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In addition, included were, i.e., 4-week intravenous toxicity in rats followed by 4 weeks of recovery, 4-week intravenous toxicity in dogs, sub-acute (14 days) intracolonic toxicity study in rats and Beagle dogs, a repeated dose (28 days) dermal toxicity study in Wistar rats, chromosome aberrations in human lymphocytes cultured in vitro, an Ames test, a micronucleus test, female fertility and early embryonal development after intravenous administration to rats, embryofetal development after intravenous administration to rats (including toxicokinetics in pregnant animals and placental transfer), embryofetal development after intravenous administration in New Zealand White rabbits, cardiovascular and respiratory systems in anesthetized dog, a sensitization study in guinea pigs (Maximization test), and an acute eye irritation/corrosion study in albino rabbits

(2011) 301:G896904