The neem tree, Azadirachta indica, provides many useful compounds that are used as pesticides and could be applied to protect stored seeds against insects. However in addition to possible beneficial health effects, such as blood sugar lowering properties, anti-parasitic, anti-inflammatory, anti-ulcer and hepatoprotective effects, also toxic effects are described. In this study we present a review of the toxicological data from human and animal studies with oral administration of different neem-based preparations. The non-aqueous extracts appear to be the most toxic neem-based products, with an estimated safe dose (ESD) of 0.002 and 12.5 microg/kg bw/day. Less toxic are the unprocessed materials seed oil and the aqueous extracts (ESD 0.26 and 0.3 mg/kg bw/day, 2 microl/kg bw/day respectively). Most of the pure compounds show a relatively low toxicity (ESD azadirachtin 15 mg/kg bw/day). For all preparations, reversible effect on reproduction of both male and female mammals seem to be the most important toxic effects upon sub-acute or chronic exposure. From the available data, safety assessments for the various neem-derived preparations were made and the outcomes are compared to the ingestion of residues on food treated with neem preparations as insecticides. This leads to the conclusion that, if applied with care, use of neem derived pesticides as an insecticide should not be discouraged.