ISO/PWI TS 7666

Evaluation method for chronic inhalation toxicity based on lung burden of nanomaterials

Scope

This document specifies the concept of new protocol(s) for rodent 2-year inhalation carcinogenesis study for the insoluble particles that are not readily biodegradable (ISP) to facilitate its utilization by shifting from its aerosol concentration in exposure chamber to the “lung burden” as a measure of its internal exposure of the experimental animals. This standard protocol is based on the principle that the lung burden is strongly related to the lung toxicity profile of the ISP, and is therefore applicable to the evaluation of chronic toxicity including carcinogenicity of the ISP.