Initial Submission: Acute Toxicity Studies with Epi-Cure 82 with Cover Letter dated 10/30/1992

摘要

In an acute oral toxicity study, hypoactivity, muscular weakness, diarrhea, and ruffed fur were observed in animals surviving to study termination. At doses producing 90 to 100% mortality, labored breathing, convulsions, ptosis, and prostration were observed in addition to the clinical signs noted at a sublethal dose. The acute oral LD50 was approximately 540 mg/kg. In the dermal toxicity study, the test material was severely irritating to the skin of albino rabbits at all dose levels. Red, well-defined erythema, moderate to severe edema, subdermal hemorrhages, third degree burns, and necrosis were observed. Animals dosed at a lethal dose of 2000 mg/kg exhibited hypoactivity, muscular weakness, ataxia, loss of right reflex, tremors, prostration, and blood in the urine. In the eye irritation test, the material was found to be corrosive. Corrosion, loss of lens, and chemical burns were seen in all animals. Third degree burns were also observed in the dermal irritation study. The pH of the product is not known.