کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8554000 | 1562695 | 2018 | 24 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol
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کلمات کلیدی
Non-irritantMDSSDSDPBSSOPRHEMTT - MTTv/v - V / Vw/v - W / VLactic acid - اسید لاکتیکHeptanoic acid - اسید هپتانReconstructed human epidermis - اپی ادیس انسانی بازسازی شدهISO - ایزوMedical devices - تجهیزات پزشکیSkin irritation - تحریک پوستIrritant - تحریک کنندهvolume/volume - حجم / حجمstandard operating procedure - روش های عملیاتی استانداردInternational Organization for Standardization - سازمان بین المللی استاندارد سازیsodium dodecyl sulfate - سدیم دودسیل سولفاتDulbecco's phosphate buffered saline - فسفات باسیل نمک Dulbeccoweight/volume - وزن / حجمoptical density - چگالی نوریVehicle control - کنترل خودروPositive control - کنترل مثبتnegative control - کنترل منفی
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol](/preview/png/8554000.png)
چکیده انگلیسی
Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, and in vivo data. The irritants were lactic acid (LA), heptanoic acid (HA), sodium dodecyl sulfate (SDS), Genapol® X-80 (GP), and Y-4 polymer. Dilute saline and sesame seed oil (SSO) solutions of each were evaluated using a 4 and 18â¯h HPT and the EpiDerm⢠SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4â¯h HPT were negative in most cases except for GP and SDS, while the 18â¯h HPT also identified some LA, HA, and GP samples as irritants. EpiDerm⢠SIT-MD correctly identified all irritants except GP in SSO due to limited solubility. Data from cutaneous rabbit irritation tests were negative, while all intracutaneous results were strongly or weakly positive except for the most dilute GP solutions. These findings indicate that EpiDerm⢠SIT-MD results correlate with those from the rabbit intracutaneous test and confirm that RhE assays are suitable replacements for animals in evaluating the tissue irritation potential of medical devices.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Toxicology in Vitro - Volume 50, August 2018, Pages 433-438
Journal: Toxicology in Vitro - Volume 50, August 2018, Pages 433-438
نویسندگان
Helena Kandárová, Hana Bendova, Silvia Letasiova, Kelly P. Coleman, Wim H. De Jong, Dagmar JÃrova,