Ocena varnosti izvlečka arnike (Arnica montana) kot kozmetične sestavine z uporabo pristopa s pragom toksikološkega tveganja

Bokal, Larisa (author), Jakopin, Žiga (mentor)

Rastline in njihove izvlečke zaradi številnih pozitivnih učinkov pogosto uporabljamo v vsakdanjem življenju, kot tudi v farmacevtski in kozmetični industriji. Izvleček arnike lahko uporabimo za razna bolezenska stanja, primeren je predvsem za celjenje ran, podplutb in oteklin, pod določenimi omejitvami pa je varna tudi peroralna uporaba izvlečka arnike. V kozmetiki izvleček arnike uporabljamo za obnavljanje in vlaženje kože, pogosto ga zasledimo v dekorativni kozmetiki. Pomembno vlogo pri uporabi kozmetičnih sestavin ima njihova varnost. Pri rastlinah in njihovih izvlečkih moramo biti še posebej previdni, saj so pogosto strupeni. V diplomski nalogi smo ocenili varnost izvlečka arnike kot kozmetične sestavine z uporabo pristopa s pragom toksikološkega tveganja (TTC), ki določa toksični potencial spojine. S pomočjo literature smo preučili kvalitativno in kvantitativno sestavo arnike in njenega izvlečka. Posamične komponente smo s programom Toxtree® razvrstili v Cramer-jeve razrede toksičnosti, katerim so pripisane specifične vrednosti TTC. S pomočjo struktur spojin in njihovih napovedanih fizikalno-kemijskih lastnosti smo izračunali permeabilnostne koeficiente in korigirane topnosti spojin, ki so omogočili oceno obsega absorpcije in s tem sistemske izpostavljenosti spojinam. Spojinam v izvlečku, ki imajo znano koncentracijo smo izpostavljenost izračunali s pomočjo enačbe, za spojine z neznano koncentracijo pa smo uporabili vrednosti TTC na osnovi njihove klasifikacije v Cramer-jeve razrede. Pri izračunih smo upoštevali nanos 18 gramov kozmetičnega izdelka z vsebnostjo 0,1 % izvlečka arnike na zdravo kožo. Izračunane vrednosti sistemske izpostavljenosti so bile manjše od ocenjene vrednosti za pripadajoče razrede TTC. Določenim sestavinam izvlečka, za katere smo v literaturi našli najvišje odmerke, pri katerih ne pride do neželenih učinkov, smo določili varno dnevno izpostavljenost. Vrednosti sistemske izpostavljenosti in vrednosti TTC smo primerjali z varno dnevno izpostavljenostjo. Slednja je bila v vseh primerih 100-krat večja od vrednosti TTC in 1000-krat večja od vrednosti potencialne sistemske izpostavljenosti. Izvleček arnike smo na osnovi naših rezultatov in vseh znanih toksikoloških študij označili kot varen za dermalno uporabo. Vseeno moramo biti pri njeni uporabi pazljivi, ker lahko povzroči mnoge neželene učinke.

• Language: Slovenian
• Keywords: arnika, izvleček arnike, sistemska izpostavljenost, dnevni varni odmerek, Cramer-jev razred, dermalna absorpcija
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2021
• PID: 20.500.12556/RUL-129909
• Publication date in RUL: 09.09.2021

Secondary language

• Language: English
• Title: Safety assessment of arnica (Arnica montana) extract as a cosmetic ingredient using the threshold of toxicological concern approach

Abstract

Plants and their extracts are often used due to their numerous beneficial effects in everyday life as well as in the pharmaceutical and cosmetic industries. Arnica extract can be used for various medical conditions, it is especially suitable for healing wounds, bruises and swelling, while oral use of arnica extract is also safe under certain restrictions. In cosmetics, arnica extract is used to regenerate and moisturize the skin, it is often found in decorative cosmetics. Their safety plays an important role in the use of cosmetic ingredients. We have to be especially careful with plants and their extracts, as they are often poisonous. In this thesis, we evaluated the safety of arnica extract as a cosmetic ingredient using the threshold of toxicological concern (TTC) approach, which determines the toxicological potential of the compound. By using the appropriate literature, we investigated the qualitative and quantitative composition of arnica and its extract. The components were classified into Cramer toxicity classes with assigned TTC values using Toxtree software. Using the structures of compounds and their predicted physicochemical properties, the permeability coefficient and the saturated solubility of the compounds were calculated thus allowing for the estimation of their extent of absorption and systemic exposure. Exposure to compounds with known concentration was calculated using the equation, for compounds with unknown concentration, TTC values were used based on their classification into Cramer classes. In our calculations, we took into account the use of 18 grams of cosmetic product with a content of 0.1% arnica extract on healthy skin. The calculated systemic exposure values were lower than the values for the corresponding TTC classes. Safe daily exposure was determined for certain components of the extract for which we found the highest doses at which no side effects occur in the literature. Systemic exposure values and TTC values were compared with safe daily exposure, which was in all cases 100 times higher than the TTC value and 1000 times higher than the potential systemic exposure value. Arnica extract was therefore labeled as a safe ingredient for dermal use, based on our results and all known toxicological studies. However, we still need to be careful when using it because it can cause many side effects.

• Keywords: arnica, extract of Arnica Montana, systemic exposure, daily safe dose, Cramer class, dermal absorption