ISO/NP TS 4963

Nanotechnologies — Radiotelemetry-spectral-echocardiography based real-time surveillance protocol for in vivo toxicity detection and monitoring of engineered nanomaterials (ENM)

Scope

This Technical specification describes background principles, method design, parameters and considerations for the short- and long-term real time assessment of cardiovascular (CVS)-related nanotoxicity induced by the intentional exposure of ENM (10 – 500nm) via intravenous administration; through the monitoring of the changes in CVS homeostasis through the use of a radio-telemetry-spectral-echocardiography in vivo assessment protocol in a conscious and unrestrained rodent model.

The current protocol aimed to detect and investigate the CVS-related nanotoxicity that is induced by the ENMs that are directly introduced into the blood circulation via intravenous route. This is applicable to the ENMs that are intended to be used as intravenously delivered therapeutic or diagnostic agents.

The current protocol can be adapted for preliminary investigation of the CVS-related nanotoxicity induced by the ENMs that enters the body via other routes of administration / environmental exposure, with:
i. the assumption that the blood circulation is the main route of ENM distribution to the CVS tissues in the body irrespective of the route of exposure.
ii. the aim to determine the theoretical threshold blood concentration of ENM that may trigger CVS-related nanotoxicity upon the ENM exposure, and to simulate the development of CVS-related toxicity upon exposure to toxic dose of ENM (done by introducing a known amount the said ENM intravenously into the test subjects)