Document ID: EPA-HQ-OPP-2005-0250-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

Page
1
of
31
DATE:
January
25,
2006
MEMORANDUM
SUBJECT:
TRIETHYLENE
GLYCOL:
Revised
Antimicrobials
Division's
Review
of
the
Disciplinary
Sciences
for
Issuance
of
the
Reregistration
Eligibility
Decision
(
RED)
Document.
Reregistration
Case
No.:
3146.
PC
Code:
083501.
CAS
Registry
No.:
112­
27­
6.
DP#:
305169.

FROM:
Michelle
M.
Centra,
Pharmacologist/
Risk
Assessor
Najm
Shamim,
Ph.
D.,
Chemist
Timothy
Leighton,
Exposure
Assessor
Regulatory
Management
Branch
II
Jonathan
Chen,
Ph.
D.,
Toxicologist
Kathryn
Montague,
Biologist
RASSB
Antimicrobials
Division
(
7510C)

THRU:
Timothy
F.
McMahon,
Ph.
D.
Senior
Toxicologist
Antimicrobials
Division
(
7510C)

TO:
Mark
Hartman,
Branch
Chief
Ben
Chambliss,
Team
Leader
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

Attached
is
the
Antimicrobials
Division's
(
AD)
risk
assessment
supporting
issuance
of
a
Reregistration
Eligibility
Decision
(
RED)
for
the
active
ingredient,
Triethylene
Glycol,
as
well
as
a
Page
2
of
31
reassessment
of
the
tolerances
for
the
inert
agricultural
uses
of
this
chemical.
This
assessment
summarizes
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
exposure
profile,
environmental
fate
and
ecotoxicity
of
triethylene
glycol.

Based
on
its
review
and
evaluation
of
all
available
information,
AD
concludes
that
there
is
a
reasonable
certainty
of
no
harm
to
the
general
population
nor
to
infants
and
children
in
particular,
resulting
from
triethylene
glycol
exposure
as
an
active
ingredient
in
air
sanitizers
and
surface
disinfectants,
and
as
an
inert
ingredient
in
agricultural
pesticide
formulations.
As
a
result,
AD
has
determined
that
a
qualitative
approach
to
assessing
human
health
risks
from
exposure
to
this
compound
is
appropriate.

The
supporting
documentation
used
to
generate
the
triethylene
glycol
risk
assessment
is
listed
below:

1.
Background
Document
on
Triethylene
Glycol
Product
Chemistry
and
Environmental
Fate
Data
Requirements.
(
Case#:
3146)
(
Memorandum:
N.
Shamim,
8/
13/
03).

2.
TRIETHYLENE
GLYCOL:
Revised
Toxicology
Chapter
in
Support
of
Issuance
of
the
Registration
Eligibility
Decision
(
RED)
Document.
PC
Code:
083501.
Reregistration
Case
Number:
3146.
CAS
Registry
Number:
112­
27­
6.
DP#:
325786
(
Memorandum:
M.
Centra,
10/
11/
05).

3.
TRIETHYLENE
GLYCOL:
Revised
Report
of
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
Memorandum:
T.
McMahon,
11/
21/
05).

4.
EPA
ID
#
083501:
Triethylene
glycol.
Review
of
Phase
IV
response
submissions
in
support
of
FIFRA
88.
EPA
Record
No.
S444604,
S444216.
Caswell
No.
888.
PC
Code:
083501.
HED
Project
No(
s).
D193163,
D192934.
(
Memorandum:
G.
Reddy,
12/
22/
93,
TXR
#:
010715).

5.
AD's
Occupational
and
Residential
Exposure
Chapter
for
the
Triethylene
Glycol
Reregistration
Eligibility
Decision
(
RED)
Document
(
Case
No.
3146).
PC
Code
083501
(
Memorandum:
T.
Leighton,
9/
26/
03).

6.
Triethylene
Glycol
Estimated
Drinking
Water
Concentrations
(
Memorandum:
S.
Abel,
9/
26/
03).

7.
TRIETHYLENE
GLYCOL:
Incident
Report
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
PC
Code:
083501.
Case
No.
3146
(
Memorandum:
J.
Chen,
9/
22/
03).

8.
Ecological
Hazard
and
Environmental
Risk
Science
Chapters
for
the
Triethylene
Glycol
RED
(
Memorandum:
K.
Montague,
8/
28/
03).
Page
3
of
31
Page
4
of
31
9.
Science
Chapter
on:
Environmental
Fate
Studies
and
Environmental
Fate
Assessment
of
Triethylene
Glycol
(
Memorandum:
N.
Shamim,
8/
13/
03).
Page
5
of
31
TABLE
OF
CONTENTS
1.0
EXECUTIVE
SUMMARY
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4
2.0
USE
PROFILE
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8
3.0
PHYSICAL/
CHEMICALPROPERTIES
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11
4.0
HAZARD
PROFILE
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12
4.1
Incident
Reports
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4.2
Dose
Response
Assessment
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16
4.3
FQPA
Considerations
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17
5.0
EXPOSURE
ASSESSMENT
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17
5.1.
Dietary
Exposure
and
Risk
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17
5.2
Drinking
Water
Exposure
and
Risk
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17
5.3
Occupational/
Residential
Exposure
and
Risk
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17
6.0
Ecological
Toxicity/
Environmental
Fate
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19
7.0
AGGREGATE
EXPOSURE
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21
7.1
Endocrine
Disruptors
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7.2
Cumulative
Effects
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8.0
SUMMARY
OF
RISK
FINDINGS
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23
9.0
REFERENCES
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25
10.0
WEBSITES
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27
Page
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1.0
EXECUTIVE
SUMMARY
This
document
addresses
the
exposures
and
risks
from
use
of
triethylene
glycol
as
an
active
ingredient
in
air
sanitizers/
hospital
disinfectants,
and
as
an
inert
ingredient
in
agricultural
pesticide
formulations.
Potential
residential
exposures
and
risks
are
also
addressed
pursuant
to
the
language
and
intent
of
the
Food
Quality
Protection
Act
(
FQPA).

1.1
Regulatory
History
Active
ingredient
Status
The
active
ingredient,
triethylene
glycol,
was
first
registered
in
1947
by
the
FDA
for
use
in
hospitals
as
an
air
disinfectant.
As
an
active
ingredient,
triethylene
glycol
is
formulated
primarily
as
a
pressurized
liquid
and
is
used
in
two
types
of
applications:
air
sanitizers/
hospital
disinfectants,
and
pest
(
mites
and
red
lice)
control
on
caged
birds.

Inert
Ingredient
Status
As
an
inert
ingredient,
triethylene
glycol
facilitates
delivery
of
formulated
pesticide
chemical
products
that
are
used
as
herbicides,
fungicides,
insecticides,
growth
regulators
and
attractants
on
a
wide
variety
of
agricultural
commodities.

Tolerance
Exemptions
The
following
tolerance
exemption
for
triethylene
glycol
is
listed
in
40
CFR
180.920:

1.
Triethylene
glycol
is
exempted
from
the
requirement
of
a
tolerance
when
used
as
a
deactivator
in
accordance
with
good
agricultural
practice
as
inert
(
or
occasionally
active)
ingredients
in
pesticide
formulations
applied
to
growing
crops
only
2.
In
addition
to
the
above,
triethylene
glycol
is
approved
by
the
Food
and
Drug
Administration
(
FDA)
as
a
preservative
for
food
packaging
adhesives
as
listed
in
21
CFR
175.105.
Currently,
however,
there
are
no
EPA
registered
products
for
this
use.

3.
Triethylene
glycol
also
has
an
indirect
food
additive
regulation
(
21
CFR
177.1200)
for
its
use
as
a
plasticizer
in
cellophane.
This
use
is
regulated
by
the
FDA.

1.2
Hazard
Profile
Published
literature
studies
submitted
by
the
CSPA
Glycols
Joint
Venture
consortium
show
low
toxicity
(
Toxicity
Categories
III
and
IV)
following
acute
exposures
by
the
oral,
dermal,
and
inhalation
routes.
Triethylene
glycol
produces
mild
and
slight
irritation
to
the
eyes
and
skin,
respectively.
In
addition,
triethylene
glycol
is
not
a
dermal
sensitizer.
Repeat
dose
toxicity
studies
by
the
oral,
dermal,
and
inhalation
routes
at
doses
near
or
above
the
limit
doses
for
such
studies
(
1000
mg/
kg/
day
for
oral
and
dermal
studies,
1000
mg/
m3
for
inhalation
studies)
have
also
Page
7
of
31
shown
a
lack
of
systemic
toxicity
or
toxicity
only
at
doses
in
excess
of
the
limit
dose.
Triethylene
glycol
administered
orally
to
experimental
animals
in
studies
designed
to
measure
developmental
and
reproductive
toxicity
was
without
any
significant
effect
at
doses
up
to
and
including
a
limit
dose.
Chronic
exposure
of
experimental
animals
to
triethylene
glycol
at
doses
equivalent
to
or
in
excess
of
the
limit
dose
for
such
studies
has
shown
the
chemical
to
be
without
adverse
toxic
effects.
Triethylene
glycol
has
been
shown
to
be
negative
for
mutagenicity
in
a
variety
of
assays
and
has
also
been
shown
to
be
negative
for
carcinogenicity
in
experimental
animals.

Based
on
a
review
of
the
available
toxicology
data,
the
Antimicrobials
Division
concluded
that
triethylene
glycol
is
of
very
low
toxicity
by
the
oral,
dermal,
and
inhalation
routes
of
exposure.
The
toxicology
database
is
adequate
to
characterize
the
hazard
of
triethylene
glycol,
and
no
data
gaps
have
been
identified.
There
are
no
indications
of
special
sensitivity
of
infants
or
children
resulting
from
exposure
to
triethylene
glycol.
Therefore,
the
special
10x
hazard­
based
safety
factor
under
FQPA
is
not
required.

1.3
Dietary
Exposure
and
Risk
Dietary
exposure
could
potentially
occur
from
the
use
of
triethylene
glycol
as
a
preservative
in
food
packaging
adhesives,
and
from
its
use
as
an
inert
ingredient
in
agricultural
pesticide
formulations.
For
such
inert
uses,
the
Agency
has
developed
a
screening­
level
assessment
tool
with
highly
conservative
assumptions
regarding
exposure
to
a
generic
inert
used
in
such
a
manner.
In
this
model,
the
following
assumptions
are
made:
(
1)
actual
crop­
specific
residue
data
for
active
ingredients
can
be
used
as
surrogate
data
for
inert
ingredient
residue
level;
(
2)
the
inert
ingredient
is
assumed
to
be
used
on
all
crops;
(
3)
100%
of
all
crops
are
"
treated"
with
the
inert
ingredient;
and
(
4)
no
adjustment
is
made
for
the
percentage
of
the
inert
in
the
formulation,
application
rate,
or
multiple
applications
of
different
active
ingredient
formulations.
The
results
of
this
modeling
represent
an
upper­
bound
estimate
of
likely
dietary
exposure
to
an
inert
resulting
from
preharvest
use.
An
estimated
acute
and
chronic
dietary
exposure
of
less
than
1
mg/
kg/
day
is
made
from
this
model.
This
value
is
orders
of
magnitude
below
the
levels
at
which
effects
are
observed
from
exposure
to
triethylene
glycol
as
noted
in
the
hazard
profile,
and
thus
dietary
exposure
does
not
present
any
risk
of
concern.

1.4
Occupational/
Residential
Exposures
and
Risks
Although
there
is
potential
inhalation
and
dermal
handler
exposure
to
triethylene
glycol
from
use
as
an
air
sanitizer,
surface
disinfectant,
and
insecticide
for
control
of
mites
and
red
lice
in
bird
cages,
no
toxicological
endpoints
of
concern
have
been
identified
for
this
chemical,
based
on
its
low
order
of
toxicity.
In
addition
to
potential
dermal
and
inhalation
handler
exposure,
there
is
the
potential
for
postapplication
exposure
to
individuals
reentering
treated
rooms
and/
or
contacting
sprayed
surfaces.
The
Office
of
Prevention,
Pesticides
and
Toxics
(
OPPT)
has
developed
a
model,
EFAST
(
Exposure
and
Fate
Assessment
Screening
Tool),
to
estimate
air
concentrations.
EFAST
bases
its
estimates
on
physical/
chemical
properties.
Modeled
results
indicate
a
screeninglevel
high
end,
peak
concentration
of
8.54
mg/
m3.
This
exposure
estimate,
while
highly
Page
8
of
31
conservative,
is
orders
of
magnitude
below
concentrations
at
which
effects
were
observed
in
inhalation
studies
with
experimental
animals
(
levels
in
excess
of
the
limit
concentration
of
1000
mg/
m3)
and
thus
postapplication
exposure
does
not
present
a
risk
of
concern.
Page
9
of
31
1.5
Ecological
Toxicity
As
a
result
of
the
Phase
IV
review
of
triethylene
glycol
for
reregistration
under
FIFRA,
ecological
effects
data
requirements
were
waived
due
to
the
intended
use
of
triethylene
glycol
as
an
indoor
microbiocide,
its
high
volatility,
and
known
low
toxicity
(
it
is
a
preferred
solvent
for
aquatic
organism
toxicity
tests).
Data
obtained
from
published
studies
provide
additional
confirmation
of
the
low
toxicity
of
the
compound
to
fish
and
aquatic
invertebrates
and
show
LC
50
values
ranging
from
10,000
to
77,400
ppm.

1.6
Environmental
Risk
For
the
RED,
the
Agency
has
relied
on
readily
available
open
literature
data
that
characterizes
the
fate
properties
of
triethylene
glycol.
The
results
of
these
studies
indicate
that
triethylene
glycol
is
miscible
in
water,
mobile
in
soils
and
stable
to
abiotic
degradation
hydrolysis
and
soil
and
aquatic
photolysis.
Biodegradation
is
expected
to
proceed
rapidly
in
surface
waters
based
on
a
number
of
River
Dye­
away
tests
(
complete
mineralization
between
7
and
11
days)
and
will
degrade
in
soils
in
days
(
primary
degradation)
to
weeks
(
complete
mineralization)
based
on
sludge
innoculum
studies
and
predictions
of
ready
biodegradability.

The
estimated
environmental
concentrations
of
triethylene
glycol
from
use
as
an
active
ingredient
(
indoor
use)
and
from
agricultural
and
non­
agricultural
(
outdoor)
inert
uses
in
surface
water
would
not
likely
exceed
a
peak
(
24­
hour
time
averaged)
concentration
of
885
ppb
or
an
annual
average
(
single
year)
concentration
of
29
ppb.
Estimated
concentrations
in
ground
water
would
not
likely
exceed
106
ppb.
Estimated
exposures
from
indoor
use
of
triethylene
glycol
as
the
active
ingredient
and/
or
as
an
inert
ingredient
are
unlikely
to
result
in
surface
water
concentrations
greater
than
those
from
outdoor
uses.
The
estimated
dose
from
the
highest
estimated
environmental
concentration
of
885
ppb
would
be
approximately
0.025
mg/
kg/
day,
an
intake
that
is
orders
of
magnitude
below
the
level
at
which
effects
are
observed
from
exposure
to
triethylene
glycol.
Thus,
estimated
concentrations
in
drinking
water
do
not
present
any
risks
of
concern.

1.7
Conclusions
From
the
available
animal
studies
and
other
data,
EPA
concludes
that
triethylene
glycol
exhibits
low
toxicity
and
that
there
is
a
reasonable
certainty
of
no
harm
to
the
general
population
as
well
as
infants
and
children
from
aggregate
exposures
to
triethylene
glycol
as
both
an
active
or
inert
ingredient,
including
all
anticipated
dietary
(
food
and
water)
exposures
and
all
other
types
of
exposures
for
which
there
is
reliable
information.
Page
10
of
31
2.0
USE
PROFILE
Triethylene
glycol
is
an
aliphatic
alcohol
prepared
from
ethylene
oxide
and
ethylene.
It
is
produced
commercially
as
a
by­
product
of
ethylene
glycol
production;
formation
of
an
ether­
ester
of
HCOCH
2
COOH
with
glycol
followed
by
hydrogenation.
1
The
major
applications
for
triethylene
glycol
are
as
(
1)
a
dehydration
agent
for
natural
gas,
(
2)
a
humectant
in
printing
inks,
gums,
resins
and
tobacco,
(
3)
a
non­
volatile
industrial
solvent,
emulsifier
and
extractant,
(
5)
a
lubricant
in
printing
inks,
textile
dyeing,
pharmaceuticals
and
cosmetics,
(
6)
a
plasticizer
in
the
manufacture
of
vinyl,
polyester,
polyurethane
resins,
cellophane,
glue,
cork,
powdered
ceramics
and
some
plastics
and
(
7)
a
heat
transfer
medium.
It
is
also
used
in
the
synthesis
of
some
organic
derivatives.

As
an
air
sanitizer,
this
active
ingredient
has
numerous
listed
active
use
sites
including
household
or
domestic
dwellings,
automobiles,
taxis,
limousines,
hospitals,
commercial
and
industrial
equipment,
laundry
equipment,
bathroom
premises,
refuse
and
solid
waste
containers,
and
hard
non­
porous
surface
treatments.

As
an
inert
ingredient,
triethylene
glycol
facilitates
delivery
of
formulated
pesticide
chemical
products
that
are
used
as
herbicides,
fungicides,
insecticides,
growth
regulators
and
attractants
on
the
following
commodities:
alfalfa,
alfalfa
(
forage),
almonds,
apples,
apricots,
artichokes,
arugula
(
foliar
treatment),
asparagus,
atenoya,
avocados,
bananas,
barley,
barley
(
grain
crop),
beans,
crensahw
melons,
beans
(
all
or
unspecified),
beech
nuts,
beets
(
all
or
unspecified),
black
sapote,
black
walnuts,
blackberries,
blueberries,
boisenberries,
brazil
nuts,
broccoli,
broccoli
raab,
brusselsprouts,
butternuts,
cabbage,
canistel,
cantaloupes,
carambolas,
carrots,
cashews,
cauliflower,
celeriac,
celery
(
all
or
unspecified),
cherries,
chestnuts,
chinese
mustard
(
foliar
treatment),
chinese
cabbage,
chinquapin
(
forest),
fallow
or
idle
agricultural
land
chive,
christmas
tree
plantations,
citrus
fruits
(
all
or
unspecified),
citrus
hybrids,
clover,
cocoa,
coffee,
collards,
conifers,
corn
(
all
or
unspecified),
corn
(
sweet),
corn
(
field
and/
or
foliage),
corn
(
pop),
cotton
(
all
or
unspecified),
crabapples,
cranberries,
cucumbers,
cucurbits,
currants,
dandelion,
deciduous
fruit,
dill,
eggplant,
endive,
field
corn,
grapefruit,
filberts,
flax
(
all
or
unspecified),
flue­
cured
tobacco,
forage
and
fodder
grasses,
garlic,
gooseberries,
gourds,
grapes,
guava,
hickory
nuts,
honey
ball
melons,
honeydew
melons,
hops,
kale,
kiwi,
kohlrabi,
kumquats,
leafy
vegetables,
lemons,
lettuce
(
all
or
unspecified),
limes,
litchi
nuts,
loganberries,
loquats,
macadamia
nuts,
mamey
sapote,
mangos,
melons,
mint
(
all
or
unspecified),
muskmelons,
mustard
(
all
or
unspecified),
nectarines,
nonbearing
deciduous
fruits,
nuts,
oats,
oats
(
grain
crop),
olives
(
all
or
unspecified),
onions
(
dry),
oranges
(
all
or
unspecified),
papayas,
parsley,
parsnips,
passion
fruit,
pastures
(
all
or
unspecified),
peaches,
peanuts
(
all
or
unspecified),
pears,
peas,
pecans,
peppermint,
peppers
(
non­
bell
type),
peppers
sweet
(
bell
type),
peppers,
pineapple,
pistachio
nuts,
plums,
potatoes,
proso
millet,
prunes,
pumpkin,
quinces,
radishes,
rangeland
(
all
or
unspecified),
rape
(
all
or
unspecified),
raspberries,
rice
(
grain),
rutabagas,
rye
(
grain
crop),
safflowers,
Page
11
of
31
sapodillaseed,
silage,
sorghum
(
all
or
unspecified),
sorghum,
sorghum
(
forage
or
fodder),
soybeans
(
all
or
unspecified),
spinach,
squash,
star
apple,
stone
fruits
(
unspecified)
strawberries,
succulent
lima
beans,
sudangrass
(
forage
or
fodder),
sugar
apple,
sugar
beets
(
all
or
unspecified),
sugarcane
(
sugar
crop),
summer
squash,
sweet
potatoes,
swiss
chard,
tangelos,
tangerines,
tobacco,
tomatoes,
triticale
(
grain
crop),
turnips,
walnuts,
wastelands,
watercress,
watermelons,
wheat
(
grain
crop).

The
active
ingredient,
triethylene
glycol,
was
first
registered
by
the
EPA
as
an
air
sanitizer
on
August
3,
1948
(
James
Varley
&
Sons'
Glyco
Mist,
EPA
Reg.
No.
421­
21).
The
majority
of
the
triethylene
glycol
formulated
pesticide
product
producers
are
represented
by
a
consortium
called
the
CSPA
(
Consumer
Specialty
Products
Association)
Glycols
Joint
Venture.
The
member
companies
currently
represented
by
this
consortium
are:
Amrep,
Inc.,
Medo
Industries,
Inc.,
S.
C.
Johnson
&
Son,
Waterbury
Companies,
Inc.
and
Chase
Products
Co.

Triethylene
glycol
is
formulated
primarily
as
a
pressurized
liquid
and
is
used
in
two
types
of
applications:
air
sanitizers/
hospital
disinfectants
and
pest
(
mites
and
red
lice)
control
on
caged
birds.
For
each
use
category,
Table
1
lists
the
registrants
and
their
respective
EPA
registration
numbers
for
products
containing
triethylene
glycol
(
0.1
to
9.15%
active
ingredient).

Table
1.
EPA
Registration
Numbers
for
Triethylene
Glycol
Products
Use
Category
Formulation
Companies
EPA
Registration
Numbers
Air
Sanitizer/
Disinfectant
Pressurized
Liquid
S.
C.
Johnson
&
Son,
Inc.
4822­
293,
­
531
Air
Sanitizer/
Disinfectant
Pressurized
Liquid
Waterbury
Companies,
Inc.
9444­
19,
­
136
Air
Sanitizer/
Disinfectant
Pressurized
Liquid
Amrep,
Inc.
10807­
7,
­
24,
­
26,
­
37,
­
38,
­
39,
­
43,
­
72
Air
Sanitizer/
Disinfectant
Pressurized
Liquid
Quest
Chemical
Corporation
44446­
20
Air
Sanitizer/
Disinfectant
Pressurized
Liquid
Medo
Industries,
Inc.
51838­
1,
­
2
Mite
and
Lice
Control
Pressurized
Liquid
Speer
Products,
Inc.
11715­
20
In
1997,
the
Office
of
Pesticide
Programs,
Health
Effects
Division
conducted
an
evaluation
of
the
toxicity
of
the
active
ingredient,
triethylene
glycol
as
required
by
law
under
FIFRA
for
the
reregistration
of
pesticidal
chemicals.

The
triethylene
glycol
mammalian
toxicity
database
consisted
of
published
literature
studies
and
monographs
submitted
by
the
Glycols
Joint
Venture
as
a
result
of
the
Phase
IV
review
of
Page
12
of
31
triethylene
glycol
for
reregistration
under
FIFRA.
These
submitted
data
were
reviewed
by
the
Agency
and
classified
as
acceptable
or
waived
as
indicated
below
in
Table
2.
At
that
time,
these
data
were
determined
to
satisfy
the
Subdivision
F
test
guideline
requirements
and
no
additional
data
requirements
were
identified
for
the
non­
food
use
of
triethylene
glycol.
1
Page
13
of
31
Table
2.
Data
Requirements
for
Non­
Food
Use
of
Triethylene
Glycol
(
1997)

Guideline
Number
Study
Type
Required
Satisfied
§
81­
1
Acute
Oral
­
Rat
Yes
Yes
§
81­
2
Acute
Dermal
­
Rabbit
Yes
Waived
§
81­
3
Acute
Inhalation
­
Rat
Yes
Yes
§
81­
4
Primary
Eye
Irritation
Yes
Yes
§
81­
5
Primary
Dermal
Irritation
Yes
Yes
§
81­
6
Skin
Sensitization
Yes
Yes
§
82­
1a
Subchronic
Oral
­
Rodent
No
No
§
82­
1b
Subchronic
Oral
­
Non
Rodent
Yes
Yes
§
82­
2
21­
Day
Dermal
Yes
Yes
§
82­
4
90­
Day
Inhalation
Yes
Yes
§
83­
3a
Developmental
Toxicity
­
Rodent
Yes
Yes
§
83­
3b
Developmental
Toxicity
­
Non
Rodent
Yes
Yes
§
83­
4
Reproductive
Toxicity
­
Rodent
Yes
Yes
§
83­
1b
Chronic
Toxicity
­
Non
Rodent
Yes
Yes
§
83­
1a
Carcinogenicity
­
Rodent
Yes
Yes
§
84­
2
Gene
Mutation
­
Ames
Yes
Waiveda
§
84­
2
Cytogenetics
­
Structural
Chromosomal
Aberration
Yes
Waiveda
§
85­
1
General
Metabolism
Yes
Yes
aThe
data
waivers
granted
by
the
Agency
in
1997
for
the
triethylene
glycol
mutagenicity
assays
are
no
longer
applicable
to
this
chemical.
Several
mutagenicity
assays
submitted
to
the
Agency's
Office
of
Prevention,
Pesticides
and
Toxics
were
reviewed
by
OPP's
Antimicrobials
Division
and
determined
to
be
acceptable/
non­
guideline
studies.
These
four
mutagenicity
studies
have
been
incorporated
into
the
toxicity
data
base
for
triethylene
glycol.

Tolerance
Exemptions
The
following
tolerance
exemption
for
triethylene
glycol
is
listed
in
40
CFR
180.920:

1.
Triethylene
glycol
is
exempted
from
the
requirement
of
a
tolerance
when
used
as
a
deactivator
in
accordance
with
good
agricultural
practice
as
inert
(
or
occasionally
active)
ingredients
in
pesticide
formulations
applied
to
growing
crops
only
Page
14
of
31
2.
In
addition
to
the
above,
triethylene
glycol
is
approved
by
the
Food
and
Drug
Administration
(
FDA)
as
a
preservative
for
food
packaging
adhesives
as
listed
in
21
CFR
175.105.
Currently,
however,
there
are
no
EPA
registered
products
for
this
use.

3.
Triethylene
glycol
also
has
an
indirect
food
additive
regulation
(
21
CFR
177.1200)
for
its
use
as
a
plasticizer
in
cellophane.
This
use
is
regulated
by
the
FDA.

3.0
PHYSICAL
AND
CHEMICAL
PROPERTIES
Triethylene
glycol
(
CAS
Registry
Number:
112­
27­
6)
is
a
colorless
to
pale
straw­
colored,
essentially
odorless,
viscous,
hygroscopic
liquid
with
the
following
chemical
properties:
molecular
weight
of
150.20
amu,
boiling
point
of
285
o
C
at
760
mm
Hg
and
165
o
C
at
14
mm
Hg,
melting
point
of
­
5
o
C
(­
7
o
C),
specific
gravity
of
1.1274,
vapor
pressure
of
0.01
mm
Hg
at
20
o
C
(
0.00132
mm
Hg
at
25
o
C),
Log
K
OW
(
octanol/
water
partition
coefficient)
of
­
1.75,
Henry's
Law
Constant
(
air/
water
partition
coefficient)
of
3.1
x
10­
11
atm
m3/
mole
and
K
OC
(
organic
carbon
ratio
in
soil)
of
10.
Triethylene
glycol
does
not
absorb
UV
light
at
wavelengths
above
290
nm.
It
is
highly
miscible
in
water
and
is
soluble
in
alcohol,
benzene
and
toluene.
Triethylene
glycol
is
practically
insoluble
in
aliphatic
hydrocarbons
and
fats
is
insoluble
in
petroleum
ether
and
many
common
solvents.
2
­
8
Common
Name:
Triethylene
Glycol
Chemical
Name:
1,2­
Bis(
hydroxyethoxy)
ethane,
2,2'­[
1,2­
Ethanediylbis(
Oxy)],
Bisethanol
Ethanol,
2,2'­[
1,2­
Ethanediylbis(
Oxy)]
Bis
Molecular
Formula:
C
6
H
14
O
4
Structure:
OH­
CH
2
­
CH
2
­
O­
CH
2
­
CH
2
­
O­
CH
2
­
CH
2
­
OH
Page
15
of
31
4.0
HAZARD
PROFILE
Acute
Toxicity
Published
literature
studies
submitted
by
the
Glycols
Joint
Venture
consortium
show
low
toxicity
(
Toxicity
Categories
III
and
IV)
following
acute
exposures
(
Table
3).
The
acute
oral
and
dermal
toxicity
of
the
chemical
appears
to
be
low,
with
reported
oral
LD
50
values
ranging
from
15­
22
g/
kg
compiled
from
monographs
and
review
articles.
The
data
available
on
acute
dermal
toxicity
were
insufficient
to
establish
a
dermal
LD
50
,
but
the
data
requirement
was
waived
based
on
the
low
order
of
toxicity
observed
in
other
studies
with
triethylene
glycol.
Data
on
inhalation
toxicity
showed
a
maximum
tolerated
level
of
800
mg/
m3
in
rats,
but
intratracheal
instillation
of
0.25
cc
undiluted
chemical
caused
marked
pulmonary
irritation,
edema,
and
later,
fibrosis
and
abcess
formation
in
these
animals
(
intratracheal
instillation
is
not
an
accepted
route
of
administration
for
the
Agency's
toxicity
testing
guidelines).
Published
literature
data
on
the
skin
and
eye
irritation
as
well
as
skin
sensitization
showed
triethylene
glycol
to
be
non­
irritating
to
the
skin
and
eye
(
when
tested
at
the
limit
doses
established
by
the
Agency
for
acute
toxicity
testing)
and
not
a
dermal
sensitizer.
1,
8,
9,
10
Triethylene
glycol
was
evaluated
for
acute
inhalation
toxicity
in
male
and
female
Sprague­
Dawley
albino
rats
in
a
study
submitted
to
the
Agency's
Office
of
Toxic
Substances.
A
review
of
this
study
by
the
Antimicrobials
Division
established
a
four
hour
LC
50
greater
than
5.2
mg/
L,
and
places
acute
inhalation
in
Toxicity
Category
IV.
Based
on
these
results,
this
study
was
determined
to
be
adequate
for
regulatory
purposes
and
it
now
replaces
the
earlier
submitted
acute
inhalation
information.
11
Table
3.
Acute
Toxicity
Profile
of
Triethylene
Glycol
Guideline
Study
Type
MRID
No.
Results
Toxicity
Category
870.1100
Acute
Oral
Toxicity
42814404
LD50
=
15­
22
g/
kg
IV
870.1200
Acute
Dermal
Toxicity
42814404
LD50
not
determined
Study
requirement
waived
870.1300
Acute
Inhalation
Toxicity
OTS0527779­
2
LC50
>
5.2
mg/
L
IV
870.2400
Acute
Eye
Irritation
Toxicity
42814404
mild
irritant
III
870.2500
Acute
Skin
Irritation
Toxicity
42814404
slight
irritant
IV
870.2600
Skin
Sensitization
42814404
non­
sensitizer
N/
A
N/
A
=
Not
applicable
Page
16
of
31
Subchronic
Toxicity
Repeat
oral
dosing
studies
conducted
in
rats
to
determine
triethylene
glycol
toxicity
showed
in
general,
that
the
chemical
was
either
without
any
adverse
effects
or
produced
toxicities
only
at
doses
at
or
greater
than
the
limit
doses
established
for
EPA
guideline
test
requirements.
Triethylene
glycol
administered
in
the
drinking
water
to
rats
at
concentrations
of
3%
and
5%
by
volume
for
30
days
showed
signs
of
toxicity
(
weight
loss,
alopecia
and
poor
grooming)
at
the
lower
concentration
with
one
animal
dying
on
day
25
of
the
study.
All
rats
in
the
3%
test
group
survived
to
study
completion
with
no
signs
of
toxicities.
12
In
a
14­
day
oral
toxicity
study,
Fischer
344
rats
receiving
triethylene
glycol
in
the
feed
(
doses
equivalent
to
1132,
2311
or
3916
mg/
kg/
day
for
males
and
1177,
2411
or
6209
mg/
kg/
day
for
females)
showed
only
changes
in
urinalysis
(
increased
urine
volume,
decreased
urine
pH,
and
decreased
urine
triple
phosphate
crystals)
at
the
highest
respective
doses
tested
in
male
and
female
rats.
13
In
a
third
oral
toxicity
study
conducted
for
90­
days
in
rats,
triethylene
glycol
was
administered
in
the
diet
at
doses
of
748,
1522
or
3849
mg/
kg/
day
(
males),
and
848,
1699
or
4360
mg/
kg
(
females).
Although
toxicities
were
noted
at
the
high
dose
in
male
and
female
rats
(
decreases
in
body
weight,
slight
decreases
in
hemoglobin
and
hematocrit,
slight
increases
in
mean
corpuscular
volume,
and
increased
relative
kidney
and
brain
weights),
these
effects
were
noted
at
dose
levels
that
exceed
the
established
limit
dose
of
1000
mg/
kg/
day
for
such
studies.
14
In
a
21­
day
dermal
toxicity
study,
there
was
no
evidence
of
dermal
or
systemic
toxicity
from
repeated
dermal
applications
of
2ml
(
approximately
600
mg/
kg)
triethylene
glycol
applied
to
the
skin
of
rabbits.
These
results
are
supported
by
triethylene
glycols'
low
dermal
irritancy
a
negative
response
as
a
skin
sensitizer.
15,
16
Sprague­
Dawley
rats
exposed
(
whole
body)
to
triethylene
glycol
in
an
aerosol
inhalation
study
at
concentrations
of
494,
2011,
or
4842
mg/
m3
(
0.5,
2.0,
or
5.0
mg/
L/
day),
for
six
hours
a
day,
nine
times
over
a
two­
week
period
showed
the
following
toxicities
at
the
highest
concentration
level
tested:
ataxia,
prostration,
unkept
fur,
labored
respiration
(
males
only),
ocular
discharge,
swollen
periocular
tissue,
perinasal
and
perioral
encrustation,
blepharospasm
and
reduced
body
weight
Necropies
revealed
hyperinflation
of
the
lungs,
ocular
opacity,
congestion
and
hemorrhage
in
many
organs
and
tissues
(
pituitary
gland,
brain,
nasal
mucosa,
kidney,
thymus
and
lungs).
All
of
the
rats
in
the
high
dose
group
died
or
were
sacrificed
moribund
by
day
5
of
the
study.
Clinical
signs
of
toxicity
observed
at
the
low­
and
mid­
dose
of
0.5
and
2.0
mg/
L/
day,
respectively,
were
limited
to
swollen
periocular
tissues
and
perinasal
encrustations.
Treatment­
related
changes
in
organ
weights
in
mid­
dose
males
included
an
increase
in
liver
and
kidney
weights
relative
to
body
weight;
mid­
dose
females
showed
increases
in
absolute
and
relative
(
to
body
and
brain
weights)
liver
and
kidney
weights.
Statistically
significant
clinical
chemistry
findings
for
males
treated
with
2.0
mg/
L/
day
triethylene
glycol
included
an
increase
in
ALT
activity
and
a
decrease
in
serum
creatinine
levels.
Mid­
dose
females
showed
increases
in
urea
nitrogen,
inorganic
phosphorus,
ALT
and
ALK
activity,
and
decreases
in
glucose,
creatinine,
and
chloride.
However,
the
changes
in
organ
weights
and
clinical
chemistry
findings
were
not
correlated
with
any
histopathological
observations.
17
Page
17
of
31
Rats
exposed
to
the
test
material
via
a
whole­
body
inhalation
protocol
are
also
receiving
the
chemical
via
the
oral
and
dermal
routes.
These
additional
routes
of
exposure
may
have
increased
the
total
dose
received
and
contributed
to
the
toxicities
observed
in
the
whole­
body
exposure
inhalation
study.
Therefore,
a
second
study
was
conducted
using
a
nose­
only
exposure
for
6
hours
a
day,
9
consecutive
days.
In
this
second
inhalation
toxicity
study,
mean
exposure
concentrations
of
102,
517,
or
1036
mg/
m3
(
approximately
0.1,
0.5,
1.0
mg/
L/
day)
triethylene
glycol
produced
no
treatment­
related
toxicities
at
any
dose
tested.
18
Monkeys
exposed
by
inhalation
to
approximately
1
ppm
vapor
from
two
weeks
to
13
months
and
human
volunteers
exposed
to
air
saturated
with
vapor
(
approximately
0.5
to
1
ppm)
showed
no
adverse
reactions
or
histopathological
changes
suggestive
of
toxicity
from
prolonged
exposure
to
triethylene
glycol.
19
Dogs
given
daily
intravenous
injections
(
0.1
or
0.5
ml/
kg)
of
triethylene
glycol
for
four
weeks
showed
no
mortality
or
toxicity
with
the
exception
of
flattened
epithelial
cells
in
the
urine
and
phlebitis
at
the
site
of
injection.
20
Chronic
Toxicity
and
Carcinogenicity
Published
literature
sources
examining
the
chronic
toxicity
and
carcinogenic
potential
of
triethylene
glycol
have
shown
the
chemical
to
be
non
toxic/
negative
in
rodent
species.

In
a
12
month
study,
monkeys
receiving
triethylene
glycol
(
0.25
mL
to
0.5
mL)
orally
in
egg
nog
(
approximately
50
to
100
times
the
quantity
an
animal
could
absorb
by
breathing
air
saturated
with
glycol)
were
without
any
adverse
effects
in
physiological
functions
or
organ
histopathology.
19
Triethylene
glycol
administered
in
feed
at
levels
of
0,
1,
2
or
4%
to
Osborn­
Mendel
rats
for
2
years
showed
that
the
body
weight
gains,
hematological
parameters
and
clinical
chemistries
were
not
affected
by
treatment.
Under
the
conditions
of
this
study,
triethylene
glycol
was
not
carcinogenic
in
rats.
The
dosages
tested
in
rats
are
equivalent
to
as
much
as
3
to
4
g/
kg/
day
which
are
well
above
the
upper
limit
dose
of
1
g/
kg/
day
(
1000
mg/
kg/
day)
for
testing
pesticides
via
the
oral
route
in
subchronic
and
chronic
toxicity
studies.
21
Mutagenicity
Triethylene
glycol
was
tested
for
mutagenic
or
genotoxic
potential
and
found
to
be
negative
in
a
battery
of
studies:
a
bacterial
gene
mutation
assay
using
Salmonela
typhimurium,
an
in
vitro
Chinese
hamster
ovary
(
CHO)
mutation
assay,
an
in
vitro
Chinese
hamster
ovary
(
CHO)
chromosomal
aberration
assay
and
an
in
vitro
sister
chromatid
exchange
assay.
22
­
25
Dermal
Absorption
No
studies
have
been
reported
dealing
with
the
skin
absorption
of
triethylene
glycol.
Page
18
of
31
Although
it
is
possible
that,
under
conditions
of
very
severe
prolonged
exposures
to
this
chemical,
absorption
through
the
skin,
it
is
doubtful
any
appreciable
systemic/
dermal
injury
would
occur
because
triethylene
glycol
has
(
1)
a
low
order
of
dermal
irritancy,
(
2)
is
not
a
skin
sensitizer,
and
(
3)
showed
no
evidence
of
dermal
or
systemic
toxicity
following
repeated
dermal
applications
of
2ml
(
approximately
600
mg/
kg)
triethylene
glycol
applied
to
the
skin
of
rabbits
in
a
21­
day
dermal
toxicity
study.

Metabolism
and
Excretion
The
fate
of
14C­
labeled
triethylene
glycol
in
rats
and
of
unlabeled
material
in
rabbits
was
recently
studied.
Following
oral
dosing,
the
rat
and
rabbit
excreted
most
of
the
triethylene
glycol
in
both
unchanged
and/
or
oxidized
forms
(
mono­
and
dicarboxylic
acid
derivatives
of
triethylene
glycol).
In
rabbits
dosed
with
200
or
2000
mg/
kg
triethylene
glycol
respectively
excreted
34.3%
or
28%,
of
the
administered
dose
in
the
urine
as
unchanged
triethylene
glycol
and
35.2%
as
a
hydroxyacid
form
of
this
chemical.
In
the
studies
with
rats,
little
if
any
C14­
oxalate
or
C14­
triethylene
glycol
in
conjugated
form
was
found
in
the
urine.
Trace
amounts
of
orally
administered
14C
triethylene
glycol
were
excreted
in
expired
air
as
carbon
dioxide
(<
1%)
and
in
detectable
amounts
in
feces
(
2
to
5
%).
The
total
elimination
of
radioactivity
(
urine,
feces
and
CO
2
)
during
the
five
day
period
following
an
oral
dose
of
labeled
compound
(
22.5
mg)
ranged
from
91
to
98%.
The
majority
of
the
radioactivity
appeared
in
the
urine.
26
Developmental
and
Reproductive
Toxicity
Triethylene
glycol
was
administered
orally
at
doses
of
0,
0.5,
5.6,
and
11.27
g/
kg/
day
in
timed
pregnant
CD­
1
mice
from
gestation
days
6
through
15.
There
were
no
treatment
related
maternal
deaths
and
no
abortions.
Hyperactivity
and
rapid
respiration
were
observed
at
the
highest
dose
level.
No
effects
were
observed
on
maternal
weight
gain
or
food
consumption
at
any
dose
level.
Pregnancy
outcome
was
unaffected
at
any
dose
level
tested.
There
were
no
treatment­
related
effects
on
external
or
visceral
malformations
in
offspring.
Some
evidence
of
delayed
ossification
was
observed
at
the
high
dose
level.
27
In
a
second
study,
pregnant
Sprague­
Dawley
rats
were
administered
triethylene
glycol
by
gavage
on
gestation
days
6
through
15
at
dose
levels
of
0,
1.0,
5.6,
and
11.27
g/
kg/
day.
There
were
no
effects
on
maternal
mortality
and
there
were
no
abortions.
Clinical
toxicity
was
observed
in
maternal
rats
at
the
high
dose
and
consisted
of
audible
respiration,
periocular
encrustation,
and
perioral
wetness.
Decreased
body
weight
and
food
consumption
was
observed
in
maternal
rats
at
the
5.6
g/
kg/
day
dose.
No
effects
were
observed
at
the
1.0
g/
kg/
day
dose.
In
offspring,
mean
fetal
body
weight
was
decreased
at
the
11.27
g/
kg/
day
dose
level,
but
there
were
no
treatmentrelated
increases
in
external,
visceral
or
skeletal
malformations.
28
Published
literature
examined
the
effect
of
triethylene
glycol
on
reproduction
in
Swiss
CD­
1
mice.
Doses
of
0,
0.3,
1.5,
and
3%
were
administered
in
drinking
water
using
a
continuous
breeding
protocol.
No
effects
on
reproductive
function
were
observed
at
any
dose
level
tested
(
up
to
the
high
dose
of
6.78
g/
kg)
including
sperm
concentration,
morphology,
and
motility.
Reduced
Page
19
of
31
pup
weight
was
observed
at
the
1.5
and
3%
doses
of
triethylene
glycol.
29,
30
In
a
study
submitted
to
the
Agency,
rats
were
exposed
to
an
atmosphere
saturated
with
triethylene
glycol
(
approx.
1
ppm)
for
12­
18
months
with
no
adverse
reproductive
effects
noted.
19,
31
The
available
developmental
and
reproductive
studies
conducted
with
triethylene
glycol
are
from
published
sources
or
from
studies
submitted
to
the
Office
of
Toxic
Substances
and
do
not
report
all
the
data
that
are
normally
reported
under
the
OPPTS
870
toxicity
test
guidelines.
However,
it
is
apparent
that
the
toxicities
observed
in
these
studies
are
consistently
manifested
only
at
doses
of
triethylene
glycol
that
exceed
the
established
limit
doses
for
animal
studies
and
are
of
a
non­
specific
nature.
Therefore,
there
is
no
concern
for
the
developmental
or
reproductive
toxicity
of
triethylene
glycol.

Neurotoxicity
From
the
available
repeat
dose
toxicity
studies,
there
was
no
evidence
of
neurotoxicity
of
triethylene
glycol,
however,
the
toxicology
data
are
inadequate
to
characterize
repeated
dose
toxicity.
Therefore,
neurotoxicity
testing
could
be
required
if
additional
data
are
needed
for
future
uses
of
triethylene
glycol.

4.1
Incident
Reports
As
early
as
1943,
interest
in
the
toxicity
of
triethylene
glycol
when
inhaled
was
initiated
by
the
observation
that
triethylene
glycol
was
an
effective
air
sanitizer.
During
these
early
studies
conducted
on
the
effectiveness
of
triethylene
glycol,
numerous
persons
were
exposed
and
according
to
these
reports,
none
were
adversely
affected.
In
addition,
human
exposure
in
the
occupational
handling
and
use
of
triethylene
glycol
has
been
uneventful
and
without
reported
cases
of
any
adverse
effects.

However,
numerous
reports
retrieved
from
the
OPP
Incident
Data
System,
Poison
Control
Centers,
California
Department
of
Pesticide
Regulation
(
1982­
2003),
National
Pesticide
Telecommunications
Network
(
NPTN)
and
published
reports
in
the
scientific
literature
have
been
associated
with
exposure
to
end­
use
products
containing
triethylene
glycol.
Inhalation
exposure
is
the
primary
exposure
route
in
these
reported
cases
followed
by
dermal
exposure.
Most
of
the
incidences
are
related
to
inhalation
irritation
and/
or
allergic­
type
reaction.
The
reported
symptoms
include
respiratory
irritation,
coughing,
chest
tightness,
difficulty
breathing,
shortness
of
breath,
and
wheezing.
However,
all
the
reported
incidences
involve
exposure
to
end­
use
products
(
residential
use)
with
greater
than
50%
of
these
incidences
documented
during
human
safety
testing
of
one
specific
air
sanitizer
product.
In
addition,
there
is
no
one
incident
reported
that
identifies
triethylene
glycol
as
the
single
chemical
exposure;
the
other
ingredients
in
the
enduse
products
may
be
substances
contributing
to
most
or
all
of
the
symptoms
reported.

4.2
Dose
Response
Assessment
Page
20
of
31
On
February
25,
2003,
the
Agency's
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
reevaluated
the
available
Toxicology
data
for
Triethylene
glycol
and
discussed
endpoint
selection
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
triethylene
glycol
was
also
evaluated
by
the
committee
in
order
to
meet
the
statutory
requirements
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

In
addition
to
the
submitted
mammalian
toxicity
data,
study
reports
were
obtained
and
reviewed
from
other
sources:
published
studies
from
the
scientific
literature
and
study
reports
submitted
to
the
Agency's
Office
of
Toxic
Substances.

The
ADTC
concluded
that
there
were
no
endpoints
of
concern
for
oral,
dermal
or
inhalation
exposure
to
triethylene
glycol
based
on
the
low
toxicity
profile
from
the
available
toxicology
studies.

4.3
Hazard­
based
Special
FQPA
Safety
Factor(
s)
for
Infants
and
Children
Based
on
the
data
available
for
triethylene
glycol,
there
is
no
pre­
or
post­
natal
evidence
for
increased
susceptibility
following
exposure
to
this
active
ingredient.
As
there
are
no
active
food
uses
registered
by
the
EPA
for
triethylene
glycol,
the
Antimicrobials
Division
determined
that
the
special
10x
hazard­
based
safety
factor
under
the
FQPA
is
not
applicable
at
this
time.
This
issue
can
be
revisited
if
food
uses
become
active
in
the
future.

5.0
EXPOSURE
ASSESSMENT
5.1
Dietary
Exposure
Dietary
exposure
could
potentially
occur
from
the
use
of
triethylene
glycol
as
a
preservative
in
food
packaging
adhesives,
and
from
its
use
as
an
inert
ingredient
in
agricultural
pesticide
formulations.
For
such
inert
uses,
the
Agency
has
developed
a
screening­
level
assessment
tool
with
highly
conservative
assumptions
regarding
exposure
to
a
generic
inert
used
in
such
a
manner.
In
this
model,
the
following
assumptions
are
made:
(
1)
actual
crop­
specific
residue
data
for
active
ingredients
can
be
used
as
surrogate
data
for
inert
ingredient
residue
level;
(
2)
the
inert
ingredient
is
assumed
to
be
used
on
all
crops;
(
3)
100%
of
all
crops
are
"
treated"
with
the
inert
ingredient;
and
(
4)
no
adjustment
is
made
for
the
percentage
of
the
inert
in
the
formulation,
application
rate
or
multiple
applications
of
different
active
ingredient
formulations.
The
results
of
this
modeling
represent
an
upper­
bound
estimate
of
likely
dietary
exposure
to
an
inert
resulting
from
preharvest
use.
An
estimated
acute
and
chronic
dietary
exposure
of
less
than
1
mg/
kg/
day
is
made
from
this
model.
This
value
is
orders
of
magnitude
below
the
levels
at
which
effects
are
observed
from
exposure
to
triethylene
glycol
as
noted
in
the
hazard
profile,
and
thus
dietary
exposure
does
not
present
any
risk
of
concern.

5.2
Drinking
Water
Exposure
Page
21
of
31
The
estimated
environmental
concentrations
of
triethylene
glycol
from
use
as
an
active
ingredient
(
indoor
use)
and
from
agricultural
and
non­
agricultural
(
outdoor)
inert
uses
in
surface
water
would
not
likely
exceed
a
peak
(
24­
hour
time
averaged)
concentration
of
885
ppb
or
an
annual
average
(
single
year)
concentration
of
29
ppb.
Estimated
concentrations
in
ground
water
would
not
likely
exceed
106
ppb.
Estimated
exposures
from
indoor
use
of
triethylene
glycol
as
the
active
ingredient
and/
or
as
an
inert
ingredient
are
unlikely
to
result
in
surface
water
concentrations
greater
than
those
from
outdoor
uses.
The
estimated
dose
from
the
highest
estimated
environmental
concentration
of
885
ppb
would
be
approximately
0.025
mg/
kg/
day,
an
intake
that
is
orders
of
magnitude
below
the
level
at
which
effects
are
observed
from
exposure
to
triethylene
glycol.
Thus,
estimated
concentrations
in
drinking
water
do
not
present
any
risks
of
concern.

5.3
Occupational
and
Residential
Exposure
The
occupational
and
residential
exposure
assessment
for
triethylene
glycol
addresses
potential
exposures
and
risks
to
humans
who
may
be
exposed
in
"
occupational
settings"
and
the
general
population
in
"
residential
settings."
An
occupational
and/
or
residential
exposure
risk
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
triethylene
glycol
there
is
potential
for
exposure,
however,
there
are
no
toxicological
endpoints
of
concern,
according
to
a
review
of
the
available
toxicity
data
by
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC
Report,
11/
21,05).

Triethylene
glycol
is
currently
used
in
two
applications:
air
sanitizer/
hospital
disinfectants
and
pest
control
on
caged
birds.
Currently,
triethylene
glycol
is
only
formulated
as
a
pressurized
liquid
and
is
used
only
in
applications
where
the
risk
of
incidental
ingestion
may
be
considered
minimal.

The
potential
handler
scenarios
identified
are
illustrated
in
Table
4.
These
scenarios
were
selected
based
on
examination
of
product
labels.
Because
air
disinfectants
may
be
applied
in
a
wide
variety
of
rooms,
the
list
of
possible
application
scenarios
is
extensive.

TABLE
4.
Potential
Handler
Scenarios
Antimicrobial
Category
Scenario
Commercial,
institutional
and
industrial
premises
and
equipment
°
Spraying
disinfectant
in
rooms
of
institutions,
offices,
schools,
motels,
hotels,
etc.

Residential
and
public
access
premises
°
Spraying
disinfectant
in
rooms
such
as
lobbies,
theaters,
reception
rooms,
sleeping
rooms,
bathrooms,
etc.
Page
22
of
31
Medical
premises
and
equipment
°
Spraying
disinfectant
on
surfaces
in
hospitals
and
nursing
homes.
°
Spraying
disinfectant
in
hospital
rooms.

No
chemical­
specific
handler
data
were
submitted
to
estimate
the
potential
exposures
associated
with
these
uses
of
triethylene
glycol
(
nor
are
they
required
at
this
time).
Specifically,
exposure
data
associated
with
spraying
an
aerosol
can
indoors,
away
from
any
surfaces
(
i.
e.,
air
sanitizer),
or
with
spraying
pets,
are
unavailable.
However,
similar
exposures
associated
with
spraying
surfaces,
such
as
crack
and
crevice
treatments,
are
available
from
data
provided
by
the
Chemical
Manufacturers
Association
(
CMA)
Antimicrobial
Assessment
Study
(
EPA,
1999)
and
the
Pesticide
Handlers
Exposure
Database
(
PHED).
The
PHED
exposure
data
for
aerosol
can
spraying
is
deemed
more
appropriate
than
the
CMA
data
(
e.
g.,
more
replicates,
better
analytical
recovery
values,
etc).
Application
rates
are
difficult
to
assess
for
triethylene
glycol
because
not
enough
information
is
provided
on
product
labels.
For
spraying
an
aerosol
in
the
air,
most
labels
did
not
specify
the
quantity
of
product
that
should
be
used
for
a
given
room
size,
but
rather
state
the
length
of
time
the
aerosol
should
be
sprayed
for
a
given
room
size.
For
spraying
surfaces,
none
of
the
labels
provided
enough
information
to
calculate
an
application
rate,
due
to
the
lack
of
data
such
as
the
volume
of
room
air
and
the
counter
top/
floor
surface
area.

In
addition
to
potential
dermal
and
inhalation
handler
exposure,
there
is
the
potential
for
postapplication
exposure
to
individuals
reentering
treated
rooms
and/
or
contacting
sprayed
surfaces.
OPPT/
EETD
has
developed
a
model,
EFAST
(
Exposure
and
Fate
Assessment
Screening
Tool),
to
estimate
air
concentrations.
More
information
and
access
to
the
EFAST
model
is
available
at
http://
www.
epa.
gov/
opptintr/
exposurel.
htm.
In
summary,
EFAST
bases
its
estimates
on
physical/
chemical
properties.
Modeled
results
using
the
aerosol
paint
scenario
in
EFAST
and
a
vapor
pressure
of
0.00132
mmHg
at
250
degrees
Celsius
indicate
a
screening­
level,
high­
end,
peak
concentration
of
8.54
mg/
M3.
No
estimates
of
spray
deposition
on
surfaces
are
available
to
estimate
potential
dermal
contact.

Based
on
the
lack
of
toxicological
concerns
for
triethylene
glycol,
a
quantitative
risk
assessment
is
not
necessary
at
this
time.
If
inhalation
toxicological
endpoints
are
identified
in
the
future,
a
screening­
level
occupational
and/
or
residential
inhalation
exposure
estimate
is
available
using
EFAST.
If
dermal
toxicological
endpoints
are
identified
in
the
future,
potential
dermal
exposure
estimates
from
treated
surfaces
will
need
to
be
developed.

6.0
ECOLOGICAL
TOXICITY/
ENVIRONMENTAL
FATE
Ecological
Toxicity
As
a
result
of
the
Phase
IV
review
of
triethylene
glycol
for
reregistration
under
FIFRA,
ecological
effects
data
requirements
were
waived
due
to
its
intended
use
as
an
indoor
microbiocide,
high
volatility,
and
known
low
toxicity
(
it
is
a
preferred
solvent
for
aquatic
organism
toxicity
tests).
Data
obtained
from
published
studies
provide
additional
confirmation
of
Page
23
of
31
the
low
toxicity
of
the
compound
to
fish
and
aquatic
invertebrates
(
Table
5).

TABLE
5.
Ecotoxicity
of
Triethylene
Glycol
Species
Percent
Active
Ingredient
Test
Type
Toxicity
Reference
Mysid
(
Mysidopsis
bahia)
99.9
96­
hour
static
acute
LC50
=
11,000
ppm
MRID
#
40228401
(
Mayer,
1986)
32
Sheepshead
minnow
(
Cyprinodon
variegatus)
99.9
96­
hour
static
acute
LC50
=
48,000
ppm
MRID
#
40228401
(
Mayer,
1986)
32
Bluegill
sunfish
(
Lepomis
macrochirus)
unknown
96
hour
static
acute
LC50
>
10,000
ppm
Verschuren,
1983
33
Menidia
beryllina
unknown
96
hour
static
LC50
>
10,000
ppm
Verschuren,
1983
33
Fathead
minnow
(
Pimephales
promelas)
unknown
96
hour
flowthrough
LC
50
59,900
­
77,400
ppm
Geiger
et
al.,
1988
34
Page
24
of
31
Environmental
Fate/
Surface
and
Ground
Water
OPP
has
no
data
base
on
environmental
fate
studies
for
triethylene
glycol
use
as
air
sanitizers.
Triethylene
glycol
is
an
aliphatic
hydroxy
chemical
and
although
a
hydrolysis
study
is
the
only
environmental
fate
data
required
for
chemicals
with
an
indoor
use
pattern,
the
Agency
granted
a
data
waiver
for
this
study
during
the
Phase
IV
review
of
triethylene
glycol
based
on
the
fact
that
this
chemical
does
not
contain
any
hydrolyzable
hydrogen.
For
the
reregistration
eligibility
decision
(
RED)
process,
the
Agency
has
relied
on
readily
available
open
literature
data
that
characterizes
the
fate
properties
of
triethylene
glycol.

Based
on
a
review
of
the
information,
triethylene
glycol
is
miscible
in
water,
mobile
in
soils,
stable
to
abiotic
degradation
hydrolysis
and
soil
and
aquatic
photolysis.
Biodegradation
is
expected
to
proceed
rapidly
in
surface
waters
based
on
a
number
of
River
Dye­
away
tests
(
complete
mineralization
between
7
and
11
days)
and
will
degrade
in
soils
in
days
(
primary
degradation)
to
weeks
(
complete
mineralization)
based
sludge
innoculum
studies
and
predictions
of
ready
biodegradability.
The
use
of
sludge
innoculum
data
as
a
surrogate
for
terrestrial
soil
metabolism
is
subject
to
considerable
uncertainty
because
sludge
innoculums
tend
to
be
acclimated
to
the
introduction
of
organic
substances,
more
so
than
soils,
and
the
biomass
on
a
per
volume
basis
tends
to
be
greater.
In
light
of
these
uncertainties,
data
reported
for
the
mineralization
of
triethylene
glycol
in
sludge
innoculums
were
assigned
an
uncertainty
factor
of
3
times
the
estimated
value
to
account
for
media
differences.
This
adjustment
factor,
in
conjunction
with
the
use
of
a
mineralization
time
rather
than
a
half­
life,
is
likely
to
bound
the
upper­
end
of
the
potential
soil
half­
life,
thus
maintaining
a
reasonble
yet
conservative
assessment.
8,
35
Application
rates
were
not
available
for
indoor
or
outdoor
uses,
although
percentages
of
formulations
were.
To
assess
the
potential
concentrations
of
triethylene
glycol
in
surface
and
ground
water,
application
rates
of
1
lb/
acre
and
10
lbs/
acre
were
assessed.
Through
experience,
the
Agency's
Lower
Toxicity
Pesticide
Chemical
FOCUS
Group
(
formerly
the
Inerts
FOCUS
Group)
has
concluded
that
with
rare
exceptions,
inert
compounds
are
not
applied
at
rates
greater
than
10
pounds
per
acre.
Therefore,
assessing
triethylene
glycol
at
a
maximum
of
10
lbs/
acre
is
considered
a
reasonable
high­
end
exposure
scenario.
Aerial
application
of
triethylene
glycol
is
assumed
although
it
is
unlikely
to
be
used
in
spray
applications
where
a
ultra
fine
droplet
size
is
used
due
to
its
vapor
pressure.

Surface
Water
and
Ground
Water
The
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
was
used
to
estimate
concentrations
of
triethylene
glycol
at
the
intake
of
a
community
water
system.
SCI­
GROW
was
used
to
estimate
concentrations
of
this
chemical
in
shallow
groundwater
drinking
water
sources.
The
environmental
fate
inputs
for
triethylene
glycol
are
presented
in
Table
6.
The
half­
life
of
triethylene
glycol
on
soils
was
assumed
to
be
equal
to
the
highest
observed
time
for
mineralization
(
95
%
of
total
applied)
of
approximately
28
days.
In
addition,
an
uncertainty
factor
of
3
times
the
mineralization
time
was
applied
to
account
for
the
differences
in
media
(
soils
vs.
sludge).
The
aerobic
aquatic
metabolism
halflife
was
modeled
at
7
and
11
days.
These
times
are
equivalent
to
Page
25
of
31
the
time
to
complete
mineralization
rather
than
a
true
half­
life
which
will
introduce
additional
conservatism
in
the
assessment.
Raw
data
were
not
available
to
determine
an
actual
half­
life
from
the
River
Dye­
away
studies.

Table
6.
Environmental
Fate
Input
Parameters
Parameter
Scenario
1
Scenario
2
Scenario
3
Scenario
4
Application
Rate/
Number
1/
1
1/
1
10/
1
10/
1
Soil
Koc
10
10
10
10
Water
Solubility
(
mg/
L)
100,000
100,000
100,000
100,000
Hydrolysis
Half­
life
(
days)
stable
stable
stable
stable
Photolysis
half­
life
(
days)
stable
stable
stable
stable
Soil
Metabolism
Half­
life
(
days)
84
84
84
84
Aerobic
Aquatic
Metabolism
Half­
life
(
days)
11
7
11
7
The
estimated
environmental
concentrations
of
triethylene
glycol
from
use
as
an
active
ingredient
(
indoor
use)
and
from
agricultural
and
non­
agricultural
(
outdoor)
uses
are
presented
in
Table
7.
Based
on
a
series
of
"
what
if"
approaches,
the
estimated
environmental
concentrations
of
triethylene
glycol
from
use
as
an
active
ingredient
(
indoor
use)
and
from
agricultural
and
nonagricultural
(
outdoor)
uses
in
surface
water
would
not
likely
exceed
a
peak
(
24­
hour
time
averaged)
concentration
of
885
ppb
or
an
annual
average
(
single
year)
concentration
of
29
ppb.
Estimated
concentrations
in
ground
water
would
not
likely
exceed
106
ppb.
Estimated
exposures
from
indoor
use
of
triethylene
glycol
as
the
active
ingredient
and/
or
as
an
inert
ingredient
are
unlikely
to
result
in
surface
water
concentrations
greater
those
from
outdoor
uses.
Releases
to
wastewater
treatment
plants
are
expected
to
be
minimally
removed
because
of
the
lack
of
residence
time
(
hours).
Predicted
removal
efficiencies
do
not
exceed
10
percent
of
the
amount
released.

Table
7.
FIRST
and
SCI­
GROW
Estimated
Environmental
Concentrations
(
ppb)

Model
Scenario
1
Scenario
2
Scenario
3
Scenario
4
FIRST
Peak
88.5
88
885
880
Annual
Average
2.9
1.9
29
19
SCI­
GROW
10.6
10.6
106
106
7.0
AGGREGATE
EXPOSURE
In
examining
aggregate
exposure,
FFDCA
section
408
(
b)(
2)(
d)(
vi)
stipulates
that
"
when
establishing,
modifying,
leaving
in
effect
or
revoking
a
tolerance
or
exemption
for
a
pesticide
Page
26
of
31
chemical
residue,
that
EPA
consider
available
information
concerning
the
aggregate
exposure
levels
of
consumers
(
and
major
identifiable
subgroups
of
consumers)
to
the
pesticide
chemical
residue"
in
food
and
all
other
non­
occupational
exposures,
including
drinking
water
from
groundwater
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns
or
buildings
(
residential
and
other
indoor
uses).

Over
1
million
pounds
of
triethylene
glycol
are
either
produced
or
imported
per
year
(
according
to
OPPTS,
triethylene
glycol
is
categorized
as
an
HPV
chemical
and
by
definition
is
produced
world­
wide
in
quantities
greater
than
one
million
pounds).
Some
of
this
production
is
used
as
a
chemical
intermediate,
in
the
production
of
other
chemicals.
Triethylene
glycol
has
been
approved
by
the
Food
and
Drug
Administration
for
use
as
an
indirect
food
additive
as
a
component
of
adhesives.
According
to
21
CFR
175.105,
triethylene
glycol
can
be
a
component
of
an
adhesive
used
as
part
of
"
articles
intended
for
use
in
packaging,
transporting
or
holding
food."

The
Agency
has
developed
screening­
level
models
to
estimate
exposures
that
could
occur
as
a
result
of
the
use
of
an
inert
ingredient
such
as
triethylene
glycol
on
agricultural
crops.
These
models
make
a
number
of
highly
conservative
assumptions
that
deliberately
over­
estimate
exposure
in
the
diet,
drinking
water,
and
from
residential
use
(
Table
8).

Table
8.
Screening­
Level
Model
Estimates
of
Exposure
to
Triethylene
Glycol
Type
of
Exposure
Exposure
Level
Dietary
­
Food
(
as
a
result
of
application
to
crops)
acute
exposure:
less
than
1
mg/
kg/
day
at
95th
percentile
chronic
exposure:
less
than
1
mg/
kg/
day
Dietary
­
Drinking
Water
acute
exposure:
much
less
than
1
mg/
kg/
day
chronic
exposure:
much
less
than
1
mg/
kg/
day
Residential
(
as
a
result
of
using
a
cleaning
product)
approximately
6
mg/
kg/
day
Residential
(
as
a
result
of
using
a
laundry
detergent)
approximately
1
mg/
kg/
day
Residential
(
as
a
result
of
application
to
a
lawn)
less
than
1
mg/
kg/
day
With
one
exception,
all
of
the
screening­
level
exposure
estimates
noted
above
are
in
the
range
of
1
mg/
kg/
day
or
less.
Examination
of
the
hazard
profile
for
triethylene
glycol
shows
that
levels
at
which
adverse
effects
are
observed
occur
in
excess
of
1000
mg/
kg/
day
by
the
oral
and
dermal
routes,
and
in
excess
of
1
mg/
L
by
the
inhalation
route.
Considering
the
worst­
case
aggregate
exposures
that
could
occur
from
the
inert
use
of
triethylene
glycol
as
well
as
the
air
sanitizer
use,
Page
27
of
31
the
total
human
exposure
is
orders
of
magnitude
below
any
dose
of
triethylene
glycol
that
has
been
shown
to
cause
an
adverse
effect.

Determination
of
Safety
Based
on
its
review
and
evaluation
of
the
available
information,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
including
infants
and
children,
from
aggregate
exposure
to
residues
of
triethylene
glycol,
including
all
active
and
inert
uses
in
pesticide
products.
7.1
Endocrine
Disruptors
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances,
including
all
pesticide
chemicals
(
both
inert
and
active
ingredients),
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
such
other
endocrine
effect..."
EPA
has
been
working
with
interested
stakeholders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
As
the
Agency
proceeds
with
implementation
of
this
program,
further
testing
of
products
containing
triethylene
glycol
for
endocrine
effects
may
be
required.

7.2
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
triethylene
glycol
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
triethylene
glycol.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
Http://
www.
epa.
gov/
pesticides/
cummulativel.
htm.

8.0
SUMMARY
OF
RISK
ASSESSMENT
FINDINGS
From
the
available
animal
studies
and
other
data,
EPA
has
concluded
that
triethylene
glycol
exhibits
low
toxicity
and
exposures
to
triethylene
glycol
used
as
both
an
active
or
inert
present
a
reasonable
certainty
that
no
harm
will
result
from
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
types
of
exposures
for
which
there
is
reliable
information.
Page
28
of
31
The
Agency
notes
that
triethylene
glycol
is
included
on
the
Agency's
list
of
chemicals
included
in
the
High
Production
Volume
(
HPV)
Challenge
Program.
HPV
chemicals
are
those
that
are
manufactured
or
imported
into
the
United
States
in
volumes
greater
than
one
million
pounds
per
year.
There
are
approximately
3,000
HPV
chemicals
that
are
produced
or
imported
into
the
United
States.
The
HPV
Challenge
Program
is
a
voluntary
partnership
between
industry,
environmental
groups,
and
the
EPA
that
invites
chemical
manufacturers
and
importers
to
provide
basic
hazard
data
on
the
HPV
chemicals
they
produce/
import.
The
goal
of
this
program
is
to
facilitate
the
public's
right­
to­
know
about
the
potential
hazards
of
chemicals
found
in
their
environment,
their
homes,
their
workplace,
and
in
consumer
products.

The
Agency
received
a
full
commitment
from
two
companies
to
sponsor
triethylene
glycol
as
part
of
the
Agency's
HPV
Challenge
Program.

Based
on
toxicity
data
already
submitted
on
triethylene
glycol,
and
the
completeness
of
the
toxicity
data
base
(
including
subchronic,
chronic,
reproduction,
teratology,
and
mutagenicity
studies),
the
Agency
feels
confident
in
proceeding
with
this
reregistration
eligibility
decision/
tolerance
reassessment
decision.
Any
submission
of
data
by
current
or
future
sponsors
of
triethylene
glycol
as
part
of
the
HPV
Challenge
Program
may,
in
the
future,
be
used
by
the
Office
of
Pesticide
Programs
to
revise
or
update
their
tolerance
reassessment
decision
for
triethylene
glycol
as
deemed
necessary
and
appropriate.
Page
29
of
31
9.0
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10.0
WEBSITES
Exposure
Literature
located
at
Http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuitedl.
htm.

EFAST
Model
located
at
Http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuitedl.
htm.

Environmental
Fate
Literature
located
at
Http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuitedl.
htm.

Cumulative
Risk
Assessment
Policy
located
at
Http://
www.
epa.
gov/
pesticides/
cummulativel.
htm.