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Ocena varnosti izvlečka navadne melise (Melissa officinalis) kot kozmetične sestavine z uporabo pristopa s pragom toksikološkega tveganja
ID Ciraj, Vita Marta (Author), ID Jakopin, Žiga (Mentor) More about this mentor... This link opens in a new window

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Abstract
Navadna melisa (Melissa officinalis) se že več kot 2000 let uporablja kot začimbna aromatična sestavina v prehrani, pa tudi kot zdravilna rastlina v tradicionalni medicini, saj ima številne ugodne učinke na počutje in zdravje. V kozmetiki se uporablja v obliki izvlečka, in sicer kot naravna sestavina z antioksidativnim, protivnetnim, protibakterijskim in regenerativnim delovanjem. Najpogosteje jo najdemo v kremah, losjonih in tonikih. V diplomski nalogi smo ocenili varnost izvlečka navadne melise kot kozmetične sestavine, z uporabo pristopa s pragom toksikološkega tveganja (TTC), ki temelji na razvrščanju spojin v Cramerjeve razrede toksičnosti, na osnovi njihove kemijske strukture. S pomočjo literature smo analizirali kvalitativno in kvantitativno sestavo izvlečka ter s programom ChemOffice izračunali izbrane fizikalno-kemijske parametre posameznih spojin, prisotnih v njem. S pomočjo teh ter znane koncentracije spojine v izvlečku smo nato izračunali potencialni obseg absorpcije. Na podlagi te vrednosti smo lahko izračunali sistemsko izpostavljenost posameznim spojinam. Ugotovili smo, da vrednosti odmerkov sistemske izpostavljenosti spojini (SED) ne presegajo tistih, ki so določene za Cramerjeve razrede toksičnosti. Spojinam, katerih koncentracij v izvlečku v literaturi nismo našli, smo, na osnovi vrednosti TTC Cramerjevega razreda, v katerega so bile uvrščene, ter potencialnega obsega absorpcije, izračunali maksimalno dopustno sistemsko izpostavljenost. V literaturi smo na koncu za nekaj spojin našli še vrednosti njihovih najvišjih odmerkov, pri katerih ne pride do pojava neželenih učinkov (NOAEL), na podlagi katerih smo potem izračunali sprejemljive dnevne odmerke spojin (ADI). Vse izračunane vrednosti ADI so bile veliko višje od tistih, ki smo jih pridobili s pristopom TTC. Na podlagi vseh izračunov smo zaključili, da snovi v izvlečku navadne melise, vsaj glede na predvidljive načine uporabe, ne predstavljajo tveganja za uporabnika, če se v kozmetičnem izdelku (KI) nahajajo v koncentraciji do 0,1%. Izvleček navadne melise je kot kozmetična sestavina torej varen za uporabo.

Language:Slovenian
Keywords:izvleček navadne melise, Cramerjevi razredi toksičnosti, obseg absorpcije, sistemska izpostavljenost, pristop TTC, dnevni varni odmerek, ocena varnosti
Work type:Bachelor thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2023
PID:20.500.12556/RUL-149614 This link opens in a new window
Publication date in RUL:08.09.2023
Views:407
Downloads:82
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Secondary language

Language:English
Title:Safety assessment of lemon balm (Melissa officinalis) extract as a cosmetic ingredient using the threshold of toxicological concern approach
Abstract:
Lemon balm (Melissa officinalis) has been used for more than 2000 years as a spice aromatic ingredient in food and as a medicinal plant in traditional medicine, as it has many beneficial effects on well-being and health. In cosmetics, it is used in the form of an extract, as a natural ingredient with antioxidant, anti-inflammatory, antibacterial and regenerative effects. It is most commonly found in creams, lotions, and tonics. In the thesis, we evaluated the safety of lemon balm extract as a cosmetic ingredient, using the threshold of toxicological concern (TTC) approach, which is based on the classification of compounds into Cramer's toxicity classes, according to their chemical structures. By a thorough literature review, we analyzed the qualitative and quantitative composition of the extract and then calculated selected physicochemical parameters of individual compounds present in the extract using the ChemOffice software. The generated values coupled with the known concentrations of compounds in the extract enabled the calculation of their potential extent of absorption and, in turn, the systemic exposure to individual compounds. We have found that the calculated values of systemic exposure (SED) do not exceed those determined for Cramer’s toxicity classes. For compounds whose concentrations in the extract were not found in literature, we calculated the maximum permissible systemic exposure based on TTC values of Cramer's class into which they were classified and their estimated potential extent of absorption. Finally, we found the no observed adverse effect level (NOAEL) values for some of the compounds in the literature, based on which we calculated their acceptable daily intakes (ADI), which by far superseeded the values obtained by the TTC approach. Based on all calculations, we concluded that substances in lemon balm extract do not pose a risk to users with predictable methods of use. The lemon balm extract is safe for use as a cosmetic ingredient.

Keywords:lemon balm extract, the Cramer classes, potential absorption, systemic exposure, TTC approach, acceptable daily intake, safety assessment

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