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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. (author)
RIVM National Institute for Public Health and the Environment, The Netherlands
Hoffmann, Sebastian (author)
Seh consulting + services, Germany
Lee, Michelle (author)
Nelson Laboratories Inc., USA
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Kandárová, Helena (author)
MatVitro Life Science Laboratories, Slovakia
Pellevoisin, Christian (author)
EPISKIN, France
Haishima, Yuji (author)
NIHS National Institute of Health Sciences, Japan
Rollins, Beau (author)
Arthrex Inc., USA
Zdawczyk, Austin (author)
NAMSA, USA
Willoughby, Jamin (author)
Cyprotex US LCC, USA
Bachelor, Michael (author)
MatTek Corporation, USA
Schatz, Timothy (author)
American Preclinical Services LLC, USA
Skoog, Shelby (author)
US Food and Drug Administration, USA
Parker, Sherry (author)
WuXi AppTec, USA
Sawyer, Anita (author)
Becton Dickinson, USA
Pescio, Paolo (author)
Eurofins Biolab Srl., Italy
Fant, Kristina (author)
RISE,Kemi och material
Kim, Kwang-Mahn (author)
Yonsei University, South Korea
Kwon, Jae Sung (author)
Yonsei University, South Korea
Gehrke, Helge (author)
Eurofins Biopharma, Germany
Hofman-Hüther, Hana (author)
Eurofins Biopharma, Germany
Meloni, Morisa (author)
VitroScreen, Italy
Julius, Conrad (author)
Envigo CRS GmbH, Germany
Briotet, Damien (author)
NAMSA, France
Letasiova, Silvia (author)
MatTek In Vitro Life Science Laboratories, Slovakia
Kato, Reiko (author)
NIHS National Institute of Health Sciences, Japan
Miyajima, Atsuko (author)
NIHS National Institute of Health Sciences, Japan
De La Fonteyne, Liset J. J. (author)
RIVM National Institute for Public Health and the Environment, The Netherlands
Videau, Christelle (author)
EPISKIN, France
Tornier, Carine (author)
EPISKIN, France
Turley, Audrey P. (author)
Nelson Laboratories Inc., USA
Christiano, Nicholas (author)
Arthrex Inc., USA
Rollins, Thor S. (author)
Nelson Laboratories Inc., USA
Coleman, Kelly P. (author)
Medtronic plc, USA
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 (creator_code:org_t)
Elsevier BV, 2018
2018
English.
In: Toxicology in Vitro. - : Elsevier BV. - 0887-2333 .- 1879-3177. ; 50, s. 439-449
Related links:
https://doi.org/10.1...
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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.

Keyword

Alternative testing
In vitro
Irritation
Medical devices
Reconstructed human epidermis

Publication and Content Type

ref (subject category)
art (subject category)

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