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Regulatory Toxicology and Pharmacology: RTP

J Lichtenberg, E Perez Calvo, K Madsen, T Østergaard Lund, F Kramer Birkved, S van Cauwenberghe, M Mourier, L Wulf-Andersen, A J M Jansman, R Lopez-Ulibarri
Safety evaluation of a muramidase produced by a Trichoderma reesei strain (safe lineage), expressing a muramidase gene isolated from Acremonium alcalophilum is presented. Intended use in feed of this enzyme is as digestive aid in broiler chickens. Muramidase 007, was non-mutagenic and non-clastogenic in vitro, and no adverse effects were observed in 90-day subchronic toxicity studies in rats at doses up to 1132 mg TOS/kg body weight/day. The enzyme did not exhibit, in vitro, skin, nor eye irritation potential...
July 15, 2017: Regulatory Toxicology and Pharmacology: RTP
Ryan C Hill, Brandon J Fast, Rod A Herman
The regulatory body that oversees the safety assessment of genetically modified (GM) crops in the European Union, the European Food Safety Authority (EFSA), uniquely requires that endogenous allergen levels be quantified as part of the compositional characterization of GM versions of crops, such as soybean, that are considered to be major allergenic foods. The value of this requirement for assessing food safety has been challenged for multiple reasons including negligible risk of altering allergen levels compared with traditional non-GM breeding...
July 15, 2017: Regulatory Toxicology and Pharmacology: RTP
K Zu, D M Pizzurro, T A Lewandowski, J E Goodman
The current acceptable daily intake (ADI) for benzoic acid and its salts as food additives is 0-5 mg/kg bw-day. This accounts for a total uncertainty factor (UF) of 100, which includes a default factor of 10 for interspecies differences. Based on pharmacokinetic data in rodents and humans, we derived a chemical-specific adjustment factor (CSAF) of 2 for the pharmacokinetic component of the interspecies UF. Additional analyses indicate that this CSAF is conservative and interspecies differences between rats and humans are likely closer to unity...
July 15, 2017: Regulatory Toxicology and Pharmacology: RTP
Nada O F Kassem, Noura O Kassem, Sandy Liles, Sheila R Jackson, Dale A Chatfield, Peyton Jacob, Neal L Benowitz, Melbourne F Hovell
Tobacco smoking and exposure to tobacco secondhand smoke (SHS) can cause lung cancer. We determined uptake of NNK (4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone), a tobacco specific potent pulmonary carcinogen, in hookah smokers and non-smokers exposed to hookah tobacco SHS. We analyzed data from a community-based convenience sample of 201 of adult (aged ≥18 years) exclusive hookah smokers (n = 99) and non-smokers (n = 102) residing in San Diego County, California. Participants spent an average of three consecutive hours indoors, in hookah lounges or private homes, where hookah tobacco was smoked exclusively...
July 14, 2017: Regulatory Toxicology and Pharmacology: RTP
Christopher John Topping, Robert Luttik
Specific protection goals (SPGs) comprise an explicit expression of the environmental components that need protection and the maximum impacts that can be tolerated. SPGs are set by risk managers and are typically based on protecting populations or functions. However, the measurable endpoints available to risk managers, at least for vertebrates, are typically laboratory tests. We demonstrate, using the example of eggshell thinning in skylarks, how simulation can be used to place laboratory endpoints in context of population-level effects as an aid to setting the SPGs...
July 14, 2017: Regulatory Toxicology and Pharmacology: RTP
G B Jena, Sapana Chavan
The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability...
July 13, 2017: Regulatory Toxicology and Pharmacology: RTP
Wenting Zeng, Chunxu Wu, Jie Wang, Lingjie Cao, Xiaobao Jin, Jiayong Zhu, Xuemei Lu
Interferon alpha as the one of FDA recommended drugs for Hepatitis B virus (HBV) infection has many side effects. Targeting IFNα to the liver may be a strategy to increase its efficacy locally and may increase efficacy of IFNα-based therapy of HBV infection. We have prepared a novel liver-targeting fusion interferon (IFN-CSP) combining IFN α2b with plasmodium region I peptide and have revealed it may be an excellent candidate as a liver-targeting anti-HBV agent. In this study, we investigated the genotoxic and teratogenic effects of IFN-CSP...
July 11, 2017: Regulatory Toxicology and Pharmacology: RTP
H Mielke, J Strickland, M N Jacobs, J M Mehta
A comprehensive biometrical assessment was conducted to compare the performance of multiple test designs for acute dermal systemic toxicity to support the animal welfare update to the original OECD Test Guideline (TG) 402 for acute dermal toxicity. The test designs evaluated included: (1) two, three, or five animals per dose group (2) evident toxicity or lethality endpoints and (3) absence or presence of a one-animal sighting study. The revision of TG 402 respected the 3R principles (replace, reduce, refine) of animal testing...
July 11, 2017: Regulatory Toxicology and Pharmacology: RTP
Jian Liang, Shu-Xian Chen, Song Huang, Ya-Yun Wu, Cai-Jie Zhou, Dong-Xu Jiang, Chu-Yan Liang, Hui-Qi Yuan, Shao-Zhen Hou, Xiao-Ping Lai
The aim of the study was to evaluate the safety of flavonoid fraction of Lithocarpus polystachyus Rehd (Sweet Tea-F, ST-F) in mice and rats through acute and sub-chronic toxicity studies respectively. For acute toxicity study, a single dose of 5000 mg/kg of ST-F was given orally to healthy KM mice. The mice were observed mortality and toxic symptoms for 24 h, then once a day up to 14 days. In the sub-chronic toxicity study, ST-F was administered orally at doses of 0, 70, 140, 560 mg/kg/day to rats for 26 weeks...
July 8, 2017: Regulatory Toxicology and Pharmacology: RTP
Anita K Bakrania, Bhavesh C Variya, Prem Madan, Snehal S Patel
Cancer has emerged as a global threat with challenges for safe chemotherapeutics. Most of the currently available anti-cancer drugs exhibit significant toxicity. Amongst novel agents, interferons have exhibited anti-proliferative and cytoprotective roles. However, due to stability drawbacks of interferons, we have identified an interferon inducer DEAE-Dextran, which resolves the stability issues. Based on the previous history of toxicity pertaining to the current chemotherapeutic agents, it is equally essential to determine the safety of DEAE-Dextran...
July 8, 2017: Regulatory Toxicology and Pharmacology: RTP
Nilutpal Sharma Bora, Manash Pratim Pathak, Santa Mandal, Bhaskar Mazumder, Rudragoud Policegoudra, Pakalapati Srinivas Raju, Pronobesh Chattopadhyay
Ultraviolet (UV) radiation exposure has been known to cause irreparable damages to human skin. The daunting risk of UV radiation exposure faced by military personnel led to the development of a sunscreen formulation which has superior sun protection factor combined with the ability to counteract reactive oxygen species. The present work deals with the preclinical safety evaluation of the sunscreen formulation comprising of four US FDA approved UV filters; namely avobenzone, octinoxate, oxybenzone, titanium dioxide along with melatonin and pumpkin seed oil, via OECD protocols of assessing acute oral and dermal toxicity; skin sensitizing; skin irritating; ocular irritating and genotoxic potential...
July 8, 2017: Regulatory Toxicology and Pharmacology: RTP
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
Katherine Groff, Patricia Bishop
The development and regulatory approval of ectoparasiticides, including flea and tick control products, involves decades-old methods and the use of large numbers of animals to evaluate toxicity and efficacy. Animals also are used to rear (breed and feed) fleas and ticks for later use in testing. Non-animal methods for regulatory-required testing and rearing currently exist and, with further development, others could soon become available. Here we provide an overview of the state-of-the-science of non-animal methods for rearing and regulatory-required efficacy testing of flea and tick control products...
July 6, 2017: Regulatory Toxicology and Pharmacology: RTP
Kazuhiro Kaneko, Satoko Ishii, Sachio Hosohara, Tsuyoshi Hirata, Motoshi Masuda, Kaori Murasawa, Airi Yamada, Takaaki Tadokoro, Masahiko Hanzawa
We developed a lead substances selection approach based on the concept of mixture classification of UN GHS for the purpose of efficient risk assessment of mixtures consisting of multiple components. Lead substances selection methods are being actively developed in Europe, but these methods are predicated on the regulations and information sources available within Europe and are therefore not readily applicable to countries outside Europe. In this study, the features of the GHS-based approach and the risk assessment results for outdoor painting work as a specific utilization example of the GHS-based approach were described...
June 29, 2017: Regulatory Toxicology and Pharmacology: RTP
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
Joan O'Callaghan, Margaret Bermingham, Maurice Leonard, Frank Hallinan, J Michael Morris, Una Moore, Brendan T Griffin
Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed...
June 27, 2017: Regulatory Toxicology and Pharmacology: RTP
Beat J Brüschweiler, Cédric Merlot
Azo dyes represent the by far most important class of textile dyes. Their biotransformation by various skin bacteria may release aromatic amines (AAs) which might be dermally absorbed to a major extent. Certain AAs are well known to have genotoxic and/or carcinogenic properties. Correspondingly, azo dyes releasing one of the 22 known carcinogenic AAs are banned from clothing textiles in the European Union. In the present study, we investigated the mutagenicity of 397 non-regulated AAs potentially released from the 470 known textile azo dyes...
June 26, 2017: Regulatory Toxicology and Pharmacology: RTP
Terry W Schultz, Mark T D Cronin
A series of case studies designed to further acceptance of read-across predictions, especially for chronic health-related endpoints, have been evaluated with regard to the knowledge and insight they provide. A common aim of these case studies was to examine sources of uncertainty associated with read-across. While uncertainty is related to the quality and quantity of the read across endpoint data, uncertainty also includes a variety of other factors, the foremost of which is uncertainty associated with the justification of similarity and quantity and quality of data for the source chemical(s)...
June 24, 2017: Regulatory Toxicology and Pharmacology: RTP
Johanna Kaltenhäuser, Carsten Kneuer, Philip Marx-Stoelting, Lars Niemann, Jens Schubert, Bernd Stein, Roland Solecki
Evaluation of data relevance, reliability and contribution to uncertainty is crucial in regulatory health risk assessment if robust conclusions are to be drawn. Whether a specific study is used as key study, as additional information or not accepted depends in part on the criteria according to which its relevance and reliability are judged. In addition to GLP-compliant regulatory studies following OECD Test Guidelines, data from peer-reviewed scientific literature have to be evaluated in regulatory risk assessment of pesticide active substances...
June 24, 2017: Regulatory Toxicology and Pharmacology: RTP
Peter N Lee, John S Fry, John F Hamling, Zheng Sponsiello-Wang, Gizelle Baker, Rolf Weitkunat
We use Population Health Impact Modelling to assess effects on tobacco prevalence and mortality of introducing a Reduced Risk Tobacco Product (RRP). Simulated samples start in 1990 with a US-representative smoking prevalence. Individual tobacco histories are updated annually until 2010 using estimated probabilities of switching between never/current/former smoking where the RRP is not introduced, with current users subdivided into cigarette/RRP/dual users where it is. RRP-related mortality reductions from lung cancer, IHD, stroke and COPD are derived from the histories and the assumed relative risks of the RRP...
June 24, 2017: Regulatory Toxicology and Pharmacology: RTP
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