کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5856397 | 1562127 | 2016 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Linking existing in vitro dermal absorption data to physicochemical properties: Contribution to the design of a weight-of-evidence approach for the safety evaluation of cosmetic ingredients with low dermal bioavailability
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کلمات کلیدی
MOSsystemic exposure doseNO(A)ELSMILEStPSASCCsTTCCDKKNIMEThreshold of toxicological concern - آستانه نگرانی سمیSafety evaluation - ارزیابی ایمنیRisk assessment - ارزیابی ریسکDermal absorption - جذب پوستیMargin of safety - حاشیه ایمنیPhysicochemical properties - خواص فیزیکی و شیمیاییIn silico prediction - در پیش بینی سیلیکاWorld Health Organisation - سازمان بهداشت جهانیTopological polar surface area - سطح زمین قطبی توپولوژیکBioavailability - فراهم زیستیCosmetic ingredient - ماده آرایشیMolecular Operating Environment - محیط عملیاتی مولکولیModelling - مدل سازیMelting point - نقطه ذوبsed - وlog P - ورودی PMOE - وزارت صنایعMolecular weight - وزن مولکولیScientific Committee on Consumer Safety - کمیته علمی ایمنی مصرف کنندهWHO - که
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
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چکیده انگلیسی
To characterize the risk of cosmetic ingredients when threshold toxicity is assumed, often the “margin of safety” (MoS) is calculated. This uncertainty factor is based on the systemic no observable (adverse) effect level (NO(A)EL) which can be derived from in vivo repeated dose toxicity studies. As in vivo studies for the purpose of the cosmetic legislation are no longer allowed in Europe and a validated in vitro alternative is not yet available, it is no longer possible to derive a NO(A)EL value for a new cosmetic ingredient. Alternatively, cosmetic ingredients with a low dermal bioavailability might not need repeated dose data, as internal exposure will be minimal and systemic toxicity might not be an issue. This study shows the possibility of identifying compounds suspected to have a low dermal bioavailability based on their physicochemical properties (molecular weight, melting point, topological polar surface area and log P) and their in vitro dermal absorption data. Although performed on a limited number of compounds, the study suggests a strategic opportunity to support the safety assessor's reasoning to omit a MoS calculation and to focus more on local toxicity and mutagenicity/genotoxicity for ingredients for which limited systemic exposure is to be expected.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 76, April 2016, Pages 74-78
Journal: Regulatory Toxicology and Pharmacology - Volume 76, April 2016, Pages 74-78
نویسندگان
Gamze Ates, Fabian P. Steinmetz, Tatyana Yordanova Doktorova, Judith C. Madden, Vera Rogiers,