JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY

Volume 2, Number 7, 1983

Mary Ann Liebert, Inc., Publishers

Final Report on the Safety

Assessment of Sodium Lauryl Sulfate
and Ammonium Lauryl Sulfate

Sodium and Ammonium Lauryl Sulfate are anionic surfactants used in

cosmetics as cleansing agents. I n absorption, metabolism, and excretion
studies, Sodium Lauryl Sulfate had a degenerative effect on the cell membranes
because of its protein denaturing properties. Low levels of skin penetration
may occur at high use concentration.
Sodium Lauryl Sulfate had an LD50 of 0.8 to 1.10 g/kg in rats. A formula-
tion containing 15% Ammonium Lauryl Sulfate caused depression, labored
breathing, diarrhea, and death in four out of 20 animals.
In acute ocular tests, 10% Sodium Lauryl Sulfate caused corneal damage to
the rabbits’ eyes if not irrigated, or if irrigation was delayed. A Draize test of a
product containing 5.1 % Sodium Lauryl Sulfate caused mild irritation, and
products containing 21% detergent were severely irritating with no rinse, and
mildly irritating when rinsed. Ammonium Lauryl Sulfate solutions containing
1.25%-27.4% detergent showed increasing irritation with increasing concen-
tration; rinsing decreased irritation.
Acute animal skin irritation studies of 0.5%-10% Sodium Lauryl Sulfate
caused slight to moderate irritation. Applications of 10%-30% detergent caused
skin corrosion and severe irritation. Solutions of 29b, lo%, and 20% Am-
monium Lauryl Sulfate were highly irritating and dangerous. One percent and
5% Sodium Lauryl Sulfate produced a significant number of comedones when
applied to the pinna of albino rabbits.
A chronic oral feeding study in rats of 0.25%, 0.5y0, and 1.0% Sodium
Lauryl Sulfate in the diet for two years produced no abnormalities. A 91-day
percutaneous toxicity study of a shampoo containing 17.5% Ammonium
Lauryl Sulfate had no treatment-related abnormalities except for moderate to
severe dermal effects.
In mutagenesis studies, rats fed 1.13v0 and 0.569b Sodium Lauryl Sulfate in
the diet for 90 days produced no more chromosomal aberrations or clastogenic
effects than did a control diet.
Sodium Lauryl Sulfate was tested for human skin irritation in concentra-
tions ranging from 0.1 % to 10%. Open patches were less irritating than closed
patches, and irritation increased directly with concentration. Similar results

127
128 COSMETIC INGREDIENT REVIEW

were obtained when formulations containing Sodium and Ammonium Lauryl

Sulfate were tested. No U V light sensitization occurred from any formulation
in this latter study.
Both Sodium and Ammonium Lauryl Sulfate appear to be safe in formula-
tions designed for discontinuous, brief use followed by thorough rinsing from
the surface of the skin. In products intended for prolonged contact with skin,
concentrations should not exceed 1%.

CHEMICAL AND PHYSICAL PROPERTIES

Production

S odium Lauryl Sulfate, an anionic surfactant, i s prepared by the sulfation of

commercially available lauryl alcohol with either sulfur trioxide or chloro-
sulfonic acid:

SO3 or
CH3( CH2) 1 0 C H g H ---------> CH3( CH2) 10CH2-OS03H
C1S03H

The product of this reaction is then neutralized with aqueous sodium

NaOH
CH3(CH2) 10CH2-OSO3H ----> CH3( CH2) 10CH20S03Na

Ammonium Lauryl Sulfate is manufactured by sulfating commercial lauryl

alcohol with sulfur trioxide or chlorosulfonic acid, as in step one above. This
product is then neutralized with aqueous ammonium hydroxide to produce the
am mon iu m an ion ic salt: ( '.*s5)

NH~OH
CH3( CH2) 10CH2-OS03H -----> CH3( CH2) 10CH20S03NH4

Structure and Synonyms

Sodium Lauryl Sulfate conforms to the formula:

CAS NO. 151-21-3

Synonyms include:
Dodecyl Sodium Sulfate
Lauryl Sodium Sulfate
Sodium N-Dodecyl Sulfate
Lauryl Sulfate Sodium Salt.
Ammonium Lauryl Sulfate has the structural formula:
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 129

CH3( CH2) 10CH20S03NH4

CAS NO. 2235-54-3

Synonyms inc I ud e :
Lauryl Ammonium Sulfate
Dodecyl Ammonium Sulfate
Ammonium Dodecyl SuIfate.( 6 )

Properties
Sodium Lauryl Sulfate has a molecular weight of 288.4 and a characteristic
fatty odor. It is commercially available in a variety of forms including a white to
yellow powder, a paste, or a clear, viscous liquid. This compound is very soluble
in polar solvents and forms a smooth, opalescent solution with ~ a t e r . ( ~ - ~For
*'-~)
other properties, see Table 1.
Ammonium Lauryl Sulfate is a surfactant with a molecular weight of 283.4.(6)
Its commercial forms range from a thin to a viscous liquid with a viscosity of 800
to 8000 cps at 25OC. It is soluble in water and highly polar soivents such as
methanol and ethanol.(5)UV spectra of 28% Ammonium Lauryl Sulfate in con-
centrations of 5,000 and 50,000 mgll in distilled water did not show absorption in
the UVA or UVB region (approximately 290 to 400 nm).''')
For other properties, see Table 1.

Reactivity
Sodium Lauryl Sulfate, an anionic detergent, binds to the positively charged
side groups of proteins, thereby causing conformational changes (denaturizing)
in the protein.'") It is stable in alkaline conditions, but will hydrolyze at room

TABLE 1. Properties.

Ammonium Lauryl
Property Sodium Lauryl Sulfate Ref. Sulfate Ref.

Molecular weight 288.4 283.4 56

Form Viscous, clear liquid; paste; Thin to viscous 5
white to yellow powder liquid
Viscosity 500-8,000 (liquid) 3 800-8,000 5
cps at 25 OC 25,OOO-50,000(paste)
Density (g/ml) 0.938 (liquid) 3 0.995 5
1.01 (paste)
0.396 (powder)
pH (Oh in water) 7.3-8.5 (liquid, paste) 3 6.8 (max) 5
7.5-11 (powder)
Cloud pt ("C) 12.2 (liquid) 3 18.3 5
25 (paste)
Index of refraction 1.461 (alpha) 9
1.491 (gamma)
SolubiIity 1 g in 10 ml water 3
Soluble in: Water 3 Water 5
Methanol Methanol
Ethanol Ethanol
130 COSMETIC INCRE DIE NT REV1EW

temperature below a pH of 5. Hydrolysis also occurs when it is exposed to cold

mineral acids in the presence of iron or other heavy

Analytical Methods
Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate, both anionic surfac-
tants, are determined by the Methylene Blue Active Substances Procedure, the
azure A colorimetric method, and the two-phase titration method. Thin-layer,
paper, and gas chromatography and Infrared and Ultraviolet spectroscopy are
useful for the analysis of the lauryl sulfates.'')

Impurities ana Additives

See Table 2 for a compilation of impurities and additives, as well as concen-
trations of the supplied products.

USE
Cosmetic Uses, Frequency, and Purpose
The cosmetic product formulation computer printout which is made
available by the Food and Drug Administration (FDA) i s compiled through volun-
tary filing of such data in accordance with Title 21 part 720.4 of Code of Federal
Regulations.('*) ingredients are listed in prescribed concentration ranges under
specific product type categories. Since certain cosmetic ingredients are supplied
by the manufacturer at less than 100% concentration, the value reported by the
cosmetic formulator may not necessarily reflect the true concentration found in
the finished product; the concentration in such a case would be a fraction of that
reported to the FDA. The fact that data are submitted only within the framework
of preset concentration ranges also provides the opportunity for overestimation
of the actual concentration of an ingredient in a particular product. An entry at
the lowest end of a concentration range is considered the same as one entered at
the highest end of that range, thus introducing the possibility of a two- to 10-fold
error in the assumed ingredient concentration. Table 3 reports the 1981 FDA

TABLE 2. Ingredients, Impurities, Additives.

Sodium Lauryl Sulfate
Ammonium Lauryl
Agent Liquid Paste Powder Ref. Sulfate Ref.

Actual ingredient (Oh) 28-30 30-41 90-98 3 22-54 5

Uncombined ingredients
(%I:
(a) Unsulfated alcohol 0.55-2.3 1.8-3.0 0.2-3.5 3 3(max) 5
(b) Sulfate as sodium sulfate- 1.5 max 8 max 3 as ammonium sulfate- 5
1.5 max 3 max
(c) Chloride as sodium chloride- 1.8 max 8 max 3 as ammonium chloride- 5
0.4 max 3 max
Preservative formaldehyde- - - 15 - -
x
up to 0.1
TABLE 3. Product Formulation Data.

No. product formulations within each concentration range (%)

Total no. of Total no.
formulations containing Unreported
Product category in category ingredient concentration >50 >25-50 > 10-25 >5-10 > 1-5 >O. 1 - 1 SO. 1

Sodium Lauryl Sulfate

Baby shampoos 35 2 -
Bath oils, tablets, and salts 237 7 -
Bubble baths 475 73 3
Bath capsules 3 2 -
Other bath preparations 132 24 3
Eye makeup remover 81 2 -
Mascara 397 9 3
Sachets 119 20 20
Other fragrance preparations 191 3 -
Hair conditioners 478 6 1
Hair straighteners 64 9 1
Permanent waves 474 9 5
Hair rinses (noncoloring) 158 1 - - 1
Hair shampoos (noncoloring) 909 226 33 64 5
Tonics, dressings, and other
hair grooming aids 290 2 1 - 1
Other hair preparations
(noncoloring) 177 6 1
Hair dyes and colors (all types
requiring caution statement
and patch test) 81 1 61 12
Hair tints 15 1 -
Hair shampoos (coloring) 16 9 -
Hair bleaches 111 21 6
Other hair coloring preparations 49 5 2
Blushers (all types) 819 1 1
Makeup foundations 740 14 12
Makeup bases 831 8 7
Rouges 21 1 1 1
Cuticle softeners 32 1 1
TABLE 3. (Continued.)
No. product formulations within each concentration range I%!
Total no. of Total no.
formulations containing Unreported
Product category in category ingredient concentration >SO >25-50 > 10-25 >5-70 > 1-5 >O. 1-1 50.I

Sodium Lauryl Sulfate (cont’d.1

Other manicuring preparations 50 1 1 -
Dentifrices (aerosol, liquid,
pastes, and powders) 42 28 8 -
Mouthwashes and breath
fresheners (liquids and sprays) 53 4
Other oral hygiene products 3 2
Bath soaps and detergents 148 11
Deodorants (underarm) 239 6
Oouches 26 1
Other personal cleanliness
products 227 7 3 -
Aftershave lotions 182 2 2 -
Shaving cream (aerosol,
brushless, and lather) 114 5 1 -
Skin cleansing preparations
(cold creams, lotions, liquids,
and pads) 680 28 11 6
Depilatories 32 8 1 3
Face, body, and hand skin care
preparations (excluding
shaving preparations) 832 27 16 4
Moisturizing skin care
preparations 747 23 16 7
Night skin care preparations 219 4 2 1
Paste masks (mud packs) 171 9 - 4
Skin lighteners 44 1 - 1
Skin fresheners 260 1 1 -
Other skin care preparations 349 6 3 2
Suntan gels, creams, and liquids 164 4 3 1
Other suntan preparations 28 2 1 1
~ ~

1981 TOTALS 703 - 12 54 89 167 118 169 94

Ammonium Lauryl Sulfate
Baby shampoos 35 2 - 2
Bath oils, tablets, and salts 237 1 1 -
Bubble baths 475 19 5 13
Hair shampoos (noncoloring) 909 131 18 48
Hair shampoos (coloring) 16 2 - 2
Bath soaps and detergents 148 4 2 1
Skin cleansing preparations
(cold creams, lotions, liquids,
and pads) 680 4 1 1
Other skin care preparations 349 1 - -
1981 TOTALS 164 - - 27 67 58 10 2 -

Data from Ref. 13.

134 COSMETIC INCREDIENT REV1EW

voluntary submission of data from cosmetic manufacturers on formulations con-

taining Sodium and Ammonium Lauryl Sulfate. There were 703 different prod-
ucts using Sodium Lauryl Sulfate in concentrations of less than 0.1 o/o to greater
than 50% and 164 with Ammonium Lauryl Sulfate as an ingredient in concentra-
tions of 0.1 0/~-500/~."3)
The types of cosmetics in which the Lauryl Sulfates are used include anti-
perspirants, bubble baths, foundations, hair colorings, hand creams, and sham-
p o o ~ . (In~ these
~ ) products, they are used as detergents, wetting, foaming, and/or
emulsifying

Surfaces to which Commonly Applied

Since the surfactants Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate
are used primarily in shampoos, bath products, facial makeup, deodorants, per-
fumes, and shaving preparations, these ingredients may contact the general body
surface, hair, nails, skin of the hand and face, and mucosal

BIOLOGICAL PROP E RTI E S

Microbiological Effects
Sodium Lauryl Sulfate can have varying effects among different types of
microorganisms. Foot and mouth disease virus i s highly resistant to Sodium
Lauryl Sulfate, but TGE virus is sensitive to it. It is fungistatic to Candida and
Tricophyton spp., and concentrations of 2% and over eliminate drug resistance
and sex transfer factors in E. coli. It also inhibits the growth of many Gram
positive bacteria, but i s ineffective against Gram negative strains.('6)

Absorption and Excretion

The absorption by and subsequent damage to the intestine caused by
Sodium Lauryl Sulfate was studied using male white rabbits. A 3 cm length of
jejunum was removed from the animals and served as the control. A 15 cm por-
tion of intestine, tied at both ends by ligatures, received a 10 ml injection of 5 %
Sodium Lauryl Sulfate. After 5, 10, 15, 30, and 60 min, 3 cm segments of the in-
testine were excised and examined. It was concluded that Sodium Lauryl Sulfate
had caused generation changes of the cell membranes of the intestinal
epithelium, of intracellular organelles, and of microvilli. The tissue-damaging ef-
fect of Sodium Lauryl Sulfate was a result of its protein-denaturing properties. It is
suggested that Sodium Lauryl Sulfate can cause an abnormality in intestinal ab-
sorption becuse it causes a disturbance in enzyme activation within
Iysosomes.( l')
The effect of Sodium Lauryl Sulfate on intestinal absorption was studied in
the rat. It was found that 17 rnM of Sodium Lauryl Sulfate increases the absorp-
tion of ouabain, phenolsulphonphthalein and pralidoxime in jejunal loops of
anesthetized rats. The absorption increases were potentiated by theophylline, in-
creased by dibutyryl cyclic AMP, and reduced by imidazole. Sodium Lauryl
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 135

Sulfate caused an increase in cyclic AMP content in the rat intestinal mucosa; the
authors believe that this increased cyclic AMP level is the basis of the ingredient‘s
effect on absorption.(18)
The effect of Sodium Lauryl Sulfate on blood sugar was determined using 26
rabbits. The animals received via gavage 0.41 glkg (body weight) in a 2.5% solu-
tion 24 h after fasting. A control group received only water. The Sodium Lauryl
Sulfate solution produced a significant rise in blood glucose.(19)
The percutaneous absorption of Sodium Lauryl Sulfate through guinea pig
skins was studied in vivo. The detergent was radiolabelled with [“C] at the
a(1)-Carbon of the alkyl chain. The surfactant, in a concentration of 16.3 pCi, was
applied in 0.6 ml of water to a 22.5 cm2area of the flanks of the animals. The sam-
ple was rubbed into the skin for 10 rnin, washed with water, and then covered
with nonocclusive patches for 24 h. No radioactivity (0.0%)was found in feces,
liver, kidney, or carcass; 0.1‘10 was found in both exhaled C 0 2and urine; 50.2%
was found on the skin at the site; the patch contained 23% and the rinsings held
53.4% of the radioactivity. The investigators concluded that the presence of a
strongly anionic terminal group in the surfactant impairs its ability to penetrate
through the skin.(’O)
The in vitro penetration of [1-14C]labeled Sodium Lauryl Sulfate was studied
using rat and human epidermis. Cjipped dorsal skin was excised from rats and
immersed in a compartment containing 0.25 ml of a 25 m M [1-I4C] solution of
Sodium Lauryl Sulfate. Ten ml of saline added to the sampling compartment
against the rat dermis were monitored hourly for [1-’4C] by removing 1.O ml and
replacing with fresh saline, thereby maintaining the 10 ml volume in the sam-
pling compartment. After 24 h, the epidermis was washed and measured for the
radiolabel. From the 1.0 ml samples taken hourly, it was found that up to 24 h
after contact, no measurable penetration of Sodium Lauryl Sulfate occurred.
After 24 h, 30% of the labeled Sodium Lauryl Sulfate was recovered in the rinsing
and 70% remained associated with the skin. No controls were reported. Human
female abdominal skin was exposed to 0.1 ml of 25 m M [1-14C] Sodium Lauryl
Sulfate. Eight ml of saline added to the sampling compartment were monitored
for [1-14C]at 0.5, 1,2,3,4, 6, 7,8,24, and 48 h. The epidermal sample was washed
after 48 h. No measurable penetration of Sodium Lauryl Sulfate occurred until
24 h after application, at which time 3.9 f 3.6 pglcm’ penetrated. At 48 h,
87.2 f 24.1 pglcm2was absorbed. Swelling of the sample occurred and 75% of
the [1-14C]sample was absorbed by the epidermis after the 48 h rinsing. No con-
trols were reported.‘21) Similar low penetration results were obtained with
rats.(22)
Labeled [1-I4C] Sodium Lauryl Sulfate was applied in 0.5 ml aliquots as a
25 m M solution to 10 cm2of rat skin for 15 min. Expired’C02, urine, feces, and
excised skin was monitored for I4Cat 24 h after treatment. Autoradiography of
the skin showed heavy deposition of Sodium Lauryl Sulfate on the skin surface
and in the upper and lower regions of the hair follicles; the urine also contained
quantifiable amounts.(21)
Sodium Lauryl Sulfate sorption by neonatal stratum corneum was studied
using skin from newly.sacrificed young rats. It was found that this surfactant’s dif-
fusion through rat stratum corneum was rapid and increased with concentration,
136 COSMETIC INGREDIENT REVIEW

and the authors postulate that high absorption and diffusion of Sodium Lauryl
Sulfate are caused, in part, to structural changes in the membranes produced by
this su rfactant. (23)
Bleached and unbleached human hair was exposed to a 10% solution of
radiotagged Sodium Lauryl Sulfate. Bleached hair absorbed 8% of the compound
in 9 h, and virgin brown hair took up 1.2% during the same time. Uptake in-
creased with increasing concentration. One percent of a 0.1 percent solution of
Sodium Lauryl Sulfate was taken up by bleached hair in 8 h; during the same
time, 4.5% of a 1.0% solution was taken up, and 6.6% of a 10% solution was
ab~orbed."~)
The effect of Sodium Lauryl Sulfate on the permeability of epidermis was
studied using human abdominal epidermis and varying concentrations of the sur-
factant. One percent Sodium Lauryl Sulfate increased water permeability and
caused some damage after skin was soaked in the solution for 22 h. Increasing
the concentration of surfactant to 5% increased both the rapidity and severity of
the damage; effects were noted after 2-6 h. The mechanism of action i s believed
to be protein denaturation, membrane expansion, hole formation in the epider-
mis, and loss of waterbinding capacity.(zs)
Three female Colworth Wistar rats were injected intraperitoneally and
another three were injected subcutaneously with 3.64 mg [1-14C]Sodium Lauryl
Sulfate. Animals were sacrificed 24 h after injection. The rate and route of excre-
tion of intraperitoneally administered surfactant were identical to the sub-
cutaneously injected solution. Most of the injected 14C was recovered in the
urine at 24 h after dosing (77 f 4%); the exhaled COz contained 1.5 f 0.4%,
the feces 2.6 f 0.7%, and the carcass 15 f 3°/o.'21)

Swelling of Stratum Corneum

The effect of Sodium and Ammonium Lauryl Sulfate on swelling of the
stratum corneum was studied using Hartley guinea pig epidermis. The concentra-
tion of surfactant was 0.05 M and squares of excised skin were soaked in the solu-
tion for 16 hours. When compared with water-treated controls, Sodium Lauryl
Sulfate produced a 13.1% increase in surface area (swelling) and Ammonium
Lauryl Sulfate, a 9.1% increase. The authors concluded that the mechanism of
swelling was not denaturation caused by the detergent, but that swelling is caused
by a reversible conformation change resulting from cooperative binding of the
detergent. ( 2 6 )

Effect of Biological Membranes

The effect of Sodium Lauryl Sulfate on biological membranes was studied
using yeast cells'27)and human and dog erythrocytes.(28)The first study in-
vestigated the interaction of Sodium Lauryl Sulfate with yeast cells and its effect
on pH, ionic strength, and lipid content in the cells. It was found that the micelles
of surfactant may penetrate into the membrane through pores in the cell wall,
and that micelle-like complexes of surfactant and proteins can destroy the mem-
brane.'") The second study investigated the lytic action of surfactants, including
Sodium Lauryl Sulfate, on erythrocyte membranes. It was concluded that the ef-
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 137

fect of the surfactant depends upon its structure and charge, as well as on the
components of the target cellular membrane.(z8)

Miscellaneous Skin Effects

Powdered human callus was used to study Sodium Lauryl Sulfate-induced
liberation of sulphydryl groups from keratin. Powdered callus was exposed to
water (control) and 1.0% and 10.0% Sodium Lauryl Sulfate. When compared
with the control, the 1 concentration produced no increase in the percent of
sulphydryl groups liberated from the callus; however, the 10% concentration
yielded a 78.9% increase in liberated sulphydryl groups. It was concluded that
the anionic terminal portion of the surfactant is the principal cause of the release
of sulphydryl groups. This release is a measure of protein unfolding during
keratin denaturation. ('O)
In a similar study, isolated human heel keratin was incubated in O%, 0.05%,
0.5%, and 5.0% Sodium Lauryl Sulfate solution at 37OC for 20 and 120 min.
Large amounts of solubilized protein and sulphydryl groups were liberated from
the keratin, and similar amounts of detergent were absorbed onto the keratin.
Treatment of keratin with 5% detergent for 20 min decreased its hygroscopicity.(29)
The extraction of soluble proteins and amino acids by Sodium Lauryl Sulfate
was studied in vivo using guinea pig stratum corneum. The left dorsal flank of the
animal was washed with 20 ml water (control), and the right flank was washed
with 20 ml of 25 m M Sodium Lauryl Sulfate. Both wash liquors were assayed for
soluble proteins and amino acids. The detergent solution eluted 75% more solu-
ble proteins and amino acids than did water.(20)
Sodium Lauryl Sulfate-mediated histamine release from mast cells was
studied in vitro using rat peritoneum. When the peritoneal mast cells came in
contact with Sodium Lauryl Sulfate at concentrations starting at 0.03 mM, up to
85% of stored histamine was r e l e a ~ e d . ( ~ ~ . ~ ~ )

Animal Toxicology

Acute
Oral
The acute oral toxicity of Sodium and Ammonium Lauryl Sulfate was studied
using rats and monkeys. The tests are detailed below and summarized in Table 4.
Unfasted female Wistar rats were intubated with doses of 10% Sodium Lauryl
Sulfate. Groups of five animals each were fed doses ranging in geometric progres-
sion from 0.252 to 7.95 g/kg. Mortality was established over a two-week post-
feeding period, and LD50 values were calculated by the Weil modification of the
Thompson method.(4')The LD50 was calculated to be 0.8-1.1 glkg and by the
criteria of Hodge and Sterner, it is moderately toxic.'31)
Sodium Lauryl Sulfate, 28.2% concentration, was tested for acute oral toxicity
in five groups of Sprague-Dawley rats (5M, 5F). Each group received 4.5, 5.5, 6.0,
6.5, or 7.5 ml/kg (or 4.2, 5.2, 5.6, 6.1, or 7.0 g/kg) of the ingredient in a single in-
gastric dose, and the animals were observed for 14 days. The LD50 was found to
be 6.0 g/kg with pulmonary hemorrhage as the major cause of death found at
necropsy. (32)
TABLE 4. Acute Oral Toxicity.
Ingredient Species, sex,
Conc. Diluted or no. of Observation No.
(%) to I%) formulation Dose/kg animals time (days) Route Vehide dead LD50//@ Comment Ref.

Sodium Lauryl Sulfate

10 - ingredient 0.252 g Groups of 14 intubation - - 0.8-1.1 8 - 31
to 5F Wistar
7.95 g Rats
28.2 - ingredient 4.5 to 5M, 5F 14 intubation - - 6.3 ml 95% confidence limits- 32
7.5 mi Sprague- Upper-7.0 mllkg
or 4.2 to Dawley rats Lower-5.6 ml/kg
7.0 g/kg per dose
86 25w/v ingredient l SM, 5F Car- 10 intubation distilled - 1290 mg No toxic signs; no gross or 33
worth Farm water microscopic lesions.
E rats
- - ingredient 529 mg Rats - - - - - Diarrhea and death 34
to
925 mg
- - ingredient - Rats - - 1650 mg Diuresis, diarrhea, lacrimation, 35
salivation, tremors, convul-
sions, sedation, anesthesia,
death. Dead rats showed
hyperemia of liver and
kidneys.
............................................................................................................................
21 - formulation 2.15 g 5/F Albino 7 intubation none No deaths at 2.15 glkg dosage 36
rats per group. All 5 rats died within
group 3.10g 24 hours in 5.0 g/kg group.
5.0 g 5/F Albino 7 intubation none No gross lesions.
rats per
group
21 - formulation 2.15 g 5/F Albino 7 intubation none Low-dose group showed 37

5.0 g
rats per
group
5/F Albino 7 intubation none
f
5
2’71
depression for 24 hours. All
animals died in high-dose
group, but no gross lesions
rats per were observed.
PUP J
Ammonium Lauryl Sulfate
27.4 - ingredient 3.0 to 5M, 5F 14 oral in- - - 4.7 ml Cause of death:pulmonary 38
5.5 ml Sprague- tubation hemorrhage
or 3.0 Dawley rats
to 5.5 per dose
dke ____________________------------------------------------
_______________-------
____________________--------------------------
15 - formulation 6.81 ml 5M, 5F 14 oral in- - Depression, labored breathing. 39
Albino rats tu bation
15 - formulation 10.0 ml 5M, 5F 14 oral in- - 8-9 ml Depression, labored respiration, VI
Albino rats tubation ataxia, ptosis, depressed E
reflexes, diarrhea. 4 died.
15 - formulation 1.0 ml 3F rhesus
monkeys
14 oral in-
tubation
-
7 One had emesis 40 3
m
>
15 - formulation 5.0 ml 3F rhesus 14 oral in- - 3 had emesis z
monkeys tubation 0
15 - formulation 10.0 ml 3F rhesus 14 oral in- - > 10 ml One animal died; prior to
monkeys tubation death it had emesis and
diarrhea; One other animal
had emesis. No abnormal
pathology.

aAcuteOral Toxicity (Prob. lethal dose to humans)

1. >15g/kg Practically nontoxic
2. 5-15 Slightly toxic
3. 0.5-5 Moderately toxic
4. 50-500 mglkg Very toxic
5. 5-50 Extremely toxic
6. < 5 Super toxic .
140 COSMETIC INGREDIENT REVIEW

Sodium Lauryl Sulfate (86% active material) was administered to groups of

five male and five female Carworth Farm E strain rats to test its acute oral toxicity.
The compound was diluted with distilled water to 25% wlv and was given in a
single dose by ingastric intubation. During the 10-day observation period follow-
ing dosing, no abnormal symptoms appeared in the rats, nor were there any
gross or microscopic changes. The acute oral LD50, with 95% confidence limits,
was found to be 1290 mglkg.(33)
Sodium Lauryl Sulfate administered orally to rats in doses of 529-925 mglkg
produced diarrhea and death.(34)
The acute oral LD50 to rats of Sodium Lauryl Sulfate was found to be
1650 mg/kg. Signs of intoxication included: diuresis, diarrhea, lacrimation, saliva-
tion, tremors, convulsions, sedation, anesthesia, and death. Dead rats had
hyperemia of the liver and kidneys.‘”)
Two formulations, each containing 70% of a 30% solution of Sodium Lauryl
Sulfate (actual concentration was 21 %) were tested for acute oral toxicity in
groups of five female albino rats. Each formulation was administered by intuba-
tion in doses of 2.15 and 5.0 glkg. One formulation produced no deaths or
abnormalities at the 2.1 5 glkg dose; however, all animals given the higher dose
died within 24 h. The acute oral LD50 for the formulation was calculated to be
3.10 glkg.(36)The second formulation caused depression in the low-dose group,
but no deaths occurred. All animals administered the 5.0 glkg dose died, but
there was no observable gross lesions at necropsy. The acute oral LD50 was
calculated to be 2.71 g/kg.(37)
A solution of the ingredient containing 27.4% Ammonium Lauryl Sulfate was
tested on five groups of 10 male and female Sprague-Dawley rats. Dosage levels
were 3.0, 4.0, 4.5, 4.75, and 5.0 rnllkg (or 3.0, 4.0, 4.5, 4.73, and 5.0 glkg); the
number of animals that died in each dosage level were 0, 1, 5, 4, and 10, respec-
tively. The LD50 for the test material was 4.7 mllkg. Pulmonary hemorrhage was
the cause of death.(3B)
A shampoo formulation containing 15% Ammonium Lauryl Sulfate was ad-
ministered in 6.81 and 10 mllkg doses to five albino rats per dosage level. No
animals died in the low-dosage group, but four of the five in the high-dose group
died within two days. Signs of toxicity occurred within 4 h of intubation. Rats in
both groups had signs of depression and ataxia, but those in the high dosage
group also suffered ptosis, ataxia, depressed righting and placement reflexes,
weight loss, excessive urination and diarrhea. The single survivor at the 10 glkg
level recovered within 8 days. Necropsy findings in animals dying during the
study were congested lungs, kidneys, livers, and adrenals; blanching of gastric
mucosa and/or inflammation of the tract. At necropsy, sacrificed animals had
lesions, hyperplasia of the gastric mucosa, and adhesions between the stomach,
spleen, liver, diaphragm and rib cage. The LD50 for the formulation was 8-9
mIlkg. ( j 9 )
Three groups of three female rhesus monkeys were used to test the acute oral
toxicity of a shampoo containing 15 percent Ammonium Lauryl Sulfate. After an
8 h fast, the animals in each group were given either 1 .O, 5.0, or 10.0 mllkg and
were observed for 14 days. One of three monkeys at the 1.O mllkg level and all
three at the 5.0 mllkg level showed emesis 2 h after administration; no deaths oc-
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAWRYL SULFATE 141

curred. The 10 mllkg dose caused one death 8-1 6 h after dosing. This animal had
emesis and severe diarrhea, and one other animal had emesis. Gross and
histopathologic examinations of the GI tract, esophagus, liver, kidney, and
spleen were negative. The LD50 of the shampoo was greater than 10 ml/kg.(40)

Ocular
The following studies are outlined in Table 5.
The ocular irritancy potential of Sodium and Ammonium Lauryl Sulfate was
tested according to the Draize method. Concentrations of 2%, l o % , and 20%
each were instilled in 0.1 ml volumes into the left eye of five rabbits. The right
eyes were used as untreated controls. Draize scores were used to assess irritation
at 1, 24, 48, and 72 h, and four and seven days. The average eye irritancy scores
of Sodium Lauryl Sulfate were as follows: at 2%, the compound was mildly ir-
ritating (Draize score = 21) at 1 h and decreased to practically nonirritating dur-
ing the seven-day observation; at l o % , the compound was moderately irritating
at 1-24 h, decreasing to mildly irritating at seven days; at a 20% concentration,
the compound was severely irritating at 2 4 h, decreasing to mildly irritating after
seven days. Ammonium Lauryl Sulfate at 2% was mildly irritating, decreasing to
practically nonirritating at seven days; at 70% and 20%, the compound was
severely irritating at 24 h, and mildly irritating thereafter.(42)
The ocular toxicity of Sodium Lauryl Sulfate was tested on three rabbits per
concentration studied (25'10, 5%, and 1 O/O aqueous solutions). The eyes were ex-
amined for existing corneal damage 24 h prior to treatment with a 5% solution of
fluorescein disodium salt. Two drops of test solution were applied to each eye
and within 30 sec, one eye was washed with flowing tap water for 2 min; the
other eye was left unwashed. Both eyes were observed for immediate effects and
then after 1, 24, and 48 h, and one week for conjunctival and corneal injury,
iritis, and lenticular damage. Both the irrigated and unwashed eyes showed: at
1 %, very slight conjunctivitis; at 5% and 10%there was slight to moderate cor-
neal injury.(31)
The method of Draize and Kelley was used to study the acute ocular toxicity
of Ammonium Lauryl Sulfate in concentrations of 1.25%, 2.5%, 5%, lo%, and
20%. Three albino rabbit eyes per concentration were used for the procedure,
For each concentration, one eye was unwashed, one eye was irrigated 2 sec after
instillation of 20 ml of 37OC distilled water, and the eye of the third rabbit was
rinsed 4 sec after instillation. One untreated eye which served as a control was
rinsed with water. Observations were made 1 h and 1 , 2 , 3,4, and 7 days after ap-
plication and standard Draize scores were used for evaluation. The 1.25% and
2.5% concentrations were moderately irritating to minimally irritating when not
rinsed; rinsing decreased irritation in all cases. Moderate to severe irritation oc-
curred in the 5%-2O0/o concentrations. Irritation decreased with rinsing and over
the seven days of
Sodium Lauryl Sulfate was tested in 10%and 100%concentrations on rabbit
eyes. When not rinsed, the 10%concentration caused corneal opacity, stippling,
and red and swollen conjunctiva in all three animals at 2 4 h; one animal had cor-
neal stippling. The eyes of three animals were instilled with 100% Sodium Lauryl
Sulfate, followed by a rinse after 4 sec. Corneal opacity and vacularization was
TABLE 5. Ocular Irritation.

No. of
Conc. Dose Solution/ Albino Observation
f %) (mlJ Formulation rabbits days Commenta Ref.

Sodium Lauryl Sulfate

2 0.1 Solution 5 7 Draize criteria; day 1 -mild irritation. At 7 days- 42
practically nonirritating.
10 0.1 Solution S 7 One to 24 h-moderately irritating. At 7 days-mildly
irritating.
20 0.1 Solution 5 7 At 24-h-severely irritating. At 7 days-mildly irritating.
1 - Solution 3 7 One eye washed 30 sec after instillation. Both washed 31
and unwashed eyes showed very slight conjunctivitis.
5 - Solution 3 7 One eye washed 30 sec after instillation. Both washed
and unwashed eyes showed slight to moderate
corneal injury.
25 - Solution 3 7 One eye washed 30 sec after instillation. Both washed
and unwashed eyes showed slight to moderate
corneal injury.
10 - Solution 35 No rinse. Corneal opacity, iritis, red, swollen, conjunctiva 43
in all three to 24 hours, only. Corneal strippling.
100 - - 35 Rinse. Corneal opacity, vacuolization, iritis, and red,
swollen conjunctiva in all 3 to 24 h.
100 - - 35 No rinse. Corneal opacity, vacuolization, iritis, red, and
swollen conjunctiva in all three.
28.2 0.1 Solution 9 14 Three animals’ eyes were irrigated after 30 sec. Draize 44
criteria. Unwashed eyes scored 35.6; moderate eye
irritation. Washed eyes scored 40.6; moderately irritating.
30 0.1 Solution 6 7 Draize criteria; No rinse; Day 1 score = 10; Day 2 = 0. 45
Minimal irritation when rinsed.
Rinse; Day 1 score = 5; Day 7 = 0.
30 0.1 Solution 6 7 Draize criteria; No rinse; Day 1 score = 32; Day 7
score = 5. 46
Rinse; Day 1 score = 30; Day 7 score = 11; Moderate
irritant when followed by a rinse.
30 0.1 Solution 6 7 Draize criteria. No rinse; Day 1 = 26; Day 7 = 0. 47
Rinse; Day 1 = 18 and 26; Day 7 = 0, and 0. Mild
irritant.

5.1 0.1 Formulation 6 7 Draize criteria. Day 1 score = 18; Day 4 score = 0. 48
Mild irritation.
21 0.1 Formulation 6 7 Draize criteria. No rinse. Day 1 score = 31, Day 7
score = 35. 49
Severe irritant
Rinse; Day 1 score = 0; Day 2 score = 5; Day 7 score = 0;
Mild irritant.
21 0.1 Formulation Draize criteria. No rinse; Day 1 score = 33. Day 7
score = 15. 50
Moderately irritating.
Rinse: Day 1 score = 7; Day 3 = 0. Minimally irritating.
26 0.1 S hampoo Draize criteria. Rinsed eyes-Day 1 score = 13; 51
formulation Day 7 score = 1; Mild irritant.
TABLE 5. (Continued.)
~ ~ - ~~ ~

No. of
Conc. Dose solution/ Albino Observation
I%) (ml) Formulation rabbits days Comment’ Ref.
Ammonium Lauryl Sulfate
2 0.1 Solution 5 7 Day 1 -mildly irritating. At 7 days-practically nonirritating. 42
10 0.1 Solution 5 7 Day 1 -severely irritating. At 7 days-mildly irritating.
20 0.1 Solution 5 7 Day 1 -severely irritating. At 7 days-mildly irritating.
1.25 0.1 Solution 3 7 Method of Draize and Kelley. Standard Draize scores. One 52
eye in each concentration level was unwashed; one eye
wa5 washed 2 sec after instillation and the 3rd washed
after 4 sec.
2.5 0.1 Solution 3 7 1.25 and 2.5% concentrations are minimally to moderately
irritating with no rinse. Rinsing decreased irritation i n all
cases.
5.0 0.1 Solution Moderate to severe irritation in unwashed eyes. Rinsing
decreased over the seven days.
10 0.1 Solution Moderate to severe irritation in unwashed eyes. Rinsing
decreased over the seven days.
20 0.1 Solution Moderate to severe irritation in unwashed eyes. Rinsing
decreased over the seven days.
27.4 0.1 Solution Draize criteria. Rinsed eyes (3 rabbits). Average Day 1 score 53
= 30.7. Moderately irritating. Unwashed eyes- Average
Day 1 score = 36.0. Moderately irritating.
 8
________________________________________--------------------------------------------__---------------_----------------
8.4 0.1 Formulation 9 14
P
Draize criteria. 6 eyes unwashed (N);3 eyes washed (W). 54 C
Both groups had slight conjunctival irritation at 24 h %
(score = 2.ON, 0.67W) and disappeared thereafter. 6
9.8 0.1 Formulation 9 14 Draize criteria. 6 eyes unwashed (N);3 eyes washed (W). 55 C
Slight conjunctival irritation occurred in unwashed eyes at s
24 hrs (score = 1 ,O). No irritation in washed eyes. s
v,
11.2 0.1 Formulation 9 14 Draize criteria. 6 eyes unwashed (N).3 eyes washed (W). 56
Slight conjunctival irritation occurred in unwashed eyes z5
for 48 hrs (score = 0.7) and in washed eyes for 24 h
(score = 0.7) ;;1
11.2 0.1 Formulation 9 14 Draize criteria. 6 eyes unwashed (N).3 eyes washed (W). 57 >
Slight conjunctival irritation occurred in unwashed eyes Z
U
for 48 h (score = 0.3).No irritation occurred in washed
eyes.
15 0.1 Shampoo 10 7 Draize criteria. Rinsed eyes. Day 1 score = 15; Day 7 score 58
formulation = 1; Mild, transient irritation.
Unrinsed eyes; Day 1 score = 34, Day 7 score = 6;
si-
C
Moderate, transient irritation. 3
15 0.1 Sha mpoo 10 7 Rinsed eyes (4 sec). No irritation. One monkey with eyes 59
formulation Monkeys washed after 15 sec showed moderate irritation. 5
C
Unrinsed eyes. Moderate irritation to seven days. ;D

aDraize scoring criteria; scale ranges from 0 (no irritation) to 110 (extreme irritation).
s
v)

E
5
2
146 COSMETIC INGREDIENT REVIEW

seen in all three animals, as well as iritis and swollen and red conjunctiva at 24 h.
The unwashed eyes of three animals instilled with 100% detergent showed cor-
neal opacity (present in one animal to Day 35), corneal vacularizatidn, iritis, and
red and swollen conjunctivae in all animals.(43)
Solutions of the ingredient Sodium Lauryl Sulfate in concentrations of 28.2%
and 30% were tested with and without rinse, using albino rabbits. Mild to
moderate ocular irritation occurred in all eyes. In some cases, rinses mitigated
the effects of the detergent. See Table 5 for test r e ~ u l t s . ( ~ ~ - ~ ' )
Sodium Lauryl Sulfate was tested in formulation according to the Draize
method. One product contained 68% of the ingredient which was supplied as a
30% solution. When the shampoo was diluted to 25% in water, the actual ingre-
dient concentration was 5.1 %. It was a mild irritant to the eyes of the six rabbits
tested, and all irritation disappeared by Day 4.(48'
Two products were tested according to the Draize method on albino rabbits.
The final test dilution of the Sodium Lauryl Sulfate therein was 21 O/O in both for-
mulations. According to the Draize scores, one formulation was a Severe irritant
to Day 7 when not rinsed, and a mild irritant following the rinse;(49)the second
product was moderately irritating with no rinse and minimally irritating following
.the rinse.(so)
One product containing 26% Sodium Lauryl Sulfate was tested in five rabbits
according to the Draize method, except that all eyes were rinsed after 4 sec.
Mild irritation was produced on Day 1; irritation decreased to Day 7. The for-
mulation was a mild irritant.(51)
The ingredient, Ammonium Lauryl Sulfate (active concentration 27.4%), was
tested according to the Draize method on nine albino rabbits. The eyes of three
rabbits were washed after 4 sec while the remaining six were unwashed. The
washed eyes had an average Draize score of 30.7 on Day 1, and the unwashed
eyes had an average score of 36.0 in the same time period. Eyes were moderately
irritated by both procedures.(53)
Modified Draize eye irritation studies were performed on four products con-
taining 30%, %%, and 40% (two products) Ammonium Lauryl Sulfate. The
detergent was supplied to the manufacturer as a 28% solution so that the actual
concentration of Ammonium Lauryl Sulfate in the products was 8.4%, 9.8%, and
11.2%, respectively. In all tests, 0.1 ml of each product was instilled into one eye
of each in four groups of nine rabbits. The eye of six rabbits in each group were
left unwashed, while washings were performed on the eyes of the remaining
groups of three rabbits. Observations were made at 24, 48, and 72 h, and seven
and 14 days. The product containing 8.4% detergent produced slight irritation in
both unwashed eyes (score = 2.0) and washed eyes (score = 0.67) at 24 h. The
irritation disappeared thereafter.'54)The product containing 9.8% Ammonium
Lauryl Sulfate caused slight conjunctival irritation in unwashed eyes for 24 h
(score = 1.0) but no irritation in washed eyes.(55)Slight conjunctival irritation
(score = 0.7) occurred for 48 h in unwashed eyes from one product containing
11.2% Ammonium Lauryl Sulfate. Washed eyes suffered slight conjunctival irrita-
tion (score = 0.7) for 24 h.(56)Similar low levels of conjunctival irritation (score
0.3) occurred in the unwashed eyes instilled with the final product containing
11.2% detergent. No irritation occurred in washed eyes."')
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 147

Two formulations, both containing 15% Ammonium Lauryl Sulfate, were

tested for eye irritation. One study used 10 albino rabbits in a Draize test. Un-
washed eyes showed mild, transient irritation, while washed eyes showed
moderate, transient irritation.(”) The second formulation was tested according to
Draize protocol on 70 cynomulgous monkeys. All animals received i n one eye
0.1 ml of the shampoo. Four eyes were rinsed after 4 sec, one after 15 sec (inad-
vertently), and the remaining five were unwashed. Eyes rinsed after 4 sec showed
no irritation, while the one rinsed after 15 sec and those eyes left unwashed
showed moderate irritation to seven
The studies show that irritation increases with increasing ingredient concen-
tration.
The acute ocular irritancy of Sodium and Ammonium Lauryl Sulfate was
assessed using the blepharospasm test.(42) The surfactants were instilled in a 0.1 ml
volume into the eyes of 10 rabbits. The onset time of each blepharospasm (spas-
modic blink) was recorded during the 30 sec after the initial reflex blink. Positive
responses were graded according to the number and rate of complete bleph-
arospasms as follows: 100% response = 3 complete blinks; 50% response = 2
complete blinks; 25% response = 1 blink. The response rate for a particular con-
centration is obtained by multiplying the number of eyes responding by the
percent response and dividing by the number of eyes tested. BD50 values, con-
centration at which 50% of the test animals elicit a 100% response, were also
determined. No controls were reported. Results are shown in Table 6.
New Zealand white rabbits were used to study the acute ocular toxicity and
maximum delay time for irrigation of Sodium Lauryl Sulfate. A 10% w/v aqueous
solution of the compound in a 0.1 ml volume was instilled into one eye of each
rabbit. The other eye served as the control. The eyes of 11 rabbits were not ir-
rigated and served as the positive control. In the other rabbits irrigation was per-
formed at 4, 10, 20, 30, 60, or 120 sec after surfactant instillation with either 20 or
100 mi of 37OC water. The eyes were examined 1 and 4 h after instillation and
after 1, 2, 3,4, 7, 14/21, 28, and 35 days, or until the reaction disappeared. Scor-
ing was according to 16 CFR 1500.42, and results are tabulated in Table 7.
Where irrigation was delayed for 20 sec or longer, corneal opacity or dulling

TABLE 6. Blepharospasrn Test Results.

Percent conc. Response
Surfactant ( x 10-3 Rate BD50 (95% conf. limits)

Sodium Lauryl Sulfate 1.5 0.4 4.6 X 10-‘(1 X loe6- 2.1 X 10”)
3.8 0.4
7.5 0.625
12.8 0.6
Ammonium Lauryl Sulfate 1.5 0.325 4.1 X 10-6(2 X 10-‘-8 X 107
4.5 0.50
9.0 0.575
16.5 0.825
27.0 0.925
~~

Data from Ref. 42.

148 COSMETIC INGREDIENT REVIEW

TABLE 7. Acute Ocular Toxicity and Effect of Irrigation of

10% Sodium Lauryl Sulfate.
Number of rabbits showing corneal damage

Delay time before irrigation of eye (sec)

Effects 4 10 20 30 60 120 N o irrig.
~~

N o opacity 7 4 - - - - -
Lack of luster 4 8 5 7 5 4 2
Opacity grade 1 - 1 3 2 5 4 0
2 - - - 1 - - 1
3 - - - 1 - - -
Total no. eyes treated 11 13 0 11 10 8 11

Data from Ref. 60.

of the surface occurred in every eye. Reactions of eyes of animals exposed to the
surfactant for 20 or 30 sec before wash were similar to those observed in animals
subjected to a 120 sec irrigation delay, and only slightly better than eyes receiv-
ing no irrigation at all. Eyes irrigated before 20 sec showed fewer instances of
damage, and where irritation was evident, it was less severe and less persistent.
When irrigation occurred before 10 sec, only one of 24 animals showed corneal
opacity. A 4 sec exposure to Sodium Lauryl Sulfate elicited no opacities, but did
dull corneal luster in four animals. The critical exposure time before damage is
produced in the rabbit eye by this surfactant is between four and 10 sec.[sOl
inhalation
The potential of Sodium and Ammonium Lauryl Sulfate to produce upper
respiratory tract irritation was studied using Swiss strain albino mice. Eight to
12 mice were used for each of six surfactant concentrations in air. The surfactants
were aerosolized into a 1 L inhalation chamber. Animal responses were deter-
mined at various atmospheric concentrations. The mice were exposed to each
concentration for two minutes and recovery was monitored for up to 20 min. The
average respiratory rate was determined for each animal as a control and the per-
cent change from this control rate was determined for each concentration as
peak inhibition. The RD50 value, the chamber concentration at which there was
a 50% reduction in respiratory rate, was determined for each compound. The
RD50s for Sodium and Ammonium Lauryl Sulfate are 88 pg/l (3.67-259.1 pg/l
confidence limit) and 114.5 pgll (59.3 to 213.9 pg/l confidence limits), respec-
'
ti vely . 4 2 )
The irritancy of Sodium and Ammonium Lauryl Sulfate on the upper respira-
tory tract was studied using mice and rabbits. Irritation of the respiratory tract
produces a reflex inhibition of respiration; therefore, the amount of inhibition
was taken as a measurement of irritation. The animals were exposed to aerosolized
15% and 25% aqueous solution of the surfactants for 2-5 min by the head ex-
posure method. Four to eight animals were used per exposure level of 130, 175,
or 73 pgll air. The aerosolized particles were less than 12.5 pm in diameter. The
rabbits, at all exposure levels, suffered a 50%-60% inhibition of respiration with
Sodium and Ammonium Lauryl Sulfates. Mice exposed to both surfactants, at a
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM MURYL SULFATE 149

concentration of 73 pgll, showed a 35%-40% inhibition. At 130 pg/l, the inhibi-

tion for both surfactants was 2%-35%, and for 170 pgA, 55°/~-650/0.(6')
lntraperitoneal injection
The mouse writhing test was used to assess the irritancy potential of Sodium
and Ammonium Lauryl Sulfate. Both test surfactants were administered IP to 10
animals at each concentration of 0.063%, 0.125%, 0.250%, and 1.0% in a 0.2 mi
volume. After injection, the mice were observed for a positive response up to
5 min. Positive responses of classical writhing included: contraction of abdomen
with extension of fore and hind limbs, preening at injection site, listlessness, high
stepping gait, ataxia, and running with arched back. Untreated animals served as
controls, WD50 values (concentrations at which 50% of the animals elicited a
response) were calculated. Both Sodium and Ammonium Lauryl Sulfate pro-
duced writhing in 30% of the mice at the 0.063% concentration, in 70% at the
0.125% concentration, and in 100% at the 0.250% and 1.O% concentrations,
W D50 concentration values for both surfactants are 0.086 percent with 0.06%-
0.12% confidence limits.(42)
An intraperitoneal LD50 to rats, reported by Woodard and Calvery,(62)was
given as 210 mglkg.
Skin irritation
The effect of Sodium Lauryl Sulfate on rat skin was studied both grossly and
microscopically. Six eight-week old female ColworthlWistar rats were shaved
free of fur on the dorsal region. This shaved area was wetted twice daily for three
days with a 1% aqueous Sodium Lauryl Sulfate solution and a solution of 0.5%
sodium sulfate was applied to three other rats as a control. A small piece of skin
from the treated area was excised for ultrastructural study. After the three days of
treatment, the treated areas showed signs of coarsening, reddening, and edema,
Electronmicroscopy showed the following epidermal changes: deposition of
lipids in mast cells, spongiosis and vesiculation, partial detachment of basal cells
from basal lamina, condensation of tonafibrils within cells of the stratum basale
and stratum spinosum, protein deposition between the deeper epidermal cells,
and thickening of the epidermis and stratum corneum. There was a reduction in
the number of keratohyalin granules and some parakeratosis and incomplete
keratinization.'")
The irritancy of Sodium Lauryl Sulfate was tested on rat skin in vivo. The sur-
factant was applied to the shaved dorsal skin of weanling rats as a 0.25 M solution
(between 5% and 10%solutions by weight). The solution was applied twice daily
for three consecutive days. After one and three days, the irritation was assessed,
Inspection of the treated site after Day 1 showed no changes in the skin when
compared to the water-treated controls. After three days, however, Sodium
Lauryl Sulfate caused thickening of the epidermis with scaling and cracking of the
stratum corneum.(20)
Sodium Lauryl Sulfate was applied to two groups of eight-week-old female
TFI mice. Their hair was in telogen and was clipped from the back, A 0.5 ml
volume of reagent was applied to a 2 cm2area of clipped skin. The first group of
15 animals received a single application of surfactant as a 10%w/v concentration
in distilled water and controls were treated with distilled water. Tissue samples
150 COSMETIC INGREDIENT REVIEW

were taken from treated animals at 30, 60, and 120 min after treatment. The ex-
posed areas showed slight thickening and erythema 1.5-2 h after treatment. Thirty
minutes after treatment, 30%-40% of the squamous cells of the epidermis ex-
hibited an intracellular vacuolation or edema. After 1 h, 80%-90% of the cells of
the epidermis displayed this anomaly; however, the stratum corneum was nor-
mal despite these epidermal changes. After 2 h, there occurred cellular
degeneration and necrosis, edema, leucocyte infiltration and some engorgement
of the more superficial blood vessels. The 15 mice in the second group were ex-
posed to repeated applications of the surfactant daily for 2, 5, or 9 days. Concen-
trations of the surfactant were 1O/O or 2.5% wlv in distilled water. The mice were
sacrificed 24 h after the last treatment and tissue samples were taken at that time.
Treatment with 1O/O percent Sodium Lauryl Sulfate caused erythema after 8-9 ap-
plications. With application of 2.5%, minimal epidermal changes were seen after
two days. After five days, the epidermal changes were more pronounced. The
stratum corneum spinosium were thickened and focal intracellular edema oc-
curred. Widespread edema and capillary engorgement occurred in the dermis.
Similar, but less intense reactions occurred at this stage in skin exposed to 1 %
Sodium Lauryl Sulfate. With both 1O/O and 2.5% solutions, there occurred further
thickening of the stratum corneum, nuclear debris in the keratin layer, and an in-
crease in the number of epidermal cells exhibiting intracellular edema. Approx-
imately 80% of the cells were affected and there appeared numerous foci of
cellular degeneration and necrosis.(64)
The acute skin irritation of Sodium Lauryl Sulfate was studied using the shaved,
intact and abraded bellies of rabbits. Aqueous dilutions of 1%, 5%, and 25%
were applied in 5 ml volumes. Ten such samples were applied to cotton pads and
held by bandages over a period of 14 days to the intact skin and three applica-
tions were made to the abraded areas. A small amount of material was likewise
applied to the ear. Applications were discontinued in the event of substantial
burn or eschar formation. Skin reactions were recorded after each application
and at intervals up to three weeks from the beginning of the study. The results
show that when applied to the belly, a 1% solution of Sodium Lauryl Sulfate
caused very slight to slight erythema; a 5% solution caused moderate chemical
burns, and a 25% solution caused severe chemical burns. When applied to the
ear, the 1o/o and 5 % solution caused very slight erythema; a 25% solution caused
severe chemical burns.(”)
Groups of four New Zealand rabbits were used to study the irritancy of
Sodium Lauryl Sulfate. The hair on four areas of the dorsal surface of each rabbit
was clipped and two of these areas were scarified. The rabbits received Sodium
Lauryl Sulfate on one test site, two other test surfactants on two other sites, and
water on the last site (control). The areas of application were rotated so each sur-
factant occupied a different area on each rabbit. A 10% wlv concentration of
Sodium Lauryl Sulfate in water, in a 0.5 ml volume, was applied under occlusion
for 24 h. The patches were removed and graded according to the Draize method
30 min later, and a second set of readings was made 48 h later. This procedure
was repeated three times. The average Draize score (Primary Irritation Index [PII])
for the three repeat applications of the surfactant was 1.48 out of a possible 8. A
PI1 of 2 or less i s considered mildly irritating.(65)
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 151

The standard Draize skin irritancy test procedure was used to assess the ef-
fect of Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate on rabbit skin. The
surfactants, tested at 2%, lo%, and 20% concentrations, were applied to the sites
and covered for 24 h. Readings were taken at 24 and 72 h, and scored according
to the Draize method. The 2% concentrations of Sodium Lauryl Sulfate and Am-
monium Lauryl Sulfate gave scores of 5.2 and 5.3, respectively. Scores of this
magnitude show that the surfactants are primary irritants and are highly
dangerous. The 10% concentrations for Sodium Lauryl Sulfate and Ammonium
Lauryl Sulfate scored 6.0 and 5.9, respectively. The 20% concentrations scored
6.0 and 6.0, respectively. Both of these surfactants in the 10% and 20% concen-
trations, like the 2% concentration, are primary skin irritants.(42)
A 10% solution of Sodium Lauryl Sulfate was tested according to the Modi-
fied Draize method on a scoring scale of 0-4. A 0.1 m l volume was applied
under occlusion to the intact and abraded skin of nine albino rabbits for 24 h.
The ingredient was severely irritating when sites were evaluated 2 and 24 h after
application. The Primary Skin Irritation (PSI) score was 3.91 out of 4.0.(66’
Sodium Lauryl Sulfate, in a 28.2% concentration, was tested in a Department
of Transportation (D.O.T.) skin corrosion test and in a Draize primary skin irrita-
tion test. In the D.O.T. test, 0.1 ml of the substance was applied to intact skin of
six New Zealand albino rabbits for 4 h and then washed off. Corrosion readings
were made at 4 and 48 h after exposure. The 4 h reading was negative but the
48 h reading showed that the material was a corrosive agent. Corrosion was con-
sidered to have occurred if the substance caused destruction or irreversible tissue
alterati~n.‘~’) This same substance was tested according to the Draize method on
the intact and abraded skin of six albino rabbits. A 0.5 ml volume of the material
was applied under occlusion for 24 h, and scores were graded on the Draize
scale of 0-8. The patches were then removed, sites were washed and then
evaluated 24 and 72 h after exposure. In intact and abraded skin at 24 and 72 h,
there occurred erythema and eschar. Edema occurred in intact skin at 24 h and
in abraded skin at 24 and 72 h. The ingredient was a moderate primary irritant
with a score of 4.54 out of 8.0.(68)
A 30% and a 100% concentration of Sodium Lauryl Sulfate were both tested
in a Modified Draize test as above, with a scoring scale of 0-4. When applied to
the nine albino rabbits, the 30% solution produced severe irritation. The PSI was
4.0.(69’The 100% solution produced a PSI of 2.96; the animals suffered moderate
irritation .( ’O)
The Draize method was used to test the skin irritation of a shampoo contain-
ing 26% Sodium Lauryl Sulfate. The formulation was diluted so that the actual
concentration of the ingredient was 0.65%. When applied to six albino rabbits,
the compound produced mild irritation.(”)
Ammonium Lauryl Sulfate, i n a concentration of 27.4%, was tested in both
the D.O.T. and Draize Method tests, as above. In the D.O.T. test, Ammonium
Lauryl Sulfate produced no corrosion at 4 h, but it was corrosive to the rabbits’
skin when observed at 48 h.(’*) In the Draize test, the ingredient produced a PI1
of 4.71; this indicates moderate primary. irritation to the abraded and intact
skin .( 73)
A shampoo containing 15% Ammonium Lauryl Sulfate was tested according
152 COSMETIC INGREDIENT REVIEW

to the Draize method. The material was diluted so that the actual concentration
of the ingredient was 1.5%. When tested on four albino rabbits, the compound
scored a 6.0, which indicated that the formulation was a severe irritant(74)(see
Table 8 ) .
Dermal toxicity
The dermal LD50 to rabbits of Sodium Lauryl Sulfate i s greater than 10,000
mglkg. Signs of intoxication included diarrhea, salivation, incoordination, and
death. Dermal irritation included severe erythema and edema with subdermal
hemorrhaging. (”)
The acute dermal toxicity of a shampoo containing 26% Sodium Lauryl
Sulfate was tested on four New Zealand albino rabbits. One 10 ml/kg dose of the
product was applied for 24 h under occlusion to the clipped skin of the back and
flanks of each animal. After 24 h, the material was removed and observations of
toxicity were made at 4 and 24 h, and daily for a total of 14 days. Necropsies
were performed after 14 days. The single 10 ml/kg application caused severe skin
irritation, including erythema, edema, desquamation, and blanched, discolored,
necrotic and fissured skin. “The damaged skin sloughed during the second week,
and the underlying skin was thickened with eschar formations.” Signs of systemic
toxicity by percutaneous absorption included: depression, labored respiration,
abnormal positions of hind legs, and nasal discharge. One animal died on Day 3
of observation. The acute dermal LD50 was greater than 10 ml/kg.(7s)
A shampoo containing 15% Ammonium Lauryl Sulfate was tested for acute
dermal toxicity on four New Zealand albino rabbits. The material was diluted so
that the actual concentration of the ingredient was 0.75%. A dosage level of
10 mllkg of the diluted material was applied to each animal, and the testing pro-
cedure continued as above. After 24 h of contact, gross signs of dermal irritation
included: moderate erythema and slight edema, accompanied by small blisters.
The edema cleared after 48 h as did the erythema after 11 days. Moderate atonia
and desquamation occurred in all animals; these conditions persisted until Day
14 in three animals. There were no gross signs of systemic toxicity; no animals
died and the LD50 of the 1:20 dilution was greater than 10 ml/kg.(76)
Sodium l a u ryl Su f fafe-mediated semitiza tion
Nilzen and Wikstrom(”) demonstrated that guinea pigs became sensitive to
nickel and chrome only when these agents were mixed with Sodium Lauryl
Sulfate. In this experiment 25 male and female white guinea pigs were clipped
free of fur on one side of the body. Groups of five animals each were painted for
eight days with 1 aqueous Sodium Lauryl Sulfate, 0.5% aqueous potassium
dichromate, 4% aqueous nickel sulfate, an aqueous mixture of 1O/O lauryl sulfate
and 0.5% potassium dichromate, and an aqueous mixture of 1 % lauryl sulfate
and 4% nickel sulfate. Paintings with Sodium Lauryl Sulfate, potassium
dichromate, and nickel sulfate produced mild to no reactions. Animals painted
with the mixtures, however, showed scaling, erythema, and infiltration. Testing
12 days after the start of the experiment with both the metal salts and the mix-
tures evoked erythema and infiltration. The authors stated that the eczematogenic
properties of the metals are “brought about by the permeability of the skin in-
TABLE 8. Skin Irritation: Sodium Lauryl Sulfate and A m m o n i u m Lauryl Sulfate.

Irritation
Contact
Conc. Dose Solution or Species and time Observation
f%) (ml) formulation number Protocol Max. score (day) time (day) Comment Ref.
Sodium Lauryl Sulfate
0.5 - Solution 6 Colworth- - - 3 3 Applications twice daily for 3 days. 63
1.0 - Solution Wistar rats - - 3 3 Skin was coarse, red, edematous.
There were microscopic changes.
5-10 - Solution Rats - - 3 1,3 Applications twice daily for 3 days. 20
After Day 3, thickening of
epidermis and scaling and
cracking of stratum corneum
was observed.
10 0.5 Solution 15 Female TFI - - 30, 60, 120 min Slight thickening and erythema 1 .5 64
mice 120 min to 2 h after treatment.
lntracellular vacuolization of
squamous cells after 1 h.
1 0.5 Solution 15 Female TFI - - 2, 5, 9 10 After 8-9 applications, erythema
mice occurred.
2.5 0.5 Solution 15 Female TFI - - 2, 5, 9 10 After 5 days, thickened stratum
mice corneum and intracellular edema.
1 5.0 Solution Rabbits - - 14 - Ten applications in 14 days. Slight 31
erythema on abdomen and ear.
5 5.0 Solution Rabbits - - 14 - Ten applications in 14 days. Moderate
chemical burns on abdomen;
slight erythema on ear.
25 5.0 Solution Rabbits - - 14 - Ten applications in 14 days.
Severe chemical burns on abdomen
and ear.
10 0.5 Aqueous 4 New Zealand Draize 1.4818.0 1 1 2 Three 24 h applications on intact and 65
solution rabbits abraded skin. Skin evaluated after
each 24 and 48 h period. Solution
was mildly irritating.
 d

TABLE 8. (Continued.) cn
e
lrritation
score Contact
Conc. Dose Sohtion or Species and time Observation
(%) (mm)l formulation number Protocol Max. score (day) time (day) Comment Ref.

Sodium Lauryl Sulfate (Cont'd.)

2 0.5 Solution Rabbits Draize 5.218.0 1 1,3 Primary skin irritant, highly dangerous. 42
10 0.5 Solution Rabbits Draize 6.0/8.0 1 1,3 Primary skin irritant, highly dangerous.
20 0.5 Solution Rabbits Draize 6.0/8.0 1 1,3 Primary skin irritant, highly dangerous.
10 0.1 Solution 9 Albino Modified 3.9114.0 1 2 Applied to shaved skin on filter disc 66
rabbits Draize under occlusion..ingredient was
(PSI) severely irritating.
28.2 1.0 Solution 6 New Zealand D.O.T. - 4 hrs 4 h, 2 days No skin corrosion at 4 H. Positive skin 67
rabbits corrosion at 48 h. Material i s
considered to be corrosive if it
causes destruction or irreversible
alteration of the tissue.
28.2 0.5 Solution 6 New Zealand Draize 4.5418.0 1 1,3 Erythema and eschar in abraded and 68
rabbits intact skin at 24 and 72 h. Edema
occurred in intact skin at 24 h and
in abraded skin at 24 and 72 h.
Ingredient was a moderate primary
irritant.
30 0.1 Solution 9 Albino Modified 4.0/4.0 1 2 Applied to shaved skin on filter disc 69
rabbits Draize under occlusion. Ingredient was
(PSI) severely irritating.
100 0.1 - 9 Albino Modified 2.9614.0 1 2 Applied to shaved skin on filter disc 70
rabbits Draize under 24 h occlusion; 5 min
(PSI) rinsed. Uniform, red erythema.
Ingredient was moderately irritating.
_______-_I-----____------------------

1 3 or 7 Applied under occlusion to intact 71

and abraded skin for 24 h. Com-
pound was mildly irritating to
rabbit skin according to Draize
scares.
 %
v)
m
ul
ul
3
m
z
5
8
C
3
Ammonium Lauryl Sulfate
2 0.5 Solution Rabbits Draize 5.318.0 1 1,3 Primary skin irritant, highly dangerous 42 6
C
according to Draize. ;ro
10 0.5 Solution Rabbits DFaize 5.918.0 1 13 Primary skin irritant, highly dangerous. ;
I
20 0.1 Solution Rabbits Draize 6.018.0 1 1,3 Primary skin irritant, highly dangerous. v)

27.4 0.1 Solution 6 New Zealand D.O.T. - 4 hrs 4 h, 2 days No skin corrosion at 4 h. Positive skin 72 5
rabbits corrosion at 48 h. Material is con- 5
sidered to be corrosive if causes ;;1
destruction or irreversibletissue *Z
alteration.
27.4 0.5 Solution 6 New Zealand Draize 4.7118.0 1 3 Material was applied under occlusion 73 U
rabbits to abraded and intact skin. Material *3
was a moderate primary irritant
3
according to the Draize scores. 0
156 COSMETIC INGREDIENT REVIEW

creasing under the influence of lauryl sulphate [sic]." They also conjecture that
the power of the allergen is enhanced by the surfactant; it can then combine with
protein via the metabolic process to cause the dermatitis.

Subchronic
Oral
A 13-week feeding study in rats was carried out on Sodium Lauryl Sulfate.
Twelve male and 12 female individually caged five-week old rats were fed dietary
levels of 40, 200, 1000, or 5000 ppm active material. A control group of 18 males
and 18 females received the basic diet. Daily observations were made on health,
and weekly observations were made on body weight and food intake. Urine
samples were obtained from the 5000 ppm group and checked for color, pH,
protein, reducing substances, bile salts, and microscopic constituents. Terminal
blood samples were made and checked for erythrocyte and leucocyte counts,
hematocrit and hemoglobin, total plasma protein, urea concentration, and
serum protein fractions. At necropsy, visceral organs were weighed and processed
for histopathologic examination. The only significant finding was an increase in
absolute organ weights in the rats of the highest dietary level, and increased
hepatic weights occurred in females in the 5000 ppm group. No lesions were
observed and 1000 ppm is considered the "no effect dietary
Weanling male rats were fed for five months drinking water containing O%,
0.05%, or 0.25% concentrations of Sodium Lauryl Sulfate. At the highest concen-
tration (0.25%), the weights of the lung and kidney were increased. Histopath-
oiogic examinations of the major organs gave evidence of bronchopneumonia
caused by ingestion of small amounts of Sodium Lauryl Sulfate. Activities of
serum enzymes were not affected. At the 0.25% concentration, the hepatic
triglyceride concentration increased but the serum triglyceride concentration
decrea~ed."~)
Sodium Lauryl Sulfate was fed to albino rats for four months. At 2% in the
diet, this surfactant produced slight but not significant growth retardation; a 4%
concentration in the diet produced significant growth retardation, and 8% in the
diet was lethal within two weeks, with severe diarrhea and bloating of the in-
testines. Gross examination showed only gastrointestinal irritation. Tissues were
not examined microscopically.~79~

Chronic

Oral
Osborne Mendel strain albino rats were fed 0.25%, 0.5%,or 1 .O% Sodium
Lauryl Sulfate in the diet for two years. During this time, weight gains were nor-
mal. Tissues taken at necropsy were free of gross and microscopic abnormalities.
The investigators concluded that Sodium Lauryl Sulfate is not toxic at dosage
levels up to 1.0% (10,000 ppm) in the diet.(79)
Another two-year study on rats showed that 2,000 ppm (0.2%)Sodium Lauryl
Sulfate in the diet gave "negative results."(80)
The chronic oral toxicity of Sodium Lauryl Sulfate was tested using four
groups of two male and two female beagle pups. Each group received for one
ASSESSMENT: S O D I U M LAURYL SULFATE A N D A M M O N I U M LAURYL SULFATE 157

year a diet containing 0.0% (control), 0.67%, 1.0%, or 2.0% Sodium Lauryl
Sulfate. Blood.samples were taken from each dog prior to testing and at 1 , 3, 6,
and 12 months to determine hemoglobin, hematocrit, total white and red cell
counts, differential white counts, red cell fragility and sedimentation rate,
Body weights of dogs receiving 1 O/O Sodium Lauryl Sulfate were comparable
to those of control dogs and greater than dogs in the 0.67% group. Dogs in the
2% group had the lowest weight gains. Blood determinations found that, when
compared with initial determinations, all dogs, including controls, had increased
red cell count, hematocrit and hemoglobin. No abnormalities attributable to
Sodium Lauryl Sulfate were found. Gross examinations found no abnormalities
that could be associated with ingestion of the compound. One dog in the 2%
group died after 24 weeks; it appeared emaciated and there was evidence of
pneumonitis. Microscopic examinations of internal organs likewise showed no
abnormalities. It was concluded that diets containing 0.67%, 1 .O%, and 2.0%
Sodium Lauryl Sulfate for one year caused no anatomical injury to dogs.(B1.82)
Percutaneous toxicit y
A shampoo containing 17.5% Ammonium Lauryl Sulfate was tested in a
91-day percutaneous toxicity study. The shampoo was diluted to lo%, making
the ingredient concentration 1.75%. Five male and five female New Zealand
albino rabbits received sixty-five 2 rnllkg doses of the dilution to unabraded skin.
At the end of the study, the animals were observed for dermal and systemic ef-
fects. Skin effects included: erythema (moderate in 2 of 10 sites and severe in 8 of
lo), edema in all sites, atonia (slight in 6 of 10 sites), desquamation (slight in 9 of
10 sites to moderate in 1 of 10 sites) and slight fissuring in 3 of 10 sites. Transient
body weight loss was noted in three animals, but overall weight gains were
recorded for all animals. Hematology showed no abnormalities that could be at-
tri buted to treatment and histology showed no treatment-related abnormalities,
except those changes found in the skin. There were no deaths due to
treatment. ( 8 3 )

Special Studies
Mutagenesis
Sodium Lauryl Sulfate was fed to Colworth/Wistar rats for 90 days to study
the effect of its ingestion on the chromosomes of cells in the bone marrow. Six
male and six female rats were used for each dosage level of 1.13% and 0.56%
Sodium Lauryl Sulfate in the diet. Control animals were fed the diet without the
detergent. At the completion of the feeding phase of this study, the animals were
sacrificed and the bone marrow of one femur of each animal was removed for ex-
amination. The results showed that feeding rats 1.13% and 0.56% Sodium Lauryl
Sulfate in the diet for 90 days produced no more increase in chromosomal ab-
berations nor did the chemical cause a clastogenic effect.(84)
Carcinogenesis
A one-year chronic oral study using beagles showed~that Sodium Lauryl
Sulfate at concentrations up to 2% in the diet was not tumorigenic or car-
ci nogenic .( )
158 COSMETIC INGREDIENT REVIEW

Teratogenesis
The effect of dermal application of Sodium Lauryl Sulfate on pregnant mice
and their fetuses was studied by Takahashi et al.(e5) Five groups of 13-week old
JCL/ACRtype mice were mated; observance of a vaginal plug determined Day"0"
of pregnancy. Daily applications of 1 .5 ml/kg of 0.4%, 4.0%,and 6.0% aqueous
Sodium Lauryl Sulfate were made to a 3 x 3 cm' shaved area of the backs of
three groups of mice on Days 6-1 3 of pregnancy. The fourth group served as an
untreated control and the fifth as a water-treated control. Mothers were observed
from Day 0 of pregnancy to Day 18, at which time they were sacrificed, and the
fetuses taken for examination. The following parameters were observed for ab-
normalities: fetal extremities, oral cavity, body measurement, resorptions, im-
plantations, bones, maternal breasts, intestines, number of eggs, spleen, heart,
lung, liver, and body weight. Table 9 lists the findings at Day 18 of pregnancy,
Table 10, the effects of Sodium Lauryl Sulfate on the pregnant dams and their off-
spring, and Table 11, the effect of Sodium Lauryl Sulfate on fetal skeletal develop-
ment.
Investigators found skin discoloration and a dramatic reduction in maternal
body weight increases in the 4.0% and 6.0% detergent-treated group. Determi-
nation of the conception rate by detection of a vaginal plug showed that 21 mice
in each detergent-treated group and in the water-treated group were pregnant.
Abnormalities found in nontreated mice included open eyelids, polydactylia,
bent tail, and clubfoot. Water-treated controls had only abdominal hernia and
open eyelids. The 0.4% Sodium Lauryl Sulfate group displayed brain hernia,
cleft palate, open eyelids, polydactylia, and clubfoot. The 4.0% group showed
cleft palate, open eyelids, and digital anomalies, and the 6.0% group had cleft
palate, open eyelids, and bent tail. There was a significant delay in bone ossifica-
tion with increasing detergent con cent ration.
In summary, there occurred a reduction in maternal weight and growth rate
with application of the detergent, and the rate of pregnancies brought to term
was low for mice in the 6% treatment group. Post-implantation examination
found that growth retardation occurred in the 4% and 6% detergent application
groups. "Open eyes" and "cleft palate" are thought to be growing phenomena in
this particular strain of mice; therefore, occurrence of these anomalies in test and
control mice may or may not be significant. Delayed ossification and fetal weight
and growth were retarded in the 4% and 6% detergent-treated groups.
Comedogenici t y
Sodium Lauryl Sulfate, in 1 % and 5% solutions, was applied to the internal
base of the pinna of the right ear of three albino rabbits. An unspecified number
of applications were made on Monday through Friday for two weeks; the left ear
served as the control. Clinical severity of lesions was scored for 0 (no increase in
visible hyperkeratosis or no comedones) to 5 (severe lesions). One percent
Sodium Lauryl Sulfate scored 3 (significant comedones) and 5% scored 4 (com-
edones of greater severity than score 3).(86)
A 10% aqueous solution of Sodium Lauryl Sulfate was applied in 100 pl
amounts twice a day, five times per week, for up to six weeks to the entire dorsal
trunk of hairless rhino female mice. The detergent produced a fine scaling of the
TABLE 9. Effect of Sodium Lauryl Sulfate (SLS)on Rates of Pregnancy and Embryonic Development in Mice.

Total no. of Total no. of Total no. of Mean body weight

No. of females No. of dams implantations surviving fetuses dead and resorbed of surviving fetuses
Group with vaginal plug (%) (mean =tS.D.) (mean f S.D.) fetuses (%) (mean f S.D.)

Nontreatment 48 39(81.3) 450 424 26(5.8) 1.36 f 0.11

(11.5 f 2.45) (10.9 2.18)
*
Distilled water 21 1g(90.5) 218 205 13(6.0) 1.29 f 0.12
(11.5 f 2.70) (10.8 f 2.37)
SLS (0.4%) 21 20(95.2) 244 228 16(6.6) 1.28 f 0.12
(12.2 f 1.79) (11.4 f 1.85)
SLS (4.0%) 21 17(81.O) 198 180 1a(9.1) 1.21 f O.lSb
(11.6 f 1.32) (10.6 1.70)
*
SLS (6.0%) 21 1 1(52.4)a 126 116 lO(7.9) 1.21 f O.lSb
(11.5 f 1.37) (10.6 f 1.69)

ap < 0.01.
bp < 0.001.
From Ref. 85.
160 COSMETIC INGREDIENT REVIEW

TABLE 10. Effect of Sodium Lauryl Sulfate (SLS) on External Anomalies of Fetuses.
SLS SLS SLS
Croup Nontreatment Distilled water 0.4% 4.0%. 6.0%

No. of fetuses examined 426 205 228 180 116

No. of abnormal fetuses 16(3.8Y E(3.9) 9(4.0) 14(7.8) 7(6.0)

13(27.1)b 7(36.8) 7(35.0) 9(52.9) S(45.6)

Brain hernia 0 0 l(0.4) 0 0

l(5.0)
Abdominal hernia 0 l(0.5) 0 0 0
l(5.3)
Cleft palate 0 0 l(0.4) 4(2.2) S(4.3)
l(5.0) 4(23.5) 4(36.4)
Open eyelids lO(2.4) 7C3.4) S(2.2) 9(5.0) l(0.9)
7(14.6) 6(31.6) 3(15.0) 6(35.3) l(O.9)
Polydactylia l(0.2) 0 l(0.4) 0 0
l(2.1) l(5.0)
Bent tail 2(0.5) 0 0 0 l(O.9)
2(4.2) l(9.1)
CIu bfoot 3(0.7) 0 l(0.4) 0 0
3(6.3) 0 l(5.0)
Subcutaneous bleeding 0 0 0 0 0
Digital anomalies 0 0 0 l(0.6) 0
l(5.9)

aNo. of fetuses ( O h ) .
bNo. of mother mice Ph).
From Ref. 85.

dorsal skin, but no other gross changes. Microscopic changes included:

moderately hyperplastic epidermis, hyperkeratotic horny layer, and a slightly
more cellular dermis with a mild infiltrate of leukocytes. The horny contents re-
mained unchanged. Untreated controls showed a slight enlargement of
pseudocomedones with greater compaction of the horny cells and a marked in-
crease in the number and size of dermal cysts. Gross sagging and wrinkling of the
rhino mouse skin increased. This study showed epidermal irritancy, but did not
show comedogenicity ,( 8 7 )

Clinical Assessment of Safety

Ocular
Two shampoo formulations, each containing 11 .O% Ammonium Lauryl
Sulfate, were tested for ocular irritation on 44 men and women. A group of 21
subjects were used in a pilot study to determine the highest concentration of a
product that is minimally to moderately irritating and that can be safely instilled
into the eye. A second group of 26 subjects were used in the main study to
evaluate the irritation of the highest concentration of the product as determined
in the pilot study. A 10% concentration of the shampoo in sterile normal saline
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 161

TABLE 11. Effect of Sodium Lauryl Sulfate (SLS)on Skeleta! Development of Mouse Fetuses.

Group Nontreatment Distilled wafer SLS 0.4% SLS 4.0% SLS 6.0%

Degree of Ossification
No. of caudal vertebrae 8.13 f 2.46Sa 8.81 f 1.726 8.70 f 1.885 8.41 f 2.617 8.08 f 2,244
Forepaw
No. of proximal phalanx (L) 3.90 f 0.616 3.97 f 0.192 3.94 f 0.282 3.84 f 0.577 3.86 f 0.456
( R) 3.91 f 0.601 3.99 f 0.145 3.95 f 0.236 3.87 f 0.458 3.89 f 0.378
No. of middle phalanx (L) 2.69 f 1.218 1.97 f 1.018 1.69 f 1.188 1.90 f 1.157 1.55 f 1.155
(R) 2.81 f 1.263 2.16 f 0.932 1.98 f 1.148 2.07 f 1.155 1.79 f 1.198
Hind Paw
No. of proximal phalanx (L) 4.54 f 1.383 4.59 f 0.775
4.53 f 0.831 3.96 f 1.486 4.20 f 1.170
( R) 4.57 f 1.218 4.64 4.56 f 0.819
f 0.716 4.18 f 1.256 4.18 f 1.174
No. of middle phalanx (L) 1.02 * 1.578 0.46 f 0.927 0.47 f 1.058 1.02 f 1.619 0.52 f 1.026
(R) 1.16 t 1.609 0.43 f 0.887 0.51 1.1 16 1.02 f 1.598 0.54 f 1.037
Separation of sternebrae 12(7.4jb 3(1.6) 3(1.5) 17(10.8) 12112.4)
Absence of cervical bodies 21(13.0) 1S(7.9) 26U2.6) 32(20.4) 14U4.4)
Defective development of
sternebrae 33(20.4) 2U.1) 6(2.9) 13(8.3) 13U3.4)
Delayed ossification 142 133 177 172 172 171 122 119 84 84
of talus (L) (R) (87.7)(82.1) (96.2)(94.0) (78.2W.2) (89.7N88.2) (94.5)(93.3)
of calcaneous (L) (R) 60 55 49 45 53 49 53 48 42 40
(30.7)(34.0) (26.6)(24.6) (24.1)(25.0) (39.6)(35.8) (47.7)(44.4)
Variation
Surplus of sternebrae lS(9.3) 17(9.0) 31(15.1) 17(10.8) 7(7.2)
Asymmetry of sternebrae 56(34.5) 30(15.9) 33(16.0) 23U4.7) ll(11.3)
Cervical rib 54(33.3) g(4.8) 4(1.9) 16(10.2) lS(15.5)
No. of rib 14 63(38.9) lOS(55.7) 132(64.1) 77(49.0) 4 7(48.5)
No. of lumber vertebrae 7 - l(0.53) 1 l(5.34) l(0.64) S(5.2)
Split of atlas and axis - 45(23.8) 62(30.1) 3N24.2) 24(24.7)
Anomalies
Adhesion of ribs - -
Absence of cervical
vertebrae - -
aMean f S.D.
bNo. of fetuses.
From Ref. 85.

(actual Ammonium Lauryl Sulfate concentration was 1.1 %) was instilled into the
right or left eye of each subject. Sterile normal saline was instilled into each con-
tralateral eye as a control. Stinging and dryness of the eye was evaluated by each
subject and irritation of the conjunctiva, cornea, and iris was evaluated by an
ophthamologist. Stinging and irritation was scored on a scale of 0 (none) to 3
(severe). The mean sting score of one product was 2.1 (moderate) and the mean
duration of the stinging was 42.9 sec. The mean tearing score was 0.5 (none to
mild), while dryness of the eye scored 0.08 immediately after instillation and 0.04
after 1 h. The mean irritation score immediately after instillation was 0.5, after 1 h
it was 0.1, and after 2 h, 0.0.(881 When a 10% concentration of the second for-
mulation (1.1 Ammonium Lauryl Sulfate) was instilled into the eyes, the mean
sting score was 1.2 (mild) and the mean duration of the effect was 21.4 sec. The
mean tearing score was 0.04 (practically none) and the mean eye-dryness scores
162 COSMETIC INGREDIENT REVIEW

immediately after instillation and after 1 h were 0.04 and 0.1 5, respectively. The
mean irritation scores immediately and 1 h after instillation were, respectively,
0.08 and 0.02 (practically none).(89)

Microscopic Effects and Irritation

The effect of Sodium Lauryl Sulfate on human epidermal mitosis was studied
using healthy adult male volunteers. Concentrations of 0.5%, 1.O%, and 2.0%
Sodium Lauryl Sulfate were applied to several sites on the upper back, and the
subjects served as their own controls. The materials were applied every 24 h and
biopsies to assess mitotic effect were taken at 24, 48, and 96 h. Six hours prior to
the readings, the patch and excess detergent were removed, and 0.5% Calcemid
cream was applied under occlusion. At the end of the 6 h, a 3 mm punch biopsy
was taken and the mitotic index was ascertained. When compared with controls,
the 1 Sodium Lauryl Sulfate solution produced mild erythema and a 30-fold in-
crease in mitotic activity which peaked at 48 h. The 0.5% and 2.0% solutions
produced similar changes in mitotic activity but to a smaller degree. It was found
that 1o/o Sodium Lauryl Sulfate is the maximum mitotic response concentration.(90)
The cumulative effect of Sodium Lauryl Sulfate on cutaneous horny layers
and on the lysosomal activity of keratin layers was studied in humans in vivo. To
study cutaneous roughness and inflammatory reaction, human forearm was
treated with Sodium Lauryl Sulfate for four successive days and clinical diagnosis
was made every day for five days. The horny layer was then stripped from the
arm in order to study the acid phosphatase activity. Homogenized dermis and
epidermis from human instep was used to study the lysosome labilizing ability of
the surfactant. The detergent produced roughness of the forearm in all subjects
by the third day; an erythematous reaction occurred in one person. The acid
phosphatase activity of the stripped, detergent-treated horny layer of the forearm
decreased before the onset of skin roughness. The epidermal lysosome labilizing
was studied by measuring spectrophotometrically the liberation of acid
phosphatase and 6-glucuronidase from the human lysosome fraction. A concen-
tration of 5 x g/kg Sodium Lauryl Sulfate released the greatest amount of
these enzymes. The authors suggest that skin roughness could result from the in-
teraction of surfactant molecules with the horny layer to labilize their mem-
branes and cause disruption of water retention and cellular adhesion abilities
within the membrane^.'^')

Skin Irritation and Sensitization

Irritation and sensitization by Sodium and Ammonium Lauryl Sulfate was
studied in humans. These studies are detailed below, and outlined in Table 12.
Sodium Lauryl Sulfate is reported to be “well known as a standard skin irri-
tant.”(92)An aqueous concentration of 5% Sodium Lauryl Sulfate was tested in
wetting tests(93) on 495 patients with occupational contact dermatitis and
cumulative insult dermatitis, and on healthy control persons. Irritant reactions
occurred in 52% of the patients with eczema and in 12% of the control subjects.
In 12 patients, 11 of whom had contact and cumulative insult dermatitis,
“crescendo” reactions occurred. These persons had been exposed previously to
TABLE 12. Human Clinical Studies: Skin Irritation/Sensitization Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate.

lngredient Irritation Score

Test Dose solution or No. of Time on
Conc. (%) (ml) formulation subjects test Max. score Comment Ref.

Sodium Lauryl Sulfate

Wetting and
Patch Test
5 - ingredient 495 - Subjects had occupational contact dermatitis 92
solution and cumulative insult dermatitis. A healthy
control group was also tested. Irritant
reactions occurred in 52% of dermatitis-
patients and in 12% of controls
0.1 - ingredient 12 Eczema in 2 of 12 patients. 92
solution
Patch Test
- - ingredient 100 48 h N o contact dermatitis 35
solution
Closed
0.25 0.3 ingredient 28 women 7 days 0.2014.0 3-24 h patches in 7 days. Faint, barely 95
solution perceptible erythema.
0.5 0.3 ingredient 28 women 7 days 0.3614.0 Faint, barely perceptible erythema.
solution
1 .o 0.3 ingredient 28 women 7 days 0.7414.0 Faint to definite erythema.
solution
0.25 50 $1 aq. ingredient 20 M,F 24 h patch - Slight erythema at 48 h, decreased at 72 h. 96
solution 72 h obsv.
0.5 50 pl aq. ingredient 20 M,F 24 h patch Slight erythema at 24 h, increased at 48 h 96
solution 72 h obsv. and decreased at 72 h.
1 .o 50 fi1 aq. ingredient 20 M,F 24 h patch Slight erythema at 24 h, bright erythema at 96
solution 72 h obsv. 48 h, slight at 72 h.
2 .o 50 $1 aq. ingredient 20 M,F 24 h patch Slight to bright erythema at 24 h. Bright 96
solution 72 h obsv. erythema with some infiltration at 48 h,
slight to bright erythema at 72 h.
TABLE 12. (Continued.)

Ingredient lrritation Score

Jest Dose solution or No. of Time on
Conc. (%J (ml) formulation subjects test Max. score Comment Ref.

hcfiurn Lauryl sulfate (Cont’d.)

Closed
0.1 0.2 ingredient 2 men 21 days 14.5184 Continuous 24 h patches. 65
solution
1 .o 0.2 ingredient 2 men 21 days 71/84 Irritation was almost maximum.
solution
2.0 0.2 ingredient 2 men 21 days 77/84 Irritation was almost maximum.
solution
4.0 0.2 ingredient 2 men 21 days 78.5184 Irritation was almost maximum.
solution
6.0 0.2 ingredient 2 men - - Concentration was too irritating to continue
solution testing.
8.0 0.2 ingredient 2 men - - Concentration was too irritating to continue
solution testing.
Open
1 .o 0.2 ingredient 2 men 21 days 0184 No irritation. 65
solution
2.o 0.2 ingredient 2 men 21 days 0184 No irritation.
solution
4.0 0.2 ingredient 1 man 21 days 0184 No irritation.
solution
6.0 0.2 ingredient 2 men 21 days 0184 No irritation.
Closed
10.0 25 pl ingredient 5M, 5F 24 h - After 24,48,72 h-mild inflammatory 97
solution reaction. After 26, 28 h-significantly
greater inflammatory reaction. After 96 h-
milder reaction than at 24 h.
10.0 0.2 ingredient 16 men 24 h 0.1218.0 PI1 after 24 and 72 h was indicative of no
solution irritation potential.
10.0 0.2 ingredient 8 men 21 days 34.1184.0 Continuous 21-day closed patch on
solution paraspinal skin of back.
Formulations
Patch Tests
1.02 0.1 formulation 20 48 h 1.314.0 24 h patch; 48 h observation. Pink, uniform 98
erythema.
21 0.1 formulation 20 48 h 0.5314.0 24 h patch. 48 h observation. Barely 99
perceptible erythema.
21 0.1 formulation 20 48 h 1.0314.0 24 h patch. 48 h-observation. Mild, 100
uniform erythema.
Schwartz-Peck
2.5 - formulation 599 see 48 h closed and open patch. 14day rest. 101
comment 2nd 48 h patch. UV irradiation. 3rd 48 h
patch. First closed 48 h patch produced
weak reactions in 221599. The 2nd closed
patch produced weak reactions in 261599
and strong reactions in 21599. Six weak
reactions occurred after UV radiation.
Nonirritating; nonsensitizing;
nonphotosensitizing.
Repeated Insult
Patch Test
0.21 and 0.10 formulation 115M. F 6 weeks See comment 0.21 aq. for 1-2 induction patches; 1.05 aq. 102-104
0.105 (see aq. solution for 3-9 induction patches and challenge
comment) patch. Nine inductions, 2-week rest, 24 h
challenge. Irritant reactions in 1 115. No
sensitization.
1.26 - formulation 57 5 weeks See comment Eight 24 h inductions; 24 h challenge. Slight 105
to severe erythema; edema in 1/57. Slight
to moderate erythema after challenge,
1.26 - formulation 54 5 weeks See comment Eight 24 h inductions; 24 h challenge. Slight 106
to well-defined erythema. No reaction
after challenge.
1.45 0.4 formulation 9F, 3M 21 days See comment 21-23 h daily occlusive patches to upper 107
aq. solution back. Highly irritating.
1.45 0.4 formulation 9OF, 62M 6 weeks - 10 24-h occlusive patches applied to upper 108
aq. solution arm. Primary irritation, no sensitization.
TABLE 12. (Continued.)

Ingredient Irritation Score

Test Dose solution or No. of Time on
Conc. (%j (ml) formulation subjects test Max. score Comment Ref.

Sodium Lauryl Sulrate (Cont’d.)

2.50 - formulation 249 - See comment 10 24-h induction patches. One 48 h 109
challenge. UV-irradiation after the 1st, 4th,
7th, loth, and 1l t h patches. Weak
reactions occurred in, at most, 12/249;
and a strong reaction in one person.
Number of weak reactions after the
number of the UV patches were: 1 after
1st; 2 after 4th; 3 after 7th; 0 after 10th;
and 4 after 11th.
Ammonium lauryl Sulfate
Patch Test
0.1 1 - shampoo (aq. 53M, F 5 weeks + 114 Slight erythema in 1/53 after the 4th and 8th 110
solution) patches, and in 2/53 after the 7th patch.
Indicative of fatiguing reactions. No
sensitization.
0.15 - shampoo (aq. 52M, F 5 weeks See comment Max score = 5 (edema, vesiculation). Slight 111
solution) erythema in 7 people. Moderate erythema
i n 2 people. Edema in one person. No
sensitization, but challenge patch
produced slight erythema after 24 h.
0.20 - shampoo (aq. 55M, F 5 weeks See comment Max score = 5 (edema, vesiculation). Slight 112
solution) erythema in 15 people; Moderate
erythema in 10; Severe erythema in one;
Edema in 2 .
1.68 0.1 shampoo (aq. 162F 5 weeks + 214 Very mild to mild primary irritant in 113
solution) 47M 16 individuals. Fatiguing agent in 56
individuals after 2 or more applications.
No sensitization.
0.84 0.1 shampoo (aq. 162F 5 weeks - Not a primary irritant. Fatiguing agent in 113
solution) 47M 2 individuals. No sensitization.
0.42 0.1 shampoo (aq. 162F 5 weeks - Not a primary irritant. No sensitization. 113
solution) 47M
0.84 - product (aq. 46F 5 weeks - No irritation or allergic reactions, 114
solution) 1O M
0.98 - product (aq. 41 F 5 weeks - No irritation or allergic reactions. 115
solution) 11M
1.12 - product (aq. 42 F 5 weeks + 1/+4 One person had mild erythema; no allergy. 116
solution) 11M
1.12 - product (aq. 43F 5 weeks + 1/+4 One person had mild erythema; no allergy. 117
solution) 11M
168 COSMETIC INGREDIENT REVIEW

Sodium Lauryl Sulfate in household and cosmetic products. These patients were
then tested according to the lymphocyte transformation test with 0.005-0.001 mg
Sodium Lauryl Sulfate per ml Ten of the 12 patients showed increased
incorporation of 3H-thymidine, but there was no increase in DNA synthesis. This,
according to Prater, is indicative of certain sensitization in at least 10 of the 12
people. Patch tests with 0.1 /'o aqueous Sodium Lauryl Sulfate caused eczematous
reactions in two of 12 patients.'92)
Twenty-eight women tested the irritation potential of Sodium Lauryl Sulfate
in concentrations of 0.25%, 0.5%, and 1 .O%. Patches containing 0.3 ml of the
test substances were fixed to the back of each panelist for three 24 h periods in
seven days. Scores were read 72 h after application of the first patch, and 48 h
after application of both the second and third. The 0.25% and 5.0% concentra-
tions caused faint, barely perceptible erythema, and scores were, respectively,
0.20 and 0.36 out of 4.0. The 1.O% concentration scored 0.74 out of 4.0, which
indicates faint to definite erythema.(95)
Sodium Lauryl Sulfate, in aqueous concentrations of 0.25%, 0.5%, 1.O%, and
2.0%, was patch-tested on the backs of 10 men and 10 women. The occlusive
patches were applied for 24 h and observations were made 24, 48, and 72 h after
application. Reactions were scored on a scale of 0 (no reaction) to 3 (erythema,
infiltration, vesicles, papules). The results showed a dose-response, and a time-
response, with stronger responses at 48 h than at 24 or 72 h. The strongest irritant
responses included bright erythema and infiltration.(96)
A 21-day continuous closed patch with multiple concentrations was used to
test the irritancy potential of Sodium Lauryl Sulfate on twelve men. The men
were placed in six groups of two each, and each group was tested with 1 %, 107'0,
20%, 40%, 60%, or 80% of the original 10% compound. The actual concentra-
tions of the ingredient were, therefore, 0.1 %, 1.O%, 2.0%, 4.0%, 6.O%, or 8.0%.
The solutions, in 0.2 ml volumes, were placed on patches which were applied to
the subjects' backs. Each patch was removed at the end of every 24 h, and sites
were read after 30 min. A fresh sample was then applied to the same area. Scor-
ing was from 0 (no reaction) to 4 (bullous reaction). Testing was continued for 21
continuous days or until a grade 4 reaction was observed. Cumulative maximum
irritation was 84 (21 days x 4). The results of the test showed that the 0.1 YO con-
centration gave a cumulative irritation score of 14.5 out of 84, the 1.O% solution
scored a 71, and the 2.0% and 4.0% solutions scored 77 and 78.5, respectively.
The higher concentrations were too irritating for continued testing.[6s)
In a 21-day open test, Sodium Lauryl Sulfate was tested in concentrations of
1 %, 2%, 4%, and 6% on 2,2, 1, and 2 men, respectively. The compound was ap-
plied to the backs of the men and the sites were circumscribed with petrolatum,
so as to confine the test liquid while the solvent evaporated. This procedure was
repeated daily for 21 days, or until a grade 4 reaction developed; the scoring
system used was the same as for the 21-day continuous patch test. None of the
concentrations produced any irritation (scores were O ) . ( 6 3 )
The degree of inflammation to human skin caused by Sodium Lauryl Sulfate
was assessed by patch testing. A 25 pI volume of 10% aqueous Sodium Lauryl
Sulfate was applied under a 24 h patch to the forearms of five men and five
women. Upon completion of the 24 h contact period, the patches were removed
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 169

and sites were graded immediately (24 h), and at 26, 28, 30, 48, 72, and 96 h. All
challenged sites developed inflammatory reactions, with scores at 26 and 28 h
significantly higher than at 24 h (immediately upon patch removal), The 48- and
72-hour scores were similar to the 24 h scores, and the 96 h score was significantly
lower than the 24."')
Sixteen adult white male volunteers tested the effect of Sodium Lauryl
Sulfate, among 14 other compounds, in a Draize rabbit type irritation test
modified for man. The men were placed into four groups of four each, and the
ventral aspects of both forearms were clipped free of hair 24 h prior to testing. A
10% w/v aqueous solution of Sodium Lauryl Sulfate was applied and covered
with occlusive patches. Results were read 24 and 72 h later. The irritation index
for Sodium Lauryl Sulfate was 0.12 out of a possible 8.0. The compound, as
tested, showed no irritation potential.(6s)
A 21-day continuous closed patch test of a 10% concentration of Sodium
Lauryl Sulfate was conducted using the paraspinal skin of the back of eight white
male volunteers. Procedure and scoring were as described for the preceding
21-day continuous closed patch test. The compound scored 34.1 out of a
possible 84. ( 6 5 )
Three shampoo formulations containing Sodium Lauryl Sulfate were tested
by 24 h occlusive patch test procedures. The volar surface of the forearm andlor
the inner aspect of the upperarm was the site of contact for the 24 h patch, After
24 and 72 h, the sites were graded on a scale of 0 (no effect) to 4 (severe
erythema, vesiculation andlor edema). One formulation contained 68% of a 30%
concentration of Sodium Lauryl Sulfate. This solution was then diluted to 5% in
water (final ingredient concentration 1.02%) and was affixed to the arms of 20 in-
dividuals. After 48 h, the formulation scored 1.3 and irritation was manifested by
mild to moderate erythema.(98)Two other formulations, each containing 70% of
30% Sodium Lauryl Sulfate (actual concentration 21 %) were each tested full
strength on 20 individuals. One product scored a 0.53 (barely perceptible
erythema) and the other, 1.03 (mild, uniform erythema).(99-'00)
The Schwartz-Peck prophetic patch procedure was used to assess the irrita-
tion, sensitization, and UV light sensitization potential of a makeup foundation
product containing 2.5% Sodium Lauryl Sulfate. The skin of the upper back of 599
individuals was cleansed and a 48 h occlusive patch containing the formulation
was affixed to each site. A simultaneous open 48 h patch was applied to the wrist,
After a 14-day rest, a challenge 48 h patch was applied to assess sensitization. The
sites were then irradiated with a Hanovia Tanette Mark I UV source quartz lamp
(I 150 W) with a continuous emission of 300-370 nm for 1 min, at a distance of 12
in. These sites were read 48 h later. After the first patch, weak, nonvesicular reac-
tions occurred in 22 panelists. The second patch caused weak reactions in 26
and strong, edematous or vesicular reactions in two people. Weak reactions oc-
curred in six people after UV irradiation. The investigators concluded that the
compound was nonirritating, nonsensitizing, and nonphotosensitizing.('O*)
A repeated insult patch test was conducted on a shampoo containing 70% of
Sodium Lauryl Sulfate, supplied as a 30% solution (actual concentration is
21 .O%). A 1.O% aqueous solution of the product (0.21O/O Sodium Lauryl Sulfate in
a 0.1 ml volume) was applied under 24 h occlusion to the backs of the 115
170 COSMETIC INGREDIENT REVIEW

panelists. Since this concentration was too irritating, it was reduced to 0.5% (or
O.10S0h) Sodium Lauryl Sulfate for induction patches 3-9 and for the 24 h
challenge patch applied after a 14-day rest. Mild erythema occurred in two in-
dividuals after challenge. The investigators concluded that the reactors were in-
dicative of irritant but not allergic responses.~'0z-'04~
Repeated insult patch tests were performed on two shaving cream formula-
tions each containing 1.26% Sodium Lauryl Sulfate. Eight occlusive 24 h patches
were applied to each panelist. A two-week rest ensued, then a challenge 24 h
patch was applied. One formulation was applied full-strength to 57 male and
female panelists. Sites scored 24 h after each induction showed that both the
number of reactions and the severity of the reactions increased with time. At
most, 19 people showed slight erythema, 12 showed moderate erythema, three
showed severe erythema, and one showed edema. Reactions after the challenge
patch showed slight erythema in six at 47 h after application, in four after 50 h,
and two after 53 h. One person showed moderate erythema after 50 h. The in-
vestigators did not believe these reactions constituted primary irritation.(Io5)The
second formulation was tested on 54 men and women. At most, very slight
erythema occurred in one person, slight erythema in three, and well defined
erythema in four. Challenge patches produced no irritation.('06)
A hair preparation containing 14.5% Sodium Lauryl Sulfate was tested in a
21-day cumulative irritancy test on nine women and three men. The product was
diluted so that the final test concentration of the detergent was 1.45%. Daily oc-
clusive 23 h patches containing 0.4 ml of the solution were applied to the
panelists' backs. Patches of baby oil and a deodorant concentration were applied
simultaneously to provide low and high-irritation frames of reference. The
cumulative irritation scores for each product were: baby oil: 1.67; shampoo: 460;
deodorant: 610.1, The investigators concluded that the shampoo was highly ir-
ritating.['O') When treated in a Draize cumulative irritancy test, this shampoo
(diluted in water to contain 1.45% Sodium Lauryl Sulfate) was applied under oc-
clusion to the arms of 90 women and 12 men. Responses included patterns of
primary irritation, but no sensitization was
A repeated insult patch test of a foundation formulation containing 2.5%
Sodium Lauryl Sulfate was conducted on 249 individuals. Ten 24-hour induction
patches, followed by a two- to three-week rest, and one 24 h challenge patch was
applied to the back. Open 24 h patches were applied to the forearm. Photosen-
sitivity was tested by irradiating the test sites after the first, fourth, seventh and
tenth inductions, and after the challenge patch. Mild, nonvesicular reactions oc-
curred in, at most, 12 individuals, and a stronger reaction occurred in one in-
dividual after the induction patches. The challenge patch produced a weak reac-
tion in six people; however, the investigators did not consider the reactions to be
indicative of sensitization. After UV irradiation with the aforementioned Hanovia
Tanette Mark I quartz lamp, one mild reaction occurred after the first patch, two
after the fourth, three after the seventh, none after the tenth, and four after the
c ha1Ienge. ( ' 0 9 )
Three shampoo formulations containing Ammonium Lauryl Sulfate were
tested for human skin irritation and sensitization using repeated insult patch test
procedures. Eight 12 h patches of the products were applied to the arms on each
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 171

Monday, Tuesday, Wednesday, and Thursday of two consecutive weeks and the
sites were read 24 h after application. After a two-week rest, a ninth 24 h
challenge patch was applied to the same site. It was read 24, 48, and 72 h after
application. A scoring scale of 0 (no reaction) to 4 o r 5 (edema, erythema,
vesiculation) was used for evaluation. One shampoo containing 11.O% Am-
monium Lauryl Sulfate was tested as above on 53 men and women. The product
was diluted to make the test concentration of the ingredient 0.11%. Slight
erythema (score = 1) occurred in one individual after the fourth and eighth in-
duction patches and in two people after the seventh; these were considered to
be fatiguing reactions. No sensitization occurred.("o)
Another shampoo containing 15% Ammonium Lauryl Sulfate was evaluated
as above with 52 men and women. The final test concentration of the ingredient
was 0.15%. Visible skin changes characteristic of a fatiguing reaction occurred i'n
seven people (slight erythema), moderate erythema occurred in two people, and
edema in one person. No sensitization occurred, but slight erythema was noted
in one person after 24 h.'"') The third and final shampoo formulation, tested as
above, also contained 15% Ammonium Lauryl Sulfate, but the final test concen-
tration of the ingredient was 0.20%. It produced slight erythema in 15 out of 55
individuals, moderate erythema in 10, severe erythema i n one, and edema in
two. Challenge patches produced slight erythema in two at 24 h and one at 48 h.
These were characterized as fatiguing reactions, but no sensitization occurred.(112)
A shampoo containing 16.8% Ammonium Lauryl Sulfate was evaluated for ir-
ritation and sensitization in a repeated insult patch test. Aqueous solutions of the
product containing 1.68%, 0.84%, and 0.42% Ammonium Lauryl Sulfate were
applied to the cleansed upper backs of 162 women and 47 men in a series of ten
24-hour induction patches. Reactions were read 48 h after contact and scores
were based on a scale of 0 (no reaction) to 4 + (erythema, edema, vesiculation,
ulceration). Fourteen days after the last induction application, one challenge
patch containing 0.84% Ammonium Lauryl Sulfate was fixed to the original test
site, and one to a virgin site on the upper arm. These patches were read 24, 48,
and 96 h after application. Under the test conditions, a solution, of the shampoo
containing 1.68% Ammonium Lauryl Sulfate was found to be a very mild to mild
primary irritant in 16 subjects, and a substantial fatiguing agent in 56 individuals
by the cumulative effect of two or more applications. The 0.84% concentration
caused no irritation but it was a fatiguing, agent in two subjects. The 0.42% con-
centration was not irritating. The three test concentrations of the ingredient
caused no s e n ~ i t i z a t i o n . ~ ' ~ ~ )
A modified Draize-Shelanski-Jordan patch test was conducted on two for-
mulations, one containing 30% Ammonium Lauryl Sulfate and the other with
35% detergent. The Ammonium Lauryl Sulfate was supplied as a 28% solution
and the actual concentration of detergent i n each product was 8.4% and 9.8%,
respectively. A 10% dilution of each formulation (0.84% and 0.98% detergent)
was applied under open patch conditions for ten alternate 24 h periods to the up-
per backs of 46 women and 10 men testing one product, and 41 women and 11
men testing the second product. Readings were made after each application.
After a 13-day rest, a 48 h challenge patch was applied t o the back, and a second
48 h patch was applied seven days later. Challenge sites were read 48 and 72 h
172 COSMETIC INGREDIENT REVIEW

+
after application. Scoring was based on a scale of 1 (mild erythema) to +4 (in-
tense erythema, edema, vesicles). No irritation or allergic reactions were pro-
duced by either p r ~ d u c t . ( ' ~ ~ * ' ' ~ )
A similar test was performed on two products each containing 40% of 28%
Ammonium Lauryl Sulfate. The actual concentration of detergent was 11.2% in
the products and the repeated insult patch tests were performed on 10% dilu-
tions of each formulation. Each product produced a + 1 reaction in the 42
women and 1 1 men testing one product and in the 43 women and 1 1 men
testing the other; however, the investigators stated that the products appear to be
safe and are neither irritants nor allergen^.(^'^^'^^)

Controled Use
A controled use study of a foundation product containing 2.5% Sodium
Lauryl Sulfate was conducted using 52 panelists, The product, applied full
strength to the face for four weeks, produced no irritation.('l*'

The "Sodium Lauryl Sulfate Provocative Test"

Kligman(lly) described the "Sodium Lauryl Sulfate provocative patch test . . . a
method designed to reveal threshold states of sensitization." This procedure calls
for pretreatment of the test site with 10% aqueous Sodium Lauryl Sulfate for 1 h
before applying the test-allergen. The use of Sodium Lauryl Sulfate in pretreat-
ment grew from studies that showed it to enhance skin permeability and,
therefore, to foster sensitization. Sodium Lauryl Sulfate may also be combined
with the test allergen, rather than pretreating the test area, provided no incom-
patibility exists between the surfactant and the test allergen.

Case Reports
Fisher(") reported a case in which a 37-year-old woman was allergic to the
formaldehyde preservative (0.03%) in Sodium Lauryl Sulfate. The author notes
~ ~ ~be' ~less
that previous reports of Sodium Lauryl Sulfate ~ e n s i t i v i t y ( may ~~~~~~
valid if the ingredient contained formaldehyde (a known sensitizer).

Cosmetic Experience
The following are cosmetic experience su bmissions for products containing
Sodium Lauryl Sulfate:
a. A hair preparation containing 14.5% Sodium Lauryl Sulfate is reported to
have a number of uses totaling 5 x lo8,a number of uses per year of 2 x los,
and a number of safety-related complaints totaling 17 over seven years.(1z2)
b. A shampoo formulation containing 30% Sodium Lauryl Sulfate has per
annum sales totalling 398,000 units, and per annum uses of 4,852,620.The
number of safety-related complaints was 1 in two years; the type of complaint
was an allergiclirritant reaction.(1Z3)
c. A shampoo formulation containing 10% Sodium Lauryl Sulfate is sold at
the rate of 390,000 units per annum, and it has 8,580,000uses per year. No
safety-related complaints were received in two years.(1z4)
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONJUM LAURYL SULFATE 173

d. Shampoo products containing 23'10, 25%, 29.2%, and 30.9% Ammonium

Lauryl Sulfate have total combined sales of 6,814,127 units per annum. There
were six safety-related complaints from these four products combined; they in-
cluded two complaints each of itchy scalp and allergy, and an instance each of
damaged hair and eye irritation.(12s~126)

SUMMARY

Sodium and Ammonium Lauryl Sulfate are anionic surfactants. Sodium

Lauryl Sulfate is supplied as a powder or a viscous liquid, and Ammonium Lauryl
Sulfate appears as a thin to viscous liquid. Both are soluble in polar solvents. The
1981 product data submitted to the FDA show that Sodium Lauryl Sulfate was
used in 703 formulations, 158 of which contain the detergent at 0.1%-1% or
greater in non-rinse-off products. Ammonium Lauryl Sulfate was used in 164, of
which four contain the surfactant at 0.1 %-1 O/O or greater and are not rinsed off.
Since they are surfactants, Sodium and Ammonium Lauryl Sulfate are primarily
used in hair and bath products.
The effects of Sodium and Ammonium Lauryl Sulfate on biological systems
have been studied. TGE virus, E. coli, and Gram-positive bacteria are sensitive to
Sodium Lauryl Sulfate. It is also fungistatic to Candida and Tricophyton spp. In
Absorption, Metabolism, and Excretion studies, 5% Sodium Lauryl Sulfate had a
degenerative effect on the cell membranes of rabbit intestinal epithelium, on in-
qtracellular organelles, and on microvilli, due to its protein denaturing properties.
Sodium Lauryl Sulfate caused an increase in cyclic AMP content in rat intestinal
mucosa, and an increase in the blood glucose level in rabbits, when a 2.5% solu-
tion was administered after a 24 h fast. In guinea pig skin penetration and absorp-
tion studies, investigators found that the strongly anionic head group of Sodium
Lauryl Sulfate impairs its ability to penetrate through the skin. Similar low levels
of penetration were found using rat and human epidermis. Another report stated
that diffusion through rat neonatal stratum corneum was rapid and increased
with concentration. The investigator postulated that the surfactant caused struc-
tural changes in the membranes, thereby allowing skin penetration.
In a study of detergent uptake by hair, it was found that bleached hair ab-
sorbed more Sodium Lauryl Sulfate than untreated hair. Permeability studies
using human abdominal epidermis showed that skin permeability to water and
skin damage increased in rapidity and severity when the epidermis was soaked in
solutions containing increasing amounts of Sodium Lauryl Sulfate. In-
traperitoneal and subcutaneous injections of this surfactant into rats showed that
the main route of excretion from the body is through the urine. Both Sodium and
Ammonium Lauryl Sulfate, in solution containing 0.05 M detergents, caused
swelling as a result of reversible conformation change in the cell membranes of
the stratum corneum. Sodium Lauryl Sulfate penetrates through pores in the cell
membranes of yeast, and has a lytic action on dog erythrocyte membranes, This
surfactant also liberates solubilized protein and sulphydryl groups from human
skin, soluble protein and amino acids from guinea pig stratum corneum, and
histamine from rat peritoneum.
174 COSMETIC INGREDIENT REVIEW

In acute oral toxicity studies, a 10% concentration of Sodium Lauryl Sulfate

had an LD50 of 0.8-1.10 g/kg in rats, a 28.2% concentration had an LD50 of
6.3 mllkg in rats, and an 86% concentration produced an LD50 of 1290 mglkg.
lntubation of “purified” 100% Sodium Lauryl Sulfate into rats had an LD50 of
2.7 mg/kg; an “unpurified” sample had an LD50 of 1 .O mg/kg. Two other 100%
samples produced diarrhea, diuresis, lacrimation, salivation, convulsions and
death in the rats; the LD50 was 1650 mg/kg. Products containing 21% Sodium
Lauryl Sulfate caused depression and death of all animals at a dosage level of
5.0 g/kg. Doses of a 27.4% concentration of Ammonium Lauryl Sulfate caused
death by pulmonary hemorrhage in 20 out of 50 rats. A formulation containing
15% Ammonium Lauryl Sulfate caused depression, labored breathing, diarrhea,
and death in four out of 20 animals. Rhesus monkeys receiving a formulation
containing 15% Ammonium Lauryl Sulfate suffered emesis and diarrhea. One
died at the 10 mllkg level.
In acute ocular tests, 10% Sodium Lauryl Sulfate caused corneal damage to
the rabbits’ eyes if not irrigated, or if irrigation was delayed for longer than 4 sec
after instillation. Draize tests of Sodium Lauryl Sulfate in concentrations of
1 %-100%, with and without rinse, showed that irritation increased with increas-
ing concentration and decreased when the eyes were rinsed. A Draize test of a
product containing 5.1 OO/ Sodium Lauryl Sulfate caused mild irritation, and prod-
ucts containing 21 detergent were severely irritating with no rinse, and mildly
irritating when rinsed. Twenty-six percent Sodium Lauryl Sulfate i n a shampoo
was mildly irritating when rinsed. Solutions of the ingredient Ammonium Lauryl
Sulfate containing 1.25%-27.4% detergent showed increasing irritation with in-
creasing concentration; rinsing decreased irritation. Two formu lations containing
15% Ammonium Lauryl Sulfate was mildly irritating when rinsed from the eyes of
monkeys and rabbits, and moderately irritating when not rinsed.
Upper respiratory tract irritation and inhibition of respiration in mice and
rabbits was caused by Sodium and Ammonium Lauryl Sulfate aerosols. The con-
centration of Sodium Lauryl Sulfate which produced irritation in mice was 88 pg/l
and in Ammonium Lauryl Sulfate, 114 pg/l. Inhalation irritation occurred in mice
exposed to either surfactant at 73 pg/l and in rabbits at 130 and 170 pg/l.
The concentration of both surfactants to cause writhing in mice after intra-
peritoneal injection is 0.086%.
Acute skin irritation studies of the ingredient, Sodium Lauryl Sulfate, show
that application of solutions containing 0.5%-10% detergent cause slight to
moderate irritation. Applications of 1O%-30°/o detergent caused skin corrosion
and severe irritation; however, one 100% application was only moderately ir-
ritating. A shampoo formulation containing the ingredient at 0.65% caused mild
irritation. Solutions of 2%, 10%, and 20% Ammonium Lauryl Sulfate were highly
irritating and dangerous. A 27.4% solution, when tested according to D.O.T. pro-
cedures, caused corrosion and irreversible tissue damage. This same solution,
tested according to the Draize Method, produced moderate irritation. A formula-
tion containing 1.5% Ammonium Lauryl Sulfate was severely irritating.
The acute dermal lethal dose of Sodium Lauryl Sulfate to rabbits i s greater
than 10 g/kg. Signs of systemic intoxication and dermal irritation were noted. A
formulation containing 26% Sodium Lauryl Sulfate was tested for acute dermal
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 175

toxicity in albino rabbits. A dose of 10 mllkg caused systemic effects including

depression, labored respiration and nasal discharge. Dermal irritation was
severe. Fifteen percent Ammonium Lauryl Sulfate in a shampoo caused moderate
skin irritation, but no systemic toxicity.
Sodium Lauryl Sulfate facilities skin sensitization to nickel and chrome in
guinea pigs.
A thirteen-week subchronic oral toxicity test in rats on dietary levels of 40,
200, 1000, or 5000 ppm Sodium Lauryl Sulfate caused only an increase in ab-
solute organ weight at the highest dose level. No other abnormalities were
found. Rats ingesting O%, 0.05%, or 0.25% Sodium Lauryl Sulfate for five months
showed bronchopneumonia and an increase in serum triglyceride levels. Rats
fed 2 % Sodium Lauryl Sulfate for four months had signs of growth retardation,
those fed 4% had greater growth retardation, and those fed 8% died within two
weeks. The high-dosed group had signs of diarrhea and gross alterations of
intestines.
A chronic oral feeding study in rats of 0.25%, 0.5%, or 1.O% Sodium Lauryl
Sulfate in the diet for two years produced no abnormalities, nor did a similar
two year study with 0.2% detergent in the diet. A chronic oral one year toxicity
study using beagle pups was conducted on O%, 0.67%, 1.O%, or 2.0% Sodium
Lauryl Sulfate. Decreased weight gain occurred in the 2% group, but no other ab-
normalities were noted.
A 91-day percutaneous toxicity study of a shampoo containing 17.5% Am-
monium Lauryl Sulfate had no treatment-related abnormalities except for
moderate to severe dermal effects.
In mutagenesis studies, rats fed 1.13% and 0.56% Sodium Lauryl Sulfate in
the diet for 90 days produced no more chromosomal abberations or clastogenic
effects than did a control diet.
Sodium Lauryl Sulfate (4.0% and 6.0%) applied topically to pregnant mice
caused cleft palate and delayed bone ossification in some offspring.
In comedogenicity tests, 1O h and 5% Sodium Lauryl Sulfate was applied for
two weeks to the skin of rabbits and significant to severe lesions were produced.
When shampoo formulations containing 11.O% Ammonium Lauryl Sulfate
were instilled into the eyes of volunteers, mild stinging and eye dryness resutted.
Concentrations of 0.5%, 1 .O%, and 2.0% Sodium Lauryl Sulfate applied to
the upper backs of male volunteers produced an increase in mitotic activity of
the skin at the application sites.
The cumulative effect of Sodium Lauryl Sulfate on cutaneous horny layers
and on lysosornal activity was studied in humans in vivo. The detergent produced
roughness on the area of the forearm to which it was applied, and a decrease in
acid phosphatase activity in the skin of the treated area. It also liberated acid
phosphatase and 0-glucuronidase from the lysosome fraction.
The ingredient Sodium Lauryl Sulfate was tested for human skin irritation in
concentrations ranging from 0.1 O h to 10%. In all cases, open patches were less ir-
ritating than closed patches, and irritation increased directly with concentration.
Formulations containing 0.21 %-2.5% Sodium Lauryl Sulfate and 0.1 1%-1.68%
Ammonium Lauryl Sulfate were tested under open and closed patch conditions
and with UV light. In all cases, the ingredient in open patches and lower concen-
176 COSMETIC INGREDIENT REVIEW

trations caused less irritation than did higher concentrations and in closed patches.
No UV light sensitization occurred from any formulation.
Sodium Lauryl Sulfate is used in a provocative skin test which calls for the
treatment of the test area with the detergent prior to the application of the test
allergen or irritant. Sodium Lauryl Sulfate is used to enhance skin permeability
and, therefore, to aid in the assessment of sensitization.
Certain case reports state that sensitivity to products containing Sodium
Lauryl Sulfate may be due to other ingredients and not to the detergent.

DISCUSSlON

Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate are irritants in patch
testing at concentrations of 2% and greater, and that irritation increases with in-
gredient concentration. In some cosmetic formulations, however, that irritant
property is attenuated. The longer these ingredients stay in contact with the skin,
the greater the likelihood of irritation, which may or may not be evident to the
user.
Although Sodium Lauryl Sulfate is not carcinogenic in experimental animals,
it has been shown that it causes severe epidermal changes to the area of skin of
mice to which it was applied. This study indicates a need for tumor-enhancing
activity assays.
Autoradiographic studies of rat skin treated with radiolabelled Sodium Lauryl
Sulfate found heavy deposition of the detergent on the skin surface and in the
hair follicles; damage to the hair follicle could result from such deposition. Fur-
ther, it has been reported that l and 5 % Sodium Lauryl Sulfate produced signif-
icant number of comedones when applied to the pinna of albino rabbits. These
two problems- possible hair loss and comedone formation -along with proven
irritancy, should be considered in the formulation of cosmetic products.
Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate appear to pose less
potential hazard when in products designed for brief, discontinuous use, follow-
ing which they are thoroughy rinsed from the surface of the skin.

CONCLUSION

Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate appear to be safe in for-
mulations designed for discontinuous, brief use followed by thorough rinsing
from the surface of the skin. In products intended for prolonged contact with
skin, concentrations should not exceed 1O h .

ACKNOWLEDGMENT

Anne F. Moore, Scientific Analyst and writer, prepared the literature review
and technical analysis used by the Expert Panel in developing this report.
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 177

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*Available on request: Administrator, Cosmetic Ingredient Review, 1 1 10 Vermont Ave., Suite 810,
Washington, DC 20005.
178 COSMETIC INGREDIENT REV1EW

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Lauryl Sulfate on skin. J. Soc. Cosmet. Chem. 12(2),36-43.
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Food Cosmet. Toxicol. 14(5),425-30.
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commercially available surfactants. 1. SOC. Cosmet. Chem. 13, 469-79.
32. PRODUCT SAFETY LABS (PSL). (Aug. 5, 1980).Submission of data by CTFA. Unpublished defined oral
LD50 to rats of Sodium Lauryl Sulfate, 28.2 percent, (2-4-3).*
33. WALKER, A.I.T., BROWN, V.K.H., FERRIGAN, L.W., PICKERING, R.G., and WILLIAMS, D.A. (1967).Tox-
icity of sodium lauryl sulfate, sodium lauryl ethoxy sulfate, and corresponding surfactants derived from
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toxicity of sodium dodecyl sulfate. Tokyo Toritsu Eisei Keykyusho Kenkyu Nempo 25, 663-7.
35. INDUSTRIAL 610-TEST LABORATORIES. (1971).Sodium Lauryl Sulfate.
36. CTFA. (March 2, 1978).Submission of data by CTFA. Unpublished acute oral toxicity study in rats of a
product containing 21 percent Sodium Lauryl Sulfate, (2-4-71).*
37. CTFA. (June7, 1979).Submission of data by CTFA. Unpublished acute oral toxicity test in rats of a product
containing 21 percent Sodium Lauryl Sulfate, (2-4-56).*
38. PSL. (Aug. 12,1980).Submission of data by CTFA. Unpublished defined oral LD50 to rats of 27.4percent
Ammonium Lauryl Sulfate, (2-4-7).*
39. CTFA. (June 1973).Submission ofdata by CTFA. Unpublished acute oral toxicity study of shampoo-15 per-
cent Ammonium Lauryl Sulfate, (2-4-29).'
'40.CTFA. (Aug. 1973).Submission of data by CTFA. Unpublished acute oral toxicity test on monkeys of a
shampoo with 15 percent Ammonium Lauryl Sulfate, (2-4-27).'
41. WEIL, C.S. (1952).Weil modification of the method of Thompson: Biometrics 8, 343.
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various methods of assessment. Drug Chem. Toxicol. 1(3), 305-24.
43. DAVIES, R.E. and LICGETT, M.P. (July 10, 1975).Unpublished irritant effects of 10 and 100 percent
Sodium Lauryl Sulfate on rabbit eye mucosa. Huntingdon, Cambridgeshire: Huntingdon Research Centre,
(2-4-33).*
44. PSL. (June 30,1980).Submission of data by CTFA. Unpublished modified eye irritation test on rabbits of
Sodium Lauryl Sulfate, 28.2 percent active, (2-4-1).*
45. CTFA. (Aug. 23, 1976).Submission of data by CTFA. Unpublished ocular toxicity of 30 percent Sodium
Lauryl Sulfate, (2-4-43):
46. CTFA. (Apr. 28,1977).Submission of data by CTFA. Unpublished ocular toxicity test of 30 percent Sodium
Lauryl Sulfate, (2-4-41):
47. CTFA. (July 5, 1973).Submission of data by CTFA. Unpublished ocular toxicity data of 30 percent Sodium
Lauryl Sulfate, (2-4-44).*
48. CTFA. (Oct. 1, 1971).Submission of data by CTFA. Unpublished ocular toxicity of shampoo containing
Sodium Lauryl Sulfate, (2-4-42).*
49. CTFA. (March 2, 1978).Submission of data by CTFA. Unpublished ocular toxicity of a product containing
Sodium Lauryl Sulfate, (2-4-72).*
50. CTFA. (June 7, 1979).Submission of data by CTFA. Unpublished ocular toxicity of a formulation contain-
ing Sodium Lauryl Sulfate, (2-4-57).*
51. CTFA. (Feb. 1979).Submission of data by CTFA. Unpublished ocular toxicity of shampoo containing 20
percent Sodium Lauryl Sulfate, (2-4-19).*
52. SERRANO, J.J., DELONCA, H., LA1 THI VlET NJA, and LIUTKUS,M. (1977).Study on the ocular tolerance
of surfactants used in shampoos. Parfums Cosmet. Aromes. 13, 55-60.
53. PSL. (June 30, 1980).Submission of data by CTFA. Unpublished modified eye irritation test of 27.4percent
Ammonium Lauryl Sulfate on rabbits, (2-4-5).*
ASSESSMENT: SODIUM LAURYL SULFATE A N D AMMONIUM UURYL SULFATE 179

54. APPLIED BIOLOGICAL SCIENCES LABORATORY (ABSL). (March 6, 1979). Submission of data by CTFA.
Unpublished modified Draize eye irritation study on a product containing 8.4 percent Ammonium Lauryl
Sulfate.'
55. ABSL. (April 26, 1979). Submission of data by CTFA. Unpublished modified Draize eye irritation study on
a product containing 9.8 percent Ammonium Lauryl Sulfate.'
56. ABSL. (Nov. 2, 1979). Submission of data by CTFA. Unpublished modified Draize eye irritation study on a
product containing 11.2 percent Ammonium Lauryl Sulfate.*
57. ABSL. (Nov. 12, 1979). Submission of data by CTFA. Unpublished modified Draize eye irritation study on
a product containing 11.2 percent Ammonium Lauryl Sulfate.*
58. CTFA. (Jan. 1974). Submission of data by CTFA. Unpublished ocular toxicity of a shampoo containing 15
percent Ammonium Lauryl Sulfate, (2-4-30).*
59. CTFA. (Apr. 1973). Submission of data by CTFA. Unpublished ocular toxicity of a shampoo containing 15
percent Ammonium Lauryl Sulfate, (2-4-32).'
60. DAVIES, R.E., KYNOCH, S.R., and LIGGETT, M.P. (1976). Eye irritation tests assessment of the maximum
delay time for remedial irrigation. J. SOC. Cosmet. Chem. 27(7), 301-6.
61. CIUCHTA, H.P. (1 976). Evaluation of the irritancy of surface active agents. Assessment of activity upon the
upper respiratory tract of guinea pigs, mice, and rabbits. Toxicol. Appl. Pharmacol. 37(1), 152-3.
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Sect. Toilet Goods Assoc. No. 3,l.
63. TOVELL, P.W.A., WEAVER, A.C., HOPE, I.,and SPROTT, W.E. (1974).Action of Sodium Lauryl Sulfateon
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64. LANSDOWN, A.B.C. and CRASSO, P. (1972). Physicochemical factors influencing epidermal damage by
surface active agents. Br. J. Dermatol. 86(4), 361-73.
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human skin response to certain irritants. Toxicol. Appl. Pharmacol. 21(3), 369-82.
66. CTFA. (Sept. 13, 1973). Submission of data by CTFA. Unpublished primary skin irritation test of a 10 per-
cent solution of 100 percent Sodium Lauryl Sulfate, (2-4-47):
67. PSL. (July 7, 1980). Submission of data by CTFA. Unpublished D.O.T. skin corrosion test of 28.2 percent
Sodium Lauryl Sulfate on rabbits, (2-4-4).*
68. PSL. (July 7,1980). Submission of data by CTFA. Unpublished primary skin irritation test in rabbits of
Sodium Lauryl Sulfate, 28.2 percent active, (2-4-2).*
69. CTFA. (Aug. 23, 1976). Submission of data by CTFA. Unpublished primary skin irritation test of 30 percent
Sodium Lauryl Sulfate, (2-4-45).*
70. CTFA. (July5, 1973). Submission of data by CTFA. Unpublished primary skin irritation of Sodium Lauryl
SuIfate, (2-4-46).*
71. CTFA. (Feb. 1977). Submission of data by CTFA. Unpublished Draize primary irritation test of a shampoo
containing Sodium Lauryl Sulfate, (2-4-20).'
72. PSL. Uune 30, 1980). Submission of data by CTFA. Unpublished D.O.T. skin corrosion test of 27.4 percent
Ammonium Lauryl Sulfate on rabbits, (2-4-8).*
73. PSL. (June 30, 1980). Submission of data by CTFA. Unpublished primary skin irritation test of 27.4 percent
Ammonium Lauryl Sulfate on rabbits, (2-4-6).*
74. CTFA. (Jan. 1974). Submission of data by CTFA. Unpublished Draize primary irritation test of a shampoo
containing Ammonium Lauryl Sulfate, (2-4-311.'
75. CTFA. (May 1979). Submission of data by CTFA. Unpublished percutaneoustoxicity of a product contain-
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76. CTFA. Uune 1973). Submission of data by CTFA. Unpublished dermal toxicity of a formulation containing
Ammonium Lauryl Sulfate, (2-4-28):
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402-9.
81. CTFA. (June22, 1959). Submission of data by CTFA. Unpublished supplemental data for chronic oral tox-
180 COSMETIC INGREDIENT REV1EW

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and Co. Research Labs.*
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84. HOPE, J. (1977). Absence of chromosome damage in the bone marrow of rats fed detergent actives for 90
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Ammonium Lauryl Sulfate, (2-4-24).*
89. CTFA. (Sept. 1977). Submission of data by CTFA. Unpublished human ocular test of a shampoo containing
Ammonium Lauryl Sulfate, (2-4-23):
90. FISHER, L.B. and MAIBACH, H.I. (1975). Effect of some irritants on human epidermal mitosis. Contact
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telexanthems mit dem Lymphozytentransformationstest. Dermatologische Monatsschrift 161, 897-901.
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test of three materials containing Sodium Lauryl Sulfate, (2-4-1l).*
96. BRUYNZEEL, D.P., van KETEL, W.C., SCHEPER, R.J., and von BLOMBERG-van der FLIER. (1982).
Delayed time course of irritation by sodium lauryl sulfate: observations on threshold reactions. Contact
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97. DAHL, M.V. and TANCIK, R.J. (1977). Sodium Lauryl Sulfate irritant patch tests: degree of inflammation at
various times. Contact Derm. 3(5), 263-6.
98. CTFA. (Oct. 18, 1971). Submission of data by CTFA. Unpublished human skin irritation of a product con-
taining Sodium Lauryl Sulfate, (2-4-501.'
99. CTFA. (March 30, 1978). Submission of data by CTFA. Unpublished human skin irritation of a product
containing Sodium Lauryl Sulfate, (2-4-741.'
100. CTFA. (March 23, 1979). Submission of data by CTFA. Unpublished human skin irritation of a product
containing Sodium Lauryl Sulfate, (2-4-59):
101. CTFA. (1972-77). Submission of data by CTFA. Unpublished Schwartz-Peck Prophetic Patch Test of a
foundation containing 2.5 percent Sodium Lauryl Sulfate, (2-4-9).*
102. CTFA. (June 6, 1978). Submission of data by CTFA. Unpublished Human Clinical Trial Final Report of a
shampoo containing Sodium Lauryl Sulfate, (2-4-76).'
103. CTFA. (June8, 1978). Submission of data by CTFA. Unpublished results of follow-up testing of a dandruff
shampoo containing Sodium Lauryt Sulfate (Appendix D, 12-4-77).'
104. CTFA. (Dec. 15, 1978). Submission of data by CTFA. Unpublished allergic contact sensitization test of
Sodium Lauryl Sulfate on humans, (2-4-75):
105. CTFA. (July 1978). Submission of data by CTFA. Unpublished human dermal occluded patch of a product
containing Sodium Lauryl Sulfate, (2-4-17).*
106. CTFA. (July 1978). Submission of data by CTFA. Unpublished human dermal occluded patch test of a
product containing Sodium Lauryl Sulfate, (2-4-181..
107. CTFA. (June 1977). Submission of data by CTFA. Unpublished human occlusion patch test of a product
containing Sodium Lauryl Sulfate, (2-4-15).*
ASSESSMENT: SODIUM LAURYL SULFATE AND AMMONIUM LAURYL SULFATE 181

108. CTFA. (Aug. 1977).Submission of data by CTFA. Unpublished human occlusion patch test of a product
containing Sodium Lauryl Sulfate, (2-4-14).*
109.CTFA. (1972-77).Submission of data by CTFA. Unpublished Repeated Insult Patch Test of foundation
containing 2.5 percent Sodium Lauryl Sulfate, (2-4-9).*
110. CTFA. (Sept. 1977).Submission of data by CTFA. Unpublished human primary irritationlsensitization
potential of a shampoo containing Ammonium Lauryl Sulfate, (2-4-22).*
1 1 1. CTFA. uuly 1974).Submission of data by CTFA. Unpublished human occluded patch test of a shampoo
containing Ammonium Lauryl Sulfate, (2-4-251.'
112. CTFA. (Dec. 1974).Submission of data by CTFA. Unpublished human occlusion patch test of a shampoo
containing Ammonium Lauryl Sulfate, (2-4-261.'
113. CTFA. (Aug. 8, 1977).Submission of data by CTFA. Unpublished human patch test of a shampoo contain-
ing Ammonium Lauryl Sulfate, (2-4-36).*
114. UNIVERSITY OF CALIFORNIA AT LOS ANCELES (UCLA). (April 5, 1979).Submission of data by CTFA.
Unpublished modified Draize-Shelanski-Jordan patch test of a product containing 30 percent Am-
monium Lauryl Sulfate (28 percent active).*
115. UCLA. (April 26, 1979).Submission of data by CTFA. Unpublished modified Drake-Shelanski-Jordan
patch test of a product containing 35 percent Ammonium Lauryl Sulfate (28percent active):
116. UCLA. (Dec. 21, 1979).Submission of data by CTFA. Unpublished modified Draize-Shelanski-Jordan
patch test of a product containing 40 percent Ammonium Lauryl Sulfate (28percent active):
117. UCLA. (Dec. 21, 1979).Submission of data by CTFA. Unpublished modified Draize-Shelanski-Jordan
patch test of a product containing 40 percent Ammonium Lauryl Sulfate (28 percent active).'
118. CTFA. (1978).Submission of data by CTFA. Unpublished controlled use data of foundation containing 2.5
percent Sodium Lautyl Sulfate, (2-4-10):
119. KLIGMAN, A.M. (1966).The identification of contact allergens by human assay. I. A critique of standard
methods. J. Invest. Dermatol. 47(5),369-92.
120. BERCSTRESSER, P.R. and EAGLSTEIN, W.H. (1973).Irritation by hydrophylic ointment under occlusion.
Arch. Dermatol. 108, 218.
121. SAMS, W.M. and SMITH, G . (1957).Contact dermatitis due to hydrocortisone ointment. Report of a case
of sensitivity to emulsifying agents in a hydrophilic ointment base. 1. Am. Med. Assoc. 164, 1212.
122. CTFA. (1981).Submission of data by CTFA. Unpublished use history and consumer complaints of a hair
preparation containing 14.5 percent Sodium Lauryl Sulfate, (2-4-16):
123. CTFA. (1981).Submission of data by CTFA. Unpublished safety data of a formulation containing Sodium
Lauryl Sulfate, (2-4-39).*
124. CTFA. (1981).Submission of data by CTFA. Unpublished use history and consumer complaints of a for-
mulation containing Sodium Lauryl Sulfate, (2-4-40).*
125. CTFA. (July 13, 1981).Submission of data by CTFA. Unpublished use history and consumer complaints of
products containing Ammonium Lauryl Sulfate, (2-4-13).*
126. CTFA. (July13, 1981).Submission of data by CTFA. Unpublished use history and consumer complaints of
a product containing 29.2 percent Ammonium Lauryl Sulfate, (2-4-12):