Safety of Elixinol Hemp Extract: In Vitro Genetic Toxicity and Subchronic Toxicity in Rats

Table 1

Clinical chemistry data for the 90-day study of main study animals at termination (unless listed otherwise).

Parameter (historical control values^†)	Control	28.94 mg/kg bw/day	50.64 mg/kg bw/day	86.81 mg/kg bw/day
Males
AST (47–266) (U/L)	67.1 ± 7.6	66.0 ± 13.2	68.2 ± 7.3	64.9 ± 10.3
ALT (16–161) (U/L)	26.00 ± 7.41	26.10 ± 6.94	20.70 ± 3.23	26.80 ± 5.98
ALKP (36–143) (U/L)	69.9 ± 16.7	66.9 ± 10.8	75.4 ± 43.3	77.6 ± 18.0
BILI (0.02–0.90) (mg/dL)	0.062 ± 0.018	0.056 ± 0.026	0.040 ± 0.018	0.036 ± 0.022
BILI (0.02–0.90) (mg/dL)-RC	0.062 ± 0.019	0.054 ± 0.023	0.054 ± 0.013	0.036 ± 0.032
BUN (8–24) (mg/dL)	12.2 ± 1.3	11.5 ± 0.8	12.6 ± 1.8	12.2 ± 1.8
CREA (0.06–0.47) (mg/dL)	0.236 ± 0.025	0.260 ± 0.083	0.295 ± 0.103	0.270 ± 0.080
CHOL (36–163) (mg/dL)	50.7 ± 11.4	42.9 ± 8.2	53.6 ± 10.6	58.1 ± 9.6
LDL (0.1–0.5) (mmol/L)	0.221 ± 0.078	0.193 ± 0.060	0.219 ± 0.071	0.218 ± 0.070
HDL (0.5–2.6) (mmol/L)	0.847 ± 0.176	0.710 ± 0.121	0.871 ± 0.146	0.949 ± 0.182
TRIG (18–376) (mg/dL)	103.0 ± 69.2	90.5 ± 33.9	110.6 ± 42.8	127.4 ± 112.2
SDH (0.2–60.3) (U/L)	14.53 ± 4.66	22.70 ± 9.59	15.95 ± 3.86	19.49 ± 8.46
GLUC (77–365) (mg/dL)	215.3 ± 54.6	216.3 ± 52.1	221.5 ± 59.0	240.1 ± 76.3
TP (4.9–7.7) (g/dL)	5.83 ± 0.33	5.51 ± 0.33	5.69 ± 0.65	6.08 ± 0.45
ALB (2.8–4.6) (g/dL)	3.82 ± 0.27	3.58 ± 0.23	3.55 ± 0.50	3.94 ± 0.46
GLOB (1.3–3.5) (g/dL)	2.01 ± 0.16	1.93 ± 0.18	2.14 ± 0.40	2.14 ± 0.33
Ca (9.1–13.4) (mg/dL)	11.06 ± 0.51	11.21 ± 0.77	10.79 ± 1.00	11.53 ± 0.76
PHOS (4.6–11.7) (mg/dL)	8.72 ± 0.75	9.14 ± 0.98	8.84 ± 0.80	9.57 ± 1.31
Na (131–157) (mmol/L)	147.2 ± 3.5	147.9 ± 2.7	143.4 ± 3.6	145.0 ± 2.8
K (3.73–11.38) (mmol/L)	7.93 ± 0.93	8.29 ± 1.32	7.86 ± 1.05	8.76 ± 1.23
Cl (93.1–112.8) (mmol/L)	102.38 ± 2.39	102.67 ± 1.65	100.53 ± 2.78	101.13 ± 1.96
TSH (1.430–9.471) (ng/mL)	1.870 ± 0.337	1.700 ± 0.227	1.767 ± 0.332	1.652 ± 0.391
T3 (0.785–8.153) (ng/mL)	1.645 ± 0.195	1.742 ± 0.172	1.549 ± 0.106	1.574 ± 0.120
T4 (24.478–51.478) (ng/mL)	38.700 ± 1.787	41.084 ± 1.924	38.204 ± 2.362	38.812 ± 2.661
Females
AST (42–341) (U/L)	55.2 ± 5.6	54.0 ± 5.8	57.1 ± 14.2	52.1 ± 6.1
ALT (13–182) (U/L)	19.20 ± 2.70	16.60 ± 3.98	19.10 ± 6.95	15.90 ± 2.60
ALKP (15–115) (U/L)	31.1 ± 7.8	32.7 ± 7.3	36.2 ± 15.3	31.3 ± 10.1
BILI (0.00 0 0.22) (mg/dL)	0.048 ± 0.022	0.035 ± 0.022	0.040 ± 0.032	0.035 ± 0.018
BUN (8–28) (mg/dL)	14.1 ± 3.1	13.7 ± 2.1	15.4 ± 4.0	13.8 ± 2.8
CREA (0.11–0.53) (mg/dL)	0.264 ± 0.080	0.254 ± 0.033	0.240 ± 0.024	0.260 ± 0.080
CHOL (28.0–249.0) (mg/dL)	67.0 ± 6.9	73.8 ± 12.8	79.7 ± 12.3	79.4 ± 15.0
LDL (0.10–0.38) (mmol/L)	0.119 ± 0.027	0.119 ± 0.021	0.138 ± 0.038	0.157 ± 0.066
HDL (0.59–2.71) (mmol/L)	1.383 ± 0.124	1.522 ± 0.236	1.662 ± 0.254	1.609 ± 0.257
HDL (0.59–2.71) (mmol/L)-RC	1.804 ± 0.425	1.970 ± 0.440	2.026 ± 0.494	2.172 ± 0.325
TRIG (24–934) (mg/dL)	111.1 ± 42.2	101.0 ± 70.2	76.6 ± 18.7	78.8 ± 20.5
SDH (0.5–81.1) (U/L)	9.94 ± 3.08	8.89 ± 1.99	13.14 ± 4.67	8.93 ± 4.10
GLUC (87–364) (mg/dL)	197.6 ± 37.3	208.7 ± 50.0	204.9 ± 33.5	182.1 ± 35.2
TP (5.1–9.0) (g/dL)	6.06 ± 0.35	6.36 ± 0.62	6.61 ± 0.63	6.49 ± 0.51
ALB (2.6–6.4) (g/dL)	4.32 ± 0.24	4.60 ± 0.42	4.82 ± 0.48	4.69 ± 0.42
ALB (2.6–6.4) (g/dL)-RC	4.86 ± 0.38	5.56 ± 0.42	5.18 ± 0.51	5.42 ± 0.23
GLOB (1.10–3.60) (g/dL)	1.74 ± 0.17	1.76 ± 0.25	1.79 ± 0.27	1.80 ± 0.17
Ca (7.7–15.5) (mg/dL)	10.89 ± 0.93	11.58 ± 0.88	11.81 ± 0.86	11.07 ± 0.65
PHOS (2.4–12.4) (mg/dL)	7.61 ± 1.77	8.15 ± 1.60	8.58 ± 0.70	8.03 ± 1.44
Na (128–159) (mmol/L)	144.8 ± 2.3	144.1 ± 2.3	142.5 ± 3.3	143.5 ± 3.8
K (3.49–12.96) (mmol/L)	7.24 ± 2.19	7.68 ± 1.47	8.09 ± 1.84	8.36 ± 2.35
Cl (89.1–114.6) (mmol/L)	101.93 ± 1.76	101.09 ± 2.55	99.32 ± 2.24	100.97 ± 1.85
TSH (1.400–10.628) (ng/mL)	1.731 ± 0.177	1.546 ± 0.155	1.470 ± 0.058	1.488 ± 0.143^+
T3 (1.004–8.009) (ng/mL)	2.200 ± 0.436	2.571 ± 0.209	1.895 ± 0.168	1.922 ± 0.104
T4 (28.955–69.296) (ng/mL)	42.325 ± 4.025	39.696 ± 3.040	39.064 ± 2.862	38.358 ± 3.847

N = 10/group for the main study and N = 5/group for recovery groups. Data are presented as mean ± standard deviation (SD). ^†Laboratory historical control ranges; Significantly different from control, Dunnett’s, or Dunn’s test (); Significantly different from control and Dunnett’s test); Significantly different from control and unknown test (; ⁺Significantly different from control and undisclosed test (. ALB = albumin; ALKP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BILI = total bilirubin; BUN = urea nitrogen; bw = body weight; Ca = calcium; CHOL = cholesterol; Cl = chloride; CREA = creatinine; dL = deciliter; g = grams; GLOB = globulin; GLUC = glucose; HDL = high-density lipoprotein cholesterol; K = potassium; kg = kilogram; L = liter; LDL = low-density lipoprotein cholesterol; mg = milligrams; mL = milliliter; mmol = millimoles; Na = sodium; ng = nanograms; NI = no information; PHOS = inorganic phosphorus; RC = recovery animals; SDH = sorbitol dehydrogenase; TP = total protein; TRIG = triglycerides; TSH = thyroid-stimulating hormone; thyroxine (T4); triiodothyronine (T3); U = units.