Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts

被引：34

作者：

De Jong, Wim H. ^{[1
]}

Hoffmann, Sebastian ^{[2
]}

Lee, Michelle ^{[3
]}

Kandarova, Helena ^{[4
]}

Pellevoisin, Christian ^{[5
]}

Haishima, Yuji ^{[6
]}

Rollins, Beau ^{[7
,23
]}

Zdawczyk, Austin ^{[8
]}

Willoughby, Jamin ^{[9
,24
]}

Bachelor, Michael ^{[10
]}

Schatz, Timothy ^{[11
]}

Skoog, Shelby ^{[12
]}

Parker, Sherry ^{[13
]}

Sawyer, Anita ^{[14
]}

Pescio, Paolo ^{[15
]}

Fant, Kristina ^{[16
]}

Kim, Kwang-Mahn ^{[17
]}

Kwon, Jae Sung ^{[17
]}

Gehrke, Helge ^{[18
]}

Hofman-Huether, Hana ^{[18
]}

Meloni, Marisa ^{[19
]}

Julius, Conrad ^{[20
]}

Briotet, Damien ^{[21
]}

Letasiova, Silvia ^{[4
]}

Kato, Reiko ^{[6
]}

Miyajima, Atsuko ^{[6
]}

De La Fonteynea, Liset J. J. ^{[1
]}

Videau, Christelle ^{[5
]}

Tornier, Carine ^{[5
]}

Turley, Audrey P. ^{[3
]}

Christiano, Nicholas ^{[7
]}

Rollins, Thor S. ^{[3
]}

Coleman, Kelly P. ^{[22
]}

机构：

[1] Natl Inst Publ Hlth & Environm RIVM, Bilthoven, Netherlands

[2] Seh Consulting Serv, Paderborn, Germany

[3] Nelson Labs Inc, Salt Lake City, UT USA

[4] MatTek Vitro Life Sci Labs, Bratislava, Slovakia

[5] EPISKIN, Lyon, France

[6] NIHS, Div Med Devices, Tokyo, Japan

[7] Arthreac Inc, Naples, FL USA

[8] NAMSA, Northwood, OH USA

[9] Cyprotex US LCC, Kalamazoo, MI USA

[10] MatTek Corp, Ashland, MA USA

[11] Amer Preclin Serv LLC, Minneapolis, MN USA

[12] Ctr Devices & Radiol Hlth, US Food & Drug Adm, Silver Spring, MD USA

[13] WuXi AppTec, St Paul, MN USA

[14] Becton Dickinson, Res Triangle Pk, NC USA

[15] Eurofins Biolab Srl, Milan, Italy

[16] SP Tech Res Inst Sweden, Boras, Sweden

[17] Yonsei Univ, Coll Dent, Seoul, South Korea

[18] Eurofms Biopharrna, Munich, Germany

[19] VitroScreen, Milan, Italy

[20] Envigo CRS GmbH, Rossdorf, Germany

[21] NAMSA, Chasse Sur Rhone, France

[22] Medtron plc, Minneapolis, MN USA

[23] Quality Tech Serv Inc, Bloomington, MN USA

[24] IonTox LCC, Kalamazoo, MI USA

来源：

TOXICOLOGY IN VITRO | 2018年 / 50卷

关键词：

Medical devices; Irritation; Alternative testing; In vitro; Reconstructed human epidermis; TOXICITY; ASSAYS;

D O I：

10.1016/j.tiv.2018.01.001

中图分类号：

R99 [毒物学（毒理学）];

学科分类号：

100405 ;

摘要：

Assessment of skin irritation is an essential component of the safety evaluation of medical devices. OECD Test Guideline 439 describes the use of reconstructed human epidermis (RhE) as an in vitro test system for classification of skin irritation by neat chemicals. An international round robin study was conducted to evaluate the RISE method for determination of skin irritant potential of medical device extracts. Four irritant polymers and three non-irritant controls were obtained or developed that had demonstrated their suitability to act as positive or negative test samples. The RhE tissues (EpiDerm (TM) and SkinEthic (TM) RHE) were dosed with 100 mu L. aliquots of either saline or sesame oil extract. Incubation times were 18 h (EpiDerm (TM)) and 24 h (SkinEthic (TM) RHE). Cell viability reduction > 50% was indicative of skin irritation. Both the EpiDerm (TM) and SkinEthic (TM) RITE tissues were able to correctly identify virtually all of the irritant polymer samples either in the saline, sesame oil or both solvent extracts. Our results indicate that RhE tissue models can detect the presence of strong skin irritants at low levels in dilute medical device polymer extracts. Therefore, these models may be suitable replacements for the rabbit skin irritation test to support the biological evaluation of medical devices.

引用

页码：439 / 449

页数：11

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