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The isomeric mixture of alpha and beta amyrin (AMY), present in the resin of Protium heptaphyllum, is popularly used as anti-inflammatory and anti-ulcer. The literature has been demonstrating pharmacological activities of these triterpenes in the central and peripheral nervous systems, and in the gastrointestinal and immunological systems. This study traces a toxicological profile of amyrin, aiming to provide information that may clarify its safety. Nine female Wistar rats (170 to 200 g) were divided into three groups of three animals each (control, amyrin 300 and amyrin 2000 mg kg-1, p.o.), which were evaluated by protocols preconized by the Organization for Economic Co-operation and Development (OECD). Open field Test and Malone Hippocratic Screening Scale were performed. AMY, mostly at 2000 mg kg-1, reduced the number of crossings by 57% vs. saline (22.67 ± 2.40) and the number of rearing by 53% vs. saline (42.67 ± 2.96), but increased the number of grooming by 26% vs. saline (1.66 ± 0.33). AMY (2000 mg kg-1) increased the serum glucose by 77% vs. saline (126.70 ± 4.33 mg dL-1), triglycerides by 50% vs. saline (78.67 ± 2.18 mg dL-1) and uric acid by 65% vs. saline (0.73 ± 0.03 mg dL-1). AMY induced vascular congestion and hemorrhage in the liver, spleen and cerebral cortex. Renal changes (cellular damage, inflammatory infiltrate, tubular protein deposition and glomeruli atrophy) were also seen. In conclusion, AMY decreased rat locomotor activity, caused minor biochemical changes, and altered the morphology of the kidney. The present study may contribute to deepen the knowledge about the safety of AMY, aiming the development of a novel pharmacological product.

Commercial production of microalgal biomass for food and feed is a recent worldwide trend. Although it is common to publish nutritional data for microalgae grown at the lab-scale, data about industrial strains cultivated in an industrial setting are scarce in the literature. Thus, here we present the nutritional composition and a microbiological and toxicological evaluation of Tetraselmis sp. CTP4 biomass, cultivated in 100-m3 photobioreactors at an industrial production facility (AlgaFarm). This microalga contained high amounts of protein (31.2 g/100 g), dietary fibres (24.6 g/100 g), digestible carbohydrates (18.1 g/100 g) and ashes (15.2 g/100 g), but low lipid content (7.04 g/100 g). The biomass displayed a balanced amount of essential amino acids, n-3 polyunsaturated fatty acids, and starch-like polysaccharides. Significant levels of chlorophyll (3.5 g/100 g), carotenoids (0.61 g/100 g), and vitamins (e.g., 79.2 mg ascorbic acid /100 g) were also found in the biomass. Conversely, pathogenic bacteria, heavy metals, cyanotoxins, mycotoxins, polycyclic aromatic hydrocarbons, and pesticides were absent. The biomass showed moderate antioxidant activity in several in vitro assays. Taken together, as the biomass produced has a balanced biochemical composition of macronutrients and (pro-)vitamins, lacking any toxic contaminants, these results suggest that this strain can be used for nutritional applications.

siRNAs have immense therapeutic potential for the treatment of various gene-related diseases ranging from cancer, viral infections and neuropathy to autoimmune diseases. However, their bench-to-bedside translation in recent years has faced several challenges, with inefficient siRNA delivery being one of the most frequently encountered issues. In order to improve the siRNA delivery especially for systemic treatment, nanocarriers made of polymers, lipids or inorganic materials have become almost essential. The 'negative aspects of these carriers such as their nanotoxicity and immunogenicity thus can no longer be overlooked. In this article, we will extensively review the nanotoxicity of siRNA carriers. The strategies for mitigating the risks of nanotoxicity and the methodology for evaluating these strategies will also be discussed. By addressing this often overlooked but important issue, it will help clear the way for siRNAs to fulfill their promise as a versatile class of therapeutic agents.

The scale of the cosmetic market is increasing every day. There are many safety risks to cosmetics, but they benefit people at the same time. The skin can become red, swollen, itchy, chronically toxic, and senescent due to the misuse of cosmetics, triggering skin injuries, with contact dermatitis being the most common. Therefore, there is an urgent need for a system that can scientifically and rationally detect the composition and perform a toxicological assessment of cosmetic products. Traditional detection methods rely on instrumentation and method selection, which are less sensitive and more complex to perform. Engineered skin tissue has emerged with the advent of tissue engineering technology as an emerging bioengineering technology. The ideal engineered skin tissue is the basis for building good in vitro structures and physiological functions in this field. This review introduces the existing cosmetic testing and toxicological evaluation methods, the current development status, and the types and characteristics of engineered skin tissue. The application of engineered skin tissue in the field of cosmetic composition detection and toxicological evaluation, as well as the different types of tissue engineering scaffold materials and three-dimensional (3D) organoid preparation approaches, is highlighted in this review to provide methods and ideas for constructing the next engineered skin tissue for cosmetic raw material component analysis and toxicological evaluation.

In this study, we prepared a series of heterogeneous Fenton catalytic materials x-CuInS 2 /BiOBr( x  = 10–60 wt%, x-CIS/BiOBr) for the degradation of levofloxacin (LVF) by in- situ hydrothermal synthesis. X-ray photoelectron spectroscopy (XPS) and electron paramagnetic resonance (EPR) show that the x-CIS/BiOBr heterogeneous Fenton catalyst has abundant oxygen vacancy (O Vs ). The experimental results showed that the degradation rate of LVF by 40%-CIS/BiOBr reached 94.1% within 60 min, and the apparent rate constant was 0.0439 min −1 , 8.92 times that of CuInS 2 and 10.4 times that of BiOBr, respectively. The BET-specific surface area and pore volume were approximately 10 times and 7 times that of pure CuInS 2 and BiOBr. Based on the characterization and quenching experiments results, the catalytic mechanism of synergistic interaction between the dual Fenton system (In 3+ /In + and Cu + /Cu 2+ ) and O Vs was proposed, the possible degradation pathways of LVF were analyzed, and the toxicity of its intermediates was evaluated. Graphical abstract

Pharmaceutical active compounds (PhACs) are some of the most recalcitrant water pollutants causing undesired environmental and human effects. In absence of adapted decontamination technologies, there is an urgent need to develop efficient and sustainable alternatives for water remediation. Metal–organic frameworks (MOFs) have recently emerged as promising candidates for adsorbing contaminants as well as providing photoactive sites, as they possess exceptional porosity and chemical versatility. To date, the reported studies using MOFs in water remediation have been mainly focused on the removal of a single type of PhACs and rarely on the combined elimination of PhACs mixtures. Herein, the eco-friendly bismuth-based MOF, SU-101, has been originally proposed as an efficient adsorbent-photocatalyst for the elimination of a mixture of three challenging persistent PhACs, frequently detected in wastewater and surface water in ng L −1 to mg·L −1 concentrations: the antibiotic sulfamethazine (SMT), the anti-inflammatory diclofenac (DCF), and the antihypertensive atenolol (At). Adsorption experiments of the mixture revealed that SU-101 exhibited a great adsorption capacity towards At, resulting in an almost complete removal (94.1 ± 0.8% for combined adsorption) in only 5 h. Also, SU-101 demonstrated a remarkable photocatalytic activity under visible light to simultaneously degrade DCF and SMT (99.6 ± 0.4% and 89.2 ± 1.4%, respectively). In addition, MOF-contaminant interactions, the photocatalytic mechanism and degradation pathways were investigated, also assessing the toxicity of the resulting degradation products. Even further, recycling and regeneration studies were performed, demonstrating its efficient reuse for 4 consecutive cycles without further treatment, and its subsequent successful regeneration by simply washing the material with a NaCl solution.

In this study, lactobionic acid (LBA) was incorporated into poly(vinyl alcohol) (PVA) and poly(ε-caprolactone) (PCL) by electrospinning. The antimicrobial effects of the nanofibers were tested using the agar diffusion method. Only the PVA formulations showed antimicrobial activity against Staphylococcus aureus. The PVA and PCL nanofibers containing LBA showed antioxidant activity ranging from 690.33 to 798.67 µM TEAC when tested by the ABTS method. The characterization of nanofibers was performed by scanning electron microscopy, Fourier transform infrared spectroscopy, thermogravimetric analysis, differential scanning calorimetry, and mechanical analysis. The nanofibers showed a uniform morphology and their average diameters ranged from 295.5 to 2778.2 nm. The LBA addition induced a decrease in the enthalpy of fusion (ΔHm) of PVA and PCL nanofibers, while the Young’s modulus was reduced from 20 to 10 MPa in PCL and PCL-LBA nanofibers, respectively. No relevant differences were observed between the FTIR spectra of the control nanofibers and the nanofibers containing LBA. All nanofibers presented hemolysis rate below 2%, thus can be considered as non-hemolytic materials. Further toxicological assessment was performed with the selected formulation PVA10 + LBA. The evaluations by mutagenicity assay, cell survival measurement, cell viability analysis and agar diffusion cytotoxicity test indicated that there are no significant toxic effects. Electrospun nanofibers PVA-LBA and PCL-LBA were successfully produced, showing good thermal and mechanical properties and non-toxic effects. Furthermore, the nanofibers showed antimicrobial activity and antioxidant activity. The findings of this study indicate that PVA and PCL electrospun nanofibers incorporating LBA are promising for use in packaging applications.

This Opinion describes recent developments in the safety assessment of chemicals in food and explores their potential impact on EFSA evaluation of food contact materials (FCM). It is not intended to be a guidance document. The draft opinion was subject to a public consultation and this final Opinion takes into account the scientific comments received. The Opinion will provide the European Commission with the scientific basis for a discussion among risk managers on possible implications for risk management. One major area to revisit is the estimation of consumer exposure. Four food consumption categories could be set. They are approximately 9, 5, 3 and 1.2 times higher than the current SCF default scenario, i.e. 17 g/kg bw per day, and so using them would afford a higher level of protection, particularly for infants and toddlers. Special exposure scenarios might be used if consumption were lower. The amount of toxicity data needed should be related to the expected human exposure. The tiered approach of the SCF is updated. For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement for additional toxicity data. Regarding the identification and evaluation of migrating substances, experience has shown that more focus is needed on the finished materials and articles. Considering the non‐intentionally added substances (NIAS), such as impurities of the substance along with reaction and degradation products including oligomers, the same approach as is used for authorised substances could, in principle, be applied for their toxicological assessment, as the same degree of safety should be warranted for all migrating substances. However, non‐testing methods could have increased importance for the assessment of genotoxicity of NIAS.

EFSA received a request from the European Commission to provide support for the preparation of the EU position for 53rd Session of the Codex Committee on Pesticide Residues (CCPR). In 2021, JMPR evaluated 38 active substances with regard to their toxicological properties and/or the setting of Codex Maximum Residue Limits (CXLs) (acetamiprid, bixafen, clofentezine, clothianidin, cyprodinil, difenoconazole, ethion, ethiprole, fenbuconazole, fenhexamid, fenpicoxamide, fenpyroximate, fipronil, fluopyram, flutianil, imazalil, isoprothiolane, isoxaflutole, mandipropamid, mefentrifluconazole, metalaxyl, metalaxyl‐M, methoprene, methoxyfenozide, pendimethalin, prothioconazole, pydiflumetofen, pyrasulfotole, pyraziflumid, quinoxyfen, spinetoram, spiropidion, sulfoxaflor, tebuconazole, tetraniliprole, thiamethoxam, trifloxystrobin, trinexapac). EFSA prepared comments on the Codex MRL proposals and the proposed toxicological reference values. In addition, EFSA provided further considerations on follow‐up assessments of JMPR on pesticides for which specific concerns on the toxicological or residue assessments were raised in the previous CCPR meetings (afidopyropen, fluensulfone, metconazole, propiconazole). The current report should serve as the basis for deriving the EU position for the CCPR meeting.

The European Commission asked EFSA to provide support in the framework of Article 43 of Regulation (EC) No 396/2005 for the preparation of the EU position for 56th Session of the Codex Committee on Pesticide Residues (CCPR). In the current report, EFSA provided comments and recommendations on the Codex maximum residue limit (CXL) proposals derived by the Joint Meeting on Pesticide Residues (JMPR) that will be discussed in the upcoming CCPR meeting. The current report should serve as the basis for deriving the EU position for the CCPR meeting.