https://ntp.niehs.nih.gov/go/37123

Target Organs and Levels of Evidence for TR-577

Toxicology and Carcinogenesis Studies of a Nondecolorized Whole Leaf Extract of Aloe Barbadensis Miller (Aloe Vera) (CASRN ALOEVLEAFEXT) in F344/N Rats and B6C3F1 Mice (Drinking Water Study)

Chemical (Study Title)
CASRN		 Peer Review Date Route/Exposure Levels Study Laboratory
Aloe vera whole leaf extract (native)
ALOEVLEAFEXT		 04/05/2011 Dosed-Water
R: 0, 0.5%, 1.0% or 1.5%; M: 0, 1%, 2% or 3%		 National Center for Toxicological Research

Levels of Evidence

Male Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Large Intestine: Proximal colon adenoma 0/44 0/44 7/46 10/41; proximal colon carcinoma 0/44 0/44 4/46 4/41; cecum adenoma 0/46 0/45 8/48 8/48; cecum carcinoma 0/46 0/45 1/48 2/48; ascending colon adenoma 0/47 0/47 19/48 8/46; ascending colon carcinoma 0/47 0/47 4/48 8/46; transverse colon adenoma 0/47 0/47 6/47 3/47; transverse colon carcinoma 0/47 0/47 1/47 1/47; adenoma 0/47, 0/48 26/48 23/48; carcinoma 0/47 0/48 10/48 14/48; all sections, adenoma and carcinoma combined 0/47 0/48 28/48 31/48
Non-Neoplastic Lesions
  • Mesenteric lymph node: hyperplasia; cystic degeneration
  • Glandular stomach: mucosa hyperplasia
  • Small intestine: jejunum mucosa hyperplasia
  • Large intestine: proximal colon mucosa hyperplasia; cecum mucosa hyperplasia; ascending colon mucosa hyperplasia; transverse colon mucosa hyperplasia; descending colon mucosa hyperplasia; colon mucosa hyperplasia; rectum mucosa hyperplasia; cecum dilatation
Female Rats: Clear Evidence
Type Organ/Tissue (Lesion)
Neoplastic Lesions
  • Large Intestine: Proximal colon adenoma 0/43 0/45 4/42 5/39; proximal colon carcinoma 0/43 0/45 2/42 4/39; cecum adenoma 0/47 0/48 1/47 6/48; ascending colon adenoma 0/47 0/48 1/46 5/46; all sections, adenoma 0/48, 0/48 6/48 13/48; carcinoma 0/48 0/48 3/48 4/48; adenoma and carcinoma combined 0/48 0/48 8/48 15/48
Non-Neoplastic Lesions
  • Mesenteric lymph node: hyperplasia, cystic degeneration
  • Glandular stomach: mucosa hyperplasia; forestomach inflammation; forestomach hyperplasia
  • Small intestine: ileum mucosa hyperplasia
  • Large intestine: proximal colon mucosa hyperplasia; cecum mucosa hyperplasia; ascending colon mucosa hyperplasia; transverse colon mucosa hyperplasia; descending colon mucosa hyperplasia; rectum mucosa hyperplasia; cecum dilatation; proximal colon inflammation
Male Mice: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Mesenteric lymph node: cellular infiltration
  • Large intestine: ascending colon, goblet cell hyperplasia; transverse colon, goblet cell hyperplasia; descending colon, goblet cell hyperplasia
  • Nasal Cavity: hyaline droplet
Female Mice: No Evidence
Type Organ/Tissue (Lesion)
Non-Neoplastic Lesions
  • Glandular stomach: epithelial hyperplasia
  • Large intestine: ascending colon, goblet cell hyperplasia; transverse colon, goblet cell hyperplasia; descending colon, goblet cell hyperplasia