[Acute toxicity test on dermal application of NT-1 tape and 10% nitroglycerin (NT-1 ointment)]

An acute toxicity of NT-1 tape was investigated in mice, rats and rabbits, and also an acute toxicity of NT-1 ointment in rabbits. An irritation of NT-1 tape was investigated in rabbits. Dead animals treated with NT-1 tape or ointment were not observed in reliable maximum administration dose of 0.88 mg/body as GTN (nitroglycerin) in mice (male; about 29.1 mg/kg, female; about 35.2 mg/kg), of 3.96 mg/body as GTN in rats (male; about 26.0 mg/kg, female; about 28.9 mg/kg) and of 480 mg/kg as GTN in rabbits. There were not toxic signs in mice and rats. The below findings were observed in rabbits treated mainly with NT-1 ointment: decreased spontaneous activity, decreased reactivity to various stimuli such as sound and touch, and behavior of binding food box. However, the rabbits recovered from those abnormal behavior in a day. Any body weight changes and any autopsy findings attributable to NT-1 tape or ointment were not observed in mice, rats and rabbits. The effects on ECG were not observed in rabbits. The GTN absorption ratio in rabbits treated with NT-1 ointment was thought to be 60-70% from GTN residual ratio. The skin irritation was not observed in rabbits treated with NT-1 tape.