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Ocena varnosti izvlečka prave kamilice (Chamomilla recutita) kot kozmetične sestavine z uporabo pristopa s pragom toksikološkega tveganja
ID Hostnik, Manica (Author), ID Jakopin, Žiga (Mentor) More about this mentor... This link opens in a new window

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Abstract
Rastlinski izvlečki ali posamezne izolirane spojine so zaradi številnih ugodnih učinkov na kožo, sluznice, lase in nohte pogoste sestavine v formulacijah kozmetičnih izdelkov. Izvleček prave kamilice (Matricaria chamomilla L.) ima pester in širok nabor spojin. Uporablja se zaradi protivnetnega, regenerativnega, toničnega in antioksidativnega delovanja. Preden uporabimo rastlinski izvleček v kozmetičnem izdelku, moramo ovrednotiti njegovo varnost, saj je sestava raznolika in lahko je celo strupena za človeka. V diplomski nalogi smo proučili kvalitativno in kvantitativno sestavo izvlečka cvetov kamilice, ki se nahaja v proučevanem kozmetičnem izdelku v znani koncentraciji. Naredili smo oceno varnosti s pomočjo uporabe pristopa s pragom toksikološkega tveganja (TTC), ki določa potencialno toksičnost na podlagi razvrščanja spojin v Cramerjeve razrede toksičnosti z določenimi vrednostmi varne izpostavljenosti spojini. Iz literature smo najprej pridobili strukturne formule in koncentracije sestavin v izvlečku, nato smo jim s pomočjo računalniškega programa ChemOffice napovedali izbrane fizikalno-kemijske lastnosti (logP in logS), da smo ocenili obseg potencialne absorpcije in sistemsko izpostavljenost. Spojinam z neznano koncentracijo v izvlečku smo določili maksimalno koncentracijo, ki je še dopustna. Obseg potencialne absorpcije je bil pri večjem delu sestavin majhen. Prav tako pri večini njihova sistemska izpostavljenost pri uporabi izdelka ni bila visoka, saj so v izvlečku prisotne v nizkih koncentracijah. Vrednosti so bile manjše tudi od dopustnih vrednosti Cramerjevih razredov, v katere smo posamične spojine razvrstili s programom Toxtree. Nekaterim izbranim spojinam smo izračunali dnevno varno izpostavljenost in jo primerjali z vrednostmi TTC-razredov toksičnosti. Vrednosti TTC, ki so pripisane določenim Cramerjevim razredom, so bile precej nižje od dnevne varne izpostavljenosti. Ugotovili smo maksimalno dopustno koncentracijo vseh spojin v izvlečku prave kamilice, če je slednji prisoten v kozmetičnem izdelku v koncentraciji 0,1 %. Po natančnem pregledu vseh izračunov in primerjav smo ocenili izvleček cvetov prave kamilice kot kozmetično sestavino, ki je varna za uporabo. Pri oceni varnosti pa moramo vseeno biti pozorni tudi na preostale sestavine v izdelku, količino in mesto uporabe ter čas in pogostost izpostavitve.

Language:Slovenian
Keywords:dnevni varni odmerek, izvleček cvetov prave kamilice, ocena varnosti, potencialna absorpcija skozi kožo, sistemska izpostavljenost, TTC pristop
Work type:Bachelor thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2022
PID:20.500.12556/RUL-139949 This link opens in a new window
Publication date in RUL:09.09.2022
Views:1042
Downloads:140
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Secondary language

Language:English
Title:Safety assessment of chamomille (Chamomilla recutita) extract as a cosmetic ingredient using the threshold of toxicological concern approach
Abstract:
Plant extracts or their isolated compounds are common ingredients in cosmetic product formulations due to their numerous beneficial effects on the skin, mucosa, hair and nails. The chamomile extract (Matricaria chamomilla L.) has a diverse chemical composition. It is used in cosmetic products beacuse of its anti-inflammatory, regenerating, tonic and antioxidant effects on the skin. Before using a plant extract, we must evaluate its safety, since the composition of the extract is complex and can even be toxic. In the scope of our thesis, we assessed the qualitative and quantitative composition of chamomile flower extract, which is found in the examined cosmetic product under study at as specific concentration. We assessed its safety using the threshold of toxicological concern (TTC) approach, which defines potential toxcity of the chemical, based on the categorization of compounds into Cramer´s toxicity classes with defined TTC values of safe exposure to the chemical. From the literature we obtained structural formulas and concentration of individual ingredients present in the extract. Using an in silico tool ChemOffice, we next determined their physicochemical properties (logP and logS), -which we later used for determination of the potential absorption and the systemic exposure. We also determined the maximal permitted concentration for compounds with unknown concentration in the extract. The potential for compound absorbtion was low for most compounds. Likewise, the systemic exposure was minimal, because the examined individual components of the extract are present in low concentrations. All values were below the TTC values of respective Cramer's classes, to which all compounds were classified using the Toxtree software. We calculated the safe daily exposure for certain selected ingredients, which allowed us to compare the values obtained with the TTC approach. The safe daily exposure of some chemicals was much higher when compared to the TTC values. We determined the maximum allowed concentrations for all the chemicals in the chamomile extract, if the latter is present in a cosmetic product iat 0,1 % concentration. After careful review of all calculations and comparisons, we assessed the extract of the flower of chamomile as an ingredient, which is safe to use in cosmetic products. However, when generating a safety assessment, we also have to take into account other ingredients of the cosmetic produc, the amount used, the site of application as well as the exposure time and frequency of application.

Keywords:chamomile flower extract, daily safe dose, dermal absorption, safety assessment, systemic exposure, TTC approach

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