National Toxicology Program

CASRN: 9005-65-6

Formula: C18-H33-O2

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. (TDB)

Short-Term Toxicity

• 14-Day (Dosed-Feed)  (C60286) Completed 
  • NTIS No. PB92-189331/AS  (Peer Review 07/10/1991)
    Citation: Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
• 13-Week (Dosed-Feed)  (C60286) Completed 
  • NTIS No. PB92-189331/AS  (Peer Review 07/10/1991)
    Citation: Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies)
  • Rats: F344/N; Mice: B6C3F1
  • Dose: 0,.31,50 %/10 PER GROUP

Long-Term Carcinogenicity

• 2-YEAR (Dosed-Feed)  (C60286) Report Complete 
  • TR-415 (NTIS No. PB92-189331/AS)  (Peer Review 07/10/1991)
    Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 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 
  • Chromosome Aberation Positive 
  • Sister Chromatid Exchange Negative 
• 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 
  • NTIS No. PB93-123826
    Citation: Final Report on the Developmental Toxicity of Polyoxyethylene Sorbitan Monooleate in Sprague-Dawley Rats
  • Rats: Sprague Dawley
  • Rats Maternal Positive 
  • Rats Fetal Positive 
  • Dose: 0, 500, 5000 MG/KG/DAY