Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate

Home , Glycol distearate

than tion the Glycol taining tion. numerous of Glycol Glycol animals. patch T ingredients

structural palmitic

which

skin

acid.

hese

Glycol Animal

Subchronic

mono- Based

show

Assessment

0.1

test

Stearate,

Distearate

Glycol R1

irritation

ingredients acid,

The

Human

formula

Final

with

categories

that

Stearate:

10%.

data

and

the

Glycol

latter

along

the Stearate

the

50%

these

Glycol Glycol

acyl

testing

test

for

diesters

CHEMICAL should

available

for

present

consists

are Glycol

with

hypersensitivity.

Glycol

The acute data of

portion

these

ingredients

Report

Stearate Stearate

mixed

cosmetic

has

lesser

levels

ingredient

for

practices

oral

ingredients information

Distearate

considered. Stearate

not

formulations

of 42.5

triple-pressed

esters

AND

amounts

toxicity,

SE,

triple-pressed

products

been

2—5%

Io H2C-O-R1 H2C-O-R

have

Distearate

is and

and

PHYSICAL of of

stearic

Human

Glycol

comprised

1 ethylene

use

is:’2

adequately

reported

low

Glycol

presented

skin Glycol

125

several

containing

and

acid

acute

stearic

concentrations

and

the

studies

stearic

subjects

PROPERTIES Distearate

concentration. glycol

Distearate

SE,

and

eye

other

herein,

40—70°!0

toxicity.

investigated

skin

about

acid.

Stearate,

acid using

irritation,

and >

Safety

presented

fatty

and

irritation

triple-pressed are

consist

and

They

formulations

acids. Glycol

ranging

the safe

equal

repeated

concluded

and

are

monoester

or primarily

The

Stearate

laboratory

amount

sensitiza

sensitiza from

evidence

cosmetic

used

general

stearic

Glycol

insult

con

that

less

in ______

2 COSMETICINGREDIENTREVIEW ASSESSMENT:GLYCC

Stearate also contains a significant portion, 3O—58%,of the diester in which both TABLE1. 1R and 2R are the acyl moiety of triple-pressed stearic acid. t2 Cosmeticpro Ingred Glycol Stearate SE: This ingredient is a self-emulsifying grade of Glycol ‘ Stearate containing free stearic acid and some sodium and/or potassium GlycolStearate stearate. ‘> Bath oils, tabiet Bubble baths

Glycol Distearate: This ingredient is the diester of ethylene glycol in which Other bath prep both 1R and 2R are the acyl moiety of triple-pressed stearic acid. Eyebrowpencil SE, 2 Eyeliner Glycol Stearate, Glycol Stearate and Glycol Distearate have similar physical properties. They are white to cream colored waxy solids. Their physical Eyeshadow properties vary within specified limits according to their proportions of mono- Mascara and diesters and other components. Depending on the intended use, a purchas- Hair conditione ing specification is used to set specific limits on the physical characteristics of Hair straightene these ingredients. Rinses (noncolo Shampoos (nom 2 Analytical Methods

Glycol Stearate and Glycol Distearate can be analyzed by gas chromatog- Tonics, dressing raphy. Mass spectrometric analysis of long-chain esters of ethanediol (ethylene hair grooming glycol)3 has been described this allows for the identification of individual esters Hair shampoos of the diol as well as of classes of diol monoesters. A method of gel-permeation Blushers (alltyp 4 Foundations chromatography for Glycol Distearate on Sephadex LH-20 has also been Lipsticks reported. Standard methods have been suggested for determining the ; Makeup bases chemical5 properties of these ingredients. Rouges Other makeup > Bath soaps and 2 Impurities Impurities such as free stearic acid (triple-pressed), the mono- or diesters, Aftershave Iotioi ethylene glycol, and corresponding derivatives of other fatty acids found in the Cleansing (cold stearic acid may be present in Glycol Stearate. cleansing lotic and pads) Ethylene glycol and/or ethylene oxide are used as starting material for the 2> Face, body and synthesis of Glycol Stearate. Since the former is known to be contaminated with (excluding sh traces of 1,4-dioxane, it is possible that such traces also appear in the synthesized preparations) material. >Analytical data on traces of 1,4-dioxane in Glycol Stearate were not Moisturizing available6to the Expert Panel. (.i.O%) When rats were given high doses of 1,4-dioxane in drinking water Other skin care for 13 months, liver lesions including hepatomas occurred.

7 Suntan gels, cre USE liquids

GIycolStearate Purpose and Frequency of Use in Cosmetics Other skin care as These ingredients are used emulsifiers, dispersants, opacifiers, and viscosity Glycol Distearat modifiers. As wax ingredients in stick preparations, they have served to control Hair conditione hardness, add slip, and increase opacity. They give lotion, cream, and detergent . Permanent way formulations an opaque or milky appearance. Shampoos (non’ As shown in Table 1, these ingredients are used in a variety of categories of t8 Hair dyes and c cosmetic products; their concentrations range from less than 0.1% to as high as 9 types requirin 10%. The cosmetic product formulation’ computer printout which is made statement and col have Irting variety ietics d near be ie H-20 han )pacifiers, )fl ethanediol Hester ‘lene

ing : solids. for tty tearate inking (2) d od nded ntout cal roportions acid. cream, (7) INGREDIENT and/or by of mono- contaminated acids of Stearate characteristics grade O.1% in determining individual served glycol gas use, material has gel-permeation 2) in the which Their water of have and which found chromatog categories and to or synthesized potassium a of also of in (ethylene purchas to were physical as detergent REVIEW (.— diesters, Glycol viscosity similar mono is which for control high esters both in 1 been made with .001o) the the the not of of as ASSESSMENT: TABLE Glycol Other Mascara Tonics, Shampoos Eyeshadow Bath Bubble Rinses Eyeliner Eyebrow Hair Hair Other Cleansing Aftershave Makeup Foundations Blushers Hair Lipsticks Ro Moisturizing Other Face, Bath Clycol Glycol Suntan Other Shampoos Permanent Hair Hair hair and cleansing (excluding preparations) types liquids statement Cosmetic u ges conditioners oils, straighteners shampoos soaps conditioners dyes body bath grooming pads) makeup Stearate skin (noncoloring) skin Stearate Distearate baths GLYCOI dressings, gels, 1. requiring bases (all pencil Ingredient tablets (cold and (noncoloririg) lotions preparations (noncoloring) care and care waves and product lotions, Product types) and creams, shaving colors preparations (coloring) SE detergents creams, hand preparations preparations aids and patch caution and STEARATE, liquids, type! salts and Formulation (all other test) GLYCOL Data.a STEARATE Concentration >0.1—1 >0.1—1 >0.1-1 >0.1—1 >0.1-1 >0.1—1 >0.1-1 >0.1-1 >0.1-1 >0.1—1 >0.1-1 >0.1—1 >0.1—1 >0.1—1 >0.1—1 >1-5 >1-5 >5—10 >5-10 >1-5 >1-5 >5-10 >1-5 >5-10 >1-5 >1-5 >1-5 >1-5 >1-5 0.1 >1-5 >1-5 >1-5 >1-5 >1-5 >1-5 >1-5 >5—10 >1-5 >1-5 >5—10 (%) >1-5 >1-5 >1-5 SE, AND GLYCOL DISTEARATE No. formulations of 44 46 75 28 88 product 4 6 3 6 2 9 3 2 3 2 8 5 2 2 2 3 8 5 2 9 2 3 2 9 5 6 4 COSMETIC INGREDIENT REVIEW ASSESSMENT:GLYC(

TABLE1. (Continued.)

Cosmetic product type/ Concentration No. of product Ingredient (%) formulations Oral Toxicity: I for five studies Deodorants (underarm) >1—5 1 in

Other personal cleanliness >5—10 1 marized in Table products in corn oil 3 weight Other shaving preparation >1—5 1 nasal hemorrhag products ministration, but Cleansing (cold creams, > 1—5 1 cleansing lotions, liquids, with high levels 01 and pads) 14-day gross a 4 the the test material.t aData from Ref. 10. For 91 days, five females, werE available by the Food and Drug Administration (FDA)is compiled through volun dients was ethyl€ tary filing of such data in accordance with Title 21 part 720.4 of the Code of and 5%. The eq Federal Regulations (1979). Ingredients are listed in prescribed concentration 0.0025—0.0125%, ranges under specific product type categories. Since certain cosmetic ingredients histopathologic e: are supplied by the manufacturer at less than %100 concentration, the value and test groups. reported by the cosmetic formulator may not necessarily reflect the true, effective concentration found in the finished product; the effective concentration in such Primary Skin a a case would be fraction of that reported to the FDA. The fact that data are only Glycol Stearate, C submitted within the framework of preset concentration ranges also provides the albino rabbit skit opportunity for overestimation of the actual concentration of an ingredient in a ritating (See TabI particular product. An entry at the lowest end of a concentration range is con were tested for cc sidered the same as one entered at the highest end of that range, thus introducing Transportation, t’ the possibility of a two- to ten-fold error in the assumed ingredient concentration. According to FDA, Glycol Stearate SEis used in one unspecified skin-care prod Sensitization uct. Glycol Distearate is principally employed in hair-care preparations Stearate and Gly its t10 however, use as a lyophilic component of self-emulsifying ointment bases has the shaven back been described.” ml injection, 0.1 Products containing these ingredients are used on all body orifices. Thus jections. Two w they may1 enter the body by several routes (though the inhalation of sprays ap ; taken 24 hours I pears to be minor as a mode of exposure and absorption). These ingredients may be applied as often as several times a day (lipsticks and Subch ron ic: lotions) or as infrequently as once every one or two months (hair dyes and mulation was ap colors). The period of time for which they remain in contact may be conditioned female rats. Obs by the frequency with which the affected part of the body is washed. behavior, hema histopathologic BIOLOGICAL PROPERTIES of the test formL A shampoo General Effects separate experir three females). i The addition of 12.5 percent Glycol Stearate as a surfactant to a vaseline male and five fer based ointment increased the cutaneous absorption of the following compounds per week to inta through the shaved skin of rats by the factors shown: 10% potassium iodide (4X); this remained ot 5% sodium salicylate (4.6X);and 5% ammonium thiocyanate (3.1X).A two-gram Two formul sample of each emulsion was rubbed into the skin for five minutes and then Distearate appliE covered with a protective bandage. Absorption was determined by the analysis treatment-jnduc( of urine specimens collected at 12 and 24 2hours.” was reported to irfactant ,onths nes LII •care ecified ange, flect icentration, ;cribed IC thalation i npiled redient

ct nges concentration 720.4 five i rmined ng y

ntration ate

potassium fact

following

cosmetic

INGREDIENT

may

body

ointment

No.

(3.1X).

washed.

the that

minutes

form

also

day

thus

preparations10;

through

skin-care

ingredient concentration. (hair

concentration

true,

ulations

orifices.

to data range product

the

of (lipsticks

provides

conditioned

introducing

compounds ingredients

A the

iodide

sprays the

bases

dyes

two-gram

Code effective and

are vaseline REVIEW

analysis

volun

value

prod

such

Thus only con

then (4X); in

and

the

has

ASSESSMENT:

weight the in with marized the nasal ministration, five dients 0.0025—0.01 and

and histopathologic

Glycol albino

Transportation, were ritating

the

jections. Stearate

taken ml

female

mulation behavior, of treatment-induced three separate histopathologic was this male Distearate per

five

Oral test 14-day

the

injection, females,

For

shaven Primary

test 5%.

high Sensitization:

Subchronic: week Two A

remained

tested

reported

hemorrhage;

studies

was and

females).

Stearate,

rabbit

test

shampoo 91

material.13

(See

rats. in

groups.’41 Toxicity:

The

and corn

levels

Two

hours

experiments was

formulations gross

to days,

five Table

ethylene GLYCOL

formulation.13

applied back

for

25%, hematology,

were

but Table

Observations Skin

intact for

0.1 equivalent Glycol

skin;

oil

applied

female weeks

corrosivity of

on examination,

they autopsy,

Glycol

four later.

A disappeared

changes. acute

produced

corn be formulation

fed

Irritation 0.005—0.025%,

For Glycol

STEARATE, the

fourth 2).

the or Sensitization

each

the

systemic to During

injections

glycol

similar

Distearate. were groups

abraded

later Both

rabbits 90

In oil

the animal five

oral

Stearate diet on ingredients

were

symptoms

dosing of

the

addition,

days, Stearate

alone.

clinical according experiment

were

found

animals

groups times

two

distearate toxicity a the

ingredients containing effects

Studies: to

of GLYCOL

stomach effects

Animal

challenge

within per

tested effects for

containing were

skin

that

weanling

various

Glycol

SE, male,

differences levels made studies

One

Each

to group.

seven

and

which

containing week

chemistry,

when were and

equivalent

ranged

produced

was appeared

given

STEARATE be

the

were

for

study

Draize Toxicology

white

at contained

ingredient

rats;

for

involved of Glycol

a Stearate

the

0.01

were

studies, Glycol

noncorrosive were

injection observed.

hours

dishwashing a

The

next for

found

rats,

91 the

included

Glycol

survival,

three Glycol

concentration

the

procedures from attributed

were

—0.05%.

guinea

type days.

found

conducted material

ethylene

SE,

each six

Distearate

Glycol six within

data each Distearate

organ

weeks at

doses times

similar

AND 0.05%

residues

was

1 observed

Stearate days.

other

was

Distearate

0% rabbits procedures 3%

The

diarrhea,

body

The

comprised

pigs.

from

day

GLYCOL Following

to to

liquid

injected Distearate

was a

nonirritating four of

to given,

weights, be of

glycol

skin

forms week

procedures, to

the concentration

rabbit the

in weight, Following

have

before

a these

the 13 the

for

which

range

each

nonsensitizing.13 and

applied

0.5%.

between

guinea liquid animals

days

irritation

one

skin or repeated

wet

primary

was U.S. DISTEARATE clipped

for distearate and

each

were

intradermally of Glycol

skin.u3)

studies

(three

washing.141

both reported appeared of

sham area appearance and oily

five

following No foundation

Department tested

pigs readings daily,

total

whose

between

were

been

the

used

but

that

irritation coats,

g!kg

evidence

backs males of

application

gross

poo.14

initial

Distearate slightly gross

are males on

often controls

were the

five

in had

tested that

resulted dosed

Glycol

ingre

body to

sum Glycol

were and

three of back; and

and

0.05

test 1 into days

be and and

and for

five

% 0,

in ir of

of Table 2. Acute Animal Toxicity.a

Draize Woodard Eye LD5O—Acute oral Skin Irritation Calvary Irritation Draize File No. Rats! Irritation No. of Ingredient No. Value Conc. Dosage Dose Conc. Animals Index Conc. Rabbits Comment Glycol Stearate 6.4b.i >10 50% in 0.464—10 5 undiluted 6 rabbits 0.13 undiluted 6 mild transient g/kg corn oil g/kg irritant in 1/6 6.4b.ii >21.3 1:2 in 0.7—21.3 5 undiluted 6 rabbits 0.0 undiluted 9 no irritation g/kg corn oil g/kg 6.4b.ii IDept. of Transportation Skin Irritation Test] undiluted 6 rabbits 0.0 6.4b.iv >10 undiluted 10 10 undiluted 6 rabbits 0.375 g/kg g/kg 6.4b.iv [Skin Sensitization Test] i.c. inject. 2 guinea not a of 0.1% pigs sensitizer in saline 6.4b.v >5000 undiluted 5000 10 undiluted 3 rabbits 0.8 undiluted 3 practically non- mg/kg mg/kg Glycol Stearate SE 6.4d.i irritating 5% in 3 rabbits 0.0 5% in 3 not an irritant water water Glycol Distearate 6.4c.i >10 50°I in 0.464—10 5 undiluted 6 rabbits 0.04 undiluted 6 practically non g/kg corn oil g/kg irritating 6.4c.ii >16 1:4 in 0.5—16 5 undiluted 6 rabbits 0.0 undiluted 9 no irritation 0 g/kg corn oil g/kg CM 6.4c.ii [Dept. of Transportation Skin Irritation Test] undiluted 6 rabbits 0.0 ru 6.4c.iv >10 undiluted 10 10 undiluted 6 rabbits 0.085 g/kg g/kg 0 6.4c.iv [Skin Sensitization Test] z i.c. inject. 2 guinea not a C, of 0.1 % pigs sensitizer ru in saline 4.4c.v >5000 undiluted 5000 10 undiluted 3 rabbits 1.0 undiluted 3 practically non- ui mg/kg mg/kg z irritating -I aData from Ref. 14. ru

0 rt. 0 fl • 0 —. (D o CM — Q• OD0O0 D fl• ( < o o - D . CM a;•c ?V (t ? ui )(D -(Dm -.‘(t--1 CM -Dm n— 0- ni — CM <. ti(D 0)t (D s-rD - (D - C 0 - ru = 0 Z C 00 © -. C —. — (D — - —. - D (D z — -< z- 0(D D 000)>0 D-+ z o3.(D —i. ‘-7’ CD —. ‘ox (D —. — D Vi —. —‘ ) _ • - D -D -* - < e D — n c_DO 0) -i.(D — —O DDCDD00--( C, C-’ 0 < < C 0 c X — D ô CD 0 0 00 -< 0 0 - . .m0tmt’CDCD =.z mn - ,- IC

-D

o o

INGREDIENT

11)

E biD

REVIEW

ASSESSMENT:

systemic microscopic Distearate associated by to Glycol tions report from observed centration. these

level. dients

Stearate, dicates which hydrolyzed released.

reviewed

from Glycol

hours final Challenge plied induction

observed hours.

quentially

Stearate),

the

4%, Two

Eye

Unpublished

Skin Potential

the (14)

separate

Eyeshadow three

insult

shampoo test.

noted

19 surfactant to to

Distearate

might

0.05% that

Distearate Irritation: toxic

formulations

the

be application

to the A

Irritation

U4) and

both

in ranged

an After

GLYCOL

blushing

patches

patch; period. ingredients review

by visible applied

it nonirritating 76 examination,

one no toxicity

same

dorsal

any be

effects.

Toxicity but

has

impurity.

and are

skin

years.

gross

containing formulations

four

expected ranged

rabbit

at subject;

Containing

clinical similar

the adverse

summarized

site The STEARATE,

0.3°I

skin

and from

were bacteria aspect

Each

eyeliner,

cream, of

According

the of

weeks,

mineral

were

sites

Patches necropsy

concentration

each

ethylene

for

Draize

Sensitization:

the changes from

extensive

Clinical or 28-day

applied

Impurities:

0.05°I data site

all

from

including

effects of irritating were

the

addition,

1—3%

practically tested test and

Monday, or

GLYCOI.

there

scores the

with

slight

oil eyeshadow

3.5%

was

containing

procedure animals

for

upon 0.05%

below.

cosmetics.

glycol

graded study compound.

mascara

characteristic was

upper

Assessment

only

Glycol

the

the literature microscopic

were

for

scored

rabbits’

were

STEARATE

Glycol

both

hematologic,

absorption, it

0.5%. performed

Wednesday,

severe.14 report,

reported

Glycol

must

at so. level development 28.days.

(five

is arm

for

the

any

repeated

dosage

Distearate was once

zero.’5 arms 0.25

(known possible

Table

sensitization

for

eyes.

Stearate:

systemic

of be male

and range

effort Slight

the

Following SE,

of Stearates

used

each

considered, g

a the of on

alterations” irritation

AND

Safety The

of levels skin day so

The in

and

irritation

each

insult

to gives

two

that of toxicity there and

to transient

sample

individual. that

was

most

125

GLYCOL

effects

contain

assess

for

concentration irritation

0.05—0.4%. results evaluate

five Fifty

formulations

and

much

subject

Friday

Glycol

details primary reactions

patch

ethylene complete

subjects

applied

a was

animals

female)

female

or in

for

total

were their the

days.

DISTEARATE

skin

showed

ethylene

the

3.5

higher

test sensitization

of no

this that

the

of deaths

Patches Stearate

safety

irritation.

the

products of at

after tissue

these applied ranging irritation

percent glycol

Approximately with evidence Investigators at

capacities days volunteers at is

was

gross

containing

concentra

of nine

present each than three-week

the

glycol resulting 48

were 50%

caused

studies.

Glycol

after

will

Glycol

ingre

and

0.3%

in for

those

times.

Glycol con

and

were The

was

were

w!v

age

be in be ap the of

after

tested

patches

preceding ethylene distearate,

shampoo.

patch after challenge

after

would

the

(Since

mulation

patch

testing.

tion

used.

duration tion

test

undiluted

Out

recorded.

irritation subjected

noted.

reported, imum

Glycol assay

any week

two-,

reported

one-half

Dermatological

the

Four

first

Formulations

the

Sixty-two was

Cream

Shampoo

challenge. the

Eyecolor

following

Eyeliner

indicative

potential

test

have

ingredient.

(Maibach

three-,

(14)

period.

were

three

The

was

final

individual

Stearate

final

dishwashing performed

glycol

was

means

was

study.

patch score

skin

672

formulation that

Twenty-two to

and

contained

Foundation

the

stated

average

was

the

induction

that

weeks,

applied

a induction

black

Containing

made

performed

and

performed

Cream

irritation

Containing

maximum

the

21-day

distearate.

study

subjects

test)

was

stated

examinations

cumulative

allergic challenge

the

Containing

the

that

5.94

induced

subject

four-week

products

evidence

the

males

along

evidence

mean

adaptation

diluted

concluded

liquids

applied

performed

was

0.005—0.0125%

Containing

insult

100

cumulative

the

containing

application,

was

application

was

repeated was

that Containing

the

were

total

sensitizers

3.5%

and

the

formulation

2—5%

not

insult

The

subjects,

value

the

sensitization.

upper 89 test

obtained

reported,

site.

the

did

containing

103

test

value

intervals

at females

dorsal

reported.

rated

Ethylene

score

subjects.

test

were

Glycol

sensitization maximum

application,

full

sensitization

formulation

that

not

The

for

Ethylene

insult

subjects

material

irritation 4.O%

arm

the

procedures

half

days

seven

the

strength

for

0.19

surface

produce

0.5

made

“none

subjects

out

were

ethylene

nor

0.58

contained

Stearate: during

hypersensitive

repeated

primary

subjects

patch

Glycol

the

entire

Glycol

1—5%

the

Glycol

after

would

using

was

score

whom

Glycol

three

individuals,

tested

assay

before

Monday,

eight

was

ingredient

the

contained

under

was

procedures

test.

the

were

any

maximum

the

there

Stearate:

ethylene

group

glycol

the

irritants.” 16 >

the

were

0.25%

were

0.5

for

Distearate: insult

Stearate:

4.0

subject

alternate

2—5°I,

were

reported.u 6 )

have

Distearate:

with

test

subjects,

reported. 16 >

products

reaction the

Over

end

upper

COSMETIC

examined

maximum

any

eight

maximum-effect

21-day

Wednesday,

was

prior

distearate.)

given

single

identical

patch

period.

contained considered

liquid

study

eyeliner

did

occlusive

the

glycol

2—5%

was

cream

indication

possible

were

0.08.(16)

days.

arm

subjects.

The

repeated

three-week

the

diluted

not

over challenge

tested

0.2%

individual.’ 6

cumulative test

solution

challenged

began

the

INGREDIENT

score

The

distearate

to ethylene

containing

group

repeated

formulation

evoke

containing

repeated

stated,

Fourteen

repeated

procedure

the

Fourteen

start

0.004—0.01

and

each

patch.

solution

those

score

and

sensitive.

demonstrated

test

dermatologist

ofsensitiza

The

and

insult

entire

value

patches.

any

basis

Friday

47.5

material

period,

subject.

and

the

irritancy

average

with

glycol

at the

hours

insult

were

REVIEW

patch

insult

days

patch

2.5%

days

reac

84.0.

3.5%

the

max

one-,

for

was

four-

The

was

the

was

test.

ASSESSMENT:

Table

cases,

tions)

sumer group

dicated

averaged period

years.

unscreened

for

very

Glycol been manufacturing

of based

potentially

through viscosity

concentrations cosmetic

primarily

enhances

longed.

Because

the

employees

Consumer

Occupational

Glycol

low,

adversely

TABIE

Distearate.a containing

Dishwashing

According

there

upon:

years

complaints

from

Stearate

results

shows

that

liquid

Animal

aData several

subjects.

they

modifier

their

product

percuta

been

GIYCO

Steara

adver

the

was

dunn

that

(a)

from

corn

whc

are

wer

the

lnf

GI’

Sen

for

aft

t s yen e ntical cream ite: nined r dnesday, )nsidered rs, ontained :he iuid rate: le ‘elmer :ts iod. ETIC cclusive lay idy of A t tearate.)

tch 16) d. ed glycol was id imum-effect r mum 2—5%

possible n indication

a 0.08.

were

subjects.

The

a arm

repeated

days. (16)

over

tested .

not the

three-week

diluted

cumulative

individuaL(16) (16)

challenge

0.2% test began

the

A INGREDIENT

solution

challenged

score

The

group

(

formulation

containing containing

evoke 16)

ethylene distearate to

repeated

stated,

repeated

the

repeated procedure start

Fourteen

patch.

Fourteen

score

0.004—0.01 and each

sensitive. demonstrated

dermatologist

and

solution

those

test

and The

ofsensitiza of

insult

entire

value

basis

any

47.5

patches. Friday

material

and

subject.

irritancy

of average period, the

the

REVIEW

with

in glycol

hours

insult patch

patch

insult

were

2.5%

3.5%

days 84.0. reac

one-,

days

max

four

was

The

was test.

was was for was

the

the 0/

ASSESSMENT:

Table

group cases, sumer tions) dicated

period years. averaged 50 unscreened

for manufacturing very Glycol been based of potentially

cosmetic through viscosity concentrations primarily

enhances

longed. Because

the

employees

Consumer No

Occupational

Glycol

low,

TABLE

Distearate.a

Dishwashing adversely

containing

According there

upon:

complaints

years

from

Stearate

results

shows

that liquid

aData

subjects.

Animal several

they

modifiers,

1.2 4 2 3 1

so of

their

products.

percutaneous

been

GLYCOL

adverse

the

was Stearate,

the

during that

(a) from it

complaints

were who

are the

Sensitization Information:

Glycol

was

for

work

affected

use

mono-

ranging

routes;

exposed

no 0.5—5%

studies Ref. some

used

range

Exposure:

1 employees

STEARATE,

for

both,

which of

presented

and

reported

unaware reaction

14.

They

time.

Glycol

over

Stearates

individuals

and

on and

from

have

indicate

Glycol

their per

absorption.

to no

Tests

subjects to years

No.

they

all function

two

One

diesters concentration

exposure

67 87 69 78 Glycol their

employee

their

GLYCOL

rate Two

million.4>

Stearate evidence

Two

been of

less

work on body on who

had million

had

Stearate.

and

manufacturer

any

Dishwashing

contact

for

that

irritation

products companies

than

had

SUMMARY

manufacturers

Distearate

for

of used

time;

surfaces,

potentially

been

STEARATE

as shampoos

Glycol

complaints

triple-pressed

SE, Glycol

beenexposed

10 reported

units

0.1%

emulsifiers,

these

with According

(b)

Detergent

years

sensitization

produced

and

caused

conc.

wax

containing

Liquids (%)

0.5 1

1 1.5

Distearates

ethylene

these

Stearate for reported

SE,

the

compounds.

noted

Glycol

products

been

containing

had

employees

that

ingredients

bob

AND

20%

having

body

reported Containing

ingredients

stearic

potentially

dispersants,

his

there.

exposed

that

the

GLYCOL

glycol

the

serves

Distearate

after Glycol

may

the

for

(various their

numerous

test

arisen

its

the

second

her (4)

4.0%

acid.

who

that This

ingredients

Range

in between Ethylene

challenge.

ethylene

distearate

labor

compounds. DISTEARATE

0.015—0.075 0.005—0.025

work

incidence

health

0.01 stick 0.01—0.05 Stearate. distearate

frequent may

been

for

they

They

a conclusion

of over

Glycol

Glycol (%)

creams

opacifiers,

—0.05

are

company,

conc.

surfactant

turnover

glycol

Glyçol 20 time;

preparations.