Testing Status of Polysorbate 80 (glycol) 10122-N

CASRN: 9005-65-6

Formula: C32-H60-O10 (mixture)

Synonyms/Common Names

• Glycol
• Polyoxyethylene sorbitan monooleate
• Tween 80
• (Z)-Sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl)-(9CI)

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C60286)  Completed 
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Dosed-Feed)  (C60286)  Completed 
  • Rats: F344/N; Mice: B6C3F1
  • Dose: 0, .31, 50 %/10 PER GROUP.

Long-Term Carcinogenicity

• 2 years (Dosed-Feed)  (C60286)  Completed 
  • TR-415 (NIH Number: 92-3146)  (Peer Review Approval 07/10/1991A )
    Toxicology and Carcinogenesis Studies of Polysorbate 80 (CASRN 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: 0, 2.5, 5.0%/20 PER GROUP.
  • Carcinogenesis Results
    • Male Rats Equivocal Evidence 
    • Female Rats No Evidence 
    • Male Mice No Evidence 
    • Female Mice No Evidence 

Genetic Toxicology

• In Vitro Cytogenetics (CA/SCE)  (862010)  Completed 
  • Sister Chromatid Exchange Negative 
  • Chromosome Aberrations Positive 
• Salmonella  (405466)  Completed 
  • Citation: Mortelmans K, Haworth S, Lawlor T, Speck W, Tainer B, Zeiger E. Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals. Environ Mutagen. 1986;8 Suppl 7:1-119
  •  Negative 

Organ Systems Toxicity

• Conventional Teratology (Gavage)  (TER91009)  Completed 
  • Rats: Sprague Dawley
  • Dose: 0, 500, 5000 MG/KG/DAY.
  • Rats Maternal Positive 
  • Rats Fetal Positive