Safety Assessment: a Comparative Analysis of Quantitative Content of Bacterial Endotoxins and Evaluation of Pyrogenicity of the Kazakhstan Vaccine QazCovid-in® against COVID-19.

We measured the levels of bacterial endotoxins in the bulk vaccine product (BVP) and finished vaccine QazCovid-in® and evaluated the effect of aluminum hydroxide (adjuvant) on the results of LAL test and pyrogenicity of samples in vivo (in rabbits receiving intravenous injection into the marginal ear vein). Administration of BVP with LPS resulted in a dose-dependent increase in body temperature in rabbits similar to that caused by LPS alone, which suggests that aluminum hydroxide in the vaccine did not affect the pyrogenic response in rabbits. Moreover, the LAL test showed that the aluminum hydroxide did not hinder LPS activity after serial dilution of samples.

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

[Determination of 7 elements in chemical treatment agent polyaluminium chloride and iron sulfate by inductively coupled plasma mass spectrometry].

OBJECTIVE: To establish a new rapid method for determination of 7elements( arsenic, selenium, mercury, cadmium, chromium, lead and silver) in two kinds of chemical water treatment agents polyaluminium chloride and iron sulfate by inductively coupled plasma mass spectrometry( ICP-MS). METHODS: Pure water was added to two kinds of chemical water treatment agents. Nitric acid was added to the solution, and the solution was incubated by water bath for 1 h. Matrix effects was eliminated by the employment of Sc, Y, In and Bi as internal standards. The concentrations of 7 elements were determined. RESULTS: The linear ranges for 7 elements were between 0 and 50. 0µg/L with a correlation coefficient for each element of higher than 0. 999. The detection limits were between 0. 05 and 0. 96 µg/L, the recoveries were between 90. 1% and106. 4%, the relative standard deviations were between 1. 6% and 5. 7%. The concentration of arsenic, selenium, and lead in certain samples of the 40 samples tested did not meet the health standards. The large majority of the unqualified samples were caused by the concentration of element lead. CONCLUSION: This method is simple, rapid, accurate and sensitive. It is very suitable for the determination of multi-elements inchemical water treatment agents.

Electrospray ionization time-of-flight mass spectrum analysis method of polyaluminum chloride flocculants.

Electrospray mass spectrometry has been reported as a novel technique for Al species identification, but to date, the working mechanism is not clear and no unanimous method exists for spectrum analysis of traditional Al salt flocculants, let alone for analysis of polyaluminum chloride (PAC) flocculants. Therefore, this paper introduces a novel theoretical calculation method to identify Al species from a mass spectrum, based on deducing changes in m/z (mass-to-charge ratio) and molecular formulas of oligomers in five typical PAC flocculants. The use of reference chemical species was specially proposed in the method to guarantee the uniqueness of the assigned species. The charge and mass reduction of the Al cluster was found to proceed by hydrolysis, gasification, and change of hydroxyl on the oxy bridge. The novel method was validated both qualitatively and quantitatively by comparing the results to those obtained with the (27)Al NMR spectrometry.

Almagate interference in breath test results for the diagnosis of Helicobacter pylori infection.

BACKGROUND: Infection by Helicobacter pylori is common and affects both genders at any age. The 13C-urea breath test is a widely used test for the diagnosis of this infection. However, multiple drugs used for the treatment of Helicobacter pylori infection symptoms have interactions with this breath test that generate false negative results. This observational study was to assess the potential interaction between almagate and the breath test. METHODS: Thirty subjects on almagate therapy who underwent a breath test were included. If the result was negative, almagate was withdrawn for a month and the breath test was then repeated. RESULTS: In general, 51.9 % of assessed subjects had a negative result after the first test, and 100 % of these also had a negative result after the second test. CONCLUSIONS: It was concluded that the use of almagate does not interfere in breath test results. These results provide a drug therapy option for the treatment of symptoms associated with Helicobacter pylori infection during the diagnostic process.

Development and in vitro evaluation of a transdermal hydrogel patch for ferulic acid.

Current work aimed to develop and evaluate a transdermal delivery system of hydrogel patch for ferulic acid to treat skin damage induced by UV radiation. VISCOMATE(TM) NP700, dihydroxy aluminium aminoacetate, glycerine, tartaric acid were used in combination in different ratios to design the hydrogel patch. In vitro release rate was selected as an index to optimize the formulation. The formulated hydrogel patch was evaluated by several parameters like tacking strength, cohesive strength, peeling strength, residuals after peeling and drug content determination. The in vitro penetration was determined by Franz diffusion technology with hairless mouse skin as permeability media. Different kinetics models were employed to simulate the release and penetrate patterns of ferulic acid from patches in order to investigate the drug transport mechanism. The residual drugs in the patch and skin were determined after the penetration experiment. The optimized preparation was dihydroxy aluminium aminoacetate: NP700: glycerine: ferulic acid as a ratio of 0.02:0.4:1.5:1.25:0.25. The cumulative percentage of release was 60.4465±1.7679% for 24h, which results from a combination of diffusion effect and polymer erosion effect. For the barrier of stratum corneum, the cumulative penetrate rate was only 1.3156±0.3588% and the release mechanism turn out to be the effect of erosion of polymer surface. The residual drugs in the patch were 97.5949±1.4932%. The in vitro data revealed that it was easy for ferulic acid to release from the paste while difficult to permeate through the skin barrier, which resulted in most of drugs residued in the paste. Hence, further experiments will be necessary for finding the penetration enhancer in ferulic acid transdermal delivery.

High-performance hydrophobic magnetic hydrotalcite for selective treatment of oily wastewater.

Oil emulsified in water is one of the most difficult mixtures to treat due to the good stability of emulsions, so there is a growing demand for more efficient methods for separating immiscible oil/water mixtures. In this context, the focus of this study was to obtain an adsorbent for the selective treatment of a simulated oily wastewater. To this aim, a modified hydrotalcite sample with hydrophobic and magnetic characteristics was prepared and characterized. Initially, the effect of sodium dodecyl sulfate (SDS) amount on the adsorbent characteristics was evaluated (266-800 mgSDS g-1LDH). The hydrophobic hydrotalcite (LDH-SDS) containing 533 mgSDS g-1LDH (LDH-SDS2) presented a higher interlayer space where the surfactant molecules were arranged perpendicular to the lamellae, allowing better access to the hydrotalcite pores and facilitating the selective adsorption of oil compounds. Moreover, the synergistic association of hydrophobic properties with super-wetting and effective adhesion oil to Fe3O4 favoured the selective adsorption of the simulated oily wastewater onto the hydrophobic and magnetic hydrotalcite (LDH-MSDS), facilitating the post-treatment separation. The kinetic analysis demonstrated that the adsorption equilibrium was attained in 120 min and the pseudo-second order model was the most suitable for predicting the removal of total organic carbon (TOC) from the simulated oily wastewater. The Langmuir model described very well the equilibrium experimental data, with a maximum adsorption capacity for TOC removal using LDH-MSDS of 659.9 mg g-1. Therefore, the modified hydrotalcite prepared in this study showed intrinsic characteristics that make it a promising adsorbent for the selective treatment of oily wastewaters.

Patterns of aluminum hydroxychloride deposition onto the skin.

BACKGROUND: Aluminum hydroxychloride (AlCl(3) ) is an antiperspirant. AIM: To revisit the AlCl(3) deposition in vivo and in vitro on glass slides and stratum corneum (SC) harvested by cyanoacrylate skin surface strippings (CSSS). METHODS: Transepidermal water loss (TEWL) was assessed following application of 5% AlCl(3) on the forearms. The AlCl(3) -coated skin, glass slides and CSSS were observed using two ultraviolet light-emitting CCD cameras in order to record changes in specular reflectance related to AlCl(3) deposition. In addition, the corneoxenometry bioassay was performed in order to predict AlCl(3) irritation. RESULTS: AlCl(3) deposited on glass slides looked as linear threads and rings of similar sizes. AlCl(3) deposits on skin were almost restricted inside the microrelief lines and as annular deposits at their crossings where acrosyringia are opening. After daily AlCl(3) applications, deposits extended on the CSSS plateaus. At rest in absence of sweating, TEWL was decreased following AlCl(3) applications. During physical exercise, the TEWL increase was limited on the AlCl(3) areas. CSSS appeared unreactive to AlCl(3) at the corneoxenometry bioassay. CONCLUSION: The similar aspect of AlCl(3) deposits on human SC and on glass slides suggested a physical property of AlCl(3) . Repetitive applications of AlCl(3) increased both the deposit area and the barrier function.

Hydrothermal treatment of MSWI bottom ash forming acid-resistant material.

To recycle municipal solid waste incinerator (MSWI) bottom ash, synthesis of hydrothermal minerals from bottom ash was performed to stabilize heavy metals. MSWI bottom ash was mixed with SiO(2), Al(OH)(3), and Mg(OH)(2) so its chemical composition was similar to that of hydrothermal clay minerals. These solid specimens were mixed with water at a liquid/solid ratio of 5. The reaction temperature was 200 degrees C, and reactions were performed for 24-240h. Generation of kaolinite/smectite mixed-layer clay mineral was found in the samples after the reaction of the mixture of bottom ash, SiO(2), and Mg(OH)(2). Calcium silicate hydrate minerals such as tobermorite and xonotlite were also generated. X-ray powder diffraction suggested the presence of amorphous materials. Leaching tests at various pHs revealed that the concentration of heavy metals in the leachates from MSWI bottom ash hydrothermally treated with SiO(2) and Mg(OH)(2) was lower than that in leachates from non-treated bottom ash, especially under acid conditions. Hydrothermal treatment with modification of chemical composition may have potential for the recycling of MSWI bottom ash.

Kinetics of neptunium sorption and desorption in the presence of aluminum (hydr)oxide minerals: Evidence for multi-step desorption at low pH.

Kinetics analyses of sorption and desorption provide important insight into reaction mechanisms occurring at the mineral-water interface. They are also needed to determine when equilibrium is achieved, identify intermediate chemical species, and inform models describing neptunium mobility. Neptunium sorption to and desorption from four different aluminum (hydr)oxides - bayerite (α-Al(OH)3), gibbsite (γ-Al(OH)3), corundum (α-Al2O3), and γ-alumina (γ-Al2O3) - were investigated as a function of mineral concentration (5 - 170 m2 L-1), neptunium concentration (10-9 - 10-7 M), and pH (5.5 - 10.5). Neptunium sorption was characterized by a two-step reaction with an initial fast sorption step occurring within minutes followed by a slower equilibrium process, which was attributed to initial sorption of neptunium to a small number of strong sorption sites followed by sorption of neptunium to a larger number of weak sorption sites. The kinetics data were modeled using the linear and non-linear forms of the pseudo-first and pseudo-second order rate equations and the goodness of fit parameters were compared. Non-linear pseudo-second order rate constants described neptunium sorption to aluminum (hydr)oxides most accurately and were used to determine the reaction orders with respect to mineral concentration and [H+]. Neptunium desorption experiments demonstrated that the desorption mechanism changed as a function of pH and that the forward and reverse reactions were not equivalent. At pH ≥ 7.5, desorption reached steady-state within an hour and was accurately described by the non-linear pseudo-second order rate equations. A desorption plateau was observed at pH 5.5 that could not be described by either pseudo-first or -second order kinetics, suggesting the possibility of a multi-step desorption reaction. The comparatively slow desorption kinetics observed here suggests that sorbed neptunium could be slowly released back into the aqueous phase and act as a continuous source of contamination to the environment.

Synthesis of polyaluminium chloride/papermaking sludge-based organic polymer composites for removal of disperse yellow and reactive blue by flocculation.

In this study, a series of polyaluminium chloride/papermaking sludge-based organic polymer (PAC-PSBF) composites with different PAC basicity and PAC/PSBF mass ratios were prepared from papermaking sludge. The basic properties of the aforementioned composites were characterized, and their flocculation efficiencies were studied in the disperse yellow (DY) and reactive blue (RB) dye removals. The results of the flocculation experiments demonstrated that PAC-PSBF composites performed better than PAC regardless of the PAC basicity or PAC/PSBF mass ratios. The composites with low PAC basicity were effective in DY and RB dye removals. PAC-PSBF composites with the same PAC basicity but higher PAC/PSBF mass ratios exerted more satisfactory color removals and floc properties in both DY and RB dye removals. PAC-PSBF composites were more pH-independent than PAC, and the excellent flocculation efficiencies of the composites was achieved at pH 4.0 to 8.0 in DY/RB dye removals. In brief, desirable flocculation efficiencies of the PAC-PSBF composites were obtained when PAC and PSBF were appropriately combined together.

Mg-Al-CO3 layered double hydroxide reinforced polymer inclusion membrane as an extractant phase for thin-film microextraction of cyanide from environmental water samples.

In this paper, a flexible and efficient nano-reinforced polymer inclusion membrane (PIM) was fabricated and used for cyanide (CN-) extraction from water samples. Aliquat 336 (a liquid anion exchanger) was embedded in poly(vinyl chloride) (PVC) support as the extractant. Mg-Al-CO3 layered double hydroxide (LDH) with high surface area and anion exchange ability was applied to promote the extraction efficiency of PIM. A PIM comprising 56% PVC, 40% Aliquat 336, and 4% Mg-Al-CO3 LDH showed the best extraction efficiency. A single beam ultraviolet-visible spectrophotometer was used for the detection of cyanide. Surface morphology of the PIM was studied by field emission scanning electron microscopy. The experimental parameters influencing the extraction process were investigated and optimized. The intra- and inter-day relative standard deviations at two different concentrations were in the range of 2.8-7.6%. The dynamic range of the method was in the range of 5-500 µg L-1, and the detection limit was 1.4 µg L-1. The LDH reinforced PIM showed proper characteristics for the extraction of cyanide from real water and wastewater samples with recoveries between 82 and 115%.

Macrophagic myofasciitis in children is a localized reaction to vaccination.

Macrophagic myofasciitis is a novel, "inflammatory myopathy" described after a variety of vaccinations, almost exclusively in adults. We examined the relevance of histological findings of this myopathy to the clinical presentation in pediatric patients. Muscle biopsies from 8 children (7 months to 6 years old) with histological features of macrophagic myofasciitis were reviewed and correlated with the clinical manifestations. Patients underwent quadriceps muscle biopsy for suspected mitochondrial disease (4 patients), spinal muscular atrophy (2 patients), myoglobinuria (1 patient), and hypotonia with motor delay (1 patient). All biopsies showed identical granulomas composed of periodic acid-Schiff-positive and CD68-positive macrophages. Characteristic aluminum hydroxide crystals were identified by electron microscopy in 2 cases. The biopsy established diagnoses other than macrophagic myofasciitis in 5 patients: spinal muscular atrophy (2), Duchenne muscular dystrophy (1), phospho-glycerate kinase deficiency (1), and cytochrome c oxidase deficiency (1). Three children with manifestations and/or a family history of mitochondrial disease had otherwise morphologically normal muscle. All children had routine vaccinations between 2 months and 1 year before the biopsy, with up to 11 intramuscular injections, including the biopsy sites. There was no correlation between histological findings of macrophagic myofasciitis in biopsies and the clinical symptoms. We believe that macrophagic myofasciitis represents a localized histological hallmark of previous immunization with the aluminum hydroxide adjuvants contained in vaccines, rather than a primary or distinct inflammatory muscle disease.

A novel method to delaminate nitrate-intercalated MgAl layered double hydroxides in water and application in heavy metals removal from waste water.

Nitrate-intercalated MgAl layered double hydroxide (LDH) was successfully delaminated in water by a facile and effective method upon reflux at 120 °C for 24 h followed by sonication at 40 °C for 5 h. This process is environmentally friendly since water is the only solvent used. The delaminated nanosheets were characterized by microscopic, spectroscopic, and particle size analyses. The delamination process successfully produced octahedron-shaped single-layer nanosheets 50-150 nm in size. X-ray photoelectron spectroscopy (XPS) data confirmed that the surface elements and their chemical status are consistent with the basic layer of MgAl LDH. The delaminated nanosheets displayed higher adsorption capacity for removing heavy metals from waste water than the original powdered LDH. After treating the waste water, a sharp and intense peak in the X-ray powder diffraction (XRD) pattern of the precipitate confirms the restacking of the LDH nanosheets.

Biological treatment of fracturing waste liquid in a membrane-coupled internal circulation aerobic biological fluidized bed with the assistance of coagulation.

Fracturing waste liquid (FWL) is generated during shale gas extraction and contains high concentrations of suspended solid, salinity and organic compounds, which needs proper management to prevent excessive environmental disruption. Biological treatment of the FWL was attempted in this study using a membrane-coupled internal circulation aerobic biological fluidized bed (MC-ICABFB) after being treated by coagulation. The results showed that poly aluminum chloride (PAC) of 30 g/L, polyacrylamide (PAM) of 20 mg/L and pH of 7.0 were suitable choices for coagulation. The pretreated FWL mixed with synthetic wastewater at different ratios were used as the influent wastewater for the reactor. The MC-ICABFB had relatively good performance on COD and NH4+-N removal and the main residual organic compound in the effluent was phthalates according to the analysis of GC-MC profiles. In addition, a suitable pretreatment process for the FWL to facilitate biological treatment of the wastewater needs further research.

Analysis and characterization of aluminum chlorohydrate oligocations by capillary electrophoresis.

Aluminum chlorohydrates (ACH) are the active ingredients used in most antiperspirant products. ACH is a water soluble aluminum complex which contains several oligomeric polycations of aluminum with degrees of polymerization up to Al13 or Al30. The characterization and quantification of ACH oligo-cations remain a challenging issue of primary interest for developing structure/antiperspirant activity correlations, and for controlling the ACH ingredients. In this work, highly repeatable capillary electrophoresis (CE) separation of Al3+, Al13 and Al30 oligomers contained in ACH samples was obtained at pH 4.8, owing to a careful choice of the background electrolyte counter-ion and chromophore, capillary I.D. and capillary coating. This is the first reported separation of Al13 and Al30 oligomers in conditions that are compatible with the aluminum speciation in ACH solution or in conditions of antiperspirant application/formulation. Al13 and Al30 effective charge numbers were also determined from the sensitivity of detection in indirect UV detection mode. The relative mass proportion of Al13 compared to Al13+Al30 could be determined in different aluminum chlorohydrate samples. Due to its simplicity, repeatability/reproducibility, minimal sample preparation and mild analytical conditions, CE appears to be a promising analytical separation technique for the characterization of ACH materials and for the study of structure/antiperspirant activity correlations.

Aluminum hydroxide adjuvant produced under constant reactant concentration.

Aluminum hydroxide adjuvant, AlO(OH), is used to potentiate the immune response to vaccines by adsorbing the antigen. The structure of aluminum hydroxide adjuvant is unusual as it is crystalline but has a high surface area due to its very small primary particles. The purpose of this study was to investigate the chemical and thermal conditions required to synthesize aluminum hydroxide adjuvant that is stable and exhibits a high protein adsorptive capacity. Aluminum hydroxide adjuvant was precipitated using a procedure in which the concentration of reactants was maintained constant throughout the precipitation. The precipitation variables were: 2.50, 2.75, and 3.00 OH/Al molar ratio; 0.5, 4.0, and 5.0 M NaCl; and 25, 60, and 65 degrees C. High sodium chloride concentration and high temperature facilitated the formation of AlO(OH) rather than crystalline forms of aluminum hydroxide, Al(OH)(3). The AlO(OH) produced was not stable because crystalline forms of aluminum hydroxide formed during aging at room temperature. Aluminum hydroxide adjuvant was stabilized for the study period of 12 weeks at room temperature by either the addition of 3.0 M NaCl after precipitation and washing or hydrothermal treatment at 110 degrees C for 4 h. Stabilization by the addition of sodium chloride required a hypertonic concentration of sodium chloride and was not practical as vaccines for parenteral administration are desired to be isotonic (equivalent to 0.15 M NaCl). Stabilization by hydrothermal treatment produced aluminum hydroxide adjuvant, which exhibited a high protein adsorptive capacity that did not change during the 12-week study period.

From sheets to fibers: A novel approach to gamma-AlOOH and gamma-A12O3 1D nanostructures.

The gamma-AIOOH (boehmite) nanofiber bundles have been synthesized via a convenient quencher method. Most nanofibers contain even smaller nanowires with an average diameter of 5 nm. A series of contrast experiments reveal that the evolvement from nanosheets to nanofibers occurs in the quencher process. gamma-Al2O3 nanofiber bundles with mesoporous character can be obtained by calcining relevant gamma-AlOOH nanostructures at 500 degrees C.

Evaluation of the bioavailability of the herbicide prosulfocarb through adsorption on soils and model soil colloids, and through a simple bioassay.

Adsorption isotherms of prosulfocarb were determined on soils with different physicochemical properties. The extent of adsorption increased with the organic carbon content, but the results also suggested the involvement of some inorganic soil surfaces. In order better to understand the role of each soil surface, adsorption-desorption isotherms were determined on model soil colloids consisting of a soil humic acid, a montmorillonite, a synthetic aluminium hydroxide and their associations. The highest adsorption was observed on the humic acid, but it was also confirmed that the montmorillonite interacted with prosulfocarb. In contrast, the aluminium hydroxide was not active and its association with montmorillonite provoked a decrease in adsorption compared with montmorillonite alone. Except for humic acid, the highest adsorption took place on the ternary association montmorillonite-aluminium hydroxide-humic acid. On each surface tested, the adsorption was largely reversible and decreased at increasing pH. The herbicidal activity of prosulfocarb was tested by the determination of the germination and growth of a typical weed, Lolium multiflorum Lam, in contact with prosulfocarb solutions at different concentrations. The herbicide did not prevent the germination of the seeds but inhibited the growth of the roots and leaves. The same test was performed in the presence of the ternary system to evaluate the influence of adsorption on the plant bioavailability. It was concluded that the presence of an adsorptive surface reduced the herbicidal activity and that the simple bioassay proposed could be useful in predicting the extent of adsorption in a given soil.

Postvaccinal sarcomas in the cat: epidemiology and electron probe microanalytical identification of aluminum.

An increase in fibrosarcomas in a biopsy population of cats in the Pennsylvania area appears to be related to the increased vaccination of cats following enactment of a mandatory rabies vaccination law. The majority of fibrosarcomas arose in sites routinely used by veterinarians for vaccination, and 42 of 198 tumors were surrounded by lymphocytes and macrophages containing foreign material identical to that previously described in postvaccinal inflammatory injection site reactions. Some of the vaccines used have aluminum-based adjuvants, and macrophages surrounding three tumors contained aluminum oxide identified by electron probe microanalysis and imaged by energy-filtered electron microscopy. Persistence of inflammatory and immunological reactions associated with aluminum may predispose the cat to a derangement of its fibrous connective tissue repair response, leading to neoplasia.