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

Wim H. De Jong, Sebastian Hoffmann, Michelle Lee, Helena Kandárová, Christian Pellevoisin, Yuji Haishima, Beau Rollins, Austin Zdawczyk, Jamin Willoughby, Michael Bachelor, Timothy Schatz, Shelby Skoog, Sherry Parker, Anita Sawyer, Paolo Pescio, Kristina Fant, Kwangmahn Kim, Jae Sung Kwon, Helge Gehrke, Hana Hofman-HütherMarisa Meloni, Conrad Julius, Damien Briotet, Silvia Letasiova, Reiko Kato, Atsuko Miyajima, Liset J.J. De La Fonteyne, Christelle Videau, Carine Tornier, Audrey P. Turley, Nicholas Christiano, Thor S. Rollins, Kelly P. Coleman

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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 RhE 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™ and SkinEthic™ RHE) were dosed with 100 μL aliquots of either saline or sesame oil extract. Incubation times were 18 h (EpiDerm™) and 24 h (SkinEthic™ RHE). Cell viability reduction > 50% was indicative of skin irritation. Both the EpiDerm™ and SkinEthic™ RHE 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.

Original languageEnglish
Pages (from-to)439-449
Number of pages11
JournalToxicology in Vitro
Volume50
DOIs
Publication statusPublished - 2018 Aug 1

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Songbirds
Irritants
Skin Tests
Epidermis
Skin
Equipment and Supplies
Sesame Oil
Polymers
Tissue
Equipment Safety
Cell Survival
In Vitro Techniques
Guidelines
Rabbits
Cells

All Science Journal Classification (ASJC) codes

  • Toxicology

Cite this

De Jong, Wim H. ; Hoffmann, Sebastian ; Lee, Michelle ; Kandárová, Helena ; Pellevoisin, Christian ; Haishima, Yuji ; Rollins, Beau ; Zdawczyk, Austin ; Willoughby, Jamin ; Bachelor, Michael ; Schatz, Timothy ; Skoog, Shelby ; Parker, Sherry ; Sawyer, Anita ; Pescio, Paolo ; Fant, Kristina ; Kim, Kwangmahn ; Kwon, Jae Sung ; Gehrke, Helge ; Hofman-Hüther, Hana ; Meloni, Marisa ; Julius, Conrad ; Briotet, Damien ; Letasiova, Silvia ; Kato, Reiko ; Miyajima, Atsuko ; De La Fonteyne, Liset J.J. ; Videau, Christelle ; Tornier, Carine ; Turley, Audrey P. ; Christiano, Nicholas ; Rollins, Thor S. ; Coleman, Kelly P. / 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. In: Toxicology in Vitro. 2018 ; Vol. 50. pp. 439-449.
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abstract = "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 RhE 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™ and SkinEthic™ RHE) were dosed with 100 μL aliquots of either saline or sesame oil extract. Incubation times were 18 h (EpiDerm™) and 24 h (SkinEthic™ RHE). Cell viability reduction > 50{\%} was indicative of skin irritation. Both the EpiDerm™ and SkinEthic™ RHE 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.",
author = "{De Jong}, {Wim H.} and Sebastian Hoffmann and Michelle Lee and Helena Kand{\'a}rov{\'a} and Christian Pellevoisin and Yuji Haishima and Beau Rollins and Austin Zdawczyk and Jamin Willoughby and Michael Bachelor and Timothy Schatz and Shelby Skoog and Sherry Parker and Anita Sawyer and Paolo Pescio and Kristina Fant and Kwangmahn Kim and Kwon, {Jae Sung} and Helge Gehrke and Hana Hofman-H{\"u}ther and Marisa Meloni and Conrad Julius and Damien Briotet and Silvia Letasiova and Reiko Kato and Atsuko Miyajima and {De La Fonteyne}, {Liset J.J.} and Christelle Videau and Carine Tornier and Turley, {Audrey P.} and Nicholas Christiano and Rollins, {Thor S.} and Coleman, {Kelly P.}",
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De Jong, WH, Hoffmann, S, Lee, M, Kandárová, H, Pellevoisin, C, Haishima, Y, Rollins, B, Zdawczyk, A, Willoughby, J, Bachelor, M, Schatz, T, Skoog, S, Parker, S, Sawyer, A, Pescio, P, Fant, K, Kim, K, Kwon, JS, Gehrke, H, Hofman-Hüther, H, Meloni, M, Julius, C, Briotet, D, Letasiova, S, Kato, R, Miyajima, A, De La Fonteyne, LJJ, Videau, C, Tornier, C, Turley, AP, Christiano, N, Rollins, TS & Coleman, KP 2018, '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', Toxicology in Vitro, vol. 50, pp. 439-449. https://doi.org/10.1016/j.tiv.2018.01.001

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. / De Jong, Wim H.; Hoffmann, Sebastian; Lee, Michelle; Kandárová, Helena; Pellevoisin, Christian; Haishima, Yuji; Rollins, Beau; Zdawczyk, Austin; Willoughby, Jamin; Bachelor, Michael; Schatz, Timothy; Skoog, Shelby; Parker, Sherry; Sawyer, Anita; Pescio, Paolo; Fant, Kristina; Kim, Kwangmahn; Kwon, Jae Sung; Gehrke, Helge; Hofman-Hüther, Hana; Meloni, Marisa; Julius, Conrad; Briotet, Damien; Letasiova, Silvia; Kato, Reiko; Miyajima, Atsuko; De La Fonteyne, Liset J.J.; Videau, Christelle; Tornier, Carine; Turley, Audrey P.; Christiano, Nicholas; Rollins, Thor S.; Coleman, Kelly P.

In: Toxicology in Vitro, Vol. 50, 01.08.2018, p. 439-449.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - De Jong, Wim H.

AU - Hoffmann, Sebastian

AU - Lee, Michelle

AU - Kandárová, Helena

AU - Pellevoisin, Christian

AU - Haishima, Yuji

AU - Rollins, Beau

AU - Zdawczyk, Austin

AU - Willoughby, Jamin

AU - Bachelor, Michael

AU - Schatz, Timothy

AU - Skoog, Shelby

AU - Parker, Sherry

AU - Sawyer, Anita

AU - Pescio, Paolo

AU - Fant, Kristina

AU - Kim, Kwangmahn

AU - Kwon, Jae Sung

AU - Gehrke, Helge

AU - Hofman-Hüther, Hana

AU - Meloni, Marisa

AU - Julius, Conrad

AU - Briotet, Damien

AU - Letasiova, Silvia

AU - Kato, Reiko

AU - Miyajima, Atsuko

AU - De La Fonteyne, Liset J.J.

AU - Videau, Christelle

AU - Tornier, Carine

AU - Turley, Audrey P.

AU - Christiano, Nicholas

AU - Rollins, Thor S.

AU - Coleman, Kelly P.

PY - 2018/8/1

Y1 - 2018/8/1

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