JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY
Volume 4, Number 5, 1985
Mary Ann Liebert, Inc., Publishers

1

Final Report on the Safety
Assessment of Stearyl Alcohol,
Oleyl Alcohol,

and Octyl

Dodecanol
Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain saturated
or unsaturated(Oleyl) fatty alcohols. They are used in numerous cosmetic
product categories at concentrationsof less than 0.1 percent to greater than 50
percent.
The metabolism of Stearyl Alcohol and Oleyl Alcohol in rats is described.
The results of acute oral toxicity studies indicate a very low order of toxicity. In
rabbit irritation tests, these alcohols produced minimal ocular irritation andminimal to mild cutaneous irritation. Stearyl Alcohol produced no evidence ofcontact sensitizationor comedogenicity.
Clinical patch testing indicates a very low order of skin irritation potential
and sensitization.
Photoreactivity
studies on products containing these ingredients were negative for phototoxicity
or photosensitization.
Based on the available data, it is concluded that Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are safe as currently used in cosmetics.

INTRODUCTION

S

tearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain fatty alcohols used in a variety of cosmetic products. The materials of commerce are
mixtures of fatty alcohols, and the terms Stearyl Alcohol, Oleyl Alcohol, andOctyl Dodecanol refer to these mixtures for the purposes of this report. If data
pertain to the pure compound rather than the cosmetic ingredient, the distinction is noted.

CHEMICALANDPHYSICALPROPERTIES

Composition
Stearyl Alcohol
Stearyl Alcohol is a mixture of solid fatty alcohols that consists predominantlyof n-octadecanol (90 percent minimum assay) with varying amounts of n-hexa1

2

COSMETIC INGREDIENTREVIEWdecanol, n-tetradecanol, n-eriosanol, and n-dodecanol along with unspecified
uneven and branched-chain alcohols. The predominant component conforms to
the formula:“-3)CH,(CHd,sCHzOH
CAS Number:

112-92-5

Synonyms
include Octadecanol, n-Octadecanol, Octa Decyl Alcohol,
Octadecyl Alcohol, Stearol, USP XIII Stearyl Alcohol, and n-l-Octadecanol.
Oleyl

n-

Alcohol

Oleyl Alcohol is a mixture of fatty alcohols that consists predominantly of thestraight-chain
unsaturated 9-n-octadecenol (55 percent minimum assay) withvarying amounts of 8-n-hexadecenol,
6-n-dodecenol,n-hexadecanol, n-octadecanol, n-tetradecanol, and 7-n-tetradecenol.
The predominant component
conforms to the formula:‘2,4~“’
CHKHKH=CH(CHJ,CH20H
CAS Number:
Synonyms
Octyl143-28-2

include cis-9Octadecen-l-OL

and Oleol.

Dodecanol

Octyl Dodecanol is an aliphatic alcohol with the structural

formula:CHKHJFCH-CH2--OH

I
CH,
Additional informationis unavailable.‘2.6’
CAS Number:
Synonyms

concerning the compositionof the material of commerce

5333-42-6

include 2-Octyl

Dodecanol.

Production

and Occurrence

Stearyl Alcohol may be produced via Ziegler aluminum alkyl hydrolysis or
the catalytic, high-pressure hydrogenation of stearic acid, followed by filtrationand distillation.
It may also be derived from natural fats and oils.“~5~7-‘o’Oleyl Alcohol is produced by catalytic, high-pressure hydrogenation of oleic
acid followed by filtration and distillation. (4s,7) It may also be prepared frombutyl oleate by Bouveault-Blanc
reduction with sodium and butyl alcohol orfrom triolein by hydrogenation in the presence of zinc chromite. Purification inthese processes is obtained through fractional crystallization
at -40°C from acetone followed by distillation.(‘O)

FINAL REPORT:

SAFETY ASSESSMENT

3

OF LONG-CHAIN ALCOHOLS

Octyl Dodecanol is produced by the condensation of 2 molecules of decyl
alcohol.‘“) Further detail concerning the method of manufacture is unavailable.
Fatty alcohols occur in small quantities as components of wax esters in plants
and animals. For example, Oleyl Alcohol has been found in the epidermis ofmany plants, and Stearyl Alcohol has been isolated from plants and insects. In
both cases, the alcohols probably serve as components of the organisms’ protective layers against water loss. Stearyl Alcohol has also been isolated from humansebaceous lipids and has been found in mammalian glands and organs. Oleyl Alcohol is found in fish oils.(10,12-23)

Properties
Stearyl Alcohol is a white, waxy, practically inert solid with a faint odor.(1.5,10.
11.15)Oleyl Alcohol is a clear, odorless, viscous liquid.(4.5*11’ Octyl Dodecanol is aclear, odorless, free-flowing liquid.‘6*11’ Other physical and chemical propertiesare listed in Table 1.

TABLE 1.

Properties

Propertiesof Stearyl Alcohol,

Oleyl Alcohol,

Stearyl A/coho/r’~3~s~7~“)

Molecular

weightand Octyl
Oley/

Dodecanol

A/COho/‘4.5.L0.L’.ZB,

Octyl

Dodecano/r6-I’)

270.5

268.5

State

Flakes, granules

Viscous liquid

Liquid

Color

White

Clear colorless

Colorless to

Odor

Faint fatty

Faint

Odorless

Specific gravity

0.8124(59”/4”C)

0.850-0.966

0.830-0.850

0.811(35”/25”C)(20”/2OT)

298.56(pure compound)to light yellow

Melting

point

51-60°C

Boiling point

210.5Y.I- 7.5oc

pale yellow(20”/2O”C)-

55-60T-

333T(15 mm)Refractive

inclex1.4388Acid value

1 .O max

Saponification

2.0 max

60°C

1.458-l,460

1.453-1.547

1 .O max

1 .O max

2.0 max

10 max2.0 max

45-98

10 max5.0 max

85-95

2.0 maxvalue

3.0 max

Iodine value
Hydroxyl

value

Soluble in

195-220

195-220165-180200-220205-215

Alcohol

Alcohol

175-190-

Acetone

Ether

Ether

AcetoneBenzeneLight mineral oil

Chloroform
Insoluble

in

Water

Water

-

ng

COSMETIC INGREDIENT

Analytical

REVIEW

Methods

Analytical methods used to detect and identify fatty alcohols include gas-liquid chromatography, thin-layer chromatography, differential scanning calorimetry, and gas chromatography.(24-27)

Impurities
Stearyl Alcohol consists of not less than 90 percent stearyl alcohol. The remainder consists chiefly of cetyl alcohol,(3) oleyl alcohol, palmityl alcohol, andother alcohols.(9) The known major constituents and minor impurities are:(‘)
n-Octadecanoln-Hexadecanol
n-Tetradecanoln-Eriosanoln-Dodecanol
Stearyl stearate
Octadecane
Stearic acid
Total hydrocarbons

90 percent minimum
Variable
Variable
Variable
Variable
2 percent maximum
1 percent maximum
0.5 percent maximum
1.8 percent (approx.)

Oleyl Alcohol consists of 9-n-octadecenol, but may contain some such unsaturated and saturated high molecular weight fatty alcohols as linoleyl, myristyl,and cetyl alcohols. (5~28)The known major components and minor impurities
are: (4)9-n-Octadecenol
8-n-Hexadecenol
6-n-Dodecenol
n-Hexadecanol
n-Octadecanol
n-Tetradecanol
7-n-Tetradecenol
Oleyl oleate
Oleic acid
Informationon the impurities

55 percent minimum
Variable
Variable
Variable
Variable
Variable
Variable
1.9 percent maximum
0.5 percent maximumof Octyl Dodecanol is unavailable.

USES
Noncosmetic

Uses

Stearyl Alcohol is used in surface-active agents, lubricants, emulsions, resins,and USP ointments
and as a substitute for cetyl alcohol and antifoaming
agents. (5.10.29)
Stearyl Alcohol (synthetic) has been approved as a direct food additive (DFA)ingredient, to be used under the same manufacturing practices as the natrual alcohol product. It also has indirect food additive (IFA) status for use in food con-

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

5

ALCOHOLS

tainers and coatings (21 CFR 172.864;
175.300;
176.200;
176.210;177.1200;
178.391 O).‘30’
Stearyl Alcohol is also used as an ingredient in over-the-counter (OTC) drugsof the miscellaneous external drug product category. It is considered to be safe ata concentration of 8 percent or less.(31)
Oleyl Alcohol is used in chemical and polymer synthesis, as a petroleum additive, and as a surfactant, plasticizer, and antifoaming agent. It is also used as aningredient in pharmaceuticals, as a metal-machining lubricant, as a componentof carbon paper, stencil paper, and ink, as an emulsifying agent, and as an emollient (5nlOo28)
bleyl Alcohol has been approved as an IFA ingredient for use in paperboard
components, as a defoaming agent, and as a lubricant (21 CFR 176.170; 176.210;
177.1210;
178.3910).‘30’
Uses for Octyl Dodecanol, other than cosmetic, were not found in the review of the available literature.

Cosmetic
Purposein Cosmetic

Uses

Products

The fatty alcohols, in general, are used primarily as emulsifiers,
emollients,
antifoaming agents, and surfactants.(5a7a32,33’
Stearyl Alcohol is used in cosmetics as an emollient, stabilizer, antifoaming
agent, emulsifier, and carrier. It is used as a water in oil (w/o) emulsifier to produce firm cosmetic products at ordinary temperatures.(‘*5*7s33) A personal communication from the Society of Cosmetic Chemists to the Cosmetic, Toiletry andFragrance Association’34’ states:
Stearyl Alcohol

is used in creams and lotions as an emollient,

ing and pearlizing

agent, thickener,

phobic in nature and will, therefore,
inducing hydration.

Whenand emulsion

auxiliarystabilizer.

produce a semiocclusive

used in sufficientconcentrations,body-

is hydro-film on the skin that aids inin the absence of liquid fats,

Stearyl Alcohol

emulsionshas a sufficiently

high melting point to deposit nongreasy films on the skin. When

powders,

leave a matte finish

emulsifier,

Stearyl Alcoholon the skin. In addition,

Stearyl Alcohol
used inStearyl Alcohol improves adhesion and imparts a soft feel to the skin. Stearyl Al-

cohol is stable in high pH formulations,cle removers.

such as hair straighteners,

It is also used in shampoos

depilatories,

and cuti-

and bubble baths as an opacifier.

Oleyl Alcohol is used as an emollient, emulsion stabilizer, surfactant, lubricant, and antifoaming agent. (4,7) A personal communication from the Society of
Cosmetic Chemists to the Cosmetic, Toiletry and Fragrance Association’34’ states:
Oleyl Alcohol

is used in a variety of cosmetic preparations

agent, emulsion

stabilizer,

and pigment suspending

as an emollient,

agent. Oleyl Alcoholsuperfatting

is miscible withfats, oils, and wax mixtures and will blend well with the oil phase of a cosmetic emulsion.
Oleyl Alcohol

is easily emulsified

metic formulation.

and aids in the hydration

In lipsticks, Oleyl Alcoholof other ingredientsin a cos-

has excellent solvent properties,

improves

glide and slip, and leaves a thin film on the lips. Oleyl Alcohol
alcohol solubility

and is easily incorporated

has an appreciable hydro-

into a wide variety of such lotions.

COSMETIC INGREDIENT

6

In regard to Octyl Dodecanol,
Octyl Dodecanol
odorless,colorless,the same communication(34)REVIEW

states:is a saturated liquid fatty alcohol with a total carbon length of 20. It is
and has an indefinite

shelf life. Octyl Dodecanolspreads easily whenapplied to the skin and leaves no visible trace of greasiness. It can be used as a carrier foroil soluble
coupling

active ingredients,

as an emollient,

as a dispersant

agent for waxes and other fatty materials.

super-fatting agent in shampoos,

Extent of Use in Cosmetic

hair conditioners,

Octyl

for pigments,

Dodecanol

and as a

is also used as aand soaps.

Products

The Food and Drug Administration(FDA), in voluntary cooperation with cosmetic ingredient manufacturers and formulators, compiles a list of cosmetic ingredients and the types of products and concentrations in which they are used.
Filing of product formulation data with the FDA conforms to the prescribed format of preset concentration ranges and product categories as described in Title
21 part 720.4 of the Code of Federal Regulations. (30) Since certain cosmetic ingredients are supplied by the manufacturer at less than 100 percent concentration,
the concentration reported by the cosmetic formulator may not necessarily reflect the true concentration found in the finished product; the actual concentration in such a case would be a fraction of that reported to the FDA. Since data are
only submitted within the framework of preset concentration ranges, the opportunity exists for a 2- to lo-fold overestimation of the actual concentration of an ingredient in a particular product.
In 1981, Stearyl Alcohol was reported to be used in 425 cosmetic formulations at concentrations ranging from less than 0.1 percent to 50 percent. Oleyl Alcohol was present in 1018 different formulations at concentrations of less than
0.1 percent to greater than 50 percent. Octyl Dodecanol was listed in 371 products at concentrations of less than 0.1 percent to greater than 50 percent. Veryfew products contain these ingredients in the highest concentration ranges(35)(Table 2).
These compounds are found in a wide variety of cosmetic products and may,therefore, contact and enter the body through numerous routes. Some products
may be applied several times daily and may remain in contact for extended periods (Table 2).

BIOLOGICAL
Absorption,

PROPERTIESMetabolism,

and Excretion

Stearyl Alcohol is found naturally in various mammalian tissues. This fatty alcohol is readily converted to stearic acid, another common constituent of mammalian tissues. Results from several studies indicate that Stearyl Alcohol is poorly
absorbed from the gastrointestinal
tract. For a review of the literature writtenfrom the years 1933 to 1978 on the absorption, metabolism, and excretion of
Stearyl Alcohol, see the Evaluation of the Health Aspects of Stearyl Alcohol as a
Food Ingredient, prepared for the Food and Drug Administration
by The Federation of American Societies for Experimental Biology.‘36)
Sieber et al.(37) studied the entry of octadecanol-l-‘4C (Stearyl Alcohol) into

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

ALCOHOLS

7

the thoracic duct lymph0 of the rat. The thoracic duct, abdominal aorta, and theduodenum below the pyloric valve were cannulated in male Sprague-Dawley
rats. The common bile duct of some animals was also cannulated. Lymph flows
were monitored, and 24 hours after surgery the radiolabeled compound (25 mCi/mmol) was administered via either the duodenal or aortic cannula. Blood andlymph were monitored for radioactivity after dosing at 0.25, 0.5, 0.75, 1, 2, 4, 6,
and 24hour
intervals. Intestinal radioactivity was determined by quantifying the‘“C or 3H of the homogenate of the intestines, which showed the percent absorbed radioactivity in the lymph was 56.6 f 14.0. Of this, more than half was
found in the triglycerides of the lymph, 6 to 13 percent in the phospholipids,
2 to
8 percent as the cholesterol esters, and 4 to 10 percent unchanged octadecanol.
Ninety percent of octadecanol was carried in the chylomicron fraction. The absorption of the compound appeared to be a function of its lipid solubility.
The metabolism of Oleyl Alcohol was studied in 1 adult sheep. The rumen
was cannulated and the animal received 66.0 g per day of Oleyl Alcohol in thediet for 12 days. Continuous measurement showed increased excretion of lipids(9 g/day fatty acids and 30 g/day unsaponifiables) and increased excretion of stearic and oleic acid. Oleyl Alcohol had no effect on either methane or heat production. (38)Cis-9-octadecanol (Oleyl Alcohol) was reported to be a prominent constituent of long-chain alcohols in rat tissue. Ethanol (0.1 ml) containing 1.85 mEq cis9-octadecanol-l-14C was injected into the tail veins of rats, and the animals weresacrificed at 1, 24, 48, or 76 hours after injection. After 1 hour, the highest
amount of radioactivity was found in the lungs, less in the liver, and the lowest
amount in the brain. At 24, 48, and 96 hours, the rate of decline of radioactivity
was greatest in the lungs and liver and least in the heart and brain. The radioactivity was incorporated mainly in glycerophosphocholines,
glycerophosphoethanolamines, and neutral lipids. It was rapidly used for biosynthesis of lipids in therat. (39)The permeability of the blood-brain barrier to long-chain alcohols in plasma
was studied using Oleyl Alcohol. Four groups of 4 male Wistar rats were fed
either a standard diet (control) or the standard diet plus 160 mg of Oleyl Alcohol(available ad lib) for 7 or 14 days. The entire supplement was consumed every
day by the individually caged rats. At the end of the specified times, the animals
were fasted for 24 hours and killed, and the organs were analyzed. No differences in growth rates were found between experimental and control groups. The
addition of Oleyl Alcohol to the diet for 7 days increased the free and esterified
long-chain alcohols in the liver. After 14 days, there was a 3-fold increase in freeand esterified alcohols when compared to control animals. The hepatic alk-lenyl acyl and alkyl acyl phosphoglycerides increased 2-to 8-fold over control values during the 18day feedings. No quantifiable changes were noted in brain
lipids after 7 or 14 days.‘40’
The fate of dietary Oleyl Alcohol was studied using 8 weanling male rats. For
the first 5 days after weaning, the animals were fed a standard diet; then 4 rats received a mixture of 85:15 lab diet:oleyl palmitate, and the other 4 received 96:4
lab diet:Oleyl Alcohol. Two weeks after commencement of feeding of the experimental diet, tha animals were killed, and the liver and intestines were removed.
Growth on the Oleyl Alcohol diet was poor when compared to the oleyl palmitate diet. The fecal distribution of ingested Oleyl Alcohol was 46 percent wax es-

TABLE 2.

Product Formulation

Datacash
No. ProductProduct Category*

Formulations

Total

Total No.

formulations

Containing

Unreported

in Category

IngredientConcentration>50>25-502---

WithinEach Concentration>lO-25>5-10

Range (%J*>l-5

>O.l-1

10.1

Stearyl Alcohol
Baby lotions, oils, powders,

and

56

2

-

creams
145

1

-

-

Eye shadow

2582

24

-

-

Mascara

3097

2

-

-

Eyebrow pencil

230

2

-

-

Sachets

119

26

-

-

Hair conditioners

478

46

-

-

Hair straighteners

64

2

-

-

474

5

-

-

158

21

-

-

909

1

-

-

811

1

-

-

111

5

-

-

49

2

-

-

Blushers (all types)

819

15

-

-

Makeup

740

8

-

-

Other eye makeup

Permanent

preparations

waves

Hair rinses (noncoloring)
Hair shampoos(noncoloring)

Hair dyes and color (all types
requiring caution

statement

-

-

4

-

-

-

-

-

-

23
2

1
-

4

4

1
14

-

1

14
-

22
1

9
-

5

-

1

2

3

10
1

6
-

1

-

3

-

-

and

patch test)
Hair bleaches
Otherhair coloring

preparations

foundations

Leg and body paints
Lipstick
Makeupbases

RougesMakeupOther

fixatives

makeuppreparations

4

3

-

-

3319

3

-

-

831

63

-

-

211

1

-

-

22

1

-

-

530

2

-

-

-

-

2
2

-

14

2

1

a

-

3

-

1

2

38

23

-

1

-

-

1
1

1

2

-

(not eye)softeners

32

2

-

-

Nail creams and lotions

25

1

-

-

Deodorants

239

3

-

-

Cuticle(underarm)

3

-

-

Other227

personal cleanliness

10

-

9

1

-

-

products
4

1

114

6

-

29

2

-

680

39

Beard softeners
Shaving cream (aerosol, brushless,

-

1

-

5

-

-

1

1

4

15

17

3

6

-

-

1

14

19

2

1

2

1

and lather)Othershaving preparation

products
Skin cleansing(cold creams,

preparations--

lotions, liquids,

and pads)
Depilatories
Face, body, and hand skin care
preparations(excluding

32

6

823

36

-

-

-

shaving

preparations
747

49

Night skin care preparations

219

12

Paste masks (mudpacks)

171

2

Skin lighteners

44

6

Skin fresheners

260

Moisturizing

Wrinkleskin care preparations

smoothers(removers)

38

1

skin care preparations349

9

Suntan gels, creams, and liquids

164

2

Indoor tanning

15

Other

preparations

-

-

-

-

-

TOTAL

1981 DATA

425

-

-

TOTAL

1979 DATA

414

23

-

17

-

22

24

-

6

4

-

1

1
1

4

1
-

-

1

1

1

-

1
1

-

-

6

1
-

3

1
1

2
-

-

-

-

13

16

109

224

60

12

16

101

208

54

2

8

1
-

1
-

-

-

Oleyl Alcohol
Bath oils, tablets, and salts

237

Bubble baths

475
3

Bath capsules
Otherbath preparations

Eyebrow

132

3

145

pencil

-

5
-

-

-

-

1
1

3

1

-

369

15

7

7

1

Eye shadow

2582

124

60

19

Mascara

397

26

36
-

-

230

8

26
2

EyelinerOther

eye makeup

preparations

-

3

2

-

-

-

-

7

2
-

1

-

-

TABLE

2.

(Continued)
No. Product

Formulations

WithinCategory*

Total
Formulations
in Category

Colognes and toilet waters

1120

2

-

Perfumes

657

5

-

119

2

-

-

191

9

-

-

478

9

-

Product

Sachets
Other fragrance

preparations

Hair conditioners
Hair straighteners
Tonics, dressings, and other hairgrooming
Other

Total No.
Containing
IngredientUnreported
Concentration

Each Concentration

Range (%)*

>50

>25-50>10-25

>5-10

>l-5

-

-

-

-

-

-

-

-

-

3

>O.l-1
2
1

-

2

-

1

-

8

1

-

3

6

-

64

4

-

290

4

-

-

177

1

-

-

-

-

-

1

811

63

-

-

-

13

-

50

-

-

13

-

-

-

so. 1

4
1

aids

hair preparations(noncoloring)
Hair dyes and colors (all types
requiring caution

statement

and patch test)
15

13

-

Hair bleaches

111

2

-

Blushers (all types)

819

13

-

Face powders

555

1

-

-

-

-

-

1

Makeup

740

5

-

-

-

-

-

3

2

-

3319

633

-

2

-

1

225
-

138

831

19
-

7
-

-

Hair tints

foundations

Lipstick
Makeupbases

RougesOther

makeuppreparations

1

2

2
-

6
-

236

211

3

-

-

-

2

530

10

-

-

-

7

2
7

1

2

1

-

-

1
3

-

-

(not eye)
41

1

-

-

-

1

239

2

-

-

-

2

21

1

-

-

227

2

-

-

lotions282

2-

Preshave lotions (all types)

29

1

-

680

2

-

-

-

Nail polish and enamel
Deodorants
Feminine
Other

remover(underarm)hygiene deodorants

personal cleanliness

1

-

-

1

-

-

2

-

-

products
Aftershave

Skin cleansing(cold creams,
and pads)

preparations
lotions, liquids,

-

-

2

1

Face, body, and hand skin care
preparations(excluding

823

6

4

1

-

1

shaving

preparations)Hormoneskin care preparations

Moisturizing

skin care preparations

Night skin care preparations

219

Paste masks (mudpacks)

171

Skin fresheners

260

Other

349

skin care preparations

Suntan gels, creams,

and liquids

-

10
747

164

TOTAL

1981 DATA

1018

TOTAL

1979 DATA

1069

Octyl

-

1

-

-

-

1

-

4

-

-

1

-

1

-

-

-

-

1

-

-

2

-

-

-

138

1

-

-

2

1
1

1

1

-

1

1

3

1

-

3

9

331

310

301

48

16

1

11

267

313

294

32

13

4

-

1

-

-

-

Dodecanol

Bath oils, tablets, and salts

237

Eyebrow145

pencil4

Eyeliner369

14

Eye shadow

2582

82

13

1

Eye lotion
Eye makeup

remover

MascaraOther-

eye makeup

preparations

Perfumes
Fragrance

powders(dusting andtalcum,excluding

aftershave

81

3

397

1

230

4

657

3

483

4

-

-

-

-

-

-

-

1

11
6

60

16

-

2

-

-

3

1

2

1
2

2

1

-

-

-

-

4

-

talc)
119

6

191

1

Hair conditioners

478

3

Hair sprays (aerosol fixatives)

265

2

Hair rinse (noncoloring)158

2

Hair dyes and colors (all types

811

41

Blushers (all types)

819

6Face powders

555

6

SachetsOther

fragrance

requiringpreparations

caution

-

-

-

6

-

-

-

-

1

-

-

-

-

-

2
1

-

1
1
2

-

1

40

3

2

1

3

1

-

-

statement

and patch test)

-

-

-

-

-

2

-

5

TABLE

2.

(Continued)
No. Product Formulations

Total
Product

Category*

Lipstick
Makeupbases

RougesMakeupOther

fixatives

makeupFormulations
in Category

Containing
Ingredient

3319

112

-

831

I

-

211

I

Unreported
Concentration

Each Concentration

530

2

>50

>25-501> IO-25

>5-10

46
-

54
-

1

-

5

-

-

-

-

-

-

-

-

-

I

-

-

-

-

1

-

-

-

-

22

preparations

WithinRange (%)*

Total
No.
>l-5

2-0.1-l

5

1

so. 1

-

1

-

-

-

-

1

(not eye)
Bath soaps and detergents

148

Deodorants

239

Other

(underarm)

personal cleaniness

227

1

-

-

-

-

-

-

-

-

-

-

-

1

1

products
Preshave lotions (all types)

29

1

-

-

1

-

1

-

-

114

-

-

Shaving cream (aerosol,

-

-

-

1

-

680

9

-

-

-

-

823

23

-

-

-

brushless,and lather)
Skin cleansing

preparations(cold creams,

-

1

3

5

7

9

1

6
I

-

3
1

-

-

-

-

lotions, liquids,

and pads)
Face, body, and hand skin care
preparations(excluding

3

2

2

-

4

2
-

shaving

preparations)skin care preparations349

7

Suntan gels, creams, and liquids

164

3

Other

28

1

-

Moisturizing

skin care preparations

747

14

Night skin care preparations

219

3

Skin lighteners

44

4

38

1

WrinkleOthersmoothers(removers)

suntan preparations

-

2

3
-

-

18

70

195

60

23

4

-

-

1

-

1979

295

294

-

with federal

filing regulations

ranges in accordance

2

1

-

-

TOTAL

and concentration

2

1

1

-

categories

-

-

371

*Preset productCosmetics.

--

1981 DATA
DATA

-

-

TOTAL

1

I
2

(21 CFR 720.4);-

see Scope and Extent of Use in

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

ALCOHOLS

13

ter, 27 percent fatty alcohol, 16 percent monoglyceride, 6 percent free fatty acid,and 5 percent diglyceride. Oleyl Alcohol deposition in liver was manifested as 7
percent wax ester, 11 percent triglyceride, 3 percent free fatty acid, 6 percent freefatty alcohol, and 72 percent phospholipid.(41)
Two additional studies investigated the metabolism of orally administered
Oleyl Alcohol in rats. The intragastric administration
to rats of 200 mglday of
Oleyl Alcohol for 14 days increased the relative concentration of alkyl and alky-lenyl moieties in alkoxylipids
in the small intestine.‘42) In another study, the incoporation of long-chain alcohols and acyl glycerols into hepatic tissues of rat wasstudied. A group of 4 rats were fed a basic diet (control), and a second group of 4
were fed the basic diet plus 100 mglday of cis-9-octadecenyl alcohol (Oleyl Alcohol) for 28 days. Experimental compounds were fed by stomach tube, and theanimals were killed 10 hours after the last feeding. The alcohol produced no abnormalities in the rats and did not effect the distributionof lipid classes or fatty
acid composition of the phosphoglycerides in the liver. Pronounced changes did
occur in both the alkyl and alkyl-l-enyl
moieties of the phosphoglycerides of theliver. Metabolites of long-chain alcohols become incorporated into the phosphoglycerides of the liver.(43)

Miscellaneous
Microbial

Effects

Effects

Yanagi and Onishi (44)found that Oleyl and Stearyl Alcohol can be utilized as
the sole source of carbon by some species of Penicillium, Candida, and Pseudomonas.
Cellularand Subcelluar

Effects

Stearyl Alcohol, a known tobacco smoke constituent, was studied for its effect on the plasma membrane of cultured human lung fibroblasts. The fibroblasts, labeled with 3H-uridine, were incubated for 30 minutes at 37°C with 25
mM alcohol in Tris-bufferedsaline. The leakage of radiolabeled intracellular substances was used to indicate plasma membrane damage. Stearyl Alcohol was inactive in inducing significant cellular damage.(45)
The differential effects of Oleyl Alcohol on the osmotic fragility of erythrocytes were studied using heparinized adult male human blood. The erythrocytes
from venous blood were washed, prepared as a 50 percent cell suspension, andthen mixed with varying concentrations of saline solution. The alcohol was dissolved in methanol and added to the cells for 10 minutes. The cells were thencentrifuged, and hemolysis was determined by measuring the supernatant hemoglobin absorbance at 540 nm. At high saline concentrations,those at whichhemolytic activity was greatest, the alcohol did not stabilize the erythrocytes
against hypotonic hemolysis.(46)Raz and Goldman’47) studied the effect of Oleyl Alcohol on the osmotic fragility of lysosomes. Rat livers were removed and homogenized, and their lysosomal fraction was extracted, To this fraction, Oleyl Alcohol was added in varying concentrations. Damage to lysosomes was determined by using the extent ofleakage of lysosomal acid phosphatase. At 2 x lo-’ M, Oleyl Alcohol had significant stabilizing
effect, and 5 x 10m5 M caused extensive damage to the lyso-

COSMETIC INGREDIENT14

REVIEW

somes. The interaction of Oleyl Alcohol with lysosomes was biphasic; it was stabilizing at low concentrations and labilizing at high concentrations.
AnimalToxicology

Oral Toxicity
Acute Studies
reported the LDso of Stearyl Alcohol was not reachedEgan and Portwood”)
even at doses of 8 g/kg given orally to male and female Holtzman albino rats.
Stearyl Alcohol is classified as “nontoxic” by the Federal Hazardous Substances
Labelling Act (FHSLA) and “practically non-toxic” by the criteria of Hodge andSterner. Other sources reported that Stearyl Alcohol had a low order of toxicity. (29.48)
Undiluted Octyl Dodecanol was administered orally as a single dose to 5 rats
at 5 g/kg, with no evident toxicity.,(49)Product formulations
containing Oleyl Alcohol or Octyl Dodecanol havebeen tested for acute oral toxicity in rats. Products containing 8.0 percent or 20
percent Oleyl Alcohol administered by gastric intubation at doses up to 10 g/kg
caused no deaths and no toxic effects. (5o-52)A lipstick containing 10.2 percent
Octyl Dodecanol was diluted to 50 percent and administered to 10 rats at a doseof 25 g/kg. The total dose of Octyl Dodecanol was 1.28 g/kg. There were no
deaths. (53)Percutaneous

Toxicity

Acute Studies
An acute percutaneous toxicity study was conducted with 100 percent Octyl
Dodecanol on 6 guinea pigs. A single dose of 3.0 g/kg was applied under occlusion to each animal on abraded and intact skin. No deaths occurred, all animals
appeared normal throughout the study, and there were no gross lesions at necropsy on the seventh day.(54’Subchronic

Studies

A subchronic percutaneous toxicity study was conducted for 3 months on a
cream product formulation containing 8.0 percent Stearyl Alcohol. In 2 groups of
10 rabbits each, animals received topical applications of the product at doses of
8.8 mg/cm2 per 8.4 percent body surface area (BSA) or 13.2 mg/cm2 per 11.2 percent BSA 3 days a week during a 3-month period. A third group of 10 rabbits
served as an untreated control. The product caused very slight to well-definederythema and mild desquamation during the first month of treatment, and mild
inflammation at the site of application was noted at necropsy. The results of hematological and blood chemistry determinations,urinalyses, organ weight measurements, and necropsy indicated no treatment-related effects. No evidence ofsystemic toxicity attributable to topical application of the product was found.(55)
OcularIrritation

Studies of irritation to the rabbit eye were conducted on samples of undiluted Stearyl Alcohol from 4 separate commercial sources. Each of the samples

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

ALCOHOLS

15

was instilled full strength into 1 eye of each of 6 rabbits. Minimal irritation wasnoted on Day 1 for 3 of the samples (maximum score of 5, scale 0 to 1101, andthere was no irritation from the remaining sample. Scores decreased to 0 by Day
4 in all cases.(56)
An irritation test of 100 percent Oleyl Alcohol using 6 rabbits gave an ocular
irritation score of 1 (max, 110) on Day 1; all scores were 0 by the second day.(57)The ocular toxicity of 4 lots of Oleyl Alcohol was tested in a modified version of
the Official French Method.“”
The undiluted ingredient in a 0.1 ml volume wasapplied to 1 eye of each of 6 rabbits, and readings were made at 1, 24, and 48
hours. The scores were 7.17 (max, 110) at 1 hour, 0.33 at 24 hours, and 0.0 at 48
hours. (59)
In an ocular irritation test 100 percent Octyl Dodecanol with 6 rabbits had an
average irritation score of 4 (max, 110) on Day 1, with a score of 0 by Day 4.‘60’ In
an identical test, 100 percent Octyl Dodecanol had scores of 1 on Days 1 and 2
and 0 on Day 3.‘61’
Several ocular irritation studies using rabbits were conducted on productformulations containing 8.0 to 20 percent Oleyl Alcohol or 3.0 to 10.2 percent
Octyl Dodecanol. In every case, there was either no or only minimal, transientocular irritation induced by these products.(52.62-67)
A Draize ocular irritation test was conducted on a hairdressing formulation
containing 1.5 percent Oleyl Alcohol after several complaints of ocular irritation
were reported from its use. A 0.1 ml volume of the undiluted product was instilled into the eyes of 3 albino rabbits both with and without tapwater rinse. The
product was practically nonirritating. The product was also tested undiluted andin a 25 percent diluted form and caused no ocular irritation in squirrel monkeys.
Furthermore, exposure of the hairdressing formulation to oxygen, UV irradiation,and 0.01 N sulfuric acid caused no increase in product-induced irritation. Instillation of the hairdressing did not potentiate the ocular irritancy of a saturated solution of NaCI, 4 percent Formosaline, or 15 percent Teepol. Irritation did occur
after the instillation
into the eyes of rabbits of rinsings taken from the humanhead after use of the hairdressing.“j*’Skin Irritation
Acute Studies
Cutaneous irritation tests using rabbits were conducted on 4 samples of Stearyl Alcohol obtained from separate commercial sources. When each sample wasapplied full strength under occlusion to the clipped skin of 9 rabbits for 24 hours,
irritation scores of 0.4, 0.5, 1.42, and 1.5 were recorded (scale 0 to 4). Thesescores were indicative of minimal to mild primary skin irritation.‘69’
Many studies on the irritant properties to the skin of Oleyl Alcohol have beenreported. According to Drill and Lazar (‘O)25 percent Oleyl Alcohol in mineral oil
caused no to low skin irritation. Four lots of Oleyl Alcohol were tested for acuteskin irritation according to a modified version of the Official French Method.‘58’
Samples were fixed for 24 hours under occlusion to the backs of rabbits. Irritation
was evaluated according to a modification of the French Method scale of 0 to 8:
nonirritant, less than 0.5; slight irritant, 0.5 to 2; moderate irritant, 2-5; severe irritant 5-8. The four lots were each tested in undiluted form and in a 10 percent
aqueous dispersion,and 2 samples were assayed twice. Each assay was per-

COSMETIC INGREDIENT16

REVIEW

formed on at least 6 animals. By this assay, Oleyl Alcohol was slightly irritatingwhen undiluted and nonirritating when in a 10 percent aqueous dilution (Table

3). (59)
A skin irritation test with 9 rabbits gave an irritation index of 0.17 (scale 0 to4) for 100 percent Oleyl Alcohol applied for 24 hours under occlusion. This score
was indicative of minimal primary skin irritation. (‘I) When undiluted Oleyl Alcohol was applied to the skin of rabbits for 4 consecutive days, the greatest average
irritation score was 2.33 (scale 0 to 4). This result was interpreted as mild primaryskin irritation.(72)Three separate cutaneous irritation tests using rabbits were conducted on
100 percent Octyl Dodecanol or a 30 percent aqueous dilution of Octyl Dodecanol in which the test material was applied under occlusion to the backs of 9 rabbits for 24 hours. The ingredient produced skin irritation indices (scale 0 to 4) of1 . 13 I (73) 0.5,(74) and zero(“) for the alcohol full strength and zero(“) for the 30
percent aqueous dilution.
Technical grade Oleyl Alcohol and 2-octyl dodecanol were tested for skin irritation using rabbits, guinea pigs, rats, miniature swine, and man.(76) In the rabbit studies, the hair on 6 areas of each of 6 albino rabbits was shaved, and test
materials were applied 24 hours later. Undiluted samples were applied in 0.1 g
amounts to the test areas for 24 hours. The sites were graded for irritation, andthe compounds were reapplied 30 minutes later. Second gradings were made 48
hours later (72 hours after the initial application), after which Evans blue solution
was injected intravenously
into each animal. One hour after injection, the animals were killed and the skin sampled. In guinea pig and rat studies, 2 dorsal
areas of each of 6 male Hartley guinea pigs and 6 Wistar rats were clipped free of
hair, and testing began 24 hours later. One site received a dose of 0.1 g of the test
compound, and the other site was left untreated. Other test parameters wereidentical to the rabbit test procedure. In the swine test, the entire dorsal area ofgroups of 6 miniature Pitman-Moore improved strain swine was clipped free of

TABLE 3.

Oleyl Alcohol,

Acute Skin Irritation’s9’
frritation

Lot
1

CompoundConcentration

Assay No.

Undiluted
10%

2

3

4

Score

interpretation

1.71

Slight irritant

1.58

Slight irritant

0.17

Nonirritant

0.33

Nonirritant

Undiluted

1.67

Slight irritant

1.75

Slight irritant

10%

0.04

Nonirritant

Undiluted

2

0.25

Nonirritant

1

1.50

Slight irritant

10%

0.29

Nonirritant

Undiluted

1.33

Slight irritant

0.42

Nonirritant

10%

1

-

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

ALCOHOLS

17

hair, and testing began 24 hours later. The test compounds (0.05 g) were applied
under occlusion for 48 hours and scored on a scale of (-), no reddening, to(+ + +), severe reddening. The results of these assays were expressed as scores of
0 (negative) to 3 (severely irritating) and compared to the results of human skinpatch testing of these compounds by the same investigators. Although irritation
was moderate to severe in the rabbit, guinea pig, and rat, no irritation occurredin swine or human skin. The two compounds were comparable in their ability to
produce irritation (Table 4). Skin samples from the rabbit, guinea pig, and rat following exposure to the 2 alcohols had changes of acanthosis, hyperkeratinization, swelling of cells, and proliferationof basal cells. Vasodilatation,
edema,
alteration of collagenous fibers, and mononuclear and polymorphonuclear
leukocyte infiltration
were observed in the dermis. In the case of Oleyl Alcohol,
edema of the epidermis developed into spongiosis, causing an “eruption” of theepidermis and “crust and ulcer” formation. Both the erupted epidermis and theinfundibulumof the hair follicles were infiltrated by inflammatory cells.
Several primary skin irritation studies have been conducted on product formulations containing various concentrations of Oleyl Alcohol or Octyl Dodecanol.~52~62~58~77-80~
Single applications under occlusion for 24 hours of products
containing 8.0 to 20 percent Oleyl Alcohol or 4.0 percent Octyl Dodecanol produced no to mild irritation with primary irritation indices (scale 0 to 4) of 0.0 to
1 .08 . (52,77-79)Product formulations containing 12.7 percent Oleyl Alcohol or 10.2
percent Octyl Dodecanol applied to the skin of rabbits for 3 to 4 consecutive
days produced minimal to mild irritation. (62,80)A product containing 1.5 percent
Oleyl Alcohol was tested for primary skin irritation undiluted and diluted 1:4
with water. Test materials were applied to the intact and abraded skin of rabbits
and to the ears of female CFll mice, for 4 daily 0.01 ml applications. The product,both diluted and undiluted, was irritating to the skin of rabbits and mice.(68) The
degree of irritation in these studies did not correlate with the concentration of
Oleyl Alcohol or Octyl Dodecanol present.
Subchronic

Studies

A 60-day modified cumulative irritation test as outlined in journal Officiel dela Republique Francaiser5*) was conducted on 4 lots of Oleyl Alcohol in undiluted form and in 10 percent dilutions. Materials were applied every day. Scoring

TABLE

4.

Comparative

Irritation of Oleyl Alcoholand 2-Octyl

DodecanolinSeveral Species”6’
Irritation
Species
RabbitGuineapig

Score*

Concentration

Dose

I%)

(I3

100

0.1

3

3

100

0.1

3

2
2

Oleyl

Alcohol

Z-Octyl

Dodecanol

Rat

100

0.1

2

Swine

100

0.05

0

0

Human

100

0.05

0

0

*0, negative; 2, moderately

irritating; 3, severely irritating.

18

COSMETIC INGREDIENTREVIEWwas expressed as a weekly average of daily observations. After 8 weeks, microscopic examinations of 2 samples of skin were conducted. A study of recovery
from cutaneous injury was performed by interrupting application for 7 days andexamining the skin thereafter. The results indicated that undiluted Oleyl Alcohol
was poorly tolerated, with thickening and drying of skin and eschar formation.
Microscopic changes were thinning of stratum corneum, acanthosis, and orthokeratosis. The 10 percent dilutions were “relatively well tolerated,” with only
slight exfoliation. Hyperplasia, moderate hypercanthosis, vascular congestion ofsuperficial dermis, and slight erythema and edema were present.(5g)GuineaPig Skin Sensitization

Two guinea pig sensitization
studies were conducted on a deodorant containing 24.0 percent Stearyl Alcohol using the Draize repeated topical application method.(81*s2) In one study, W) 25 animals received 9 induction applicationsof the deodorant, diluted to 50 percent in petrolatum, under occlusion for 24hours on abraded skin sites. This was followed by a 2-week nontreatment period
and then challenge applications to both intact and abraded untreated sites.
Groups of 5 animals served as petrolatum and untreated controls. At challenge, 1of 25 treated animals and 1 of 5 petrolatum controls gave a f (equivocal) scoreat 24 hours on the intact skin sites; all other test sites were nonreactive. In the second similar experiment,@*)no evidence of reaction at challenge was noted, although 2 of the 10 test animals died during the experiment. Under these test conditions, Stearyl Alcohol was not a contact sensitizer.
Comedogenicity
Stearyl Alcohol was not comedogenic when applied to the ear canal of 2 rabbits 5 days per week, for 2 weeks.(83)

Special Studies
Mutagenicity
Stearyl Alcohol was tested for mutagenic activity in an Ames assay using 4histidine-requiringmutants of Salmonella typhimurium(TA98, TAlOO, TA1535,
TA1537). The compound was tested both with and without metabolic activating
S-9 fractions from the livers of rats pretreated with Aroclor 1254 or methylcholanthrene. Stearyl Alcohol was not mutagenic.(*4)
Tumorigenicity
Site(“)studied the tumor-promoting
activity of alkanes and 1-alkanols.
Thirty female Swiss strain mice received an initiating dose of 7,12-dimethylbenz[a]anthracene to the shaved skin of the back. Beginning 1 week after the initiating dose, 1 drop (20 ,uI) of a solution of Stearyl Alcohol in cyclohexane (20 g/
100 ml) was applied 3 times weekly for 60 weeks over the initiated area. Twentythree of the 30 mice survived the study, and 1 tumor appeared on the initiatedarea of one mouse at 30 weeks.‘85)

FINAL REPORT:

SAFETY ASSESSMENT

Clinical

OF LONG-CHAIN

Assessment

ALCOHOLS

19

of Safety

Eye Irritation
Ten human volunteers used 3 ml of a hairdressing product containing 1.5
percent Oleyl Alcohol daily for 5 days. The head was rinsed daily with 50 ml ofwater. One drop of the rinse water was instilled 4 times daily for 5 days into thesame eye. No irritation occurred in any voIunteers.(68’
Skin Irritationand Sensitization

Patch TestingIn 24hour single insult occlusive patch tests, mild irritation was produced by
100 percent Stearyl Alcohol in 1 of 80 subjects W) and by 100 percent Octyl Dodecanol in 1 of 40 subjects (Table 5).(*‘)
Occlusive 48-hour patches using undiluted technical grade Oleyl Alcoholand Octyl Dodecanol in 0.05 g amounts were applied to randomized sites on theskin of the back of 50 adult male volunteers. (76)The patches were removed, and30 minutes later the sites were evaluated. Observations also were made at 72 and96 hours and, if necessary, at 120 hours. There were no signs of skin irritation.
The North American Contact Dermatitis Group reported results of 48- and
96-hour screening patch tests of 30 percent Stearyl Alcohol in petrolatum fromseveral 1-year intervals. Allergic reactions occurred in 2 of 172 individuals tested
during the year ending in June 1976, ~3) 1 of 446 during the year ending June
1977,“‘) 6 of 824 during the year ending June 1979,“”
and 6 of 634 during theyear ending June 1980(g11 (Table 5).
Hjorth and Trolle-Lassen (‘*) studied allergic skin reactions to ointment bases.
Out of a test population of 1664 panelists, each tested with all 3 ingredients, Stearyl Alcohol (30 percent in liquid paraffin) caused 4 positive reactions, Oleyl Alcohol (30 percent in petrolatum) produced 10 positive reactions, and Octyl Dodecanol (30 percent in petrolatum) caused 6 positive reactions (Table 5). Of the 10
patients sensitive to Oleyl Alcohol, 3 were also sensitive to Stearyl Alcohol, andthe investigators suggest that cross-sensitization
may have occurred.
Lanette-0 (20 percent in petrolatum) is a mixture of Cetyl and Stearyl Alcohols. Lanette-0 was patch tested on 21 patients, and Stearyl Alcohol (50 percent
in petrolatum) was tested on those patients who were sensitive to the Lanette-0.
Of 7 individuals who were sensitive to the Lanette-0, 4 were sensitive to the
Stearyl Alcohol.(g3’Calnan and Connor(g4) reported 4 positive reactions to carbon paper among
40,000 subjects tested. One of the four had dermatitis and a positive reaction to
Oleyl Alcohol.
A number of product formulations containing various alcohols at concentrations of 2.5 to 24 percent have also been tested for human skin irritation (Table
6). Single insult occlusive patch tests on lipstick-formulations
containing 20 percent Oleyl Alcohol and a moisturizing
cream containing 4.0 percent Octyl Dodecanol produced no or only minimal irritation. (g5-g7)Daily patch testing of 5
product formulations containing 8.0 to 24 percent Stearyl Alcohol, 2.5 percent
Oleyl Alcohol, or 3.0 percent Octyl Dodecanol for 21 days produced ratings of“essentially nonirritating” or “slightly irritating. “(g8-102)Controlled use of a lipstick
containing 8.0 percent Oleyl Alcohol for 4 weeks produced no irritation.‘lo3’ Re-

TABLE

5.

Clinical Skin Patch Tests with Stearyl Alcohol,

Oleyl Alcohol,or Octyl

Concentration

JestMethod
24-hourMaterial

single insult occlusive

patch
Single insult screening

patch

for contact sensitization

Single insult screening

patch

for contact sensitization

TestedAlcoholof(%)

Dodecanol
No. of
Subjects

Reference

Results

Stearyl Alcohol

100

80

Mild irritationin 1 subject

86

Octyl

100

40

Mild irritationin 1 subject

87

Dodecanol

Stearyl Alcohol

30 in petrolatum

172

2 positive reactions;

Stearyl Alcohol

30 in petrolatum446

1 positive reaction; 0.22%

89

Stearyl Alcohol

30 in petrolatum824

6 positive reactions; 0.73%

90

Stearyl Alcohol

30 in petrolatum634

6 positive reactions; 0.95

%

91

1664
1664

4 positive reactions; 0.24
10 positive reactions; 0.60

%
%

92
92

8

1664

6 positive reactions; 0.36

%

92

g

Stearyl Alcohol

30 in liquid paraffin

Oleyl Alcohol

30 in petrolatum

Oleyl

30 in petrolatum

Dodecanol

1 .2 %

88

ii
I
g
E
;
f

TABLE

6.

Clinical

Skin Patch Tests with Product Formulations

Test Method
24-hoursingle insult

occlusive

patch

Containing

Material

Concentration

TestedAlcoholof

Stearyl Alcohol,

cumulative

No. of20 Oleyl Alcohol

19

No signs of irritation

95

Lipstick

20 Oleyl Alcohol

16

No signs of irritation

96

Moisturizing

4.0 Octyl

20

PII, 0.03

Dodecanol(max 4.0); minimal

24 Stearyl Alcohol

12

total composite

100

99

17 Stearyl Alcohol

27

Essentially nonirritating

8.0 Stearyl Alcohol

9

Essentially nonirritating;

Moisturizer

2.5 Oleyl Alcohol

10

Slightly irritating; total composite

score was 36/630
was 59/630
3.0 Octyl

Dodecanol

16

max

Essentially nonirritating;days/week

score

101

total composite

102

max

score was 7.5/630.

use (4 weeks

98

max

Cream

Eye pencil

97

score

Slightly irritating; total composite

Antiperspirant

days)

Controlled

irritation in

1 subject

was 1281630

patch

Reference

Results

Lipstick

Deodorant

for 2 1 consecutive

Dodecanol

Subjects

irritancy (23-hour
occlusiveor Octyl

f%)

cream
2l-dayOleyl Alcohol,

Patches applied5

for 21 total patches
103

Lipstick

8.0 Oleyl Alcohol

52

No irritation

Lipstick

8.0 Oleyl Alcohol308

Mild irritation with closed patch in 3of daily use)
Schwartz-Peckprophetic

patch test (open andsubjects at first exposure;

closed 4%hour

of sensitization.

repeated

patches,

exposure

after 2 weeks)

104

no evidence

Supplemental

UV

after second insult produced

no reactions
Modifiedrepeated

insultpatch test (12- or 24-

Antiperspirant

17 Stearyl Alcohol

Antiperspirant

17 Stearyl Alcohol

52

Minimalirritation;

45

Minimalto mild irritation with evidenceof fatigue; no evidence

hour patches 4 days/
week for 8 induction
patches; challenge
after 2-week

rest)

patch

no sensitization

Antiperspirant

14 Stearyl Alcohol

50

105
106

of sensitization

No irritation; no sensitization

107

TABLE

6.

(Continued)

Test Method
Draize-Shelanski

Material

Concentrdrrun

TestedAlcoholof(%)

No. of
Reference

Results

Subiects

repeated

Deodorant

24 Stearyl Alcohol

176

Minimalirritation;

insult patch test (24- or

Deodorant

24 Stearyl Alcohol150

Minimalirritation; no sensitization

48-hour

Antiperspirant

17 Stearyl Alcohol50

Minimalirritation;

patches 3 days/

no sensitization
1 subject demon-week for 10 induction

strated reaction

patches; challenge

contact dermatitis

at challenge;

how-ever, rechallenge

at untreatedsite was

2-week

after

rest)

indicativeof allergic

negative
Antiperspirant

14 Stearyl Alcohol100

No irritation;

Hand cream

12 Stearyl Alcohol

205

MinimalDeodorant

12 Stearyl Alcohol48

Mild irritation;

Deodorant

12 Stearyl Alcohol

154

Minimalirritation: no sensitization

114

irritation;

115

no sensitization

irritation;

Cream

8.0 Stearyl Alcohol

213

MinimalCream

12.7 Oleyl Alcohol102

No irritation;

Lipstick

8.0 Oleyl Alcohol

154

Minimal

112
113

no sensitization
no sensitization

116

no sensitization

irritation;

Supplemental
induction

111

no sensitization

no sensitization.

UV exposure

104

after

patches 1, 4, 7, and 10

and after challenge

showednophotosensitization
Cream

2.5 Oleyl Alcohol

210

Mild irritationin 1 subject during induc-tion and 1 at challenge;
to be indicativeCream

2.5 Oleyl Alcohol

205

Minimal117

none thoughtof sensitization

to mild irritation during induc-tion and at challenge;

118

none were

thought to be indicative

‘i

119

ff
I1

120

i

of

sensitization
Lipstick10.2 Octyl Dodecanol197

No irritation;

Unspecified

3.0 Octyl Dodecanol

210

Isolated mild induction

product
formulation

no sensitization
reactionsin 2

subjects; no reactions at challenge
5
E
<
S
s

FINAL REPORT:

SAFETY ASSESSMENT

OF LONG-CHAIN

ALCOHOLS

23

sults indicative of irritation from product formulations
are difficult to interpretwith respect to a single ingredient.
Several product formulations
containing the alcohols have been tested forskin sensitization on a total of 2629 subjects using a variety of test methods. Thesestudies included: 1 Schwarz-Peck prophetic patch test on a product formulation
containing 8.0 percent Oleyl Alcohol, 3 modified repeated insult patch tests on
antiperspirant formulations containing 14 or 17 percent Stearyl Alcohol, and 14
Draize-Shelanski
repeated insult patch tests on products containing 8.0 to 24 percent Stearyl Alcohol, 2.5 to 12.7 percent Oleyl Alcohol, or 3.0 or 10.2 percent
Octyl Dodecanol. Of the 2629 subjects in these studies, there were no reactions
indicative of sensitization(Table 6).
Case Reports
Contact sensitization to Stearyl Alcohol has been reported in 3 individuals: 2
had an urticarial-type reaction, and 1 of these reactions was thought to be due toimpurities in the Stearyl Alcohol sample.‘g*‘2’~‘22’
Photoreactivity
A phototoxicity study was conducted on a cream product formulation containing 2.5 percent Oleyl Alcohol using 10 subjects. A single 24hour skin patchof the product with 1X Minimal Erythema Dose (MED) exposure to a Krohmeyer
Hot Quartz Lamp produced no reactions. (123)The same product was tested forphotoallergenicity with 25 subjects. Five daily 24hour induction patches with exposure for 30 seconds to a windowglass-filtered
Krohmeyer Hot Quartz Lamp
were followed by a 12-day nonexposure period and then a single 24-hour challenge with the same UV light exposure. No signs of photosensitivity
were present (123)
A repeated insult photosensitization
test using 23 subjects was conducted ona lipstick formulation
containing 10.2 percent Octyl Dodecanol. Each subject
had applied a 24hour occlusive patch of the test material followed by UV irradiation of the test site with 3 times the individual’s MED. The light source was a filtered 150W Xenon Arc Solar Simulator that produced a continuous emission
spectrum in the UVA and UVB region (290 to 400 nm). Patches and irradiation
were repeated twice weekly for a total of 6 exposures. Following a lo-day nonexposure period, patches and irradiation were repeated on a previously untreatedsite. There were no reactions and thus no evidence of phototoxicity or photoallergenicity.(124)
Schwartz-Peck and Draize-Shelanski
skin sensitization tests on a lipstick formulation containing 8.0 percent Oleyl Alcohol (summarized in Table 6) also included supplemental UV light exposure, with no resultant reactions.‘lo4’
SUMMARY
Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain saturated or unsaturated (Oleyl) fatty alcohols. The materials of commerce are mixtures of fatty acids, with the predominant species being the named compound.
These alcohols have a wide variety of uses in pharmaceutical, food, andother industries. Stearyl Alcohol is approved for use in certain over-the-counter
drugs, and Stearyl and Oleyl Alcohols are approved for some food additive appli-

COSMETIC INGREDIENT24

REVIEW

cations. They are used in numerous cosmetic product categories at concentrations of less than 0.1 percent to greater than 50 percent. They are chiefly used atconcentrations less than 25 percent.
The metabolism of Stearyl Alcohol and Oleyl Alcohol in rats is well described. They are used in the biosynthesis of lipids and other naturally occurring
cellular constituents or enter metabolic pathways for energy production.
Stearyl Alcohol was not mutagenic in the Ames Assay, and it did not promotetumor formation when tested with DMBA. Oleyl Alcohol and Octyl Dodecanol
were not tested in these assays. Due to the chemical nature and benign biologicalactivity of these compounds, they are not suspected of significant potential for
carcinogenesis.
The results of acute oral toxicity studies in rats of undiluted Stearyl Alcoholand Octyl Dodecanol and of products containing Oleyl Alcohol and Octyl Dodecanol at concentrations up to 20 percent indicate a very low order of toxicity.
Results of percutaneous toxicity studies with 100 percent Octyl Dodecanol andwith products containing 8.0 percent Stearyl Alcohol or 8.0 percent Oleyl Alcohol also indicate a low order of toxicity. In rabbit irritation tests, these alcohols
produced minimal ocular irritation and minimal to mild primary cutaneous irritation. In 1 assay system, the skin irritancy of technical grade Oleyl Alcohol andOctyl Dodecanol was moderate to severe in rabbits, guinea pigs, and rats,
whereas no irritation was seen in swine and human skin. Observations made in a
subchronic skin irritation study indicated that 100 percent Oleyl Alcohol was“poorly tolerated” when applied to the skin of rabbits daily for 60 days, whereas
10 percent dilutions were”relatively
well tolerated.” A product containing 24 percent Stearyl Alcohol produced no evidence of contact sensitizationin the guinea
pig. A rabbit ear comedogenicity test on Stearyl Alcohol was negative.
The results of single insult clinical patch testing indicate a very low order ofskin irritation potential for undiluted Stearyl Alcohol and Octyl Dodecanol. Several studies of screening patch testing for contact sensitizationin large populations had rates of 19 of 3740 (0.51 percent) for Stearyl Alcohol, 10 of 1664 (0.60
percent) for Oleyl Alcohol, and 6 of 1664 (0.36 percent) for Octyl Dodecanol.
Reports of isolated cases of contact dermatitis from Stearyl Alcohol are available.
Tests of product formulations in humans demonstrated low potentials for significant skin irritation or sensitization from the alcohols in formulation.
Photoreactivity studies on products containing 2.5 percent Oleyl Alcohol or 10.2 percent
Octyl Dodecanol were negative for phototoxicity or photosensitization.
A hairdressing product containing 1.5 percent Oleyl Alcohol was nonirritating to thehuman eye.

CONCLUSION
Based on the available data, Stearyl Alcohol,
decanol are safe as currently used in cosmetics.

Oleyl Alcohol,

and Octyl Do-

ACKNOWLEDGMENT
Jeffrey Moore, MD, Scientific Analyst and writer, prepared the TechnicalAnalysis used by the Expert Panel in developing this report.

FINAL REPORT:

SAFETY ASSESSMENT

25

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Submission

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Alcohol.*

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(CTFA Code 2-10-15).
data. CIR safety data test summary,Acute dermal toxic-(CTFA Code 2-10-70).

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Stearyl Alcohol.*on the7.

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Dodecanol.*

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15(3), 203-l

effects of lipids on the osmotic fragility of Iyso-

Properties in industrial Materials,

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15, 1977).

ity test on Octyl
55.

Differential

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on lipstick containing
54.

Effect of tobacco

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Oleyl Alcohol.*

Biochim.

447-9.

containing

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test on product52.

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FINAL57.

REPORT:

SAFETYASSESSMENT

CTFA. (June 15, 1979).
on Oleyl Alcohol.*58.

JOURNAL
5/6/73,

OF LONG-CHAIN

Submission of unpublisheddata. CIR safety data test summary.

Eye irritation test

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OFFICJEL DE LA REPUBLIQUE

ed.

27

ALCOHOLSFRANCAISE(JORF). DU 21/2/71,
d’analyse

edition Lois et Decrets,

Documents

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Dodecanol.*Submission of unpublished

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69.

Octyl

Dodecanol.’3, 1978).

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Dodecanol.’

Oleyl Alcohol.*

STILLMEADOW.

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pencil containing

Octyl

ABBE, N.J. (Oct.

Submission

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Eye irritation.

CTFA. (Feb. 1, 1973).

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Eye24(14),

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DRILL, V.A.,

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MOTOYOSHI,New York: Academic

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Dodecanol.’

CTFA. (Oct. 5, 1979).
tion test on Octyl

Toxicity.

(CTFA Code 2-10-105).

Dodecanol.*

CTFA. (July 28, 1978).

Primary skin irrita-

data. CIR safety data test summary.

1, 1973). Submission of unpublishedtion test on Octyl
75.

Cutaneous

CTFA. (June 15, 1979). Submission of unpublishedtion test on Octyl
74.

data. CIR safety data test summary.

(CTFA Code 2-10-102).

71,

test on Oleyl Alcohol.*data by CTFA.

685-92.

70.

tion test on Oleyl Alcohol.*

Eye irritation test on

15).

of unpublishedChem.

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(CTFA Code 2-10-l

Dodecanol.*Eye irritation test

(CTFA Code 2-10-67).

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data. CIR safety data test summary.

(CTFA Code 2-10-l 19).

Octyl

containing

Eye irritation test on(CTFA Code 2-10-13).

on product

VAN

Eye irritation test on

data. Dermal and ocular irritation test on product con-

CTFA. (Oct. 19, 1979).

product

Eye irritation test

(CTFA Code 2-10-42).

CTFA. (Dec. 2, 1977). Submission of unpublishedon product65.

data. CIR safety data test summary.

CTFA. (Sept. 21, 1973). Submission of unpublishedlipstick containing
64.

data. CIR safety data test summary.

(CTFA Code 2-10-71).

taining Oleyl Alcohol.*63.

of cosmetic raw mate-28, 377-93.

data. CIR safety data test summary.

Submission of unpublished

Dodecanol.”Primary skin irrita-(CTFA Code 2-10-74).
data. CIR safety data test summary.

Primary skin irrita-(CTFA Code 2-10-73).

K., TOYOSHIMA,Y., SATO,

M., and YOSHIMURA,

M. (1979).

Comparative

the irritancy of oils and synthetic perfumes to the skin of rabbit, guinea pig, rat, miniature
Cosmet.
77.

Toiletries

94(8),

containing

CTFA. (Dec. 2, 1980).
tion test on product80.

containing

data. CIR safety data test summary.

CTFA. (Dec.

Octyldata. CIR safety data test summary.

Dodecanol.’1, 1977).

Oleyl Alcohol.*data. CIR safety data test summary.
data. CIR safety data test summary.
data. CIR safety data test summary.

containing

82.

CTFA. (Sept. 6, 1977).

Submission of unpublished83.

zation test on deodorant containing Stearyl Alcohol.*(CTFA Code 2-10-56).
KLICMAN,
A.M., and MILLS, O.H. JR. (1972). Acne cosmetica. Arch. Dermatol.

84.

FLORIN,85.

SICE, 1. (1966).

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Stearyl Alcohol.*L., CURVALL,

Guinea pig sensitiza-(CTFA Code 2-10-55).
data, CIR safety data test summary.

M., and ENZELL, C.R. (1980).

using the Ames test. Toxicology

Tumor-promoting

Primary skin irrita-(CTFA Code 2-10-14).

tion test on deodorantI., RUTBERG,

Primary skin irrita-(CTFA Code 2-10-l 16).

Dodecanol.*

CTFA. (July 6, 1977). Submission of unpublished

Primary skin irrita-(CTFA Code 2-10-68).

Submission of unpublished
Octyl

Primary skin irrita-(CTFA Code 2-10-l 20).

Submission of unpublishedcontaining

tion test on lipstick containing
81.

Oleyl Alcohol.*

CTFA. (Oct. 10, 1979). Submission of unpublishedtion test on product

79.

45-8.

CTFA. (March 3, 1978). Submission of unpublishedtion test on product

78.

41-3,

studies onswine and man.

activity of n-alkanes

Guinea106(6),

Screening oftobacco

pig sensiti-

843-50.
smoke constitu-

15(3), 219-32.
and 1-alkenols.

Toxicol.

Appl.

Pharmacol.

9, 70.

COSMETIC INGREDIENT

28
86.

CTFA. (Jan. 24, 1973).

Submission of unpublishedtion test on Stearyl Alcohol.*87.

CTFA. (Feb. 23, 1973).
tion test on Octyl

88.

RUDNER,

89.

NORTH

Submission of unpublished

E.J. (1977).

data. CIR safety data test summary.

North Americangroup results. Contact

DERMATITIS

GROUPDermatitis(NACDG).

Epidemiology

NACDC.

(1979).

Epidemiology

of contact

dermatitis

in North America(unpublished).

NACDG.

(1980).

Epidemiology

of contact dermatitis

in North America(unpublished).

HJORTH,N., and TROLLE-LASSEN,

England: St. Johns Hosp. Derm.

94.

BANDMANN,

95.

6(3), 227-8.

CALNAN,

C.D., and CONNOR,

CTFA. (Nov. 1, 1979).

Octyl

containing

FOOD

AND

DRUG

CTFA. (1980).

110.

Oleyl Alcohol.*

CTFA. (1980-81).

CTFA. (Jan. 1979).

Human cumulative

irri-

data by CTFA. Study of cumulative

irri-

Stearyl Alcohol.*

Product containing(CTFA Code 2-10-47).

data by CTFA. Study of cumulative

Oleyl Alcohol.*ir-(CTFA Code 2-10-40).
data by CTFA. Clinicalirritation test on product containing

Octyl Dodeca-

data. CIR safety data test summary.

Controlled

data. CIR safety data test summary.

Oleyl Alcohol.*(May 14, 1979).

Stearyl Alcohol.*

containing
containing

Prophetic and repeat in-(CTFA Code 2-10-g).

Submission of unpublishedcontaining

Submission of unpublisheddata by CTFA. Modified

repeatedin-

Modifiedrepeatedin-

Modifiedrepeatedin-

Repeated

insult patch

Repeated

insult patch

data by CTFA. Repeatedinsult patch(CTFA Code 2-10-30).

data. CIR safety data test summary.

Stearyl Alcohol.*(CTFA Code 2-10-25).

data. CIR safety data test summary.

Stearyl Alcohol.*(CTFA Code 2-10-28).

CTFA. (Aug. 1977).

Submission of unpublisheddata. CIR safety data test summary.

test on deodorantcontaining(CTFA Code 2-10-51).

Stearyl Alcohol.*

CTFA. (Nov. 1977).

Submission of unpublisheddata. CIR safety data test summary.

test on deodorantcontaining(CTFA Code 2-10-52).

HILL TOP RESEARCH.

test on productStearyl Alcohol.*(June 4, 1979).

Submission of unpublished

CTFA. (June 4, 1979).

Stearyl Alcohol.*

Submission

10, 1981).

patch test on deodorantcontaining

Stearyl Alcohol.*(CTFA Code 2-10-27).

data. CIR safety data test summary.

Repeated

data. CIR safety data test summary,

Stearyl Alcohol.*

Submission of unpublisheddata. CIR safety data test summary.
(CTFA Code 2-10-54).

Stearyl Alcohol.*

114.

CTFA. (June 1981).

115.

test on deodorant containing Stearyl Alcohol.*(CTFA Code 2-10-53).
CTFA. (July 1979). Submission of unpublished data. Repeated insult patch test. Product
Alcohol.*(CTFA Code 2-10-46).

Repeated

insultRepeated

insult(CTFA Code 2-10-24).

containing

Submission of unpublishedinsult patch(CTFA Code 2-10-29).

of unpublishedpatch test on hand cream containing
CTFA. (March

Submission of unpublishedand intact skin. Antiperspirant
containing

use test on lip-

(CTFA Code 2-10-10).

CTFA. (April 1980). Submission of unpublished

11 1. CTFA. (July 1980).

113.

irri-

(CTFA Code 2-10-26).

Product containing

Submission of unpublished

HILL TOP RESEARCH.

test on abraded112.

skin irrita-

cumulative

data. CIR safety data test summary.

Stearyl Alcohol.*

Submission of unpublishedsult patch test on antiperspirant

109.

Human

(CTFA Code 2-10-21).

sult patch test on antiperspirant

108.

skin irrita-

Human

RESEARCH LABS. (July 12, 1979). Submission of unpublishedsult patch test. Antiperspirant

107.

Human

(CTFA Code 2-10-50).

of 10 cosmetic products, Cumulative

sult patch tests on lipstick containing

106.

data. CIR safety data test summary.

of a series of test materials.

skin irrita-(CTFA Code 2-10-69).

Stearyl Alcohol.*of a series of test materials.

stick containing

105.

data. CIR safety data test summary.

Dodecanol.*containing

Humandata. CIR safety data test summary.

HILL TOP RESEARCH. (April 18, 1979). Submission of unpublished

nol.*

104.

data. CIR safety data test summary.

HILL TOP RESEARCH. (July 16, 1979). Submission of unpublishedsafety evaluation
103.

paper dermatitis due to nigrosine. Berufsdermatosen(CTFA Code 2-1 O-l 17).

Submission of unpublishedcontaining

CTFA. (Feb. 1979). Submission of unpublishedritant properties
102.

Rep. London,(CTFA Code 2-10-121).

Oleyl Alcohol.*

CTFA. (July 1977). Submission of unpublishedtant properties
101.

Oleyl Alcohol.*

containing

tation test on antiperspirant
100.

CarbonCTFA. (Aug. 18, 1980). Submission of unpublishedtation test on deodorant99.

bases. Trans.

Lanette-0 another test substance for lower leg series. Contact

B.L. (1972).

containing

tion test on product98.

Skin reactions to ointment

CTFA. (April 26, 1978). Submission of unpublishedtion test on product97.

C. (1963).

248-54.

tion test on product96.

of contact der-Sot. 49, 127-40.

H.-J., and KEILIG, W. (1980).

Dermatitis
20(5),

skin irrita-(unpublished).

90.

93.

Human

3, 208.

(1977).

91.
92.

skin irrita-(CTFA Code 2-10-76).

CONTACT

matitis in North America

Human(CTFA Code 2-10-103).

Dodecanol.*

AMERICAN

data. CIR safety data test summary.

REVIEW

data. CIR safety data test summary,Repeated

insult patch

containing

StearylFINAL REPORT:
116.

LEO WINTERASSOCIATES.

(MarchCTFA.

(Jan. 6, 1978).

Submission

LEO WINTERASSOCIATES.

121.

GAUL,

122.

SUSKIND,

L.E. (May 1969).
R.R. (1979).

Submission

Oleylof unpublisheddata by CTFA.

Repeated

insultinsult patch test. Product containing

Oleyl(CTFA Code 2-10-41).
data. Repeated

LEO WINTER

lipstick containing(Dec.

of unpublishedfrom cetyl and stearyl alcohols.
1979).

Dodecanol.*insultdata by CTFA.

Repeated

insult(CTFA Code 2-10-36).

reactions to cosmetics.

containing

Repeated(CTFA Code 2-10-16).

Submission

Dodecanol.*Arch.

J. Dermatol.

Submission of unpublished

Oleyl Alcohol.*

Submission of unpublishedOctyldata. CIR safety data test summary.

Dodecanol.*1979).

Octyl

Dermatitis

ASSOCIATES.

CTFA. (Jan. 6, 1978).

of unpublished
Octyl

Cutaneous

genicity testing of product124.

1979).

(Marchpatch test. Product containing123.

insult patch test. Product containing(CTFA Code 2-10-59).

patch test on lipstick containing
120.

data. Repeated

Oleyl Alcohol.*

CTFA. (April 1980). Submission of unpublished
Alcohol.*

119.

29

ALCOHOLS(CTFA Code 2-10-43).

patch test. Product containing
118.

OF LONG-CHAIN

CTFA. (Sept. 1973). Submission of unpublished
Alcohol.*

117.

SAFETY ASSESSMENT

Dermatol.

99, 593.

(Tokyo) 6(4), 203-10.
data by CTFA. Photocontact

aller-(CTFA Code 2-10-44).

data. CIR safety data test summary.

(CTFA Code 2-10-17).

Photopatch

test on