Implementing Alternative Approaches for Inhalation Toxicity Testing

Inhalation toxicity testing provides the basis for hazard labeling and risk management of chemicals when there is potential for exposure of the respiratory tract. The tests commonly included in regulatory test guidelines typically use rodents; however, work is underway to develop reliable non-animal approaches for assessing inhalation toxicity that will provide more human-relevant data and a better understanding of the mechanism of toxicity. This special issue explores the regulatory and non-regulatory needs for inhalation toxicity data and the alternative approaches that may be used to meet those needs. Articles will highlight reference data sources, use of a mathematical approach to classify mixtures based on ingredient toxicity, and the use of human cells or three-dimensional human reconstructed lung tissue models, with a focus on the mechanisms of inhalation toxicity and application of adverse outcome pathways (AOPs) as a framework for designing intelligent testing strategies. How to overcome existing obstacles and achieve global implementation of such approaches will also be discussed.

These features will be highlighted in an upcoming special issue of Applied In Vitro Toxicology.

Original and review articles are sought in the following general categories:

• Availability and variability of reference data
• Application of non-animal approaches for inhalation toxicity testing: Use of human cell or tissue models; Use of the GHS mixtures equation for product formulations; Non-testing methods (e.g., quantitative structure activity relationships, grouping, or read-across); Case studies using integrated approaches that combine existing information, physico-chemical properties, and in silico and in vitro data
• Dosimetry considerations and in vitro to in vivo extrapolation, including the use of human-relevant doses and interpretation of in vitro data
• AOP development and their use to design non-animal testing batteries
• Overview of the current regulatory requirements for inhalation toxicity testing and the key information requirements for regulatory decision-making
• Advantages and challenges of regulatory acceptance of non-animal approaches for assessing inhalation toxicity
• Roadmap towards the use and regulatory acceptance of animal-free approaches for inhalation toxicity testing
  

• Rapid, high-quality peer review
• Open access options available
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Contributions will receive prompt and thorough peer review. Please refer to our Instructions for Authors before submitting your manuscript for consideration.