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CAS Number: 53694-15-8
Molecular Weight: 446.49126000
Molecular Formula: C18 H38 O12
Emulsifier; emulsion stabilizer
This is a safety assessment of polysorbates as used in cosmetics.
These ingredients mostly function as surfactants in cosmetics.
The safety assessment combined the polysorbates reviewed in 3 former safety assessments with polysorbates that had not been assessed for safety into 1 report.
The Panel reviewed relevant data related to these ingredients.
The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) concluded that polysorbates were safe as cosmetic ingredients in the practices of use and concentration of this safety assessment when formulated to be nonirritating.
This conclusion supersedes the conclusion reached in the 3 former safety assessments.
This is a re-review of the available scientific literature and unpublished data relevant to assessing the safety of polysorbates as used in cosmetics.
This safety assessment combines polysorbates reviewed previously in 3 safety assessments with other polysorbates that have not been reviewed by the CIR Panel into a group of 20 polyethoxylated sorbitan or sorbitol esters of fatty acids.
These ingredients have a common core structure of sorbitan or sorbitol, etherified with polyethyoxy (PEG) chains, and esterified with fatty acids.
These ingredients mostly function as surfactants in cosmetics.
In the original safety assessment published in 1984, the CIR Panel concluded that 9 polysorbates were safe as used These ingredients are:
Polysorbate 20
Polysorbate 21
Polysorbate 40
Polysorbate 60
Polysorbate 61
Polysorbate 65
Polysorbate 80
Polysorbate 81
Polysorbate 85
Other polysorbates, which are also polyethoxylated sorbitan or sorbitol esters of fatty acids and contain a PEG moiety, have been reviewed by the CIR Panel.
In 20002, a safety assessment was published with a safe-as-used conclusion for the following 33 PEG sorbitan/sorbitol fatty acid esters:
PEG-20 sorbitan cocoate
PEG-40 sorbitan diisostearate
PEG-2 sorbitan isostearate
PEG-5 sorbitan isostearate
PEG-20 sorbitan isostearate
PEG-40 sorbitan lanolate
PEG-75 sorbitan lanolate
PEG-10 sorbitan laurate
PEG-40 sorbitan laurate
PEG-44 sorbitan laurate
PEG-75 sorbitan laurate
PEG-80 sorbitan laurate
PEG-3 sorbitan oleate
PEG-6 sorbitan oleate
PEG-80 sorbitan palmitate
PEG-40 sorbitan perisostearate
PEG-40 sorbitan peroleate
PEG-3 sorbitan stearate
PEG-6 sorbitan stearate
PEG-40 sorbitan stearate
PEG-60 sorbitan stearate
PEG-20 sorbitan tetraoleate
PEG-30 sorbitan tetraoleate
PEG-40 sorbitan tetraoleate
PEG-60 sorbitan tetraoleate
PEG-60 sorbitan tetrastearate
PEG-20 sorbitan triisostearate
PEG-160 sorbitan triisostearate
PEG-18 sorbitan trioleate
Sorbeth-40 hexaoleate (previously PEG-40 sorbitol
hexaoleate)
Sorbeth-50 hexaoleate (previously PEG-50 sorbitol
hexaoleate)
Sorbeth-30 tetraoleate laurate (previously PEG-30
sorbitol tetraoleate laurate)
Sorbeth-60 tetrastearate (previously PEG-60 sorbitol
tetrastearate)
Uses of SORBETH-20:
Polysorbate 20, used as a wetting agent in mouth drops
Polysorbate 40 Polysorbate 60, used as an emulsifier in powdered drink preparations such as hot cocoa mix.
Appearance of SORBETH-20:
Light yellow to yellow petrolatum-like substance or solid
SORBETH-20 is classified as:
Solvent
Viscosity controlling
Chemical Class of SORBETH-20:
Polyoxyethylene Lanolins
Lanolin Alcohols
Beeswax Derivatives
Functions of SORBETH-20:
Surfactant, Emulsifier, Stabilizer
Solvent: Dissolves other substances
Viscosity control agent: Increases or decreases the viscosity of cosmetics
Industry of SORBETH-20:
Cosmetic, Pharmaceutical
Physical Properties of SORBETH-20:
Assay: 95.00 to 100.00 %
Food Chemicals Codex Listed: No
Boiling Point: 634.27 °C. @ 760.00 mm Hg (est)
Flash Point: 639.00 °F. TCC ( 337.40 °C. ) (est)
logP (o/w): -3.927 (est)
Soluble in: water, 1e+006 mg/L @ 25 °C (est)
Chem/IUPAC Name of SORBETH-20:
Poly(oxy-1,2-ethanediyl)
.alpha.-hydro-.omega.-hydroxy-
ether with d-glucitol (6:1)
Synonyms of SORBETH-20:
1,4- anhydro-D-glucitol, ethoxylated, esters with beeswax (20 mol EO average molar ratio)
cithrol S20BW
nikkol GBW-125
peg-20 sorbitan beeswax
polyethylene glycol (20) sorbitan beeswax
polyoxyethylene (20) sorbitan beeswax
SORBETH-20 BEESWAX
PEG-20SORBITAN
Atlas G 1726
SORBETH-20
PEG-20 sorbitan
PEG 1000 sorbitan
POE (20) sorbitol
Polysorbate 20 (glycol)
Polyoxyethylene 20 sorbitan monooleate
Inhibited ethylene glycol, antifreeze
2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-{2-[(9E)-octadec-9-enoyloxy]ethyl}hexofuranoside
PEG-3 Sorbitan oleate
sorbate20
glycosperse 0-20
Tween&trade 20
glycosperse 0-20x
liposorb 0-20
glycospers e 0-20
Polyoxyethylene (20)
glycosperse 0-20 veg
Tween(R) 20
polysorb ate 20 b.p.c
Polysorbate 20 B.P.C
Polysorbate 20, U.S.P
POE(6) Sorbitan Monooleate
POE (5) sorbitan monooleate
Sorethytan (20) mono-oleate
POE (20) sorbitan monooleate
Sorbitan mono-oleate polyoxyethylene
Polyethylene oxi de sorbitan mono-oleate
Polysorbate 80 [USAN:BAN:INN:JAN]
2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate
Sorbitan, monooleate polyoxyethylene deriv
POLYOXYETHYLENESORBITAN MONOOLEATE (TWEEN 80)
(x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-9-octadecanoate, poly(oxy-1,2-ethanediyl) derivs., (Z)-
2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-[2-(oleoyloxy)ethyl]hexofuranoside
