TOXICOLOGICAL STUDIES ON DEBITTERIZED NEEM OIL (AZADIRACHTA-INDICA)

Azadirachta indica, popularly known as 'Neem' in India, is widely grow n all over the tropics. The seed contains 45% oil and is a minor oil o f considerable potential. Neem oil is bitter and inedible. Recently, a method has been developed to completely remove the bitter and odofife rous principles and leave a bitterless, odourless and colourless oil. The nutritional and chemical evaluation of debitterized neem oil (NO) was reported earlier (C. Rukmini, Food Chemistry 1987, 26, 119). We re port here a three-generation study, carried out according to WHO/FDA p rotocol in groups of 15 male and 15 female rats fed a diet containing 10% NO or groundnut oil (GNO). Reproductive toxicology was monitored f or three generations. The results obtained in both the matings in all the three generations did not show any adverse effects on the reproduc tive parameters studied in rats fed NO and were similar to those obser ved in rats fed GNO. The mean organ weights and the histopathological evaluation of all the organs were similar to those of the control (GNO -fed) rats. A mutagenicity test of NO was also found to be negative in Ames test as reported earlier (K. Polasa and C. Rukmini, Food and Che mical Toxicology 1987, 25, 763). These studies indicate that NO devoid of all the bitter and odoriferous principles, may be recommended as s afe for consumption by humans.