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 and Escherichia 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 |