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Skin toxicology and 3Rs-Current challenges for public health protection
Christian Riebeling1, Andreas Luch1, Tewes Tralau1
1Department of Chemical and Product Safety, German Federal Institute for Risk Assessment (BfR), Berlin, Germany.
Abstract:
Driven by the fast paced development of complex test systems in vitro, mass spectrometry and omics, we finally have the tools to unravel the molecular events that underlie toxicological adversity. Yet, timely regulatory adaptation of these new tools continues to pose major challenges even for organs readily accessible such as skin. The reasons for this encompass a need for conservatism as well as the need of tests to serve an existing regulatory framework rather than to produce scientific knowledge. It is important to be aware of this in order to align regulatory skin toxicity with the 3R principles more readily. While most chemical safety testing is still based on animal data, regulatory frameworks have seen a strong push towards non-animal approaches. The endpoints corrosion, irritation, sensitisation, absorption and phototoxicity, for example, can now be covered in vitro with the corresponding test guidelines (TGs) being made available by the OECD. However, in vitro approaches tend to be more reductionist. Hence, a combination of several tests is usually preferable to achieve satisfying predictivity. Moreover, the test systems and their combined use need to be standardised and are therefore subject not only to validation but also to the ongoing development of so-called integrated approaches to testing and assessment (IATAs). Concomitantly, skin models are being refined to deliver the complexity required for increased applicability and predictivity. Given the importance of regulatory applicability for 3R-derived approaches to have a long-lasting impact, this review examines the state of regulatory implementation and perspectives, respectively.
Insights
New in vitro methods and integrated approaches to testing and assessment (IATAs) advance toxicological adversity understanding. Regulatory adaptation for skin toxicity testing, however, faces challenges, impacting the alignment with the 3R principles.
Area of Science:
- Toxicology
- Dermatology
- Regulatory Science
Background:
- Advanced in vitro systems, mass spectrometry, and omics technologies enable detailed molecular analysis of toxicological adversity.
- Regulatory frameworks struggle to keep pace with these rapid technological advancements, particularly for accessible organs like the skin.
- There's a growing imperative to align regulatory skin toxicity testing with the 3R principles (Replacement, Reduction, Refinement).
Purpose of the Study:
- To review the current state of regulatory implementation for non-animal testing approaches in skin toxicity.
- To examine the challenges and perspectives for integrating new in vitro methods into regulatory frameworks.
- To assess the impact of regulatory applicability on the long-term success of 3R-derived approaches.
Main Methods:
- Review of current regulatory guidelines and test systems for skin toxicity endpoints.
- Analysis of the development and validation of in vitro test guidelines (TGs) by the Organisation for Economic Co-operation and Development (OECD).
- Examination of the progress in developing and standardizing integrated approaches to testing and assessment (IATAs) and advanced skin models.
Main Results:
- While OECD TGs exist for in vitro assessment of endpoints like corrosion, irritation, sensitization, absorption, and phototoxicity, regulatory adaptation remains a challenge.
- In vitro approaches are often reductionist, necessitating the combination of multiple tests for predictive accuracy.
- Refinement of skin models and standardization of IATAs are crucial for increased applicability and predictivity.
Conclusions:
- Timely regulatory adaptation of advanced in vitro tools for skin toxicity is essential for aligning with the 3R principles.
- A combination of validated and standardized in vitro tests within IATAs is preferred for robust toxicological assessment.
- Continued refinement of skin models and regulatory frameworks is necessary to ensure the lasting impact of non-animal testing approaches.
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