Use of Short-Term Inhalation Study to Obtain Initial Hazard Data and Prepare for Subacute and Subchronic Inhalation Studies, and Toxicokinetic Studies

Abstract

A short-term inhalation study (STIS) protocol that has been specifically developed for testing nanomaterials can be used as an alternative testing choice for acute toxicity testing, and a range-finding study for subacute and subchronic studies. The STIS can also be used to characterize the nanoparticle physicochemical properties and determine the type of exposure and particle monitoring methods in the inhalation chamber for subsequent subacute and subchronic inhalation studies. In addition, importantly, the particle generation method and particle concentration stability can be studied before and during the STIS. Furthermore, combining an STIS with a lung burden analysis, which is now a mandatory requirement for OECD 412 (subacute) and 413 (subchronic) test guidelines, can provide toxicokinetic information, including the biodistribution and lung clearance of nanoparticles.