Defencath: genotox, carcinogenicity and repro: done or skipped?

“Although taurolidine is positive for genotoxicity in vitro regardless of metabolic activation (mouse lymphoma and Ames tests), it is negative in vivo.”

“Carcinogenicity studies were not needed for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”

“Reproductive and developmental toxicology studies were waived for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”

“Taurolidine was mutagenic in TA98 and TA100 in the absence and presence of metabolic activation.”

“Taurolidine-induced forward mutations at the thymidine kinase (TK) locus of L5178Y mouse lymphoma cells in the absence and presence of metabolic activation.”

“Data from a study in rats demonstrated that micronuclei were not induced in bone marrow polychromatic erythrocytes, and DNA damage was not detected in liver cells in a comet assay when taurolidine was administered intravenously up to a maximum tolerated dose of 600 mg/kg/day for three days.”

“Carcinogenicity studies were not needed for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”

“Carcinogenicity studies were not needed for Defencath because the product is not intended for systemic administration and clinical exposure to its components is negligible when used as directed.”