Intrarectal administration of 5-aminosalicylic acid (5-ASA) to rabbits and dogs was performed to obtain safety data. Groups of rabbits and dogs received twice daily intrarectal doses of 250, 500 or 1000 mg 5-ASA for 14 consecutive days. Treatment had no adverse effect on the behaviour or performance of the animals and microscopic examination revealed no evidence of systemic or local toxicity.