Chapter 5 - Acute systemic toxicity

Abstract

Acute systemic toxicity studies evaluate the health hazards arising from acute exposure and can also be used as a bookmark to establish dosage regimen in subacute or subchronic studies. Acute systemic toxicity study provides information on the mode of toxic action, by the intended clinical exposure route. The appropriate test selection for device systemic toxicity assessment can be performed based on risk assessment approach as described in ISO 10993-1. The device factors such as duration and mode of contact, the manufacturing and processing conditions of the medical devices and their physicochemical properties such as pH, stability, viscosity, solubility and sterility are considered in the study design. The results of an acute systemic toxicity study should be evaluated based on preceeding studies when available and toxic effects and gross necropsy findings. The results of the systemic toxicity tests should be expressed in terms of relationship between the dose of the test sample and with or without the occurrence and severity of behavioral and clinical abnormalities, gross lesions, body weight changes, effects on mortality and any other general or specific effects.