FINALACETYLATEDREPORT OF THE SAFETY ASSESSEMENT FOR
LANOLIN
ALCOHOLAND RELATED COMPOUNDSThe results of tests on animals and humans with Acetylated
Lanolin and its related cosmetic ingredients are reviewed.
This group of ingredients is used extensively in cosmetics aswell as in many other consumer products. They have low acutetoxicity and are nonsensitizing
to animal skin. However, extensive clinical experience indicates that there is a low incidenceof sensitivity to these materials among exposed persons. This
experience wouldseem to involve mainly the lanolin alcohols.
Based on the available animal data and human experience, it isconcluded that lanolin and related lanolin materials describedin the report are safe for topical application
to humans in thepresent practice of use and concentration.
CHEMICAL

AND PHYSICALPROPERTIESThis report covers the following

group of related compounds:

Lanolin
Lanolin Oil
Lanol in Wax
Lanolin Acid
Lanolin Alcohol
Acetylated Lanolin
Acetylated Lanolin Alcohol
Hydrogenated Lanolin
Hydroxylated Lanolin
Structure
Lanolin
Lanolin is the purified secretory product of the sheep sebaceous
gland. The raw material is referred to as Adeps lanae, wool wax, wool fat orwool grease. Lanolin comprises 10 to 25% of the weight of sheared wool
(Schlossman and McCarthy, 1977).
Lanolin is a complex mixture of a large number of compounds. High
molecular weight esters make up aproximately 87% of a typical Lanolinsample (Table 1) (Chemtob, eta/., 1975; Fawaz et al., 1973a). The remainder ofthe mixture is comprised of 11% free compounds (aliphatic alcohols, sterols,
fatty acids and hydrocarbons) and of 2% unidentified compounds. Since
Lanolin is composed predominantlyof high molecular weight esters, it isciassified chemically as a wax arid not as a fat. The esters have not beencharacterized (Schlossman and McCarthy, 1977).
‘Available

upon request.

Washington,

Administrator,

DC. 20005.

Cosmetic

Ingredient

Review, Suite 212,

1133

15th St., NW,

ACETYLATED LANOLIN ALCOHOL AND RELATED COMPOUNDS

64

Crude Lanolin can be separated into Lanolin Wax and Lanolin Oil (Liquid
Lanolin) by solvent fractionation or crystallization (Schlossman and McCarthy,
1977; Chemtob et a/., 1974, 1975). Lanolin Oil, Wax and Crude (Whole)
Lanolin can be modified chemically to produce a large number of substancesof interest to the cosmetic chemist. The constituent esters and free compoundsof Lanolin Wax and Oil are listed in Table 1 for comparison with those ofWhole Lanolin.
Although the exact chemical nature of the Lanolin esters still remains
unknown, most of the constituent fatty acids and alcohols of these esters havebeen identified through the works of Fawaz, Chemtob and associates (Chemtob et al., 1974, 1975; Fawaz et al., 1973a, b; 1974a, b, c). Lanolin esters canbe hydrolyzed
by saponification. The saponification products of a typicalsample of Lanolin are seen in Table 2 (Schlossman and McCarthy, 1977;
Chemtob et al., 1974, 1975; Fawaz et al., 1973a, b; 1974a, b, c). The
predominant ester acid is of the unsubstituted, saturated, aliphatic type. However, the predominant ester alcohol is the sterol. Further delineations of thecomponent fatty acids and alcohols of Lanolin are found in Table 3 (Fawaz etal., 1973b; 1974a) and Table 4 (Fawaz et a/., 1974b, c), respectively.

TABLE

1. Typical

Compositionsof Whole

Lanolin,

Lanolin Wax and Lanolin Oil (Chemtob et a/., 1975:

Fawaz et a/., 1973a)
Whole Lanolin

Lanolin Wax

Lanolin Oil

(%)

(%I

(96)

35.4

28.9

44.0

23.7

13.9

16.0

20.0

16.4

15.0

7.9

9.3

7.7

Free aliphatic alcohols

5.6

20.2

10.4

Free sterols

4.1

5.3

4.4

Free hydrocarbons

0.6

0.4

0.3

Free fatty acids

0.5

1 .o

0.7

Unknowns

2.2

4.6

1.5

100.0

100.0

100.0

Group
Esters of sterols andtriterpene alcohols
Esters of aliphatic
alcohols
Monohydroxyesters

ofsterols and of triterpene and aliphatic
alcohols
Di- and polyhydroxyesters
and free diols

TOTAL

Approximately 63% of the Lanolin fatty acids are nonhydroxylated, while
32% are monohydroxylated
at either the alpha or omega carbon (Table 3). The
predominant
nonhydroxylated
fatty acids are of the anteiso (containing an
isobutyl group) and the iso (containing an isopropyl group) types. The monohydroxylated acids (alpha and omega) are mainly of the normal (straight-chain)

ACETYLATEDLANOLIN

ALCOHOLTABLE 2. Typical
1977;

ChemtobAND

Saponification

et al., 1974,

Products of Lanolin (Schlossman and McCarthy,

1975; Fawaz et al., 1973a, b; 1974a. b, c)

SubgroupGroup
Fatty acid

Alcohols

Percentage

Aliphatic

31.1

Alpha-hydroxy

13.8

Omega-hydroxy

2.6

Unsaturated

2.4

Others1.1

Cholesterols

19.6

Lanosterols

12.6

Aliphatic

8.0

1,2 diols

4.1

Others2.7.

Unspecified

65

RELATED COMPOUNDS.

.

Subtotal = 51%

Subtotal = 47%

2.0

type. The length of the Lanolin fatty acid chain varies from 7 to 41 carbon
atoms.
The main fatty acids are palmitic (Cl6), stearic (Cl8) and longer
molecules (C20 to C 32) (Fawaz et a/., 197313, 1974a).
Approximately 26% of the Lanolin Alcohols are aliphatic structures: 17%
monohydric alcohols and 9% diols (Table 4). The anteiso and iso forms are thepredominant types of mono- and di-hydric alcohols found in Lanolin. Most of
the aliphatic alcohols are long-chain molecules (Cl 6 and greater). Over 68%
of the Lanolin alcohols are sterols: 42% dimethyl sterols (cholesterols) andTABLE

3. Typical Fatty Acid CompositionGroup
Non-hydroxylated

Alpha-hydroxylated

Omega-hydroxylated

Poly-hydroxylatedof Lanolin (Fawaz eta/., 197313, 1974a)

Percentage

Carbon Chain

Predominant Constituents(%I

Length Rangeof Subgroup

nor

12.69

8-38

c24(18.7’),

is0

22.08

8-38

C20(17), Cl6(16.5),

ante

26.23

7-41

c25(14.7~,c19(13.5),c27(13.4)

SubgroupCl6(18),C26(15.5)
C2614.6)

unsat

2.10

nor

21.71

lo-32

Cl 6C88.3)

is0
ante

4.48
0.81

12-34

C18(71.9)

11-33

C23(40.9),

nor
is0

3.05

22-36

C30(45), C32(2 1.8), C28(16.1)

0.81

22-36

C30(39.6),

ante

1.34

23-35

C31(361, C25(26.9L

all

4.70

TOTAL
‘Percent of all within specified subgroup.

100.00mostlyC16andC18

C25(19.8)
Cj2(32.6)

not characterized

C33U6.3)

ACETYLATED

66

LANOLIN

ALCOHOLAND

RELATED COMPOUNDS

26% pentamethyl sterols (lanosterols). The latter group is also referred to as thetriterpene alcohols (Fawaz et al., 1974b, c).
lanolin Oil and lanolin Wax
Lanolin Oil is the liquid-phase resulting
from solvent fractionation (such as with ethyl acetate) of crude Lanolin via
vacuum distillation or solvent crystallization. Lanolin Wax is the solid-phaseproduct of this separatory process (Schlossman and McCarthy, 1977; Chemtob
eta/., 1974, 1975; CTFA, 1978).

TABLE 4. Typical Alcohol Compositionof Lanolin (Fawaz et af., 1974b, c)
Percentage Carbon Chain

nor

1.59

14-34

GJ4(41.1’),

c*6(33.8)

is0

6.46

14-36

C26(34.6),

C20l34.3)

ante

9.05

13-35

C21(42).

C27(31),

C25(15)

nor

0.39

12-25

C,6(43).

C20(24L

C,8(18)

is0

5.87

12-30

C22c32.4).

ante

2.44

13-29

Subgroup

Aliphatics

mono-OH

Sterols

dimethylpentamethylcholesterol

38.00

dihydrocholesterolTrace

7-keto cholesterol

3.60

lanosterol

14.80

dihydrolanosterol

10.30

7-keto lanosterol
Otherspolyols and.

of Subgroup

Length RangeGroup

1,2 diol

Predominant Constituents

(%)

Class

.

.

C,8(30),C20(17.5),

C*4(17)

C23(50),C2, (36.4)

1.60
5.90

unknowns
TOTAL

100.00‘Percent of all within specified subgroup

Lanolin Acid Saponification of Lanolin with alcoholic or hydroalcoholic
alkali results in the hydrolytic cleavage of its constituent esters. The reaction
product is a mixture of alkaline soaps of fatty acids and unsaponifiable alcohols. The fatty alcohols can be extracted (such as with ethyl acetate, trichloroethane or aliphatic hydrocarbon solvents) from the acid-alcohol mixture
leaving behind the lanolin soaps. These alkali soaps are reacted with sulfuric or
phosphoric acid and then water washed to remove excess mineral acid andresultant salts. The Lanolin Acids are then dried and further refined. Lanolin
Acid is a mixture of long-chain fatty acids in which the nonhydroxylated
species predominates (Tables 2,3) (Schlossman and McCarthy, 1977; Fawaz etal., 197313, 1974a, CTFA, 1978).
Lanolin Alcohol
Lanolin Alcohol is derived from Lanolin via hydrolysis
followed by extraction as described above. Lanolin Alcohol is a mixture ofalcohols comprised of about two-thirds sterols and one-fourth aliphatic al-

ACETYLATEDLANOLIN

ALCOHOLAND

67

RELATED COMPOUNDS

cohols. It should be noted that neither squalene nor glycerol is found in Lanolin(Tables 2,4) (Schlossman and McCarthy, 1977; Fawaz et a/., 1974b, c; CTFA,
1978).
Acetylated Lanolin
Lanolin undergoes acetylation when reacted withacetic anhydride. Ester bonds are formed between the acetate moieties and thehydroxyl groups of the Lanolin hydroxyesters as seen below (Schlossman and
McCarthy, 1977):
-

0

OH
2

-

-

-

R-C-C-O-C-R’+ (CH3CO)2W

2

O-k3
R-b-C-0-C-R’

&
6
-

-

Lanolin ester

Acetic anhydride

Acetylated

Lanolinwhere R is hydroxyacid and R’ is alcohol.
The free alcohols in a Lanolin sample may also undergoesterification withacetic anhydride. These two reactive groups (hydroxyesters and free alcohols)
make up nearly 38% (Table 1) of crude Lanolin. Total acetylation of Lanolin
would result, then, in the chemical alteration of over one-third of the original
sample (Schlossman and McCarthy, 1977; CTFA, 1978).
Acetylated Lanolin Alcohol
Once Lanolin has been fractionated into its
alcohol and fatty acid components, the former group can be further processedby reacting it with acetic anhydride. Each free hydroxyl group can potentiallyform an ester linkage with acetate. Since Lanolin Alcohol is a mixtureof mono-,
di- and polyols, Acetylated Lanolin Alcohol will contain mono-, di- andpolyacetates (Schlossman and McCarthy, 1977; CTFA, 1978).
Hydrogenated
Lanolin
Exposing Lanolin to hydrogen at high temperature and pressure in the presence of nickel or chromium catalyst results in asequence of four chemical reactions. First, most unsaturated double-bonds
become saturated with hydrogen. Second, the Lanolin esters undergo hydrogenolysis. Third, the resulting free fatty acids are reduced to fatty alcohols.
Fourth, some of these alcohols, as well as some of those resulting from the ester
cleavage step, are further reduced to simple hydrocarbons. Hydrogenated
Lanolin has never been fully characterized chemically, but its low saponification value indicates the nearly total absence of esters. Additionally, the highhydroxyl value of Hydrogenated
Lanolin suggests the presence of a highpercentage of free alcohols (94 to 99.8%) (Schlossman and McCarthy, 1977;
CTFA, 1978).

ACETYLATED

68

LANOLIN

ALCOHOLAND

RELATED COMPOUNDSThe hydroxylation of Lanolin involves the addiHydroxylated
Lanolintion of two hydroxyl groups across a double-bond. The resulting compound isa glycol (dial). Lanolin is mixed with acetic acid, hydrogen peroxide andsulfuric acid (catalyst). The active reactant, peracetic acid (acetyl hydroperoxide), is formed in situ in the reaction medium and is consumed immediately as
it is generated. Peracetic acid mediates the opening of the unsaturated bondand the concomitant addition of two hydroxyl groups as indicated below(Schlossman and McCarthy, 1977, CTFA).

0II
CH3COH
Aceticacid0+ H202
Hydrogen
Peroxide-CH=CHunsaturated
bond

H2S04

Peracetic Acidl

CH3!-O-OH+ H20

Peracetic

Water

acid

>

-CH-CHI
I
OH
OH
glycolProperties
Lanolin is an ointment-likematerial which has a slight, characteristic
odor. When heated in a steam bath, Lanolin separates into two layers with thelower layer being water. Additional heating drives off this water phase; if not
more than 0.25% water remains, the material is classified as anhydrous Lanolin. While still warm, the Lanolin material is transparent. Upon cooling, it
becomes a yellow, tenacious, unctous mass. Lanolin is not soluble in water ormineral oil but is miscible without phase separation with about twice its weightof water. It is sparingly soluble in cold alcohol and more so in hot alcohol.
Lanolin is highly soluble in chloroform and ether (Schlossman and McCarthy,1977). The melting range of Lanolin is 36.0 to 42.O”C (CTFA, 1978). Lanolin
displays strong emollient, penetrating and emulsifying properties. It blends
well with nearly all other substances used in cosmetic formulations. Lanolin
possesses adhesive and tackifying characteristics as well (Schlossman and
McCarthy, 1977).
lanolin Oil
Lanolin Oil is a clear, amber-colored liquid which is lesstacky and has less drag than Whole Lanolin. However, it retains the emollient
characteristics of Lanolin and displays a high spreading coefficient. Liquid
Lanolin is soluble in mineral and vegetable oils and in silicone fluids (Schlossman and McCarthy, 1977).

ACETYLATEDLANOLIN

ALCOHOLAND

RELATED COMPOUNDS

69

lanolin
Wax
Lanolin Wax is an odorless, tasteless, ceraceous solid
which is a better water/oil (w/o) emulsifying agent than Whole Lanolin. The
melting range is 41 to 51 “C (Schlossman and McCarthy, 1977; CTFA, 1978).
lanolin Acid
Lanolin Acid is a hard, waxy, yellow-tan solid with a mild
waxy odor. The melting range is 40 to 62°C. The constituent fatty acids arepolar molecules giving amphoteric properties to Lanolin Acid (CTFA, 1978;
Amerchol, 1976).
Lanolin Alcohol
Lanolin Alcohol is a firm, waxy, amber solid with acharacteristic odor. The melting range is 47 to 65°C (CTFA, 1978).
Acetylated Lanolin
Acetylated Lanolin is more hydrophobic than Lanolin since many of the hydrophilic hydroxyl groups in the latter substance havebeen esterified to acetate. Acetylated Lanolin, therefore, fails to form w/oemulsions, is soluble in cold mineral oil and has a slightly lower melting range(30 to 40°C) than Lanolin. Acetylated Lanolin forms a water resistant film whenapplied to the skin resulting in the reduction of transepidermal water loss
(Schlossman and McCarthy, 1977; CTFA, 1978).
Acetylated Lanolin Alcohol
Acetylated Lanolin Alcohol is a lemon-yellow to straw-colored,
oily, hydrophobic liquid with a characteristic blandodor. It has a refractive index of 1.4445 to 1.4485 at 20°C and a specific gravityof 0.850 to 0.880 at 25°C (CTFA, 1978).
Hydrogenated
LanolinHydrogenated Lanolin is a light yellow to whitetacky solid which is soluble in ethyl ether and chloroform but insoluble inwater. Its melting range is 48 to 53°C. Hydrogenated Lanolin retains theemollient and adhering characteristics of Lanolin but loses the latter’s odor,
taste, color, and tackiness (Schlossman and McCarthy, 1977; CTFA, 1978).
Hydroxylated
lanolin
The introduction of highly polar hydroxyl groups
renders Hydroxylated
Lanolin more hydrophilic than Lanolin. The productbecomes more amphoteric resulting in increased inter-facial and surface activities. Hydroxylated
Lanolin is superior to Lanolin in forming stable w/o
emulsions. Its melting range is 39 to 46°C (Schlossman and McCarthy, 1977;
CTFA, 1978).
Reactivity
Since Lanolin products contain unsaturated fatty acids, alcohols, esters,
sterols and terpenols, autoxidation may occur during storage and especiallyduring exposure to sunlight. At present, the chemical nature of such autoxidation products is unknown; however, peroxides and epoxides have been suggested as likely structures (Stutsman, 1977). The addition of stabilizing agents
such as alpha-tocopherol
and BHT prevents the autoxidation of Lanolin products (Stutsman, 1977; Sugai and Higashi, 1975). BHT has been used in some
preparations at the 200 to 500 ppm level. Some brands of Acetylated Lanolin
Alcohol contain 4% by weight oleyl acetate and/or BHT (CTFA, 1978).

ACETVLATED

70

Analytical

LANOLIN

ALCOHOLAND

RELATED COMPOUNDS

Methods

Spilker and Richey (1948) have described a number of analytic methods
useful for Lanolin and Lanolin derivatives. These generally involve hydrolysis,
fractionation, separation by chromatography and identification.
Manufacturing

Methods

Lanolin is obtained by one of the following methods (Gillespie, 1948;
Clark, 1971):
1. Solvent extraction of wool fleece.
2.
Scouring of wool with soap or neutral detergent followed by:a. Centrifugation of the resulting emulsion. This may introduce small
amounts of detergents as impurities in the Lanolin.
b. Breaking of the emulsion with acid, orProduction of foam (with air) and collection of the froth.
C.
Impurities
Lanolin and related materials may contain additives and contaminants
which may vary widely. These include detergents and the antioxidants BHT
and alpha-tocopherol.
Chlorophyll, pesticides from the fleece, and trace metals such as copper, nickel, and chromium might also be present.
Purpose and Extent of Use in Cosmetics
Cosmetic uses of Lanolin are discussed by a number of authors. Lanolin
and its derivatives have been used as w/o emulsifiers and as emollients for skinprotection and relief of dryness of the skin. They serve as vehicles for external(topical) use on skin, lips, nails, and hair, which may bring them into theproximity of mucous membranes and eyes (Fr. Demande, 1976; Bolderson,
1976; Bradner, 1976; Chalmers, 1972, 1976; Chen, 1976; Clark, 1974;
Courtin, 1976; Kelly and Ritter, 1976; Mayer, 1976; McCarthy, 1976; MCCarthy et al., 1976; McCarthy and Schlossman, 1975; Moeller and Osberghaus, 1976; Mores and McCarthy, 1976; Roney, 1976; Scott, 1976; Tentsova
et a/., 1977). Lanolin materials are used in over 5,000 formulations. For each of
the materials, the approximate extent of use and concentrations used aresummarized in Table 5 (FDA, 1976).

BIOLOGICAL
GeneralPROPERTIES

Effects

Lanolin and its derivatives are used for their emollient properties on theskin, nails, and hair. The principal emollient of the skin and nails is water,
contained particularly in the stratum corneum. Hydration of the stratum corneum depends, in part, upon the rate at which water reaches the horny layerfrom the deeper dermal and epidermal layers and upon the rate of evaporationof water from the surface layers. It is thought that this water-binding capacity ofACETYLATEDLANOLIN

ALCOHOLAND RELATEDCOMPOUNDS

71

the stratum corneum depends upon the presence of hygroscopic water-soluble
substances. Emollients act to decrease the rate of evaporation by forming abarrier or occlusive material on the skin surface permitting hydration or rehydration from the deeper layers (Kammerau et al., 1976). Sebaceous glandexcretions provide an emollient effect, presumably by virtue of the lipids they
contain. The composition of the skin surface lipids varies considerably fromsite to site. A similar water-binding capacity effect is observed in the cuticle ofthe hair (Anonymous, 1973; Peter et al., 1969).

TABLE

5. Product Formulation

Ingredient
Lanolin

Data (FDA, 1976)
Concentration

Number ofW)

Product Formulations

Cosmetic Product Type
Baby products (skin, hair,>O.l to 10

9>O.l to 5

4

mucous membranes)
Bath preparations (skin,mucous membranes)
Eye makeup preparations

co.1 to >50

243>O.l to 10

37

50.1

to 50

137

>O.l to >50

7SO.1 to >50

1318>O.l to 50

18>O.l to 5

23

(eye)
Colognes and toilet waters(skin)
Hair preparations (noncoloring) (hair)
Hair coloring preparations(hair)
Makeup preparations (noteye) (skin, lips)
Manicuring

preparations(nails)
Personal cleanliness (mucous
membranes, skin)Shaving preparations (skin)co.1 to 5

31

Skin care preparations

so.1

to >50531>O.l to 50

31>O.l to 5

6~0.1 to 25

44

so.1

to 50

135

>O.l

to 5

9

so.1

to 5

17

SO.1 to 5

9(creams, lotions, powders,and sprays) (skin)
Suntan and sunscreen preparations (skin)
Lanolin Oil

Baby products (skin, hairmucous membranes)
Bath preparations (skin,mucous membranes)
Eye makeup preparations(eye)
Colognes and toilet waters(skin)
Hair preparations fnoncotoring) (hair)
Hair coloring preparations(hair)ACETYLATED

72

TABLE

5. (continued) Product Formulation

Incrredient

LANOLIN

ALCOHOLAND RELATEDCOMPOUNDS

Data (FDA, 1976)
Concentration

Number of(%)

Product Formulations

Cosmetic Product Tvw

to >50087>O.l to 50

10->l to 5

3

Makeup preparations (not eye) 20.1
(skin, lips)
Manicuring preparations(nails)
Personal cleanliness (mucous
membranes, skin)

to 5

2

SO.

to 50

218

>O.

to 10

16

Eye makeup preparations (eye) >O. 1 to 10

23

Hair preparations (noncolor-

2

Shaving preparations (skin)>o.

Skin care preparations(creams, lotions, powder, andsprays) (skin)
Suntan and sunscreen preparations (skin)
Lanolin Acid

>l

to5

ing) (harr)
Makeup preparations (not eye) >O. 1 to 10

13(skin, lips)
Manicuring preparations

‘,l

to5

2

(nails)Shaving preparations (skin)

rO.l

to 1

1

Skin care preparations>O.l to 10

10>O.l to 5

2>O.l to 10

28

Eye makeup preparations (eye) >O.l to 25

120

Colognes and toilet waters>O.l to 25

13

50. 1 to 25

15

>o.

to 1

4

50.

to 25

422

SO. 1 to 5

6(creams, lotions, powders
and sprays) (skin)
Lanolin

Alcohol

Baby products (skin, hair,mucous membranes)
Bath preparations (skin,mucous membranes)(skin)
Hair preparations (noncoloring) (hair)
Hair coloring preparations(hair)
Makeup preparations (noteye) (skin, lips)
Personal cleanliness(mucous membranes, skin)Shaving preparations (skin)

>O.

to 5

Skin care preparations-,0.

to >507115(creams, lotions, powders, and sprays) (skrn)
Suntan and sunscreen pre->O.l to 5

6>O.l to 1

2

>l

2

parations (skin)
Acetylated Lanolin

Baby products (skin, hairmucous membranes)
Bath preparations (skin,mucous membranes)

to5ACETYLATEDTABLELANOLIN

ALCOHOLAND RELATED

5. (continued) Product Formulation

Ingredient73

COMPOUNDS

Data (FDA, 1976)
Concentration

Number of(5)

Product Formulations

Cosmetic Product TypeEye makeup preparations (eye) >O. 1 to 50

5

Colognes and toilet waters>O.l to 1

4>O.l to 5

3

Makeup preparations (not eye) >O. 1 to50

57

(skin)
Harr preparations (noncotoring) (hair)(skin, lips)
Shaving preparations (skin)SO. 1 to 1

6

Skin care preparations>o. 1 to25

50

>l

4

(creams, lotions, powders,and sprays) (skin)
Acetylated Lanolin Alcohol

Bath preparations (skin,

to5

mucous membranes)
Eye makeup preparations (eye) >O.l to 10

31

Colognes and toilet waters>O.l to 25

16>o. 1 to 5

4

Makeup preparations (not eye) >O.l to 25

133(skin)
Acetylated Lanolin Alcohol

Hair preparations (noncotoring) (hair)(cont’d)(skin, lips)
SO.1 to 5

2

SO.1 to 50

105>O.l to 5

11

Eye makeup preparations (eye) >5 to 10

1

Colognes and toilet waters

1

Manicuring

preparations(nails)Skin care preparations(creams, lotions, powders,and sprays) (skin)
Suntan and sunscreen preparations (skin)Hydrogenated

Lanolin>lto5(skin)
Makeup preparations (not eye) > 1 to 25

58(skin, lips)
Manicuring

preparations

>l

to5

1

(nails)Shaving preparations (skin)>O.l to 1

1

Skin care preparations>O.l to 10

15>O. 1 to 5

4

Makeup preparations (not eye) >5 to 25(skin, lips)

7

Skin care preparations>O.l to 5

5>lO to 25

2

>l

11

(creams, lotions, powders,and sprays) (skin)
Suntan and sunscreen preparations (skin)Hydroxylated

Lanolin(creams, lotions, powders,and sprays) (skin)
Lanolin Wax

Suntan and sunscreen preparations (skin)
Colognes and toilet waters(skin)

to25

ACETYLATED

74

TABLE

5. (continued) Product Formulation

Ingredient

LANOLIN

ALCOHOLAND RELATEDCOMPOUNDS

Data (FDA, 1976)
Concentration

Number of(5)

Product Formulations

Cosmetic Product Type
Manicuring preparations

>l

to5

1

(nails)Shaving preparations (skin)

21 to5

1

Eye makeup preparations (eye) >O. 1 to 25

41

Skin care preparations

rO.l

to 5

9

>O.l

to 1

3

Makeup preparations (not eye) ~0.1

to 50

69

(creams, lotions, powders,and sprays) (skin)
Hair preparations (noncoloring) (hair)(skin, lips)

Emollient preparations are often chosen, in part, because of their compatability with normal skin surface lipids. Lanolin and its derivatives are notchemicallysimilar to human sebum. Sebum contains approximately 50%
glycerides; Lanolin contains none. The variations among derivatives of Lanolin
lead to variations in properties from hydrophilic, water-soluble and nonocclusive to hydrophobic, oil-soluble and occlusive (Kammerau et al., 1976).
AnimalToxicology

GeneralStudiesAcute Oral Toxicity (Tables 6-14)
Each of the nine Lanolin ingredientshas been tested in rats for acute oral toxicity in a variety of studies. All exhibit
low oral toxicity. Only the most pertinent acute oral LD50 for each ingredient
will be reported: undiluted Lanolin (>64 cc/kg), undiluted Lanolin Oil (46.5
cc/kg), 50% Lanolin Wax in corn oil (>32 g/kg), undiluted Lanolin Acid (56.5
cc/kg), 66% Lanolin Alcohol in corn oil P42.7g/kg), undiluted Acetylated
Lanolin (>64 cc/kg), undiluted Acetylated Lanolin Alcohol (>64 cc/kg), undiluted Hydrogenated Lanolin (>64 cc/kg), and undiluted Hydroxylated Lanolin(>lO cc/kg) (CTFA: Amerchol a,b,c,d,e; CTFA: Avon; CTFA: Croda a,b,c,d,e,f,g; CTFA: Malmstrom a,b,c,d,e,f,g,h; CTFA: R.I.T.A.; CTFA: RobinsonWagner a,b,c,d; CTFA: Westbrook a,b,c,d,e,f,g).
Acute Dermal Toxicity
The acute dermal LD50 of Lanolin Oi I as applied
to the rabbit skin has been determined to be in excess of 10 ml/kg (CTFA:
R.I.T.A.). In a two-dose (1 or 2 g/kg) study in rats, the LD50 of Hydroxylated
Lanolin was found to be greater than 2.0 g/kg (CTFA: Avon).
Acute Skin Irritation (Tables 6-14)
With one exception, the Lanolin
ingredients are either nonirritating or at most mildly irritating to the skin ofexperimental
animals. The exception is Lanolin Acid which is a mild skinirritant. It should be noted that Lanolin Acid is seldom, if at all, found incosmetic formulations as the free acid. In the five tests conducted on undiluted

ACETYLATEDLANOLIN

ALCOHOLAND RELATEDCOMPOUNDS

75

Lanolin Acid, the Primary Irritation Index (PII) ranged from 0.78 to 2.2 (maximum of 8) (CTFA: Amerchol, b; CTFA: Croda, c; CTFA: Malmstrom, d; CTFA:
Westbrook, c). The highest PII value obtained for each of the other undiluted
Lanolin ingredients is as follows: Lanolin (0.71), Lanolin Oil (1 .O), Lanolin Wax(0.67), Lanolin Alcohol (1.5), Acetylated Lanolin (1.62), Acetylated Lanolin
Alcohol (2.3), Hydrogenated
Lanolin (0.6), and Hydroxylated Lanolin (0.0)(CTFA: Amerchol a,c,d; CTFA: Avon; CTFA: Croda a,b,d,e,f,g; CTFA: MalmStrom a,b,c,e,f,g,h; CTFA: R,I.T.A.; CTFA: Robinson-Wagner a,b,c,d; CTFA:
Westbrook a,b,d,e,f,g).
With one exception, all the Lanolin
Acute Eye Irritation (Tables G-14)
ingredients were either nonirritating or at most mildly irritating to the eyes ofexperimental
animals. In three of four ocular irritation studies conducted on
rabbits, undiluted Lanolin Acid was found to be a mild or moderately severe
irritant (CTFA: Amerchol, b; CTFA: Croda, c; CTFA: Malmstrom, d; CTFA:
Westbrook, c). For the other eight Lanolin ingredients, no or only mild transient
reactions were reported (CTFA: Amerchol, a,c,d,e; CTFA: Avon; CTFA: Croda
a,b,d,e,f,g; CTFA: Malmstrom a,b,c,e,f,g,h; CTFA: R.I.T.A.; CTFA: RobinsonWagner a,b,c,d; CTFA: Westbrook a,b,d,e,f,g).
A skin sensitization study with
Subchronic Skin Irritation/Sensitizationeight guinea pigs was done with Acetylated Lanolin Alcohol suspended inphysiological saline. Ten intracutaneous injections on alternate days followedby challenge
injection two weeks later showed no sensitization (CTFA:
Amerchol, d).
Hydrogenated
Lanolin was not a sensitizer when applied to the skin ofguinea pigs three times a week for seven or more applications. A 2% solution in
1 :1:3 acetone:dioxane:corn
oil was used. The challenge was applied two
weeks after the last induction dose (CTFA: R.I.T.A.)
Neither Lanolin Oil applied 15 times to the rabbits skin at concentrationsof 5, 15, or 50% nor 50% Hydroxylated Lanolin applied 65 times to the rat skincaused any local skin irritation effects (CTFA: R.I.T.A.; CTFA: Avon).
Lanolin Wax suspended in corn oil was a mild skin sensitizer in 10 guinea
pigs as indicated by an average score of 0.95 (scores between 0.1 and 2.0 are
mild sensitizers). The material was injected intracutaneously three times/week
for a total of 10 injections with an eleventh challenge injection two weeks later(CTFA: Robinson-Wagner,c).
Special Studies
Simpson et a/. (1945) reported that 3methylcholanthrene dissolved in anhydrous Lanolin was less carcinogenic when painted on
the skin of mice as compared to its carcinogenic effect when benzene was thevehicle. The concentrationof 3-methylcholanthrenein Lanolin applied inthese studies was one-half that of the compound in benzene. However, thevolume of the benzene solution applied was twice that of the Lanolin solution.
Berenblum and Schoental (1947) observed a similar diminution in thecarcinogenie potency of methylcholanthrene
when Lanolin was used as a diluent.
They reported the inhibitory effect even with concentrations that exceeded theconcentrationof the carcinogen in benzene used as a positive control. Theyobtained similar results with another carcinogen, 7,12-dimethylbenz(a)anthracene, on mice.

ACETYLATED

76

z

aJ
.N
:
.-E
f
.E
lu
2

i
s

E&
z .o, ‘;
E 22
m ‘r
=. .k

5
o=
= .2
k

5

2
0.

.

:

-0
2
3
=
7
3

E

.!
;
k
7
t
:
c
c
e
u
u
E
2

cl

WY
-z
E
z

.

.
.
.

Y
z

Y
2

z
m

E
m

m
.*
2
F
0.

m
s?
3
=
-E
3

=
7
3

=
73

2 .a,
E$‘;
E 5 .z
b .L

YI
Y

s
l$

s
z

2
9

h
.c

vi
C
2
e
\D

-0
B
3
=
7
3

=
7
3

m
B3
T=
F3

2;
;iiw
,4

>o$
z
;4

“;o+J
EO
b-l=

I y”
03
P.i u
3
ca +
ui9

I y”
03
& g

f;
P
9

b

I 22
0‘3
c-i ;

2
3

.
.

.
.
.

wi
99
=
0

.F 2
g%=
m 0
$2

.F
-5
,8

B
2

y”
-2

.

5:
/

F2
.A

.

.

r%

.

-E
-8

.

9
2
N

.

/:

2
$g
L;

E‘
;iO
LLz

25
u-2

LE

LE
-is

3

z

r-4

zz

m

d

0

3

1 YM
03
NV
cc39
GZ

.E ‘0
-E
‘8

.G“0
-E
-8

2
2
N
r.A

YM
22
:
A

m

m

ru

ark
a 2
EE
22

Eg
2 .a, ‘;rE 5 .g
b .k

m
.5
2
2
G

.

‘;
QO
:a
vz

EE
z .a, ‘C
E $ .g
LL

2 ti
ECC
co .E
v! .k
0

>a
3s
mu

z
6
i
2

COMPOUNDS

0

P
x
E
E
Q

s
C
2

AND RELATED

0

-0
2
3
1

:
c

ALCOHOL

a

xl
2
3
=
7
2

g

:
L
.!
7
c
r

l

.

.:aT? al .Ezd x
F 02 .e c
“sp
-k-

-E
0
8
a
Q

.
.

z
2

%

s

.-s
8
.E
c
2

LANOLIN

m
;iO
ug
LE

E-

F
2

m
5

Lr

m
r
r-x

CTFA:

8

Malmstrom,

9

CTFA:

164 cc/kg

undilutedaRobinson-

-5.0

g/kg

Wagner, a

6 @ 4.0 -5 rats/64.0 cc/kg

dose

2 5 % in1 @ 5.0

10 rats/

corn oil

g/kg

dose

undiluted

6 rabbits

0.1 noundiluted

9 rabbits

no damageundiluted

9 rabbits

no damageundiluted

9 rabbits

transient

irritation

undiluted

6 rabbits

0.38 mild
irritant

mild
M

TABLE

CTFA:

.,20.025% In5 @ 1.25 -5 rats/

Croda, ag/kg

corn 011

20 g/kgdose

7. Acute Animal Toxicity-

undiluted

6 rabbits

0.71 mild

irritation

irritant

Lanolin Oil
DraizeSkin Irritation

Acute Oral

Calvery

Draize-Irritation

SampleNumberEye Irritation

WoodardReference

LD50

CTFA:

>16 ml/Westbrook,

b

-

Cont.

DosageAnimalsCont.

Animals

Index

Cont.

Animals

undiluted

1 @16

10 rats/

undiluted.3 rabbits

0.5 mildundiluted

3 rabbits

ml/kg

dose

5 @ 1.25 -5 rats/LO.O ml/kg

dose

5 @ l.O-

5 rats/21.5 ml/kg

dose

5 @ 8.0 -5 rats/undiluted

3 rabbits

1.4 mild

64.0 cc/kg

dose

undiluted

6 rabbits

0.30 slightkg

Comment
noirritant

irritant

mild
2

CTFA:

>20 ml/Croda, bkg

undiluted

undiluted

6 rabbits

1 .oundiluted

6 rabbits

transient
irritant

mild
CTFA:

Robinson-

Wagner, b

undiluted

ml/kg

CTFA:
Malmstrom,

>21.5

46.5
b

cc/kg

undiluted

undiluted

6 rabbits

0.17

undiluted

6 rabbits

in 1
animalundiluted

9 rabbits

no

5
2

*
E
7

5
6
B
6
6
23
0
8
3
E

TABLE

7. (Continued) Acute Animal Toxicity-LanolinOilirritant

propylene
5

CTFA:
Malmstrom,

6

b

CTFA:

TABLE

glycol

7 @ 2.0-

5 rats/g/k

vehicle32.0 g/kg

dose

undiluted

1 @ 1010 rats/

10% tnmin-

ml/kg

dose

eral oil

110

R.I.T.A.

ml/kg

8. Acute Animal Toxicity

undiluted

24.8-

h rabbits

undiluted

0.13

9 rabbits

to unwashedslight6 rabbits

0eyeundiluted

9 rabbits

not
Irritating

Lanolin Wax
DraizeAcute Oral

Skrn trritatron

Woodward

Eye Irritation

DraizeCalvery
SampleIrritation

Number

Reference

1

CTFA:
Malmstrom,

2

c

CTFA:
Matmstrom,

3

CTFA:

LDSO

Cont.

DosageAnimalsCont.

Animals

Index

Cont.

Animals

Comment

48-64

1:l in6 @ 4.0-

5 rats/undiluted

6 rabbits

0.28 mild

undiluted

9 rabbits

no damagecc/kg

corn oil

64.0 cc/kg

dose_-~42.7

66% in6 @ 2.0-

5 rats/g/kg

corn oil

64 cc/kg

dose

1:l

-

c

Robrnson-

,32

g/kg

Wagner, c

4

.

CTFA:
Amerchol

,a

.

.

in

6 @ 2.0-

5 rats/corn oil

64 cc/kg

dose

.

.

.

.

.

.

.

.

.

irritant

undiluted

6 rabbits0

undiluted

9 rabbits

no damageundiluted

3 rabbits0

undiluted

6 rabbits

no damageundiluted

3 rabbits

0.67 mild
irritant

.

.

.

.

.

.

.

.

.

ACETYLATEDLANOLIN

ALCOHOLAND RELATED

E rdpz
i

w
3
n
c
.P
z
r

1i E 2 .2: f s.k
Y
;i>

In
.*
2
2
G

.-E
<

COMPOUNDSE-ow=z ‘3; $
E C ‘C
z .k

I F
c ‘;
.m
C
2
F
cl

Y
g
c
iD

79

-s-

E5
‘E Y
‘C .k

2
p!
E 9!
9 .2
e
z zL

vi
.e
%
F
m

2
>

:>
1
15

2
z
-E
3

z
T=
7
3

-A
P
a, m 2s?p.r! s 5 :x ,
2 ‘G
$f >
61;
g_;f
3

0
,-I
ES
s.z
..b

2
,
.-z
:

m
.Z
2
c
9

m
.=
2
c
9

ui
.C
%
F
iD

m
C
2
e
a

: 1>
(51

2
1
7
3

-0
i?
3
%
5

u
s
3
=
T
3

u
23
r=
7
3

v
I
.-z
:

.
.
.

>
%
30
c-4-0

>‘4(

3i
zi?
;:

Bb
51
iI

.
.
.

XT

EGFj
dZ”
m .k

I!.E
EC0
m .:
9 .k

Pi

5
5
2
G
Y
u-l

3
3
B
z
4
3
:
.I
?
(:
I

.i
i
I;
E
._
:
a
r
i
4
0
Y
E
z

3
r=
-is
3
%
g;
2 .t
E .k
N

:,
21

.
.
.

5I
2/

.
.
.

B

8
E

i
2

50

mu

;j

c&l?
Lng

I 2
03
9: u
cap
I\%

2
z
e
3

2
r=
7
3

2
=
F3

L? 32
‘03
mu

YM
a
;;

I 2

:

E
0,”

x

”
%
$2
ta
uz

u

I)
$2
L:

r3

q
z

N

L
<rr:
k:E
“C

$i

zz

d

VI

TABLE10

Acute Animal Toxicity-Lanolin

AlcoholDraizeSkin Irritation

Acute Oral

Eye Irritation

WoodardDraizeCalvery
SampleNumberIrritation
Reference

LD50

CTFA:

1

Westbrook,>16g/kg
d

. . .

CTFA:

2

Westbrook,

Animals

Comment

.

. . .

. . .

undiluted

3 rabbits

slightCont.

DosageAnimalsCont.

Animals

Index

Cont.

40%

. . .

. . .

.

.

undiluted

3 rabbits

in

1 @ 16g/

10 rats/arachis oil

kg

dose

. . .

. . .

.

.

.

.

.

.

very
0

d

irritant2

propylene
3

CTFA:

Robinson-2 7 g/kg

Wagner, d

glycol8 @ l.O-

5 rats/vehicle32.0 g/kg

dose

eraloilw/

5 @ 1.25-

5 rats/mineral

CTFA:

>20.0

Croda, d

ml/kg

5% propy-

20.0 ml/kg

dose

oil

undiluted

6 rabbits

0

50% in50% in min4

undiluted

6 rabbits

50% in6 rabbits

1.5 mildmineralirritantoil

6 rabbits

no3

irritation

B

mild

g
z
z;;

transient
irritantlene glycol

052 mglrr corn
5

CTFA:
Malmstrom,

e

12.1

oil w/s%pro-mgk

pyleneA=I

6 @ 8.0-

5 rats/

64.0

dose

cc/kg

undiluted

6 rabbits

1 .S mild

undiluted

9 rabbits

undiluted

9 rabbits

irritantnodamage5
6glycolg
6

CTFA:
Malmstrom,

7

e

CTFA:
Malmstrom,

23.3

2 mg/ccot

5 @ 16.0-

5 rats/mgkg

corn oil

64.0 cc/kg

dose

66% in6 @I 2.0-

5 rats/corn oil

64.0 cc/kg

dose

>42.7
e

kg

gJ

undiluted

6 rabbits

1.05 mild
irritant

undiluted

6 rabbits0

undiluted

9 rabbits

no0

damage8noidamage6
VI

CTFA:

8

Malmstrom,

50% in6 @ 2.0-

5 rats/corn oi I

64.0 cc/kg

dose>32 g/kgeundiluted

6 rabbits

9 rabbits

undiluted

0

nodamagepropylene
CTFA:

9

Malmstrom,Malmstrom,Malmstrom,

7 @ 2.0-

5 rats/vehicle32.0 g/kg

dose

21.3g/

1~2 w/v in

6 @ 2.0-

5 rats/kg

corn oil

64.0 cc/kg

dose

21.3cc/112 w/v in

6 @ 2.0-

5 rats/kg

corn oil

64.0 cc/kg

dose

-

Acetylated Lanolin

e

CTFA:

11

glycol

kg

e

CTFA:

10

21.lg/e

TABLE11 Acute Animal Toxicity

undiluted

6 rabbits

9 rabbits

undiluted

0

nodamage

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

DraireSkin Irritation

Acute Oral

1

Reference
CTFA:
Westbrook,

2

CTFA:

DosageAnimalsCont.

Animals

Index

Cont.

Animals

Comment>16 g/kg

undiluted

1 @16

10 rats/

undiluted

6 rabbits

0.3 mildundiluted

8 rabbits

marginal

g/kg

dose

50% in

1 @15

20 mice/

oil

ml/kg

dose

>I5

CTFA:
Malmstrom,

4

!

Cont.

e

ml/kg

>64 cc/kg

CTFA:
Amercholundilutedf>lOml/kg,f

undiluted

6 @ 4.0-

5 rats/64.0 cc/kg

dose

5 @ 2.5-

2 rats/40.0 ml/kg

dose

irritant

undiluted

3 rabbits

0

8
5
6
6
R
5
;;1
0
8

Draize

LD50

Croda, e
3

Eye Irritation

Irritation

SampleNumberWoodard

A
3
6
;;1
0
6
$
r
z
>

8

irritant

undiluted

3 rabbitsnoirritation

undiluted

6 rabbits

0.5 mildundiluted

9 rabbits

irritant

undiluted

6 rabbits

Avg. 1.62
mild
irritantnoirritation

mild
undiluted

6 rabbits

transient
irritation

0,TABLE12Acute Animal Toxicity-

Acetylated Lanolin Alcohol
DraizeSkin Irritation

Acute Oral

Eye Irritation

WoodardDraizeCalverv
Irritation

SampleNumber1

Reference
CTFA:
Malmstrom,

LD50

Cont.

64 cc/kg

undilutedg

DosageAnimalsCont.

Animals

Index

Cont.

Animals

Comment

undiluted

6 rabbits0

undiluted

9 rabbitsnoirritation

undiluted

6 rabbits

I .3 mild

undiluted

6 rabbits

transient

6 @ 4.0-

5 rats/64.0 cc/kg

dose

5 @ 2.5-

2 rats/

40 ml/kg

dose

mild
2

CTFA:
Amerchol40.0 ml/,dundiluted

kg
40%

3

CTFA:
Westbrook,

16 g/kgf

irritant

irritant

A
1
5
4
0
5
g

in

arachis1 @ 16

10 rats/

oil

g/k

dose

undiluted

1 @ 16

10 rats/

ml/kg

dose

undiluted

6 rabbits

2.3 mod.

undiluted

6 rabbits

not anirritant

irritant

Z
Lx;;
OI

4

CTFA:
Westbrook,

16 ml/kgg

undiluted

6 rabbits

2.1 mod.

undiluted

8 rabbits

marginals!

irritant

irritant

z
5

CTFA:
Croda, f

40 g/kg

undiluted

5 @ 2.5-

5 rats/40.0 g/kg

dose

undiluted

3 rabbits0

undiluted

3 rabbits

not anirritant

E
5
0
8

t!
$

TABLE13Acute Animal Toxicity-

Hydrogenated Lanolin
DraizeAcute Oral

Skin Irritation

WoodardEye Irritation

DraizeCalvery
SampleNumber1-2

3

Irritation
Reference
CTFA:
Malmstrom,

h

CTFA:
Malmstrom,

h

LD50

Cont.

DosageAnimalsCont.

Animals

Index

Cont.

Animals>64.0

undiluted

6 @ 4.064 occlkg

5 rats/dose

undiluted

6 rabbits

0.1 mild
irritant

undiluted

9 rabbits0

undiluted

cc/kg

66% incorn oil

6 @ 2.064 occlkg

5 rats/dose

undiluted

glkg>5 g/kg

undiluted

t@5
g/kg

10 rats/

undiluted

2@5&

5 rats/
dose

>42.7

CTFA:
Croda, g

6 rabbits

Commentnodamage9 rabbitsdazge

6 rabbits

dose

0.6 mildundiluted

6 rabbitsnoirritant

damage25% in4

CTFA:
R.I.T.A.

8.12
g/kg

TABLE14Acute Animal Toxicity-

propylene
glycolHydroxylated

1@g/kgundiluted

6 rabbits

50% aque- 9 rabbits

0

ous pastenoirritation

LanolinDraizeSkin Irritation

Acute Oral

Eve Irritation

WoodardDraizeIrritation

SampleNumber

Reference

LD50

Cont.

DosageAnimalsCont.

Animals

Index

Cont.

Animals

Comment

1CTFA:

2.0 g/kg

undiluted

2 @ l.O-

5 rats/undiluted

9 rabbits0

undiluted

6 rabbits

transient

2.0 g/kg

dose

5 @ 2.5-

2 rats/40.0 ml/kg

dose

mild
Avon

2

CTFA:
Amerchol>lO ml/,ekg

undiluted

irritation

.

.

.

.

.

.

.

.

.

undiluted

3 rabbitsnoirritation

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMPOUNDS

84

ClinicalAssessment of Safety

General Assessment No scientific reports of adverse reactions among
persons occupationally
exposed during production or use of Lanolin over a
50-year period have been reported (Table 15) (CTFA: Westbrook, a). Similarly
there have been no reported adverse experiences in 22,22,25,30,
6 and 14years of use by workers or customers for Lanolin Oil (CTFA: Westbrook, b),
Lanolin Wax (CTFA: Westbrook, h), Lanolin Acid (CTFA: Westbrook, c),
Lanolin Alcohol (CTFA: Westbrook, d), Acetylated Lanolin (CTFA: Westbrook,e), and Acetylated Lanolin Alcohol (CTFA: Westbrook, f,g), respectively.
Skin Irritation Numerous patch tests were conducted on volunteers with
Lanolin and related cosmetic ingredients. These studies are summarized inTable 15. Undiluted
Lanolin showed no evidence of primary irritation or
sensitizationin over 250 subjects (CTFA: Malmstrom, a; CTFA: Croda, a).
Lanolin Oil has been skin tested in more than 300 volunteers without adverse
reactions (CTFA: Croda, b; CTFA: Malmstrom, b). Undiluted Lanolin Wax
showed extremely low irritation potential and no evidence of sensitization inover 200 subjects (CTFA: Malmstrom, c). Ofthe 115 subjectsexposed topicallyto Lanolin Acid, three showed increased reaction not considered sensitizationand one showed sensitization (CTFA: Westbrook, c; CTFA: Amerchol, b;
CTFA: Croda, c). There were no adverseeffects noted when 50 volunteers were
exposed to undiluted Lanolin Alcohol in a repeated insult patch test (CTFA:
Croda, d). Questionable evidence of fatiguing was found in 2 of 53 subjects
exposed to Acetylated Lanolin (CTFA: Amerchol, c). Acetylated Lanolin Alcohol caused an extremely low level of irritation in over 60 individuals (CTFA:
Malmstrom, g; CTFA: Amerchol, d). In a repeated insult test on 50 subjects,
undiluted Hydrogenated Lanolin presented no suggestions of irritation, fatiguing, or sensitization (CTFA: Croda, g). There were no visible skin changes
observed in 53 volunteersexposed
to Hydroxylated Lanolin (CTFA: Amerchol,d.

Skin Sensitization Over the years of its use, Lanolin has been observed to
produce allergic or hypersensitivity reactions. The first reports of Lanolin skinsensitization were published in 1930 (Ramirez and Eller, 1930). Since then,numerous reports of Lanolin allergy have been published, several of which will
be elaborated upon below. The incidence of hypersensitivity among persons
exposed has been a matter of great uncertainty (Anonymous, 1971; Clark et a/.,1977; Clark, 1975; DeBeukelaar, 1968; Epstein 1972; Fisher et a/., 1971;
Hannuksela et al., 1976; Schorr, 1974, 1975; Taub, 1976; Wilson, 1973).
Clark (1975) has summarized three large European retrospectivestudiesof
dermatology
patients with Lanolin Alcohol hypersensitivity with a reported
incidence of 0.70, 2.38, and 1.82%. Using numerous assumptions, the incidence in the general population was estimated to be no more than 9.7 cases per
million people.
Epstein (1972) and Breit and Bandmann (1973) suggested for detection of
Lanolin allergy the use of 30% wool wax alcohol in petrolatum as the testing
agent for Lanolin materials in patch testing. With this Lanolin fraction, Lanolin

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMPOUNDS

assensitivity was successfully identified. It was noted that addition of salicylic
acid to the Lanolin fraction produced false-positive reactions (Epstein, 1972).
Peter et a/., (1969) concluded from his studies that the greatest allergenic
reaction is given by CT4-CT 6 Lanolin Alcohols.
A European study group noted that the incidence of hypersensitivity to
topical medicaments was 14% (560/4000) in clinic patients with eczema.
Positive test reactions were reported for neomycin @I%), wool alcohols (3%),
iodochlorohydroxyquin(2%), parabens (2%), and chlorquianaldol(1%). The
difference between these total values of 12%, and the overall total of 14% was
not stated (Bandman et al., 1972).
The North American Contact Dermatitis Group has issued a series ofreports on results of diagnostic patch testing of dermatitis patients using astandard array of test substances. Out of 1200 patients tested over an 18-month
period ending in June 1972, wool wax alcohols (30% in petrolatum) ranked
eighth in frequency of reaction with 3% of the patients reacting (North American Contact Dermatitis Group, 1973). In the subsequent two-year testing
period, wool wax alcohol ranked eleventh, again experiencing a 3% reaction
rate out of 3 165 patients tested (North American Contact Dermatitis Group,1975). A preliminary report of a more recent testing period (July 1,1975-June30, 1976) showed wool alcohol ranking thirteenth with a reaction incidence of
2.9% of 900-2000
patients tested (Rudner, 1977). An unpublished tabulationof 1976-l 977 data from the groups shows a sensitivity index of 2% for wool
alcohol and 1% for 100% hydrous Lanolin (North American Contact Dermatitis Group, 1976-77).
Clark et a/., (1977) demonstrated in Lanolin-sensitive patients that theremoval of free fatty Lanolin Alcohols and detergents reduced the incidence ofdetectable hypersensitivity by 96%. An anonymous submission suggests thatparabens, alkyl esters of p-hydroxybenzoic
acid, cosmetic preservatives, may
increase or be responsible for Lanolin hypersensitivity (Anonymous, 1971;
DeBeukelaar,1968).
Estimates of the extent of hypersensitivity vary apparently according to thetype of provocative patch test applied or according to the populations tested.
Salicylic acid as a keratolytic agent has been used to increase the sensitivity to
Lanolin in patch testing systems with differing results according to the type of
Lanolin material used (Lanolin esters or alcohols). It has even been suggested
that autoxidation
products may contribute to the allergenicity of Lanolin
Alcohols (Stutsman, 1977; DeBeukelaar, 1968).

Photosensitivity Two product formulations, each containing 0.75% Lanolin Acid, 3.0% Lanolin Alcohol, and 0.5% Hydroxylated Lanolin, were tested
for phototoxicity
on 20 human subjects and for photosensitization
on 25
human subjects. There was no evidence of either phototoxicity or photosensitivity (CTFA Task Force).

TABLE15. Clinical Adverse Reactions -Clinical

TrialsR
Human ResoonseIngredient/
Brand Number

Reference

No. ofNo. ofIncubation

Final

Test

Subiects

Aoolications

Concentration

PeriodChallenge

Comment

. . .

. . .

. . .

. . .

. . .

. . .

no reported adverse experiences

Lmolin1

CTFA:
Westbrook,in 50 yrs of use by workers

aor customers
2

Draize200

1o, 3x’s/wk

undiluted

duration

CTFA:

repeated insult

50

every other day

undiluted

lo-14 days

Croda, apatches

CTFA:
Maimstrom,3

yesno evidence of sensitizationyes

no evidence of primary irritation,

not givenafatiguing or sensitizationfor 10applications?

Lanolin Oil
1

. . .

CTFA:
Westbrook,

.

.

.

. . .

. . .

.

.

.

. . .

b

no reported adverse experiencesin 22 yrs of use by workers
or customers

CTFA:

repeated insult

Croda, bpatches50

every other day

undiluted

lo-14 days

yes

no evidence of fatiguing, primary
irritationfor 10or sensitizatron

applications
CTFA:
Malmstrom,

2 1-day cumulativeb

CTFA:
Malmstrom,

dailyfordays

50

dailyforl5days

undiluted

.

.

.

. . .

undiluted

21 daysyes

extremely low irritancy potential

irritancy assay
repeated insult

b

CTFA:
Malmstrom,

8

Draize200

1o, 3x’s/wk

undiluted

durationyes

no evidence of irritancy,

fatiguingor sensitization
no evidence of sensitization

not given

b

5
u
6
g
z
g
8
8
6
6
it
5
;;I
u
8

Lanolin Acid
1

A

CTFA:
Westbrook,

applied to skinc12

undiluted

3 wks

ves

3 subjects showed increased reactions not consideredsensitization!
B
VI

ACETYIATED LANOLIN ALCOHOL AND RELATEDCOMPOUNDS

3
8
8
zr
ww
a
‘C
if
gp r”, z
;sg
.E
ki%9U
>>l;
umow zI
es2
B
,zLLn
F
8,
e .L z
P
2

.-s
z
El
E%
xg
<r
00.E
.E
.-&
3

2
s
:r
‘G
ww
ss
‘C+
‘C‘i;
go
.‘R
gsr
2.r;
c$E 2.2&sg@-g,‘smou x 0.
xrh 2 b 8.E
8 4 {‘5 .s
s!.E w-z

.
.
.

s%

B

.
.
.

.
.
.

r
4
m
-

z
z
v
-7
0

.
.
.

ks

SE
f$Z
Ng=
“ET
2
$ .5
s
2
.E
Tw 0 .g
r$$:z>m F p=
‘G
!
2

.
.
.

.
.
.
.
.
.

2

.
.
.

c
.o
t;
G
.G

”

.
.
.

.
.
.

z

=
3
=M
h]$
E&”

25
k-“b
u*
P

a
*o;iz
K-E *g
uwut
5

N

m

-3

z
zd
7
0

.
.
.

r
?I
m

s
Tz
73
s E
-0
G0 .g
s-2
O$I=
5- ki
z

.
.
.

6OE

.
.
.

2!
28
.E
22
p”

UZ

Q-0
d
EB
U

P

2
87
<
.t
7
4

w:Ezz
En0
WN
> w s a, .E
P23+m
JZ%
se
is
'$f
o-

e
.
.
.

s

;i$
ki

‘t
WB
F
wz.a

:
$
>

.
.
.

-0

8
.-5
L
g2r
GEr

N

6
%

87

3
2
5
5

M
ze
.gj

M
$2
.g

.;

gpr
$$sr
'5
.E su zsf
$$E
zw
zx&gg
&%B
2 z B: 5
024
rn0"
Em m%
E xrq&
r2z
t
g;
g:
L .L
@
?

5
.g
.3
9
-z
f
P
ir:
w
.
.
.

6
A

.
.
.

.
.
.

.
.

z
G

.
.

l

2

.

.
.
.
.
.
.

?sJ
ZT
a%
B .E

.
.
.

5

.
.
.

$3
>r.?
‘2

.
.
.

m
VI

.
.
.
w

u
$2
l-k!

3

5

uw

.
.
.

.
.
.

.

‘0

E m
2-t; ‘a:<
2.2
.F
-yk
c ‘N

;i$
F;j
UZ

c;:

s
.;-%
7%

.-z
t;
4
.E

.

.
.
.

.

cc

@n
.
..g<....yx

-0

.

n-

M
.
<$

,glg=LL

Lp,LJ,
zz

2’2

-t

~~

3

$

Table 15 (continued). Clinical Adverse Reactions -Clinical

TrialsHydrogenated
Lanolin1

CTFA:

repeated insults

every other day

50

undiluted

IO-Iddays

noevidenceoffatiguing,w

irritationor sensitizationfor 10

Croda, gapplications

Hydroxylated
Lanolin1

induction

CTFA:

53

Amerchol , e

4x’s/wk for

100 & 20-80%

3 wks

in petrolatum

18 daysno visible skin damage

yes

$
z
a

Lanolin Wax
1

CTFA:
Malmstrom,

2

CTFA:
Malmstrom,3

Zl-daycCTFA:cumulative

dailyfor8

days

undiluted

. . .

l

l

l

extremely

low irritancy potential

irritancy assay
Draize200

10,3 times/
week

c
.

.

.

.

.

.

.

.

.

not

undiluted

no evidence of sensitization

yes

specified
.

.

.

5

.

.

.

l

l

l

no reported adverse experiencesin 22 yrs of use by workers
or customers

g
ol
6
6
z
5
;;I
0
8
!
G
w

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMPOUNDS

89

Comedone Formation (Acnegenic Effect) Kligman and Mills (1972) andFulton et a/., (1976) have studied the acnegenic properties of cosmetics including those containing Lanolin and Lanolin related materials. Their papers described the comedogenic effects of these ingredients. Other ingredients incosmetics that were indicated as comedogenic included petrolatum, certain
vegetable oils, butyl stearate, lauryl alcohol, oleic acid, isopropyl myristate,and sodium lauryl sulfate.
Effect on the Eyes Fraunfelder et a/., (1973) attempted to determine
whether Lanolin-containing
ophthalmic materials, applied topically, could beincorporated
into the cornea. It is their conclusion, following a series of
provocative animal tests, that no Lanolin-containing ointment was trapped in
the cornea unless the surface of the cornea was directly and repeatedly
disrupted and abraded. These findings further substantiate the animal toxicity
data reported previously in Tables 6-14.

SUMMARY
The results of tests on animals and humans with Acetylated Lanolin, its
related cosmetic ingredients, and with numerous cosmetic formulations containing these materials attest to the safety of these ingredients as presently used.
These ingredients, as a group, are used extensively in cosmetics as well as
in many other consumer products, and there has been ample opportunity for alarge proportion of the population to be exposed to some of these materials.
The acute toxicity of these materials is low, and the animal tests for skinsensitization are negative. However, extensive clinical experience indicatesthat there is a low incidence of sensitivity to these materials among exposed
persons. This appears to be mainly due to the Lanolin Alcohols. There was noevidence of photosensitizationinduced by these ingredients. Comedogenic
effects from cosmetics incorporating Lanolin and related materials have beenreported.
The safety assessment of these ingredients rests on the information at handand on the considerable usage in various concentrations in a variety of COSmetic formulations.
Additional
biological assessment of these ingredientsmight reasonably be expected to include more extended studies in the areas of
percutaneousabsorption, cutaneous hypersensitivity, chronic toxicity, andmutagenicity.
CONCLUSIONS
Based on the available animal data and human experience, the Panelconcludes that Lanolin and related Lanolin materials described herein are safefor topical application to humans in the present practice of use and concentration.

98

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMF’OUNDSREFERENCES
Amerchol.:

Isopropyl

Anonymous.:

Lanolates and Lanolin fatty acids. Edison, N.J., 1976, p. 3.

Cream bases for topical agents can cause dermatitis.

J. Am. Med. Assoc. 2 17(7):893-896,

1971.
Anonymous.:

Dermatitis

Bandmann,from applied medicaments. Br. Med. J. 1(848):250,

H.J.,Calnan,C.D.,Cronin,

Meneghini,CL.,matol. 106:335,
Bereblum,

Piril’a,E., Fregert,S.,

V., and Wilkinson,

Hjorth,

D.S.:

1972.

N., Magnusson, B., Maibach, H.,MaJten,

Dermatitis

K.E.,

from applied medicaments. Arch. Der-

1972.

I., and Schoental,

R.: The apparent anticarcinogenic action of lanolin. Cancer Res. 7:390-392,

1947.
Bolderson,
Breit,

I.: Cosmetic preparations containingvitamin

A. Ger. Offen. Pat. No. 2,609,575,

Sept. 30,1976.

R. and Bandmann, H.J.: Contact dermatitis. XXII. Dermatitis from lanolin. Br. J. Dermatol. 88(4):414-

416,1973.
Bradner,H.: Suntan composition

containing fluorescent compounds.

US.

Pat. No. 3,988,437,

Oct. 26,

1976.
Chalmers,

L.: Cosmetic materials and the skin. Soap Perfum. Cosmet. 45(7):419-426,

Chalmers,

L.: Water-in-oil

Chemtob,

C., Fawaz,

cosmetic emulsions.

F., and Puisieux,

chemical composition
composition
Chen, T.M.:

F.: Analysisof ointments,

oils,

1972.
145, 1976.

and waxes. XVIII.

Study of theof liquid lanolin. 2. Study of alcohols. Ann. Pharm. Fr. 32(7-8):433-441,

Chemtob, C., Fawaz, F., and Puisieux,of waxy lanolin.

33(2):109-118,

Soap Perfum. Cosmet. 49(4):141-143,

F.: Analysisofointments,

I. Fractionation

1974.

oils, and waxes. XIX. Studyofthechemicalof the sample and study of the acids. Ann. Pharm. Fr.

1975.

Shaving napkins containing cosmetic emulsions

or solutions.

Belg. Pat. No. 836,756,

Apr. 16,1976.
Clark, E.W., Cronin,E., and Wilkinson,

Contact Dermatitis.
Clark,

E.W.:

3(2):69-74,

Water absorption

properties).

D.S.: Lanolin with reduced sensitizing

properties of lanolin (analysis of nonionic detergents affecting absorptive

J. Sot. Cosmet. Chem. 22(6):421-437,

Clark, E.W.:

Lanolin derivatives

Clark, E.W.:

Estimation

potential. A preliminary note.

1977.
1971.

in skin lotions. Cosmet. Perfum. 89(4):53-59,of the general incidenceofspecific1974.

lanolin allergy. J. Sot. Cosmet. Chem. 26(7):323-

335,1975.
Courtin,
CTFA

J.: Product aiding the sun-tanning

Submission

ingredients’,
CTFA.:

Amerchol,of data: Cosmeticof the skin. Fr. Demande Pat. No. 2,295,735,

ingredient descriptions

July 23, 1976.

for acetylated lanolin alcohol and related

1978.
a Lanolin Wax’.

CTFA.: Amerchol, b Lanolin Acid’.
CTFA.: Amerchol , c Acetylated Lanolin’.
CTFA.:

Amerchol, d Acetylated Lanolin Alcohol’.

CTFA.:

Amerchol, e Hydroxylated

CTFA.:

Avon Products, Inc. Hydroxylated

CTFA.:

Croda, Inc., a Lanolin’.

CTFA.:

Croda, Inc., b Lanolin Oil’.

Lanolin’.

CTFA.:

Croda, Inc., c Lanolrn Acid’.

CTFA.:

Croda, Inc., d Lanolin Alcohol’.

Lanolin’.

CTFA.:

Croda, Inc., e Acetylated Lanolin’.

CTFA.:

Croda, Inc., f Acetylated Lanolin Alcohol’.

CTFA.:

Croda, Inc., g Hydrogenated Lanolin’.

CTFA.:

Malmstrom

Chemicals.,

CTFA.:

Malmstrom

Chemicals.,b Lanolin Oil’.

CTFA.:

Maimstrom

Chemicals.,c Lanolin Wax’.

a Lanolin’.

CTFA.:

Malmstrom

Chemicalss,d Lanolin Acid’.

CTFA.:
CTFA.:

MalmstromMalmstrom

Chemicals.,
Chemicals.,e Lanolin Alcohol’.
f Acetylated Lanolin’.

‘Available upon request. Administrator,
Washington, DC 20005.

Cosmetic Ingredient

Review, Suite 212,

1133

15th St., NW,

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMPOUNDS

CTFA.:

Malmstrom

Chemicals.,g Acetylated Lanolin Alcohol’.

CTFA.:

Malmstrom

Chemicals.,h Hydrogenated Lanolin’.

CTFA.:

R.I.T.A.

91

Chemical Co. Hydrogenated Lanolin; Lanolin Oil’.

CTFA.:

Robinson-Wagner

CTFA.:

Robinson-Wagner

Co., a Lanolin’.
Co., b Lanolin Oil’.

CTFA.:

Robinson-Wagner

Co., c Lanolin Wax’.

CTFA.:

Robinson-Wagner

Co., d Lanolin Alcohol’.

CTFA

Task

Force: Submission

materials.

of data in support of the safety of acetylated lanolin alcohol and related

Lanolin and its derivatives.

Products containing: lanolin acid, hydroxylated lanolin,

lanolinalcohol’.
CTFA.:

Westbrook

Lanolin Co., a Section F. Lanolin’.

CTFA.:

Westbrook

Lanolin Co., b Section C. Lanolin Oil’.

CTFA.:

Westbrook

Lanolin Co., c Section D. Lanolin Acid’.

CTFA.:

Westbrook

Lanolin Co., d Section E. Lanolin Alcohol’.

CTFA.:

Westbrook

Lanolin Co., e Section C. Acetylated Lanolin’.
Lanolin Co., f Section B. Acetylated Lanolin Alcohol’.

CTFA.:

Westbrook

CTFA.:

Westbrook

Lanolin Co., g Section A. Acetylated Lanolin Alcohol’.

CTFA.:

Westbrook

Lanolin Co., h Section I. Lanolin Wax’.

DeBeukelaar,L.: Allergic reactions to wool fat alcohols. Dermatologica

J36(5):434-439,

1968.

Epstein, E.: The detection of lanolin allergy. Arch. Dermatol.

106(5):678-681,

Fawaz,

oils, and waxes. XII. Study of the chemicalF., Miet, C., and Puisieux,

compositionof wool fat (lanolin). I. Preliminary examination and fractionation of a sample. Ann. Pharm.

Fr. 11(1):63-72,
Fawar,

F.: Analysis of ointments,

1973a.

F., Chaigneau, M., and Puisieux,

lanolin.

F.: Analysis of ointments,

2. Study of the nonhydroxylated

3 1(3):217-226,
Fawar,

oils, and waxes. XIII. Compositionofacids of total lanolin and its various fractions. Ann. Pharm. Fr.

1973b.

F., Miet, C., and Pulsieux,

F.: Analysis of ointments, oils, and waxes. XIV. Composition(wool fat). 3. Study of the hjydroxylated
32(1):59-68,

1972.

of lanolin

acids of total lanolin and its various fractions. Ann. Pharm. Fr.

1974a.

Fawaz, F., Chaigneau. M., Puisieux,

F.. Gin/, L., and Ricard, L.P.: Analysis of ointments, oils, and waxes, XV.

Chemical composition of lanolin. 4. Aliphatic alcohols of total lanolin and of its various fractions, Ann.
Pharm. Fr. 12(3-4):215-225,
1974b.
Fawaz, F., Chaigneau, M., and Puisieux. F.: Analysis of ointments, oils, and waxes. XVI. Chemicalcomposition
fractions.

of lanolin.

5. Study of sterols and triterpene alcohols of total lanolin and of its various

Ann. Pharm. Fr. 32(5):301-308,

FDA: Cosmetic product formulation
Fisher,

A.A.,

1974.

data. Computer Pnntout, Aug. 31, 1976.

Pascher, F., and Kanof, N.B.:

Allergic contact dermatitis“vehicle tray” for patch testing. Arch. Dermatol. 104(3):286-290,
Fraunfelder,

F.T.,

Hanna, C., Cable, M., and Hardberger, R.E.: Entrapment of ophthalmic ointment

cornea. Am. j. Ophthalmol.

76(41:475-484,

Fr. Demande: Agent for preshampooing
lanolin.

due to ingredients of vehicles.

Pat. No. L,288,51

Gillespie,in the1973.

treatment oi the hair, containing an oil-in-watertype emulsionof

1, May 21, 1976.

Fulton, I.E., Jr., Bradley, S.. Agundez, A., and Black, T.: Non-comedogeniccosmetics.
349-35A

1971.

Cutls 17(2):344-345,

1, 1976.
D.T.C.:

Hannuksela,

Wool wax. A review of its properties, recovery, and utilization.

M., Kousa. M., and Piril’s,

J. Text. Inst. 39:45,1948.

V.: Allergy to ingredients of vehicles. Contact Dermatitis

2(2):105-

110,1976.
Kammerau,B., Klebe, U., Zesch,A., and Schaefer, H.: Penetration,

permeation, and resorptionof 8-

methoxypsoralen.
Comparative in vitro and ,n v~vo studies after topical application of four standard
preparations. Arch. Dermatol. Res. 255(1):31-42,
1976.
Kelly, R. and Ritter, E.J.: Skin protective compositions.
Kligman,

A.M., and Mills,

O.H.,

Jr.: “AcneCosmetica.”

U.S. Pat. No. 3,981,990.
Arch. Dermatol.

Mayer, F.S.: Hardening ammal finger and toenail tissue. U.S. Pat. No. 3.989.817,
McCarthy,
1976.

J.P.: Lanolin

derivatives

Sept. 21, 1976.

l&(6):843-850,

in sunscreen preparations. Household

1972.

NOV. 2, 1976.

Pers. Prod. Ind. 13(7):44,

46,

ACETYLATEDLANOLIN ALCOHOL AND RELATEDCOMPOUNDS

92

McCarthy, J.P. and Schlossman,

M.L.: Some propertiesoiethoxylated

cosmetic applicatron. J. Sot. Cosmet. Chem. 26(11):523-530,
McCarthy,J.P., Mores,

L.R.,

and Schlossman,

M.L.:

New lanolin acid quaternary salts for use in hairtreatment preparatrons. J. Sot. Cosmet. Chem. 27(11):559-570,
Moeller,

H. and Osberghaus,

2,517,216,
Mores,

lanolin derrvatives and their effect on

1975.
1976.

R.: Cosmetic composition containing skin moisturizers.

Cer. Offen. Pat. No.

Oct. 28. 1976.

L.R. and McCdrthy,

J.P.: Development of a lanolin substitute.

Drug Cosmet. Ind. J19(8):50-56,

1976.
North American

Contact Dermatitis

Arch. Dermatol.

Group: Epidemiology of contact dermatitis

108(10):537-540,

North American Contact Dermatitis
Contact Dermatrtis

I-277-280,

Group: The frequency of contact sensitivity
Group: 1976-77

as confirmed by patch test’.
Peter, C., Schropl, I., and Franzwa,

in North America 1972-74.

Tabulation of contact allergy in dermatology patients

H.: Experimentelle

Untersuchungen

Wollwachsachsalkoholen.
Hautarzt 201450.455,
1969.
Ramirez, M., and Eller, J.J.: The patch test in contact dermatitis

iiber die ahergene Wirkung

allergy. (Dermatitis

vanVenenata). I. Allergy

1930.

Roney, B.H.:

Milk shdmpoo. Ger. Offen. Pat, No, 2,623,250,

Dec. 9, 1976.

Rudner, E.J.: North American group results. Contact Dermatitis

Schlossman,

1972.

1975.

North American Contact Dermatitrs

l:489-495,

in North America:

1973.

j(4):208-209,

1977.

M.L. and McCarthy, J.P.: Lanolin and its derivatives, Symposium:“Fats in Cosmetics”

AOCS

meeting, New York, May, 1977.
Schorr, W.F.:

Contact dermatitis.

Schorr, W.F.:

Allergic skin drsease caused bycosmetrcs. Am. Fam. Physician

Scott, H.L.:
Simpson,Lubricating
W.L.,

dissolved
Spilker,

Stutsman,and management. Minn. Med. 57(10):831-837,

or softening the skrn. U.S. Pat. No. 3,932,614,

Carruthers,

12(3390-95,

1974.

1975.

Jan. 13, 1976.

C., and Cramer, W.: Loss ofcarcinogenrc activity when methylcholanthrene

isin anhydrous lanolin. Cancer Res. 511.4, 1945.

C.W. and Richey, T.B.:

88(9):43-48,

Officediagnosis

Analytical procedures for lanolin and lanolin derivatrves. Cosmet. Perfum.

1948.

M.J.: Analvsrs of hair fixative. Newburger’s Man. Cosmet. Anal. 2nd ed., 72-77,

Sugai, T. and Higashi,I.: Hypersensitivity

to hydrogenated lanolin. Contact Dermatitis.

Taub, S.J.: Cosmetrc allergies: What goeson underyourmakeup.

1977.

J(3): 146-l 57, 1975

Eye Ear NoseThroatMon.

55(4):113-l

15,

1976.
Tentsova,

A.I., Gol’denberg, V.I., Cryadunova, G.P., and Sandalova, L.K.: Chemiluminescencemethod of

selecting antroxidants for ointment bases. Farmatsiya (Moscow) 26(3):16-21,
1977.
Wilson,L.: Betamethasone 17.valerateointment
in a lanolin-free base. Curr. Med. Res. Opin, 1(4):2X+232,
1973.