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Nanotechnology has been a central focus of scientific investigation over the past decades owing to its versatile applications. The synthesis of silver nanoparticles (AgNPs) through plant secondary metabolites is a cost-effective and eco-friendly approach. The present study employed Brassica carinata microgreen extracts (BCME) to promote the reduction of silver nitrate (AgNO3) salt into Brassica carinata microgreen silver nanoparticles (BCM-AgNPs). The physicochemical properties of the biosynthesized AgNPs were characterized through both spectroscopy and microscopy techniques. Furthermore, the antimicrobial property of the biosynthesized AgNPs was assessed against six selected pathogenic microorganisms, and finally, their safety was evaluated on a normal Vero cell line through an MTT cytotoxicity assay. The UV-visible spectrum revealed that BCM-AgNPs exhibited an absorption peak at 420 nm. The potential functional groups involved in the biosynthesis of AgNPs were identified by Fourier transform infrared (FTIR) analysis. Scanning electron microscopy (SEM) revealed a spherical nature of the biosynthesized AgNPs. Transmission electron microscopy (TEM) analysis revealed the crystallinity of the AgNPs, averaging 34.68 nm in size. X-ray diffraction (XRD) investigation further confirmed the crystalline structure of the AgNPs. The zeta potential exhibited a significant value of − 22.5 ± 1.16 mV. Regarding the antimicrobial potential, BCM-AgNPs exhibited promising antimicrobial activity against the tested pathogens, with a minimum inhibitory concentration (MIC) of 62.5 µg/mL observed in Pseudomonas aeruginosa. Further cytotoxicity assessment of BCM-AgNPs conducted on Vero cells demonstrated their safety. This study presents a novel approach to synthesizing AgNPs using a nutraceutical microgreen, offering a biocompatible and promising alternative for combating multi-drug resistance. [ABSTRACT FROM AUTHOR]

Introduction: All cosmetic ingredients must be evaluated for their safety to consumers. In the absence of in vivo data, systemic concentrations of ingredients can be predicted using Physiologically based Pharmacokinetic (PBPK) models. However, more examples are needed to demonstrate how they can be validated and applied in Next-Generation Risk Assessments (NGRA) of cosmetic ingredients. We used a bottom-up approach to develop human PBPK models for genistein and daidzein for a read-across NGRA, whereby genistein was the source chemical for the target chemical, daidzein. Methods: An oral rat PBPK model for genistein was built using PK-Sim® and in vitro ADME input data. This formed the basis of the daidzein oral rat PBPK model, for which chemical-specific input parameters were used. Rat PBPK models were then converted to human models using human-specific physiological parameters and human in vitro ADME data. In vitro skin metabolism and penetration data were used to build the dermal module to represent the major route of exposure to cosmetics. Results: The initial oral rat model for genistein was qualified since it predicted values within 2-fold of measured in vivo PK values. This was used to predict plasma concentrations from the in vivo NOAEL for genistein to set test concentrations in bioassays. Intrinsic hepatic clearance and unbound fractions in plasma were identified as sensitive parameters impacting the predicted Cmax values. Sensitivity and uncertainty analyses indicated the developed PBPK models had a moderate level of confidence. An important aspect of the development of the dermal module was the implementation of first-pass metabolism, which was extensive for both chemicals. The final human PBPK model for daidzein was used to convert the in vitro PoD of 33 nM (from an estrogen receptor transactivation assay) to an external dose of 0.2% in a body lotion formulation. Conclusion: PBPK models for genistein and daidzein were developed as a central component of an NGRA read-across case study. This will help to gain regulatory confidence in the use of PBPK models, especially for cosmetic ingredients. [ABSTRACT FROM AUTHOR]

Autonomous vehicles (AVs) must fulfill adequate safety requirements before formal application, and performing an effective functional evaluation to verify vehicle safety requires extensive testing in different scenarios. However, it is crucial to rationalize the application of different scenarios to support different testing needs; thus, one of the current challenges limiting the development of AVs is the critical evaluation of scenarios, i.e., the lack of quantitative criteria for scenario design. This study introduces a method using the Spherical Fuzzy-Analytical Network Process (SF-ANP) to evaluate these scenarios, addressing their inherent risks and complexities. The method involves constructing a five-layer model to decompose scenario elements and using SF-ANP to calculate weights based on element interactions. The study evaluates 700 scenarios from the China In-depth Traffic Safety Study–Traffic Accident (CIMSS-TA) database, incorporating fuzzy factors and element weights. Virtual simulation of vehicles in the scenarios was performed using Baidu Apollo, and the performance of the scenarios was assessed by collecting the vehicle test results. The correlation between the obtained alternative safety indicators and the quantitative values confirms the validity and scientific validity of this approach. This will provide valuable guidance for categorizing audiovisual test scenarios and selecting corresponding scenarios to challenge different levels of vehicle functionality. At the same time, it can be used as a design basis to generate a large number of effective scenarios to accelerate the construction of scenario libraries and promote commercialization of AVs. [ABSTRACT FROM AUTHOR]

In the search for a repository site for high-level radioactive waste in Germany, the perception of safety and trust in the actors are central to public acceptance. In communicating safety, methods of safety assessment and the role of uncertainties need to be addressed. Given the complexity of the issue, there is a need for indicators that are suitable both for assessing the long-term safety of repositories and for communicating with the general public. Similarly, there is a requirement to communicate uncertainties in an accessible manner. The TRANSENS project provides basic research in nuclear waste management (NWM) and utilizes a transdisciplinary approach: Non-experts who are not directly affected by the site selection process and who have no stated interest in NWM are involved in the research process, as are practice actors. A series of four transdisciplinary workshops was specifically designed to explore the perspectives of individuals with a high level of disciplinary knowledge but no system knowledge of NWM. Participants were selected from doctoral students in science and technology who had no prior knowledge in this area. Two of these workshops address the questions stated above and are presented here. The article describes the considerations underlying the workshop planning and implementation phases, and the content developed in the workshops on indicator selection and visualisation of uncertainties. The participants compiled a list of desirable indicator properties, which showed a high degree of congruence with the relevant literature. A proposal for a database to collect, administer and assess uncertainties shows similarities with the approach followed by the German implementer and complements it with an interactive visualisation. Transdisciplinary work is resource-intensive and its use in a research context must be carefully considered for each individual application. A transdisciplinary approach was successfully used for the purposes of method validation, method optimisation and the development of disciplinary impulses. An application of transdisciplinary approaches for optimising the Safety Case of nuclear repositories is feasible. [ABSTRACT FROM AUTHOR]

Introduction: Herbal medicine has been a cornerstone of healthcare for centuries, with an estimated 80% of the world's population relying on it. In Africa, herbal medicine is the backbone of rural healthcare, serving 80% to 90% of the population. Despite its widespread use, the safety of herbal medicine raises a significant concern considering the lack of regulation and testing, particularly in Africa. Microbial contamination is a primary safety risk threatening consumer health. In this systematic review, we aimed to synthesise evidence on microbial contamination in herbal medicines across Africa, provide a clear understanding of the problem, and inform effective public health interventions regarding microbial contamination of herbal medicines in Africa. Method: The systematic review was conducted in accordance with the PRISMA guidelines. A literature search was conducted across PubMed, Web of Science, Science Direct, Scopus, and Google Scholar using appropriate search terms. Eligible studies were selected based on predetermined criteria, and data were extracted and analysed. Results: The review included fifty eligible studies in Africa, with a combined sample size of 1996, of which 1791 showed microbial contamination. Bacterial contaminants were reported in 98% of studies, with Escherichia coli (62%) being the most reported bacteria, followed by Staphylococcus aureus (57%), and Bacillus spp. (55%). Fungal contaminants were reported in 70% of studies, with Aspergillus spp. (40%) being the most reported, followed by Penicillium spp. (27%) and Candida spp. (26%). Parasitic contaminants were reported in 2% of the studies reviewed. A total of 70 bacterial species, 37 fungal species, and 6 parasite species were identified in this review. Conclusion: Herbal medicines in Africa pose significant health threats to consumers due to the high prevalence of diverse microbial contaminants and clinically significant pathogens. This emphasises the need for stricter regulations and quality control measures in the production, sale and use of herbal medicines. [ABSTRACT FROM AUTHOR]

It is very important to accurately predict the strain of dented pipelines accurately for the safety evaluation of pipelines in service with dent defect. However, the strain prediction formula of dented pipe in existing American Society of Mechanical Engineering (ASME) standard neglects the influence of internal pressure on the strain of pipe. Therefore, a finite element model of dented pipe was established with internal pressure load, the influence of indenter radius, material property, pipe internal pressure, pipe wall thickness and pipe diameter on the maximum equivalent plastic strain (ε max 0 ) of the pipe at different dent depths were studied, a strain prediction model for pipelines in service with dent defect was proposed. The results show that when the relative dent defect depth is 6%, the internal pressure of the pipeline increases from 0 MPa to 8 MPa, and the ε max 0 increase rate is 50. 26%. The average error of ε max 0 prediction model is 5. 32% compared with the result of the finite element model. The maximum error and minimum error are 12. 51% and 4. 74% compared with the result of test results in the literature. The prediction model provides some reference for safety evaluation of pipeline in service. [ABSTRACT FROM AUTHOR]

Pseudoalteromonas piscicida 2515, isolated from Litopenaeus vannamei culture water, is a potential marine probiotic with broad anti-Vibrio properties. However, genomic information on P. piscicida 2515 is scarce. In this study, the general genomic characteristics and probiotic properties of the P. piscicida 2515 strain were analysed. In addition, we determined the antibacterial mechanism of this bacterial strain by scanning electron microscopy (SEM). The results indicated that the whole-genome sequence of P. piscicida 2515 contained one chromosome and one plasmid, including a total length of 5,541,406 bp with a G + C content of 43.24%, and 4679 protein-coding genes were predicted. Various adhesion-related genes, amino acid and vitamin metabolism and biosynthesis genes, and stress-responsive genes were found with genome mining tools. The presence of genes encoding chitin, bromocyclic peptides, lantibiotics, and sactipeptides showed the strong antibacterial activity of the P. piscicida 2515 strain. Moreover, in coculture with Vibrio anguillarum, P. piscicida 2515 displayed vesicle/pilus-like structures located on its surface that possibly participated in its bactericidal activity, representing an antibacterial mechanism. Additionally, 16 haemolytic genes and 3 antibiotic resistance genes, including tetracycline, fluoroquinolone, and carbapenem were annotated, but virulence genes encoding enterotoxin FM (entFM), cereulide (ces), and cytotoxin K were not detected. Further tests should be conducted to confirm the safety characteristics of P. piscicida 2515, including long-term toxicology tests, ecotoxicological assessment, and antibiotic resistance transfer risk assessment. Our results here revealed a new understanding of the probiotic properties and antibacterial mechanism of P. piscicida 2515, in addition to theoretical information for its application in aquaculture. [ABSTRACT FROM AUTHOR]

Background: Probiotics, which are live microorganisms that, when given in sufficient quantities, promote the host's health, have drawn a lot of interest for their ability to enhance gut health. Enterococcus faecalis, a member of the human gut microbiota, has shown promise as a probiotic candidate due to its functional attributes. However, safety concerns associated with certain strains warrant comprehensive evaluation before therapeutic application. Materials and Methods: In this study, E. faecalis EF-2001, originally isolated from fecal samples of a healthy human infant, was subjected to a multi-faceted assessment for its safety and probiotic potential. In silico analysis, CAZyme, biosynthetic, and stress-responsive proteins were identified. Results: The genome lacked biogenic amine genes but contained some essential amino acid and vitamin synthetic genes, and carbohydrate-related enzymes essential for probiotic properties. The negligible difference of 0.03% between the 1st and 25th generations indicates that the genetic information of the E. faecalis EF-2001 genome remained stable. The live E. faecalis EF-2001 (E. faecalis EF-2001L) demonstrated low or no virulence potential, minimal D-Lactate production, and susceptibility to most antibiotics except some aminoglycosides. No bile salt deconjugation or biogenic amine production was observed in an in vitro assay. Hemolytic activity assessment showed a β-hemolytic pattern, indicating no red blood cell lysis. Furthermore, the EF-2001L did not produce gelatinase and tolerated simulated gastric and intestinal fluids in an in vitro study. Similarly, heat-killed E. faecalis EF-2001 (E. faecalis EF-2001HK) exhibits tolerance in both acid and base conditions in vitro. Further, no cytotoxicity of postbiotic EF-2001HK was observed in human colorectal adenocarcinoma HT-29 cells. Conclusions: These potential properties suggest that probiotic and postbiotic E. faecalis EF-2001 could be considered safe and retain metabolic activity suitable for human consumption. [ABSTRACT FROM AUTHOR]

Swing yarders in running skyline configuration using either grapples or chokers represent the most common configuration for cable yarding in coastal British Columbia. In this context, whole-tree logging and short work cycles lead to heavy and repeated loads applied to the trees and stumps when used as anchors for the rigging cables. Moreover, increased harvesting of second-growth forest stands leads to the unavailability of large and safe trees, thus introducing new challenges to identify suitable anchors and potentially increases safety risks of cable yarding operations. The present study aimed to collect evidence of the mechanical response provided by anchors for typical cable yarders used in second-growth harvesting in coastal British Columbia, and test the suitability of innovative techniques for the stability assessment based on the relationship between the anchor root-plate rotations and the related applied tensile forces. A conspicuous dataset could be derived from all the surveys, storing anchor rotations from a total of 1522 work cycles of which 1224 work cycles included also tensions measurements. The methodological approach was proven effective for monitoring different rigging configurations giving proof that repeated loading affects the stability of a tree/stump which can rapidly change over few hours of active yarding operations. Acquired data proved also that comparing theoretical failure limits with anchor rotations could be a valid approach however a considerable amount of species-specific data from tree pulling tests is required. [ABSTRACT FROM AUTHOR]

• A rigid-flexible coupling dynamics model and safe landing criteria are developed. • A method for constructing locally refined rocky terrain is proposed. • The effect of the flexible appendages on probe landing process cannot be ignored. • Landing success rate first increases and then decreases with increasing probe mass. • Landing success rate is inversely correlated with rock size, number and power index. Studying the landing of a legged probe on asteroids with widely distributed rocks is of great significance. However, the landing safety of legged probes with flexible appendages (solar panels and touchdown legs) on the rocky terrain of asteroids is still unclear. In this study, we establish a complete rigid-flexible coupling touchdown dynamics model for an asteroid probe, and propose a new method for constructing locally refined rocky terrain. Moreover, two criteria for safe touchdown of the probe are established. Monte Carlo simulations are performed to analyze the landing success probability of the probe on different locally refined rocky terrains. The validity of the rock generation method and safety assessment is confirmed through repeated landing simulations. The simulation results show that the effect of the flexible appendages on the probe landing process cannot be ignored. With the same propulsion force of the probe, the landing success probability first increases and then decreases with increasing probe mass. Based on the original terrain, increases in rock size, quantity and power- index lead to the increase of the root-mean-square (RMS) height and RMS slope of rocky terrain, and then cause a decrease in the landing success probability of the legged probe. The results are expected to provide guidance for asteroid touchdown missions. [ABSTRACT FROM AUTHOR]

Copyright of Aero Weaponry is the property of Aero Weaponry Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Gas pipelines are buried and installed across rivers to supply the gas necessary for daily life. When crossing rivers, gas pipelines are typically installed on bridges; however, when installation on bridges is not feasible, the pipelines are buried in riverbeds. This study utilized both a one-dimensional model (HEC-RAS) and two-dimensional models (SMS) to simulate river flow and estimate the potential for scour and deposition around buried pipelines. The hydrodynamic simulations considered critical factors, including sediment transport, river discharge, and geological characteristics, to derive the maximum scour depth and assess the risk of pipeline exposure. The findings from the long-term and short-term simulations confirmed that riverbed changes due to natural hydrological events do not exceed the minimum burial depth standards, thereby ensuring pipeline safety. In addition, the study proposed specific reinforcement measures tailored to local site conditions, addressing concerns of continuous subsidence and ensuring long-term structural stability. This research offers important insights into pipeline risk management and contributes to the development of more effective regulatory standards for gas pipelines buried in riverbeds, enhancing both their safety and environmental sustainability [ABSTRACT FROM AUTHOR]

Proprioseiopsis asetus and Amblyseius swirskii are excellent natural enemies of plant-feeding mites and small pests. In order to clarify the safety of the acaricide spirodiclofen to the predatory mites P. asetus and A. swirskii, here, we investigated the toxicity of the acaricide on the pest mite T. urticae (nymphs and adult females) and on both species of predatory mites, P. asetus and A. swiskii (eggs, nymphs, and female adults) by using the spray, slide-dip, and leaf residual toxicity methods, compared the selective toxicity and assessed the safety to these natural enemies. The results demonstrated that the corrected mortality in P. asetus and A. swirskii female adults was <5% at recommended spirodiclofen concentrations in the spray method. In the leaf residual toxicity method, P. asetus and A. swirskii egg-hatching rates did not differ significantly from the pure water control group. In the slide-dip method, spirodiclofen lethal concentration 50 (LC50) in P. asetus and A. swirskii female adults was noted to be 9,494.875 and 3,064.187 mg·L–1, respectively. In the spray method, spirodiclofen LC50 in P. asetus and A. swirskii nymphs was found to be 4,292.664 and 1,081.609 mg·L–1, respectively, and that in T. urticae female adults and nymphs was 55.189 and 40.862 mg·L–1, respectively. Spiroclofen selective toxicity ratios (STRs) in P. asetus female adults–T. urticae and P. asetus nymphs–T. urticae were 172.013 and 105.053, respectively, indicating that spiroclofen has a high positive selectivity toward the pest T. urticae and its natural enemy P. asetus. In contrast, spiroclofen STRs in A. swirskiis female adults–T. urticae and A. swirskiis nymphs–T. urticae were 55.522 and 26.470, respectively, indicating spiroclofen has a moderate positive selectivity toward the pest T. urticae and its natural enemy A. swirskii. In the safety evaluation, the spirodiclofen safety factor for P. asetus female adults and nymphs was 158.248–237.37 and 71.544–107.317, respectively, whereas that for A. swirskii female adults and nymphs was 50.070–76.605 and 18.027–27.040 respectively. All spirodiclofen safety factor values were much higher than 5, indicating that spirodiclofen is highly safe for P. asetus and A. swirskii; in particular, spirodiclofen is safer for P. asetus than for A. swirskii. [ABSTRACT FROM AUTHOR]

Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers. Applicants should integrate the data presented in different sections to provide their overall considerations on how the information provided supports the safety of the new micronutrient source and the quantification of its relative bioavailability compared to a reference source under the proposed conditions of use. As preparatory work for the development of this guidance, EFSA launched an Expert Survey and held an online workshop on 9th March 2023 inviting scientific input from stakeholders and scientific experts, the report of which is now available online in the EFSA's webpage. [ABSTRACT FROM AUTHOR]

These toxicity studies aimed to assess the safety and tolerability of a novel intravenous diclofenac sodium (37.5 mg/mL) formulation containing povidone K12 (80 mg/mL) as the key excipient in Wistar rats. This formulation was tested at doses of 3, 7, and 15 mg/kg/day and was administered daily for 28 days by intravenous route. Toxicokinetic estimation revealed a dose-proportional increase in plasma exposure to diclofenac. The formulation was well tolerated in males; however, mortality was observed in females (2/15) at the highest dose (15 mg/kg/day). Adverse gastrointestinal events related to NSAIDS and a few other treatment-related effects on clinical and anatomic pathology were noted at the 15 mg/kg/day dose, which normalized at the end of the 2-week recovery period. In addition, the excipient povidone K12 was present in a higher amount than the approved Inactive Ingredient Database (IID) limit in the proposed novel formulation. It was qualified through a separate 28-day repeated dose toxicity study by intravenous route in Wistar rats. Povidone K12 was found to be well tolerated and safe up to a dose of 165 mg/kg/day. No treatment-related adverse effects were observed in this study. In conclusion, repeated administration of a novel intravenous formulation containing diclofenac sodium was found to be safe up to the dose of 7 mg/kg/day in female rats and 15 mg/kg/day in male rats. [ABSTRACT FROM AUTHOR]

This study explores the comprehensive approach of utilizing physiographical and geophysical electrical resistivity tomography (ERT) investigation to evaluate and address the challenges associated with abandoned, unplanned water-filled galleries in Chasnala Colliery, located in Jharkhand, India. The integrated methodologies facilitate a thorough examination of subsurface conditions, encompassing factors such as geological stability, hydrological fluctuations, and environmental considerations. Utilizing physiographical analysis is of utmost importance in identifying locations with potential risks and developing appropriate site-specific reclamation procedures in the study area. The ERT analysis has successfully confirmed the findings of the physiographical study, revealing the presence of five distinct underground galleries, namely, GL1, GL2, GL3, GL4, and GL5, that are likely submerged in water. These galleries establish connections between the underground spaces and the groundwater, as indicated by their low resistivity values of ~50 Ωm or less. The resistivity measurements exhibit variations that can be attributed to fluctuations in the underground water content. The Wenner, Schlumberger, and dipole–dipole arrays have adeptly discerned the existence of water-filled underground galleries with commendable accuracy. However, the joint array configuration stands out as the pre-eminent choice among these standards due to its unparalleled technical robustness. The findings concurred with the notable correlation between water-filled galleries’ spatial arrangement and shallow groundwater level. The integration of physiographical and ERT data improves the precision of subsurface characterization, facilitating informed decision-making for efficient water management and site rehabilitation in the context of opencast mining. [ABSTRACT FROM AUTHOR]

Copyright of Food Science & Technology & Economy is the property of Grain Science & Technology & Economy Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Probiotics, as defined by the World Health Organization, are live microorganisms that, when consumed in sufficient quantities, provide health benefits to the host. Although some countries have approved specific probiotic species for use in food, safety concerns may still arise with individual strains. Lacticaseibacillus paracasei subsp. paracasei NTU 101 (NTU 101), isolated from the gut of healthy infants, has demonstrated various probiotic effects and shown safety in a prior 28-day animal feeding study. To further verify its safety and mitigate potential risks, we performed a comprehensive genotypic and phenotypic safety evaluation in accordance with the European Food Safety Authority guidelines for safety assessment through whole genome sequencing and related literature. In this research, minimum inhibitory concentration testing identified NTU 101’s resistance to chloramphenicol; however, subsequent gene analysis confirmed no associated risk of resistance. Assessments of safety, including biogenic amine content, hemolytic activity, mucin degradation, and D-lactic acid production, indicated a low level of risk. Additionally, a repeated-dose 90-day oral toxicity study in Sprague-Dawley rats revealed no toxicity at a dose of 2000 mg/kg body weight, further supporting the strain’s safety for consumption. Based on these comprehensive analyses, NTU 101 is considered safe for regular consumption as a health supplement.

The safety of the pyrotechnic and power components of air-to-air missiles under braking and inertial running out conditions is one of the key factors that restrict the launch of air-to-air missiles on aircraft carriers. How-ever, there is no quantitative method for evaluating the safety of ammunition under braking and inertial running out conditions in practical applications. Based on the FLL ignition engineering criterion, relying on standard part test of large sample and whole missile braking and inertial running out test of small sample, a safety evaluation method of braking and inertial running out for ammunition is established, and the technical issue of braking and inertial running out for ammunition safety that can not be quantitative evaluated is resolved. An example of evaluating computation is showed together with the data from braking and inertial running out test, and the evaluation results are in good agreement with the actual test findings.

Background Rabies, a zoonotic disease, poses a significant global public health challenge, and post-exposure prophylaxis (PEP) is crucial for prevention. Monoclonal antibodies (mAbs) have emerged as a promising alternative to rabies immunoglobulins due to their high efficacy and standardized manufacturing process. Materials and Methods A prospective, open-label post-marketing surveillance study was conducted with patients of WHO category-III suspected rabid animal bites. TwinRab™, a novel cocktail of docaravimab and miromavimab, was administered at a dosage of 40 IU/kg in and around the wound, along with the anti-rabies vaccine, which was administered intradermal as per Thai Red Cross regimen. Results In this study, 200 subjects received TwinRab™ with a 100% completion rate. Three (1.5%) patients showed solicited local AEs, and two (1%) patients showed solicited systemic AEs, which were resolved after appropriate treatment intervention. The overall tolerability assessment showed positive ratings from doctors (94%) and patients (74%). Conclusion The post-marketing surveillance study demonstrated the safety of TwinRab™ in patients who experienced category-III suspected rabid animal bites, thereby supporting its potential as an alternative option for PEP in the management of animal bite for the prevention of rabies.

In the construction of the Shenzhen–Zhongshan Link, a temporary anchorage system, distributed uniformly along the pipe wall, has been employed. To assess the safety and reliability of this system, a combined method utilizing numerical analysis and model experiments was applied to study the safety of the temporary anchorage system and the reliability of the tension rods. Firstly, an overall model of the caisson segment based on GINA rebound force was established to analyze the stress state of the entire system. Secondly, a comprehensive numerical analysis and model experiment verification were conducted for the single tensioning system, revealing its failure mode and safety margin. The results indicate that the tension rod systems are uniformly stressed at an average of 444 kN during underwater jointing, with a safety factor of 1.94. At this point, the maximum von Mises stresses appearing at the front plate corners and the lower edge of the U-groove, with stress values of 181.8 MPa and 172.4 MPa, and safety factors of 1.54 and 1.71, respectively. When the tension rod force reaches 940 kN, the tensioning system reaches its bearing limit, with initial yielding occurring at the front plate corners. Model experiments were conducted to verify the theoretical analysis results, under a test load of 444 kN, the stresses at the front plate corners and the lower edge of the U-groove were 159.6 and 195.9 MPa, respectively. As the test load increased to 940 kN, these stresses reached 390 and 389 MPa, exhibiting good agreement with the numerical analysis. Considering the uncertainty of loads and materials, a reliability analysis of the tension rods was conducted, yielding a reliability index of 4.34, meeting the secondary safety standard. Based on the comprehensive analysis, it can be concluded that the temporary anchorage system in the caisson segments of the Shenzhen–Zhongshan Link exhibits excellent safety margins.

Paralytic shellfish toxins (PSTs) are a class of acute neurotoxins with nearly 60 congeners. Shellfish that filter feed on toxin-producing algae exhibit PST accumulation in tissues, and the consumption of toxic shellfish poses a major threat to human health. China has the largest aquaculture industry in the world, with shellfish production of approximately 15.89 million tons in 2022 and many shellfish consumers. The PST poisoning incidents in China exhibit the characteristics of a wide distribution area, recurring regional risk, diverse toxin sources, and seasonal differences. PST consumption causes acute symptoms of poisoning and even death in many people, with a high lethality rate. This is a serious threat to the health of consumers and detrimental to the social stability of the region. In northern China, Hebei Province has rich fisheries resources, with a mariculture output of approximately 580, 000 tons in 2022. In recent years, PSTs have been detected several times in bivalve shellfish inshore in Hebei Province, especially along the coast of Qinhuangdao. A serious shellfish poisoning episode was reported in Qinhuangdao in 2016, with PST concentrations exceeding the safety limit of 800 μgSTX equivalents/kg (μg STXeq/kg) by a factor of 65. The main algal species responsible for the poisoning was Alexandrium catenella. However, the current investigations of PST pollution in Hebei Province mainly focus on the shellfish species Mytilus galloprovincialis and Argopecten irradians in the sea area of Shanhaiguan, Qinhuangdao, and investigations on other coastal cities of Hebei Province and a wide range of different shellfish species are lacking. Moreover, few risk assessment studies have been conducted.A continuous PST survey was conducted in 2022 on six species of shellfish, namely M. galloprovincialis, Scapharca subcrenata, A. irradians, Scapharca broughtonii, Ruditapes philippinarum, and Crassostrea gigas, collected by netting in Tangshan and Qinhuangdao, and the residual status of PSTs was assessed for acute exposure using liquid chromatography-tandem mass spectrometry. The results showed that PSTs were detected in shellfish samples collected from March to June, with a detection rate of 100%. However, no values exceeded the European Union limit. Among the shellfish samples collected from March to June, those assessed in April had the highest average concentration, followed by those in May, March, and June, which had the lowest average concentration. The main components detected in shellfish samples from March to June were gonyautoxins (GTX) 1–4; the highest concentrations were detected in April. Highly toxic saxitoxin (STX) and decarbamoylneosaxitoxin (dcNEO) were detected from April to June and not in March. Decarbamoylgonyautoxin (dcGTX) 2 was not detected in March or April; however, it was detected in May and June. The sea area near Qinhuangdao was more polluted than that near Tangshan. Among the collected shellfish samples, significant differences were observed in the average concentration of PSTs in shellfish samples of different species, and the concentration ranged from highest to lowest in species as follows: M. galloprovincialis > S. subcrenata > A. irradians > S. broughtonii > R. philippinarum > C. gigas. Large differences were observed between the six shellfish species regarding the accumulation of 11 PST components, among which GTX1–4 and carbamatetoxin (C) 1 and 2 were the most commonly detected components. The highest concentrations of GTX1 and 4 were observed in M. galloprovincialis, the highest concentrations of GTX2 and 3 were observed in S. subcrenata, and the highest concentrations of C1 and 2 were observed in A. irradians. A low detection rate was recorded for highly toxic STX and neosaxitoxin (NEO in samples, except in M. galloprovincialis and S. subcrenata, in which all 11 PSTs were detected. In the other four shellfish species, only certain of the components were detected. Statistical analysis of the highest levels of PSTs in nearshore shellfish in Hebei Province in recent years showed a decreasing trend. Acute exposure assessments using the maximum value of PSTs showed that none of the six shellfish species exceeded the acute reference dose values recommended by the Food and Agriculture Organization of the United Nations/World Health Organization and European Food Safety Authority, suggesting that toxin levels were safe and acceptable. M. galloprovincialis had the highest dietary exposure risk, as a few residues were present, and symptoms of PST poisoning, such as dizziness and nausea, may occur after ingesting large quantities of M. galloprovincialis. Increased attention should be paid to shellfish with high dietary exposure assessment values, such as M. galloprovincialis and S. subcrenata.In this study, we investigated PSTs in shellfish from Hebei coastal waters and observed that PSTs were detected in shellfish samples from March to June, with the highest average concentration in April, followed by May and March, with the lowest average concentration in June. In addition, the main components detected in shellfish samples were GTX1–4. The analysis of different shellfish species showed that M. galloprovincialis had the highest average PST concentration, followed by S. subcrenata, A. irradians, S. broughtonii, R. philippinarum, and C. gigas; GTX1–4 and C1 and 2 were detected in all six shellfish species. Dietary exposure assessment for consumers in Hebei Province showed that the toxin levels were safe and acceptable. However, follow-up surveys and studies are necessary due to the paucity of surveys for different cities and species on the coast of Hebei.

The risk of hydrogen explosion accident in solution reactor system is high, because both hydrogen and oxygen are released simultaneously from the solution reactor vessel during normal operation. Once hydrogen explosion accident occurs, the overpressure and temperature loads induced by explosion could threaten the integrity and security of radioactive containment boundary. Thus, the structural safety assessment in the event of a hydrogen explosion accident is a key question, which is highly concerned by both designers and nuclear safety reviewers. In this paper, a multi-subject coupling analytical process of structural safety assessment under hydrogen explosive load was presented, which considered chemistry, thermodynamics and mechanics, and this multi-subject coupling analytical process was applied to the structural safety assessment of solution reactor system successfully. Firstly, the governing equation numerical simulation was built up based on computational fluid dynamics (CFD) method and combustion model to simulate hydrogen explosion behaviors. Considering the solution reactor system consisted of vessel and pipelines, the hydrogen explosion behavior in a narrow channel experiment and in a large-scaled vessel experiment was simulated respectively, and the numerical simulation results, such as overpressure and flame front speed, were compared with experimental data to verify the reasonableness and accuracy of numerical simulation method. Then, the authors established the full-scaled numerical model of solution reactor system and simulated the overpressure and temperature rise in the event of a hydrogen explosion accident, using the numerical method above. The initial hydrogen volume concentration, pressure and temperature derived from accident analysis, two ignition positions (the outlet of reactor vessel and the end of pipeline) were taken into account. Furtherly, the overpressure and temperature induced by hydrogen explosion were applied to the radioactive containment boundary, and the structural dynamic response of solution reactor under hydrogen explosive load was obtained. The results show that the validation of the simulation of hydrogen explosion in narrow channel experiment and large-scaled vessel experiment is verified, and the calculated result can fit well with experimental data. It proves that the numerical method above is accurate and is applicable to solution reactor system. The simulation of hydrogen explosion in solution reactor system presents that a significant overpressure and temperature rise occurs within the radioactive containment boundary. The explosive hazard is greater when the ignition position is located at the end of pipeline. However, even the worse explosive load is unable to undermine the integrity of radioactive containment boundary, the solution reactor system can maintain safety in the event of hydrogen explosion accident.

Abstract Background Standard systematic review can be labor-intensive and time-consuming meaning that it can be difficult to provide timely evidence when there is an urgent public health emergency such as a pandemic. The ClinicalTrials.gov provides a promising way to accelerate evidence production. Methods We conducted a search on PubMed to gather systematic reviews containing a minimum of 5 studies focused on safety aspects derived from randomized controlled trials (RCTs) of pharmacological interventions, aiming to establish a real-world dataset. The registration information of each trial from eligible reviews was further collected and verified. The meta-analytic data were then re-analyzed by using 1) the full meta-analytic data with all trials and 2) emulated rapid data with trials that had been registered and posted results on ClinicalTrials.gov, under the same synthesis methods. The effect estimates of the full meta-analysis and rapid meta-analysis were then compared. Results The real-world dataset comprises 558 meta-analyses. Among them, 56 (10.0%) meta-analyses included RCTs that were not registered in ClinicalTrials.gov. For the remaining 502 meta-analyses, the median percentage of RCTs registered within each meta-analysis is 70.1% (interquartile range: 33.3% to 88.9%). Under a 20% bias threshold, rapid meta-analyses conducted through ClinicalTrials.gov achieved accurate point estimates ranging from 77.4% (using the MH model) to 83.1% (using the GLMM model); 91.0% to 95.3% of these analyses accurately predicted the direction of effects. Conclusions Utilizing the ClinicalTrials.gov platform for safety assessment with a minimum of 5 RCTs holds significant potential for accelerating evidence synthesis to support urgent decision-making.

Catastrophe theory was used to establish a safety assessment model to reduce the reliance on subjective judgments in evaluation of timber-framed heritage buildings. This study was conducted in three phases. Initially, a comprehensive evaluation index system was established from the perspective of foundation. It consisted of eight aspects and 25 safety evaluation indicators using superstructure load-bearing elements, maintenance structures, and their interconnections in timber-framed heritage buildings. The 25 safety evaluation indicators included foundation, base, stone piers, columns, beams, lintels (beams, pads, and other bending components), bracket sets, arches, maintenance walls, beam-brace connections, and roof structures. The bottom-level indicators in the index system were dimensionless. The second phase employed typical catastrophe models (cusp, swallowtail, and butterfly) for normalization, resulting in calculated catastrophe scales and evaluation levels. The case study of the Buddha Hall of Zhihua Temple, Beijing, was applied in the final phase. It was found that the catastrophe scales method solved the subjectivity issues in determining weights. Additionally, the calculations were found to be concise and reliable, providing accurate results. The model can be used as a theoretical reference for the future safety assessment of timber-framed heritage buildings.

Background/Objectives: This study evaluated the hemostatic performance and safety of ActiClot (ATC), a new flowable hemostatic agent, through in vivo tests. Methods: ATC was compared with the commercially available FLOSEAL®. ATC consists of carboxymethyl starch, thrombin, and sorbitol powders in Syringe I, and a calcium chloride solution in Syringe II. In vivo evaluation used rat liver bleeding and porcine heart bleeding models. Safety was assessed using a rat subcutaneous implantation model. Results: ATC significantly reduced hemostasis time (70.00 ± 7.35 s) compared to gauze control (240.63 ± 32.31 s) in the rat liver model, showing a 70% reduction. There was no significant difference between ATC and FLOSEAL® (58.75 ± 13.42 s). In the porcine heart model, both agents achieved 100% hemostasis within 3 min, with no significant difference in success rates within 2 min (ATC 87.5%, FLOSEAL® 75%). The gauze control group failed in all tests. The rat subcutaneous implantation model showed no visual ATC observation after 48 h, indicating biocompatibility, with no inflammation observed. Conclusions: ATC demonstrated effective hemostatic performance similar to FLOSEAL® in two in vivo models, with faster hemostasis in the rat liver model. It also showed excellent safety and biocompatibility, indicating its potential for surgical and emergency bleeding control. [ABSTRACT FROM AUTHOR]

Soy protein is considered to be a high-quality protein with a range of important biological functions. However, the applications of soy protein are limited due to its poor solubility and high level of allergenicity. Its peptides have been of interest because they exert the same biological functions as soy protein, but are easier to absorb, more stable and soluble, and have a lower allergenicity. Moreover, recent research found that an attachment of chemical moieties to peptides could improve their properties including their biodistribution, pharmacokinetic, and biological activities with lower toxicity. This study therefore aimed to acquire scientific evidence to support the further application and safe use of the soybean oligopeptide (OT) conjugated with allulose (OT-AL) or D-mannose (OT-Man). The anti-inflammation, cytotoxicity, and genotoxicity of OT, OT-AL, and OT-Man were investigated. The results showed that OT, AL, Man, OT-AL, and OT-Man at doses of up to 1000 µg/mL were not toxic to HepG2 (liver cancer cells), HEK293 (kidney cells), LX-2 (hepatic stellate cells), and pre- and mature-3T3-L1 (fibroblasts and adipocytes, respectively), while slightly delaying the proliferation of RAW 264.7 cells (macrophages) at high doses. In addition, the oligopeptides at up to 800 µg/mL were not toxic to isolated human peripheral blood mononuclear cells (PBMCs) and did not induce hemolysis in human red blood cells (RBCs). OT-Man (200 and 400 µg/mL), but not OT, AL, Man, and OT-AL, significantly reduced the production of NO and the expression of inducible nitric oxide synthase (iNOS) and cyclooxygenase-2 (COX2) stimulated by lipopolysaccharide (LPS) in RAW 264.7 cells, suggesting that the mannose conjugation of soy peptide had an inhibitory effect against LPS-stimulated inflammation. In addition, the secretion of interleukin-6 (IL-6) stimulated by LPS was significantly reduced by OT-AL (200 and 400 µg/mL) and OT-Man (400 µg/mL). The tumor necrosis factor-α (TNF-α) level was significantly decreased by OT (400 µg/mL), AL (400 µg/mL), OT-AL (200 µg/mL), and OT-Man (200 and 400 µg/mL) in the LPS-stimulated cells. The conjugation of the peptides with either AL or Man is likely to be enhance the anti-inflammation ability to inhibit the secretion of cytokines. As OT-Man exhibited a high potential to inhibit LPS-induced inflammation in macrophages, its mutagenicity ability was then assessed in bacteria and Drosophila. These findings showed that OT-Man did not trigger DNA mutations and was genome-safe. This study provides possible insights into the health advantages and safe use of conjugated soybean peptides. [ABSTRACT FROM AUTHOR]

Summary: The enzymatic activity exhibited by native enterococci could, in turn, result in a reduction in the cheese ripening time. However, they may also carry virulence factors or resistance to antibiotics that prevent their use in food. A total of 69 enterococci isolates were obtained from a Spanish traditional raw goat's milk cheese and identified by Maldi‐Tof/MS. Different enzymatic activities of technological interest were evaluated and the safety of those with greater technological suitability was studied. The strains were identified as E. malodoratus, E. italicus, E. gilvus, E. faecium, E. durans, E. casseliflavus and E. faecalis. Some strains had very high acidifying and proteolytic activities. Most strains had medium or low amino and carboxypeptidase activities and high dipeptidase activities, while esterase activities were medium. A total of 10 strains were selected based on their enzymatic activities. Of these, five showed β‐haemolysin activity, eight showed gelatinase activity and eight produced tyramine. These activities represent virulence factors that could potentially affect food safety. Finally, all selected strains were susceptible to the antibiotics tested. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the substances 'wax, rice bran, oxidised' and 'wax, rice bran, oxidised, calcium salt', used as additives up to 0.3% in polyethylene terephthalate (PET), polyamide (PA), thermoplastic polyurethane (TPU), polylactic acid (PLA) and poly(vinyl chloride) (PVC) in contact with all food types for long‐term storage at room temperature and below, after hot‐fill and/or heating. The substances consist of the chemical classes wax esters, carboxylic acids, alcohols and calcium salts of acids, along with an unidentified organic fraction up to ■■■■■ w/w. Migration into 10% ethanol and 4% acetic acid was below 0.012 mg/kg for each chemical class, and about 0.001 mg/kg for the unidentified fraction. In isooctane, migration was up to 0.297 mg/kg food for wax esters, below 0.01 mg/kg food for the other chemical classes and about 0.02 mg/kg food for the unidentified fraction. The contact with dry food and food simulated by 20% ethanol were considered covered by the migration tests with aqueous simulants. Based on genotoxicity assays and compositional analyses, the constituents of the chemical classes did not raise a concern for genotoxicity. The potential migration of individual constituents or groups of chemically‐related compounds of the unidentified fraction would result in exposures below (for aqueous food) and above (for fatty food) the threshold of toxicological concern for genotoxic carcinogens. Therefore, the FCM Panel concluded that the substances are not of safety concern for the consumer, if used as additives up to 0.3% w/w in PET, PLA and rigid PVC materials and articles intended for contact with all food types except for fatty foods, for long‐term storage at room temperature and below, including hot‐fill and/or heating up to 100°C for up to 2 h. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Lietpak (EU register number RECYC327), which uses the EREMA MPR technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

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To carry out digital and intelligent research on structural safety assessment methods for rail transport infrastructure, which has an essential impact on the maintenance and management of rail transport infrastructure. This study selects 22 risk indicators, which are then used in a comprehensive evaluation of the operational context of the structure, which aims to develop a holistic risk assessment index system encompassing the interactions between structure, vehicle, and environment. Using a dynamic weight model, we compute node weights and construct a weighted Bayesian network model. This approach addresses the limitations of the conditional independence assumption typical in standard Bayesian network models., thereby addressing the restrictions associated with the conditional independence assumption inherent in the Bayesian network model. The utilization of trapezoidal fuzzy numbers and the maximum noise algorithm to compute network parameters, as well as in the determination of the safety probability of a given structure and the identification of the most probable risk factors associated with it. The findings reveal that the security level of this structure, as determined by a standard Bayesian network, is classified as level I. In contrast, the Level II security status obtained from the weighted Bayesian network corroborates with the fuzzy analytic hierarchy method's results, indicating a significant enhancement in inference accuracy with the weighted approach. [ABSTRACT FROM AUTHOR]

This paper introduces a novel approach to assessing structural safety, specifically aimed at evaluating the safety of existing structures. Firstly, a point cloud model of the existing commercial complex was captured utilizing three-dimensional (3D) laser scanning technology. Subsequently, an intelligent method for identifying holes within the point cloud model was proposed, built upon a YOLO v5-based framework, to ascertain the dimensions and locations of holes within the commercial complex. Secondly, Poisson surface reconstruction, coupled with partially self-developed algorithms, was employed to reconstruct the surface of the structure, facilitating the three-dimensional geometric reconstruction of the commercial complex. Lastly, a finite element model of the framed structure with holes was established using the reconstructed 3D model, and a safety analysis was conducted. The research findings reveal that the YOLO v5-based intelligent hole identification method significantly enhances the level of intelligence in point cloud data processing, reducing manual intervention time and boosting operational efficiency. Furthermore, through Poisson surface reconstruction and the self-developed algorithms, we have successfully achieved automated surface reconstruction, where the resulting geometric model accurately reflects the dimensional information of the commercial complex. Additionally, the maximum uniformly distributed surface load that the floor slabs within the framed structure with holes can withstand should not exceed 17.7 kN/m2, and its vertical deformation resistance stiffness is approximately 71.6% of that of a frame without holes. [ABSTRACT FROM AUTHOR]

Introduction: SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO). Methods: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product. Results: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study. Conclusions: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease. Trial Registration: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12. [ABSTRACT FROM AUTHOR]

Background: Standard systematic review can be labor-intensive and time-consuming meaning that it can be difficult to provide timely evidence when there is an urgent public health emergency such as a pandemic. The ClinicalTrials.gov provides a promising way to accelerate evidence production. Methods: We conducted a search on PubMed to gather systematic reviews containing a minimum of 5 studies focused on safety aspects derived from randomized controlled trials (RCTs) of pharmacological interventions, aiming to establish a real-world dataset. The registration information of each trial from eligible reviews was further collected and verified. The meta-analytic data were then re-analyzed by using 1) the full meta-analytic data with all trials and 2) emulated rapid data with trials that had been registered and posted results on ClinicalTrials.gov, under the same synthesis methods. The effect estimates of the full meta-analysis and rapid meta-analysis were then compared. Results: The real-world dataset comprises 558 meta-analyses. Among them, 56 (10.0%) meta-analyses included RCTs that were not registered in ClinicalTrials.gov. For the remaining 502 meta-analyses, the median percentage of RCTs registered within each meta-analysis is 70.1% (interquartile range: 33.3% to 88.9%). Under a 20% bias threshold, rapid meta-analyses conducted through ClinicalTrials.gov achieved accurate point estimates ranging from 77.4% (using the MH model) to 83.1% (using the GLMM model); 91.0% to 95.3% of these analyses accurately predicted the direction of effects. Conclusions: Utilizing the ClinicalTrials.gov platform for safety assessment with a minimum of 5 RCTs holds significant potential for accelerating evidence synthesis to support urgent decision-making. [ABSTRACT FROM AUTHOR]

As electromobility and especially the electrification of public transportation develops, it is necessary to safeguard human health and minimize environmental impact. Electromagnetic fields generated by the current flowing through on-board batteries, installations, converters, propulsion, air conditioning, heating, lighting, or wireless communication systems in these vehicles may pose risks to drivers and passengers. This research investigates electromagnetic fields induced by extreme low-frequency currents and permanent magnets on electric and trolleybuses implanted in Lublin, Poland. The identification of electromagnetic fields concerned an electric bus model and two trolleybus models. A comparative analysis of the results obtained with the permissible limits in the environment was carried out. [ABSTRACT FROM AUTHOR]

In the context of 'energy shortage', developing a novel energy-based power system is essential for advancing the current power system towards low-carbon solutions. As the usage duration of lithium-ion batteries for energy storage increases, the nonlinear changes in their aging process pose challenges to accurately assess their performance. This paper focuses on the study LiFeO4(LFP), used for energy storage, and explores their performance degradation mechanisms. Furthermore, it introduces common battery models and data structures and algorithms, which used for predicting the correlation between electrode materials and physical parameters, applying to state of health assessment and thermal warning. This paper also discusses the establishment of digital management system. Compared to conventional battery networks, dynamically reconfigurable battery networks can realize real-time monitoring of lithium-ion batteries, and reduce the probability of fault occurrence to an acceptably low level. [ABSTRACT FROM AUTHOR]

Based on a soft rock tunnel in a mountainous area of northwest Yunnan Province, a refined numerical model of different support forms considering structural interaction is established to comprehensively evaluate the structural failure mechanisms and mechanical responses of different support forms. Research shows that compared to steel rib structures, the axial force and bending moment of sprayed concrete structures is larger under different combinations of support structures. Compared with a single-layer support structure, the stress distribution at each position of the double-layer I-shaped steel structure is more uniform, and the sprayed concrete structure only experiences compression damage at the corner of the side wall. As the strength of sprayed concrete increases, the stress distribution of sprayed concrete at the arch waist becomes more uniform. The stress concentration state of sprayed concrete at the corner of the tunnel wall and the plastic yield state of the steel rib structure have also been improved. The higher the concrete strength, the lower the stress ratio on the steel rib's inner and outer sides. [ABSTRACT FROM AUTHOR]

As part of the safety assessment of salicylate esters in cosmetics, we developed a metabolism factor based on in vitro to in vivo extrapolation (IVIVE) to provide a better estimation of the aggregate internal exposure to the common metabolite, salicylic acid. Optimal incubation conditions using human liver S9 were identified before measuring salicylic acid formation from 31 substances. Four control substances, not defined as salicylic esters but which could be mistaken as such due to their nomenclature, did not form salicylic acid. For the remaining substances, higher in vitro intrinsic clearance (CLint, in vitro) values generally correlated with lower LogP values. A "High-Throughput Pharmacokinetic" (HTPK) model was used to extrapolate CLint, in vitro values to human in vivo clearance and half-lives. The latter were used to calculate the percentage of substance metabolised to salicylic acid in 24 h in vivo following human exposure to the ester, i.e. the "metabolism factor". The IVIVE model correctly reproduced the observed elimination rate of 3 substances using in silico or in vitro input parameters. For other substances, in silico only-based predictions generally resulted in lower metabolism factors than when in vitro values for plasma binding and liver S9 CLint, in vitro were used. Therefore, in vitro data input provides the more conservative metabolism factors compared to those derived using on in silico input. In conclusion, these results indicate that not all substances contribute equally (or at all) to the systemic exposure to salicylic acid. Therefore, we propose a realistic metabolism correction factor by which the potential contribution of salicylate esters to the aggregate consumer exposure to salicylic acid from cosmetic use can be estimated. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Guolong (EU register number RECYC323), which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migrations of 0.1 and 0.15 μg/kg food, derived from the exposure scenarios for infants and toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Ecopacking (EU register number RECYC324), which uses the EREMA Basic technology. The input material is ■■■■■ washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor ■■■■■ before being extruded. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migrations of 0.1 and 0.15 μg/kg food, derived from the exposure scenarios for infants and toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Palamidis (EU register number RECYC325), which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migrations of 0.1 and 0.15 μg/kg food, derived from the exposure scenarios for infants and toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process KGL (EU register number RECYC326), which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migrations of 0.1 and 0.15 μg/kg food, derived from the exposure scenarios for infants and toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Fucine Film (EU register number RECYC322), which uses the Reifenhäuser technology. The input material consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are extruded under vacuum into sheets. The recycled sheets are intended to be used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, excluded drinking water and beverages, for long‐term storage at room temperature, with or without hotfill. Based on the limited data available, the Panel concluded that the information submitted to EFSA was inadequate to demonstrate that the recycling process Fucine Film is able to reduce potential unknown contamination of the input PET flakes to a concentration that does not pose a risk to human health. [ABSTRACT FROM AUTHOR]

In the context of entry into force of Regulation (EU) 2022/1616, EFSA updated the scientific guidance to assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a 'post‐consumer mechanical PET' recycling process (as defined in Annex I of Regulation (EU) 2022/1616) intended to be used for manufacturing materials and articles intended to come into contact with food. This Guidance describes the evaluation criteria and the scientific evaluation approach that EFSA will apply to assess the decontamination capability of recycling processes, as well as the information required to be included in an application dossier. The principle of the scientific evaluation approach is to apply the decontamination efficiency of a recycling process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post‐consumer PET, set at 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each surrogate in recycled PET is then compared to a modelled concentration in PET that is calculated using generally recognised conservative migration models, such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg body weight (bw) per day. This is the lowest threshold for toxicological concern (TTC) value, i.e. for potential genotoxicity, below which the risk to human health would be negligible. The information to be provided in the applications relates to: the recycling process (i.e. collection and pre‐processing of the input, decontamination process, post‐processing and intended use); the determination of the decontamination efficiency by the challenge test; the self‐evaluation of the recycling process. On the basis of the submitted data, EFSA will assess the safety of the mechanical PET recycling process. [ABSTRACT FROM AUTHOR]

Streptococcus salivarius is a common, harmless, and prevalent member of the oral microbiota in humans. In the present study, the safety of S. salivarius UBSS-01 was evaluated using in silico methods and preclinical and clinical studies. In an acute toxicity study, rats were administered with 5 g/kg (500 × 109 CFU) S. salivarius UBSS-01. The changes in phenotypic behaviors and hematological, biochemical, electrolytes, and urine analyses were monitored. No toxicity was observed at 14 days post-treatment. The no observable effects limit (NOEL) of S. salivarius UBSS-01 was >5 g/kg in rats. In a 28-day repeat dose toxicity study, rats were administered S. salivarius UBSS-01 once daily at doses of 0.1, 0.5, and 1 g/kg (10, 50, and 100 billion CFU/kg, respectively) body weight. S. salivarius UBSS-01 did not influence any of the hematology parameters and clinical chemistry parameters in plasma and serum samples after 28-day repeated administration. No structural abnormality was observed in the histological examination of organs. Whole genome analysis revealed the absence of virulence factors or genes that may transmit antibiotic resistance. In the double-blind study with 60 human participants (aged 18–60 years), consumption of S. salivarius UBSS-01 for 30 days was found to be safe and results were comparable with placebo treatment These findings indicate that S. salivarius UBSS-01 may be safe for human consumption. [ABSTRACT FROM AUTHOR]

Non-alcoholic fatty liver disease (NAFLD) is identified by lipid accumulation in the liver and liver injury due to obesity and metabolic syndrome. Herbs have been used in the treatment of various diseases, including liver disease. The present systematic review aimed to identify plants and the doses used in the management and prevention of NAFLD, as well as to assess the safety of these plants and determine their mechanisms of action, providing the preclinical evidence-based usage of herbs. Scientific databases, namely, Scopus, PubMed, Springer, NCBI, Google Scholar, Science Direct, and Web of Science were searched with key words, such as 'non-alcoholic fatty liver disease', 'non-alcoholic steatohepatitis', 'metabolic-associated fatty liver disease', 'medicinal plants', 'hyperlipidemia' and 'plant extracts' from January, 2016 to November, 2023. Manual screening, quality assessment, and data extraction of the search results were performed according to the inclusion and exclusion criteria. Herbs were identified which were able to ameliorate NAFLD symptoms in rodents through lipid metabolism, insulin resistance, inflammation and oxidative stress. These herbs were identified to lead to a reduction in steatosis in the histopathological assessment. The acute or chronic toxicity studies were not found to indicate any signs of toxicity. The present study provides information on the highest dose evaluated and which was effective against NAFLD, with safety assessment in studies using rats. Since chronic liver diseases progress over a long period of time with minimal or no symptoms, the consumption of herbs may provide alternative treatment strategies for the prevention of NAFLD. Further studies are warranted however, to identify their bioactive compounds for drug development or for the standardization of crude extracts. Drug-herb interactions also need to be further evaluated when used concurrently with drugs. [ABSTRACT FROM AUTHOR]

• A four sub-model crash causation model for rear-end scenario generation is proposed. • The crash causation model considers off-road glances, low deceleration, short headway, and no reaction. • Challenges of validating scenario generation are identified and addressed. • A sample selection transform is needed for accurate validation. Safety assessment of crash and conflict avoidance systems is important for both the automotive industry and other stakeholders. One type of system that needs such an assessment is a driver monitoring system (DMS) with some intervention (e.g., warning or nudging) when the driver looks off-road for too long. Although using computer simulation to assess safety systems is becoming increasingly common, it is not yet commonly used for systems that affect driver behavior, such as DMSs. Models that generate virtual crashes, taking crash-causation mechanisms into account, are needed to assess these systems. However, few such models exist, and those that do have not been thoroughly validated on real-world data. This study aims to address this research gap by validating a rear-end crash-causation model which is based on four crash-causation mechanisms related to driver behavior: a) off-road glances, b) too-short headway, c) not braking with the maximum deceleration possible, and d) sleepiness (not reacting before the crash). The pre-crash kinematics were obtained from the German GIDAS in-depth crash database. Challenges with the validation process were identified and addressed. Most notably, a process was developed to transform the generated crashes to mimic the crash severity distribution in GIDAS. This step was necessary because GIDAS does not include property-damage-only (PDO) crashes, while the generated crashes cover the full range of severities (including low-severity crashes, of which many are PDOs). Our results indicate that the proposed model is a reasonably good crash generator. We further demonstrated that the model is a valid method for assessing DMSs in virtual simulations; it shows the safety impact of shorter 'longest' off-road glances. As expected, 'cutting away' long off-road glances substantially reduces the number of crashes that occur and reduces the average delta-v. This work highlights the need to both a) thoroughly understand the process of generating virtual scenarios and b) have the tools to validate them. While more work to develop validation processes for scenario generation is needed across all levels of crash severity, the transform and other validation tools that were developed bring us one step closer to accurate validation methodologies. [ABSTRACT FROM AUTHOR]

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Introduction: We performed an exposure-based Next Generation Risk Assessment case read-across study using New Approach Methodologies (NAMs) to determine the highest safe concentration of daidzein in a body lotion, based on its similarities with its structural analogue, genistein. Two assumptions were: (1) daidzein is a new chemical and its dietary intake omitted; (2) only in vitro data were used for daidzein, while in vitro and legacy in vivo data for genistein were considered. Methods: The 10-step tiered approach evaluating systemic toxicity included toxicokinetics NAMs: PBPK models and in vitro biokinetics measurements in cells used for toxicogenomics and toxicodynamic NAMs: pharmacology profiling (i.e., interaction with molecular targets), toxicogenomics and EATS assays (endocrine disruption endpoints). Whole body rat and human PBPK models were used to convert external doses of genistein to plasma concentrations and in vitro Points of Departure (PoD) to external doses. The PBPK human dermal module was refined using in vitro human skin metabolism and penetration data. Results: The most relevant endpoint for daidzein was from the ERa assay (Lowest Observed Effective Concentration was 100 ± 0.0 nM), which was converted to an in vitro PoD of 33 nM. After application of a safety factor of 3.3 for intra-individual variability, the safe concentration of daidzein was estimated to be 10 nM. This was extrapolated to an external dose of 0.5 µg/cm2 for a body lotion and face cream, equating to a concentration of 0.1%. Discussion: When in vitro PoD of 33 nM for daidzein was converted to an external oral dose in rats, the value correlated with the in vivo NOAEL. This increased confidence that the rat oral PBPK model provided accurate estimates of internal and external exposure and that the in vitro PoD was relevant in the safety assessment of both chemicals. When plasma concentrations estimated from applications of 0.1% and 0.02% daidzein were used to calculate bioactivity exposure ratios, values were >1, indicating a good margin between exposure and concentrations causing adverse effects. In conclusion, this case study highlights the use of NAMs in a 10-step tiered workflow to conclude that the highest safe concentration of daidzein in a body lotion is 0.1%. [ABSTRACT FROM AUTHOR]