title: Safety evaluation of calcium administered intranasally to mice.
abstract: 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.
authors.affiliation: Institute for Biological Sciences, National Research Council of Canada, 100 Sussex Drive, Ottawa, Ontario, Canada. girish.patel@nrc-cnrc.gc.ca
authors.forename: Girishchandra B
authors.initials: GB
authors.lastname: Patel
authors.forename: Hongyan
authors.initials: H
authors.lastname: Zhou
authors.forename: Amalia
authors.initials: A
authors.lastname: Ponce
authors.forename: Wangxue
authors.initials: W
authors.lastname: Chen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000633:toxicity*; D000281:Administration, Intranasal; D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D002122:Calcium Chloride / Q000008:administration & dosage* / Q000633:toxicity*; D002626:Chemistry, Pharmaceutical; D005260:Female; D008111:Liver Function Tests; D051379:Mice; D008807:Mice, Inbred BALB C; D008810:Mice, Inbred C57BL; D013045:Species Specificity
chemical_list: D000276:Adjuvants, Immunologic; D002122:Calcium Chloride