Investigation of acute dermal irritation/corrosion, acute inhalation toxicity and cytotoxicity tests for Nanobiocide®

Objective(s): Nanomaterials, especially silver Nanoparticles (Ag-NPs), are employed in an increasing number of commercial products. This has led to an ever growing exposure of human beings to this substance. The first purpose of the Nano Committee of Food and Drug Administration of The Islamic Republic of Iran (IFDA) is developing guidelines to assess and approve commercial nano-health products for their safety of human applications. Nanobiocide® as a commercial product of stable colloid including 2000 ppm Ag-NPs for surface antimicrobial applications was investigated according to IFDA guidelines in the approval process. Methods: The first fabrication and characterization method of the product were determined. The human exposure to Nanobiocide® were studied by cytotoxicity assay, dermal irritation and inhalation toxicity assay based on the standard assay. Results: According to cytotoxicity assay by MTT method the concentration- dependent of cell viability was reduced and Inhibitory concentration-50 was about 1160 ppm. The Draize dermal irritation scoring system (DDIS) showed no irritation to the skin of rabbits. No sign of gross toxicity, adverse pharmacological effect, or abnormal behavior based on inhalation toxicity was observed. Conclusions: The consideration of toxicity of Nanobiocide® is one of the major key for medical application. The results obtained revealed that the Nanobiocide® may be safe using in domestic and veterinary applications.