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A study on the acute dermal irritation of a novel polyherbal anesthetic formulation for parenteral administration in wistar albino rats


Pharmacy & Pharmacology International Journal
Shan Sasidharan,1,3 Kaveri Nair A,2 Sithara MS,3 Hareendran Nair J4

Abstract

The major aim of the present study is to assess the acute dermal irritation of a novel topical polyherbal anaesthetic formulation for parenteral application. Currently, this formulation does not have any scientific evidence on the safety aspects to validate its usage in human clinical trials and also to develop this as a product that fulfils all domestic and international regulatory guidelines. Hence, in vivo safety data is absolutely essential to validate this product. Therefore, the current study aimed to assess the skin irritation potential of a polyherbal anaesthetic formulation on a single application in Wistar albino rats. The rats were dermally exposed to the polyherbal anaesthetic formulation and after that any change in each application site was recorded at 1 h, 24 h, 48 h, 72 h, 7th day and 14th day. The dermal reactions, which are normally defined as erythema and edema, were assessed based on the scoring system for skin reactions. In the 14-day observation period, our formulation did not induce any responses on intact skin sites after the application. So, the primary skin irritation index of the polyherbal anaesthetic formulation was recorded to be 0.0, which seemed to fall under the category of non-irritant in the experimental rats. Furthermore, no treatmentassociated mortality was observed in this study. In addition to this, normal weight gain was recorded in all rats. Hence, it can be concluded that polyherbal anaesthetic formulations are non-irritants and safe on rat skin. Further study on this topic is needed to provide more specific evidence to support the findings.

Keywords

erythema, polyherbal anaesthetic formulation, skin irritation toxicity

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