Publications

Standards of Good Practices for the Conduct of In Vitro Toxicity Studies

December 19, 2025

The field of in vitro toxicity studies presents the opportunity for great innovation while providing many scientific challenges. This chapter discusses implementing standards of good practice within in vitro laboratories as a way to address the problems caused by a lack of reproducibility of scientific work. This chapter serves as a practical resource for researchers striving to enhance the quality, reproducibility, and integrity of their laboratory work. It walks through points to consider in the set-up of the laboratory, reagent handling, test system procurement, handling, and use, study design for bias control, documentation, and data analysis. (more…)

Advanced In Vitro Systems Available for Respiratory Toxicology

December 19, 2025

Increasing concerns in respect to the transferability of data from animal studies to real human health effects further supported by established legal frameworks in many juridical areas have pushed the development of advanced in vitro models (Stucki et al., 2022). Such development of complex in vitro cell models based on human cells can clearly contribute to potentially replace ethically and often scientifically debatable in vivo studies (Clippinger et al., 2021; Stucki et al., 2022). Attempts to fill the existing gap between in vivo and in vitro data have received considerable attention.

Assessment of Phototoxicity Potential of Botanicals as Cosmetic Ingredients Using the In Vitro 3T3 Neutral Red Uptake Phototoxicity Test

December 19, 2025

Cosmetics and personal care products are frequently formulated with botanical ingredients due to their beneficial properties, the nature of their composition, and consumers’ interest for products with more natural or organic profiles. Compounds that absorb light significantly and are in contact with the skin have potential to become phototoxic upon exposure to sunlight. Here we demonstrate that an in vitro test methodology, the 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU PT), is an effective screening tool in evaluation of botanical ingredients that absorb light in the Ultraviolet/Visible (UV/Vis) range. (more…)

New Horizons in Skin Sensitization Assessment of Complex Mixtures: The Use of New Approach Methodologies Beyond Regulatory Approaches

December 19, 2025

Skin sensitization is a complex biological process induced by a wide range of chemicals, from single molecules to complex mixtures and finished products. While single chemical entities were used to design and validate sophisticated safety assessment assays, complex chemistries have proven challenging to test in practice using these methods. These assays range from in silico and in chemico methods to cell-based and reconstructed tissues-based approaches and target the key events now grouped within the Adverse Outcome Pathway. (more…)

A Proof-of-Concept for Safety Evaluation of Inhalation Exposure to Known Respiratory Irritants Using In Vitro and In Silico Methods

December 19, 2025

There is increased interest in developing non-animal test systems for inhalation exposure safety assessments. However, defined methodologies are absent for predicting local respiratory effects from inhalation exposure to irritants. The current study introduces a concept for applying in vitro and in silico methods for inhalation exposure safety assessment. Three in vitro systems, representing the upper (MucilAir™—nasal epithelial tissue) and lower (A549 cells and human precision-cut lung slices) human respiratory regions, were exposed to six respiratory irritants. (more…)

New Approach Methodologies (NAMs) for the In Vitro Assessment of Cleaning Products for Respiratory Irritation: Workshop Report

August 22, 2025

The use of in vitro new approach methodologies (NAMs) to assess respiratory irritation depends on several factors, including the speci cs of exposure methods and cell/tissue-based test systems. This topic was examined in the context of human health risk assessment for cleaning products at a 1-day public workshop held on 2 March 2023, organized by the American Cleaning Institute® (ACI). The goals of this workshop were to (1) review in vitro NAMs for evaluation of respiratory irritation, (2) examine different perspectives on current challenges and suggested solutions, and (3) publish a manuscript of the proceedings.

Evaluation of a Non-Animal Toolbox Informed by Adverse Outcome Pathways for Human Inhalation Safety

August 22, 2025

This work evaluated a non-animal toolbox to be used within a next-generation risk assessment (NGRA) framework to assess chemical-induced lung effects using human upper and lower respiratory tract models, namely MucilAir -HF and EpiAlveolar systems, respectively.

Development of Preliminary Candidate Surface Guidelines for Air Force-Relevant Dermal Sensitizers Using New Approach Methodologies

August 22, 2025

Allergic contact dermatitis (ACD) is an immunologic reaction to a dermal chemical ex-posure that, once triggered in an individual, will result in an allergic response following subsequent encounters with the allergen. Air Force epidemiological consultations have in-dicated that aircraft structural maintenance workers may experience ACD at elevated rates compared to other occupations. We aimed to better understand the utility of non-animal testing methods in characterizing the sensitization potential of chemicals used during Air Force operations by evaluating the skin sensitization hazard of Air Force-relevant chemicals using new approach methodologies (NAMs) in a case study.

Optimizations of the Reconstructed Human Epidermis-Based Phototoxicity Testing to Evaluate the Safety of Long-Lasting Cosmetic Products

January 10, 2025

The safety of cosmetic products coming in contact with consumers’ skin is often assessed using New Approach Methodologies, which include Reconstructed human Epidermis (RhE) tissue models that have demonstrated utility as reliable test systems. In our manuscript, we evaluated the phototoxicity potential of long-lasting cosmetic products, such as lipsticks and foundations containing UV-absorbing ingredients. given their design to persist on application areas of skin, technical challenges were encountered in the experiments using RhE tissues as the products could not be entirely removed at the end of the exposure period. (more…)

A Proof-of-Concept for Safety Evaluation of Inhalation Exposure to Known Respiratory Irritants Using In Vitro and In Silico Methods

January 8, 2025

There is increased interest in developing non-animal test systems for inhalation exposure safety assessments. However, defined methodologies are absent for predicting local respiratory effects from inhalation exposure to irritants. The current study introduces a concept for applying in vitro and in silico methods for inhalation exposure safety assess- ment. (more…)