Session 3 - b . Advancements in Laboratory Animal Care, Welfare and Health Record Management
Nov 09, 2018 11:05 AM - 12:40 PM
Inhalation toxicology permits the safety evaluation and risk assessment of aerosolized compounds, including pharmaceutical drugs, agricultural chemicals, and aerosol generated from tobacco products. We have established a state-of-the-art inhalation toxicology facility specializing in aerosol generation and delivery to rodents in the context of toxicological or in vivo pharmacological studies. The experimental strategy used at our facility to conduct quantitative risk assessment of complex aerosols, mainly derived from potential reduced-risk products (i.e., smoke-free products), will be described, with focus on the in vivo work. This includes:
1) Biochemical and bioanalytical analysis: Aerosol characterization (e.g., harmful or potentially harmful constituent levels in the aerosol) and demonstration of aerosol uptake.
2) Inhalation toxicology: Following standardized guidelines (OECD Test Guidelines), 28-day or 90-day inhalation exposure studies are conducted to generate an overall indication of safety and risk potential of the delivered aerosols.
3) Systems toxicology: Classic inhalation exposure endpoints are supplemented with molecular analysis (transcriptomics, proteomics, lipidomics) focusing on potential target tissues, such as the lungs, blood, and cardiovascular tissues.
4) In vivo disease models: Disease risk can be evaluated using models for pulmonary emphysema, cardiovascular disease, or cancer to support the toxicological findings.
This multifunctional approach is used to assess the risk profile following exposure to aerosol generated from potential reduced-risk products compared with that following exposure to cigarette smoke. The results provide a holistic understanding of the overall risks from aerosol exposure and may be included in submissions to regulatory authorities worldwide.