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Table 7 Mean serum chemistry parameters 29 days after the start date in male dogs

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)

33.5

9.9

4

32

8.6

4

37.3

6.8

4

51

25.9

4

U/L

Aspartate transaminase (AST)

34.8

3.2

4

36.5

5.7

4

46

8.8

4

49.8

5.9

4

U/L

Alkaline phosphatase (ALKP)

96

24.4

4

104.3

37.1

4

116

71.9

4

227

315.9

4

U/L

Lactate deshydrogenase (LDH)

57.8

6.4

4

61

18.7

4

70

21.8

4

55

18.9

4

U/L

Total bilirubin (TBILI)

0.03

0.05

4

0.03

0.05

4

0.03

0.05

4

0

0

4

mg/dL

Gamma-Glutamyl transferase (GGT)

0

0

4

0

0

4

0

0

4

0

0

4

U/L

Creatine phosphokinase (CK)

246.3

79.8

4

185.3

61.2

4

272.3

145.6

4

133

29.1

4

U/L

Sodium (Na)

148.5

1.3

4

148

0.8

4

147.8

0.5

4

148

1.4

4

mmol/L

Potassium (K)

4.35

0.31

4

4.5

0.26

4

4.08

0.32

4

4.48

0.21

4

mmol/L

Chloride (CL)

115.8

1

4

115

0.8

4

115

1.3

4

118.8

0.5

4

mmol/L

Calcium (CA)

10.83

0.25

4

10.88

0.33

4

11.05

0.13

4

10.35

0.29

4

mg/dL

Inorganic phosphorus (PHOS)

5.13

0.75

4

5.45

0.29

4

4.68

0.26

4

3.98

0.32

4

mg/dL

Blood urea nitrogen (BUN)

18.3

2.1

4

18.8

3.3

4

19.3

1.9

4

24.3

1.7

4

mg/dL

Creatinine (CREA)

0.6

0.14

4

0.6

0

4

0.58

0.1

4

0.55

0.08

4

mg/dL

Glucose (GLU)

102.5

4

4

96.3

9

4

96.8

11.2

4

80.8

8.4

4

mg/dL

Total protein (TPRO)

5.25

0.3

4

5.38

0.28

4

5.38

0.24

4

4.45

0.42

4

g/dL

Albumin (ALB)

3.33

0.26

4

3.23

0.29

4

3.18

0.21

4

2.45

0.1

4

g/dL

Globulin (GLOB)

1.93

0.1

4

2.15

0.06

4

2.2

0.14

4

2

0.34

4

g/dL

Albumin/Globulin ratio (A/G)

1.729

0.141

4

1.502

0.152

4

1.448

0.14

4

1.247

0.184

4

Ratio

Cholesterol (CHOL)

168.8

35.4

4

176

28

4

152.3

19.4

4

104.5

183.4

4

mg/dL

Triglycerides (TRIG)

34

8.1

4

41.3

9.7

4

33.3

5.6

4

45.5

14.3

4

mg/dL

Females

Alanine transaminase (ALT)

27.3

5.1

4

26.3

1.9

4

35.8

10.2

4

45.5

20.9

4

U/L

Aspartate transaminase (AST)

29

4.7

4

36.3

5.3

4

31.5

3.1

4

45.8

19.5

4

U/L

Alkaline phosphatase (ALKP)

98.8

12.4

4

78.8

22.5

4

178

131.5

4

251.3

211.2

4

U/L

Lactate deshydrogenase (LDH)

82.3

25.8

4

74

19.8

4

69.5

5.9

4

73

19.5

4

U/L

Total bilirubin (TBILI)

0.03

0.05

4

0.05

0.06

4

0.03

0.05

4

0.03

0.05

4

mg/dL

Gamma-Glutamyl transferase (GGT)

0

0

4

0.3

0.5

4

0

0

4

0

0

4

U/L

Creatine phosphokinase (CK)

162.8

54.3

4

198.8

44.1

4

162.3

40.6

4

147.3

47.6

4

U/L

Sodium (Na)

147.8

1

4

148.5

1.9

4

148.5

0.6

4

148.3

1

4

mmol/L

Potassium (K)

4.4

0.34

4

4.53

0.17

4

4.38

0.31

4

4.65

0.34

4

mmol/L

Chloride (CL)

114.5

1.7

4

115.5

1

4

115.5

1

4

117.8

2.8

4

mmol/L

Calcium (CA)

10.7

0.35

4

11.05

0.38

4

11.05

0.37

4

10.25

0.84

4

mg/dL

Inorganic phosphorus (PHOS)

5.03

0.54

4

4.25

0.9

4

4.4

0.47

4

4.35

0.58

4

mg/dL

Blood urea nitrogen (BUN)

17.5

2.4

4

14.5

1.3

4

18.5

1.3

4

23.5

7.9

4

mg/dL

Creatinine (CREA)

0.5

0.08

4

0.58

0.1

4

0.53

0.1

4

0.63

0.05

4

mg/dL

Glucose (GLU)

103.3

4.8

4

102.8

11.5

4

108.8

7.8

4

84.8

2.1

4

mg/dL

Total protein (TPRO)

5.28

0.17

4

5.35

0.31

4

5.3

0.22

4

4.65

0.3

4

g/dL

Albumin (ALB)

3.35

0.17

4

3.38

0.25

4

3.35

0.19

4

2.8

0.22

4

g/dL

Globulin (GLOB)

1.93

0.1

4

1.98

0.1

4

1.95

0.17

4

1.85

0.13

4

g/dL

Albumin/Globulin ration (A/G)

1.745

0.142

4

1.71

0.109

4

1.729

0.191

4

1.516

0.118

4

Ratio

Cholesterol (CHOL)

167.5

24.6

4

179

22.4

4

147.3

10.6

4

98.3

13

4

mg/dL

Triglycerides (TRIG)

40

9.8

4

42

8.8

4

43.5

5.8

4

50

8.3

4

mg/dL

  1. Male dogs received indicated doses of α-TEA lysine salt daily for 28 days. After 28 daily treatments, blood was collected from 4 dogs per treatment group and analyzed