Author: Mitchell Gaydash

03 Aug The Impossible Made Possible Through the use of New Approach Methodologies

Toxicological profiling is a critical component of the regulatory process required to inform the hazard characterisation and labelling of chemicals, thus guiding their safe handling and use. Skin irritation is a key endpoint for regulatory registrations, traditionally assessed by using the Draize rabbit test, which...

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

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.

19 Dec Advanced In Vitro Systems Available for Respiratory Toxicology

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...

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

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.

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

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.

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

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.