In Vitro and Clinical Safety Assessment of the Multiple W/O/W Emulsion Based on the Active Ingredients from Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L.
Abstract:The multiple W/O/W emulsion supplemented with the extracts of Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L. was prepared in the study, its active compounds were determined by HPLC and its safety was evaluated in vitro by the means of reconstituted human skin model EpiDerm™ for the assessment of its irritation, phototoxicity and early skin inflammation effects and by the 48 h human skin patch test for its skin irritation and allergenic potential. The microbiological challenge test of W/O… Show more
“…The dose-dependent response of prepared (nano)materials is proved by MTT assay with utilized the (nano)materials at varying concentrations namely 0.1, 0.5, 1, 5, 10, 50 µg/mL; Fig. 8 C,F depicts the IC-50 values 73 , 89 , 106 , 107 . Figure 8 The average results of MTT assay after 24 h ( A ) and 48 h ( D ) of treatment on HEK-293 cell line.…”
Nanotechnology is one of the most impressive sciences in the twenty-first century. Not surprisingly, nanoparticles/nanomaterials have been widely deployed given their multifunctional attributes and ease of preparation via environmentally friendly, cost-effective, and simple methods. Although there are assorted optimized preparative methods for synthesizing the nanoparticles, the main challenge is to find a comprehensive method that has multifaceted properties. The goal of this study has been to synthesize aminated (nano)particles via the Rosmarinus officinalis leaf extract-mediated copper oxide; this modification leads to the preparation of (nano)particles with promising biological and photocatalytic applications. The synthesized NPs have been fully characterized, and biological activity was evaluated in antibacterial assessment against Bacillus cereus as a model Gram-positive and Pseudomonas aeruginosa as a model Gram-negative bacterium. The bio-synthesized copper oxide (nano)particles were screened by MTT assay by applying the HEK-293 cell line. The aminated (nano)particles have shown lower cytotoxicity (~ 21%), higher (~ 50%) antibacterial activity, and a considerable increase in zeta potential value (~ + 13.4 mV). The prepared (nano)particles also revealed considerable photocatalytic activity compared to other studies wherein the dye degradation process attained 97.4% promising efficiency in only 80 min and just 7% degradation after 80 min under dark conditions. The biosynthesized copper oxide (CuO) (nano)particle’s biomedical investigation underscores an eco-friendly synthesis of (nano)particles, their noticeable stability in the green reaction media, and impressive biological activity.
“…The dose-dependent response of prepared (nano)materials is proved by MTT assay with utilized the (nano)materials at varying concentrations namely 0.1, 0.5, 1, 5, 10, 50 µg/mL; Fig. 8 C,F depicts the IC-50 values 73 , 89 , 106 , 107 . Figure 8 The average results of MTT assay after 24 h ( A ) and 48 h ( D ) of treatment on HEK-293 cell line.…”
Nanotechnology is one of the most impressive sciences in the twenty-first century. Not surprisingly, nanoparticles/nanomaterials have been widely deployed given their multifunctional attributes and ease of preparation via environmentally friendly, cost-effective, and simple methods. Although there are assorted optimized preparative methods for synthesizing the nanoparticles, the main challenge is to find a comprehensive method that has multifaceted properties. The goal of this study has been to synthesize aminated (nano)particles via the Rosmarinus officinalis leaf extract-mediated copper oxide; this modification leads to the preparation of (nano)particles with promising biological and photocatalytic applications. The synthesized NPs have been fully characterized, and biological activity was evaluated in antibacterial assessment against Bacillus cereus as a model Gram-positive and Pseudomonas aeruginosa as a model Gram-negative bacterium. The bio-synthesized copper oxide (nano)particles were screened by MTT assay by applying the HEK-293 cell line. The aminated (nano)particles have shown lower cytotoxicity (~ 21%), higher (~ 50%) antibacterial activity, and a considerable increase in zeta potential value (~ + 13.4 mV). The prepared (nano)particles also revealed considerable photocatalytic activity compared to other studies wherein the dye degradation process attained 97.4% promising efficiency in only 80 min and just 7% degradation after 80 min under dark conditions. The biosynthesized copper oxide (CuO) (nano)particle’s biomedical investigation underscores an eco-friendly synthesis of (nano)particles, their noticeable stability in the green reaction media, and impressive biological activity.
“…The main advantage of the in vitro reconstructed skin equivalents is that they can be generated from human cells, and therefore, they are relevant, have good predictive potency and a low variability. The use of full-thickness three-dimensional (3D) skin models and humanreconstructed epidermis (HRE) is widespread in irritation, penetration and toxicological studies [1][2][3][4][5]. However, the structural mapping of these tissues and, in parallel, their functionality has not been analysed in detail yet.…”
Several ex vivo and in vitro skin models are available in the toolbox of dermatological and cosmetic research. Some of them are widely used in drug penetration testing. The excised skins show higher variability, while the in vitro skins provide more reproducible data. The aim of the current study was to compare the chemical composition of different skin models (excised rat skin, excised human skin and human-reconstructed epidermis) by measurement of ceramides, cholesterol, lactate, urea, protein and water at different depths of the tissues. The second goal was to compile a testing system, which includes a skin-on-a-chip diffusion setup and a confocal Raman spectroscopy for testing drug diffusion across the skin barrier and accumulation in the tissue models. A hydrophilic drug caffeine and the P-glycoprotein substrate quinidine were used in the study as topical cream formulations. The results indicate that although the transdermal diffusion of quinidine is lower, the skin accumulation was comparable for the two drugs. The various skin models showed different chemical compositions. The human skin was abundant in ceramides and cholesterol, while the reconstructed skin contained less water and more urea and protein. Based on these results, it can be concluded that skin-on-a-chip and confocal Raman microspectroscopy are suitable for testing drug penetration and distribution at different skin layers within an exposition window. Furthermore, obese human skin should be treated with caution for skin absorption testing due to its unbalanced composition.
“…The authors found that the doses of the compounds tested (up to 1000 µM) did not induce phototoxicity in the human cell line. Other photo-safety assessments of natural extracts are summarised in Table 2 [83,84]. According to Maddaleno and Vinardell [94], there is a lack of validated in vitro and in silico methods specifically for the assessment of photoallergenicity.…”
Consumer preferences, safety, and sustainability aspects of conventional cosmetic ingredients have contributed to an increase in the demand for natural cosmetic ingredients and products. Naturally derived active cosmetic agents and excipients may come into contact with various naturally occurring and synthetic contaminants throughout the supply chain, and substantiating their safety is essential. This review examines the safety and legislative requirements applicable to natural cosmetic ingredients in the European Union (EU). Cosmetic safety requirements include technical data based on the ingredient profile, presence of hazards and the risks associated with the intended conditions of use. The hazard analysis includes screening for microbial contaminants such as aerobic mesophilic bacteria, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans; chemical contaminants such as lead, cadmium, arsenic, and mercury; and naturally occurring toxins, such as allergens. The toxicological assessment considers both local effects (such as skin sensitisation, eye/skin irritation, and photo-induced effects) and systemic effects (including acute dermal toxicity, sub-acute and sub-chronic toxicity, mutagenicity and carcinogenicity, reproductive toxicity, and toxicokinetics). The EU legislative requirements prohibit the use of animal-based tests for the toxicological evaluation of cosmetic ingredients, paving the way for alternatives termed as New Approach Methodologies (NAMs). The validation of NAMs is critical for their wider usage, and despite advancements, few have been validated, particularly for systemic toxicity testing. The use of NAMs in evaluating the safety of complex natural cosmetic ingredients is further examined.
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