Safety Evaluation of Calcium Administered Intranasally to Mice

• Published in: International journal of toxicology Vol. 28; no. 6; pp. 510 - 518
• Main Authors: Patel, Girishchandra B., Zhou, Hongyan, Ponce, Amalia, Chen, Wangxue
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-11-2009
• Subjects: Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - toxicity; Administration, Intranasal; Animals; Behavior, Animal - drug effects; Blood Chemical Analysis; Body Weight - drug effects; Calcium Chloride - administration & dosage; Calcium Chloride - toxicity; Chemistry, Pharmaceutical; Female; Liver Function Tests; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Species Specificity; toxicity; vaccine; intranasal; calcium; safety
• ISSN: 1091-5818; 1092-874X
• DOI: 10.1177/1091581809347388

Calcium, a component of approved human vaccines administered via systemic routes, has a good safety profile. Recently, intranasally administered vaccines containing calcium have shown promise in generating mucosal immune responses in animal models. However, the safety of intranasally administered calcium is unknown. This study evaluates the safety of intranasally administered calcium at 2- to 13-fold higher doses than used in experimental vaccines. At a calcium dose of 22 mg/kg, 80% of the Balb/c and 20% of the C57BL/6 mice die within the first 24 hours. At 11.0 mg/kg, there is no overt toxicity in either strain, based on body weight, clinical scores, blood chemistry, and histopathology of major organs at 7 days post administration. In C57BL/6 mice, apart from acute and subacute inflammation in the lungs at up to 3 days post administration, especially at the 22-mg/kg dose, there is no overt toxicity. Doses of calcium up to 11 mg/kg appear to be safe in a mouse model.