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Table 6 Mean serum chemistry parameters in dogs 10 days prior to treatment

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

   Vehicle 100 mg/kg 300 mg/kg 1500 mg/kg Unit
   Mean SD N Mean SD N Mean SD N Mean SD N  
Males Alanine transaminase (ALT) 58.2 47.5 6 55.8 42.2 4 37.7 5.4 6 36.8 15.2 6 U/L
Aspartate transaminase (AST) 27.3 2.1 6 29.8 5.4 4 32.5 3.8 6 29.7 3.7 8 U/L
Alkaline phosphatase (ALKP) 91.2 20.5 6 109.8 39.9 4 93.8 21.7 6 128.7 40.1 6 U/L
Lactate deshydrogenase (LDH) 75.3 24.7 6 71.3 14.4 4 76 13.8 6 67.5 24.5 6 U/L
Total bilirubin (TBILI) 0 0 6 0 0 4 0 0 0 0 0 6 mg/dL
Gamma-Glutamyl transferase (GGT) 0 0 6 0 0 4 0 0 6 0 0 6 U/L
Creatine phosphokinase (CK) 0 0 6 0 0 4 0 0 4 0 0 6 U/L
Sodium (Na) 146 1.5 6 145.5 1 4 146.2 1.3 6 146.7 0.8 6 mmol/L
Potassium (K) 4.65 0.19 6 4.65 0.17 4 113.3 1 6 113 1.1 6 mmol/L
Chloride (CL) 113.5 1.5 6 113.3 1 4 113 1.1 6 113.5 2.4 6 mmol/L
Calcium (CA) 10.13 0.19 6 10.28 0.15 4 10.43 0.3 6 10.53 0.45 0 mg/dL
Inorganic phosphorus (PHOS) 5.43 0.77 6 5.98 0.7 4 5.23 0.38 6 5.3 0.45 6 mg/dL
Blood urea nitrogen (BUN) 14.2 0.8 6 14.5 0.6 4 17 2.7 6 16 2.1 6 mg/dL
Creatinine (CREA) 0.63 0.12 6 0.58 0.05 4 0.6 0 6 0.67 0.08 6 mg/dL
Glucose (GLU) 97.3 3.5 5 91.3 8.3 4 92.3 7.4 6 96 8.9 6 mg/dL
Total protein (TPRO) 4.75 0.24 6 4.98 0.29 4 4.9 0.14 6 4.87 0.26 6 g/dL
Albumin (ALB) 2.88 0.17 6 2.93 0.26 4 2.92 0.12 6 2.83 0.28 6 g/dL
Globulin (GLOB) 1.87 0.18 6 2.05 0.13 4 1.98 0.04 6 2.03 0.23 6 g/dL
Albumin/Globulin ratio (A/G) 1.555 0.165 6 1.431 0.155 4 1.471 0.051 6 1.415 0.249 6 Ratio
Cholesterol (CHOL) 168.3 48.5 6 160.8 9.3 4 150.5 31.5 6 163.8 24 6 mg/dL
Triglycerides (TRIG) 37.3 8.2 6 38.3 5.9 4 36 4 6 40.2 5 6 mg/dL
Females Alanine transaminase (ALT) 31.8 6.6 6 32.8 7.4 4 30.3 4.1 6 37.5 16.3 6 U/L
Aspartate transaminase (AST) 29.3 4.1 6 31.8 11.2 4 27.5 3.4 6 28.3 3.7 6 U/L
Alkaline phosphatase (ALKP) 100 32 6 83.8 18.3 4 95.7 25.5 6 75.3 13.7 6 U/L
Lactate deshydrogenase (LDH) 60.3 18.1 6 65.3 25.1 4 52.2 15.4 6 62.2 21.8 6 U/L
Total bilirubin (TBILI) 0.02 0.04 6 0 0 4 0 0 6 0 0 6 mg/dL
Gamma-Glutamyl transferase (GGT) 0 0 6 0 0 4 0 0 6 0 0 6 U/L
Creatine phosphokinase (CK) 165.7 37.4 6 161.5 73.7 4 141 30.1 6 142 43.6 6 U/L
Sodium (Na) 146.8 1.5 6 147.3 1.7 4 146.7 1 6 147.3 0.8 6 mmol/L
Potassium (K) 4.48 0.26 6 4.48 0.05 4 4.43 0.31 6 4.43 0.21 6 mmol/L
Chloride (CL) 114.2 2.1 6 116 2.2 4 114.7 2.9 6 115 1.3 6 mmol/L
Calcium (CA) 10.48 0.26 6 10.58 0.21 4 10.95 0.27 6 10.82 0.31 6 mg/dL
Inorganic phosphorus (PHOS) 5.3 0.23 6 4.83 0.31 4 5.35 0.55 6 5.17 0.5 6 mg/dL
Blood urea nitrogen (BUN) 15.2 2.3 6 13.3 1 4 14.2 2.6 6 14 3 6 mg/dL
Creatinine (CREA) 0.57 0.05 6 0.6 0 4 0.58 0.08 6 0.65 0.08 6 mg/dL
Glucose (GLU) 99.3 5 6 99.3 7.5 4 99.7 7.4 6 94.5 7 6 mg/dL
Total protein (TPRO) 4.85 0.27 6 5 0.28 4 4.8 0.14 6 5.13 0.16 6 g/dL
Albumin (ALB) 2.95 0.26 6 3.1 0.14 4 2.95 0.18 6 3.13 0.16 4 g/dL
Globulin (GLOB) 1.9 0.09 6 1.9 0.18 4 1.85 0.14 6 2 0 6 g/dL
Albumin/Globulin ratio (A/G) 1.556 0.157 6 162.3 10.5 4 1.607 0.21 6 1.567 0.082 6 Ratio
Cholesterol (CHOL) 160 20.2 6 162.3 10.5 4 142.3 11.3 6 158.2 33 6 mg/dL
Triglycerides (TRIG) 37.3 3.8 6 36 14.1 4 34 4.8 6 46.3 10.4 6 mg/dL
  1. Male and female dogs received indicated doses of α-TEA lysine salt daily for 28 days. Ten days before the treatment start, blood was collected from 6 dogs per treatment group (0, 300, 1500 mg/kg) or 4 dogs (100 mg/mL) and analyzed for serum chemistry parameters