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Toxics
Special Issues
Skin Sensitization Testing Using New Approach Methodologies
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Skin Sensitization Testing Using New Approach Methodologies

A special issue of Toxics (ISSN 2305-6304). This special issue belongs to the section "Novel Methods in Toxicology Research".

Deadline for manuscript submissions: 19 July 2024 | Viewed by 968

Special Issue Editor

Dr. Judy Strickland

E-Mail Website
Guest Editor
Inotiv, Inc., P.O. Box 13501, Research Triangle Park, NC 27709, USA
Interests: contact dermatitis; validation; method development; toxicity tests; prediction; cytotoxicity assays; toxicology; validation studies toxicity

Special Issue Information

Dear Colleagues,

At present,  the skin sensitization testing of chemical substances and products on the market can be conducted without animal testing. Integrating the results of individual test methods using defined approaches makes it possible to derive regulatory classifications for skin sensitization hazard or potency. Defined approaches that can be used for risk assessments to determine safe levels of sensitizers that are expected to be approved for regulatory use in the near future. This special edition seeks contributions that explore the application of new approach methodologies to overcome the regulatory challenges of assessing skin sensitization. These new approach methodologies include in chemico, in vitro, in silico, and other non-animal approaches and strategies that combine the outcomes of such methods. Interesting topics include, but are not limited to, the testing of mixtures (chemical products or medical device extracts, for example) for skin sensitization hazard or potency classification, test method development, and the evaluation of new methods, such as those to predict T cell proliferation, the development and use of appropriate reference data for evaluations, and the development of new defined approaches.

Dr. Judy Strickland
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Toxics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • skin sensitization
  • alternatives to animal testing
  • regulatory testing
  • reference data
  • defined approaches
  • chemical allergy
  • new approach methodologies
  • adverse outcome pathway

Published Papers (1 paper)

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Research

17 pages, 6154 KiB  
Article
A Human Skin Explant Test as a Novel In Vitro Assay for the Detection of Skin Sensitization to Aggregated Monoclonal Antibodies
by Ana Martins-Ribeiro, Arathi Kizhedath, Shaheda Sameena Ahmed, Jarka Glassey, Abbas Ishaq, Matthew Freer and Anne Mary Dickinson
Toxics 2024, 12(5), 332; https://doi.org/10.3390/toxics12050332 - 30 Apr 2024
Viewed by 486
Abstract
Introduction: Monoclonal antibodies (mAbs) are important therapeutics. However, the enhanced potential for aggregation has become a critical quality parameter during the production of mAbs. Furthermore, mAb aggregation may also present a potential health risk in a clinical setting during the administration of mAb [...] Read more.
Introduction: Monoclonal antibodies (mAbs) are important therapeutics. However, the enhanced potential for aggregation has become a critical quality parameter during the production of mAbs. Furthermore, mAb aggregation may also present a potential health risk in a clinical setting during the administration of mAb therapeutics to patients. While the extent of immunotoxicity in patient populations is uncertain, reports show it can lead to immune responses via cell activation and cytokine release. In this study, an autologous in vitro skin test designed to predict adverse immune events, including skin sensitization, was used as a novel assay for the assessment of immunotoxicity caused by mAb aggregation. Material and Methods: Aggregation of mAbs was induced by a heat stress protocol, followed by characterization of protein content by analytical ultra-centrifugation and transmission electron microscopy, revealing a 4% aggregation level of total protein content. Immunotoxicity and potential skin sensitization caused by the aggregates, were then tested in a skin explant assay. Results: Aggregated Herceptin and Rituximab caused skin sensitization, as shown by histopathological damage (grade II–III positive response) together with positive staining for Heat Shock Protein 70 (HSP70). Changes in T cell proliferation were not observed. Cytokine analysis revealed a significant increase of IL-10 for the most extreme condition of aggregation (65 °C at pH3) and a trend for an overall increase of IFN-γ, especially in response to Rituximab. Conclusions: The skin explant assay demonstrated that aggregated mAbs showed adverse immune reactions, as demonstrated as skin sensitization, with histopathological grades II-III. The assay may, therefore, be a novel tool for assessing immunotoxicity and skin sensitization caused by mAb aggregation. Full article
(This article belongs to the Special Issue Skin Sensitization Testing Using New Approach Methodologies)
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