Abstract: The objective of the present study was to evaluate the acute dermal toxicity of the
Lawsonia inermis ethanolic leaves extract gel formulation on Wistar rats as per OECD guideline no. 402.
10% Lawsonia inermis ethanolic leaves extract was prepared by mixing dried leaves powder in 70% ethanol and obtained filtrate was evaporated. The 10% (w/v) gel was prepared by using extract, carbopol and tri-ethanolamine. Acute dermal toxicity study of Lawsonia inermis ethanolic leaves extract gel was conducted as per OECD guideline no. 402. The animals were observed immediately after dosing and 24, 48 & 72 hrs after exposure period and daily thereafter for 14 days of experimental period. Weekly feed consumption, body weight, the skin reactions were observed and graded by using Draize scoring criteria and necropsy for histopathological examinations of skins and different vital organs of exposed animals were carried out on 14th day of experimental period. There were neither any mortality nor any abnormal reactions on gross and microscopic examination of the drug applied skin of exposed rats were observed. There were no significant changes in the weekly feed consumption and body weights from drug applied rats were noticed.
From the results of this study, it is concluded that the Lawsonia inermis ethanolic leaves extract gel formulation is safe to apply on the skin.