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CISATRACURIUM BESYLATE (cisatracurium besylate) Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term animal studies to evaluate the carcinogenic potential of cisatracurium besylate have not been performed.

Mutagenesis

Cisatracurium besylate was evaluated in a battery of four genotoxicity assays. Evaluation of cisatracurium besylate in the in vitro mouse lymphoma forward gene mutation assay resulted in mutations in the presence and absence of exogenous metabolic activation. The in vitro bacterial reverse gene mutation (Ames) assay, in vitro human lymphocyte chromosomal aberration assay, and an in vivo rat bone marrow cytogenetic assay did not demonstrate evidence of mutagenicity or clastogenicity.

Impairment of Fertility

Studies to determine if cisatracurium besylate impacts fertility have not been completed.

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