Yuwei Dong, Huanxuan Li, MeiQing Jin
Perfluorooctane sulfonate (PFOS) and ZnO nanoparticles (Nano-ZnO) are two kinds of environmental contaminants that have been frequently detected in natural waters. The potential joint toxicity of PFOS and nano-ZnO remains to be fully elucidated. The objective of this study was to evaluate co-exposure effects of PFOS and nano-ZnO on growth in initial generation (F0) zebrafish after chronic exposure and to examine possible parental transfer of PFOS and nano-ZnO transgenerational effects on the growth of first generation (F1) larvae...
July 12, 2018: Regulatory Toxicology and Pharmacology: RTP
Meredith Rocca, LaRonda L Morford, Diann L Blanset, Wendy G Halpern, Joy Cavagnaro, Christopher J Bowman
Toxicity studies in pregnant animals are not always necessary for assessing the human risk of developmental toxicity of biopharmaceuticals. The growing experience and information on target biology and molecule-specific pharmacokinetics present a powerful approach to accurately anticipate effects of target engagement by biopharmaceuticals using a weight of evidence approach. The weight of evidence assessment should include all available data including target biology, pharmacokinetics, class effects, genetically modified animals, human mutations, and a thorough literature review...
July 12, 2018: Regulatory Toxicology and Pharmacology: RTP
Hiroto Bushita, Shujie Liu, Takafumi Ohta, Yuichi Ito, Kazutoshi Saito, Yuko Nukada, Naohiro Ikeda, Osamu Morita
Recent studies suggest that diets supplemented with alpha-linolenic acid (ALA)-enriched diacylglycerol (DAG) oil provide potential health benefits in preventing or managing obesity. However, available safety information about reproductive and developmental toxicities of ALA-DAG oil is limited. This study was conducted to clarify the effect, if any, of ALA-DAG oil on embryo-fetal development, following maternal exposure during the critical period of major organogenesis. ALA-DAG oil was administered via gavage to pre-mated female Sprague Dawley rats from gestation day 6 through 19, at dose levels of 0, 1...
July 12, 2018: Regulatory Toxicology and Pharmacology: RTP
Michael Aschner, Herman Autrup, Colin L Berry, Alan R Boobis, Samuel M Cohen, Wolfgang Dekant, Corrado L Galli, Jay I Goodman, Gio B Gori, Helmut A Greim, Norbert E Kaminski, Curtis D Klaassen, James E Klaunig, Marcello Lotti, Hans Wj Marquardt, Angelo Moretto, Olavi Pelkonen, I Glenn Sipes, Kendall B Wallace, Hiroshi Yamazaki
Several recent and prominent articles in Science and Nature deliberately mischaracterized the nature of genuine scientific evidence. Those articles take issue with the United States Environmental Protection Agency's recent proposal to structure its policies and rules only from studies with transparently published raw data. The articles claim it is an effort to obfuscate with transparency, by eliminating a host of studies not offering raw data. A remarkable declaration by a Science editorial is that properly trained experts can verify the scientific evidence of studies without access to raw data, We assert the Agency's proposal must be sustained...
July 11, 2018: Regulatory Toxicology and Pharmacology: RTP
Haiyan Yang, Cong Li, Zhongjian Chen, Hanzhou Mou, Liqiang Gu
Chidamide is a new subtype-selective histone deacetylase inhibitor (HDACi), which has been approved for the treatment of recurrent or refractory peripheral T-cell lymphoma (PTCL) in China. However, there are few studies about the application of chidamide in PTCL with central nervous system (CNS) involvement. It is essential to investigate the penetration of chidamide in the blood brain barrier (BBB). LC-MS methods were established firstly to determine the concentration of chidamide in rat plasma and CSF. Then five rats were anaesthetized and the plasma and CSF samples were collected at the time of 5, 15, 30, 60, 120, 180, 240, 360 and 480 min after being administered 1 mg/kg chidamide by intravenous injection, respectively...
July 6, 2018: Regulatory Toxicology and Pharmacology: RTP
Yi Yang, Tiantian Li, Lichen Yan, Yang Yu, Shuo Wang, Chao Li, Yang Wen, Yuanhui Zhao
It is well known that the critical body residue (CBR) can be estimated via bioconcentration factor (BCF). However, the relationship between CBR and BCF in zebrafish has not been carried out based on bio-uptake kinetics for nitro-aromatics. In this paper, the time-variable concentrations and CBRs in zebrafish were determined for five nitro substituted benzenes. The result shows that CBR values can well be calculated from the BCF and external critical concentrations (LC50 ). Although CBRs measured from 5 h exposure period are greater than the CBRs obtained from 96 h for the five nitro-aromatics, no significant difference was observed, indicating that the CBR approach is a truer measure of chemical levels in exposed organisms and an ideal indicator to reflect the toxicity of a chemical...
July 6, 2018: Regulatory Toxicology and Pharmacology: RTP
Hunjoo Lee, Nam Ji Kwon, Yongsoo Kim, Eunyoung Han
Risk assessment has been used to prevent health problems associated with eating habits in response to increased interest in a balanced diet. For nutritional risk assessment (NRA), it is important to 1) consider personal nutrition status based on year-round dietary intake, 2) organize core datasets such as food composition, intake, and health based guidance value (HBGV) datasets with public confidence, and 3) assess and predict the effects by using the computerized NRA tool. Our research staff constructed an integrated database system by compiling and organizing core datasets produced sporadically by different organizations and with different formats and developed a nutritional exposure and risk assessment system called Nutri-Risk (NUTRItional RISK assessment platform), which contained the database...
July 2, 2018: Regulatory Toxicology and Pharmacology: RTP
M Belushkin, M Esposito, G Jaccard, C Jeannet, A Korneliou, D Tafin Djoko
Testing standards for tobacco and related products are an important basis for product science-based regulation. The recent emergence and rapid growth of products offering an alternative to continued smoking for adult smokers who would otherwise continue to smoke, urgently calls for the establishment of quality and assessment standards relevant for these products. The two main categories of products under consideration are electronic cigarettes and heated tobacco products, which both deliver nicotine in the aerosol that is not smoke, because tobacco is not burned in the process, and in particular no solid particles are generated as a result...
July 2, 2018: Regulatory Toxicology and Pharmacology: RTP
Johirul Islam, Kamaruz Zaman, Srijita Chakrabarti, Pronobesh Chattopadhyay
In the recent years, growing concern about the potential toxicity of synthetic repellents has led to the development of environmentally safe non-toxic insect control methods. Present investigation explores the toxicological impacts of ethyl anthranilate-loaded mosquito repellent patch (EAMRP) on respiratory system following acute and sub-chronic inhalation exposure in Wistar rats. Lungs parameters such as enhanced pause, tidal volume, respiration rate, inspiration time, and expiration time were determined using whole body plethysmograph...
June 30, 2018: Regulatory Toxicology and Pharmacology: RTP
Josje Arts, Steffen Bade, Marta Badrinas, Nicholas Ball, Stuart Hindle
Aminocarboxylic acid (ethylenediamine-based) chelating agents, such as DTPA and EDTA, are widely used in a variety of products and processes. Recently the European RAC proposed to classify DTPA as a developmental toxicant Category 1B according to CLP. This paper provides unequivocal and significant evidence that developmental effects cannot be considered an intrinsic property of the chelating substances themselves since: (1) animals fed a zinc deficient diet during gestation exhibit developmental toxicity of a similar nature and severity to that observed in studies involving such chelates, (2) sufficient supplementation of zinc in the diet, or administration of zinc bound chelates, completely negates the developmental effects...
June 28, 2018: Regulatory Toxicology and Pharmacology: RTP
Heather N Lynch, Robyn L Prueitt, Julie E Goodman
In 2016, the American Conference of Governmental Industrial Hygienists (ACGIH) lowered the 8-hr Threshold Limit Value - time-weighted average (TLV-TWA) for toluene diisocyanate (TDI) from 5 ppb to 1 ppb, and the 15-min short-term exposure limit (STEL) from 20 ppb to 5 ppb. We evaluated ACGIH's basis for lowering these values. It is our opinion that the ACGIH's evaluation of the evidence for occupational asthma and respiratory effects from TDI exposure does not fully integrate the results of all the available human and animal studies...
June 28, 2018: Regulatory Toxicology and Pharmacology: RTP
D A Basketter, A Natsch, G Ellis, A M Api, A Irizar, B Safford, C Ryan, P Kern
For many endpoints in toxicology, an interspecies safety factor remains a standard requirement. However, for skin sensitization, the hazard and potency predictions, notably from the local lymph node assay (LLNA) have been shown to correlate well with human data. Despite this, there are always exceptions, both over and under predictions. For this reason it has been suggested that an interspecies factor of 15 would accommodate potential "errors". An alternative approach is suggested in which an evidence-based strategy is taken: the large majority of the information indicates a human:LLNA ratio of 1, therefore a corrective factor would best be applied where our knowledge of the underlying chemistry of sensitization indicates that it is necessary...
June 28, 2018: Regulatory Toxicology and Pharmacology: RTP
Stefanie Wieck, Oliver Olsson, Klaus Kümmerer, Ursula Klaschka
Consumers are confronted with a large number of fragrance allergens from various sources. Until now, the discussion of exposure sources has mainly addressed cosmetic products and neglected other scented products in households. For the first time, fragrance allergens were evaluated in a complete set of detergents in households. In 131 households, we investigated the prevalence of detergents and searched their lists of ingredients for 26 fragrance allergens liable to be indicated on products according to the European Detergents Regulations...
June 22, 2018: Regulatory Toxicology and Pharmacology: RTP
Shiying Zou, Jiao Lu, Yunbo Luo, Xiaozhe Qi, Bryan Delaney, Wentao Xu, Kunlun Huang, Xiaoyun He
Soybean is an important food resource for the eastern countries and herbicide-tolerant genetically modified soybeans (GMS) were widely developed to deal with weeds problems. Unprocessed soybean flour instead of dehulled and defatted soybean meal was used to reflect the safety of soybean food in whole. Rats were given formulated diets containing DP-356Ø43 or non-GM soybean JACK at an incorporation rate of 7.5%, 15%, or 30% (w/w), respectively for 90 days. Targeted traditional toxicological response variables were measured to reflect the holistic health of animals...
June 22, 2018: Regulatory Toxicology and Pharmacology: RTP
Eelco N Pieke, Kit Granby, Bruno Teste, Jørn Smedsgaard, Gilles Rivière
The shortage of data on non-intentionally added substances (NIAS) present in food contact material (FCM) limits the ability to ensure food safety. Recent strategies in analytical method development allow investigating NIAS by using chemical exploration; but this has not been sufficiently investigated in risk assessment context. Here, exploration is applied on two paperboard FCM samples followed by risk prioritization for chemicals that can potentially migrate to food. Concentration estimates from exploration are converted into a tentative exposure assessment, while predicted chemical structures are assessed using quantitative structure-activity relationships (QSAR) models for carcinogenicity, mutagenicity, and reproductive toxicity...
June 19, 2018: Regulatory Toxicology and Pharmacology: RTP
Edyta Czepielewska, Magdalena Makarewicz-Wujec, Filip Różewski, Elżbieta Wojtasik, Małgorzata Kozłowska-Wojciechowska
Food supplements have been playing an increasingly important role in the consumers' awareness nowadays. They are widespread and - according to popular belief - healthier and safer than synthetic drugs. In the European Union (EU) food supplements are classified as foodstuffs and thus not subjected to any specific safety assessments prior to commercialisation. With the growing popularity of food supplements, there is an increased need for more effective control of their production and distribution. The aim of this study was to examine the food notifications, recorded since 2003 via the EU RASFF database with particular regard to recent years, as well as to evaluate the involvement of different EU state structures in the fight against drug-adulterated food supplements with regard to efficacy and safety...
June 19, 2018: Regulatory Toxicology and Pharmacology: RTP
N A Nikitin, V A Zenin, E A Trifonova, E M Ryabchevskaya, O A Kondakova, A N Fedorov, J G Atabekov, O V Karpova
Spherical particles (SPs) generated by thermally denatured tobacco mosaic virus (TMV) coat protein can act as an adjuvant, as they are able to enhance the magnitude and longevity of immune responses to different antigens. Here, the toxicity of TMV SPs was assessed prior to it being offered as a universal safe adjuvant for the development of vaccine candidates. The evaluation included nonclinical studies of a local tolerance following the single administration of TMV SPs, and of the local and systemic effects following repeated administrations of TMV SPs...
June 19, 2018: Regulatory Toxicology and Pharmacology: RTP
Hao Chen, Xiaopeng Zhang, Xudong Jia, Zhaoping Liu
Benchmark dose (BMD) analysis is generally recognized superior to generate a point of departure (PoD) to conduct risk assessment on environmental toxicants, comparing with the traditionally employed no observed adverse effect level (NOAEL) or lowest observed adverse effect level (LOAEL) methods. However, only a few studies compared the two on producing PoD of thyroid toxicity caused by environmental chemicals. Here, we presented BMD analyses on several thyroid toxicity endpoints caused by a model chemical - propylthiouracil (PTU)...
June 18, 2018: Regulatory Toxicology and Pharmacology: RTP
Flávia C M Pinto, Rosangela R De-Carvalho, Ana Cecilia A X De-Oliveira, Isabella F Delgado, Francisco J R Paumgartten
β-ionone (BIO) is used in fragrances, toiletries and non-cosmetic products, and as a flavor food additive. Notwithstanding the widespread human exposure, there are limited data on the reproductive toxicity of BIO. This study evaluated the developmental toxicity of BIO (0, 125, 250, 500 and 1000 mg/kg body weight/day) given orally to rats on days 6-15 of gestation (GD6-15). C-section was on GD21 and implantations, living and dead fetuses and resorptions were recorded. Fetuses were weighed, and examined for external abnormalities and skeleton and visceral anomalies...
June 18, 2018: Regulatory Toxicology and Pharmacology: RTP
Guy Jaccard, Athanasios Kondylis, Irfan Gunduz, Johannes Pijnenburg, Maxim Belushkin
Tobacco-specific nitrosamines (TSNA) levels in tobacco cut filler and cigarette smoke were measured in more than 1000 commercially available cigarettes sampled between 2008 and 2014. Relative contributions to their transfer from tobacco to the mainstream smoke in terms of direct transfer by distillation, pyrorelease, and pyrosynthesis were evaluated on the basis of the comparison with the transfer of nicotine from tobacco to smoke. N'-nitrosonornicotine (NNN) was transferred essentially by distillation, while N'-nitrosoanatabine (NAT), 4-(methylnitrosamino)-1-(3-bipyridyl)-1-butanone (NNK) and N'-nitrosoanabasine (NAB) were transferred by pyrorelease or pyrosynthesis as well...
June 18, 2018: Regulatory Toxicology and Pharmacology: RTP
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