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Development and Validation of Analytical Methods to Quantitate PFAS Compounds in Gavage Dose Formulations for Rodent Toxicology Studies
Citation:
Bui, T., J. Blake, D. Coleman, J. Ambroso, L. Adams, AND J. Tomayko. Development and Validation of Analytical Methods to Quantitate PFAS Compounds in Gavage Dose Formulations for Rodent Toxicology Studies. SERMACS, Durham, NC, October 25 - 28, 2023. https://doi.org/10.23645/epacomptox.24790293
Impact/Purpose:
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Description:
Per- and polyfluoroalkyl substances (PFAS) are used in industrial processes and found in commercial products. Through their manufacture, use, and disposal, these compounds have become anthropogenic contaminants in air, soil, and water. These chemicals tend to be bioaccumulative and persistent in the environment. Several of these compounds, of which there may be thousands, have been detected in human blood. Some PFAS compounds are associated with chronic effects such as immunotoxicity and potentially cancer. However, for many of the PFAS compounds, the available data on the potential in vivo toxic effects from acute and chronic exposure are limited. The objective of this work was to develop and validate a procedure to formulate and analyze selected PFAS compounds in corn oil vehicle for gavage administration in rodents in support of toxicology studies. The PFAS compounds included 1H,1H,2H,2H-perfluorohexyl iodide (PFHI),1H,1H,9H-perfluorononyl acrylate (PFNA), and methyl heptafluoropropyl ketone (MHFPK). The oral route was chosen as this is anticipated to be the major route of exposure for the general population, either through contaminated drinking water or food. Similar analysis methods, using gas chromatography coupled with flame ionization detector (GC/FID), were developed and validated to determine the concentrations of the individual PFAS compounds over the concentration ranges of: 0.8 to 40 mg/mL (PFHI), 0.015 to 10 mg/mL (PFNA), and 3 to 30 mg/mL (MHFPK). Validation parameters included linearity (r ≥ 0.99), accuracy (% relative error ≤ 10%), and precision (% relative standard deviation ≤ 8%). The methods were suitable for analysis of formulations with target concentrations up to 80 mg/mL (PFHI),12 mg/mL (PFNA), and 100 mg/mL (MFHPK) by diluting into the validated ranges with vehicle. All formulations were solutions and therefore homogeneity assessments were not conducted. Preliminary stability studies were conducted and suggested acceptable stability at 2 mg/mL for each PFAS compound at room temperature. These data demonstrate that suitable formulation and analysis methods were developed to quantitate the three individual PFAS compounds in support of rodent toxicology studies.
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DOI: Development and Validation of Analytical Methods to Quantitate PFAS Compounds in Gavage Dose Formulations for Rodent Toxicology Studies
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