| Abstract |
Acute oral toxicity studies were conducted with denatonium benzoate in adult male and female albino rats, neonatal albino rats, and adult male and female rabbits. The test compound was administered orally to adult albino rats at dosage levels of 127.1, 201.7, 320.2, 508.4, 807, and 1.281 mg / kg; to neonatal rats (undifferentiated as to sex) at dosage levels of 7.9, 12.5, 19.8, 31.5, 50.0, 79.4, 125, and 315 mg / kg; and orally to albino rabbits at dosage levels of 201.7, 320.2, 508.4, 807, and 1.1281 mg / kg. Five male and five female rats and two male and two female rabbits were used at each dosage level in the adult studies. Ten neonatal rates (undifferentiated as to sex) were used in the neonatal study. Observations for pharmacodynamic signs and mortality were made frequently on the day of compound administration and daily thereafter for a total of 14 days. A summary of the pharmacodynamic signs and mortalities obtained in each of the studies is presented in the text. Based upon the results obtained, the acute oral toxicity values for denatonium benzoate in adult albino rats, neonatal albino rats, and adult albino rabbits were calculated to be as follows: acute oral toxicity in albino rats was 640 (554 - 740) mg / kg; in female rate 584 (485 - 702) mg / kg; and in combined male and female albino rats, it was 612 (558 - 671) mg / kg. Acute oral toxicity in neonatal albino rats was 23 (19 - 27) mg / kg. In albino rabbits, the acute oral toxicity was as follows: in males, 508 (202 - 1281) mg / kg; in females, 640 (508 - 807) mg / kg; and in combined male and female rabbits, 593 (483 - 728) mg / kg. Data tables are provided, and one statistical reference is given. (Author abstract modified). |