Table 6.

Summary of selected† clinical chemistry findings in the 14-day repeated oral toxicity study.

Group	ALT	GGT	ALP	TBIL	CREA	Pi	Na+	Cl−	ALB
(mg/kg bw/day)	U/L	U/L	U/L	μmol/L	μmol/L	mmol/L	mmol/L	mmol/L	mmol/L
Male (main groups, n = 5 each, except 3000 mg/kg bw/day group, n = 2)
Control	49.74 ± 6.56	0.30 ± 0.46	233.00 ± 51.06	2.25 ± 0.43	21.66 ± 1.45	2.69 ± 0.23	142.80 ± 1.48	102.70 ± 0.58	34.14 ± 0.84
1000	58.00 ± 8.98	1.92 ± 0.68∗∗	182.60 ± 31.83	1.79 ± 0.21	20.96 ± 1.38	2.34 ± 0.36	142.40 ± 1.14	102.88 ± 0.64	33.86 ± 0.67
2000	79.10 ± 30.74	11.94 ± 4.60∗∗	312.80 ± 54.34∗	4.09 ± 1.15∗∗	20.78 ± 1.48	2.55 ± 0.24	142.40 ± 1.14	102.70 ± 1.06	33.80 ± 1.49
3000††	140.70 ± 83.72	29.80 ± 14.00	452.00 ± 84.85∗∗	16.27 ± 11.79	18.70 ± 0.00	2.43 ± 0.01	140.50 ± 2.12	102.05 ± 0.92	31.45 ± 3.89
Historical range♮	26.5–87.9	0.0–1.2	111–316	1.01–2.69	17.2–31.1	2.20–3.10	136.0–145.0	99.7–106.2	31.8–36.8
Female (main groups, n = 5 each, except 3000 mg/kg bw/d group, n = 3)
Control	44.82 ± 8.55	1.72 ± 0.26	119.60 ± 15.44	1.96 ± 0.23	21.30 ± 1.74	2.38 ± 0.23	142.60 ± 0.89	103.66 ± 0.56	34.64 ± 0.47
1000	67.82 ± 23.86	5.32 ± 2.03∗∗	135.00 ± 32.14	2.01 ± 0.20	20.50 ± 2.28	2.32 ± 0.25	142.40 ± 0.55	104.14 ± 1.92	33.92 ± 0.67
2000	87.92 ± 16.57∗∗	16.76 ± 4.09∗∗	234.00 ± 54.18∗∗	4.34 ± 2.25∗∗	17.58 ± 1.38∗	2.57 ± 0.23	141.20 ± 2.95	102.74 ± 2.64	33.76 ± 0.42∗
3000††	76.93 ± 18.50∗	41.80 ± 30.45∗	228.67 ± 78.49∗∗	6.16 ± 2.11∗	13.93 ± 3.46∗∗	2.98 ± 0.44∗	144.67 ± 1.15∗	107.47 ± 2.65∗	32.00 ± 2.69
Historical range♮	21.3–74.2	0.1–3.3	53–194	0.89–2.26	19.4–37.3	1.71–3.13	137.0–145.0	101.6–107.9	32.4–38.5

Data represent the mean values and the standard deviation.

†: only parameters with statistically significant findings are shown in table.

††: dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.

∗P < 0.05 and ∗∗P < 0.01, significance determined with Duncan's multiple range test or with Mann–Whitney U test versus control.

♮: minimum and maximum levels reported as the range of historical control values.