Applicability of New Approach Methodologies (NAMs) to Skin Sensitization: Insights from Industry and Regulatory Perspectives

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

Deadline for manuscript submissions: 31 December 2025 | Viewed by 64

Special Issue Editors


E-Mail Website
Guest Editor
Institute for In Vitro Sciences, Inc., 30 W Watkins Mill Road #100, Gaithersburg, MD 20878, USA
Interests: in vitro testing; new approach methodologies; dermal safety; skin sensitization; mucosal irritation

E-Mail Website
Guest Editor
Institute for In Vitro Sciences, Inc., 30 W Watkins Mill Road #100, Gaithersburg, MD 20878, USA
Interests: skin sensitization; dermal safety; medical devices; in vitro testing; new approach methodologies

Special Issue Information

Dear Colleagues,

Skin sensitization is a key endpoint within the safety assessment framework that needs to be addressed prior to launching finished products for consumer use. In recent years, through converging efforts of the scientific community from academic, industry and regulatory institutions, it became possible to address skin sensitization without the use of animal testing. The complex skin sensitization adverse outcome pathway can be investigated using equally sophisticated testing strategies based on new approach methodologies (NAMs) of various levels of complexity. Depending on the industry branch employing defined approaches based on NAMs to address skin sensitization, the data can be submitted for regulatory purposes or can be used to inform internal decisions.

This Special Issue is focused on how NAMs are practically used in regulatory and non-regulatory applications, addressing skin sensitization as a safety concern. We welcome original papers, review articles, short communications and regulatory position articles detailing the use of modern non-animal approaches for skin sensitization. We also encourage contributions on established and emerging methodologies derived from academic research, as well as perspectives on the current global regulatory landscape concerning the use of NAMs for skin sensitization. This Special Issue is open to receiving reports on chemicals, agrochemicals, medical and consumer devices, botanical extracts, cosmetic and personal care industry, etc., that facilitate a comparative analysis of the use and regulatory acceptance status of NAMs for skin sensitization within multiple industry sectors.

Dr. Gertrude-Emilia Costin
Dr. Argel Islas-Robles
Guest Editors

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Keywords

  • skin sensitization
  • allergic contact dermatitis
  • new approach methodologies
  • regulatory testing
  • defined approaches
  • adverse outcome pathway
  • cosmetic industry
  • medical devices
  • mixtures
  • botanicals

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