Polyoxyethylene sorbitan monooleate

604.81300

604.41900

500-019-9

DTXSID0021175

Yellow to orange colored, oily liquid|Lemon- to amber-colored, oily liquid

2932999099

133.14000

4.46260

Polysorbate 80 is an amber-colored viscous liquid. pH (5% aqueous solution) 5-7. Faint odor and bitter taste. (NTP, 1992)

1.06-1.10 g/cm³

-21ºC

> 100ºC

>110ºC

1.471-1.473

H2O: 5-10 g/100 mL at 23 ºC

Store at RT.

<1 mm Hg ( 20 °C)

LD50 in mice, rats (ml/kg): 7.5, 6.3 i.p. (Varma)

pH of 5% aqueous solution between 6 and 8

Hydroxyl radical reaction rate constant = 3.35X10-10 cu cm/molec-sec at 25 °C (est)

Water soluble.

Ethers

POLYSORBATE 80 is incompatible with strong alkalis and oxidizers. (NTP, 1992)

NONH for all modes of transport

1

R22; R36/37/38; R37/38; R41

S24/25

WG2934000

Xi

Polysorbates are stable to electrolyes and weak acids and bases; gradual saponification occurs with strong acids and bases. The oleic acid esters are sensitive to oxidation. Polysorbates are hygroscopic and should be examined for water content prior to use and dried if necessary. Also, in common with other polyoxyethylene surfactants, prolonged storage can lead to the formation of peroxides.

SRP: The most favorable course of action is to use an alternative chemical product with less inherent propensity for occupational harm/injury/toxicity or environmental contamination. Recycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal and plant life; and conformance with environmental and public health regulations.|Observe all federal, state, and local environmental regulations.

Discoloration and/or precipitation occur with various substances, especially phenols, tannins, tars, and tarlike materials. The antimicrobial activity of paraben preservatives is reduced in the presence of polysorbates.|Materials to avoid: Strong oxidizing agents.

The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use. ... (b) Special use - (1) Diluents in color additive mixtures for marking food - (i) Inks for marking food supplements in tablet form, gum, and confectionery. Substance: Polyoxyethylene sorbitan monooleate (polysorbate 80); Definitions and specifications: As set forth in section 172.840 of this chapter; Restrictrions: None.|The following diluents may be safely used in color additive mixtures that are exempt from certification and which are to be used for coloring drugs, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. Such listing of diluents is not to be construed as superseding any of the other requirements of the Federal Food, Drug, and Cosmetic Act with respect to drugs, including new drugs. If a definition and specification for a particular diluent is not set forth in this subpart, the material shall be of a purity consistent with its intended use. (a) Ingested drugs -(1) General use. ... Substance: Polyoxyethylene sorbitan monooleate (polysorbate 80); Definitions and specifications: As set forth in section 172.840 of this chapter; Restrictrions: None.|Polysorbate 80 is a food additive permitted for direct addition to food for human consumption as a synthetic flavoring substance and adjuvant in accordance with the following conditions: a) they are used in the minimum quantity required to produce their intended effect, and otherwise in accordance with all the principles of good manufacturing practice, and 2) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, prior-sanctioned for such use, or regulated by an appropriate section in this part.|Polysorbate 80 is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.|For more FDA Requirements (Complete) data for Polysorbate 80 (7 total), please visit the HSDB record page.

DHHS/NTP; Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies) Technical Report Series No. 415 (1992); NIH Publication No. 92-3146[Available from, as of March 8, 2010: http://ntp.niehs.nih.gov/ntp/htdocs/LT_rpts/tr415.pdf]|DHHS/NTP; Developmental Toxicology of Polyoxyethylene Sorbitan Monooleate (CAS No. 9005-65-6) in Sprague-Dawley CD Rats, NTP Study No. TER91009 (October 1992). /Abstract/[Available from, as of August 16, 2002: http://ntp.niehs.nih.gov/index.cfm?objectid=0847FF31-90CC-C685-88B4D7EAC975BD44]

This chemical is probably combustible. (NTP, 1992)

Not Classified

SMALL SPILLS AND LEAKAGE: If you spill this chemical, FIRST REMOVE ALL SOURCES OF IGNITION. Then, use absorbent paper to pick up all liquid spill material. Seal the absorbent paper, as well as any of your clothing which may be contaminated, in a vapor-tight plastic bag for eventual disposal. Wash any surfaces you may have contaminated with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should store this chemical under refrigerated temperatures, and keep it away from oxidizing materials. STORE AWAY FROM SOURCES OF IGNITION. (NTP, 1992)

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)|Eye protection and gloves are recommended.|Respiratory protection: Respiratory protection is not required. Where protection is desired, use multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).|Hand protection: For prolonged or repeated contact use protective gloves.|Eye protection: Safety glasses.

Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.|Special protective equipment for fire-fighters: Wear self contained breathing apparatus for fire fighting if necessary.

Personal precautions: Avoid breathing vapors, mist or gas.|Environmental precautions: Do not let product enter drains.|Methods for cleaning up: Keep in suitable, closed containers for disposal.

Handling: Normal measures for preventive fire protection.|In case of skin contact: Wash off with soap and plenty of water.|In case of eye contact: Flush eyes with water as a precaution.|Hygiene measures: General industrial hygiene practice.

An eye irritant|May cause respiratory tract irritation. May cause skin irritation. May cause eye irritation.

Effect of polysorbate 80 on the bioavailability and distribution of methotrexate (MTX) was studied in NMRI and Porton mice following oral administration. In these two strains of mice concentrations of MTX were increased in various organs by this nonionic surfactant.|Tween 80 potentiated the antitumor effects of daunomycin both in rats with Ehrlich ascites tumor and in isolated tumor cells. At the subcellular level, Tween 80 increased binding of daunomycin to the nucleus and mitochondria.|In cultures of Chinese hamster cell lines resistant to actinomycin D and daunomycin, treatment with the nonionic surfactant Tween 80 potentiated the effects of the 2 antibiotics in growth studies and enhanced uptake.|Adriamycin in a 10% Tween 80 aqueous solution injected iv into sarcoma-bearing mice had higher antitumor activity and produced higher adriamycin levels in the spleen, lung, and kidney than did adriamycin given alone.|For more Interactions (Complete) data for Polysorbate 80 (7 total), please visit the HSDB record page.

LD50 Rat ip 6804 mg/kg|LD50 Rat iv 1790 mg/kg|LD50 Mouse oral 25000 mg/kg|LD50 Mouse ip 7600 mg/kg|For more Non-Human Toxicity Values (Complete) data for Polysorbate 80 (6 total), please visit the HSDB record page.

... Toxicity and carcinogenicity studies were conducted by administering polysorbate 80 (which met all compendial specifications) in feed to groups of F344/N rats and B6C3F1 mice of each sex for ... 2 years. ... 2 Yr Studies: Doses for the 2 yr studies ... groups of 60 rats and 60 mice of each sex received diets containing 0, 25,000 or 50,000 polysorbate 80 for up to 103 wk. Conclusions: Under the conditions of these 2 yr feed studies, there was equivocal evidence /carcinogenicity/ of polysorbate 80 in male F344/N rats based /on fingding/ pheochromocytomas of the adrenal medulla. There was no evidence of carcinogenic activity for polysorbate 80 in female F344/N rats or in male or female B6C3F1 mice given 25,000 or 50,000 ppm.|... Timed-mated Sprague-Dawley-derived (CD) rats (25/group) were exposed to 0, 500 or 5,000 mg/kg/day of polyoxyethylene sorbitan monooleate (TW80). Aqueous solns were delivered by gavage in a volume of 5 ml/kg of body weight on gestational days (gd) 6-15. ... All treated females survived to scheduled necropsy & 19-23 pregnancies/group were confirmed. No dose-related signs of toxicity were observed for individual animals during the in-life phase of the study or at scheduled necropsy. Avg maternal body weight (gestational days 0, 3, 6, 9, 12, 15, 18, or 20) did not differ among treatment groups, nor was there a treatment related change in maternal weight gain during treatment or gestation (absolute or corrected). There were no treatment-related effects upon the following maternal organ weights: gravid weight (absolute), kidney weight (absolute or relative), & heart weight (absolute or relative). Relative maternal liver weight (% body weight on gestational day 20 or % corrected body weight) was elevated in both olyoxyethylene sorbitan monooleate groups & absolute liver weight was elevated at 500 mg/kg/day. Maternal food intake was comparable across groups during the pre- & post-treatment periods, but was decreased by 14% during the first 3 days of treatment at 5,000 mg/kg/day relative to the vehicle control group. Maternal relative water intake was comparable among treatment groups throughout gestation. No differences among groups were noted for the number of corpora lutea/dam, the number of implantation sites/dam or the % preimplantation loss/litter. No adverse effects were noted on the growth, viability or morphological development of the conceptuses. In conclusion, the maternal LOAEL was 500 mg/kg/day (based upon an incr in maternal relative liver weight). No definitive adverse effects of olyoxyethylene sorbitan monooleate upon prenatal development were noted in this study. Thus, the developmental NOAEL was >5,000 mg/kg/day.

According to the 2006 TSCA Inventory Update Report, the number of persons reasonably likely to be exposed in the industrial manufacturing, processing, and use for Polysorbate 80 is 1 to 99; the data may be greatly underestimated(1).|NIOSH (NOES Survey 1981-1983) has statistically estimated that 162,120 workers (112,349 of these were female) were potentially exposed to Polysorbate 80 in the US(1).

1. 1= Practically nontoxic: probable oral lethal dose (human) above 15 g/kg, more than 1 quart (2.2 lb) for 70 kg person (150 lb).

Heavy metals (as Pb): not more than 10 mg/kg; Ash: not more than 0.25%; Water: not more than 3%

SYMPTOMS: Symptoms of exposure to this compound may include chemical pneumonitis, intestinal obstruction, and eye, skin and respiratory tract irritation. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits acrid smoke and fumes. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. If symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop, call a physician and be prepared to transport the victim to a hospital. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: DO NOT INDUCE VOMITING. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATELY call a hospital or poison control center. Be prepared to transport the victim to a hospital if advised by a physician. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. (NTP, 1992)

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/|/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

/HUMAN EXPOSURE STUDIES/ Tween 80 did not cause irritation to human skin.|/SIGNS AND SYMPTOMS/ Polysorbates are widely used in cosmetics, food products, and oral, parenteral, and topical pharmaceutical formulations, and are generally regarded as nontoxic and nonirritant materials. There have, however, been occasional reports of hypersensitivity to polysorbates following their topical and intramuscular use. Polysorbates have also been associated with serious adverse effects, including some deaths, in low birthweight infants intravenously administered a vitamin E preparation containing a mixture of polysorbates 20 and 80.|/SIGNS AND SYMPTOMS/ May be harmful if inhaled. May cause respiratory tract irritation. May be harmful if absorbed through skin. May cause skin irritation. May cause eye irritation. May be harmful if swallowed.|/CASE REPORTS/ Unintentionally administered to a 4-month /old/ infant at daily dose of 19.2 g/kg for 2 consecutive days. The patient passed 6 loose stools but showed no other evidence of intoxication.

GRADE: Polyoxyethylene (20) sorbitan monolaurate /Polysorbate 20/; Polyoxyethylene (20) sorbitan monostearate /Polysorbate 60/; Polyoxyethylene (20) sorbitan tristearate /Polysorbitan 65/|GRADE: Polyoxyethylene (20) sorbitan monooleate

Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs.: ACTIVE|XU - indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711).|One of a group of nonionic surfactants obtained by esterification of sorbitol with one or three molecules of a fatty acid (stearic, lauric, oleic, palmitic) under conditions that cause splitting out of water from the sorbitol, leaving sorbitan. About 20 moles of ethylene oxide per mole of sorbitol are used in the condensation to effect water solution. /Polysorbate/|A general term for dihydric alcohols that are physically and chemically similar to glycerol.

EPA Safer Chemical Functional Use Classes -> Surfactants|Safer Chemical Classes -> Green circle - The chemical has been verified to be of low concern|Food Additives -> EMULSIFIER; -> JECFA Functional Classes|Cosmetics -> Emulsifying; Surfactant

Food Additives -> EMULSIFIER;