U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Unknown

Approved Use

Unknown
PubMed

PubMed

TitleDatePubMed
Patents

Patents

Sample Use Guides

The Joint FAO / WHO Expert Committee on Food Additives (JECFA) established in 197, based on data on the absence of adverse effects at doses up to 2500 mg / kg / day and safety factor 100, the maximum allowable daily intake of polysorbates in 25 mg / Kg.
Route of Administration: Oral
For 1-day and 5-day cultures, Caco-2 cells were seeded into regular 96-well tissue culture plates at 2 × 104 cells per well in 200 μL of growth medium, and, for 21–23 daymonolayer cultures, the cellswere seeded at the same density into 96-well transwell plates. After being cultured for indicated periods of time, Caco-2 cells were treated with individual test formulations (containing Polysorbate 80) in a final volume of 200 μL per well in 96-well plates at specified concentrations diluted with culture medium for two hours. Immediately after treatment, cytotoxicity was evaluated using MTT cell viability assay
Name Type Language
POLYSORBATE 80
FCC   FHFI   HSDB   II   INCI   MART.   MI   USAN   VANDF   WHO-DD   WHO-IP  
INCI   USAN  
Official Name English
POLYOXYETHYLENE 20 SORBITAN MONOOLEATE [WHO-IP]
Common Name English
POLYSORBATE 80 [WHO-DD]
Common Name English
POLYSORBATE 80 [JAN]
Common Name English
POLYOXYETHYLENE 20 SORBITAN MONOOLEATE
WHO-IP  
Common Name English
MF59 COMPONENT TWEEN 80
Common Name English
POLYSORBATE 80 [VANDF]
Common Name English
POLYSORBATE 80 [FCC]
Common Name English
PEG-20 SORBITAN OLEATE
INCI  
INCI  
Official Name English
INS NO.433
Code English
POLYSORBATE 80 [USP-RS]
Common Name English
POLYSORBATE 80 [MART.]
Common Name English
E-433
Code English
POLYSORBATE 80 [FHFI]
Common Name English
FEMA NO. 2917
Code English
INS-433
Code English
SORBIMACROGOL OLEATE 300
Common Name English
POLYSORBATE 80 [WHO-IP]
Common Name English
POLYSORBATE 80 [USAN]
Common Name English
PEG-20 SORBITAN OLEATE [INCI]
Common Name English
POLYSORBATE 80 [EP MONOGRAPH]
Common Name English
SORBAX PMO-20
Brand Name English
TWEEN-80
Brand Name English
POLYOXYETHYLENE(20)SORBITAN MONOOLEATE
Common Name English
POLYSORBATE 80 [INCI]
Common Name English
POLYSORBATE 80 [HSDB]
Common Name English
POLYSORBATE 80 [MI]
Common Name English
POLYSORBATA 80 [WHO-IP LATIN]
Common Name English
TWEEN 80
Brand Name English
POLYSORBATE 80 [II]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C83486
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
CFR 21 CFR 172.515
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
JECFA EVALUATION INS-433
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
CFR 21 CFR 172.840
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
EPA PESTICIDE CODE 79086
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
Food Contact Sustance Notif, (FCN No.) FCN NO. 1021
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
CODEX ALIMENTARIUS (GSFA) INS-433
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
CFR 21 CFR 349.12
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
Code System Code Type Description
WIKIPEDIA
POLYSORBATE 80
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
USP_CATALOG
1547969
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY USP-RS
RXCUI
8560
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY RxNorm
DRUG BANK
DB11063
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
FDA UNII
6OZP39ZG8H
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
MERCK INDEX
M8973
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY Merck Index
EVMPD
SUB12557MIG
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
POLYSORBATE 80
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY Description: Polysorbates 20 and 80 are yellowish or yellowish brown, oily liquids. Polysorbate 60 is a gelatinous mass, and aclear liquid above 25 ?C.Solubility: Miscible with water, ethanol (~750 g/l) TS, methanol R, and ethyl acetate R; practically insoluble in fatty oils and inliquid paraffin R.Category: Nonionic surfactant.Storage: Polysorbates should be kept in tightly closed containers, protected from light.Additional information: Relative densities of Polysorbates 20 and 60 = about 1.10; Polysorbate 80 = about 1.08.Definition: Polysorbates are mixtures of partial fatty acid esters of sorbitol and its anhydrides, copolymerized with approximately20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydride.In Polysorbate 20 the fatty acid is lauric acid which may contain other fatty acids. In Polysorbate 60 the fatty acid is stearic acidwhich may contain other fatty acids, especially palmitic acid. In Polysorbate 80 the fatty acid is oleic acid.
ChEMBL
CHEMBL1697847
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
NCI_THESAURUS
C80656
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
JECFA MONOGRAPH
INS-433
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
CAS
9005-65-6
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
GENERIC (FAMILY)
DRUG CENTRAL
2227
Created by admin on Fri Jun 25 21:07:56 UTC 2021 , Edited by admin on Fri Jun 25 21:07:56 UTC 2021
PRIMARY
Display Structure of POLYSORBATE 80