13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate the carcinogenic potential of Fentanyl Citrate Injection have not been conducted.
Studies in animals to evaluate the mutagenic potential of Fentanyl Citrate Injection have not been conducted.
Impairment of Fertility
Decreased pregnancy rates occurred in a multigenerational study in which pregnant rats were treated subcutaneously during the first 21 days of pregnancy with 160 mcg/kg to 1250 mcg/kg fentanyl (0.26 times to 2.0 times a human dose of 100 mcg/kg based on body surface area).
Studies in animals to characterize the effect of fentanyl on male fertility have not been conducted.