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Table 1 Group assignment and dose levels

From: GMP-grade α-TEA lysine salt: a 28-Day oral toxicity and toxicokinetic study with a 28-Day recovery period in Beagle dogs

Group Number of animals (M/F) Test article Nominal dose level (mg/kg/day) Actual dose levela Number of animals for necropsy (M/F)
      Terminal (Day 29) Recovery (Day 57)
1 6/6 Vehicle 0 0 4/4 2/2
2 4/4 α-TEA 100 130 4/4 -
3 6/6 α-TEA 300 390 4/4 2/2
4 6/6 α-TEA 1500 1950 4/4 2/2
  1. aDose levels have been corrected for lysine salt using a correction factor of 1.3
  2. A total of 44 Beagle dogs (22 males and 22 females) received α-TEA lysine salt at different concentrations (0, 100, 300, 1500 mg/kg). Eight dogs from each group (4 females and 4 males) were necropsied at the end of dosing period (Day 29) or at the end of recovery period (Day 57)