Showing papers in "Regulatory Toxicology and Pharmacology in 2016"

TL;DR: The chemical composition, in vitro genotoxicity, and cytotoxicity of the mainstream aerosol from the Tobacco Heating System 2.2 were compared with those of the mainline smoke from the 3R4F reference cigarette to evaluate under extreme climatic and puffing conditions.

TL;DR: The study objective was to determine the effect of variable power applied to the atomizer of refillable tank based e-cigarette devices, and to estimate daily exposure to formaldehyde, acetaldehyde, and acrolein from EC aerosols from specific devices.

TL;DR: The clinical study confirmed the reduced exposure to HPHCs in smokers switching to THS2.2, and the associated transcriptomic study confirmedThe utility of a gene expression signature, consisting of only 11 genes tested in the blood transcriptome of subjects enrolled in the clinical study, as a complementary measure of exposure response.

TL;DR: Regulatory requirements and recent case studies are reviewed to illustrate how the risk assessment (RA) of chemical mixtures is conducted, considering both the effects on human health and on the environment.

TL;DR: Nicotine-related impurities in the e-cigarette formulations were below the identification and qualification thresholds proposed in ICH Guideline Q3B(R2), and levels of potentially harmful chemicals detected in the aerosols were determined to be below published occupational exposure limits.

TL;DR: In the proposed risk assessment strategy, approaches for (Quantitative) Structure Activity Relationships, grouping and read-across are integrated and expanded to guide the user how to prioritise those nanomaterial applications that may lead to high risks for human health.

TL;DR: The DF4nanoGrouping is a hazard assessment strategy that strictly uses animals as a last resort and provides a solid rationale for their sub-grouping to specify the further information needs.

TL;DR: This paper presents a meta-analysis of the literature on determinants of infectious disease and its applications to infectious disease treatment and its implications for medicine and public health.

TL;DR: The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD).

TL;DR: Inhalation, pharyngeal aspiration, and intratracheal instillation studies revealed that SWCNTs caused acute and chronic inflammation, granuloma formation, collagen deposition, fibrosis, and genotoxic effects in the lungs.

TL;DR: Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group, although exposure to nicotine was similar to CC at the end of the confinement period.

TL;DR: The data presented here shows the potential EVPs may offer smokers looking for an alternative to CCs and decrease in nicotine equivalents coincided with an increase in nicotine withdrawal symptoms, measured by a questionnaire, which subsided after two weeks.

TL;DR: Exposure to DvSnf7 RNA, both directly and indirectly, is safe for NTOs at the expected field exposure levels, and no adverse effects were observed with any species tested at the maximum expected environmental concentration (MEEC).

TL;DR: This paper outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7 guideline to be included in a regulatory submission.

TL;DR: Toxicological changes observed in the respiratory tract organs of THS2.2 aerosol-exp exposed rats were much less pronounced than in 3R4F-exposed rats while other toxicological endpoints either showed no exposure-related effects or were comparable to what was observed inThe 3R 4F- Exposed rats.

TL;DR: Adoption and widespread implementation of the current recommendations for QRA, taken in concert with improved assessment of aggregate exposure from multiple sources, should ensure that the frequency of contact allergy will decrease over the coming years.

TL;DR: Oral health and safety, as well as alternative materials, and human safety, are investigated in the context of dental amalgam use.

TL;DR: The Tobacco Heating System (THS2.2), which uses "heat-not-burn" technology, generates an aerosol from tobacco heated to a lower temperature than occurs when smoking a combustible cigarette, which results in significantly lower concentrations of harmful and potentially harmful constituents (HPHCs) than in smoke produced by combustible cigarettes.

TL;DR: An algorithmic, automated approach to evaluate the utility of using in vitro bioactivity data ("bioactivity descriptors", from EPA's ToxCast program) in conjunction with chemical descriptor information to derive local validity domains to facilitate read-across for up to ten in-vivo repeated dose toxicity study types.

TL;DR: The levels of biomarkers of exposure to HPHCs were significantly reduced in participants switching to THS 2.2, compared to CC use, and the magnitude of exposure reduction observed was close to that which was seen in participants who abstained from smoking for 5 days, while nicotine uptake was maintained.

TL;DR: The findings of the lifetime study and the weight-of-evidence factors collectively indicate that romosozumab administration would not pose a carcinogenic risk to humans.

TL;DR: An initiative to agree upon a standardized, internationally acceptable methodology for carcinogen assessment is needed now and should incorporate principles and concepts of existing international consensus-based frameworks including the WHO IPCS mode of action framework.

TL;DR: The olmesartan nanoemulsion was found to be safe and non-toxic, as it neither produced any lethality nor remarkable haematological, biochemical and structural adverse effects as observed during the 28-days sub-chronic toxicity studies in experimental Wistar rats.

TL;DR: In simulations evaluating THS 2.2, the concentrations of most studied analytes did not exceed the background concentrations determined when non-smoking panelists were present in the environmentally controlled room under equivalent conditions.

TL;DR: The purpose of this paper is to explore the nature of the regulatory processes in the US and EU and to determine the requirements of each in the approval process of a biosimilar.

TL;DR: A conceptual strategy is proposed which is based on the "weight-of-evidence approach" for food derived from GM plants and other strategies that were previously published in the literature, which will give more guidance on how to assess the allergenicity of novel food proteins and protein sources.

TL;DR: SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Safety of the use of bisphenol A in medical devices, 18 February 2015.

TL;DR: It is found that the FOB/IT are not adequate for predicting 'somnolence/fatigue' nonclinically in man, and in drug development, these five most prevalent AEs are rarely responsible for delaying or stopping further progression of CDs.

TL;DR: Systemic toxicity and alterations in the respiratory tract were significantly lower in THS2.2M-exposed rats compared with MRC and 3R4F, and Pulmonary inflammation and the magnitude of the changes in gene and protein expression were also dramatically lower.

TL;DR: The analysis here showed that skin metabolism was not likely to be a major consideration for assessing sensitization potential and that sensitizers requiring activation could be identified correctly using one or more of the current non-animal methods.