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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