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https://ntp.niehs.nih.gov/go/10479

Polysorbate 80 (glycol): Target Organs and Levels of Evidence for TR-415

Toxicology and Carcinogenesis Studies of Polysorbate 80 (CASRN 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
Polysorbate 80 (glycol)
9005-65-6
07/10/1991Emulsifier and dispersing agent for internal medicinal products. Defoamer in foods. Neutralizer for quaternary ammonium compounds.Dosed-Feed
0,2.5,5.0%/20 PER GROUP
Southern Research Institute

Levels of Evidence

Male Rats: Equivocal Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Adrenal Gland Medulla: PHEOCHROMOCYTOMA 21/50 19/50 29/50
Non-Neoplastic Lesions
  • ADRENAL GLAND: HYPERPLASIA
Female Rats: No Evidence
Male Mice: No Evidence
TypeOrgan/Tissue (Lesion)
Non-Neoplastic Lesions
  • FORESTOMACH: SQUAMOUS HYPERPLASIA; INFLAMMATION
Female Mice: No Evidence
TypeOrgan/Tissue (Lesion)
Non-Neoplastic Lesions
  • FORESTOMACH: SQUAMOUS HYPERPLASIA; INFLAMMATION; ULCER