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[Current Issues in Photosafety Evaluation].

Satomi Onoue1, Hirokazu Kouzuki2, Akemi Toyoda3

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Summary

This review covers phototoxicity mechanisms and evaluation methods for pharmaceuticals and cosmetics. It highlights updated OECD guidelines for accurate photosafety assessments, including new in vitro tests.

Keywords:
3T3 neutral red uptake (NRU) phototoxicity testphotosafetyphototoxicityreactive oxygen species (ROS) assay

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Area of Science:

  • Toxicology
  • Photobiology
  • Dermatology

Background:

  • Phototoxicity, a light-induced chemical reaction, includes photoirritation, photoallergy, photogenotoxicity, and photocarcinogenicity.
  • Accurate photosafety evaluation is crucial for pharmaceuticals and cosmetics in the 21st century.
  • Various guidelines from European and U.S. agencies, and the OECD, address photosafety assessment.

Purpose of the Study:

  • To review the mechanisms and evaluation of phototoxicity.
  • To discuss current challenges and advancements in pharmaceutical and cosmetic photosafety evaluation.
  • To highlight updated OECD test guidelines for photosafety assessment.

Main Methods:

  • Discussion of phototoxicity mechanisms and their evaluation.
  • Review of the current state and challenges in photosafety evaluation for pharmaceuticals and cosmetics.
  • Description of the latest OECD test guidelines (TG), including revisions to TG 432 and adoption of TG 495.

Main Results:

  • Updated OECD guidelines and test methods are available for photosafety evaluation.
  • New in vitro assays, such as the reactive oxygen species (ROS) assay (TG 495), complement existing methods like the 3T3 neutral red uptake (NRU) phototoxicity test (TG 432).
  • The review emphasizes selecting appropriate evaluation methods based on current guidelines and legal criteria.

Conclusions:

  • Accurate photosafety evaluation requires understanding phototoxicity mechanisms and utilizing updated OECD guidelines.
  • Advancements in in vitro testing provide more refined methods for assessing chemical photosafety.
  • Selecting the correct evaluation strategy is paramount for regulatory compliance and product safety in the pharmaceutical and cosmetic industries.