National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-10122-n

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)

Known Uses

Emulsifier and dispersing agent for internal medicinal products. Defoamer in foods. Neutralizer for quaternary ammonium compounds.

Chemical Properties

Toxicity Effects (HSDB)

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

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C60286)  Report Complete 
    • 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
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: 0,2.5,5.0%/20 PER GROUP.

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., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 

Organ Systems Toxicity

  • Conventional Teratology (Gavage)  (TER91009)  Completed 
    • Citation: Final Report on the Developmental Toxicity of Polyoxyethylene Sorbitan Monooleate in Sprague-Dawley Rats
    • Rats: Sprague Dawley
    • Rats Maternal Positive 
    • Rats Fetal Positive 
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.