Abstract
Acute and subacute toxicities of gargle (TG-89), containing azulene sodium sulfonate and benzethonium chloride, were investigated to obtain the following results : The LD50 value in the acute toxicity study was approximately 1500 folds of the estimated clinical dose. In the acute toxicity study, disorders such as congestion observed by histopathological examination in the liver, kidney and spleen were found over 1000 folds of the estimated clinical dose. In the subacute toxicitiy study, no significant abnormality in general behavior, body weight, naked eye observation in gingiva was found. Histopathological examination also indicated no specific disorder except for the high doses. A trend of hypertrophy in the liver was indicated at a high dose of the gargle in acute and subacute toxicity tests. Thus, the gargle, containing azulene sodium sulfonate and benzethonium chloride, may be applied safely as an external preparation in the oral cavity.
