Safety and toxicological evaluation of a novel anti-obesity formulation LI85008F in animals.
LI85008F is a novel synergistic composition of Moringa oleifera, Murraya koenigi, and Curcuma longa. These herbs are well recognized and widely used in ayurvedic system of medicine for treating a variety of diseases and are also have been used for culinary purposes for thousands of years. LI85008F inhibits preadipocyte differentiation and potentiates lipid breakdown in mature adipocytes. In diet-induced obese rats, LI85008F significantly reduced weight gain and improved serum adiponectin levels. These findings motivated the authors to determine the broad-spectrum safety of LI85008F. Acute oral toxicity, acute dermal toxicity, primary skin irritation, primary eye irritation, and dose-dependent 28-day sub-acute toxicity studies were conducted. The acute oral LD50 of LI85008F was greater than 5000 mg/kg in female SD rats and no changes in body weight or adverse effects were observed following necropsy. Acute dermal LD50 of LI85008F was greater than 2000 mg/kg. LI85008F was classified as non-irritating to skin in a primary dermal irritation study conducted using New Zealand Albino rabbits. LI85008F caused minimal irritation to eyes in a primary eye irritation test conducted on New Zealand Albino rabbits. A dose-dependent 28-day sub-acute toxicity study demonstrated no significant changes in selected organ weights. Evaluations on hematology, clinical chemistry, and histopathology did not show any significant adverse changes. The NOAEL of LI85008F was found to be greater than 2500 mg/kg body weight. These results demonstrate the broad spectrum safety of LI85008F in animal models.
Laila Impex R&D Centre, Unit-I, Phase-III, Jawahar Autonagar, Vijayawada 520007, India.
A V
AV
Krishnaraju
D
D
Sundararaju
P
P
Srinivas
C V
CV
Rao
K
K
Sengupta
G
G
Trimurtulu
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000818:Animals; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000633:toxicity*; D002626:Chemistry, Pharmaceutical; D030024:Curcuma; D004305:Dose-Response Relationship, Drug; D005123:Eye / Q000187:drug effects / Q000473:pathology; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D008515:Medicine, Ayurvedic; D029588:Moringa oleifera; D032101:Murraya; D019055:No-Observed-Adverse-Effect Level; D028321:Plant Preparations / Q000008:administration & dosage / Q000633:toxicity*; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D012867:Skin / Q000187:drug effects / Q000473:pathology; D023422:Skin Irritancy Tests; D013997:Time Factors
D019440:Anti-Obesity Agents; C549097:LI85008F; D028321:Plant Preparations