EVALUATION OF SAFETY PROFILES OF ANURADHA OIL-AN HERBAL WOUND HEALING FORMULATION IN LABORATORY ANIMALS
Keywords:
Anuradha oil, Dermal toxicity, AcuteSub acute safety, Mucus membrane irritation, Rats RabbitsAbstract
Objective: To investigate Acute, Sub-acute dermal toxicity, Mucus membrane irritation activity of Anuradha Oil's (AO and AO11) – An herbal formulation having wound healing potential.
Methods: The formulations were derived from Curcuma longa Linn and Glycyrrhiza glabra Linn rhizhomes, Hamiltonia suaveolens Roxb bark, Typha angustifolia Linn flowers, Azadirachta indica A. Juss leaves without/with pig fat (AO and AO11 respectively)mixed in certain proportion using Sesamum indicum Linn oil as a base, manufactured at a GMP certified facility. Acute, sub-acute dermal safety, mucus membrane irritation profiles were studied by OECD guidelines number 434, 410 and 405 in Wistar rats and New Zealand rabbits respectively. For acute study dermal application of 2000 mg/kg single dose and for sub-acute study limit dose protocol of 1000 mg/kg for 28 days was used. For mucus membrane irritation test 0.10 ml dose was used.
Results: In an acute study no local reaction, behavioral changes and mortality was observed at 2000 mg/kg by dermal route till 14 days. In sub-acute study with dermal application of 1000 mg/kg for 28 days, there were no abnormal signs/symptoms at the application site, no difference in body weight, food consumption, hematology/enzyme profiles, urine analysis, relative organ weights and histopathological observations of vital organs in comparison to control animals. Mucus membrane of rabbits showed no evidence of irritation for both oils.
Conclusion: Acute dermal LD50 cut off for AO and AO11was found to be>2000 mg/kg, safe for dermal application for 28 days using the dose of 1000 mg/kg and non-irritant.
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