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Regulatory Toxicology and Pharmacology: RTP

Xiaoyan Xing, Xuehong Deng, Jinjin Shi, Meishuang Zhang, Guibo Sun, Shimin Tang, Qiuling Huang, Xiaobo Sun
Zishen Yutai pill (ZYP) is an oriental herbal formula, while hepatotoxicity assessment of ZYP was rarely evaluated. Therefore, our aim is to re-evaluate its hepatotoxicity in both normal and carbon tetrachloride (CCl4) induced chronic liver injury rats. In the normal model, two doses of ZYP (1.575 and 9.450 g kg(-1) d(-1); i.e. 1 × , 6 × clinical doses) were given orally to rats for 24 weeks. In the chronic liver injury model, 10% CCl4 was administered to rats abdominally twice a week at a dose of 5 mL kg(-1) for 12 consecutive weeks...
December 1, 2016: Regulatory Toxicology and Pharmacology: RTP
Ricardo Arrieta-Cortes, Paulina Farias, Carlos Hoyo-Vadillo, Mina Kleiche-Dray
: Perfluoroalkyls are stable synthetic chemicals, able to repel oils, fats and water. These compounds have been used in the manufacturing of products such as Teflon(®), lubricants, paints, fire-fighting foams, coatings for pans, carpets, clothes, and paperboard for packaging, among others. It is believed that populations are exposed constantly to them. Its regulation in the world is under development and several controversies are in the course of litigation. One occupational study shows bladder cancer risk...
November 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Laurence H Hand, Kevan Richardson, Stephen T Hadfield, Sarah Whalley, Paul Rawlinson, Ewan D Booth
This paper describes the further development of a read-across approach applicable to the toxicological assessment of structurally-related xenobiotic metabolites. The approach, which can be applied in the absence of definitive identification of all the individual metabolites, draws on the use of chemical descriptors and multi-variate statistical analysis to define a composite "chemical space" and to classify and characterize closely-related subgroups within this. In this example, consideration of the descriptors driving grouping, combined with empirical evidence for lack of significant further biotransformation of metabolites, leads to the conclusion that, in the absence of any specific structural alerts, the relative toxicity of metabolites within a single grouping will be determined by their relative systemic exposure as described by their ADME characteristics...
November 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Ian Kimber, G Frank Gerberick, David A Basketter
Skin sensitization is unique in the world of toxicology. There is a combination of reliable, validated predictive test methods for identification of skin sensitizing chemicals, a clearly documented and transparent approach to risk assessment, and effective feedback from dermatology clinics around the world delivering evidence of the success or failure of the hazard identification/risk assessment/management process. Recent epidemics of contact allergy, particularly to preservatives, have raised questions of whether the safety/risk assessment process is working in an optimal manner (or indeed is working at all!)...
November 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Nor Aijratul Asikin Mohamad Shalan, Noordin M Mustapha, Suhaila Mohamed
Noni (Morinda citrifolia) leaf and fruit are used as food and medicine. This report compares the chronic toxicity of Noni fruit and edible leaf water extracts (two doses each) in female mice. The 6 months study showed the fruit extract produced chronic toxicity effects at the high dose of 2 mg/ml drinking water, evidenced through deteriorated liver histology (hepatocyte necrosis), reduced liver length, increased liver injury marker AST (aspartate aminotransferase) and albumin reduction, injury symptoms (hypoactivity, excessive grooming, sunken eyes and hunched posture) and 40% mortality within 3 months...
November 18, 2016: Regulatory Toxicology and Pharmacology: RTP
Alain Sewer, Ulrike Kogel, Marja Talikka, Ee Tsin Wong, Florian Martin, Yang Xiang, Emmanuel Guedj, Nikolai V Ivanov, Julia Hoeng, Manuel C Peitsch
Modified-risk tobacco products (MRTP) are designed to reduce the individual risk of tobacco-related disease as well as population harm compared to smoking cigarettes. Experimental proof of their benefit needs to be provided at multiple levels in research fields. Here, we examined microRNA (miRNA) levels in the lungs of rats exposed to a candidate modified-risk tobacco product, the Tobacco Heating System 2.2 (THS2.2) in a 90-day OECD TG-413 inhalation study. Our aim was to assess the miRNA response to THS2.2 aerosol compared with the response to combustible cigarettes (CC) smoke from the reference cigarette 3R4F...
November 17, 2016: Regulatory Toxicology and Pharmacology: RTP
Christophe Rousselle
No abstract text is available yet for this article.
November 14, 2016: Regulatory Toxicology and Pharmacology: RTP
Dr Christophe Rousselle
No abstract text is available yet for this article.
November 12, 2016: Regulatory Toxicology and Pharmacology: RTP
Florian Martin, Marja Talikka, Nikolai V Ivanov, Christelle Haziza, Julia Hoeng, Manuel C Peitsch
As part of current harm reduction strategies, candidate modified risk tobacco products (MRTP) are developed to offer adult smokers who want to continue using tobacco product an alternative to cigarettes while potentially reducing individual risk and population harm compared to smoking cigarettes. One of these candidate MRTPs is the Tobacco Heating System (THS) 2.2 which does not burn tobacco, but instead heats it, thus producing significantly reduced levels of harmful and potentially harmful constituents (HPHC) compared with combustible cigarettes (CC)...
November 11, 2016: Regulatory Toxicology and Pharmacology: RTP
Nikoletta Jedlinszki, Boglárka Balázs, Erzsébet Csányi, Dezső Csupor
Mutagenic and teratogenic pyrrolizidine alkaloids (PAs) have been identified in several plant species. The industrially most important PA-containing plant is Symphytum officinale (common comfrey). The application of its root is restricted in several countries due to its PA content. In medicines, the daily alkaloid quantity and duration of treatment may be limited even in case of topical application. Due to the confirmed good absorption of PAs from the gastrointestinal tract, the prohibition of oral use is justified, however the limitation of external application is not supported by relevant data...
November 11, 2016: Regulatory Toxicology and Pharmacology: RTP
Jian Yu, Li-Qiang Gu, Yan-Fei Xin, Yun-Sheng Bai, Sheng Zhang, Hai-Yan Gao, Pan-Sheng Xu, Zhu-Feng Ma, Zhen-Qiang You, Zhi Wang, Yao-Xian Xuan
SHENMAI injection (SMI), derived from famous Shen Mai San, is a herbal injection widely used in China. Ginsenosides are the major components of SMI. To monitor the exposure level of SMI during long-term treatment, a 6-month toxicokinetic experiment was performed. Twenty-four beagle dogs were dived into four groups (n = 6 in each group): a control group (0.9% NaCl solution) and three SMI groups (2, 6 or 3 mg/kg). The dogs were i.v. infused with vehicle or SMI daily for 180 d. Blood samples for analysis were collected at specific time points as follows: pre-dose (0 h); at 10, 30, and 60 min during infusion; and at 10, 30, 60, 90, 120, 240, and 300 min post-administration...
November 10, 2016: Regulatory Toxicology and Pharmacology: RTP
Emily May Lent, Lee C B Crouse, William S Eck
Periodate salts are being developed as potential replacements for perchlorate due to potential health hazards associated with exposure to perchlorate. The aim of this study was to investigate acute and subacute effects of periodate salts in rats. Acute oral toxicity of potassium and sodium periodate was determined using the Sequential Stage-Wise Probit method. The LD50 for potassium periodate was 732 (95% CI = 539-838, slope = 13.4) and 685 mg/kg (95% CI = 580-809, slope = 10.6) for females and males, respectively...
November 10, 2016: Regulatory Toxicology and Pharmacology: RTP
Chukwujindu M A Iwegbue, Omotekoro S Emakunu, Godwin E Nwajei, Francisca I Bassey, Bice S Martincigh
The concentrations of nine metals (Cd, Pb, Ni, Cr, Co, Cu, Fe, Mn and Zn) were measured in selected brands of medicated, moisturizing and skin-lightening soaps and shower gels with the aim of evaluating the human health risk associated with metal exposure from the use of these products. The concentrations of metals in these products were determined by means of atomic absorption spectrophotometry after sample digestion with a mixture of acids. The concentration ranges of the metals in the bathing soaps and shower gels were found to be: <0...
November 10, 2016: Regulatory Toxicology and Pharmacology: RTP
R J Lee, D R Van Orden, L A Cox, S Arlauckas, R J Kautz
No abstract text is available yet for this article.
November 9, 2016: Regulatory Toxicology and Pharmacology: RTP
Martin Harper, Rosa J Key-Schwartz
No abstract text is available yet for this article.
November 5, 2016: Regulatory Toxicology and Pharmacology: RTP
Marie Lefevre, Silvia M Racedo, Muriel Denayrolles, Gabrielle Ripert, Thomas Desfougères, Alexandra R Lobach, Ryan Simon, Fanny Pélerin, Peter Jüsten, Maria C Urdaci
Bacillus subtilis CU1 is a recently described probiotic strain with beneficial effects on immune health in elderly subjects. The following work describes a series of studies supporting the safety of the strain for use as an ingredient in food and supplement preparations. Using a combination of 16S rDNA and gyrB nucleotide analyses, the species was identified as a member of the Bacillus subtilis complex (B. subtilis subsp. spizizenii). Further characterization of the organism at the strain level was achieved using random amplified polymorphic DNA polymerase chain reaction (RAPD PCR) and pulsed field gel electrophoresis (PFGE) analyses...
November 5, 2016: Regulatory Toxicology and Pharmacology: RTP
Ulrike Kogel, Bjoern Titz, Walter K Schlage, Catherine Nury, Florian Martin, Alberto Oviedo, Stefan Lebrun, Ashraf Elamin, Emmanuel Guedj, Keyur Trivedi, Nikolai V Ivanov, Patrick Vanscheeuwijck, Manuel C Peitsch, Julia Hoeng
Modified risk tobacco products (MRTPs) are being developed with the aim of reducing smoking-related health risks. The Tobacco Heating System 2.2 (THS2.2) is a candidate MRTP that uses the heat-not-burn principle. Here, systems toxicology approaches were engaged to assess the respiratory effects of mentholated THS2.2 (THS2.2M) in a 90-day rat inhalation study (OECD test guideline 413). The standard endpoints were complemented by transcriptomics and quantitative proteomics analyses of respiratory nasal epithelium and lung tissue and by lipidomics analysis of lung tissue...
November 4, 2016: Regulatory Toxicology and Pharmacology: RTP
Alberto Oviedo, Stefan Lebrun, Ulrike Kogel, Jenny Ho, Wei Teck Tan, Bjoern Titz, Patrice Leroy, Gregory Vuillaume, Monali Bera, Florian Martin, Gregory Rodrigo, Marco Esposito, Ruth Dempsey, Nikolai V Ivanov, Julia Hoeng, Manuel C Peitsch, Patrick Vanscheeuwijck
The toxicity of a mentholated version of the Tobacco Heating System (THS2.2M), a candidate modified risk tobacco product (MRTP), was characterized in a 90-day OECD inhalation study. Differential gene and protein expression analysis of nasal epithelium and lung tissue was also performed to record exposure effects at the molecular level. Rats were exposed to filtered air (sham), to THS2.2M (at 15, 23 and 50 μg nicotine/l), to two mentholated reference cigarettes (MRC) (at 23 μg nicotine/l), or to the 3R4F reference cigarette (at 23 μg nicotine/l)...
November 3, 2016: Regulatory Toxicology and Pharmacology: RTP
Yong Sun Lee, Jung-Sun Yi, Souk Jin Seo, Joo Hwan Kim, Mi-Sook Jung, Im-Kwon Seo, Ilyoung Ahn, Kyungyuk Ko, Tae Sung Kim, Kyung Min Lim, Soojung Sohn
The local lymph node assay using 5-bromo-2-deoxyuridine (BrdU) with flow cytometry (LLNA: BrdU-FCM) is a modified LLNA that is used to identify skin sensitizers by counting BrdU-incorporated lymph node cells (LNCs) with flow cytometry. Unlike other LLNA methods (OECD TG 429, 442A and 442B) in which the CBA/J mouse strain is used, LLNA: BrdU-FCM was originally designed to be compatible with BALB/c, a mouse strain that is more widely used in many countries. To justify the substitution of CBA/J for BALB/c, the equivalence of the test results between two strains shall be established prior to the official implementation of LLNA: BrdU-FCM...
November 2, 2016: Regulatory Toxicology and Pharmacology: RTP
Christelle Haziza, Guillaume de La Bourdonnaye, Dimitra Skiada, Jacek Ancerewicz, Gizelle Baker, Patrick Picavet, Frank Lüdicke
The Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (SA group; 39 participants)...
November 2, 2016: Regulatory Toxicology and Pharmacology: RTP
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