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. Author manuscript; available in PMC: 2011 Jan 19.
Published in final edited form as: Pharmacol Rev. 2008 May 15;60(2):146–180. doi: 10.1124/pr.107.07105

TABLE 2. Results of adjudin toxicity study.

Results of standard toxicity studies on adjudin performed by licensed toxicologists according to FDA guidelines. [Adapted and reproduced from Mruk DD, Wong CH, Silvestrini B, and Cheng CY (2006) A male contraceptive targeting germ cell adhesion. Nat Med 12:1323–1328. Copyright © 2006 Nature Publishing Group. Used with permission.]

Test Regimen and Dosing Administration Route Species Results
Acute toxicity study 100 mg/kg b.wt. (1 dose) Intraperitoneal Mouse; males (n = 3) Negative
1000 mg/kg b.wt. (1 dose) Intraperitoneal Mouse; males (n = 3) Negative
Acute toxicity study 2000 mg/kg b.wt. (1 dose) Oral Rat; males (n = 5) and females (n = 5) Negative
Bacterial mutation assay 0.586–18.8 µg/plate In vitro Salmonella typhimurium andEscherichia coli Negative in both species
Mammalian erythrocyte micronucleus test 500, 1000, and 2000 mg/kg b.wt. (1 dose) Oral Mouse; males (n = 5) and females (n = 5) Negative in all three dosings
Mammalian chromosome aberration test 6.25–100 µg/ml In vitro CHO cells Negative in inducing numerical chromosome aberrations; positive in inducing structural chromosome aberrations
29-Day subchronic toxicity study 50 mg/kg b.wt. every day for 29 days Oral Rat; male (n = 10) and female (n = 10) Negative in female; positive in male