Safety Assessment of Polysilicone-11 as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polysilicone-11 as used in cosmetic formulations. This ingredient is reported to function as a film former. The Panel considered the available data and concluded that Polysilicone-11 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Derivation of the toxicological threshold of silicon element in the extractables and leachables from the pharmaceutical packaging and process components.

Silicon is one of the most monitored elements in extractables and leachables studies of pharmaceutical packaging systems and related components. There is a need to review and evaluate toxicological thresholds of silicon because of its direct contact with drug products (DP) especially a liquid form of DP with the widely used pharmaceutical packaging systems made of silicon materials like glass and silicone. It is required by regulatory authorities to test silicon content in DP; however, there are no official guidelines on the toxicology of silicon that are currently available, yet the knowledge of toxicological thresholds of silicon is critical to justify the analytical limit of quantification (LOQ). Therefore, we reviewed the toxicity of silicon to derive a toxicological threshold by literature review of toxicity studies of both inorganic and organic silicon compounds. Oral toxicity is low for inorganic silicon like silicon dioxide or organic silicon polymers such as silicone tube/silicone oil (polydimethylsiloxane, or namely, PDMS as the major ingredient). In comparison, inhalational toxicity of silicon dioxide leads to pulmonary silicosis or even lung cancer. When orally administered, the toxicity of silicon dioxide, glass, polymers, or PDMS oligomers varies depending on their morphology, molecular weight (MW), and degrees of polymerization. PDMS with high MW has minimal toxic symptoms with non-detectable degradation/elimination by both intraperitoneal and subcutaneous administration routes, while exposure to either PDMS or small molecule dimethyl silicone compounds by the intravenous administration route may lead to death. We here determined a general parenteral permitted daily exposure (PDE) of 93 µg/day for inorganic silicon element and 100 µg/day for organic silicon element by reviewing toxicological data of both forms of silicon. In conclusion, this work provides evidence for pharmaceutical companies and regulatory agencies on the PDEs of silicon elements in pharmaceutical packaging and process components through a variety of administration routes.

Entirely S-Protected Thiolated Silicone: A Novel Hydrophobic Mucoadhesive and Skin Adhesive.

The aim of this study was the synthesis and evaluation of an entirely S-protected thiolated silicone as novel hydrophobic mucoadhesive and skin adhesive. 2-[(2-Amino-2-carboxyethyl)disulfanyl]nicotinic acid was covalently attached to a poly(dimethylsiloxane)-graft-polyacrylate via amide bond formation. Adhesive properties were determined via the rotating cylinder method and tensile studies on porcine small intestinal mucosa besides on porcine abdominal skin. Rheological characteristics were evaluated on a cone-plate rheometer. The S-protected thiolated silicone exhibited 128 ± 18 µmol immobilized 2-mercaptonicotinic acid per gram of polymer and showed a 5.9-fold extended time of mucosal adhesion compared with the unmodified silicone on the rotating cylinder. With a 2.3-fold higher maximum detachment force and a 1.7-fold higher total work of adhesion tested on porcine small intestinal mucosa, the S-protected thiolated silicone is superior to the unmodified silicone. Furthermore, using porcine abdominal skin, a 2.4-fold higher maximum detachment force and a 4.4-fold higher total work of adhesion obtained for the S-protected thiolated silicone outlines the preferentially adhesion to skin. Triggered by N-acetyl-L-cysteine liberated thiol groups form interchain and intrachain disulfide bonds within the polymer (6.7% m/v) causing a 23.0-fold increase in dynamic viscosity (ƞ). In parallel, the elastic modulus (G') and the viscous modulus (G") increased 39.2-fold and 8.1-fold, respectively.

Ultrafine carbon particles promote rotenone-induced dopamine neuronal loss through activating microglial NADPH oxidase.

BACKGROUND: Atmospheric ultrafine particles (UFPs) and pesticide rotenone were considered as potential environmental risk factors for Parkinson's disease (PD). However, whether and how UFPs alone and in combination with rotenone affect the pathogenesis of PD remains largely unknown. METHODS: Ultrafine carbon black (ufCB, a surrogate of UFPs) and rotenone were used individually or in combination to determine their roles in chronic dopaminergic (DA) loss in neuron-glia, and neuron-enriched, mix-glia cultures. Immunochemistry using antibody against tyrosine hydroxylase was performed to detect DA neuronal loss. Measurement of extracellular superoxide and intracellular reactive oxygen species (ROS) were performed to examine activation of NADPH oxidase. Genetic deletion and pharmacological inhibition of NADPH oxidase and MAC-1 receptor in microglia were employed to examine their role in DA neuronal loss triggered by ufCB and rotenone. RESULTS: In rodent midbrain neuron-glia cultures, ufCB and rotenone alone caused neuronal death in a dose-dependent manner. In particularly, ufCB at doses of 50 and 100µg/cm2 induced significant loss of DA neurons. More importantly, nontoxic doses of ufCB (10µg/cm2) and rotenone (2nM) induced synergistic toxicity to DA neurons. Microglial activation was essential in this process. Furthermore, superoxide production from microglial NADPH oxidase was critical in ufCB/rotenone-induced neurotoxicity. Studies in mix-glia cultures showed that ufCB treatment activated microglial NADPH oxidase to induce superoxide production. Firstly, ufCB enhanced the expression of NADPH oxidase subunits (gp91phox, p47phox and p40phox); secondly, ufCB was recognized by microglial surface MAC-1 receptor and consequently promoted rotenone-induced p47phox and p67phox translocation assembling active NADPH oxidase. CONCLUSION: ufCB and rotenone worked in synergy to activate NADPH oxidase in microglia, leading to oxidative damage to DA neurons. Our findings delineated the potential role of ultrafine particles alone and in combination with pesticide rotenone in the pathogenesis of PD.

Reabsorção óssea associada ao implante de silicone em mentoplastia: relato de caso clínico / Bone reabsorption associated with silicone implants in mentoplasty: a clinical case report

Durante muitos anos, os implantes de silicone foram utilizados em cirurgias reconstrutivas e estéticas, principalmente em casos em que o perfil facial do paciente apresenta deficiência no terço inferior da face. Este material tem provado ser bem sucedido na maioria dos aspectos, contudo, algumas complicações já foram bem relatadas na literatura, como é o caso das reabsorções ósseas na região de mento mandibular. No presente artigo os autores apresentam dois casos clínicos de reabsorção óssea da cortical anterior do mento, associada ao implante de silicone e discutem a etiologia, as complicações e o plano de tratamento.

For many years, silicone implants were used in reconstructive and esthetic surgeries, especially in cases in which the facial profile of patients presented deficiencies in the inferior third of the face. This material proved to be successful in most aspects. However, several complications were well reported in the literature, as the case of bone reabsorption in the region of the mandibular chin. In this article, the authors present two clinical cases of bone reabsorption from the anterior cortex of the chin associated with silicone implants and discuss the etiology, complications, and treatment plan.

Determination of Insecticidal Effect (LC50 and LC90) of Organic Fatty Acids Mixture (C8910+Silicone) Against Aedes aegypti and Aedes albopictus (Diptera: Culicidae).

Emerging and re-emerging vector-borne diseases such as chikungunya and dengue and associated Aedes vectors are expanding their historical ranges; thus, there is a need for the development of novel insecticides for use in vector control programs. The mosquito toxicity of a novel insecticide and repellent consisting of medium-chain carbon fatty acids (C8910) was examined. Determination of LC50 and LC90 was made against colony-reared Aedes aegypti (L.) and Aedes albopictus (Skuse) using probit analysis on mortality data generated by Centers for Disease Control and Prevention bottle bioassays. Six different concentrations of C8910 + silicone oil yielded an LC50 of 160.3 µg a.i/bottle (147.6-182.7) and LC90 of 282.8 (233.2-394.2) in Ae. aegypti; five concentrations yielded an LC50 of 125.4 (116.1-137.6) and LC90 of 192.5 (165.0-278.9) in Ae. albopictus. Further development of C8910 and similar compounds could provide vector control specialists novel insecticides for controlling insect disease vectors.

Design and Characterization of Silicone and Surfactant Based Systems for Topical Drug Delivery.

Nanotechnology offers advantages for new drug delivery design by providing drug targeting while minimizing the side effects. Polyoxyethylene 20 cetyl alcohol (CETETH-20) is a surfactant that may form nanostructured systems, such as liquid crystals, when in contact with water/oil, which are structurally similar to biological membranes and may improve skin interaction. The aim of this study was to develop and characterize CETETH 20-based nanostructured systems by combining CETETH-20 with water and different oily phases, including PEG-12-dimethicone for topical drug administration. The systems were characterized by polarized light microscopy (PLM), small-angle X-ray scattering (SAXS), rheology, texture profile analyses (TPA), in vitro cytotoxicity and histopathological analyses of rabbits' skin. Lamellar, hexagonal and cubic phases were identified and their viscoelastic moduli varied according to each phase. The stiffness of the cubic phase was 3-fold higher and twice more adhesive than the hexagonal phase. The formulations did not affect the normal macrophages cells, neither promoted skin irritation. They were spontaneously obtained by simply mixing the components, which corroborates for an ease scaled-up. These results suggest that systems composed of CETETH 20, PEG-12-dimethicone and water are a promising new approach for designing nanostructured topical drug delivery systems.

Physico-chemical characteristics of coated silicone textured versus smooth breast implants differentially influence breast-derived fibroblast morphology and behaviour.

Capsule formation is an inevitable consequence of silicone breast implantation. Clinically challenging dense fibrocollagenous capsular contractures occur at different rates between smooth compared to textured surfaces. Host response is influenced by several factors including implant surface texture, chemistry and interactions between cells and the extracellular matrix (ECM). Specific coatings can modify the physico-chemical properties of implant surfaces eliciting specific cellular reactions. Therefore, we evaluated the physico-chemical characteristics of coated smooth versus textured silicone breast implants on breast-derived fibroblast morphology and behaviour using (a) confocal laser microscopy, (b) Raman spectroscopy and (c) the effect of four unique protein and glycosaminoglycan (GAG) coatings (aggrecan, collagen I, fibronectin and hyaluronic acid) on breast-derived fibroblast attachment, proliferation, morphology, spreading, cytotoxicity and gene expression. Collagen I, fibronectin and hyaluronic acid coatings exhibited satisfactory fibroblast adhesion (p<0.001) in comparison to uncoated surfaces. Cell adhesion was less on smooth surfaces compared to textured surfaces (p<0.001). Fibroblasts cultured on collagen I, fibronectin and hyaluronic acid coated implants demonstrated improved cell proliferation than uncoated surfaces (p<0.001). LDH assay showed that coating surfaces with collagen I, fibronectin and hyaluronic acid did not induce cytotoxicity. Alpha-actinin expression and fibroblast adhesion to the substrate were upregulated (p<0.001), in textured versus smooth surfaces. FAK, vinculin and paxillin expression were upregulated (p<0.001), in all surfaces coated with fibronectin and collagen I. In conclusion, we present original data for expression of adhesion-related genes, cell morphology and proliferation in breast fibroblasts following the application of specific coatings on breast implant surfaces.

Consequences of developmental exposure to concentrated ambient ultrafine particle air pollution combined with the adult paraquat and maneb model of the Parkinson's disease phenotype in male mice.

Current evidence suggests suceptibility of both the substantia nigra and striatum to exposure to components of air pollution. Further, air pollution has been associated with increased risk of PD diagnsosis in humans or PD-like pathology in animals. This study examined whether exposure of mice to concentrated ambient ultrafine particles (CAPS; <100nm diameter) during the first two weeks of life would alter susceptibility to induction of the Parkinson's disease phenyotype (PDP) in a pesticide-based paraquat and maneb (PQ+MB) model during adulthood utilizing i.p. injections of 10mg/kg PQ and 30mg/kg MB 2× per week for 6 weeks. Evidence of CAPS-induced enhancement of the PQ+MB PDP was limited primarily to delayed recovery of locomotor activity 24 post-injection of PQ+MB that could be related to alterations in striatal GABA inhibitory function. Absence of more extensive interactions might also reflect the finding that CAPS and PQ+MB appeared to differentially target the nigrostriatal dopamine and amino acid systems, with CAPS impacting striatum and PQ+MB impacting dopamine-glutamate function in midbrain; both CAPS and PQ+MB elevated glutamate levels in these specific regions, consistent with potential excitotoxicity. These findings demonstrate the ability of postnatal CAPS to produce locomotor dysfunction and dopaminergic and glutamateric changes, independent of PQ+MB, in brain regions involved in the PDP.

Assessment of oxidative stress and chromosomal aberration inducing potential of three medical grade silicone polymer materials.

Medical expenditures for devices are increasing along with the ageing of human population and the synthesis of materials such as silicone polymers is on upsurge for manufacturing these devices. The International Organization for Standardization (ISO) emphasizes a battery of tests for preclinical assessment of biocompatibility of medical devices. Genotoxicity assays have become an integral component of these test procedures and it employs a set of in vitro and in vivo experiments to detect mutagens. Hence, this study was performed with an intention to investigate the genotoxic potential of the physiological saline extracts of three medical grade silicone polymer materials by the in vitro chromosomal aberration assay using human peripheral blood lymphocytes. Further, the oxidative stress inducing potential of the material extracts was investigated in vivo in mice liver homogenates using cyclophosphamide as positive control. The investigation revealed that none of the three materials were able to produce marked human lymphocyte chromosomal aberration, suggesting the absence of mutagens. The materials also showed negative results in their oxidative stress inducing potential, which was revealed by the normal levels of lipid peroxidation and unaltered levels of glutathione and its metabolizing enzymes in the mice liver tissue homogenates. It was interesting to observe a significant correlation between the genotoxic and antioxidant parameters investigated. Hence, it is suggested that the estimation of antioxidant status would serve as a better preliminary testing procedure prior to evaluating the genetic and molecular toxicity mechanisms of medical devices and/or materials intended for manufacture of such devices.

Histopathological reaction over prosthesis surface covered with silicone and polyurethane foam implanted in rats.

PURPOSES: To evaluate whether polyurethane foam leads more intense foreign-body reaction than silicone foam. To compare the vascularization of the capsules surrounding the foam implants. To investigate if the capsule of polyurethane foam implanted has greater amount of collagen than that of silicone foam. METHODS: Sixty-four young male Wistar rats were allocated into two groups: polyurethane foam and silicone foam. Subcutaneous discs were implanted into the dorsum of the animals in both groups. The capsules were assessed 28 days, two months, three months and six months postoperatively. Microscopic analysis with H&E stain was performed to evaluate the acute and chronic inflammatory process, foreign-body reaction and neovascularization. The analysis with picrosirius red was performed using the ImageProPlus software, to measure the number of vessels and collagen types I and III. RESULTS: There were no statistical differences between the two groups regarding the acute and chronic inflammatory processes. All rats from the polyurethane group, in all times, exhibited moderate or intense foreign-body reaction, with statistic significant difference (p=0.046) when compared with the silicone group, in which the reaction was either mild or nonexistent at two months. Vascular proliferation was significantly different between the groups at 28 days (p=0.0002), with the polyurethane group displaying greater neovascularization with H&E stain. Similar results were obtained with picrosirius red, which revealed in the polyurethane group a much greater number of vessels than in the silicone group (p=0.001). The collagen area was larger in the polyurethane group, significantly at 28 days (p=0.001) and at two months (p=0.030). CONCLUSIONS: Polyurethane foam elicited more intense foreign-body reaction when compared with silicone foam. The number of vessels was higher in the capsules of the polyurethane foam implants 28 days after the operation. The capsule of the polyurethane foam implants showed a greater amount of collagen than that of the silicone foam implants.

Histopathological reaction over prosthesis surface covered with silicone and polyurethane foam implanted in rats / Reação histopatológica sobre a superfície de próteses cobertas por espuma de silicone e poliuretano implantadas em ratos

PURPOSES: To evaluate whether polyurethane foam leads more intense foreign-body reaction than silicone foam. To compare the vascularization of the capsules surrounding the foam implants. To investigate if the capsule of polyurethane foam implanted has greater amount of collagen than that of silicone foam. METHODS: Sixty-four young male Wistar rats were allocated into two groups: polyurethane foam and silicone foam. Subcutaneous discs were implanted into the dorsum of the animals in both groups. The capsules were assessed 28 days, two months, three months and six months postoperatively. Microscopic analysis with H&E stain was performed to evaluate the acute and chronic inflammatory process, foreign-body reaction and neovascularization. The analysis with picrosirius red was performed using the ImageProPlus software, to measure the number of vessels and collagen types I and III. RESULTS: There were no statistical differences between the two groups regarding the acute and chronic inflammatory processes. All rats from the polyurethane group, in all times, exhibited moderate or intense foreign-body reaction, with statistic significant difference (p=0.046) when compared with the silicone group, in which the reaction was either mild or nonexistent at two months. Vascular proliferation was significantly different between the groups at 28 days (p=0.0002), with the polyurethane group displaying greater neovascularization with H&E stain. Similar results were obtained with picrosirius red, which revealed in the polyurethane group a much greater number of vessels than in the silicone group (p=0.001). The collagen area was larger in the polyurethane group, significantly at 28 days (p=0.001) and at two months (p=0.030). CONCLUSIONS: Polyurethane foam elicited more intense foreign-body reaction when compared with silicone foam. The number of vessels was higher in the capsules of the polyurethane foam implants 28 days after the operation. The capsule of the polyurethane foam implants showed a greater amount of collagen than that of the silicone foam implants.

OBJETIVOS: Avaliar, em relação ao uso de próteses, se a espuma de poliuretano apresenta maior reação de corpo estranho no organismo ao ser comparada com a espuma de silicone. Se há diferenças na vascularização das cápsulas formada ao redor das duas espumas implantadas. Se as cápsulas dos implantes de espuma de poliuretano apresentam quantidade maior de fibras colágenas ao serem comparadas com as da espuma de silicone. MÉTODOS: Utilizou-se 64 ratos albinos da linhagem Wistar, distribuídos em dois grupos de 34, grupo espuma de poliuretano e grupo espuma de silicone e receberam implantes discóides subcutâneos em seu dorso. Foram analisadas as cápsulas peri-implante com 28 dias, dois, três e seis meses após a introdução. A análise microscópica com H&E considerou as variáveis: inflamação aguda, inflamação crônica, reação de corpo estranho e neoformação vascular. A análise da coloração com picrosirius-red usando ImageProPlus considerou o número de vasos e colágeno tipo I e tipo III. RESULTADOS: Em relação à inflamação aguda e crônica, não foram encontradas diferenças estatísticas nos dois grupos. Todos os animais do grupo poliuretano, em todos os momentos, apresentaram reação de corpo estranho moderada ou intensa e foi encontrada diferença estatística significativa (p=0,046) ao serem comparados com o grupo silicone, cuja reação era ausente ou discreta aos dois meses. A neoformação vascular apresentou diferenças significativas nos dois grupos, aos 28 dias (p=0,0002); o grupo poliuretano com H&E apresentava quantidade maior de vasos neoformados e o mesmo ocorrendo com o picrosirius, cujo número de vasos era maior que no grupo silicone (p=0,001). A área de colágeno em todos os momentos foi maior no grupo poliuretano, sendo significativa com 28 dias (p=0,001) e com dois meses (p=0,030). CONCLUSÕES: A espuma de poliuretano apresentou maior reação de corpo estranho no organismo do que a espuma de silicone. A quantidade de vasos foi maior na cápsula da espuma de poliuretano com 28 dias após o implante. Aos 28 dias as cápsulas dos implantes de espuma de poliuretano apresentaram quantidade significativamente maior de colágeno do que as de espuma de silicone.

Surface modification of silicone for biomedical applications requiring long-term antibacterial, antifouling, and hemocompatible properties.

Silicone has been used for peritoneal dialysis (PD) catheters for several decades. However, bacteria, platelets, proteins, and other biomolecules tend to adhere to its hydrophobic surface, which may lead to PD outflow failure, serious infection, or even death. In this work, a cross-linked poly(poly(ethylene glycol) dimethacrylate) (P(PEGDMA)) polymer layer was covalently grafted on medical-grade silicone surface to improve its antibacterial and antifouling properties. The P(PEGDMA)-grafted silicone (Silicone-g-P(PEGDMA)) substrate reduced the adhesion of Staphylococcus aureus , Escherichia coli , and Staphylococcus epidermidis , as well as 3T3 fibroblast cells by ≥90%. The antibacterial and antifouling properties were preserved after the modified substrate was aged for 30 days in phosphate buffer saline. Further immobilization of a polysulfobetaine polymer, poly((2-(methacryloyloxy)ethyl)dimethyl-(3-sulfopropyl)ammonium hydroxide) (P(DMAPS)), on the Silicone-g-P(PEGDMA) substrate via thiol-ene click reaction leads to enhanced antifouling efficacy and improved hemocompatibility with the preservation of the antibacterial property. Compared to pristine silicone, the so-obtained Silicone-g-P(PEGDMA)-P(DMAPS) substrate reduced the absorption of bovine serum albumin and bovine plasma fibrinogen by ≥80%. It also reduced the number of adherent platelets by ≥90% and significantly prolonged plasma recalcification time. The results indicate that surface grafting with P(PEGDMA) and P(DMAPS) can be potentially useful for the modification of silicone-based PD catheters for long-term applications.

An assessment of the skin sensitisation hazard of a group of polyfunctional silicones using a weight of evidence approach.

Discordant results were observed when testing five prototype polyfunctional silicone materials for skin sensitization potential in the murine local lymph node assay (LLNA) and in the guinea pig maximization test (GPMT). While all five silicone materials were consistently negative in the GPMT, the testing in the LLNA revealed weak to moderate skin sensitisation potential for four of the five test materials. Neither study quality nor other known chemical factors could explain these findings. Further analysis did not provide sufficient evidence for a link between the LLNA responses and the irritancy of the test substances. Only in the case of one of the test materials, the occurrence of an excessive level of irritation could be linked to the positive LLNA result. Considering all existing information including physico-chemical and structure activity and animal data as well as existing human experience from silicone exposures at the workplace or their use in cosmetic products, the weight of evidence suggests that none of the examined silicone materials represents a significant skin sensitization hazard to humans. The suitability of the LLNA appears questionable for this class of materials. In case of any additional data needs for other or new silicone materials, the skin sensitization testing strategy will require careful evaluation and will need to be set up on a case by case basis.

Lack of promoting effect of titanium dioxide particles on chemically-induced skin carcinogenesis in rats and mice.

Nano-sized titanium dioxide particles (TiO(2)) are widely used in cosmetics, sunscreens and food additives. We previously reported that topical application of non-coated rutile type TiO(2) did not exhibit a promoting effect on ultraviolet B-initiated skin carcinogenesis in rats, and that this was likely due to lack of penetration of TiO(2) into the epidermis. In the present study, we examined the promoting effect of silicone coated TiO(2 )(sTiO(2)) suspended in silicone oil and non-coated TiO(2 )(ncTiO(2)) suspended in Pentalan 408 on a two-stage skin chemical carcinogenesis model: sTiO(2) suspended in silicon oil forms smaller particles than ncTiO(2) suspended in Pentalan because of the smaller sizes of aggregates formed. The model used skin carcinogenesis-sensitive human c-Ha-ras proto-oncogene transgenic mice (rasH2) and rats (Hras128) and their wild-type counterparts and CD-1 mice to test the effects of topical application of TiO(2). Animals were initially treated with a single dose of 7,12-dimethylbenz[a]anthracene (DMBA) and then with 0, 10, or 20 mg sTiO(2) (mice) or 0, 50, or 100 mg ncTiO(2) (rats). The incidence and multiplicity of skin tumors (squamous cell papilloma and carcinoma) did not increase over DMBA alone controls in skin carcinogenesis-sensitive mice or rats or wild-type animals. Analysis of rat skin indicated that sTiO(2) and ncTiO(2) did not penetrate though either healthy or damaged skin. Furthermore sTiO(2) did not penetrate an in vitro human epidermis model. Our results indicate that treatment with sTiO(2) or ncTiO(2) did not promote skin carcinogenesis in mice or rats, probably due to lack of penetration through the epidermis.

The effects of model polysiloxane and fouling-release coatings on embryonic development of a sea urchin (Arbacia punctulata) and a fish (Oryzias latipes).

In recent decades attention has focused on the development of non-toxic fouling-release coatings based on silicone polymers as an alternative to toxic antifouling coatings. As fouling-release coatings gain market share, they will contribute to environmental contamination by silicones. We report effects of eight model polysiloxane and three commercial foul-release coatings on embryonic development of sea urchins and fish, Japanese medaka. We used model coatings because they have known composition and commercially available components and molecules leaching from these coatings have been partially characterized. The commercial fouling-release coatings are purported to be non-toxic and components are proprietary. Our goal was to expose embryos of well studied model animals to the coatings to determine if the complex mixtures leaching from the coatings impact development. Urchins were chosen because development is rapid and embryos can enter the non-slip layer over surfaces. Medaka was chosen because the female deposits the sticky eggs onto the anal fin and then scrapes them off onto surfaces. Embryos were confined in water over coatings in 24 well plates. Fresh model coatings had no effect on urchin development while commercial fouling-release coatings inhibited development. Fish embryos had delayed hatching, increased mortality of hatchlings and dramatically decreased ability of hatchlings to inflate the swim bladder and reduced hatching success on all coatings. After one-month immersion of coatings in running seawater to simulate initial application in the marine environment, sea urchin embryos died when placed over model silicones. Effects of the commercial coatings were reduced but included retarded development. Effects on fish embryos over leached coating were reduced compared to those of fresh coating and included decreased hatching success, decreased hatchling survival and inability to inflate the swim bladder for commercial coatings. These findings suggest, similar to medical conclusions, compounds leaching from silicone coatings can impact development and the topic deserves study.

Liquid silicone to mitigate plantar pedal pressure: a literature review.

Disruption of the body's plantar fat pad can occur as a result of one of three mechanisms: simple fat pad atrophy associated with age-related degeneration, steroid use, or collagen vascular disease. Actual or relative displacement in to the underlying osseous prominences may be seen in association with structural deformity of the foot. Disease states such as diabetes may alter the normal structural integrity of soft tissues through nonenzymatic glycation leading to increased stiffness and thus reduced attenuating capacity. Fat pad atrophy, regardless of the cause, is often associated with substantial emotional, physical, productivity, and financial losses. In situations where the patient is sensate, the resultant skin on bone situation is extremely painful, especially when walking.

[Preliminary study on immunosuppressive effects evaluation of biomaterial].

In this paper, an immunosuppression model of immunotoxicity built through applying immunosuppressive agent-cyclophosphamide. Subsequently the changes of some assessment indexes including total amount of lymphocytes and concentration of cytokine TNF-alpha in peripheral blood were observed and were used to evaluate immunotoxicity induced by Medical Heat Vulcanizing Silicone Rubber. The final results showed no immunosuppressive effect caused by this material. The study provide effective and sensitive detection technique for evaluation of medical devices and biomaterials' immunotoxicity.

Toxicity evaluation of root canal sealers in vitro.

AIM: To compare the toxicity of methacrylate resin-based root canal sealers with sealers based on epoxy resin and silicone by two-well established cell culture methods. METHODOLOGY: Specimens of AH Plus, EndoREZ, RoekoSeal and Epiphany were prepared for direct contact in the Millipore filter diffusion test and as extracts in the MTT assay. Mouse fibroblasts (L929) were used as toxicity targets. Differences in cytotoxicity between fresh and set specimens and between the extracts of root canal sealers were determined by t-test (P < 0.05). RESULTS: In the filter diffusion test, freshly mixed Epiphany and AH Plus were rated severely toxic and RoekoSeal and EndoREZ nontoxic. When set, Epiphany was moderately toxic, whereas AH Plus, RoekoSeal and EndoREZ were nontoxic. Epiphany was significantly more toxic than RoekoSeal and EndoREZ (P < 0.05). In the MTT assay with set specimens, Epiphany was rated severely toxic; AH Plus and RoekoSeal slightly toxic; and EndoREZ nontoxic. Epiphany was significantly more toxic than the other three materials in this test (P < 0.001). CONCLUSION: The multi-methacrylate resin-based (Epiphany) root canal sealer was significantly more toxic to L-929 cells than the silicone-based Roeko Seal and the single methacrylate-based EndoREZ root canal sealers. AH Plus showed intermediate toxicity.