A pharmacologically active ingredient or intermediate with biological activity at approximately 15 micrograms per kilogram of body weight or below in humans or a daily therapeutic dose of 1 mg or below per day; or an active pharmaceutical ingredient or intermediate with an occupational exposure limit ( OEL ) at or below 10 micrograms per cubic meter of air as an eight-hour time weighted average; or a pharmacologically active ingredient or intermediate with high selectivity (as in the ability to bind to specific receptors or inhibit specific enzymes) and/or the potential to cause cancer, mutations, developmental effects or reproductive toxicity at low doses; or a novel compound of unknown potency and toxicity.