Dermal Replacement Product

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of cajuput oil obtained from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., when used as a sensory additive for all animal species. The FEEDAP Panel concluded that cajuput oil is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for sows and dogs, 50 mg/kg for horses and ornamental fish, 40 mg/kg for salmon and 5 mg/kg for cats...

Skin tissue engineering faces challenges due to the absence of vascular architecture, impeding the development of permanent skin replacements. To address this, a heparin-functionalized 3D-printed bioink (GH/HepMA) was formulated to enable sustained delivery of vascular endothelial growth factor (VEGF), comprising 0.3 % (w/v) hyaluronic acid (HA), 10 % (w/v) gelatin methacrylate (GelMA), and 0.5 % (w/v) heparin methacrylate (HepMA). The bioink was then used to print dermal constructs with angiogenic functions, including fibroblast networks and human umbilical vein endothelial cell (HUVEC) networks...

Algae of the order Cladophorales are the source of a unique nanocellulose with high crystallinity and a large aspect ratio, enabling broad surface modification. Cellulose nanocrystals (CNCs) are obtained via acid hydrolysis of nanocellulose, which is highly crystalline. However, the production of CNCs from Cladophorales algae is limited and still uses a conventional heating method. Thus, this study aimed to develop a microwave-assisted extraction (MAE) method for fast and efficient extraction of CNCs from Cladophora glomerata algae...

Phthalates are widely used as plasticizer and associated with various health issues. Recently, non-phthalate plasticizers are replacing phthalates; however, the exposure to these substances and the risk in Japan is unclear. In this study, we assessed the concentrations of phthalates, non-phthalate plasticizers, and phthalate degradation products in house dust and determined their respective exposure risks via oral and dermal routes. Twelve phthalates, seven non-phthalate plasticizers, and two degradation products were determined in the house dust obtained from 100 Japanese homes...

Natural products are generally preferred medications owing to their low toxicity and irritancy potential. However, good number of herbal therapeutics (HT) exhibit solubility, permeability and stability issues that eventually affect the oral bioavailability. Transdermal administration has been successful in resolving some of these issues which has lead in commercialization of a few herbal transdermal products. Polymeric Microneedles (MNs) has emerged as a promising platform in transdermal delivery of HT that face problems in permeating the skin...

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of Coriandrum sativum L. (coriander oil), when used as a sensory additive in feed for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of coriander oil is safe up to the maximum proposed use levels of 30 mg/kg complete feed for piglets, pigs for fattening, sows, veal calves (milk replacer), cattle for fattening, sheep, goats and horses, salmonids, dogs and ornamental fish...

BACKGROUND: Skin tissue engineering is a rapidly evolving field of research that effectively combines stem cells and biological scaffolds to replace damaged tissues. Human Wharton's jelly mesenchymal stromal cells (hWJ-MSCs) are essential to generate tissue constructs, due to their potent immunomodulatory effects and release of paracrine factors for tissue repair. Here, we investigated whether hWJ-MSC grown on human acellular dermal matrix (hADM) scaffolds and exposed to a proinflammatory environment maintain their ability to produce in vitro growth factors involved in skin injury repair and promote in vivo wound healing...

Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA...

BACKGROUND: Hybrid breast reconstruction combines free tissue transfer with implant placement. Various mesh products have been successfully used to secure the implant position in these reconstructions. In this study, the authors investigate the impact of mesh type on long-term outcomes following hybrid breast reconstruction. METHODS: A retrospective analysis of all patients with at least 24 months of follow-up after immediate bilateral prepectoral hybrid breast reconstruction was performed...

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of lemongrass oil obtained from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson when used as a sensory additive for all animal species. The FEEDAP Panel concluded that lemongrass oil is safe up to the maximum proposed use levels in complete feed of 125 mg/kg for salmonids; 100 mg/kg for sows and horses; 75 mg/kg for veal calves (milk replacer), cattle for fattening, dairy cows, sheep and goats; and 50 mg/kg for dogs and ornamental fish...

This study analysed settled dust samples in Sweden to assess children's combined exposure to 39 organohalogenated flame retardants (HFRs) and 11 organophosphate esters (OPEs) from homes and preschools. >94 % of the targeted compounds were present in dust, indicating widespread use of HFRs and OPEs in Swedish homes and preschools. Dust ingestion was the primary exposure pathway for most analytes, except BDE-209 and DBDPE, where dermal contact was predominant. Children's estimated intakes of ∑emerging HFRs and ∑legacy HFRs from homes were 1-4 times higher than from preschools, highlighting higher exposure risk for HFRs in homes compared to preschools...

Tris(chloropropyl) phosphate (TCPP) is used as a flame retardant in textiles, furniture foam, and other related products. In addition, it is manufactured for use in construction materials, electronic products, paints, coatings, and adhesives. Several flame retardants, including structurally similar organohalogen compounds, have been removed from products in commerce due to toxicity concerns, and TCPP has been proposed as a replacement flame retardant for use in these products. An anticipated increase in use of TCPP has generated concerns for increased human exposure through oral, dermal, and inhalation routes; however, publicly available toxicity data are scarce...

INTRODUCTION: Patients with major burns can undergo temporary coverage while skin graft donor sites heal, where dermal templates have an emerging role. The aim of this study was to evaluate the clinical outcomes and resource utilisation in patients with major burns treated with a bilayer biodegradable synthetic matrix (NovoSorb BTM). METHOD: This retrospective cohort study included patients admitted to the Royal Brisbane and Women's Hospital Adult Burn Unit with burns to at least 40 % TBSA who survived their acute admission...

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 4-methyl-5-vinylthiazole [15.018] belonging to chemical group 29 (thiazoles, thiophene and thiazoline), when used as sensory additive (flavourings) in feed for all animal species. The FEEDAP Panel concluded that 4-methyl-5-vinylthiazole [15.018] was safe at the maximum proposed use level of 0.5 mg/kg complete feed for veal calves (milk replacer), dogs, salmonids and ornamental fish...

Cutaneous hyaluronan (HA) is depolymerized to intermediate sizes in the extracellular matrix, and further fragmented in the regional lymph nodes. Previously, we showed that the HA-binding protein involved in HA depolymerization (HYBID), also known as KIAA1199/CEMIP, is responsible for the first step of HA depolymerization. Recently, mouse transmembrane 2 (mTMEM2) with high structural similarity to HYBID was proposed to be a membrane-bound hyaluronidase. However, we showed that knockdown of human TMEM2 (hTMEM2) conversely promoted HA depolymerization in normal human dermal fibroblasts (NHDFs)...

Historically, formaldehyde was used as a preservative in personal care products to extend product shelf-life; however, given its skin sensitization potential it has been phased out of use and replaced with formaldehyde-releasing preservatives, such as Dimethyloldimethyl hydantoin (DMDMH). A relationship has been established between positive patch test results following exposure to DMDMH and previous sensitization to formaldehyde. Upon direct contact with the skin, formaldehyde can react with skin proteins and cause an acute inflammatory reaction, which may progress to skin sensitization following repeated exposure...

Plastics, long-chain artificial polymers, are used worldwide with a global production of 350 million tonnes per year. Various degradation processes transform plastics into smaller fragments divided into micro, meso and macroplastics. In various industries, such as construction, certain plastic additives are used to improve flexibility and enhance performance. Plastic additives include phthalates (PAE), dibutyl phthalate (DPB) and diethyl phthalate (DEP). Due to the use of plastics and plastic additives, these small fragments of different shapes and colours are present in all environmental compartments...

BACKGROUND: Acellular dermal matrix (ADM) is treated using various devitalization and aseptic processing methods. The processing effects on ADM were evaluated by histochemical tests. METHODS: From January 2014 to December 2016, 18 patients [average age, 43.0 (range, 30-54) years] who underwent breast reconstruction with an ADM and tissue expander were prospectively enrolled. During the permanent implant replacement, a biopsy of the ADM was performed. We used three different human-derived products, namely, Alloderm®, Allomend®, and Megaderm®...

BACKGROUND: There remains much interest in improving cryopreservation techniques for advanced therapy medicinal products (ATMPs). Recently, human platelet lysate (hPL) has emerged as a promising candidate to replace fetal bovine serum (FBS) as a xeno-free culture supplement for the expansion of human cell therapy products. Whether hPL can also substitute for FBS in cryopreservation procedures remains poorly studied. Here, we evaluated several cryoprotective formulations based on a proprietary hPL for the cryopreservation of bioengineered tissues and cell therapy products...

All cosmetic ingredients registered in Europe must be evaluated for their safety using non-animal methods. Microphysiological systems (MPS) offer a more complex higher tier model to evaluate chemicals. Having established a skin and liver HUMIMIC Chip2 model demonstrating how dosing scenarios impact the kinetics of chemicals, we investigated whether thyroid follicles could be incorporated to evaluate the potential of topically applied chemicals to cause endocrine disruption. This combination of models in the HUMIMIC Chip3 is new; therefore, we describe here how it was optimized using two chemicals known to inhibit thyroid production, daidzein and genistein...