Irritation Potential Research Articles

Assessment of the feed additive consisting of Limosilactobacillus fermentumNCIMB 30169 for all animal species for the renewal of its authorisation (Microferm Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of Limosilactobacillus fermentum NCIMB 30169 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumDSM 18113 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 18113 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum DSM 18113 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumDSM 18114 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 18114 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumer and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum DSM 18114 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumATCC 55944 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) ATCC 55944 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumer and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum ATCC 55944 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lentilactobacillus buchneriATCC PTA-6138 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lentilactobacillus buchneri ATCC PTA-6138 as a technological additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions could be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumATCC 55943 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) ATCC 55943 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum ATCC 55943 should be considered a potential skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

The Effect of Infrared (IR) and Mirror Exercise on Increasing Muscle Strength and Functional Ability in Bell's Palsy Cases

Bell's Palsy is an acute, ipsilateral facial nerve (VII) paralysis. Bell's palsy is alsocaused by swelling and pressure on the nerve in the stylomastoid foramen whichcauses damage to the facial nerve. Problems that sufferers often experience after realizing facial muscle weakness from a physiotherapy perspective include facial asymmetry, a feeling of stiffness and thickness on the affected side of the face and decreased facial muscles. force on the affected side has the potential for spasm and tissue adhesions, as well as potential irritation to the affected side of the eye. The population of this study consisted of 30 respondents. Special examination for Bell's palsy sufferers using the Ugo Fisch scale and a treatment program using infrared (IR) and mirror exercise methods. This action aims to increase facial muscle strength, reduce muscle spasm, increase functional activity of facial muscles, and increase functional activity. The sample for this research consisted of 20 respondents. From the results of the hypothesis test, a p-value of 0.000 (alpha < 0.05) is obtained as a critical limit, which means that H0 is rejected and Ha is accepted. So, the results of this therapy show a significant increase in facial muscle strength and functional ability between before and after therapy. Based on these results, the intervention given in the form of infrared (IR) and mirror exercise was effective in increasing muscle strength and functional ability as well as improving the participants' nerves.

Valorisation of Raspberry Seeds in Cosmetic Industry-Green Solutions.

The fruit processing industry generates large quantities of by-products well known to be rich in bioactive compounds with numerous nutritional properties and beneficial effects for human health. We developed a strategy to valorise raspberry seeds and obtain valuable ingredients with potential application in cosmetic skincare formulas. Cold press extraction technology was applied to extract oil, and the remaining defatted raspberry seed cake was treated with three proline based deep eutectic solvents (DES) to extract polyphenols. The most potent was proline/citric acid extract, with free and total ellagic acid content (52.4 mg/L and 86.4 mg/L), total phenolic content (TPC, 550.1 mg GAE/L) and radical scavenging activity (RSA, 4742.7 mmol TE/L). After the direct mixing of the extract and after encapsulation with starch as a carrier, the skincare emulsion and microemulsion were characterised by irritation potential (Zein test), transepidermal water loss (TEWL), red blood cell (RBC), and DPPH antioxidant test. The resulting preparations were of improved quality in comparison to the control hand cream, with a low skin irritation effect, lower TEWL, and higher antioxidant potential. This work complies with circular economy principles and green technology standards, and represents the efficient model on how to reuse natural resources through waste minimization.

Silk Fibroin Formed Bioadhesive Ophthalmic Gel for Dry Eye Syndrome Treatment.

Dry eye syndrome (DES), arising from various etiologic factors, leads to tear film instability and ocular surface damage. Given its anti-inflammatory effects, cyclosporine A (CsA) has been widely used as a short-term treatment option for DES. However, poor bioavailability and solubility of CsA in aqueous phase make the development of a cyclosporine A-based eye drop for ocular topical application a huge challenge. In this study, a novel strategy for preparing cyclosporine A-loaded silk fibroin nanoemulsion gel (CsA NBGs) was proposed to address these barriers. Additionally, the rheological properties, ocular irritation potential, tear elimination kinetics, and pharmacodynamics based on a rabbit dry eye model were investigated for the prepared CsA NBGs. Furthermore, the transcorneal mechanism across the ocular barrier was also investigated. The pharmacodynamics and pharmacokinetics of CsA NBGs exhibited superior performance compared to cyclosporine eye drops, leading to a significant enhancement in the bioavailability of CsA NBGs. Furthermore, our investigation into the transcorneal mechanism of CsA NBGs revealed their ability to be absorbed by corneal epithelial cells via the paracellular pathway. The CsA NBG formulation exhibits promising potential for intraocular drug delivery, enabling safe, effective, and controlled administration of hydrophobic drugs into the eye. Moreover, it enhances drug retention within the ocular tissues and improves systemic bioavailability, thereby demonstrating significant clinical translational prospects.

Silver Nanoparticles Produced In Vitro by Berberis vulgaris Fruit and Their Antioxidant, Antimicrobial and Ex Ovo Irritation Potential Study

Green synthesis was successfully used for silver nanoparticles (Ag NPs) preparation using Berberis vulgaris aqueous extracts. The ultraviolet and visible (UV–Vis) spectroscopy, photon cross-correlation spectroscopy (PCCS), transmission electron microscopy (TEM) and selected area electron diffraction (SAED) techniques were used for characterization of the Ag NPs and confirmed the presence of Ag(0) in nanoparticles. The bimodal morphology was discovered, namely, the larger particles had elongated shape and size around 200 nm, while the smaller ones were spherical with a size of up to ten microns. All the nanoparticles (NPs) showed antioxidant activity against radical DPPH and ferric-reducing antioxidant power. The Ag NPs possess antibacterial effects against Escherichia coli and Staphylococcus aureus comparable to silver nitrate solution. In addition, also irritation potential of the produced Ag NPs has been investigated ex Ovo and no irritation of vessels and their surroundings was found, which shows the harmless character of the products.

Clinical Efficacy in Skin Hydration and Reducing Wrinkles of Nanoemulsions Containing Macadamia integrifolia Seed Oil.

This study aimed to assess natural oils for their antioxidant and anti-hyaluronidase properties and select the most effective candidate for development into nanoemulsions (NE) for clinical evaluations. The oils were assessed using 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid (ABTS•+) and ferric thiocyanate assays for antioxidant properties and an enzyme-substrate reaction assay for anti-hyaluronidase activity. The most potent oil was formulated into conventional emulsions (CE) and NE, which were characterized and evaluated for their stability, both in accelerated and long-term conditions. The irritation potential was assessed using both the hen's eggs chorioallantoic membrane test and a clinical trial. Skin hydration enhancement and skin wrinkle reduction efficacy were clinically assessed. Macadamia integrifolia oil exhibited significant potency as an ABTS•+ radical scavenger, lipid peroxidation inhibitor, and hyaluronidase inhibitor (p < 0.05). Both the CE and NE, comprising 15% w/w oil, 5% w/w Tween® 80 and Span® 80, and 80% w/w DI water, were found to be optimal. NE with an internal droplet size of 112.4 ± 0.8 nm, polydispersity index of 0.17 ± 0.01, and zeta potential of -31.5 ± 1.0 mV, had good stability and induced no irritation. Both CE and NE enhanced skin hydration and reduced skin wrinkles in human volunteers, while NE was outstanding in skin hydration enhancement.

Micellar extracts obtained from Bistortae rhizoma, Fraxinus excelsior, and Romex crispus as components of hair shampoos

Abstract The aim of the present study was to evaluate the potential applications of micellar extracts derived from Bistortae rhizoma, Fraxinus excelsior, and Romex crispus as components of hair shampoos and to examine the impact of these micellar extracts on the specific properties of the formulated cosmetics. The antioxidant activity, polyphenol content, and vitamin C content of the plant materials selected for the study were assessed. In addition, particle size analysis was performed for the obtained micellar extracts. The shampoos prepared on the basis of original formulations were evaluated for irritation potential, viscosity, foam stability index, and color. The plants evaluated in the study exhibited a high level of antioxidant activity, and the derived extracts were found to contain micellar aggregates. The application of the extracts was shown to reduce the skin irritation potential of the shampoos and reduce their viscosity. In addition, the formulated shampoos were characterized by a high foam stability index. Substantial variations in the color of the cosmetics were observed upon the introduction of the micellar extracts into the formulations.

Efficacy of the feed additive consisting of Saccharomyces cerevisiaeCNCM I-4407 (Actisaf® Sc47) for cattle for fattening (Lesaffre International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae CNCM I-4407 (Actisaf® Sc47) as a zootechnical feed additive (functional group: gut flora stabiliser) in cattle for fattening. The additive is already authorised for use in feed for dairy cows, calves for rearing, lambs for fattening, dairy goats, dairy sheep and dairy buffaloes. In a previous opinion, the EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that Actisaf® Sc47 was safe for cattle for fattening, the consumers and the environment. Additionally, the Panel considered that Actisaf® Sc47 is not a skin irritant, and no conclusions could be drawn on the additive's eye irritancy and dermal sensitisation potential. Due to the lack of adequate data, the Panel could not conclude on the efficacy of the additive in cattle for fattening at the proposed conditions of use. In the current application, the applicant submitted three trials to support the efficacy in cattle for fattening. However, two of them were not considered for the assessment. The other trial showed an improved zootechnical performance of the animals at the proposed use level of 4 × 109 CFU/kg complete feed. Considering the additive is authorised in dairy cows and calves for rearing and the requirements of the current Guidance on the assessment of the efficacy of feed additives, no further demonstration of efficacy is necessary to extrapolate the conclusions previously reached to all ruminants. The significant positive effect shown in one trial in cattle for fattening supports the above extrapolation. Therefore, the FEEDAP Panel concludes that Actisaf® Sc47 is efficacious as a zootechnical additive for cattle for fattening at the proposed conditions of use.

Assessment of the feed additive consisting of Pediococcus pentosaceusDSM 14021 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Pediococcus pentosaceus DSM 14021, a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel considers that any exposure through skin and respiratory tract is considered a risk. The Panel cannot conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Levilactobacillus brevisDSM 21982 for all animal species for the renewal of its authorisation (Marigot Ltd T/A Celtic Sea Minerals).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Levilactobacillus brevis DSM 21982 as a technological feed additive, silage additive, for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of inactivated selenised yeast (Saccharomyces cerevisiaeCCTCC M 2022402) for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance-efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust-free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

Development of a Probability-Based In Vitro Eye Irritation Screening Platform.

Traditional eye irritation assessments, which rely on animal models or ex vivo tissues, face limitations due to ethical concerns, costs, and low throughput. Although numerous in vitro tests have been developed, none have successfully reconciled the need for high experimental throughput with the accurate prediction of irritation potential, attributable to the complexity of irritation mechanisms. Simple cell models, while suitable for high-throughput screening, offer limited mechanistic insights, contrasting with more physiologically relevant but less scalable complex organotypic corneal tissue constructs. This study presents a novel strategy to enhance the predictive accuracy of screening-compatible simple cell models in eye irritation testing. Our method combines the results of two in vitro assays-cell apoptosis and nociceptor (TRPV1) activation-using micropatterned chips to partition human corneal epithelial cells into numerous discrete small populations. Following exposure to test compounds, we measure apoptosis and nociceptor activation responses. The large datasets collected from the cell micropatterns facilitate binarization and statistical fitting to calculate a mathematical probability, which assesses the compound's potential to cause eye irritation. This method potentially enables the amalgamation of multiple mechanistic readouts into a singular index, providing a more accurate and reliable prediction of eye irritation potential in a format amenable to high-throughput screening.

Comparative toxicological analysis of two pristine carbon nanomaterials (graphene oxide and aminated graphene oxide) and their corresponding degraded forms using human in vitro models

Despite the wide application of graphene-based materials, the information of the toxicity associated to some specific derivatives such as aminated graphene oxide is scarce. Likewise, most of these studies analyse the pristine materials, while the available data regarding the harmful effects of degraded forms is very limited. In this work, the toxicity of graphene oxide (GO), aminated graphene oxide (GO-NH2), and their respective degraded forms (dGO and dGO-NH2) obtained after being submitted to high-intensity sonication was evaluated applying in vitro assays in different models of human exposure. Viability and ROS assays were performed on A549 and HT29 cells, while their skin irritation potential was tested on a reconstructed human epidermis model. The obtained results showed that GO-NH2 and dGO-NH2 substantially decrease cell viability in the lung and gastrointestinal models, being this reduction slightly higher in the cells exposed to the degraded forms. In contrast, this parameter was not affected by GO and dGO which, conversely, showed the ability to induce higher levels of ROS than the pristine and degraded aminated forms. Furthermore, none of the materials is skin irritant. Altogether, these results provide new insights about the potential harmful effects of the selected graphene-based nanomaterials in comparison with their degraded counterparts.

Sweeteners in Orodispersible Films: How Much is too Much?

Four natural sweeteners (sucrose, xylitol, fructose, and isomalt) were selected to examine the influence of their qualities and amounts on the characteristics of orodispersible films. Sodium carboxymethylcellulose (2% w/w) was utilized as the film-forming polymer and 1% w/w glycerol as a plasticizer. Films were produced through the solvent casting method, rendering them suitable for convenient application in community or hospital pharmacy settings. The physicochemical and optical properties of the films were analyzed, and Fourier-transform infrared analysis was carried out. All films exhibited acceptable disintegration time, uniformity of mass, thickness, and optical characteristics, with significant dependence (p<0.05) on both sweetener type and quantity. Disintegration time varied based on the employed method, as well as the characteristics and amount of sweetener. Additionally, all films maintained pH values within the oral cavity range, suggesting no potential irritancy upon administration. Fourier-transform infrared analysis confirmed the formation of the film and demonstrated compatibility between its components.

Research on strategies for reducing the irritability of potassium cocoyl glycinate in cleansing

BackgroundPotassium cocoyl glycinate, a kind of amino acid surfactant, is widely used as major component for facial cleansing. However, the interaction between surfactants and compounds in the stratum corneum has been suggested as a contributing factor to their potential skin irritancy. ObjectiveThis study aimed to the effects of adding surfactants, polymers, lipids and active substances on diminishing skin irritation caused by potassium cocoyl glycinate. Materials and methodsZein test and Hemolysis test enabled the identification of irritation to proteins and cells in the studied binary systems. The critical micelle concentration (CMC) was evaluated by the surface tension method. The power of the analyzed polymers to diminish irritation of potassium cocoyl glycinate was represented by the reduction rate. Results(1) Amphoteric surfactants and nonionic surfactants are effective at reducing the irritation of potassium cocoyl glycinate in some cases by reducing CMC; (2) Addition of polymers to the potassium cocoyl glycinate solutions improves its safety of use. Hydroxypropyl methylcellulose could reduce the irritation by 88.63%; (3) Combining most lipids can assist in declining the irritation, Lppg-28-Buteth-35 could inhibit the irritation of red blood cells by 16.52%; (4) The effects of active substances varied, hydrolyzed sodium hyaluronate results in a significant reduction in irritation to cells. ConclusionIn facial cleansers based on potassium cocoyl glycinate, supplying co-surfactant, polymers, lipids and active substances can reduce the irritation to some extent, however, the effects are various.