ACUTE DERMAL TOXICITY AND IRRITABILITY STUDIES OF Ag2Ga NANONEEDLE MEDIATED SILVER FORMULATION AS PER OECD 402 AND 404 PROTOCOLS

We have developed Ag2Ga nanoneedles and achieved individual nanoneedles with diameter ranging from 200 to 250 nm with sharp tip and micro scale length required for a drug carrier to deliver drugs to site of application. Nanoneedles are designed to be inserted in human tissue and therefore they have to be compatible with the local environment of both in terms of toxicity and intended function. The variation of toxicity results for various nanostructures were reported in literatures. Hence, it is important to assess the information about toxicity of novel needle shaped nanostructures. Acute toxicity study was performed to examine the acute dermal toxicity of Ag2Ga nanoneedle mediated silver gel formulation on the rat’s skin, according to the OECD Guidelines Test no.402. Additionally, acute dermal irritation study was also performed to examine the irritancy potential following single, 1 h and 4 h, semi occluded application of Ag2Ga nanoneedle preparation on the rat’s skin according to OECD Guidelines Test no. 404. Acute toxicity study observations showed no skin toxicity or mortality and no vital transformations (statistically significant P< 0.05) in the weight of the body among all groups of animal after single dose administration of nanoneedle preparation.  The results of acute dermal irritation trials did not show any signs of health hazard related to skin irritation and allergic risks. The Ag2Ga nanoneedles produced a primary irritation index of zero and was classified as a non-irritant to animal skin after administration according to Draize classification scheme.