TABLE 5.

Incidence of Nonneoplasic Lesions in Male and Female B6C3F1 Mice Administered Aloe Vera Whole-Leaf Extract in the Drinking Water for 2 Yearsa

		Aloe vera whole-leaf extract (%)b
Lesion	Sex	0	1.0	2.0	3.0
Asending colon goblet cell hyperplasia	Male	2/47 (4%)***1.0	16/44 (36%)***1.3	20/45 (44%)***1.6	19/42 (45%)***1.6
	Female	1/43 (2%)***1.0	15/43 (35%)***1.2	20/44 (46%)***1.3	25/43 (58%)***1.7
Tranvserse colon goblet cell hyperplasia	Male	4/47 (9%)***1.0	14/44 (32%)***1.4	21/45 (47%)***1.7	22/43 (51%)***1.6
	Female	2/42 (5%)***1.0	18/42 (43%)***1.2	23/44 (52%)***1.3	26/43 (61%)**1.7
Decending colon goblet cell hyperplasia	Male	0/47 (0%)***—	7/44 (16%)**1.3	12/45 (27%)***1.5	17/43 (40%)***1.4
	Female	0/43 (0%)***—	4/43 (9%)1.3	7/44 (16%)**1.4	17/43 (40%)***1.6
Large intestine all sites goblet cell hyperplasiac	Male	4/47 (9%)***1.0	17/44 (39%)***1.4	22/45 (49%)***1.9	22/44 (50%)1.7
	Female	3/43 (7%)***1.0	19/43 (44%)***1.2	24/44 (55%)***1.3	28/43 (65%)***1.7
Mesenteric lymph node cellular infiltration	Male	0/48 (0%)**—	1/45 (2%)3.0	4/45 (9%)2.3	6/43 (14%)*3.2
Nose hyaline droplets	Male	6/48 (13%)*1.2	31/47 (66%)***1.8	39/47 (83%)***2.0	13/47 (28%)1.8

^aThe data are reported as the number of animals with a lesion per number of animals examined microscopically, the % incidence (in parentheses), and the mean severity of the lesion, where 1 = minimal, 2 = mild, 3 = moderate, 4 = marked.

^b p values that are significant are annotated with * to indicate p < 0.05, ** to indicate p <0.01, or *** to indicate p < 0.001. p values associated with the 0% Aloe vera whole-leaf incidence correspond to Poly-3 trend tests. p values associated with a specific treatment correspond to differences compared to the 0% Aloe vera whole-leaf incidence.

^cTotal number of mice with goblet cell hyperplasia in the ascending colon, transverse colon, or descending colon.