Because it contains free iodine, Lugol's solution at 2% or 5% concentration without dilution is irritating and destructive to mucosa, such as the lining of the esophagus and stomach. Doses of 10 mL of undiluted 5% solution have been reported to cause gastric lesions when used in endoscopy. The LD50 for 5% Iodine is 14,000 mg/kg (14 g/kg) in rats, and 22,000 mg/kg (22 g/kg) in mice.
The World Health Organization classifies substances taken orally with an LD50 of 5–50 mg/kg as the second highest toxicity class, Class Ib (Highly Hazardous). The Global Harmonized System of Classification and Labeling of Chemicals categorizes this as Category 2 with a hazard statement "Fatal if swallowed". Potassium iodide is not considered hazardous.