Showing papers in "Regulatory Toxicology and Pharmacology in 2019"

TL;DR: Exposure to the concentration of fluoride in drinking water resources of Showt city in West Azerbaijan Province in, Iran, and its related potential health risk assessment issues to the resident populations are considered.

TL;DR: An overview is provided of progress in the TGP and WPMN, and information on supporting initiatives, regarding the development of TGs for nanomaterials addressing Physical Chemical Properties, Effects on Biotic Systems, Environmental Fate and Behaviour, and Health Effects.

TL;DR: A comprehensive review of key absorption, distribution, metabolism, and excretion parameters across different mammalian species for five perfluoroalkyl substances (PFAS) and how these data can be used to inform human health risk assessment of these substances is conducted.

TL;DR: Hesperidin isolated from citrus fruit showed a good safety profile in animal study and has median lethal dose (LD50) of 4837.5 mg/kg, and Low Observed Adverse Effect Level (LOAEL) at 1000 mg/kg for both male and female Sprague-Dawley rats.

TL;DR: From the results obtained in this study, it is recommended that there be implementation of the appropriate remediation for defluoridation of water to circumvent the population from the probable health risks of F-.

TL;DR: It was found that elevating blood βHB concentrations from 0.1 to 4.1 (±1.1) mM three times a day for 28 days had no effect on body weights or composition, fasting blood glucose, cholesterol, triglyceride or electrolyte concentrations, nor blood gases or kidney function, which were invariably normal.

TL;DR: A transition from the bioassay to a decision-tree matrix that can be applied to a broader range of chemicals, with better predictivity, based on the premise that cancer is the consequence of DNA coding errors that arise either directly from mutagenic events or indirectly from sustained cell proliferation is recommended.

TL;DR: Overall, the tested e‐cigarette products induced significantly less cytotoxicity than conventional cigarette smoke under the conditions of test and suggest such products have the potential for reduced health risks.

TL;DR: The genetic toxicity in silico (GIST) protocol is described, which outlines a hazard assessment framework including key effects/mechanisms and their relationships to endpoints such as gene mutation and clastogenicity.

TL;DR: A unified theory of carcinogenesis is proposed that will illuminate better ways to evaluate and regulate chemicals and have implications for testing chemicals for carcinogenic potential and risk management.

TL;DR: This study investigated the value and concordance of the Tanimoto similarity values calculated using six widely used fingerprints within six toxicological datasets and suggested generic fingerprint‐derived similarities are likely to be optimally predictive for local datasets, i.e. following sub‐categorisation.

TL;DR: It is concluded that dose limiting toxicities in animals and in humans are generally related to the payload.

TL;DR: A critical review of data relevant to such a risk assessment, including epidemiological studies and in vivo and in vitro toxicity studies that examined PFHxA acute, subchronic, and chronic toxicity, concludes that PFHXA is not carcinogenic, is not a selective reproductive or developmental toxicant, and does not disrupt endocrine activity.

TL;DR: The long-term rodent bioassay is neither appropriate nor efficient to evaluate carcinogenic potential for humans and to inform risk management decisions and is not reproducible because of the probabilisitic nature of the process it is evaluating combined with dose limiting toxicity, dose selection, and study design.

TL;DR: Information is presented on actions taken by regulatory agencies, source of the nitrosamine impurities, range of possible risk assessments based mainly on ICH M7 criteria, epidemiological assessment and analytical aspects of this phenomenon.

TL;DR: Histopathological finding suggested no significant alteration in tissue histology with slight fatty cells in bone marrow indicating non‐significant bone marrow suppression and Hematological investigation did not show any alteration in transaminases and other blood homeostasis parameters, which supports safety of gallic acid in mice.

TL;DR: It was concluded that the basil cultivated under tested levels of SSGI and SSNI is not permissible for human consumption because of the high concentrations of copper, zinc, iron, nickel, lead, and cadmium.

TL;DR: Stem cells including induced pluripotent stem cell-based system for personalized toxicological assessment could be a better option as an in vitro model system in comparison with immortalized cells with abnormal phenotype or primary cells with small quantity and batch-to-batch variation.

TL;DR: Toxicity testing has shown mefentrifluconazole (MFZ) to be non-genotoxic and non-carcinogenic, and the absence in toxicity studies of effects that would indicate an endocrine disrupting potential is illustrated.

TL;DR: PHxA and related fluorotelomer precursors currently appear to present negligible human health risk to the general population and are not likely to drive or substantially contribute to risk at sites contaminated with PFAS mixtures.

TL;DR: The European Commission's Joint Research Centre hosted a workshop titled “Bridging communities in the field of Nanomedicine” in Ispra/Italy, where experts from regulatory bodies, research institutions and industry came together to discuss the next generation of nanomedicines and their needs to obtain regulatory approval.

TL;DR: Nonclinical data in total indicate no safety signal of concern to date and provide adequate margins of exposure between the observed safe doses in animals and clinical dose levels.

TL;DR: Data indicate that under the experimental conditions of this study, severe liver toxicity induced by PFOA administration is not associated with oxidative stress, and no genotoxic effect is observed in liver and in the other tissues examined.

TL;DR: Based on expert review, sources of uncertainties, variabilities and biases, as well as areas of influence in QSARs for toxicity prediction were established, and the applicability of the assessment criteria to identify potential weaknesses in the use of aQSAR for a specific purpose was demonstrated.

TL;DR: A Working Group comprised a balance of multiple stakeholders (cosmetics and chemical industries, the EPA and JRC and academia) with relevant experience and expertise and workshop to critically evaluate the requirements to establish an iTTC.

TL;DR: The Workshop sought to gain a more detailed understanding of the barriers to the adoption of suitable animal-free alternatives at an international level, and to explore opportunities to use alternative (non-animal) methods for hazard identification and classification without compromising human or environmental safety.

TL;DR: The field trials of chlorothalonil in water spinach were operated under good agricultural practice (GAP) in China to human health protective, highlighting that the dietary risk of chlorothsalonil under GAP was acceptable.

TL;DR: The dissipation dynamics and residue amounts of lambda‐cyhalothrin, thiamethoxam and clothianidin in apple were investigated by using rapid resolution liquid chromatography triple quadrupole mass spectrometer (RRLC‐MS/MS) and gas chromatographymass spectrometry (GC‐MS).

TL;DR: Since maximum residue limit (MRL) at pre-harvest interval (PHI) of 5 days is impractical, as tomato is usually harvested and consumed almost everyday after the last spray, the risk assessment was performed at minimum PHI of 1 day.

TL;DR: The high structural similarity of the two analogous substances based on the available data is demonstrated and how metabolome data add confidence concerning mechanistic similarity in this read-across approach is reported.