Significance of the Biodurability of Man-Made Vitreous Fibers to Risk Assessment

It is generally agreed that the biodurability of man-made vitreous fibers is a major factor for the characterization of potential health effects. As there is currently no standardization of experimental protocols to determine biodurability, the results of the clearance assays have not been used up to now for regulatory purposes. Methods used to analyze biodurability in animal models are short-term inhalational exposure and intratracheal instillation of rat respirable fibers. Both test methods have strengths and limitations for regulatory purposes. We outline recommended procedures for standardized biodurability assays that can be used to compare different fiber types. In animal experiments, biodurability is difficult to seperate from biopersistence, as mucociliary and macrophage-mediated clearance occur simultaneously with dissolution and disintegration. (Abstract truncated