116 draft oils

GREEN BOOK 2 &

GREEN BOOK 3

Vegetable Oils Nut Oils

CIR EXPERT PANEL MEETING AUGUST 30-31, 2010

GREEN BOOK 2

Oils

CIR EXPERT PANEL MEETING AUGUST 30-31, 2010

CIR Panel Book Page 1

Memorandum

To: CIR Expert Panel Members and Liaisons

From: Christina L. Burnett, Scientific Writer/Analyst

Date: July 30, 2010

Subject: Draft Report of the Vegetable Oil Group The Scientific Literature Review (SLR) for this group of edible vegetable (and fruit) oils was announced April 23, 2010. A related SLR on edible nut oils was announced in June of this year, and is to be reviewed by the Panel at this meeting as well. If the Panel does not see any major differences in the overall toxicity potential of these two oil groups, it may consider combining the reports into one major edible oil report. Both reports are taking a slightly new approach to reviewing multiple related ingredients at one time and are including oil ingredients that have previously been reviewed by the CIR Expert Panel, which are designated in italic print.

At the time that the SLR was announced, CIR sought the following additional information:

1. Manufacturing information about oils used in cosmetic formulation, particularly on methods used to remove non-fatty acid components (e.g., glycidol fatty acid esters);

2. Cosmetic grade specifications, if such exist, for oils used in cosmetic formulations.

3. Fatty acid composition for those oils covered in this report (where such information has not been provided or differs from what is presented).

4. Irritation and sensitization testing on cosmetics (finished products) containing specified concentrations of oils covered in this report.

5. Irritation and sensitization testing on those fatty acids present in the oils covered in this report that have previously not been reviewed by CIR.

6. Any other information that pertains to the safety of the use in cosmetics of the oils covered in this report.

Data on fatty acid compositions and cosmetic grade specifications, as well as an HRIPT studies on numerous oils have been received from the Personal Care Products Council and are incorporated in this draft report in Tables 3, 4, and 7, respectively. Due to the voluminous amount of unpublished data (800+ pages), data will be accessible online. Paper copies will be mailed out only by request.

Please note that the new use table is being employed in this report. The raw data from which the table was created along with any available concentration of use information have been included in the book materials.

If the data provided are sufficient for the Panel to assess the safety of these ingredients, a tentative conclusion should be developed regarding their safety in cosmetics, along with a rationale for that conclusion. The report will then be issued as a Tentative Safety Assessment. If additional data are needed, these should be identified and an Insufficient Data Announcement should be issued.

For your convenience, the materials for this report can also be found at http://www.cir-safety.org/aug10.shtml.


CIR Expert Panel History with Vegetable Oils

April 2010 - CIR issued a Scientific Literature Review.


Literature Search on Vegetable Oils

1

Ingredients Toxline PubMed

ChemIDplus HSDB CAplus NTIS HPV Merck USP

Ingredients were searched by Latin botanical (INCI) names, common names, and CAS numbers, when available. The list of ingredients searched is found in Table 1 of the vegetable oil report.

Literature searches included chemical composition, fatty acid composition, dermal toxicity, irritation, and sensitization qualifiers.

Searches were performed between November 20, 2009 and March 30, 2010 and updated June 30 through July 8, 2010.


Report


Draft Report

Vegetable Oil, Related Plant-Derived Oils, and Other Derivatives as Used in Cosmetics

August 30, 2010

The 2010 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, 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 L. Burnett and Monice Fiume, Scientific Analyst/Writers.

Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 " Washington, DC 20036-4702 " ph 202.331.0651 " fax 202.331.0088 "

[email protected]


ii

TABLE OF CONTENTS

INTRODUCTION ................................................................................................................................................................. 1 Chemistry ............................................................................................................................................................................... 1

Processing ...................................................................................................................................................................... 2 Analytical Methods ............................................................................................................................................................ 2

Impurities ....................................................................................................................................................................... 2 Use ......................................................................................................................................................................................... 3

Cosmetic ............................................................................................................................................................................ 3 Non-Cosmetic .................................................................................................................................................................... 4

ANIMAL TOXICOLOGY .................................................................................................................................................... 4 OILS .............................................................................................................................................................................. 4

Dermal Irritation/Sensitization/Phototoxicity .................................................................................................................... 4 Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 4 Carthamus Tinctorius (Safflower) Oil ........................................................................................................................... 4 Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 4 Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 5 Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 5 Oryza Sativa (Rice) Bran Oil and Germ Oil .................................................................................................................. 5 Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 5 Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 6 Zea Mays (Corn) Oil ...................................................................................................................................................... 6

Ocular Irritation ................................................................................................................................................................. 6 Adansonia Digitata Seed Oil [Baobab] .......................................................................................................................... 6 Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 6 Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 6 Linum Usitatissimum (Linseed) Seed Oil ...................................................................................................................... 6 Olea Europea (Olive) Fruit Oil ...................................................................................................................................... 7 Oryza Sativa (Rice) Bran and Rice Germ Oil ................................................................................................................ 7 Ribes Nigrum (Black Currant) Seed Oil ........................................................................................................................ 7 Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 7 Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 7 Zea Mays (Corn) Oil ...................................................................................................................................................... 7

CARCINOGENICITY .......................................................................................................................................................... 7 CLINICAL ASSESSMENT OF SAFETY ............................................................................................................................ 8

Irritation/Sensitization/Allergenicity ................................................................................................................................. 8 Carthamus Tinctorius (Safflower) Oil ........................................................................................................................... 9 Elaeis Guineensis (Palm) Oil ......................................................................................................................................... 9 Gossypium Herbaceum (Cotton) Seed Oil..................................................................................................................... 9 Oryza Sativa (Rice) Bran Oil ......................................................................................................................................... 9 Persea Gratissima (Avocado) Oil ................................................................................................................................... 9 Sesamum Indicum (Sesame) Seed Oil ........................................................................................................................... 9 Triticum Vulgare (Wheat) Germ Oil ............................................................................................................................. 9

Ocular Irritation ................................................................................................................................................................. 9 Linum Usitatissimum (Linseed) Seed Oil ...................................................................................................................... 9 Ribes Nigrum (Black Currant) Seed Oil ...................................................................................................................... 10

Comedogenicity ............................................................................................................................................................... 10 Ribes Nigrum (Black Currant) Seed Oil ...................................................................................................................... 10

Case Studies ..................................................................................................................................................................... 10 Glycine Soja (Soybean) Oil ......................................................................................................................................... 10 Helianthus Annuus (Sunflower) Oil ............................................................................................................................ 10 Olea Europea (Olive) Fruit Oil .................................................................................................................................... 11 Persea Gratissima (Avocado) Oil ................................................................................................................................. 11

SUMMARY ......................................................................................................................................................................... 11 FIGURES AND TABLES ................................................................................................................................................... 14

Figure 2. Basic oil refinement flowchart.3 .................................................................................................................... 15 Table 2. Previously reviewed oil and fatty acid ingredients. ........................................................................................... 18 Table 3. Fatty acid composition. ...................................................................................................................................... 20 Table 4. Chemical properties. .......................................................................................................................................... 26


iii

Table 5. Frequency of use according to duration and exposure. ...................................... Error! Bookmark not defined. Table 6. Non-food, non-cosmetic uses of edible oils.3 ................................................................................................... 42

REFERENCES .................................................................................................................................................................... 48


1

INTRODUCTION Vegetable oil and related edible seed oils have been safely consumed by humans for millennia. Because there is no

significant safety concern with these ingredients following oral exposure and their general biology is well characterized due to

extensive use in food materials, this safety assessment will focus solely on the basic chemistry, manufacturing/production, uses,

and irritation and sensitization data available on these oils as they are used in cosmetic ingredients. Various oils have been used on

the skin since antiquity. Initially used for anointing in religious ceremonies, oils and their components have long been used on the

skin for cosmetic purposes. The full list of ingredients this report covers, which includes oils, hydrogenated oils, unsaponifiables,

oil fatty acids, and simple salts, is found in Table 1. For the sake of brevity, the common name of the oil, when available, will be

used throughout this report. While a large number of oils derived from plants are included in this literature review, there is a

commonality in that they all are mixtures of triglycerides containing fatty acids and fatty acid derivatives, the safety of which in

cosmetics have been established.

This report includes cosmetic ingredients that have been previously reviewed by the Cosmetic Ingredient Review Expert

Panel. The ingredients, their conclusion, and published citations are found in Table 2. Previously reviewed fatty acids and

glyceryl triesters are also found in Table 2. This report excludes tree and ground nut oils, are covered in another safety

assessment.

CHEMISTRY The group of ingredients characterized as fats and oils are the glyceryl esters of fatty acids (triglycerides) normally found

in plant tissues, including those which have been hydrogenated to reduce or eliminate unsaturation.1 Figure 1 is the general

structure of fats and oils. The raw oil may include plant sterols, pigments, glucosides, proteins, vitamins and impurities. The

extent to which these components are removed during processing varies. The available fatty acid compositions for the oils in this

report are found in Table 3. The available information on chemical properties and other constituents, including Food Chemicals

Codex specifications when provided, are found in Table 4.2

The percentage of chemical constituents in individual oil types is dependent on region where the oilseed plant is grown,

individual cultivars, and plant genetics.3 This is especially true in with rapeseed, where the erucic acid content varies from 1% to

58.6%. Low erucic acid rapeseed oil is also known as canola oil.

The nutritional content of these oils varies with oil type. For example, sunflower oil contains high levels of vitamins A,

D, and K, while palm oil is a rich source of vitamins A and E. Crude sunflower oil also has the highest content of vitamin E in the

form of -tocopherol amongst vegetable oils.3


2

Processing Oils used in cosmetics are probably produced using the same process used in the food industry. Depending on the source,

oil may be directly expressed from the source (seed or pulp) followed by solvent extraction. Baileys Industrial Oil and Fat

Products states that the removal of pigments and polar materials is mandatory for most cosmetic applications.4 The process used

for oil refining for foods may be adequate for this purpose, or additional steps may be required. Special refining methods to yield

colorless and odorless oils are used by the cosmetic industry and include proprietary adsorption chromatography and supercritical

fluid extractions.

The majority of the oils presented in this report are produced either from mechanical extraction or solvent extraction or a

hybrid of both methods, known as prepress solvent extraction.3 In solvent extraction, hexane is the most commonly used solvent

as it is economical and has low toxicity potential when compared to other solvents. Seeds that are rich in oil can be cold pressed to

extract oil without the use of solvents.5

After the initial extraction by methods such as solvent extraction, the crude (degummed) oil is often refined.3 The first

step is treating the oil with caustic soda to neutralize free fatty acids, hydrolyze phosphatides, and remove some colored pigments

and unsaponifiable materials. Soap stock is usually a by-product of this step. The next step involves bleaching the neutralized oil

with activated earth to further absorb pigments. The last major step in refining oil is deodorizing, which removes all oxidative

cleavage products that impart odor or flavor to the oil. Deodorization also removes tocopherols, sterols, and other minor

constituents of free fatty acids and undesirable foreign materials. Figure 2 is a flowchart of the basic refinement process.

After deodorization, oils can be further processed by hydrogenation, which makes oil more resistant to oxidative and

thermal damage, and by winterization, where oil is slowly cooled to promote formation of crystals that cause cloudiness and

filtered to remove the crystals.

Cosmetic grade vegetable oils may include a physical refining step that involves heating crude vegetable oil under

vacuum.5 This step allows for the removal of volatile components such as color compounds, odor compounds, and free fatty acids,

which gives the refined oil a lighter color, less odor, and lower acid values.

Analytical Methods According to Crevel et al., a validated analytical methodology for establishing the protein content of oil is needed.6

Impurities Many edible oils are derived from foods that are recognized as potent food allergens. It has been shown that often an

individual that is allergic to a food will generally not react to the refined oil.6 It should be noted that while the Panel has found a

general lack of clinical effects for edible oils already reviewed,7-15 other researchers have raised concerns. Halsey et al. reported

that Lowry protein determinations of cold-pressed and refined sunflower oil found 2-8 g/ml protein,16 while Zitouni et al.


3

reported trace amounts of protein in the refined oil.17 Olszewski et al. found 0.1-0.2 g protein per g of peanut oil,18 while

Ramazzotti et al. reported finding IgE responsive residual proteins in peanut oil extracts.19 Porras et al. found soy protein is some

samples of soy oil, but not others.20 Awazuhara et al. reported 1.4-4.0 g protein per 100 g of soy oil.21 Although Paschke et al.

found approximately 35 g/ml protein content in refined soybean oil, no IgE-binding activity was detectable.22 The European

Medicines Agency (EMEA) Working Party on Herbal Medicinal Products concluded that soy and peanut products should be

treated as allergenic unless they have an analytically-monitored non-allergenic specification and a safe maximum daily dose.23

The EMEA found that threshold concentrations for induction of a protein contact dermatitis were not available and recommended

that all medications for topical use containing soya or peanut products should be treated as allergenic.

USE Cosmetic

Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, moisturizing and

other properties. A total of 124 of the 208 oil ingredients included in this safety assessment are reported to be used; 108 of the in-

use ingredients have never been reviewed by CIR, while 16 have been reviewed previously. For the ingredients being reviewed

for the first time, the frequency of use, as supplied to the Food and Drug Administration (FDA) by industry as part of the

Voluntary Cosmetic Registration Program (VCRP),24 and/or concentration of use, as supplied by industry in response to a Personal

Care Products Council (Council) survey,25,26 can be found in Table 5a. For the ingredients that have been reviewed previously, the

current and historical8,10,11,15,27-30 frequency and concentration of use is given in Table 5b. The 84 ingredients not currently

reported to be used are listed in Table 5c. Table 5d lists the 41 ingredients for which a concentration of use survey has not yet

been completed.

Sunflower seed oil has the greatest number of reported uses in cosmetic and personal care products, with a total of 1414.

Many other ingredients are used in an extensive number of formulations. For example, olive oil and soybean oil have 915 and 912

uses, respectively. Most of the in-use ingredients have uses in both leave-on and rinse-off product types, and many are used in

products that are applied around the eye or that can possibly be ingested. Some are used in products that involve mucous

membrane exposure, and a few are used in underarm deodorant formulations. Many of the products are used in formulations at

relatively high concentrations. Olive oil is used at up to 100%, avocado oil is used at up to 98%, sunflower seed oil at up to 96%,

and soybean oil at 95%.

The oil ingredients described in this report may be used in hair sprays, and effects on the lungs that may be induced by

aerosolized products containing these ingredients are of concern. The aerosol properties that determine deposition in the

respiratory system are particle size and density. The parameter most closely associated with deposition is the aerodynamic

diameter, da, defined as the diameter of a sphere of unit density possessing the same terminal settling velocity as the particle in


4

question. In humans, particles with an aerodynamic diameter of 10m are respirable. Particles with a da from 0.1 - 10m settle

in the upper respiratory tract and particles with a da < 0.1 m settle in the lower respiratory tract.31,32

Particle diameters of 60-80 m and 80 m have been reported for anhydrous hair sprays and pump hairsprays,

respectively.33 In practice, aerosols should have at least 99% of their particle diameters in the 10 110 m range and the mean

particle diameter in a typical aerosol spray has been reported as ~38 m.34 Therefore, most aerosol particles are deposited in the

nasopharyngeal region and are not respirable.

None of the oils or their related counterparts described in this report were restricted from use in any way under the rules

governing cosmetic products in the European Union.35

Non-Cosmetic The primary uses for edible oils are for cooking. Palm oil is the world's most widely consumed edible oil (41.7 million

metric tons), followed by soybean oil, rapeseed oil, sunflower seed oil, cottonseed oil, peanut oil, palm kernel oil, coconut oil, ,and

olive oil.3,36 Non-food, non-cosmetic uses for edible oils are found in Table 6.

ANIMAL TOXICOLOGY

OILS Irritation, sensitization and phototoxicity data available were reviewed and are summarized below. Information from

previous CIR reports on edible oils is identified by italics. No information was found for some of the oils listed in this report.

Dermal Irritation/Sensitization/Phototoxicity

Adansonia Digitata Seed Oil [Baobab]

In an alternative to the Draize test, 100% baobab oil was tested for dermal irritation in a MatTek EpiDerm MTT

viability assay.37 The MatTek EpiDerm tissue samples were incubated with 100 l of the test material for 1, 4, or 24 h along

with the positive control material, 1% Triton X-100, which was incubated for 4 or 9 h, and the negative control, undosed tissues,

which were incubated for 4 h. After treatment, the viability of the tissues was determined with MTT uptake and conversion. The

positive control provided expected results. The test material was classified as non-irritating.

Carthamus Tinctorius (Safflower) Oil

Undiluted safflower oil was minimally irritating in a repeat open patch test using rabbits and was not a primary irritant

or sensitizer in a maximization study using guinea pigs15.

Gossypium Herbaceum (Cotton) Seed Oil

Cosmetic formulations containing 3.4-8.97% hydrogenated cottonseed oil were not irritating to rabbit skin.10


5

Elaeis Guineensis (Palm) Oil

Undiluted palm oil was practically non- to minimally irritating to rabbit skin.8 Palm oil, 5%, was non-allergenic in a

maximization study. A facial lotion containing 1.5% palm oil was not phototoxic in the phototoxicity yeast assay.

Olea Europea (Olive) Fruit Oil

Hartley and/or Himalayan guinea pigs were used to determine the sensitization potential of olive oil. 38 Single drops of a

USP-grade olive oil that had been stored in its original metal container for 10 yrs were applied to an area clipped free of hair on the

backs of 12 guinea pigs. (The composition of the oil was not determined.) Applications were made at 2-6 wk intervals over a

period of 5 mos. Four guinea pigs were treated similarly using store-bought virgin olive oil. None of the animals had a positive

reaction following the initial application of either oil. Using the 10-yr-old olive oil, 11 of 12 of the animals had a positive reaction

at some point during the study. Some, but not all, of these guinea pigs reacted consistently following the first positive reaction; 2

animals had only one positive reaction. Two guinea pigs in this group died by wk 16. In the group dosed with virgin olive oil, one

animal had a positive reaction at wk 2 and one animal had a positive reaction at wks 4 and 6.

Twenty-two guinea pigs sensitive to the 10-yr-old USP olive oil were used to determine cross-reactivity with the store-

bought virgin olive oil, another store-bought olive oil (not specified as virgin olive oil), corn oil, and peanut oil. The 5 oils were

applied simultaneously to the backs of the guinea pigs. Eighteen of the animals reacted to the virgin olive oil, and 18 reacted to the

other store-bought olive oil. (Overlap of these animals was not complete.) Cross-reactivity to corn or peanut oil was not observed.

The researchers then applied single drops of the unsaponifiable fraction of the 10-yr-old oil to 8 sensitized and 4 non-

sensitized guinea pigs. All of the sensitized animals reacted to the unsaponifiable fraction, while the non-sensitized animals did

not react.

Olive oil is used as a vehicle in the murine local lymph node assay (LLNA), an in vitro assay developed to assess a

chemicals potential to induce allergic contact dermatitis in humans.39 The LLNA protocol states that the solvent/vehicle should

be selected on the basis of maximizing the test concentrations while producing a solution/suspension suitable for application of the

test substance. The recommended vehicle is acetone/olive oil (4:1 v/v).

Oryza Sativa (Rice) Bran Oil and Germ Oil

Undiluted rice bran oil was not irritating to rabbits, and in a guinea pig maximization study, no reactions were observed

when 55 was used at induction and 25 and 50% rice bran oil were used at challenge. 11 Rice germ oil was not a primary dermal

irritant, and a rice bran oil/rice germ oil mixture, concentrations not stated, did not cause a contact allergy response. Undiluted

hydrolyzed rice protein was also not irritating or sensitizing. Undiluted rice bran oil and rice germ oil, 75%, were not

phototoxic or photosensitizing.

Sesamum Indicum (Sesame) Seed Oil


6

Undiluted sesame oil was non- or minimally irritating to rabbit skin.30

Triticum Vulgare (Wheat) Germ Oil

Wheat germ oil, undiluted and at 2% in formulation, was non- to mildly irritating, and undiluted wheat germ oil was not

sensitizing to guinea pigs.13

Zea Mays (Corn) Oil

A group of 6 Hartley and/or Himalayan guinea pigs were used to determine the sensitization potential of store-bought

corn oil. 38 None of the animals had a positive reaction following the initial application. Two animals had positive reactions

following application at wks 4 and 6, while one animal had a positive reaction following application at wk 12.

Ocular Irritation Adansonia Digitata Seed Oil [Baobab]

In an alternative to the Draize rabbit eye test, 100% baobab oil was tested for ocular irritation in a MatTek EpiOcular

MTT viability assay.37 The MatTek EpiOcular tissue samples were treated with 100 l of the test material for 16, 64, or 256

minutes along with the positive control material, 0.3% Triton X-100, which was treated for 15 or 45 minutes, and the negative

control, tissue culture water, which was treated for 16 minutes. After treatment, the viability of the tissues was determined with

MTT uptake and conversion. The positive control provided expected results. The test material was classified as non-irritating.


Undiluted palm oil and cosmetic lotions and creams containing 1.5-2.0% palm oil were minimally irritating to the eyes of

rabbits, while one lotion containing 1.5% palm oil was moderately irritating.8 Hydrogenated palm oil suppositories were mildly

irritating to rabbit eyes.


Cosmetic formulations containing 3.4-12.3% hydrogenated cottonseed oil were mildly irritating to the eyes of rabbits.10

Linum Usitatissimum (Linseed) Seed Oil

A mascara containing 9.4% linseed oil was tested for eye irritation potential in an in vitro study using neutral red release

(NRR), hens egg test on chorio-allantoic membrane (HET-CAM), and reconstituted human epithelial culture (REC) assays.40 For

the NRR assay, the test product was diluted at 0%, 5%, 15%, 25%, 35%, and 50% in mineral oil. The NR50 of the test product was

greater than 50% and the test product was considered slightly cytotoxic. In the HET-CAM assay, the score was 6.25 and the test

product was considered moderately irritating when applied under a 67.1% solution in mineral oil. Finally in the REC assay, the

cumulative simplified mean cytotoxicity index (SMCI) was calculated to be 0.25 and the test product was considered slightly

cytotoxic when applied under a 66.9% solution in mineral oil. Overall, the study concluded that the mascara containing 9.4%

linseed oil may be slightly irritating.


7


The ocular irritation potential of high purity olive oil was evaluated using in vivo and in vitro testing.41 In vivo, a Draize

test was conducted using New Zealand rabbits. (The number of animals used was not specified.) Undiluted olive oil was not an

ocular irritant in this test. Using human conjunctival epithelial cells in an in vitro study, olive oil did not induce cellular necrosis

or apoptosis.

Oryza Sativa (Rice) Bran and Rice Germ Oil

A mixture of rice bran oil and rice germ oil, concentrations not stated, were not irritating to rabbit eyes.11 Undiluted rice

bran oil was considered minimally irritating, and rice germ oil, concentration not stated, was not a primary irritant.

Ribes Nigrum (Black Currant) Seed Oil

A 50% dilution of an eye mask containing 0.2% black currant seed oil was tested in a HET-CAM assay.42 Two eye gels

with vitamin E at 50% were used as reference products. The average score was 2.00, where a mean score of 0-4.9 considered

practically none for irritation potential.


Undiluted sesame oil was non- to minimally irritating to rabbit eyes, and a lipstick containing 10-11% sesame oil was not

an ocular irritant.30


Undiluted wheat germ oil was, at most, a minimal ocular irritant, and 2% in a water emulsion was not irritating.13

Zea Mays (Corn) Oil

The ocular irritation potential of high purity corn oil was evaluated using in vivo and in vitro testing.41 In vivo, a Draize

test was conducted using New Zealand rabbits. (The number of animals used was not specified.) Undiluted corn oil was not an

ocular irritant in this test. Using human conjunctival epithelial cells in an in vitro study, corn oil did not induce cellular necrosis or

apoptosis.

CARCINOGENICITY The safety of glycidol fatty acid esters in refined vegetable oils was assessed by IARC. Glycidol was determined to be a

Group2A (probably carcinogenic to humans) chemical while Glycidol Fatty Acid Esters was determined to be a Group 3 (not

classifiable as to carcinogenicity to humans) chemical.43,44

The Federal Institute for Risk Assessment in Germany released a summary of their initial evaluation of the assessment of

levels of glycidol fatty acid esters detected in refined vegetable fats.45 While acknowledging that the levels of glycidol that may be


8

released from glycidol fatty acid esters are not known, the evaluation noted that glycidol is classified as probably carcinogenic to

humans. The evaluation was based on findings of the German Chemical and Veterinary Test Agency (CVUA).

In a presentation by Weisshauer from the CVUA, the conversion of glycidol to 3-chloropropanediol was presented as an

artifact of the analytical method, and it appeared to be the 3-chloropropanediol that was detected its indicative of the presence of

glycidol.46 The levels of 3-chloropropanediol were negligible at the crude oil, degummed, neutralized, and bleached stages, but

levels were significant at the deodorized stage.

CLINICAL ASSESSMENT OF SAFETY Edible oils are commonly believed to be safe for use on the skin.4 de Groot notes that no documentation exist to show that

high quality edible lipids cause adverse reactions in normal individuals (except for potential comedogenicity).47 Very few reports

of adverse reactions to cosmetic use of edible oils have been reported.

Irritation/Sensitization/Allergenicity Many edible oils are derived from foods that are recognized as potent food allergens. It has been shown that often an

individual that is allergic to a food will generally not react to the refined oil.6 A prime example is peanut oil. While the safety of

peanut oil is not being addressed in this assessment, it is being discussed here to demonstrate that although a food might cause

allergic reactions, the oil usually does not. Peanuts are extremely allergenic to a large population, but reaction to the oil is rare. In

its safety assessment on peanut (Arachis hypogaea) oil, the Expert Panel noted that the major concern associated with allergic

reactions to peanuts is the protein.9 The protein does not partition into the refined oil, and therefore the oil is safe for use in

cosmetics. Crevel et al. also concluded that chemically refined peanut oil is safe for the majority of peanut allergic individuals.6

They stated that as peanut is acknowledged to be one of the most potent food allergens, it is reasonable to extrapolate the

conclusions drawn up for peanut oil to other edible oils. However, they concede that validated analytical methodology for

establishing the protein content of oil is needed.

In support of the conclusions stated earlier, Crevel et al. also examined the allergenicity of some other oils. Very few

instances of allergic reactions to other major edible oils have been reported. Even sesame oil, which differs from the other oils in

that it is used as a flavorant and therefore is not as refined and expected to contain significantly more protein that the other edible

oils, has had very few reports of allergic reaction. Additional studies demonstrating safety are summarized later in this section.16,48

Specific information on clinical dermal irritation and sensitization findings from previous CIR reports on edible oils are

described below and are identified by italics. New clinical irritation and sensitization data is summarized in Table 7.


9

Carthamus Tinctorius (Safflower) Oil

Cosmetic formulations containing 3-5% safflower oil were not irritating to humans in occlusive patch tests and were not

primary irritants or sensitizers in repeated insult patch tests.15


Palm oil, 15% in petrolatum or cosmetic formulations containing 1.0-2.0%, was not an irritant or sensitizer in clinical

studies.8 Bar soap flakes, tested at dilutions that contained 2.13% palm kernel oil, were not irritating or sensitizing.


In a clinical patch test, the irritation potential of a cosmetic formulation containing 3.4% hydrogenated cottonseed oil

was mildly low, and the severity of reaction to 10.4% hydrogenated cottonseed oil was acceptably low in a use study.10 Cosmetic

formulations containing 10.6-20.86% hydrogenated cottonseed oil were not irritating or sensitizing. Patients that were

hypersensitive to cottonseed proteins were not sensitive to cottonseed oil in a skin prick test.

Oryza Sativa (Rice) Bran Oil

Rice is generally regarded as hypoallergenic, although some case studies of allergic reactions to raw rice have been

reported.11 In clinical testing, formulations containing 1.04-8.0% rice bran oil were not irritating or sensitizing, and formulations

containing 1.04% rice bran oil were not photosensitizing. Hydrolyzed rice protein was not irritating to human subjects.

Persea Gratissima (Avocado) Oil

Avocado was not an irritant or sensitizers when human subjects were patch tested with cosmetic formulations containing

up to 10.7% avocado oil or in patch tests using 100% avocado oil.14


In clinical testing, undiluted sesame oil was not irritating.30 Cosmetic formulations containing 8-14.3% sesame oil were

non- to essentially non-irritating. Prophetic patch testing with formulations containing 10-11% sesame oil were not irritating with

or without UV light. Patients with contact allergy to sesame oil were patch tested, and most had positive reactions to sesamol,

sesamin, and sesamolin.


In clinical testing, wheat germ oil was not an irritant or a sensitizer.13

Ocular Irritation Linum Usitatissimum (Linseed) Seed Oil

The ocular irritation potential of a mascara containing 9.4% linseed oil was tested in 33 female subjects for 4 weeks.49 Of

the 33 subjects, 16 were contact lens wearers and the remaining 17 were self-assessed sensitive eye non-contact lens wearers. One

subject dropped out of the study for non-treatment related reasons. Subjects were evaluated with subjective questionnaires


10

regarding ocular sensation following product use as well as with objective ophthalmic findings. Trace increases in palpebral

conjunctival irritation were observed in only one subject, but this result was thought to be non-treatment related by the study

investigators. No subjective irritation was reported and no adverse events were reported. The study concluded that the test

material was clinically safe for use by contact lens wearers and self-assessed sensitive eye non-contact wearers.

Ribes Nigrum (Black Currant) Seed Oil An in-use 4 week study was conducted on an eye mask that contained 0.2% black currant seed oil (undiluted) in 52

subjects.50 Subjects were evaluated by an ophthalmologist and a dermatologist at baseline and at the end of the study. No adverse

reactions were observed. The eye mask was considered ophthalmologist tested and safe for contact lens wearers.

Comedogenicity Ribes Nigrum (Black Currant) Seed Oil

A comedogenicity study of an eye mask containing 0.2% black currant seed oil (undiluted) was performed on 6

subjects.51 The test material was applied with occlusive patches. The average score was 0.00 comedones/cm2. The eye mask was

found to be non-comedogenic.

Case Studies Glycine Soja (Soybean) Oil

Seven patients with a history of immediate hypersensitivity reaction after the ingestion of soybeans were enrolled in a

double-blind crossover study.48 The patients were first skin tested by the puncture method with a crude whole soybean extract, a

partially hydrogenated oil, a non-hydrogenated oil, and a cold-pressed soybean oil. Olive oil from a retailer was used as a negative

control. Since all 7 patients had negative skin tests to the oils and positive reactions to the crude soybean extract, they were

challenged orally with capsules of each of the oils in random order on 4 separate days. None of the patients reacted to the oral

challenges. The researchers remarked that while a reaction to the cold-pressed soybean oil did not occur in this study, cold-pressed

oils may contain soybean protein and should be avoided.

The sera from 4 patients with known allergy to soybean was used to examine the allergenicity of soy oil proteins.21

Neither the IgE nor the IgG4 in the sera reacted to protein in the soy oil.

Helianthus Annuus (Sunflower) Oil

Two cases were reported of patients having anaphylactic reactions following ingestion of sunflower seeds.16 No

reactions were seen upon oral or open challenge with refined or cold-pressed sunflower oils, both of which were shown to contain

detectable amounts of protein. However, in a case report of a woman who had been desensitized to mugwort (a member of the

Compositae family) pollen for a year, but then had an anaphylactic reaction to sunflower (also a member of the Compositae

family) seeds, it was found that she had a delayed positive reaction to sunflower oil in a skin prick test.52 Prick test results with 10


11

control subjects were negative. In an oral challenge test, a delayed reaction was again observed, with symptoms occurring 2.25-8

h after administration.


Throughout the literature, it is stated that sensitization to olive oil is considered rare. Case reports have been described,

however, and generally involved patients with venous eczema, some type of dermatitis or lesion, or an occupational exposure.

Patch testing with olive oil produced positive reactions in most of these cases, and these results were usually regarded as

allergenic. The concentrations of olive oil tested were not always given, but when stated, test concentrations giving positive

results, ranged from 30-100%. In some cases, the constituents of olive oil were tested as well, but the results of that testing were

negative.53-60

Krnke et al. investigated whether the reactions to olive oil were contact sensitization or irritation, using open and

occlusive testing. They concluded that olive oil presented as a weak irritant rather than a contact sensitizer in the few case studies

they observed. The capacity to produce an irritant result was increased using occlusive conditions.61 Zipprich and Hauser

remarked that components capable of inducing an irritant reaction can form if the olive oil isnt stored properly.62

Persea Gratissima (Avocado) Oil

A case study was reported in which a female subject had dermatitis around the eyes and earlobes.63 Patch testing with her

sunscreen resulted in positive results. In subsequent patch testing of the individual ingredients, a positive reaction to undiluted

avocado oil, but not to the active ingredient, was observed. Twenty controls subjects were used, and reactions to avocado oil were

not seen.


A case study was reported in which a woman applied a Chinese ointment containing sesame oil, resulting in pruritic

erythema, papules, and vesicles. 64 Patch testing was performed with the ointment and with the individual ingredients, including

undiluted sesame oil. Both the ointment and sesame oil produced positive reactions on days 2, 3, 4, and 11. The other components

did not cause a reaction. Results were negative in patch testing of sesame oil using 20 healthy subjects.

SUMMARY The oils derived from vegetable and fruit plants are composed of mono-, di-, and triglycerides, free fatty acids and other

minor components, including natural antioxidants and fat-soluble vitamins. The percentage of chemical constituents and

nutritional content of individual oil types is dependent on region where the oil plant is grown, individual cultivars, and plant

genetics. Oils used in cosmetics are likely produced in the same manner as those used in the food industry. Oils may be expressed


12

through mechanical or solvent extraction. The oils may undergo further refining to remove pigments, odors, unsaponifiable

materials, and other undesirables.

It has been shown that often an individual that is allergic to a food will generally not react to the refined oil. The CIR

Expert Panel has found a general lack of clinical effects for edible oils that they have already reviewed; however, other researchers

have raised concerns about the presence of residual proteins oils, such as peanut and soy. These ingredients may also contain

aflatoxins, a metabolic products of certain molds that are carcinogenic to humans. The FDA action level for aflatoxin in foods is

20 ppb.

Of the oils described in this report, sunflower seed oil has the most reported uses in cosmetic and personal care products

with a total of 1414 and is used at a maximum concentration of 96%. Oils are used in a wide variety of cosmetic products,

including use in hair spray and other aerosolized products. None of the oils or the related counterparts described in this report

were restricted from use in the European Union.

Oils not summarized in the animal toxicity section or clinical studies section of this report had no available data for

review.

In dermal irritation studies in animals, Adansonia Digitata seed oil [baobab], hydrogenated cottonseed oil, rice bran oil,

and rice germ oil were not irritating. Undiluted safflower oil was minimally irritating in rabbits, but it was not a primary irritant in

guinea pigs. Undiluted palm oil, sesame oil, and wheat germ oil were practically non-irritating to minimally irritating in rabbits.

Safflower oil, palm oil, rice bran oil, rice germ oil, and wheat germ oil were non-sensitizing in animal studies. Rice bran oil, rice

germ oil, and palm oil were not phototoxic in animals studies.

In animal ocular studies, Adansonia Digitata seed oil [baobab], olive oil, rice germ oil, black currant seed oil, 10-11%

sesame seed oil, 2% wheat germ oil, and corn oil were non-irritating. Undiluted palm oil and palm oil at 2% were minimally

irritating to rabbit eyes. Hydrogenated palm oil and 3.4% - 12.3% hydrogenated cottonseed oil were considered mildly irritating.

In a HET-CAM study, 9.4% linseed oil was slightly irritating. Undiluted rice bran oil and undiluted wheat germ oil were

minimally irritating to eyes, while undiluted sesame oil was non- to minimal ocular irritants.

Glycidol and glycidol fatty acid esters, possible constituents in refined vegetable oils, were determined to be Group 2A

(probably carcinogenic to humans) and Group 3 (not classifiable as to carcinogenicity to humans) chemicals, respectively, by

IARC.

Edible oils are believed to be safe for use on the skin and very few reports of adverse reactions have been reported. The

proteins that are responsible for allergenic responses in individuals with food allergies do not partition into refined oils.


13

In previously reviewed oils, safflower oil, palm oil, hydrogenated cottonseed oil, rice bran oil, avocado oil, sesame oil,

and wheat oil were non-irritating and/or non-sensitizing in human studies. In many of the oils found in this report, no irritation

and/or sensitization reactions were observed in human repeated insult patch tests.

In clinical studies, 0.2% black currant seed and 9.4% linseed oil were not ocular irritants. Black currant seed oil at 0.2%

was also non-comedogenic. Cases of contact allergy have been reported for soybean oil, sunflower oil, olive oil, avocado oil, and

sesame seed oil.


14

FIGURES AND TABLES

OCR

O

H2C

HC OCR'

O

H2C OCR"

O

-OCR, -OCR', and -OCR" may be the same or diff erent f atty acid radicals.

Figure 1. General structure of fats and oils.1


15

-

Crude Oil

Degummed Oil Lecithin Sludge

Alkali Refined Oil Soap Stock

Salad Oil

Cooking Oil Salad and Cooking Oil

Partially Hydrogenated Oil

Other Fatty Oil

Shortening Stock

Blended Oils

Margarine Stock

Bleached Oil

Salad Oil

Water

Alkali

Deodorization

Deodorization

Deodorization

Deodorization

Deodorization

Deodorization

Activated Earth

H2, Catalyst

Winterization & Deodorization

Figure 2. Basic oil refinement flowchart.3


16

Tabl

e 1.

Ed

ible

oils

a

nd

thei

r de

rivativ

es.*

Veg

etab

le (O

lus)

Oil

(CA

S N

o. 68

956-

68-3)

Hel

ian

thu

s A

nn

uu

s (S

un

flow

er) S

eed

Oil

(CA

S N

o. 80

01-21

-6)

Bra

ssic

a N

apu

s Se

ed O

il [R

apes

eed]

Hyd

roge

ante

d V

eget

able

O

il (C

AS

No. 68

334-

28-1)

Hel

ian

thu

s A

nn

uu

s (S

un

flow

er) S

eed

Oil

Un

sapo

nifi

able

s B

rass

ica

Ole

race

a A

ceph

ala

Seed

O

il [K

ale]

Ma

jor O

ils

Hyd

roge

nat

ed Su

nflo

wer

Se

ed O

il B

rass

ica

Ole

race

a Ita

lica

(Bro

ccoli)

Se

ed O

il B

rass

ica

Cam

pest

ris (R

apes

eed)

Seed

O

il (C

AS

No. 80

02-13

-9)

Sun

flow

er Se

ed A

cid

(CA

S N

o. 84

625-

38-7)

Cam

elin

a Sa

tiva

Seed

O

il [F

alse

Fl

ax]

Bra

ssic

a Ca

mpe

stris

(R

apes

eed)

Oil

Un

sapo

nifi

able

s O

lea

Euro

pea

(Oliv

e) Fr

uit

Oil

(CA

S N

o. 80

01-25

-0)

Hyd

roge

nat

ed Ca

mel

ina

Sativ

a Se

ed O

il

Hyd

roge

nat

ed Ra

pese

ed O

il (C

AS

No. 84

681-

71-0)

Hyd

roge

nat

ed O

live

Oil

Cam

ellia

Ja

ponic

a Se

ed O

il Po

tass

ium

R

apes

eeda

te

Hyd

roge

ante

d O

live

Oil

Un

sapo

nifi

able

s Ca

mel

lia K

issi S

eed

Oil

[Tea

] R

apes

eed

Aci

d O

live

Aci

d (C

AS

No. 92

044-

96-7)

Cam

ellia

O

leife

ra Se

ed O

il [T

ea Se

ed]

Sodi

um

Ra

pese

edat

e O

lea

Euro

paea

(O

live)

Hu

sk O

il H

ydro

gen

ated

Ca

mel

lia O

leife

ra Se

ed O

il Ca

nola

O

il (C

AS

No. 80

02-13

-9;

12

0962

-03

-0)

Ole

a Eu

ropa

ea (O

live)

Oil

Un

sapo

nifi

able

s (C

AS

No. 15

6798

-12

-8)

Cam

ellia

Si

nen

sis Se

ed O

il Ca

nola

O

il U

nsa

pon

ifiab

les

Pota

ssiu

m O

livat

e (C

AS

No. 68

154-

77-8)

Caric

a Pa

paya

Se

ed O

il [P

apay

a] H

ydro

gen

ated

Ca

nola

O

il So

dium

O

livat

e (C

AS

No. 64

789-

88-6)

Cary

oca

r B

rasil

ien

se Fr

uit

Oil

[Peq

ui]

Cart

ham

us

Tin

cto

rius

(Sa

fflo

wer

) See

d Oi

l (CAS

N

o. 80

01-23

-8)

Ory

za Sa

tiva

(R

ice)

Bra

n O

il (C

AS N

o. 68

553-

81-1;

84

696-

37-7)

Chen

opo

diu

m Qu

inoa

Seed

O

il [Q

uin

oa]

Hyd

roge

nat

ed Sa

fflow

er Se

ed O

il O

ryza

Sa

tiva

(R

ice)

Ger

m O

il Ci

tru

llus

Lan

atu

s (W

ater

mel

on

) See

d O

il Po

tass

ium

Sa

fflo

wer

ate

Ric

e B

ran

Ac

id (C

AS N

o. 93

165-

33-4)

Citr

us

Au

ran

tifolia

(L

ime)

Seed

O

il Sa

fflo

wer

A

cid

Hyd

roge

nat

ed Ri

ce B

ran O

il Ci

tru

s A

ura

ntif

olia

(L

ime)

Seed

O

il U

nsa

ponifi

able

s

Sodi

um

Sa

fflow

erat

e O

ryza

Sa

tiva

(Ric

e) Se

ed O

il

Hyd

roge

nat

ed Li

me

Seed

O

il E

laei

s G

uin

een

sis (P

alm

) Oil

(CAS

N

o. 80

02-75

-3)

Sesa

mu

m In

dicu

m (S

esam

e) Se

ed O

il (C

AS N

o. 80

08-74

-0)

Hyd

roge

nat

ed Li

me

Seed

O

il U

nsa

pon

ifiab

les

Ela

eis

Gu

inee

nsis

(P

alm

) Ker

nel

Oi

l (CAS

N

o. 80

23-79

-8)

Hyd

roge

na

ted

Sesa

me

Seed

O

il Ci

tru

s A

ura

ntiu

m D

ulc

is (O

ran

ge) S

eed

Oil

Hyd

roge

na

ted

Palm

Oi

l (CAS

N

o. 80

33-29

-2;

68

514-

74-9)

Sesa

mu

m In

dicu

m (S

esam

e) O

il U

nsa

pon

ifiabl

es

Citr

us

Au

ran

tium

D

ulc

is (O

ran

ge) S

eed

Oil

Un

sapo

nifi

able

s

Hyd

roge

na

ted

Palm

K

ern

el Oi

l (CAS

N

o. 68

990-

82-9;

84

540-

04-5)

Sodi

um

Se

sam

esee

date

Hyd

roge

nat

ed O

ran

ge Se

ed O

il Pa

lm K

ern

el A

cid

Sesa

mu

m In

dicu

m (S

esam

e) Se

ed B

utte

r H

ydro

gen

ated

O

ran

ge Se

ed O

il U

nsa

pon

ifiab

les

Elae

is G

uin

een

sis (P

alm

) Bu

tter

(CA

S N

o. 80

02-75

-3)

Zea M

ays

(C

orn

) Oil

(CAS

N

o. 80

01-30

-7)

Citr

us

Gra

ndi

s (G

rape

fruit)

Se

ed O

il El

aeis

Ole

ifera

K

ern

el O

il Ze

a M

ays

(C

orn

) Ger

m O

il Ci

tru

s G

randi

s (G

rape

fruit)

Se

ed O

il U

nsa

pon

ifiab

les

Elae

is (P

alm

) Oil

Zea M

ays

(C

orn

) Oil

Un

sapo

nifia

bles

Citr

us

Para

disi

(Gra

pefru

it) Se

ed O

il

Palm

A

cid

Corn

Ac

id (C

AS N

o. 68

308-

50-9)

Hyd

roge

nat

ed G

rape

fruit

Seed

O

il H

ydro

gen

ated

Pa

lm A

cid

Pota

ssiu

m Co

rna

te (C

AS N

o. 61

789-

23-9)

Hyd

roge

nat

ed G

rape

fruit

Seed

O

il U

nsa

ponifi

able

s

Pota

ssiu

m Pa

lmat

e M

inor

Oils

Citr

us

Lim

on

(L

emon

) See

d O

il (C

AS

No. 85

085-

28-5)

Pota

ssiu

m H

ydro

gen

ated

Pa

lmat

e A

ctin

idia

Ch

inen

sis (K

iwi)

Seed

O

il Co

ix La

crym

a-Jo

bi (Jo

b's Te

ars)

Seed

O

il Po

tass

ium

Pa

lm K

ern

elat

e A

dan

son

ia D

igita

ta O

il [B

aoba

b]

Cram

be A

byss

inic

a Se

ed O

il [A

byss

inia

n M

ust

ard]

Sodi

um

H

ydro

gen

ated

Pa

lmat

e A

dan

son

ia D

igita

ta Se

ed O

il Cu

cum

is Sa

tivu

s (C

ucu

mbe

r) Se

ed O

il (C

AS

No. 70

955-

25-8)

Sodi

um

Pa

lmat

e (C

AS

No. 61

790-

79-2)

Hyd

roge

nat

ed A

dan

son

ia D

igita

ta Se

ed O

il Cu

curb

ita Pe

po (P

um

pkin

) See

d O

il (C

AS

No. 80

16-49

-7)

Sodi

um

Pa

lm K

ern

elat

e (C

AS

No. 61

789-

89-7)

Am

aran

thu

s H

ypoch

on

dria

cus

Seed

O

il [A

mar

anth

] H

ydro

gen

ated

Pu

mpk

in Se

ed O

il G

lyci

ne

Soja

(Soyb

ean

) Oil

(CA

S N

o. 80

01-22

-7)

Arc

tium

La

ppa

Seed

O

il [B

urd

ock

] Cy

nar

a Ca

rdun

culu

s Se

ed O

il [A

rtic

hoke

] (CA

S N

o. 92

3029

-60

-1)

Gly

cin

e So

ja (S

oyb

ean

) Oil

Un

sapo

nifi

able

s (C

AS

No. 91

770-

67-1)

Arg

ania

Sp

inosa

K

ern

el O

il [A

rgan

] Eu

terp

e O

lera

cea

Fru

it O

il [A

cai]

Hyd

roge

nat

ed So

ybea

n O

il (C

AS

No. 80

16-70

-4)

Hyd

roge

nat

ed A

rgan

ia Sp

inosa

K

ern

el O

il Fr

agar

ia A

nan

assa

(S

traw

berr

y) Se

ed O

il So

y A

cid

(CA

S N

o. 68

308-

53-2)

Ast

roca

ryu

m M

uru

mu

ru Se

ed Bu

tter

[Mu

rum

uru

] Fr

agar

ia Ch

iloen

sis (S

traw

berr

y) Se

ed O

il Po

tass

ium

So

yate

Sodi

um

A

stro

cary

um

M

uru

mu

ruat

e Fr

agar

ia V

esca

(S

traw

berr

y) Se

ed O

il So

dium

So

yate

A

ven

a Sa

tiva

(Oat

) Ker

nel

O

il

Frag

aria

V

irgin

ian

a (S

traw

berr

y) Se

ed O

il G

oss

ypiu

m H

erba

ceu

m (C

otto

n) S

eed

Oil

(CAS

N

o. 80

01-29

-4)

Bas

sia B

uty

race

a Se

ed B

utte

r G

arci

nia

In

dica

Se

ed B

utte

r [K

oku

m]

Cotto

nse

ed Ac

id (C

AS N

o. 68

308-

51-0)

Bas

sia La

tifolia

Se

ed Bu

tter

[Mah

wa]

Gu

izotia

A

byss

inic

a Se

ed O

il [R

amtil

] H

ydro

gen

ate

d Co

tton

seed

O

il (C

AS N

o. 68

334-

00-9)

Bora

go O

ffici

nal

is Se

ed O

il [B

ora

ge] (

CAS

No. 22

5234

-12

-8)

Hip

poph

ae Rh

amn

oid

es O

il [S

ea-B

uck

thorn

] * pr

evio

usly

re

vie

wed

in

gred

ients

ar

e in

bo

ld a

nd

italic

s


17

Tabl

e 1.

Ed

ible

oils

a

nd

thei

r de

rivativ

es.*

Hip

poph

ae Rh

amn

oid

es Fr

uit

Oil

[Sea

-B

uck

thorn

] H

ydro

gen

ated

Pa

ssifl

ora

Ed

ulis

Se

ed O

il H

ydro

gen

ated

Ra

spbe

rry

Seed

O

il H

ippo

phae

Rh

amn

oid

es Se

ed O

il [S

ea-B

uck

thorn

] Pe

rilla

O

cym

oid

es Se

ed O

il [P

erill

a] Sc

lero

cary

a B

irrea

Se

ed O

il [M

aru

la]

Irvin

gia

Gab

on

ensis

K

ern

el B

utte

r [D

ika]

(CA

S N

o. 19

2230

-28

-7)

Pers

ea G

ratis

sima (A

voca

do) O

il (C

AS N

o. 80

24-32

-6)

Sily

bum

M

aria

num

Se

ed O

il [T

hist

le]

Lim

nan

thes

A

lba

(Mea

dow

foam

) See

d O

il (C

AS

No. 15

3065

-40

-8)

H

ydro

gen

ated

A

voca

do O

il So

lan

um

Ly

cope

rsic

um

(T

om

ato) S

eed

Oil

Hyd

roge

nat

ed M

eado

wfo

am Se

ed O

il

Pers

ea G

ratis

sima

(Avoca

do) B

utte

r So

lan

um

Ly

cope

rsic

um

(T

om

ato) F

ruit

Oil

Lin

um

U

sitat

issim

um

(L

inse

ed) S

eed

Oil

(CA

S N

o. 80

01-26

-1)

Pers

ea G

ratis

sima

(Avoca

do) O

il U

nsa

ponifi

able

s (C

AS

No. 91

770-

40-0)

Theo

brom

a Ca

cao (C

oco

a) Se

ed B

utte

r (C

AS

No. 80

02-31

-1)

Lin

seed

A

cid

(CA

S N

o. 68

424-

45-3)

Sodi

um

A

voca

doat

e So

dium

Co

coa

Butte

rate

Luffa

Cy

lindr

ica

Seed

O

il [L

uffa

] Pl

uke

net

ia V

olu

bilis

Se

ed O

il [S

acha

In

chi]

Theo

brom

a G

ran

diflo

rum

Se

ed Bu

tter

[Cupu

acu] (

CAS

No.

3942

36-97

-6)

Lupi

nu

s A

lbu

s Se

ed O

il [W

hite

Lu

pine]

Pru

nu

s A

rmen

iaca

(A

pric

ot)

Ker

nel

O

il (C

AS

No. 72

869-

69-3)

Sodi

um

Th

eobr

om

a G

ran

diflo

rum

Se

edat

e

Lupi

nu

s A

lbu

s O

il U

nsa

pon

ifiab

les

Hyd

roge

nat

ed A

pric

ot K

ern

el O

il To

rrey

a N

uci

fera

Se

ed O

il [K

aya]

Lyci

um

Ba

rbar

um

Se

ed O

il [G

oji B

erry

] H

ydro

gen

ated

A

pric

ot K

ern

el O

il U

nsa

ponifi

able

s Tr

iticu

m Vu

lga

re (W

heat)

Ger

m Oi

l (CAS

N

o. 80

06-95

-9;

68

917-

73-7)

Man

gife

ra In

dica

(M

ango

) See

d O

il Pr

unu

s A

rmen

iaca

(A

pric

ot)

Ker

nel

O

il U

nsa

ponifi

able

s H

ydro

gen

ated

W

heat

G

erm

O

il M

angi

fera

In

dica

(M

ango

) See

d B

utte

r Pr

unu

s A

viu

m (S

wee

t Che

rry)

Seed

O

il H

ydro

gen

ated

W

heat

G

erm

O

il U

nsa

pon

ifiab

les

Sodi

um

M

ango

seed

ate

Pru

nu

s D

om

estic

a Se

ed O

il [P

run

e/Pl

um

] Tr

iticu

m A

estiv

um

(W

heat

) Ger

m O

il M

orin

da Ci

trifo

lia Se

ed O

il [N

oni]

Pru

nu

s Pe

rsic

a (P

each

) Ker

nel

O

il (C

AS

No. 80

02-78

-6;

80

23-98

-1)

Triti

cum

V

ulg

are

(Whe

at) G

erm

O

il U

nsa

pon

ifiab

les

Morin

ga O

leife

ra Se

ed O

il [B

en]

Hyd

roge

nat

ed Pe

ach

Ker

nel

O

il W

heat

G

erm

A

cid

(CA

S N

o. 68

938-

32-9)

Morin

ga Pt

eryg

osp

erm

a Se

ed O

il

Punic

a G

ran

atu

m Se

ed O

il [P

om

egra

nte

] V

acci

niu

m Co

rym

bosu

m (B

lueb

erry

) See

d O

il O

enoth

era

Bien

nis

(Eve

nin

g Pr

imro

se) O

il H

ydro

gen

ated

Pu

nic

a G

ran

atu

m Se

ed O

il V

acci

niu

m M

acro

carp

on (C

ranbe

rry)

Seed

O

il H

ydro

gen

ated

Ev

enin

g Pr

imro

se O

il Py

rus

Mal

us

(App

le) S

eed

Oil

Hyd

roge

nat

ed Cr

anbe

rry

Seed

O

il O

rgib

nya

Co

hun

e Se

ed O

il [C

ohu

ne]

Rib

es N

igru

m (B

lack

Cu

rran

t) Se

ed O

il (C

AS

No. 97

676-

19-2)

Vac

ciniu

m M

yrtil

lus

Seed

O

il [B

ilber

ry] (

CAS

No. 11

6192

1-09

-0)

Orb

ign

ya O

leife

ra Se

ed O

il [B

abas

su] (

CAS

No. 91

078-

92-1)

Hyd

roge

nat

ed B

lack

Cu

rran

t See

d O

il V

acci

niu

m V

itis-

Idae

a Se

ed O

il [L

igo

nbe

rry]

Orb

ign

ya Sp

ecio

sa K

ern

el O

il [B

abas

su]

Rib

es Ru

bru

m (C

urr

ant) S

eed

Oil

Van

illa

Plan

ifolia

Fr

uit

Oil

[Van

illa]

(CA

S N

o. 80

24-06

-4)

Bab

assu

A

cid

Rosa

Ca

nin

a Fr

uit

Oil

[Dog

Rose

] V

itis

Vin

ifera

(G

rape

) See

d O

il (C

AS

No. 80

24-22

-4)

Pota

ssiu

m B

abas

suat

e H

ydro

gen

ated

R

osa

Ca

nin

a Fr

uit

Oil

Sodi

um

G

rape

seed

ate

Sodi

um

Ba

bass

uat

e R

ubu

s Ch

amae

moru

s Se

ed O

il [C

loudb

erry

] H

ydro

gen

ated

G

rape

seed

O

il Pa

ssifl

ora

Ed

ulis

Se

ed O

il [P

assio

n Fr

uit]

(C

AS

No. 87

676-

26-1)

Rubu

s Id

aeu

s (R

aspb

erry

) See

d O

il

* pr

evio

usly

re

vie

wed

in

gred

ients

ar

e in

bo

ld a

nd

italic

s


18

Tabl

e 2.

Pr

evio

usly

re

vie

wed

o

il a

nd

fatt

y a

cid

ingr

edie

nts

.

Ingr

edie

nts

Pu

blic

atio

n D

ate

C

on

clu

sion

Oil

Ingr

edie

nts

Cart

ham

us

Tin

ctoriu

s (S

afflo

wer

) See

d O

il (C

AS

No. 80

01-23

-8)

JACT

4(5

):171

-19

7, 19

85;

Re-

revie

wed

, n

ot r

eope

ned

IJ

T 25

(2):1

-89

, 20

06

Safe

Elae

is G

uin

een

sis (P

alm

) Oil

(CA

S N

o. 80

02-75

-3)

IJT

19(S

2):7-

28, 20

00

Safe

Elae

is G

uin

een

sis (P

alm

) Ker

nel

O

il (C

AS

No. 80

23-79

-8)

Hyd

roge

nat

ed Pa

lm O

il (C

AS

No. 80

33-29

-2;

68

514-

74-9)

Hyd

roge

nat

ed Pa

lm K

ern

el O

il (C

AS

No. 68

990-

82-9;

84

540-

04-5)

Goss

ypiu

m H

erba

ceu

m (C

otto

n) S

eed

Oil

(CA

S N

o. 80

01-29

-4)

IJT

20(S

2):21

-29

, 20

01

Safe

Cotto

nse

ed A

cid

(CA

S N

o. 68

308-

51-0)

Hyd

roge

nat

ed Co

tton

seed

O

il (C

AS

No. 68

334-

00-9)

Ory

za Sa

tiva

(Ric

e) B

ran O

il (C

AS

No. 68

553-

81-1;

84

696-

37-7)

IJT

25(S

2):91

-12

0, 20

06

Safe

Ory

za Sa

tiva

(Ric

e) G

erm

O

il R

ice

Bra

n A

cid

(CA

S N

o. 93

165-

33-4)

Sesa

mu

m In

dicu

m (S

esam

e) Se

ed O

il (C

AS

No. 80

08-74

-0)

JACT

12

(3):2

61-27

7, 19

93;

Am

ende

d Fi

nal

R

eport

, 20

09

Safe

Hyd

roge

nat

ed Se

sam

e Se

ed O

il Se

sam

um

In

dicu

m (S

esam

e) O

il U

nsa

pon

ifiab

les

Sodi

um

Se

sam

esee

date

Zea

May

s (C

orn

) Oil

(CA

S N

o. 80

01-30

-7)

Fin

al R

eport

, 20

08

Safe

Zea

May

s (C

orn

) Ger

m O

il

Zea

May

s (C

orn

) Oil

Un

sapo

nifi

able

s

Corn

A

cid

(CA

S N

o. 68

308-

50-9)

Pota

ssiu

m Co

rnat

e (C

AS

No. 61

789-

23-9)

Pers

ea G

ratis

sima

(Avoca

do) O

il (C

AS

No. 80

24-32

-6)

JEPT

4(4

):93-

103,

19

80;

Re-

revie

wed

, n

ot r

eope

ned

IJ

T 22

(1):1

-35

, 20

03

Safe

Triti

cum

V

ulg

are

(Whe

at) G

erm

O

il (C

AS

No. 80

06-95

-9;

68

917-

73-7)

JEPT

4(4

):33-

45, 19

80;

Re-

revie

wed

, n

ot r

eope

ned

IJ

T 22

(1):1

-35

, 20

03

Safe

Fatty

Ac

ids

Ara

chid

on

ic A

cid

(CA

S N

o. 50

6-32

-1)

JACT

12

(5)

:481

-55

9, 19

93

Insu

ffici

ent d

ata

Hyd

rox

yste

aric

A

cid

(CA

S N

o. 10

6-14

-9)

IJT

18(S

1):1-

10, 19

99

Safe

Lau

ric A

cid

(CA

S N

o. 14

3-07

-7)

JACT

6(3

):321

-40

1, 19

87;

Re-

revie

wed

, n

ot r

eope

ned

IJ

T 25

(2):1

-89

, 20

06

Safe

Myr

istic

A

cid

(CA

S N

o. 54

4-63

-8)

Ole

ic A

cid

(CA

S N

o. 11

2-80

-1)

Palm

itic

Aci

d (C

AS

No. 57

-10

-3)

Stea

ric A

cid

(CA

S N

o. 57

-11

-4)


19

Tabl

e 2.

Pr

evio

usly

re

vie

wed

oil

and

fatty

ac

id in

gred

ien

ts (co

ntin

ued

). I n

gred

ien

ts

Publ

ica

tion

D

ate

C

on

clu

sion

Gly

cery

l Trie

ster

s

Trila

urin

IJT

20 (S

4):61

-94

, 20

01

Safe

Tria

rach

idin

Trib

ehen

in

Tric

aprin

Tric

apry

lin

Trie

ruci

n

Trih

epta

noin

Trih

epty

lun

deca

noin

Triis

on

on

anoin

Triis

opa

lmiti

n

Triis

ost

earin

Trili

nole

in

Trim

yrist

in

Trio

ctan

oin

Trio

lein

Trip

alm

itin

Trip

alm

itole

in

Triri

cin

ole

in

Trist

earin

Triu

nde

can

oin

Gly

cery

l Tria

cety

l Hyd

rox

yste

arat

e

Gly

cery

l Tria

cety

l Ric

inole

ate

Gly

cery

l Ste

arat

e D

iace

tate


20

Tabl

e 3.

Fa

tty

aci

d co

mpo

sitio

n.

Fatt

y A

cids

Co

rn

Oil2

8,65

,66

*

Co

tto

n

Seed

O

il10

Oliv

e O

il3

Palm

Oil8

Palm

K

ern

el

Oil8

Ra

pese

ed

Oil3

Fully

Hyd

roge

na

ted

Ra

pese

ed O

il2

Ca

nola

O

il2

Saffl

ow

er

Seed

O

il15,

67

Sesa

me

Seed

Oil7

,30

Ca

pro

ic (C

6)

0.3

Ca

pryl

ic (C

8)

4.4

Ca

pric

(C

10)

3.7

Lau

ric

(C12

)

0.2

48.3

Myr

istic

(C

14)

0.1

- 1.

7 2

Trac

e 1.

1 15

.6

< 1.

0

116 draft oils

Documents

cir panel book page

cir expert panel history

cir expert panel members

fruit oils

numerous oils

edible nut oils

draft report

green book