Ocena varnosti izvlečka navadnega bršljana (Hedera helix) kot kozmetične sestavine z uporabo pristopa s pragom toksikološkega tveganja

Levstek, Manca (author), Jakopin, Žiga (mentor)

Na trgu pogosto najdemo kozmetične izdelke, ki vsebujejo ekstrakte ali izolirane spojine pridobljene iz rastlin. Izvlečki navadnega bršljana se v kozmetiki uporabljajo zaradi svojega protivnetnega, protimikrobnega in blažilnega učinka na kožo. Učinki njegovih aktivnih sestavin pa so seveda odvisni tudi od njihove koncentracije v končnem izdelku. Rastlinski izvlečki imajo kompleksno kemijsko sestavo in se lahko med seboj po količini in vrsti prisotnih spojin razlikujejo, tudi če so pridobljeni iz iste rastline, zato moramo ustrezno določiti njihovo varnost, preden jih uporabimo v formulaciji kozmetičnega izdelka. V diplomskem delu smo se lotili preučevanja kvalitativne in kvantitativne sestave izvlečka listov in plodu navadnega bršljana, ki se v modelnem kozmetičnem izdelku nahajajo v znani koncentraciji, njihovo varnost pa smo določili s pomočjo pristopa praga toksikološkega tveganja (TTC). Ta nam namreč omogoča razvrstitev posameznih spojin v tri Cramer-jeve razrede toksičnosti, s pripisanimi vrednostmi TTC, ki predstavljajo mejo varne izpostavljenosti. S programom ChemOffice smo pridobili informacije o fizikalno-kemijskih lastnosti spojin (logP in logS), in sicer na osnovi njihovih strukturnih formul. Pridobljene podatke smo skupaj z znanimi koncentracijami posameznih spojin v izvlečku uporabili za določitev njihovega potencialnega obsega absorpcije skozi kožo in sistemske izpostavljenosti. Za vse spojine pa podatka o njihovi koncentraciji v izvlečku ni bilo, zato smo tem spojinam določili maksimalno dovoljeno koncentracijo, ki se še lahko nahaja v izvlečku, nekaterim izbranim spojinam pa smo določili tudi varni dnevni odmerek, ki smo ga nato primerjali z mejnimi vrednostmi TTC teh spojin. Izračuni so pokazali, da je pri večini spojin predpostavljen maksimalno 10% obseg absorpcije. Sistemska izpostavljenost spojinam je bila nižja od njihove pripisane vrednosti TTC, z izjemo hederasaponina C, katerega sistemska izpostavljenost je ob 11% koncentraciji v izvlečku večja od varne meje izpostavljenosti. Dnevna varna izpostavljenost za izbrane spojine je bila bistveno višja od primerjane vrednost TTC. Izvleček navadnega bršljana vsebuje tudi spojine, ki so znani alergeni (falkarinol, didehidrofalkarinol in 11,12-dehidrofalkarinol), zato morajo biti ob uporabi kozmetičnih izdelkov, s tem izvlečkom previdni predvsem tisti z že znano preobčutljivostjo na rastline iz družine Araliacea. Varna uporaba kozmetičnega izdelka z vsebnostjo izvlečka navadnega bršljana pa je seveda odvisna tudi od same formulacije izdelka in preostalih komponent, ki so prisotne v njem.

• Language: Slovenian
• Keywords: izvleček listov in plodov navadnega bršljana. ocena varnosti, TTC pristop, dermalna absorpcija, sistemska izpostavljenost
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2021
• PID: 20.500.12556/RUL-133360
• Publication date in RUL: 24.11.2021

Secondary language

• Language: English
• Title: Safety assessment of common ivy (Hedera helix) extract as a cosmetic ingredient using the threshold of toxicological concern approach

Abstract

Numerous cosmetic products that contain plant-based extracts or isolated individual compounds can be found on the market. Extracts of common ivy are used in the cosmetic industry for their anti-flammatory, antimicrobial and soothing effect on the skin. Effects of its active compounds depend on their concentration in the end product. Plant-based extracts have a complex chemical structure and can differ in terms of their quantity and type of contained compounds, even if they are extracted from the same plant. For this reason, we have to determine their safety before using them in a formulation of a cosmetic product. In this thesis, we examined qualitative and quantitative composition of extracts obtained from leaves and fruits of common ivy, which are present in a representative cosmetic product in a known concentration and whose safety was determined by the threshold of toxicological concern (TTC) approach. Based on the TTC values, which represent a threshold of safe exposure, individual compounds can be divided into three Cramer classes of toxicity. By using the ChemOffice program, we obtained information on physical and chemical properties of compounds (logP and logS) based on their structural formulas. In addition to the known concentrations of separate compounds in the extract, the obtained data were used to determine their potential extent of absorption through the skin and systemic exposure. However, data on their concentration in the extract were not available for all compounds, which is why we determined their maximum permissible concentration that the extract still contains, and we also determined a safe daily dose for selected compounds, which was then compared to their TTC values. The calculations showed that maximum 10% extent of absorption is characteristic of most compounds. The systemic exposure of compounds was lower than their attributed TTC value, except for hederasaponin C, whose level of systemic exposure at 11% concentration in the extract was greater than its safe level of exposure. Safe daily exposure of individual compounds was substantially higher than the compared TTC values. The extract of common ivy also contains compounds that are known allergens (falcarinol, didehydrofalcarinol and 11,12-dehydrofalcarinol); those that are hypersensitive to plants from the Araliacea family must therefore be careful when using cosmetic products with this extract. Lastly, safe use of cosmetic products with the extract of common ivy also depends on the product formulation and its other components.

• Keywords: ivy leaf and fruit extract, safety assessment, TTC approach, dermal absorption, systemic exposure