[Speaker] Nubila N Imelda:1
[Co-author] Iroka J Udeinya:1, Uzoamaka A Okoli:1, Tochukwu M Okafor:1, Aaron C Okpe:1
1:PHARMACOLOGY AND THERAPEUTICS, University of Nigeria, Nigeria

BACKGROUND: Extracts from neem tree also called dogonyaro in Nigeria are most consistently recommended in ancient medical texts for various disorders. A very important aspect of the neem plant is its reported strengthening impact on the immune system and recent studies have shown that neem leave extract has significant anticancer activity in vitro.
OBJECTIVE: To determine the safety of a fractionated acetone-water neem extract (IraC) by investigating the LD50 in male and female albino mice.
METHODS: Twenty-eight healthy inbred mice were used for this study. LD50 study was carried out by a modified OECD guidelines for Testing of Chemicals, section 4 Up-and-Down Procedure. As required in the procedure, a limit test LD50 was conducted with eight mice (four females and four males) at 2000mg/kg body weight (bw) of IraC by the subcutaneous (sc) route. This was followed by the Main test with 5000mg/kg bw IraC administered to 6 mice (3 of each sex). The Limit and Main Test was repeated in a different group of mice for oral LD50 investigation. All treated animals were monitored for seven days for signs of toxicity. All procedures were approved by the Institutional Animal Care and Use Committee and had free access to food and water ad libitum. LD50 value was calculated using Acute Oral Toxicity (Guideline 425) Statistical Program (AOT425StatPgm) software.
 RESULTS: Only one death was recorded in the female group given 5000mg/kg body weight subcutaneous injection of IraC after 48 hours while at 2000mg/kg, no death was recorded. In male mice, no death was recorded in mice administered 2000mg/kg and 5000mg/kg body weight of IraC after seven days in both routes of administration. Animals did not show any sign of toxicity. Feeding and water intake was normal. No lethargy,weight loss, change in eye colour, fur appearance or stool consistency was observed. Calculated LD50 of IraC, oral and subcutaneous in male and female mice was >5000mg/kg.
CONCLUSION: IraC appears to have a high safety margin and is safe for oral as well as sc administration. The results suggests its safety and suitability for further investigation of its anticancer and immunomodulatory activities.

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