Olive Oil PEG-7 Esters

Distributed for Comment Only -- Do Not Cite or Quote
Amended Safety Assessment of PEGylated Oils as Used in

Cosmetics
Status: Tentative Report for Public Comment

Release Date: September 21, 2012
Panel Meeting Date: December 10-11, 2012
The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V.
Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald
C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is F. Alan Andersen, Ph.D.
This report was prepared by Christina Burnett, Scientific Analyst/Writer, and Bart Heldreth, Ph.D., Chemist CIR.
Cosmetic Ingredient Review

1101 17th Street, NW, Suite 412 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢
cirinfo@cir-safety.org
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TABLE OF CONTENTS
TABLE OF CONTENTS.............................................................................................................................................................ii
INTRODUCTION ....................................................................................................................................................................... 1
CHEMISTRY .............................................................................................................................................................................. 1
Physical and Chemical Properties ........................................................................................................................................... 2
Impurities ................................................................................................................................................................................ 2
USE.............................................................................................................................................................................................. 2
Cosmetic .................................................................................................................................................................................. 2
Non-Cosmetic.......................................................................................................................................................................... 3
TOXICOKINETICS .................................................................................................................................................................... 3
Absorption, Distribution, Metabolism, Excretion ................................................................................................................... 3
Penetration Enhancement ........................................................................................................................................................ 3
TOXICOLOGICAL STUDIES ................................................................................................................................................... 4
Acute Toxicity ......................................................................................................................................................................... 4
Intravenous – Non-Human .................................................................................................................................................. 4
Repeated Dose Toxicity .......................................................................................................................................................... 4
Reproductive and Developmental Toxicity ................................................................................................................................. 4
GENOTOXICITY ....................................................................................................................................................................... 4
CARCINOGENICITY ................................................................................................................................................................ 5
IRRITATION AND SENSITIZATION ...................................................................................................................................... 5
Irritation ................................................................................................................................................................................... 5
Dermal – Non-Human ......................................................................................................................................................... 5
Ocular.................................................................................................................................................................................. 5
Sensitization ............................................................................................................................................................................ 6
CLINICAL USE .......................................................................................................................................................................... 6
Case Studies ............................................................................................................................................................................ 6
Summary ...................................................................................................................................................................................... 6
Discussion .................................................................................................................................................................................... 7
CONCLUSION............................................................................................................................................................................ 8
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ABSTRACT
The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of PEGylated oils, which function primarily as
surfactants in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment,
and concluded that PEGylated oils were safe as cosmetic ingredients in the present practices of use and concentration when
formulated to be non-irritating.
INTRODUCTION
In 1997, the Cosmetic Ingredient Review (CIR) published the safety assessment on PEG-30, -33, -35, -36, -40 castor
oil and PEG-30 and -40 hydrogenated castor oil with the conclusion “PEG-30, -33, -35, -36, and -40 castor oil are safe for
use in cosmetics at concentrations up to 50% and that PEG-30 and -40 hydrogenated castor oil are safe for use at
concentrations up to 100%.”1 These PEGylated castor oils function primarily as surfactants in cosmetic products.
Since the original review, numerous additional studies were published related to the noncosmetic use of PEG-35
castor oil and PEG-40 hydrogenated castor oil (trade names Cremophor EL and Cremophor RH, respectively) in drug
delivery systems. The few of these studies that appear relevant to assessing the safety of PEGylated oils in cosmetics are
summarized in this safety assessment. Overall, single-dose and repeated-dose toxicity, reproductive and developmental
toxicity, genotoxicity, carcinogenicity, dermal and ocular irritation, and sensitization and photosensitization data were
available.
Because of similarities in chemical properties and cosmetic function, the PEGylated oils listed in Table 1 have been
added to the safety assessment of PEG-30 castor oil, et al. These cosmetic ingredients include components that have been
previously reviewed and concluded to be safe for use by the CIR Expert Panel, most notably the recent safety assessments on
plant-derived fatty acid oils, polyethylene glycols (PEGs) with an average of 4 moles of ethylene oxide or greater, and alkyl
PEG ethers. The ingredients, their conclusions, a summary of the findings, and published citations are found in Table 2.
CHEMISTRY
The definitions of the PEGylated oils can be found in Table 3.
Just as oils and other PEGylated materials are mixtures, PEGylated oils are mixtures. As most natural source oils
are primarily triglycerides (and mono- and diglycerides) and fatty acids, PEGylated oils are primarily PEGylated glycerides,
along with some PEGylated fatty acids. PEGylation of glycerides occurs not only as an etherification of the free alcohol
groups of the glycerides with ethylene oxide groups, but also as a transesterification, which results in net insertion of PEG
groups between the glyceryl and fatty acid components of the glyceride.2,3 For example, the primary component of castor oil,
the ricinoleate triglyceride, is ethoxylated as shown in Figure 1, wherein n is equal to the number of ethylene oxide repeat
units and need not be the same at all places of the molecule. It should be noted that n is not equal to X. In other words,
wherein the value of X in PEG-X is equal to 2 (e.g., PEG-2 Castor Oil), n is not equal to 2. Instead, X represents the number
of stoichiometric equivalents of ethylene oxide that were added to one stoichiometric equivalent of castor oil. Therefore, the
sum of all of the different n values in the mixture may be no more than X. Indeed, when one mole of ethylene oxide is
reacted with one mole of fatty alcohol, adducts having no added ethylene oxide are the predominate material in the mixture.2
Furthermore, when ethylene oxide reacts with castor oil it is approximately twice as likely that it will react at an ester site
versus an alcohol site. Moreover, a percentage (13% in one specific case) of the ethylene oxide simply reacts with other
molecules of ethylene oxide, resulting in some polyethylene glycols unattached to glycerides or acid groups.
While castor oil triglycerides are primarily (approximately 87%) composed of ricinoleic acid residues,
approximately 7% are oleic acid, 3% are linoleic acid, 2% are palmitic acid, 1% are stearic acid, and a trace are
dihydroxysteric acid.1 Thus, these PEGylated castor oil ingredients, and all of the PEGylated oil ingredients, are rather
complex mixtures of structurally related molecules.
Figure 1. Glyceryl triricinoleyl polyethylene glycol

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The available free fatty acids found in castor oil, and the other oils, may also be esterified by the ethoxylation
process, as seen in Figure 2 (and etherified with ethylene oxide groups if there are any reactive alcohol functionalities on the
fatty acids).
Figure 2. Fatty acid esterification
Some of the castor oil derived ingredients in this report have been hydrogenated. Hydrogenation of castor oil
primarily results in the reduction of the Ω-9 unsaturation of ricinoleate triglycerides (and the Ω-9 unsaturation of any free
ricinoleic fatty acids).2 Accordingly, hydrogenated castor oil is principally 12-hydroxystearic triglyceride. The resultant
ethoxylated triglyceride, therefore, differs from that of PEGylated non-hydrogenated castor oil only in the loss of these
double bonds, as seen in Figure 3.
Figure 3. Glyceryl 12-hydroxystearyl polyethylene glycol
Physical and Chemical Properties

Physical and chemical properties of PEG-30, -33, -35, -36, -40 castor oil and PEG-30 and -40 hydrogenated castor
oil can be found in the original safety assessment.1 A supplier reports that PEG-30,-35, and-40 are pale yellow viscous liquids
at 30° C and have a maximum water content of 0.2%.4 PEG-40 hydrogenated castor oil is reported to be a waxy liquid at 30°
C and also has a maximum water content of 0.2%.
Impurities
PEGs are the condensation products of ethylene oxide and water, with the chain length controlled by number of
moles of ethylene oxide that are polymerized. PEGs may contain trace amounts of 1,4-dioxane, a by-product of ethoxylation.
1,4-Dioxane is a known animal carcinogen.5 FDA has been periodically monitoring the levels of 1,4-dioxane in cosmetic
products, and the cosmetic industry reported that it is aware that 1,4-dioxane may be an impurity in PEGs and, thus, uses
additional purification steps to remove it from the ingredient before blending into cosmetic formulations.6,7
USE
Cosmetic
Table 4a presents the historical and current product formulation data for PEG-30, -33, -35, -36, -40 castor oil and
PEG-30 and -40 hydrogenated castor oil. These PEGylated castor oils function primarily as surfactants (emulsifying or
solubilizing agents) in cosmetic formulations.8 According to information supplied to the Food and Drug Administration’s
(FDA) Voluntary Cosmetic Registration Program (VCRP) database by industry in 1997, PEG-40 hydrogenated castor oil had
2
the most uses at 268, with the majority of the uses reported in leave-on products with a dermal exposure route.1 The
ingredient with the second most uses was PEG-40 castor oil with 170 uses, most in leave-on products with a dermal exposure
route. An industry survey reported use concentrations for PEG-40 hydrogenated castor oil and PEG-40 castor oil of < 10%
and < 5%, respectively. Currently, the FDA’s VCRP database indicates that uses have decreased for PEG-30 castor oil,
PEG-40 castor oil, and PEG-30 hydrogenated castor oil, with the most significant decrease occurring for PEG-40 castor oil,
which now has 95 reported uses.9 Increases in use are reported for the remaining PEGylated castor oils from the original
report. The most significant increase is for PEG-40 hydrogenated castor oil, which now has 2107 reported uses (up from 268
uses). In a recent survey of use concentrations, PEG-40 hydrogenated castor oil had a maximum use concentration range of
7.0 x 10-5% to 22%, with 22% reported in leave-on non-coloring hair products.10 PEG-30 castor oil had a maximum use
concentration of 0.1% in a rinse-off non-coloring hair product.
Table 4b presents the current product formulation data for the cosmetic ingredients that were added to the
PEGylated oil safety assessment. Currently, the VCRP database indicates that, of the additional ingredients, PEG-60
hydrogenated castor oil has the most uses (349) with the majority in leave-on products with a dermal exposure route.9 The
maximum use concentration range for PEG-60 hydrogenated castor oil was 4.0 x 10-5% to 18%, with the 18% reported in
leave-on non-coloring hair products.11 Olive oil PEG-7 esters had the second most reported uses (97). The maximum use
concentration range for olive oil PEG-7 esters was 0.05% to 97%, with the 97% reported in a rinse-off product.
In some cases, reports of uses were received from the VCRP, but no concentration of use data were available. For
example, PEG-33 castor oil is reported to be used in 41 formulations, but no use concentration data were available. In other
cases, no reported uses were received from the VCRP, but a use concentration was provided in the industry survey. For
example, PEG-25 castor oil was not reported in the VCRP database to be in use, but the industry survey indicated that it is
used in leave-on formulations at maximum concentrations ranging from 3%-17%. It should be presumed that PEG-25 castor
oil is used in at least one cosmetic formulation.
PEGylated oils were reported to be used in fragrance products, hair sprays, deodorants, and indoor tanning
preparations and could possibly be inhaled. For example, PEG-60 castor oil was reported to be used in aerosol hair sprays at
a maximum concentration of 16%. In practice, 95% to 99% of the droplets/particles released from cosmetic sprays have
aerodynamic equivalent diameters >10 µm, with propellant sprays yielding a greater fraction of droplets/particles below 10
µm compared with pump sprays.12-15 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be
deposited in the nasopharyngeal and bronchial regions and would not be respirable (i.e., they would not enter the lungs) to
any appreciable amount.13,14 There is some evidence indicating that deodorant spray products can release substantially larger
fractions of particulates having aerodynamic equivalent diameters in the range considered to be respirable.14 However, the
information is not sufficient to determine whether significantly greater lung exposures result from the use of deodorant
sprays, compared to other cosmetic sprays.
The PEGylated oils are not restricted from use in any way under the rules governing cosmetic products in the
European Union.16
Non-Cosmetic
PEG-30 castor oil and PEG-40 hydrogenated castor oil may be used as nonionic surfactants in oral, topical, and
parenteral drug delivery systems.3,4,17-23 PEGylated castor oil derivatives may also be used in animal feeds and textiles.4
PEG-30, -33, -35, -36, and -40 castor oil have been approved by the FDA as indirect food additives in adhesives
and components of coatings (21 CFR § 175.105 and §175.300) and packaging and food contact surfaces (21 CFR §176.210,
§177.2800). PEG-30 and -40 hydrogenated castor oil are approved as direct food additives (21 CFR §73.1) as well as in
indirect food additives in packaging and food contact surfaces (21 CFR §177.2800).
TOXICOKINETICS
Toxicokinetics data were available supporting the safety of alkyl PEG ethers and castor oil, as summarized in Table 2.
Absorption, Distribution, Metabolism, Excretion
The disposition of PEG-35 castor oil was determined in 31 cancer patients treated with a 1-h infusion of paclitaxel
(87.8 mg PEG-35 castor oil per mg drug).24 Dose levels of PEG-35 castor oil ranged from 70 to 100 mg/m2. Plasma
concentrations were measured. Clearance of PEG-35 castor oil appeared to be independent of infusion duration and the
administered dose in the range studied (P =0.797). Exposure measures increased in near proportion to an increase in dose.
PEG-35 castor oil had a half-life and clearance of 35.7 + 18.9 h and 0.216 + 0.075 L/h, respectively (P < 0.00001). The
volume of distribution at steady state was 9.48 + 2.59 L and indicated limited distribution of the excipient outside of the
central compartment. These results were compared to those of the excipient Tween 80, which had a shorter terminal half-life
(0.607 + 0.245 h) and total plasma clearance (7.70 + 2.90 L/h). The other values were similar. The study concluded that use
of PEG-35 castor oil as a formulation vehicle could result in drug interaction and excipient-related toxic side effects due to its
relatively low rates of elimination.
Penetration Enhancement
A study of the development of a topical gel for treatment of acne vulgaris reports that various types of PEGs are
hydrophilic penetration enhancers and are used in topical dermatological preparations.17 The authors selected PEG-40
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hydrogenated castor oil because of its properties as a very hydrophilic, non-ionic solubilizer for fat-soluble vitamins A, D, E,
and K, and for its stability and clarity in alcohol solution.
In a study evaluating vehicle effects on in vitro skin permeation of model drugs caffeine and testosterone, apricot
kernel oil PEG-6 esters facilitated the flux and diffusivity of caffeine across the stratum corneum, when compared to
propylene glycol.25
TOXICOLOGICAL STUDIES
Acute Toxicity
Dermal and oral acute and repeated dose toxicity data were available supporting the safety of alkyl PEG ethers and
castor oil as summarized in Table 2.
Intravenous – Non-Human
PEG-X CASTOR OIL
Castor oil with an unspecified number of stoichiometric equivalents of ethylene oxide (generically listed as
Cremophor) mixed with dimethyl acetamide (DMA) was evaluated as a vehicle in a diabetes drug.26 The mixture was
composed of 23%-45% DMA/10%-12% Cremophor in water and the dose volume was 1.67 to 3 ml/kg. Groups of 3 New
Zealand White rabbits received intravenously the test material, saline, insulin, or N-methyl-2-pyrrolidone (NMP) into the
marginal ear vein. Blood was drawn just before injection and again at 0.25, 0.5, 1, 2, 4, and 24 h after injection to determine
glycemia values. Glycemia after injection with the DMA/Cremophor mixture remained stable and within the normal range of
3.6 to 5.0 mM. These results were comparable to those for the rabbits that received saline. In addition, the test material did
not elicit irritation at the site of injection.
PEG-60 HYDROGENATED CASTOR OIL

The toxicity of PEG-60 hydrogenated castor oil was evaluated in male and female Beagle dogs, male and female
cynomolgus monkeys, male New Zealand White rabbits, male Hartley guinea pigs, and male Sprague Dawley rats.27 The test
material was injected intravenously to groups of 3 dogs at 0.625, 1.25, 2.5, or 10 mg/kg; in groups of 3 monkeys or 5 rabbits
at 50 or 100 mg/5 ml/kg; and in groups of 5 guinea pigs, and 5 rats at 10 or 100 mg/5 ml/kg. Blood pressure was monitored
in the dogs before the injection and 10, 30, and 60 min after injection. Blood was taken in all animals to measure plasma
histamine levels. In dogs, further histopathological examinations were performed on mast cells in the liver and skin. Clinical
signs of toxicity were observed until 60 min after injection in all animals.
In dogs injected with 1.25, 2.5 or 10 mg/kg of the test material, blood pressure decreased and flush, swelling and
itching were observed. Additionally, in the 10 mg/kg dose group, a decrease in spontaneous motility was observed. An
increase in histamine levels was observed in the 2.5 and 10 mg/kg dose groups. Degranulation was observed after injection
in the mast cells of the skin, but not in the liver cells. No signs of toxicity were observed in monkeys, rabbits, guinea pigs or
rats and there was no change in plasma histamine levels. The toxicity of PEG-60 hydrogenated castor oil may be species
specific.27
Repeated Dose Toxicity
PEG-35 CASTOR OIL

Several rat studies investigated the effects of the use of Cremophor EL (PEG-35 castor oil) as a vehicle in
intravenous drugs.28-31 Effects on cardiac and skeletal function have been observed at concentrations of 100 µg/L.
REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

Reproductive and developmental toxicity data were available supporting the safety of PEGS, castor oil, and alkyl
PEG ethers, as summarized in Table 2.
GENOTOXICITY
Genotoxicity data were available supporting the safety of castor oil, PEGs, and alkyl PEG ethers, as summarized in
Table 2.

The genotoxic potential of PEG-60 hydrogenated castor oil was studied in a reverse mutation test in Salmonella
typhimurium strains TA100, TA98, TA1535, and TA1537 and in Escherichia coli strain WP2uvrA, with and without
metabolic activation.32 The test concentrations ranged from 313-5000 μg/plate. The positive controls were 9-aminoacridine,
sodium azide, 2-(2-furyl)-3-(5-nitro-2-furyl)-acrylamide, and 2-aminoanthracene. No biologically relevant increases in
revertant colony numbers were observed in any test strain at any dose level, with or without metabolic activation. Controls
yielded expected results. The study concluded that PEG-60 hydrogenated castor oil was not genotoxic.
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The research study above also investigated the genotoxic potential of PEG-60 hydrogenated castor oil in a
chromosome aberration study with Chinese hamster V79 cells, with and without metabolic activation.32 The test
concentrations ranged from 313-5000 μg/ml. The positive controls were mitomycin C and dimethylnitrosamine. The test
material without metabolic activation had dose-related inhibition of cell proliferation after 24- and 48-h treatments. With
metabolic activation, the test material induced only slight inhibition of cell proliferation even at the highest concentration
after 6 h treatment. PEG-60 hydrogenated castor oil did not induce chromosome aberrations at any dose, with or without
metabolic activation. The controls yielded expected results. The study concluded that PEG-60 hydrogenated castor oil was
not genotoxic.
The same study also researched the genotoxic potential of PEG-60 hydrogenated castor oil in a mouse micronucleus
test using BDF1 male and female mice.32 A dose range finding experiment preceded the main study. In the main study,
groups of 5 mice of each sex received single intraperitoneal injections of 2000 mg/kg body weight PEG-60 hydrogenated
castor oil. Control groups received physiological saline or mitomycin C. Bone marrow cells were collected at 24, 48, or 72
h. The number of micronucleated erythrocytes in 1000 polychromatic erythrocytes and the number of polychromatic
erythrocytes in 1000 erythrocytes were recorded for each mouse. In the dose range-finding study, no deaths occurred. In the
main study, no treatment-related mortalities or clinical signs of toxicity were observed. No significant increase of
micronucleated polychromatic erythrocytes or significant decrease of the ratio of polychromatic to normochromatic
erythrocytes were observed in male or female mice that received the test material. The controls yielded expected results. The
study concluded that PEG-60 hydrogenated castor oil was not genotoxic.
CARCINOGENICITY
Carcinogenicity data were available supporting the safety of PEGs and alkyl PEG ethers, as summarized in Table 2.
IRRITATION AND SENSITIZATION

Irritation
Irritation data were available supporting the safety of PEGs, mink oil, and plant-derived fatty acid oils, as
summarized in Table 2.
Dermal – Non-Human
PEG-35 CASTOR OIL
A skin irritation study of a pharmaceutical microemulsion that contained 20% w/w PEG-35 castor oil was performed
in male guinea pigs (strain not specified).33 The hair on the backs of the guinea pigs was removed 24 h before treatment, and
the animals were divided into a group with intact skin and a group with skin injury from scarification. These groups were
again subdivided into single and multiple applications. There were a total of 5 guinea pigs in each subgroup. All guinea pigs
received the test material and a control cream. Single application animals were treated for 24 h and the test sites were
inspected for erythema and edema 1, 24, 48, and 72 h after material removal. Multiple-application animals were treated for
24 h, followed by assessment for skin irritation 1 h after material removal, in a total of 7 applications. The test sites were
observed for an additional 3 days after the last application. While very slight irritation was observed on average at the 1-h
observation point in guinea pigs treated with multiple applications with damaged skin, the average scores were still in the
range that was considered to indicate “no irritation”. No irritation was observed in any of the single-application animals or in
the intact skin of the multiple-application animals. It was concluded that single and multiple applications of the
microemulsion that contained 20% w/w PEG-35 castor oil did not cause irritation effects in guinea pigs.
PEG-40 HYDROGENTATED CASTOR OIL

A dermal irritation test was performed in mice (species and number not described) to investigate the potential
irritancy of a microemulsion that contains 20% PEG-40 hydrogenated castor oil.23 A single dose of 10 μl of the test
microemulsion was applied to the left ear of the mouse. The right ear served as a control. The mice were observed for
development of erythema for 6 days. No signs of irritation were observed in the mice. The authors concluded that the
formulation containing 20% PEG-40 hydrogenated castor oil would probably not irritate human skin.
The dermal irritancy potential of a microemulsion gel system that contained 20.66% PEG-40 hydrogenated castor
oil as a surfactant was studied in male albino rats using the Draize method.34 Animals were divided into 3 groups of 6: a
negative control (no treatment), a positive control (0.8% aq. formalin), and the test formulation. The rats received a dose of
0.5 g of the formulation on a 5-cm2 area on the shaved dorsal side daily for 3 consecutive days. Signs of erythema and edema
were monitored daily for 3 days. After 3 days, the rats were killed and skin samples were taken for histopathological
examination. No signs of irritation were observed in the test formulation. The controls yielded expected results.
Histopathological examination found no apparent signs of skin irritation. The study concluded that the test formulation that
contained 20.66% PEG-40 hydrogenated castor oil was not a skin irritant.
Ocular
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PEG-35 CASTOR OIL

Several different formulations of a potential glaucoma drug in a nanoemulsion were tested for ocular irritation
potential.35 A few of these formulations contained PEG-35 castor oil as a surfactant. Groups of 6 New Zealand albino
rabbits received test formulations that contained 0%-13% PEG-35 castor oil. In each rabbit, the right eye received 50 μl of
the tested formulation, while the left eye was used as a control. The rabbits received the test formulation every 2.5 h through
a period of 7.5 h per day for 3 successive days and once on the fourth day. Eyes were examined according to the Draize
method 1 and 24 h after the last instillation. The eyelids, cornea, iris, conjunctiva, and anterior chamber were inspected for
inflammation or other toxic reactions. The eyes were then stained with fluorescein and examined under UV light to verify
possible corneal lesion. A few nanoemulsion formulations that contained up to 13.5% PEG-35 castor oil were found to be
non-irritating and tolerated well by the rabbit eye. Cross sections from the corneas of rabbits’ eye after application of the
tested formulations together with a control section showed that both corneal structure and integrity were unaffected by
treatment.
Sensitization
Sensitization data were available support the safety of PEGs, mink oil, plant-derived fatty acid oils, and alkyl PEG
ethers, as summarized in Table 2.
CLINICAL USE
Case Studies
PEG-35 CASTOR OIL
A 40-year-old female undergoing chemotherapy treatment for breast cancer had a cutaneous lupus erythematous-like
reaction within 24 h of intravenous administration of the drug paclitaxel that contained the diluent, PEG-35 castor oil.36
When treatment was switched to a formulation of paclitaxel bound to albumin, without PEG-35 castor oil, no lupus-like
reactions were observed. The case study concluded that PEG-35 castor oil induced the lupus-like reaction and suggested that
previously reported incidences of lupus-like reaction in chemotherapy patients was from this diluent and not from the
chemotherapeutic agent.

A 73-year-old male was reported to have an eczematous rash on the face and neck after use of a sunscreen lotion.37
The patient was patch tested with an extended British Contact Dermatitis Society standard series, medicament series, facial
series, photoallergic series, and the sunscreen. A positive reaction was elicited only with the patient’s sunscreen, both on
nonirradiated and irradiated skin. When tested with the individual ingredients of the sunscreen, a positive reaction occurred
to 10% PEG-7 hydrogenated castor oil in petrolatum (+ on days 2 and 4). Negative reactions were observed to the remaining
sunscreen ingredients.

A 27-year-old male undergoing maintenance chemotherapy for acute myeloblastic leukemia developed a high-grade
fever and erythroblastopenia within 6 h of after intravenous administration of the chemotherapy drugs that included
enocitabine.38 The enocitabine product contained PEG-60 hydrogenated castor oil. When enocitabine was administered
alone, the same symptoms reoccurred. Co-culturing the patient’s bone marrow with enocitabine or PEG-60 hydrogenated
castor oil found significant growth inhibition of late erythroid progenitors in the presence of the patient’s IgG. The
researchers of the study believe that PEG-60 hydrogenated castor oil acted as a hapten and caused the immunological
suppression of the growth of erythroid progenitors through a hypersensitive reaction mediated by IgG.
SUMMARY
Just as oils and other PEGylated materials are mixtures, PEGylated oils are mixtures. As most natural source oils
are primarily triglycerides (and mono- and diglycerides) and fatty acids, PEGylated oils are primarily PEGylated glycerides,
along with some PEGylated fatty acids.
PEGs are the condensation products of ethylene oxide and water, with the chain length controlled by number of
moles of ethylene oxide that are polymerized. PEGs may contain trace amounts of 1,4-dioxane, a by-product of ethoxylation.
The PEGylated castor oils function primarily as surfactants that function as emulsifying or solubilizing agents in
cosmetic formulations. Of the 130 PEGylated oil ingredients described as cosmetic ingredients, only 35 have uses reported
by either the FDA’s VCRP database or the Personal Care Products Council. Current FDA data indicate that PEG-40
hydrogenated castor oil has the largest number of reported uses, 2107, with a maximum use concentration range of 7.0 x 10-
5
% to 22%, with the 22% reported in leave-on non-coloring hair products.
PEG-30 castor oil and PEG-40 hydrogenated castor oil may be used as nonionic surfactants in oral, topical, and
parenteral drug delivery systems. PEGylated castor oil derivatives may also be used in animal feeds and textiles. PEG-30, -
33, -35, -36, and -40 castor oil have been approved by the FDA as indirect food additives in adhesives and PEG-30 and -40
hydrogenated castor oil are approved as direct and indirect food additives.
6
Various types of PEGs are hydrophilic penetration enhancers and are used in topical dermatological preparations.
Unspecified PEG castor oil did not elicit irritation at the site of injection in rabbits when evaluated as a vehicle in an
intravenous drug.
The toxicity of PEG-60 hydrogenated castor oil was evaluated in male and female beagle dogs, male and female
cynomolgus monkeys, male New Zealand White rabbits, male Hartley guinea pigs, and male Sprague Dawley rats. Toxicity,
including decreased blood pressure, flush, swelling, itching, and increase histamine levels, was observed in dogs injected
with 1.25, 2.5 or 10 mg/kg of the test material. No signs of toxicity were observed in monkeys, rabbits, guinea pigs or rats.
Several rat studies investigated the effects of the use of Cremophor EL (PEG-35 castor oil) as a vehicle in
intravenous drugs. Effects on cardiac and skeletal function have been observed at a concentration of 100 µg/L.
The genotoxic potential of PEG-60 hydrogenated castor oil was studied in a reverse mutation test, in a chromosome
aberration study, and in a mouse micronucleus test: the studies concluded that PEG-60 hydrogenated castor oil was not
genotoxic.
A study of single and multiple applications of a microemulsion that contained 20% w/w PEG-35 castor oil did not
cause irritation effects in guinea pigs. A dermal irritation test performed in mice concluded that a formulation containing 20%
PEG-40 hydrogenated castor oil would probably not irritate human skin. A study of the dermal irritancy potential of a
microemulsion gel system in rats concluded that the test formulation containing 20.66% PEG-40 hydrogenated castor oil was
not a skin irritant. Nanoemulsions containing up to 13.5% PEG-35 castor oil were non-irritating in rabbit eyes.
Case studies of adverse events occurring in cancer patients were reported following use of chemotherapy drugs that
contained PEG-35 castor oil and PEG-60 hydrogenated castor oil. Another case study reported an adverse dermatological
event following use of a sunscreen containing PEG-7 hydrogenated castor oil.
DISCUSSION
Overall, toxicokinetics, single-dose and repeated-dose toxicity, reproductive and developmental toxicity,
genotoxicity, carcinogenicity, dermal and ocular irritation, and sensitization data were available for PEG castor oils.
Similarly, extensive supportive data exist for the components of the PEGylated oils, which are complex mixtures of the
etherification and transesterifcation products of fatty acid glycerides and fatty acids derived from the identified plant source
with the equivalents of ethylene oxide to reach the desired PEG length. PEG compounds will be present unattached to
glycerides or fatty acid groups. Because of this unique chemistry, the Panel determined that the available data in previous
safety assessments of PEGs and of plant-derived fatty acids strongly supported the safety of PEGylated oils in a “read-
across” fashion.
The Panel expressed concern regarding the possible presence of ethylene oxide and trace amounts of 1,4-dioxane as
impurities in any cosmetic ingredient containing a PEG moiety. They stressed that the cosmetic industry should continue to
use the necessary purification procedures to remove these impurities from the ingredient before blending it into cosmetic
formulations.
The Panel also expressed concern regarding pesticide residues and heavy metals that may be present in botanical
ingredients. They stressed that the cosmetics industry should continue to use the necessary procedures to limit these
impurities in the ingredient before blending into cosmetic formulation.
While a safety assessment of diethylene glycol (aka PEG-2) has not been completed, the safety assessment of the
PEGs group of ingredients includes PEG-4, which is a mixture that includes PEG-2. This suggested that PEG-2 would be
safe for use in cosmetics.
The Panel recognized that some of these ingredients can enhance the penetration of other ingredients through the
skin. They cautioned that care should be taken in formulating cosmetic products that may combine these ingredients with any
ingredients whose safety was based on their lack of dermal absorption, or when dermal absorption was a concern.
The Panel looked at changes in the pattern of use and concentration of use since the original safety assessment of
PEG castor oils and noted that the earlier safety assessment had specified safe up to 50% use concentration. As PEG castor
oils and the rest of the PEGylated oils now are used at concentrations below 50% in leave-on products, the Panel determined
that concentration limits need no longer be specified. Products using these ingredients should be formulated to be non-
irritating
The Panel noted that adverse reactions have been reported for PEG-35 castor oil used as a vehicle in intravenous
drugs. Because this route of exposure does not occur from cosmetic use, the Panel considered that such data were not
relevant to assessing the safety of the ingredient in cosmetics.
The Panel discussed the issue of incidental inhalation exposure from fragrance products, hair sprays, deodorants,
and indoor tanning preparations. There were no inhalation toxicity data available. The Panel considered pertinent data
indicating that incidental inhalation exposures to some of these ingredients in such aerosolized cosmetic products would not
cause adverse health effects, including dermal irritation and sensitization.
The Panel noted that 95% – 99% of droplets/particles produced in cosmetic aerosols would not be respirable to any
appreciable amount. The potential for inhalation toxicity is not limited to respirable droplets/particles deposited in the lungs;
in principle, inhaled droplets/particles deposited in the nasopharyngeal and thoracic regions of the respiratory tract may cause
toxic effects depending on their chemical and other properties. However, coupled with the small actual exposure in the
7
breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental
inhalation would not be a significant route of exposure that might lead to local respiratory or systemic effects. A detailed
discussion and summary of the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic
products is available at http://www.cir-safety.org/cir-findings.
CONCLUSION
The CIR Expert Panel concluded that the PEGylated oil ingredients listed below are safe in the present practices of
use and concentration in cosmetics when formulated to be non-irritating. This conclusion supersedes the earlier conclusion
issued by the Expert Panel in 1997.
PEG-2 Castor Oil* PEG-20 Hydrogenated Castor Oil Laurate*

PEG-9 Castor Oil PEG-20 Hydrogenated Castor Oil PCA Isostearate*
PEG-10 Castor Oil* PEG-30 Hydrogenated Castor Oil PCA Isostearate*
PEG-11 Castor Oil* PEG-40 Hydrogenated Castor Oil PCA Isostearate
PEG-15 Castor Oil* PEG-60 Hydrogenated Castor Oil PCA Isostearate*
PEG-16 Castor Oil* PEG-50 Hydrogenated Castor Oil Succinate
PEG-20 Castor Oil* Potassium PEG-50 Hydrogenated Castor Oil Succinate*
PEG-25 Castor Oil Sodium PEG-50 Hydrogenated Castor Oil Succinate*
PEG-26 Castor Oil* PEG-5 Hydrogenated Castor Oil Triisostearate*
PEG-30 Castor Oil PEG-15 Hydrogenated Castor Oil Triisostearate*
PEG-33 Castor Oil PEG-20 Hydrogenated Castor Oil Triisostearate
PEG-50 Castor Oil Adansonia Digitata Seed Oil PEG-8 Esters*
PEG-54 Castor Oil* Almond Oil PEG-6 Esters*
PEG-55 Castor Oil* Almond Oil PEG-8 Esters *
PEG-60 Castor Oil Apricot Kernel Oil PEG-6 Esters
PEG-75 Castor Oil* Apricot Kernel Oil PEG-8 Esters*
PEG-80 Castor Oil* Apricot Kernel Oil PEG-40 Esters*
PEG-100 Castor Oil* Argan Oil PEG-8 Esters*
PEG-200 Castor Oil* Avocado Oil PEG-8 Esters*
PEG-18 Castor Oil Dioleate* Avocado Oil PEG-11 Esters
PEG-60 Castor Oil Isostearate* Bertholletia Excelsa Seed Oil PEG-8 Esters*
PEG-2 Hydrogenated Castor Oil Borage Seed Oil PEG-8 Esters*
PEG-5 Hydrogenated Castor Oil* Coconut Oil PEG-10 Esters
PEG-6 Hydrogenated Castor Oil* Corn Oil PEG-6 Esters*
PEG-7 Hydrogenated Castor Oil Corn Oil PEG-8 Esters*
PEG-8 Hydrogenated Castor Oil* Grape Seed Oil PEG-8 Esters
Hydrogenated Castor Oil PEG-8 Esters* Hazel Seed Oil PEG-8 Esters*
PEG-10 Hydrogenated Castor Oil Hydrogenated Palm/Palm Kernel Oil PEG-6 Esters
PEG-16 Hydrogenated Castor Oil Jojoba Oil PEG-8 Esters
PEG-20 Hydrogenated Castor Oil Jojoba Oil PEG-150 Esters*
PEG-25 Hydrogenated Castor Oil Linseed Oil PEG-8 Esters*
PEG-30 Hydrogenated Castor Oil Macadamia Ternifolia Seed Oil PEG-8 Esters*
PEG-35 Hydrogenated Castor Oil Mango Seed Oil PEG-70 Esters*
PEG-40 Hydrogenated Castor Oil Mink Oil PEG-13 Esters*
PEG-45 Hydrogenated Castor Oil Olive Oil PEG-6 Esters*
PEG-50 Hydrogenated Castor Oil Olive Oil PEG-7 Esters
PEG-54 Hydrogenated Castor Oil* Olive Oil PEG-8 Esters*
PEG-55 Hydrogenated Castor Oil* Olive Oil PEG-10 Esters
PEG-60 Hydrogenated Castor Oil Orbignya Oleifera Seed Oil PEG-8 Esters*
PEG-65 Hydrogenated Castor Oil* Palm Oil PEG-8 Esters*
PEG-80 Hydrogenated Castor Oil Passiflora Edulis Seed Oils PEG-8 Esters*
PEG-100 Hydrogenated Castor Oil Peanut Oil PEG-6 Esters*
PEG-200 Hydrogenated Castor Oil* PEG-75 Crambe Abyssinica Seed Oil*
PEG-5 Hydrogenated Castor Oil Isostearate* PEG-75 Meadowfoam Oil
PEG-10 Hydrogenated Castor Oil Isostearate* Pumpkin Seed Oil PEG-8 Esters*
PEG-15 Hydrogenated Castor Oil Isostearate* Rapeseed Oil PEG-3 Esters*
PEG-20 Hydrogenated Castor Oil Isostearate* Rapeseed Oil PEG-20 Esters*
PEG-30 Hydrogenated Castor Oil Isostearate* Raspberry Seed Oil PEG-8 Esters*
PEG-40 Hydrogenated Castor Oil Isostearate* Safflower Seed Oil PEG-8 Esters*
PEG-50 Hydrogenated Castor Oil Isostearate* Schinziophyton Rautanenii Kernel Oil PEG-8 Esters*
PEG-58 Hydrogenated Castor Oil Isostearate* Sclerocarya Birrea Seed Oil PEG-8 Esters*
8
Sesame Seed Oil PEG-8 Esters* Sunflower Seed Oil PEG-32 Esters*
Soybean Oil PEG-8 Esters* Sweet Almond Oil PEG-8 Esters*
Soybean Oil PEG-20 Esters* Watermelon Seed Oil PEG-8 Esters*
Soybean Oil PEG-36 Esters* Wheat Germ Oil PEG-40 Butyloctanol Esters*
Sunflower Seed Oil PEG-8 Esters* Wheat Germ Oil PEG-8 Esters*
*Not in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories
and at concentrations comparable to others in this group.
2
Table 1. PEGylated Oils

PEG-2 Castor Oil PEG-50 Hydrogenated Castor Oil Succinate
PEG-3 Castor Oil Potassium PEG-50 Hydrogenated Castor Oil Succinate
PEG-4 Castor Oil Sodium PEG-50 Hydrogenated Castor Oil Succinate
PEG-25 Castor Oil Adansonia Digitata Seed Oil PEG-8 Esters
PEG-26 Castor Oil Almond Oil PEG-6 Esters
PEG-29 Castor Oil Almond Oil PEG-8 Esters
PEG-36 Castor Oil Argan Oil PEG-8 Esters
PEG-40 Castor Oil Avocado Oil PEG-8 Esters
PEG-44 Castor Oil Avocado Oil PEG-11 Esters
PEG-50 Castor Oil Bertholletia Excelsa Seed Oil PEG-8 Esters
PEG-54 Castor Oil Borage Seed Oil PEG-8 Esters
PEG-55 Castor Oil Coconut Oil PEG-10 Esters
PEG-60 Castor Oil Corn Oil PEG-6 Esters
PEG-75 Castor Oil Corn Oil PEG-8 Esters
PEG-80 Castor Oil Grape Seed Oil PEG-8 Esters
PEG-100 Castor Oil Hazel Seed Oil PEG-8 Esters
PEG-200 Castor Oil Hydrogenated Palm/Palm Kernel Oil PEG-6 Esters
PEG-18 Castor Oil Dioleate Jojoba Oil PEG-8 Esters
PEG-60 Castor Oil Isostearate Jojoba Oil PEG-150 Esters
PEG-2 Hydrogenated Castor Oil Linseed Oil PEG-8 Esters
PEG-5 Hydrogenated Castor Oil Macadamia Ternifolia Seed Oil PEG-8 Esters
PEG-6 Hydrogenated Castor Oil Mango Seed Oil PEG-70 Esters
PEG-7 Hydrogenated Castor Oil Mink Oil PEG-13 Esters
Hydrogenated Castor Oil PEG-8 Esters Olive Oil PEG-7 Esters
PEG-20 Hydrogenated Castor Oil Orbignya Oleifera Seed Oil PEG-8 Esters
PEG-25 Hydrogenated Castor Oil Palm Oil PEG-8 Esters
PEG-30 Hydrogenated Castor Oil Passiflora Edulis Seed Oils PEG-8 Esters
PEG-35 Hydrogenated Castor Oil Peanut Oil PEG-6 Esters
PEG-40 Hydrogenated Castor Oil PEG-75 Crambe Abyssinica Seed Oil
PEG-45 Hydrogenated Castor Oil PEG-75 Meadowfoam Oil
PEG-50 Hydrogenated Castor Oil Pumpkin Seed Oil PEG-8 Esters
PEG-54 Hydrogenated Castor Oil Rapeseed Oil PEG-3 Esters
PEG-55 Hydrogenated Castor Oil Rapeseed Oil PEG-20 Esters
PEG-60 Hydrogenated Castor Oil Raspberry Seed Oil PEG-8 Esters
PEG-65 Hydrogenated Castor Oil Safflower Seed Oil PEG-8 Esters
PEG-80 Hydrogenated Castor Oil Schinziophyton Rautanenii Kernel Oil PEG-8 Esters
PEG-100 Hydrogenated Castor Oil Sclerocarya Birrea Seed Oil PEG-8 Esters
PEG-200 Hydrogenated Castor Oil Sesame Seed Oil PEG-8 Esters
PEG-5 Hydrogenated Castor Oil Isostearate Soybean Oil PEG-8 Esters
PEG-20 Hydrogenated Castor Oil Isostearate Sunflower Seed Oil PEG-8 Esters
PEG-30 Hydrogenated Castor Oil Isostearate Sunflower Seed Oil PEG-32 Esters
PEG-40 Hydrogenated Castor Oil Isostearate Sweet Almond Oil PEG-8 Esters
PEG-50 Hydrogenated Castor Oil Isostearate Watermelon Seed Oil PEG-8 Esters
PEG-58 Hydrogenated Castor Oil Isostearate Wheat Germ Oil PEG-40 Butyloctanol Esters
PEG-20 Hydrogenated Castor Oil Laurate Wheat Germ Oil PEG-8 Esters
PEG-30 Hydrogenated Castor Oil Laurate
PEG-20 Hydrogenated Castor Oil PCA Isostearate
2
Table 2. Summaries of previous CIR safety assessments.

Ingredient(s) Conclusion Summary Reference
PEGylated Castor Oils PEG‐30, ‐33, ‐35, ‐36, and ‐40 castor PEG Castor Oils and PEG Hydrogenated Castor Oils are IJT 16(3):269‐
oil are safe for use in cosmetics at used as skin conditioning agents and as surfactants 306, 1997
concentrations up to 50% and PEG‐ (emulsifying and/or solubilizing agents). Results from
30 and ‐40 hydrogenated castor oil animal studies indicate very high LD50 values. Repeated
are safe for use at concentrations up exposure studies with intravenous exposure produced
to 100% some evidence of toxicity in dogs, but intramuscular
injection and oral studies were negative. No ocular
irritation was observed in studies in rabbits. Some
irritation was observed in animals, but no sensitization
was found on challenge in guinea‐pig studies using up
to 50% PEG‐35 Castor Oil. No evidence of
developmental toxicity was seen in mice and rat
feeding studies. These ingredients, tested as vehicle
controls, produced no mutagenic or carcinogenic
effect. Clinical data were generally negative for
irritation and sensitization.
Ricinus Communis (Castor) Oil and Safe for use in cosmetics in the Castor oil, its salts and esters function primarily as skin‐ IJT 26 (Suppl.
Hydrogenated Castor Oil present practices of use and conditioning agents, emulsion stabilizers, and 3):31-77, 2007
concentration surfactants in cosmetics. The principle component of
castor oil, ricinoleic acid, penetrated rat skin at only 5%
of applied material. These ingredients are not acute or
repeated dose toxicants. Undiluted castor oil was an
irritant in several animal studies. Castor oil was not
genotoxic in bacterial or mammalian test systems. No
dose‐related reproductive toxicity was found in mice
fed up to 10% castor oil for 13 weeks. Castor oil is not a
significant skin irritant, sensitizer, or photosensitizer in
human clinical tests, but it was a mild ocular irritant.
Plant-Derived Fatty Acid Oils Safe for use in cosmetics in the Oils are used in a wide variety of cosmetic products for CIR 2011
present practices of use and their skin conditioning, occlusive, emollient, and
concentration moisturizing properties. Undiluted, technical grade,
Arachis Hypogaea (Peanut) Oil was moderately
irritating to rabbits and guinea pig skin, and 5% aq.
solutions of a bar soap containing 13% sodium cocoate
had irritation scores of 1.6‐4.0/8 in animal studies.
However, the remaining animal and clinical irritation
and/or sensitization studies conducted on a large
number of the oils included in this report, primarily in
formulation, did not report any significant irritation or
sensitization reactions, indicating that refined oils
derived from plants are not ocular or dermal irritants
or sensitizers.
Triethylene Glycol and Polyethylene Safe for use in cosmetics in the PEGS function primarily as binders, humectants, and CIR 2010
Glycols (PEGs) > 4 present practices of use and solvents in cosmetic ingredients. In general, PEGs are
concentration not oral toxicants, exhibit little ocular irritation, and
have minimal dermal irritation and sensitization. PEGs
are not genotoxic or carcinogenic. PEGs are not
reproductive or developmental toxicants. Use of
antimicrobial creams with a PEG vehicle was associated
with renal toxicity when applied to burned skin, but
studies of extensively tape stripped skin demonstrated
that the levels of PEGs that could penetrate in a worst
case analysis are >100 times less than the renal toxicity
no observable effect level, providing a margin of safety.
Simmondsia Chinensis (Jojoba) Seed Safe for use in cosmetics in the Simmondsia Chinensis (Jojoba) Seed Oil and the CIR 2008
Oil present practices of use and hydrogenated oil function primarily as hair and skin
concentration conditioning agents. The oil was not an acute oral
toxicant to mice or rats. Neither the wax nor the oil
were toxic when applied dermally to the shaved backs
of guinea pigs in short‐term tests. Simmondsia
Chinensis (Jojoba) Seed Oil may be a slight ocular
irritant. None of the tested ingredients were genotoxic
and there were no structural alerts for carcinogenicity.
No carcinogenicity, reproductive or developmental
toxicity data were available. In clinical tests,
Simmondsia Chinensis (Jojoba) Seed Oil was neither a
significant dermal irritant, nor a sensitizer. Simmondsia
Chinensis (Jojoba) Seed Oil and Jojoba Alcohol were not
3
phototoxic.
Mink Oil Safe for use in cosmetics in the Mink oil functions primarily as a hair‐conditioning IJT 24
present practices of use and agent, skin‐conditioning agent, and surfactant. This (Suppl.3):57-
concentration ingredient does not absorb significant UVA or UVB 64, 2005
radiation. Mink oil is not an acute oral toxicant. Non‐
human test data indicate that mink oil is not a dermal
or ocular irritant or a dermal sensitizer. No irritation
was observed in clinical studies of mink oil up to 28%,
although some transient irritation was noted in
exaggerated‐use studies. Because mink oil is a mixture
of glycerides, namely triglycerides, it may enhance the
penetration of other chemicals.
Akyl PEG Ethers Safe for use in cosmetics in the These ingredients primarily function in cosmetics as CIR 2010
present practices of use and surfactants, and some have additional functions as skin
concentration when formulated to conditioning agents, fragrance ingredients, and
be non‐irritating emulsion stabilizers. Alkyl PEG ethers are readily
absorbed through the skin of guinea pigs and rats and
through the intestinal mucosa of rats, and they are
quickly eliminated from the body through the urine,
feces, and expired air. Some alkyl PEG ethers, such as
ceteareths and oleths, have been reported to enhance
the penetration of certain compounds through the
skin. Acute oral toxicity data were available for with
the LD50 ranging from 1 mg/kg to >10,000 mg/kg, while
dermally, the data available indicated the LD50 values
were mostly >2000 mg/kg for these families of
ingredients. Multiple repeated dose feeding studies
have been performed. These ingredients were not
carcinogenic. Most of the alkyl PEG ethers produced
ocular and dermal irritation in studies with animals;
however they were not sensitizers in guinea pigs.
These ingredients were not reproductive or
developmental toxicants and were not genotoxic in in
vivo or in vitro assays. In clinical studies, many of the
alkyl PEG ethers were irritants but not sensitizers.
4
Table 3. Names, CAS registry numbers, and definitions of the PEGylated Oil ingredients
Ingredient CAS No. Definition8(italicized text has been generated by CIR)
PEGylated Castor Oils & PEGylated Hydrogenated Castor Oils
PEG-2 Castor Oil PEG-2 Castor Oil is a polyethylene glycol derivative of Ricinus Communis (Castor) Oil, with an average of 2 moles of
61791-12-6 (generic to any ethylene oxide. PEG-2 Castor Oil is a mixture of the etherification and esterification products of castor oil glycerides
number PEG Castor Oil, i.e. and fatty acids from castor oil, with two equivalents of ethylene oxide.
PEG-X Castor Oil)
PEG-3 Castor Oil PEG-3 Castor Oil is a polyethylene glycol derivative of Ricinus Communis (Castor) Oil with an average of 3 moles of
61791-12-6 (generic) ethylene oxide. PEG-3 Castor Oil is a mixture of the etherification and esterification products of castor oil glycerides
and fatty acids from castor oil, with three equivalents of ethylene oxide.
and fatty acids from castor oil, with four equivalents of ethylene oxide.
and fatty acids from castor oil, with five equivalents of ethylene oxide.
and fatty acids from castor oil, with eight equivalents of ethylene oxide.
and fatty acids from castor oil, with nine equivalents of ethylene oxide.
and fatty acids from castor oil, with ten equivalents of ethylene oxide.
and fatty acids from castor oil, with eleven equivalents of ethylene oxide.
and fatty acids from castor oil, with fifteen equivalents of ethylene oxide.
and fatty acids from castor oil, with sixteen equivalents of ethylene oxide.
and fatty acids from castor oil, with twenty equivalents of ethylene oxide.
and fatty acids from castor oil, with twenty-five equivalents of ethylene oxide.
and fatty acids from castor oil, with twenty-six equivalents of ethylene oxide.
and fatty acids from castor oil, with twenty-nine equivalents of ethylene oxide.
61791-12-6 (generic) ethylene oxide. PEG-30 Castor Oil is a mixture of the etherification product of castor oil glycerides and the
esterification product of the fatty acids from castor oil, with one end of a polyethylene glycol chain, averaging thirty
ethylene glycol repeat units in length.
61791-12-6 (generic) ethylene oxide. PEG-33 Castor Oil is a mixture of the etherification product of castor oil glycerides and the
esterification product of the fatty acids from castor oil, with one end of a polyethylene glycol chain, averaging thirty-
three ethylene glycol repeat units in length.
and fatty acids from castor oil, with thirty-five equivalents of ethylene oxide.
and fatty acids from castor oil, with thirty-six equivalents of ethylene oxide.
and fatty acids from castor oil, with forty equivalents of ethylene oxide.
and fatty acids from castor oil, with forty-four equivalents of ethylene oxide.
and fatty acids from castor oil, with fifty equivalents of ethylene oxide.
and fatty acids from castor oil, with fifty-four equivalents of ethylene oxide.
5
and fatty acids from castor oil, with fifty-five equivalents of ethylene oxide.
and fatty acids from castor oil, with sixty equivalents of ethylene oxide.
and fatty acids from castor oil, with seventy-five equivalents of ethylene oxide.
and fatty acids from castor oil, with eighty equivalents of ethylene oxide.
PEG-100 Castor Oil PEG-100 Castor Oil is a polyethylene glycol derivative of Ricinus Communis (Castor) Oil with an average of 100 moles
61791-12-6 (generic) of ethylene oxide. PEG-100 Castor Oil is a mixture of the etherification and esterification products of castor oil
glycerides and fatty acids from castor oil, with one-hundred equivalents of ethylene oxide.
PEG-200 Castor Oil PEG-200 Castor Oil is a polyethylene glycol derivative of Ricinus Communis (Castor) Oil with an average of 200 moles
61791-12-6 (generic) of ethylene oxide. PEG-200 Castor Oil is a mixture of the etherification and esterification products of castor oil
glycerides and fatty acids from castor oil, with two hundred equivalents of ethylene oxide.
Diesters
PEG-18 Castor Oil Dioleate PEG-18 Castor Oil Dioleate is the oleic acid diester of ethoxylated castor oil in which the average ethoxylation value is
18.
PEG-60 Castor Oil Isostearate PEG-60 Castor Oil Isostearate is the ester of Isostearic Acid and PEG-60 Castor Oil.
Hydrogenated
PEG-2 Hydrogenated Castor PEG-2 Hydrogenated Castor Oil is a polyethylene glycol derivative of Hydrogenated Castor Oil with an average of 2
Oil moles of ethylene oxide. PEG-2 Hydrogenated Castor Oil is a mixture of the etherification and esterification products of
61788-85-0 (generic) hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with two equivalents of ethylene oxide.
61788-85-0 (generic) hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with five equivalents of ethylene oxide.
61788-85-0 (generic) hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with six equivalents of ethylene oxide.
61788-85-0 (generic) hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with seven equivalents of ethylene oxide.
61788-85-0 (generic) hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with eight equivalents of ethylene oxide.
Oil moles of ethylene oxide. PEG-10 Hydrogenated Castor Oil is a mixture of the etherification and esterification products
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with ten equivalents of ethylene oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with sixteen equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with twenty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with twenty-five equivalents of
ethylene oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with thirty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with thirty-five equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with forty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with forty-five equivalents of ethylene
oxide.
6
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with fifty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with fifty-four equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with fifty-five equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with sixty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with sixty-five equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with eighty equivalents of ethylene
oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with one hundred equivalents of
ethylene oxide.
61788-85-0 (generic) of hydrogenated castor oil glycerides and fatty acids from hydrogenated castor oil, with two hundred equivalents of
ethylene oxide.
PEG-8 block added transester
Hydrogenated Castor Oil PEG- Hydrogenated Castor Oil PEG-8 Esters is a product obtained by the transesterification of Hydrogenated Castor Oil and
8 Esters PEG-8.
PEGylated Hydrogenated Castor Oil Diesters
PEG-5 Hydrogenated Castor PEG-5 Hydrogenated Castor Oil Isostearate is a polyethylene glycol derivative of the isostearic acid ester of
Oil Isostearate Hydrogenated Castor Oil with an average ethoxylation value of 5.
PEG-20 Hydrogenated Castor PEG-20 Hydrogenated Castor Oil Laurate is a polyethylene glycol derivative of the ester of Lauric Acid and
Oil Laurate Hydrogenated Castor Oil, with an average ethoxylation value of 20
[868047-47-6, generic to all
PEG-X Hydrogenated Castor
Oil]
Oil Laurate Hydrogenated Castor Oil, with an average ethoxylation value of 30.
[868047-47-6 (generic)]
[868047-47-6 (generic)]
[868047-47-6 (generic)]
[868047-47-6 (generic)]
7
PEG-20 Hydrogenated Castor PEG-20 Hydrogenated Castor Oil PCA Isostearate is the diester of PEG-20 Hydrogenated Castor Oil and a mixture of
Oil PCA Isostearate PCA and Isostearic Acid.
PEG-50 Hydrogenated Castor PEG-50 Hydrogenated Castor Oil Succinate is a polyethylene glycol derivative of the succinic acid ester of Hydrogenated
Oil Succinate Castor Oil with an average ethoxylation value of 50.
PEG-5 Hydrogenated Castor PEG-5 Hydrogenated Castor Oil Triisostearate is the triester of isostearic acid and Hydrogenated Castor Oil with an
Oil Triisostearate average of 5 moles of ethylene oxide.
[188734-82-9, generic to all
PEG-X Hydrogenated Castor
Oil Triisostearate]
[188734-82-9 (generic)]
PEG-20 Hydrogenated Castor PEG-20 Hydrogenated Castor Oil Triisostearate is the isostearic acid triester of Hydrogenated Castor Oil with an average
Oil Triisostearate ethoxylation value of 20.
[188734-82-9 (generic)]
[188734-82-9 (generic)]
[188734-82-9 (generic)]
Oil Triisostearate of 50 moles of ethylene oxide.
[188734-82-9 (generic)]
Oil Triisostearate of 60 moles of ethylene oxide.
[188734-82-9 (generic)]
Potassium PEG-50 Potassium PEG-50 Hydrogenated Castor Oil Succinate is the potassium salt of PEG-50 Hydrogenated Castor Oil
Hydrogenated Castor Oil Succinate.
Succinate
Sodium PEG-50 Hydrogenated Sodium PEG-50 Hydrogenated Castor Oil Succinate is the sodium salt of PEG-50 Hydrogenated Castor Oil Succinate.
Castor Oil Succinate
Other PEG-X block added Oils
Adansonia Digitata Seed Oil Adansonia Digitata Seed Oil PEG-8 Esters is the product obtained by the transesterification of Adansonia Digitata Seed
PEG-8 Esters Oil and PEG-8.
Almond Oil PEG-6 Esters Almond Oil PEG-6 Esters is the product obtained by the transesterification of Prunus Amygdalus Dulcis (Almond) Oil
and PEG-6.
Almond Oil PEG-8 Esters Almond Oil PEG-8 Esters is the product obtained by the transesterification of Prunus Amygdalus Dulcis (Almond) Oil
and PEG-8.
Apricot Kernel Oil PEG-6 Apricot Kernel Oil PEG-6 Esters is the product obtained by the transesterification of Prunus Armeniaca (Apricot) Kernel
Esters Oil and PEG-6.
Apricot Kernel Oil PEG-8 Apricot Kernel Oil PEG-8 Esters is the product obtained by the transesterification of Prunus Armeniaca (Apricot) Kernel
Apricot Kernel Oil PEG-40 Apricot Kernel Oil PEG-40 Esters is the product obtained by the transesterification of Prunus Armeniaca (Apricot)
Esters Kernel Oil and PEG-40.
Argan Oil PEG-8 Esters Argan Oil PEG-8 Esters is the product obtained by the transesterification of Argania Spinosa Kernel Oil and PEG-8.
Avocado Oil PEG-8 Esters Avocado Oil PEG-8 Esters is the product obtained by the transesterification of Persea Gratissima (Avocado) Oil and
PEG-8.
Avocado Oil PEG-11 Esters Avocado Oil PEG-11 Esters is the product obtained from the transesterification of Persea Gratissima (Avocado) Oil and
PEG-11.
Bertholletia Excelsa Seed Oil Bertholletia Excelsa Seed Oil PEG-8 Esters is the product obtained from the transesterificaton of Bertholletia Excelsa
PEG-8 Esters Seed Oil and PEG-8.
Bitter Cherry Seed Oil PEG-8 Bitter Cherry Seed Oil PEG-8 Esters is a product obtained by the transesterification of Prunus Cerasus (Bitter Cherry)
Esters Seed Oil and PEG-8.
Borage Seed Oil PEG-8 Esters Borage Seed Oil PEG-8 Esters is the product obtained by the transesterification of Borago Officinalis (Borage) Seed Oil
and PEG-8.
Coconut Oil PEG-10 Esters Coconut Oil PEG-10 Esters is a polyethylene glycol derivative of Cocos Nucifera (Coconut) Oil with an average of 10
moles of ethylene oxide.
Corn Oil PEG-6 Esters Corn Oil PEG-6 Esters is a product obtained by the transesterification of Zea Mays (Corn) Oil and PEG-6.
Corn Oil PEG-8 Esters Corn Oil PEG-8 Esters is a product obtained by the transesterification of Zea Mays (Corn) Oil and PEG-8.
8
Grape Seed Oil PEG-8 Esters Grape Seed Oil PEG-8 Esters is the product obtained by the transesterification of Vitis Vinifera (Grape) Seed Oil and
PEG-8.
Hazel Seed Oil PEG-8 Esters Hazel Seed Oil PEG-8 Esters is the product obtained by the transesterification of Corylus Avellana (Hazel) Seed Oil and
PEG-8.
Hydrogenated Palm/Palm Hydrogenated Palm/Palm Kernel Oil PEG-6 Esters is the product obtained by the transesterification of Hydrogenated
Kernel Oil PEG-6 Esters Palm Kernel Oil, Hydrogenated Palm Oil and PEG-6.
Jojoba Oil PEG-8 Esters Jojoba Oil PEG-8 Esters is the polyethylene glycol derivative of the acids and alcohols derived from Simmondsia
Chinensis (Jojoba) Oil containing an average of 8 moles of ethylene oxide.
Jojoba Oil PEG-150 Esters Jojoba Oil PEG-150 Esters is the polyethylene glycol derivative of the acids and alcohols derived from Simmondsia
Chinensis (Jojoba) Oil containing an average of 150 moles of ethylene oxide.
Linseed Oil PEG-8 Esters Linseed Oil PEG-8 Esters is the product obtained by the transesterification of Linum Usitatissimum (Linseed) Oil and
PEG-8.
Macadamia Ternifolia Seed Oil Macadamia Ternifolia Seed Oil PEG-8 Esters is the product obtained by the transesterification of Macadamia Ternifolia
PEG-8 Esters Seed Oil and PEG-8.
Mango Seed Oil PEG-70 Esters Mango Seed Oil PEG-70 Esters is the product obtained by the transesterification of Mangifera Indica (Mango) Seed Oil
and PEG-70.
Mink Oil PEG-13 Esters Mink Oil PEG-13 Esters is the product obtained by the transesterification of Mink Oil and PEG-13.
Olive Oil PEG-6 Esters Olive Oil PEG-6 Esters is a product obtained by the transesterification of Olea Europaea (Olive) Oil and PEG-6.
Olive Oil PEG-7 Esters Olive Oil PEG-7 Esters is a product obtained by the transesterification of Olea Europaea (Olive) Oil and PEG-7
Orbignya Oleifera Seed Oil Orbignya Oleifera Seed Oil PEG-8 Esters is the product obtained by the transesterification of Orbignya Oleifera Seed Oil
PEG-8 Esters and PEG-8.
Palm Oil PEG-8 Esters Palm Oil PEG-8 Esters is the product obtained by the transesterification of Elaeis Guineensis (Palm) Oil and PEG-8.
Passiflora Edulis Seed Oils Passiflora Edulis Seed Oils PEG-8 Esters is a product obtained by the transesterification of a blend of Passiflora Edulis
PEG-8 Esters Seed Oil with PEG-8.
Peanut Oil PEG-6 Esters Peanut Oil PEG-6 Esters is the product obtained by the transesterification of Arachis Hypogaea (Peanut) Oil and PEG-6.
PEG-75 Crambe Abyssinica PEG-75 Crambe Abyssinica Seed Oil is a polyethylene glycol derivative of Crambe Abyssinica Seed Oil with an average
Seed Oil of 75 moles of ethylene oxide. PEG-75 Crambe Abyssinica Seed Oil is a mixture of the etherification and esterification
products of crambe abyssinica seed oil glycerides and fatty acids from crambe abyssinica seed oil, with seventy-five
equivalents of ethylene oxide.
PEG-75 Meadowfoam Oil PEG-75 Meadowfoam Oil is a polyethylene glycol derivative of Limnanthes Alba (Meadowfoam) Seed Oil with an
average of 75 moles of ethylene oxide. PEG-75 Meadowfoam Oil is a mixture of the etherification and esterification
products of meadowfoam oil glycerides and fatty acids from meadowfoam oil, with seventy-five equivalents of ethylene
oxide.
Pumpkin Seed Oil PEG-8 Pumpkin Seed Oil PEG-8 Esters is the product obtained by the transesterification of Cucurbita Pepo (Pumpkin) Seed Oil
Esters and PEG-8.
Rapeseed Oil PEG-3 Esters Rapeseed Oil PEG-3 Esters is the product obtained by the transesterification of Brassica Campestris (Rapeseed) Oil and
PEG-3.
Rapeseed Oil PEG-20 Esters Rapeseed Oil PEG-20 Esters is the product obtained by the transesterification of Brassica Campestris (Rapeseed) Oil and
PEG-20.
Raspberry Seed Oil PEG-8 Raspberry Seed Oil PEG-8 Esters is the product obtained by the transesterification of Rubus Idaeus (Raspberry) Seed Oil
Esters and PEG-8.
Safflower Seed Oil PEG-8 Safflower Seed Oil PEG-8 Esters is the product obtained by the transesterification of Carthamus Tinctorius (Safflower)
Schinziophyton Rautanenii Schinziophyton Rautanenii Kernel Oil PEG-8 Esters is the product obtained by the transesterification of Schinziophyton
Kernel Oil PEG-8 Esters Rautanenii Kernel Oil and PEG-8.
Sclerocarya Birrea Seed Oil Sclerocarya Birrea Seed Oil PEG-8 Esters is the product obtained by the transesterification of PEG-8 with Sclerocarya
PEG-8 Esters Birrea Seed Oil.
Sesame Seed Oil PEG-8 Esters Sesame Seed Oil PEG-8 Esters is the product obtained by the transesterification of PEG-8 with Sesamum Indicum Seed
Oil.
Soybean Oil PEG-8 Esters Soybean Oil PEG-8 Esters is the product obtained by the transesterification of Glycine Soja (Soybean) Oil and PEG-8.
Soybean Oil PEG-20 Esters Soybean Oil PEG-20 Esters is the product obtained by the transesterification of Glycine Soja (Soybean) Oil and PEG-20
Soybean Oil PEG-36 Esters Soybean Oil PEG-36 Esters is the product obtained by the transesterification of Glycine Soja (Soybean) Oil and PEG-36.
Sunflower Seed Oil PEG-8 Sunflower Seed Oil PEG-8 Esters is the product obtained by the transesterification of Helianthus Annuus (Sunflower)
Sunflower Seed Oil PEG-32 Sunflower Seed Oil PEG-32 Esters is the product obtained by the transesterification of Helianthus Annuus (Sunflower)
Sweet Almond Oil PEG-8 Sweet Almond Oil PEG-8 Esters is the product obtained by the transesterification of Prunus Amygdalus (Sweet Almond)
Watermelon Seed Oil PEG-8 Watermelon Seed Oil PEG-8 Esters is the product obtained by the transesterification of PEG-8 with Citrillus Lanatus
Esters (Watermelon) Seed Oil.
9
Wheat Germ Oil PEG-40 Wheat Germ Oil PEG-40 Butyloctanol Esters is a the product obtained by the reaction of a mixture of Triticum Vulgare
Butyloctanol Esters (Wheat) Germ Oil (q.v.) and Butyloctanol with PEG-40. Wheat Germ Oil PEG-40 Butyloctanol Esters is the
transesterification product obtained by the reaction of a mixture of Triticum Vulgare (Wheat) Germ Oil with
2-butyloctanol and PEG-40.
Wheat Germ Oil PEG-8 Esters Wheat Germ Oil PEG-8 Esters is the product obtained by the transesterificaton of Triticum Vulgare (Wheat) Germ Oil
and PEG-8.

10
Table 4a. Historical and current use and concentration of use data for PEG-30, -33, -35, -36, -40 Castor Oil and PEG-30 and-40 Hydrogenated Castor Oil.1,9
# of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%)
PEG-30 Castor Oil PEG-33 Castor Oil PEG-35 Castor Oil
Data Year 1997 2012 1997 2012 1997 2012 1997 2012 1997 2012 1997 2012
Totals* 77a 1 > 50b 0.1 13 41 NR NR 4 35 NR 0.001-1
Duration of Use
b
Leave-On NR NR NR 10 30 NR NR 4 21 NR 0.005-1
b
Rinse-Off 73 1 0.1 3 11 NR NR NR 14 NR 0.001-1
b
Diluted for (Bath) Use NR NR NR NR NR NR NR NR NR NR NR
Exposure Type
b
Eye Area NR NR NR NR 1 NR NR NR 2 NR NR
b
Incidental Ingestion NR NR NR NR NR NR NR NR NR NR NR
b
Incidental Inhalation-Spray NR NR NR NR NR NR NR 1 1 NR NR
b
Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR NR
b
Dermal Contact 1 NR NR 8 35 NR NR 3 24 NR 0.005
b
Deodorant (underarm) NR NR NR NR NR NR NR NR NR NR NR
b
Hair - Non-Coloring NR 1 0.1 5 6 NR NR 1 11 NR 0.001-1
b
Hair-Coloring 72 NR NR NR NR NR NR NR NR NR 0.2-0.4
b
Nail NR NR NR NR NR NR NR NR NR NR NR
b
Mucous Membrane NR NR NR NR NR NR NR NR 1 NR 0.005
b
Baby Products NR NR NR NR NR NR NR NR NR NR NR
PEG-36 Castor Oil PEG-40 Castor Oil PEG-30 Hydrogenated Castor Oil
Data Year 1997 2012 1997 2012 1997 2012 1997 2012 1997 2012 1997 2012
Totals* 3 6 NR NR 170c 95 < 10b NR 5 3 < 0.1b 0.06-10
Duration of Use
b b
Leave-On 3 6 NR NR 60 59 NR 2 1 0.06-2
b b
Rinse Off NR NR NR NR 46 36 NR 3 2 2-10
b b
Diluted for (Bath) Use NR NR NR NR 1 NR NR NR NR NR
Exposure Type
b b
Eye Area NR NR NR NR 1 1 NR NR NR NR
b b
Incidental Ingestion NR NR NR NR NR NR NR NR NR NR
b b
Incidental Inhalation-Spray NR NR NR NR 7 1 NR 1 NR NR
b b
Incidental Inhalation-Powder NR NR NR NR NR NR NR NR NR NR
b b
Dermal Contact 3 6 NR NR 74 63 NR 5 2 2-10
b b
Deodorant (underarm) NR NR NR NR NR NR NR 1 NR NR
b b
Hair - Non-Coloring NR NR NR NR 33 29 NR NR NR NR
b b
Hair-Coloring NR NR NR NR NR 2 NR NR 1 NR
b b
Nail NR NR NR NR NR 1 NR NR NR 0.06
b b
Mucous Membrane NR NR NR NR 2 14 NR NR NR 10
b b
Baby Products NR NR NR NR NR NR NR NR NR NR
PEG-40 Hydrogenated Castor Oil

1997 2012 1997 2012
d b 0.00007-
Totals* 268 2107 <5 *Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all
22
Duration of Use exposure types may not equal the sum of total uses.
b 0.0007- NR = Not reported
Leave-On 186 1319
22
a Total includes4 uses listed under trade name of mixtures, exact duration of use and exposure type
b 0.00007-
Rinse-Off 50 754 could not be determined.
14
b
Diluted for (Bath) Use 20 34 0.001-5 b Breakdown not available.
Exposure Type c Total includes 63 uses listed under trade name of mixtures, exact duration of use and exposure type
b
Eye Area 9 53 0.002-15 could not be determined.
b
Incidental Ingestion NR 4 0.9-4 d Total includes 11 uses listed under trade name, exact duration of use and exposure type could not be
b
Incidental Inhalation-Spray 31 279 0.003-6e determined.
b
Incidental Inhalation-Powder 3 3 0.002
e
b 0.00007- 0.5% in a baby detangling spray; 0.003% in an other spray fragrance; 6% in an
Dermal Contact 197 1461
10 other pump spray fragrance; 0.02-0.4% in an aerosol hair spray; 0.2-0.7% in a pump
b
Deodorant (underarm) 2 27 0.02-4 hair spray; 0.5% in a tonic, dressing, and other hair grooming aids spray; 4% in an
b
Hair - Non-Coloring 54 537 0.008-22 aerosol deodorant spray; 3% in a body and hand cream spray; 3% in a foot spray;
Hair-Coloring 2 93 b
0.06-14 and 2% in a skin freshener spray.
b
Nail NR 4 0.8
b
Mucous Membrane 30 390 0.001-10
b
Baby Products 1 18 0.5-4

11
Table 4b. Frequency and concentration of use (2012) according to duration and type of exposure for expanded PEGylated Oils group.9
PEG-9 Castor Oil PEG-25 Castor Oil PEG-50 Castor Oil
Totals* 1 0.3 NR 3-17 2 NR
Duration of Use
Leave-On 1 0.3 NR 3-17 2 NR
Rinse-Off NR NR NR NR NR NR
Diluted for (Bath) Use NR NR NR NR NR NR
Exposure Type
Eye Area NR NR NR NR NR NR
Incidental Ingestion NR NR NR NR NR NR
Incidental Inhalation-Spray 1 NR NR 3a NR NR
Incidental Inhalation-Powder NR NR NR NR NR NR
Dermal Contact NR NR NR NR 2 NR
Deodorant (underarm) NR NR NR NR NR NR
Hair - Non-Coloring 1 0.3 NR 3-17 NR NR
Hair-Coloring NR NR NR NR NR NR
Nail NR NR NR NR NR NR
Mucous Membrane NR NR NR NR NR NR
Baby Products NR NR NR NR NR NR
PEG-60 Castor Oil PEG-2 Hydrogenated Castor Oil PEG-7 Hydrogenated Castor Oil
Totals* NR 0.002-23 5 NR 11 0.05-8
Duration of Use
Leave-On NR 0.04-23 5 NR 9 0.05-8
Rinse Off NR 0.002-11 NR NR 2 NR
Diluted for (Bath) Use NR 6 NR NR NR NR
Exposure Type
Eye Area NR 0.08-1 5 NR NR 5
Incidental Ingestion NR 0.06-2 NR NR NR 8
Incidental Inhalation-Spray NR 0.04-16b NR NR 4 NR
Incidental Inhalation-Powder NR 0.2 NR NR NR NR
Dermal Contact NR 0.002-11 NR NR 9 0.6-5
Deodorant (underarm) NR 0.04-0.5 NR NR NR NR
Hair - Non-Coloring NR 0.5-23 NR NR 2 0.05
Hair-Coloring NR 0.6-8 NR NR NR NR
Mucous Membrane NR 0.06-6 NR NR 2 8
PEG-10 Hydrogenated Castor Oil PEG-16 Hydrogenated Castor Oil PEG-20 Hydrogenated Castor Oil
Totals* 5 3 1 NR 5 0.05-0.5
Duration of Use
Leave-On 5 3 1 NR 4 0.05-0.5
Rinse-Off NR NR NR NR 1 NR
Exposure Type
Incidental Ingestion 1 NR 1 NR NR NR
Incidental Inhalation-Spray NR NR NR NR NR NR
Dermal Contact 3 3 NR NR 5 0.05-0.5
Hair - Non-Coloring 1 NR NR NR NR NR
Mucous Membrane 1 NR 1 NR NR NR
12
Totals 39 0.01-23 1 NR 2 NR
Duration of Use
Leave-On 34 0.01-23 1 NR 1 NR
Rinse Off 5 0.3 NR NR 1 NR
Exposure Type
Incidental Inhalation-Spray 4 NR 1 NR NR NR
Incidental Inhalation-Aerosol NR NR NR NR NR NR
Dermal Contact 16 0.01-2 1 NR 1 NR
Hair - Non-Coloring 23 3-23 NR NR 1 NR
Mucous Membrane 3 NR NR NR NR NR
Baby Products NR NR NR NR 1 NR
Totals* 349 0.00004-18 4 NR NR 0.02-4
Duration of Use
Leave-On 251 0.00004-18 3 NR NR 0.02-3
Rinse-Off 94 0.00004-0.5 1 NR NR 1-2
Diluted for (Bath) Use 4 NR NR NR NR 4
Exposure Type
Eye Area 9 3-5 NR NR NR NR
Incidental Ingestion 1 6 NR NR NR 0.5
Incidental Inhalation-Spray 13 0.3-1c NR NR NR 0.3d
Dermal Contact 307 0.00004-5 4 NR NR 0.02-4
Deodorant (underarm) 2 NR NR NR NR NR
Hair - Non-Coloring 41 0.3-18 NR NR NR 0.2-3
Nail NR 3 NR NR NR NR
Mucous Membrane 37 0.004-6 NR NR NR 0.5-4
Baby Products 1 NR NR NR NR NR
Triisostearate Triisostearate Succinate
Totals* 3 NR NR 0.002-0.003 NR 1-40
Duration of Use
Leave-On 3 NR NR NR NR 40
Rinse-Off NR NR NR 0.002-0.003 NR 1
Exposure Type
Eye Area 3 NR NR NR NR 1
Dermal Contact NR NR NR 0.002-0.003 NR 1
Hair - Non-Coloring NR NR NR 0.003 NR 40
Mucous Membrane NR NR NR 0.002-0.003 NR NR
13
PEG-40 Hydrogenated Castor Oil
Apricot Kernel Oil PEG-6 Esters Avocado Oil PEG-11 Esters
PCA Isostearate
Totals* 2 NR 24 0.8-1 NR 0.1
Duration of Use
Leave-On 1 NR 23 0.8-1 NR 0.1
Rinse-Off 1 NR NR NR NR NR
Diluted for (Bath) Use NR NR 1 NR NR NR
Exposure Type
Eye Area NR NR 1 1 NR NR
Incidental Ingestion NR NR 4 NR NR NR
Dermal Contact 1 NR 20 0.8-1 NR NR
Hair - Non-Coloring 1 NR NR NR NR 0.1
Mucous Membrane NR NR 5 NR NR NR
Hydrogenated Palm/Palm Kernel

Coconut Oil PEG-10 Esters Grape Seed Oil PEG-8 Esters
Oil PEG-6 Esters
Totals* 8 NR 18 NR 4 0.6-24
Duration of Use
Leave-On 2 NR 10 NR 4 0.6-24
Rinse-Off 6 NR 8 NR NR NR
Exposure Type
Eye Area NR NR NR NR 1 9-24
Incidental Inhalation-Spray NR NR 1 NR NR 0.6
Incidental Inhalation-Powder NR NR NR NR NR 16
Dermal Contact 2 NR 18 NR 4 0.6-24
Hair - Non-Coloring 6 NR NR NR NR NR
Mucous Membrane NR NR 6 NR NR NR
Jojoba Oil PEG-8 Esters Olive Oil PEG-7 Esters Olive Oil PEG-10 Esters
Totals* 40 0.5 97 0.05-97 NR 0.002-0.009
Duration of Use
Leave-On 26 NR 45 0.9-12 NR 0.002
Rinse Off 7 0.5 52 0.05-97 NR 0.003-0.009
Diluted for (Bath) Use 7 NR NR NR NR NR
Exposure Type
Eye Area NR NR 3 NR NR NR
Incidental Ingestion NR NR NR 0.9 NR NR
Incidental Inhalation-Spray NR NR 2 1e NR NR
Incidental Inhalation-Powder 1 NR NR NR NR NR
Dermal Contact 34 NR 74 0.1-97 NR 0.002-0.009
Deodorant (underarm) NR NR 1 NR NR NR
Hair - Non-Coloring 6 0.5 23 0.05-1 NR NR
Mucous Membrane 7 NR 22 0.1-0.9 NR 0.003-0.009
Baby Products 3 NR 1 NR NR NR
14
Table 4b. Frequency and concentration of use according to duration and type of exposure for expanded PEGylated Oils group.9
# of Uses Max Conc of Use (%)
PEG-75 Meadowfoam Oil
Totals* 1 0.08
Duration of Use
Leave-On 1 0.08
*Because each ingredient may be used in cosmetics with multiple exposure types,
Rinse-Off NR NR the sum of all exposure types may not equal the sum of total uses.
Diluted for (Bath) Use NR NR NR = Not reported
Exposure Type a 3% in a pump hair spray.
Eye Area NR NR b 0.5% in a pump hair spray and 16% in an aerosol hair spray; 0.04% in an aerosol
Incidental Ingestion NR NR deodorant; and 0.4% in a face and neck cream spray.
Incidental Inhalation-Spray NR 0.08f c 0.3% in an aerosol Hairspray, 0.9% in a pump Hairspray, and 1% in a face and
Incidental Inhalation-Powder NR NR Neck cream spray
d0.3% in an aerosol other fragrance preparation.
Dermal Contact NR NR
e 1% in a pump spray
Deodorant (underarm) NR NR
f 0.08% in a pump spray
Hair - Non-Coloring 1 0.08
Hair-Coloring NR NR
Nail NR NR
Mucous Membrane NR NR
Baby Products NR NR
15
Table 4c. Not reported to be in use

PEG-2 Castor Oil PEG-15 Hydrogenated Castor Oil Isostearate Corn Oil PEG-8 Esters
PEG-3 Castor Oil PEG-20 Hydrogenated Castor Oil Isostearate Hazel Seed Oil PEG-8 Esters
PEG-4 Castor Oil PEG-30 Hydrogenated Castor Oil Isostearate Jojoba Oil PEG-150 Esters
PEG-5 Castor Oil PEG-40 Hydrogenated Castor Oil Isostearate Linseed Oil PEG-8 Esters
PEG-8 Castor Oil PEG-50 Hydrogenated Castor Oil Isostearate Macadamia Ternifolia Seed Oil PEG-8 Esters
PEG-10 Castor Oil PEG-58 Hydrogenated Castor Oil Isostearate Mango Seed Oil PEG-70 Esters
PEG-11 Castor Oil PEG-20 Hydrogenated Castor Oil Laurate Mink Oil PEG-13 Esters
PEG-15 Castor Oil PEG-30 Hydrogenated Castor Oil Laurate Olive Oil PEG-6 Esters
PEG-16 Castor Oil PEG-40 Hydrogenated Castor Oil Laurate Olive Oil PEG-8 Esters
PEG-20 Castor Oil PEG-50 Hydrogenated Castor Oil Laurate Orbignya Oleifera Seed Oil PEG-8 Esters
PEG-26 Castor Oil PEG-60 Hydrogenated Castor Oil Laurate Palm Oil PEG-8 Esters
PEG-29 Castor Oil PEG-20 Hydrogenated Castor Oil PCA Isostearate Passiflora Edulis Seed Oils PEG-8 Esters
PEG-44 Castor Oil PEG-30 Hydrogenated Castor Oil PCA Isostearate Peanut Oil PEG-6 Esters
PEG-54 Castor Oil PEG-60 Hydrogenated Castor Oil PCA Isostearate PEG-75 Crambe Abyssinica Seed Oil
PEG-55 Castor Oil Potassium PEG-50 Hydrogenated Castor Oil Succinate Pumpkin Seed Oil PEG-8 Esters
PEG-75 Castor Oil Sodium PEG-50 Hydrogenated Castor Oil Succinate Rapeseed Oil PEG-3 Esters
PEG-80 Castor Oil PEG-5 Hydrogenated Castor Oil Triisostearate Rapeseed Oil PEG-20 Esters
PEG-100 Castor Oil PEG-10 Hydrogenated Castor Oil Triisostearate Raspberry Seed Oil PEG-8 Esters
PEG-200 Castor Oil PEG-15 Hydrogenated Castor Oil Triisostearate Safflower Seed Oil PEG-8 Esters
PEG-18 Castor Oil Dioleate PEG-30 Hydrogenated Castor Oil Triisostearate Schinziophyton Rautanenii Kernel Oil PEG-8 Esters
PEG-60 Castor Oil Isostearate PEG-50 Hydrogenated Castor Oil Triisostearate Sclerocarya Birrea Seed Oil PEG-8 Esters
PEG-5 Hydrogenated Castor Oil PEG-60 Hydrogenated Castor Oil Triisostearate Sesame Seed Oil PEG-8 Esters
PEG-6 Hydrogenated Castor Oil Adansonia Digitata Seed Oil PEG-8 Esters Soybean Oil PEG-8 Esters
PEG-8 Hydrogenated Castor Oil Almond Oil PEG-6 Esters Soybean Oil PEG-20 Esters
Hydrogenated Castor Oil PEG-8 Esters Almond Oil PEG-8 Esters Soybean Oil PEG-36 Esters
PEG-54 Hydrogenated Castor Oil Apricot Kernel Oil PEG-8 Esters Sunflower Seed Oil PEG-8 Esters
PEG-55 Hydrogenated Castor Oil Apricot Kernel Oil PEG-40 Esters Sunflower Seed Oil PEG-32 Esters
PEG-65 Hydrogenated Castor Oil Argan Oil PEG-8 Esters Sweet Almond Oil PEG-8 Esters
PEG-200 Hydrogenated Castor Oil Avocado Oil PEG-8 Esters Watermelon Seed Oil PEG-8 Esters
PEG-5 Hydrogenated Castor Oil Isostearate Bertholletia Excelsa Seed Oil PEG-8 Esters Wheat Germ Oil PEG-40 Butyloctanol Esters
PEG-10 Hydrogenated Castor Oil Isostearate Borage Seed Oil PEG-8 Esters Wheat Germ Oil PEG-8 Esters
Corn Oil PEG-6 Esters
16
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19

Olive Oil PEG-7 Esters

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Amended Safety Assessment of PEGylated Oils as Used in

Status: Tentative Report for Public Comment

Cosmetic Ingredient Review

Figure 1. Glyceryl triricinoleyl polyethylene glycol

Figure 2. Fatty acid esterification

Figure 3. Glyceryl 12-hydroxystearyl polyethylene glycol

Physical and Chemical Properties

PEG-60 HYDROGENATED CASTOR OIL

PEG-35 CASTOR OIL

REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

PEG-60 HYDROGENATED CASTOR OIL

IRRITATION AND SENSITIZATION

PEG-40 HYDROGENTATED CASTOR OIL

PEG-35 CASTOR OIL

PEG-7 HYDROGENATED CASTOR OIL

PEG-60 HYDROGENATED CASTOR OIL

PEG-2 Castor Oil* PEG-20 Hydrogenated Castor Oil Laurate*

Table 1. PEGylated Oils

Table 2. Summaries of previous CIR safety assessments.

PEG-40 Hydrogenated Castor Oil

Hydrogenated Palm/Palm Kernel

Table 4c. Not reported to be in use

4. Shree Vallabh Chemicals. Castor Oil Ethoxylate. http://www.shreechem.in/castor_oil_ethoxylates.html. Date

7. Food and Drug Administration (FDA). 1,4-Dioxane.

13. Rothe H. Special Aspects of Cosmetic Spray Evalulation. 9-26-2011.

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