Document ID: EPA-HQ-OPP-2005-0262-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

TRICHLOROMELAMINE
RISK
ASSESSMENT
FOR
THE
REREGISTRATION
ELIGIBILITY
DECISION
September
15,
2005
Case
3144
PC
Code
077101
Office
of
Pesticide
Programs
Antimicrobials
Division
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
Page
2
of
38
1.0
EXECUTIVE
SUMMARY
Trichloromelamine
(
1,3,5­
triazine­
N,
N',
N'­
trichloro­
2,4,6­
triamino)
is
a
pesticide
that
has
been
formulated
for
use
in
food­
contact
surface
sanitizing
and
disinfecting
products,
as
well
as
in
a
fruit
and
vegetable
disinfectant.
Trichloromelamine
is
expected
to
rapidly
break
down
into
hypochlorous
acid
and
melamine
in
the
presence
of
organic
material
(
EPA,
1988).

Based
on
a
review
of
acute
toxicity
studies,
EPA
has
determined
that
trichloromelamine
should
be
classified
in
toxicity
category
I
for
primary
eye
irritation,
in
category
II
for
acute
inhalation
and
oral
toxicity
and
primary
skin
irritation,
and
in
category
III
for
acute
dermal
toxicity.

Based
on
the
available
hazard
information
on
trichloromelamine
and
the
use
pattern
for
this
chemical,
the
Agency
has
performed
a
quantitative
risk
assessment
for
this
chemical.
A
screening­
level
assessment
was
performed
to
determine
potential
exposure
to
workers
who
use
the
chemical
to
treat
food
utensils,
food
surfaces,
fruits,
and
vegetables;
restaurant/
bar
and
mess
hall
patrons
who
ingest
residues
left
on
treated
food
utensils,
fruits,
and
vegetables;
and
individuals
as
a
result
of
transfer
of
residues
of
trichloromelamine
from
countertops
to
food
(
indirect
food
contact).
The
total
aggregate
MOEs
for
restaurant
workers
washing
countertops
and
washing
utensils
were
calculated
to
be
240
and
3200,
respectively.
The
total
combined
mixer/
loader
and
applicator
MOE
for
Army
mess
hall
workers
washing
mess
kits
or
washing
fruits
and
vegetables
was
calculated
to
be
170.
For
restaurant
patrons,
the
aggregate
acute
and
chronic
dietary
risks
calculated
ranged
from
6.77%
of
the
aPAD
for
adult
males
to
53.7%
of
the
cPAD
for
a
15kg
child.
For
Army
mess
hall
patrons,
the
aggregate
dietary
risks
were
calculated
to
be
between
6.20%
aPAD
(
adult
male)
and
21.3%
cPAD
(
adult
female).
The
aggregate
risks
to
adults
from
dietary
exposure
and
from
cleaning
countertops
(
calculated
using
the
aggregate
risk
index
[
ARI]
method)
were
1.89
(
male)
and
1.83
(
female)
(
EPA,
2001).
ARI
values
greater
than
or
equal
to
1
indicate
no
risk
of
concern.

Although
there
is
not
enough
information
regarding
melamine
(
a
metabolite
of
trichloromelamine)
toxicity
for
an
ecological
hazard
assessment,
evidence
suggests
that
melamine
may
be
chronically
toxic
to
fish
and
invertebrates,
causing
adverse
effects
on
reproduction
and
embryonic
development.
Because
use
of
trichloromelamine
is
limited
to
use
as
a
food
and
food­
contact
surface
sanitizer
in
homes,
restaurants,
and
similar
establishments,
trichloromelamine
(
or
the
degradate
melamine,
as
a
result
of
use
of
the
parent
chemical)
is
not
expected
to
enter
the
environment
and
risk
to
terrestrial
and
aquatic
organisms
is
not
expected
due
to
the
lack
of
exposure.

Taking
into
consideration
all
available
information
on
trichloromelamine,
there
is
a
reasonable
certainty
that
no
harm
will
occur
to
the
general
public
or
any
population
subgroup
from
aggregate
exposure.
Page
3
of
38
2.0
USE
INFORMATION
The
tolerance
exemption
being
reassessed
in
this
document,
the
40
CFR
location
of
the
established
tolerance
exemption,
and
the
use
pattern
of
the
chemical
as
an
active
ingredient
are
listed
in
Table
1.

Table
1.
Tolerance
Exemptions
Being
Reassessed
in
this
Document
Tolerance
Exemption
Expression
CAS
No.
40
CFRa
PC
Code
Use
Pattern
(
Pesticidal)
List
Classification
Trichloromelamine
(
1,3,5­
triazine,
N,
N'N"
­
trichloro­
2,4,6­
triamino­)
7673­
09­
8
180.940
(
c)
077101
Food
contact
surface
sanitizing
solutions
(
for
use
on
food
processing
equipment
and
utensils)
Algicide,
Disinfectant,
Microbiocide/
microbiostat
for
slime­
forming
bacteria,
fungi,
and
algae,
Sanitizer
a
Residues
of
chemicals
listed
in
40
CFR
§
180.940
are
exempted
from
the
requirement
of
a
tolerance
when
used
in
accordance
with
good
manufacturing
practice
as
ingredients
in
an
antimicrobial
pesticide
formulation,
provided
that
the
substance
is
applied
on
a
semipermanent
or
permanent
food­
contact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food.
The
chemicals
listed
in
subsection
(
c)
are
exempted
from
the
requirement
of
a
tolerance
when
applied
to
food
processing
equipment
and
utensils.
For
trichloromelamine,
40
CFR
states
that
for
ready
for
use
products,
the
end­
use
concentration
should
not
exceed
200
ppm
as
total
available
chlorine.

2.1
Active
and
Inert
Uses
According
to
the
EPA's
Office
of
Pesticide
Programs
Information
Network
(
OPPIN)
database,
trichlormelamine
is
registered
as
an
active
ingredient
in
six
end­
use
products
and
two
technical
grade
products
(
one
product
specified
as
manufacturing
use
only).
All
of
the
end­
use
products
are
listed
for
use
as
a
sanitizer
or
disinfectant
(
PC
Code
077101).
EPA's
OPPIN
database
does
not
identify
trichloromelamine
as
an
inert
ingredient
in
any
registered
products.

Uses
listed
on
labels
include
use
on
utensils,
glasses,
and
hard
surfaces
in
eating
establishments
and
industrial
and
institutional
food
service
areas,
as
well
as
in
food
processing
facilities
and
on
food
dispensing
equipment.
In
addition,
it
can
be
used
on
non­
food
contact
surfaces
in
hospitals
(
non­
critical
areas),
nursing
homes
(
non­
critical
areas),
and
schools.
One
trichloromelamine
product
is
registered
for
use
as
a
disinfectant
for
mess
gear
as
well
as
fresh
fruits
and
vegetables.
The
use
involves
thoroughly
washing
the
fresh
fruits
and
vegetables
in
the
trichloromelamine
use
solution.
After
washing,
the
fruits
and
vegetables
are
immersed
in
a
freshly
prepared
solution.
According
to
the
label,
the
immersion
is
followed
by
a
potable
water
rinse
of
the
fruits
and
vegetables.

2.2
FDA­
Approved
Uses
Melamine,
a
metabolite
of
trichloromelamine,
is
cleared
by
the
FDA
for
use
as
an
adhesive
for
food­
packaging
material
(
21
CFR
§
175.105).
Page
4
of
38
3.0
PHYSICAL
AND
CHEMICAL
PROPERTIES
The
physical/
chemical
data
for
trichloromelamine
are
presented
in
Table
2.
Figure
1
represents
the
molecular
structure
of
trichloromelamine.
Sources
for
these
data
include
the
submitted
guideline
studies
(
MRIDs
42131101,
42283401,
42385101,
43350301,
43350302,
43350303,
and
43395401),
European
Inventory
of
Existing
Commercial
Substances
(
ECB,
2004)
and
a
Material
Safety
Data
Sheet
(
H&
S,
2004).
Vapor
pressure
information
was
found
in
EPI
Suite,
a
modeling
program
which
is
a
screening­
level
predictive
tool
used
to
estimate
physical
and
chemical
properties
of
chemicals
(
EPA,
2005).

Table
2.
Physical/
Chemical
Properties
of
Trichloromelamine
Property
Value
Molecular
Formula
C3H3Cl3N6
Molecular
Weight
229.46
Physical
State
Cream
colored
powder
Melting
Point
Above
300
E
C
Solubility
in
Water
0.064
g/
100
mL
at
20
E
C.

pH
4.7
(
5%
slurry
H2O)

Density/
Specific
Gravity
0.34
g/
cm3
Log
Kow
­
0.38
Vapor
Density
NA
Vapor
Pressure
7.1
x
10­
5
mm
Hg
at
25
E
C
Dissociation
Constant
NA
Estimated
Henry's
Law
Constant
1.3x10­
9
atm/
m3­
mole
at
25
E
C
Estimated
Soil
Sorption
Coefficient
(
KOC)
150
Stability
Oxidizing
agent,
with
highly
available
chlorine
content
Flammability
Auto­
ignition
occurs
at
320
E
F
Explodability
Does
not
explode
Storage
Stability
Corrosive
to
metals
NA
=
Not
Available
Page
5
of
38
Figure
1.
Molecular
Structure
of
Trichloromelamine
4.0
HAZARD
ASSESSMENT
4.1
Hazard
Profile
Table
3
summarizes
the
available
toxicology
data
for
trichloromelamine.
Trichloromelamine
instantaneously
breaks
down
into
hypochlorous
acid
and
melamine
in
the
presence
of
organic
material
(
EPA,
1988).
Trichloromelamine
in
the
presence
of
water
will
produce
a
small
amount
of
unreacted
trichloromelamine,
hypochlorous
acid,
and
melamine.
Melamine
is
relatively
stable
and
would
be
expected
to
remain
as
a
residue
on
food
and
food
contact
surfaces
(
EPA,
2004b).
Chronic
toxicity
studies
are
not
required
for
trichloromelamine
based
on
its
rapid
degradation.

Table
3.
Summary
of
Toxicity
Data
for
Trichloromelamine
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
Acute
Toxicity
81­
1
Acute
Oral
43165701
LD50
=
398
mg/
kg
II
81­
2
Acute
Dermal
43159901
LD50
>
2000
mg/
kg
III
81­
3
Acute
Inhalation
43368501
LC50
=
0.4
mg/
L,
males
and
0.780
mg/
L,
females
II
81­
4
Primary
Eye
Irritation
43159902
Severe
conjunctival
irritation
I
81­
5
Primary
Skin
Irritation
43159903
Severe
irritant
II
81­
6
Dermal
Sensitization
43159904
No
sensitization
reactions
for
group
treated
with
0.1%
[
w/
v]
solution
NA
N
H
Cl
N
N
H
Cl
N
N
H
Cl
N
Page
6
of
38
Guideline
No.
Study
Type
MRID
#(
s)
Results
Toxicity
Category
Subchronic
Toxicity
82­
1(
a)
90­
day
Oral
Study
(
Rodent)
43064301
NOAEL
=
30
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day,
based
on
the
observation
of
histological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland).
NA
Developmental
Toxicity
Systemic
Toxicity
NOAEL
<
30
mg/
kg/
day
and
LOAEL
 
30
mg/
kg/
day,
based
on
depressions
in
mean
maternal
body
weights
and
decreased
mean
feed
consumption
values.
NA
43614301
(
Rabbit)

Developmental
toxicity
NOAEL
$
120
mg/
kg/
day
NA
Maternal
NOAEL
<
62.5
mg/
kg/
day
and
LOAEL
 
62.5
mg/
kg/
day,
based
on
clinical
signs
at
several
or
all
dose
levels
(
alopecia,
gasping,
altered
respiration,
salivation,
lethargy,
chromodacryorrhea),
reduction
in
body
weight
gains,
and
statistically
significant
trends
for
decreased
food
consumption
at
all
dose
levels.
NA
83­
3
Developmental
Toxicity
43614302
(
Rat)

Developmental
toxicity
NOAEL
=
500
mg/
kg/
day
NA
Mutagenicity
Studies
84­
2(
a)
84­
2(
b)
84­
2(
c)
Gene
Mutation
42148801,
42021801,
42021701
Positive
result
at
25
Fg/
plate
for
TA98
and
at
50
Fg/
plate
in
Chinese
hamster
ovary
cells,
both
with
and
without
metabolic
activation.
Negative
result
in
primary
rat
hepatocytes.
NA
Notes:
LC
=
Lethal
Concentration;
LD
=
Lethal
Dose;
LOAEL
=
Lowest
Observed
Adverse
Effects
Level;
NA
=
Not
Applicable;
NOAEL
=
No
Observed
Adverse
Effects
Level
4.1.1
Acute
Toxcity
EPA
reviewed
an
acute
oral
toxicity
study
in
rats
(
MRID
43165701).
In
this
study,
rats
(
5/
sex/
dose)
were
administered
100,
300
or
500
mg/
kg
of
trichloromelamine
by
gavage
in
aqueous
suspension.
The
acute
oral
LD50
values
were
413
mg/
kg
for
males
and
387
mg/
kg
for
females;
the
combined
LD50
value
was
398
mg/
kg.
Clinical
signs
observed
included
hypoactivity,
staggered
gait,
prostration,
absence
of
righting
reflex,
mydriasis,
hunched
posture,
dyspnea
and
soft
stool.
This
study
is
classified
acceptable.
Page
7
of
38
EPA
reviewed
an
acute
dermal
toxicity
study
in
rabbits
(
MRID
43159901).
In
this
study,
the
test
chemical
(
93%
a.
i.)
was
applied
to
the
intact
skin
of
rabbits
at
2000
mg/
kg
for
a
period
of
24
hours.
The
test
material
produced
severe
dermal
irritation,
including
"
severe
erythema
and
edema,
marked
atonis
and
coriaceousness,
and
slight
desquamation
and
fissuring.
Eschar,
exfoliation
and
possible
necrotic
areas
were
also
seen."
No
systemic
toxicity
was
observed.
This
study
is
classified
acceptable.

EPA
reviewed
an
acute
inhalation
toxicity
study
in
rats
(
MRID
43368501).
In
this
study,
rats
were
exposed
to
aerosol
concentrations
of
powdered
trichloromelamine
(
100%
a.
i.)
for
4
hours.
The
test
material
caused
"
breathing
difficulties,
wet
and
stained
fur,
decreased
activity,
head
tilt,
weakness,
cold
to
touch,
and
pale
skin.
[
The]
majority
of
these
signs
disappeared
by
the
end
of
the
first
week
in
the
surviving
rats;
no
clinical
signs
were
seen
at
termination....
In
rats
that
died,
gross
necropsy
was
indicative
of
respiratory
failure;
principal
gross
lesions
were
uncollapsed
and
mottled
lungs."
This
study
is
classified
acceptable.

EPA
reviewed
a
primary
eye
irritation
study
on
rabbits
(
MRID
43159902).
The
test
chemical,
0.05
g
(
95%
a.
i.),
was
placed
into
the
conjunctival
sac
of
rabbits
(
3/
sex).
The
chemical
produced
"
severe
conjunctival
irritation
that
included
petite
hemorrhaging,
blanching,
redstained
discharge,
and
possible
necrotic
areas."
This
study
is
classified
acceptable.

EPA
reviewed
a
primary
dermal
irritation
study
on
rabbits
(
MRID
43159903).
The
technical
grade
of
the
test
chemical
(
95.1%
a.
i.)
was
applied
to
the
intact
skin
under
semioccluded
conditions.
The
chemical
produced
"
moderate­
severe
to
severe
erythema;
slight
to
severe
edema;
subcutaneous
hemorrhaging;
blanching;
possible
necrotic
areas;
exfoliation;
and
possible
scar
tissue."
Irritation
continued
to
be
present
at
Day
21
of
observation.
This
study
is
classified
acceptable.

EPA
reviewed
a
dermal
sensitization
study
on
rabbits
(
MRID
43159904).
Guinea
pigs
received
dermal
applications
of
the
test
chemical
(
95.1%
a.
i.)
as
a
50%
(
first
induction
dose)
and
25%
(
second
and
third
induction
doses)
w/
v
mixture
in
mineral
oil.
Fourteen
days
after
the
last
induction,
the
animals
were
challenged
at
a
concentration
of
1%.
No
irritation
was
observed
in
any
of
the
animals.
This
study
is
classified
acceptable.

4.1.2
Subchronic
Toxicity
EPA
reviewed
a
90­
day
subchronic
oral
toxicity
study
in
rats
(
MRID
43064301).
In
this
study,
trichloromelamine
(
92.07%
a.
i.)
was
dissolved
in
0.08%
Triton
X­
100
and
administered
by
gavage
at
doses
at
doses
of
30,
150,
and
300
mg/
kg/
day
to
groups
of
10
male
and
female
rats
per
dose.
"
Histopathology
revealed
engorgement
of
the
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland
as
well
as
pulmonary
edema
in
rats
that
died
during
the
study
at
150
and
300
mg/
kg/
day."
A
NOAEL
of
30
mg/
kg/
day
and
a
LOAEL
of
150
mg/
kg/
day
were
established,
based
on
histopathological
lesions.
This
study
is
classified
acceptable.
Page
8
of
38
4.1.3
Developmental
Toxicity
Studies
EPA
reviewed
a
rabbit
developmental
toxicity
study
(
MRID
43614301).
In
this
study,
pregnant
rabbits
were
administered
30,
60,
90,
or
120
mg/
kg/
day
(
16
rabbits/
dose
group)
of
the
test
chemical
by
gavage
on
gestation
days
6
through
19.
On
gestation
day
30,
the
animals
were
sacrificed
and
gross
necropsies
performed.
"
Administration
of
[
the
test
chemical]
produced
dose­
related
depressions
in
mean
maternal
body
weights
during
gestation
days
7­
19
(
statistically
significant)
and
generally
throughout
the
dosing
period....
Mean
feed
consumption
values
were
significantly
decreased
for
gestation
days
7­
9,
9­
12,
and
7­
19."
No
evidence
of
developmental
effects
was
observed.
A
systemic
toxicity
NOAEL
<
20
mg/
kg/
day
and
LOAEL
 
30
mg/
kg/
day
and
a
developmental
NOAEL
 
120
mg/
kg/
day
were
established.
This
study
is
classified
acceptable.

EPA
reviewed
a
rat
developmental
study
(
MRID
43614302).
In
this
study,
rats
were
administered
0,
62.5,
250,
or
500
mg/
kg/
day
(
25
sperm­
positive
rats/
dose
group)
of
the
test
chemical
by
gavage
on
gestation
days
6
through
15.
On
gestation
day
20,
the
animals
were
sacrificed
and
gross
necropsies
performed.
The
study
found
"
clinical
signs
at
several
or
all
dose
levels
(
alopecia,
gasping,
altered
respiration,
salivation,
lethargy,
chromodacryorrhea),
reduction
in
body
weight
gains
at
two
top
doses
during
gestation
days
6­
9,
and
statistically
significant
trends...
for
decreased
food
consumption
at
all
dose
levels."
No
evidence
of
developmental
effects
was
observed.
A
maternal
NOAEL
<
62.5
mg/
kg/
day
and
LOAEL
 
62.5
mg/
kg/
day
and
a
developmental
NOAEL
of
500
mg/
kg/
day
were
established.
This
study
is
classified
acceptable.
4.1.4
Mutagenicity
Studies
EPA
reviewed
three
gene
mutation
studies
(
MRIDs
42148801,
42021801,
and
42021701).
These
studies
were
classified
as
acceptable
by
EPA.
In
these
studies,
cells
were
exposed
to
the
test
chemical.
The
cells
used
included
salmonella,
S.
typhimurium
stains
TA98,
TA100,
TA1535,
TA
1537,
and
TA1538,
Chinese
hamster
ovary
cells,
and
primary
rat
hepatocytes.
Tests
with
and
without
metabolic
activation
were
used
for
all
cells
except
primary
rat
hepatocytes,
which
used
only
tests
without
metabolic
activation.
Positive
results
were
seen
at
concentrations
of
25
µ
g/
plate
for
TA98
and
TA100,
both
with
and
without
the
metabolic
activation.
Positive
results
were
seen
at
concentrations
of
50
µ
g/
mL
in
Chinese
hamster
cells.
"
The
aberrations
observed
[
a
high
frequency
of
complex
arrangements
such
as
triradial
and
quadriradials]
were
typical
of
a
chemical
clastogen
rarely
seen
in
untreated
control
cultures
[
of
Chinese
hamster
cells]."
There
were
no
indications
of
mutagenic
response
in
the
strains
TA1535,
TA1537,
or
TA1538.
No
mutagenic
response
was
observed
in
the
primary
rat
hepatocytes.
These
studies
are
classified
acceptable.

4.1.5
Melamine
Studies
Trichloromelamine
is
expected
to
rapidly
break
down
into
hypochlorous
acid
and
melamine
(
EPA,
1994).
A
number
of
toxicity
studies
have
been
performed
to
characterize
the
hazard
of
melamine.
Page
9
of
38
Based
on
a
review
of
a
number
of
acute
toxicity
studies
(
EPA,
1983),
the
FDA
concluded
and
EPA
concurred
that:

1.
Oral
LD50
values
were
3,161
and
3,828
mg/
kg
for
male
and
female
rats,
respectively.
Melamine
can
be
classified
as
a
moderate
to
slight
weak
acute
toxicant.
2.
Melamine
caused
little
or
no
irritation
when
dermally
applied
to
guinea
pigs.
3.
Mild
transient
irritation
was
produced
when
dry
melamine
was
instilled
into
the
eyes
of
rabbits.
4.
Melamine
is
absorbed
rapidly
and
distributed
in
the
body
tissue
waters,
and
rapidly
eliminated
in
the
urine
unchanged
after
oral
dosing.
5.
The
weight­
of­
evidence
is
not
sufficient
to
reasonably
anticipate
that
melamine
will
cause
serious
or
irreversible
chronic
health
effects.
6.
For
the
mice
tested,
the
incidence
effecters
were
greater
in
the
males
than
in
the
females.
7.
Melamine
is
not
mutagenic
in
the
Salmonella/
mammalian
microsomal
assay.

The
FDA
Cancer
Committee
reviewed
a
number
of
melamine
studies
(
EPA,
1984).
The
committee,
based
on
these
studies,
concluded
that
"
melamine
is
associated
with
an
increase
in
the
incidence
of
urinary
bladder
neoplasms
in
male
rats.
Melamine
is
also
associated
with
the
production
of
bladder
calculi
in
male
rats."

The
Health
Effects
Division
Carcinogenicity
Peer
Review
Committee
(
PRC)
concluded
that
it
was
unlikely
that
melamine
is
a
carcinogenic
hazard
to
humans
from
the
pesticidal
usage
of
a
pesticide
product
(
Cyromazine)
(
Cyromazine
is
a
pesticide
whose
main
metabolite
is
melamine;
Cyromazine
is
a
developmental
toxicant
in
rabbits)
(
EPA,
1988).
They
noted
that
"
humans
are
not
likely
to
be
exposed
to
the
high
doses
of
melamine
that
produce
the
urinary
tract
toxicity
that
precedes
and
seems
to
lead
to
the
carcinogenic
response
in
rats"
(
EPA,
1993).
This
conclusion
is
based
on
the
review
of
a
number
of
studies,
including
a
mouse
carcinogenicity
study
in
which
no
evidence
of
tumors
were
found
due
to
exposure
to
melamine
at
the
highest
dose
tested
(
4,500
ppm).

4.1.6
Dietary
Studies
FDA
cleared
trichloromelamine
as
an
indirect
food
additive
(
21
CFR
178.1010(
b)(
10))
and,
therefore,
no
dietary
exposure
assessment
was
required
(
EPA,
1988).
However,
one
product
label
notes
that
the
product
can
be
used
as
a
fruit
and
vegetable
wash
(
Reg.
No.
40510­
1).
In
addition,
indirect
food­
contact
sanitizers
are
now
under
the
jurisdiction
of
the
Office
of
Pesticide
Programs
(
OPP).
A
dietary
exposure
assessment
was
conducted
based
on
FDA
guidelines
(
Refer
to
Tables
9
­
13).

4.2
FQPA
Considerations
Under
the
Food
Quality
Protection
Act
(
FQPA),
P.
L.
104­
170,
which
was
promulgated
in
1996
as
an
amendment
to
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
the
Agency
was
directed
to
"
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children"
from
aggregate
exposure
to
a
pesticide
chemical
residue.
The
law
further
states
that
in
the
case
of
threshold
Page
10
of
38
effects,
for
purposes
of
providing
this
reasonable
certainty
of
no
harm,
"
an
additional
tenfold
margin
of
safety
for
the
pesticide
chemical
residue
and
other
sources
of
exposure
shall
be
applied
for
infants
and
children
to
take
into
account
potential
pre­
and
post­
natal
toxicity
and
completeness
of
the
data
with
respect
to
exposure
and
toxicity
to
infants
and
children.
Notwithstanding
such
requirement
for
an
additional
margin
of
safety,
the
Administrator
may
use
a
different
margin
of
safety
for
the
pesticide
residue
only
if,
on
the
basis
of
reliable
data,
such
margin
will
be
safe
for
infants
and
children."

Trichloromelamine
will
not
cause
an
FQPA
concern
since
there
is
no
evidence
from
the
available
toxicology
data
that
it
will
induce
neurotoxic
effects.
Prenatal
toxicity
studies,
in
both
the
rat
and
rabbit,
did
not
provide
quantitative
or
qualitative
evidence
of
increased
susceptibility
to
fetus
following
in
utero
exposure.

4.3
Dose­
Response
Assessment
The
doses
and
toxicological
endpoints
selected
for
various
exposure
scenarios
are
summarized
in
Table
4
below.

Table
4.
Doses
and
Toxicological
Endpoints
Used
in
Exposure
Scenarios
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SFa
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
Population
including
infants
and
children)
NOAEL
=
30
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
90­
Day
Oral
Rodent
Study
(
MRID
43064301)

LOAEL
=
150
mg/
kg/
day
A
NOAEL
of
30
mg/
kg/
day
was
determined,
based
on
histopathological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland)
observed
at
the
next
highest
dose
of
150
mg/
kg/
day.

Acute
Dietary
(
Females
13+
years
of
age)
Endpoint
for
this
population
was
not
identified
in
the
database
Chronic
Dietary
(
All
populations)
NOAEL
=
30
mg/
kg/
day
UF
=
300b
Chronic
RfD
=
0.1
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
FQPA
SF
=
0.1
mg/
kg/
day
90­
Day
Oral
Rodent
Study
(
MRID
43064301)

LOAEL
=
150
mg/
kg/
day
A
NOAEL
of
30
mg/
kg/
day
was
determined,
based
on
histopathological
lesions
(
engorgement
of
small
blood
vessels
of
the
adrenal
gland,
brain,
kidneys,
liver,
lung,
and
pituitary
gland)
observed
at
the
next
highest
dose
of
150
mg/
kg/
day.
Page
11
of
38
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SFa
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term
Incidental
Oral
(
1­
30
days)
NOAEL=
30
mg/
kg/
day
UF
=
100
Target
MOE
=
100
Occupational
=
NA
See
Chronic
Dietary
Endpoint
Intermediate­
Term
Incidental
Oral
(
1­
6
months)
NOAEL=
30
mg/
kg/
day
UF
=
100
Target
MOE
=
100
Occupational
=
NA
See
Chronic
Dietary
Endpoint
Short­
Term
and
Intermediate­
Term
Dermal
Exposure
Oral
Study
NOAEL=
30
mg/
kg/
day
UF
=
100
Dermal
Absorption=
100%
Target
MOE
=
100
See
Chronic
Dietary
Endpoint
Short­
Term
and
Intermediate­
Term
Inhalation
Exposure
No
appropriate
route­
specific
study
was
available.
The
oral
endpoint
of
30
mg/
kg
with
a
Margin
of
Exposure
of
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
is
used.
An
additional
10x
route­
to­
route
extrapolation
is
used
to
determine
if
a
confirmatory
inhalation
toxicity
study
is
warranted.

Notes:
UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose
(
NOAEL/
UF),
MOE
=
margin
of
exposure
a
The
developmental
toxicity
studies
both
showed
a
lack
of
effects
in
offspring
up
to
and
including
the
highest
doses
tested
in
both
studies,
and
the
LOAELs
for
both
studies
were
based
on
general
systemic
effects
that
were
not
considered
severe.
Both
studies
were
well­
designed
and
provided
an
adequate
dose­
response
for
trichloromelamine.
Therefore,
the
FQPA
Safety
Factor
is
removed.

b
UF
of
300
includes
a
10x
interspecies
extrapolation,
10x
intraspecies
variation,
and
3x
extrapolation
from
subchronic
study
to
chronic
endpoint.
The
Agency
considers
the
NOAEL
of
30
mg/
kg/
day
to
be
conservative,
as
residues
of
trichloromelamine
are
likely
to
disappear
quickly
based
on
the
chemistry
of
trichloromelamine,
and
chronic
exposure
is
likely
to
be
very
low.

4.4
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA,
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
has
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
Page
12
of
38
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
trichloromelamine
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

5.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
A
review
of
the
EPA
Pesticide
Product
Database
(
EPA,
2004c)
showed
that
there
are
eight
trichloromelamine
products
with
currently
active
registrations.
With
the
exception
of
the
technical
grade
products,
the
concentrations
of
trichloromelamine
in
these
products
ranged
from
9.5%
to
19.3%,
and
the
listed
uses
for
these
products
include
use
as
a
surface
sanitizer,
including
on
food
surfaces,
and
as
a
fruit
and
vegetable
wash.
The
product
with
the
highest
concentration
of
trichloromelamine
(
Reg.
No.
40510­
1,
19.3%
a.
i.)
appears
to
be
exclusively
for
use
of
the
Department
of
the
United
States
Army.
The
product
with
the
second
highest
concentration
of
trichloromelamine
(
Reg.
No.
8160­
1,
18%
a.
i.),
as
diluted
per
label
directions,
is
to
be
used
on
food­
contact
surfaces
in
restaurants
and
bars,
homes,
and
other
institutional
and
commercial
sites.
In
addition,
another
product
(
Reg.
No.
65169­
1,
18.7%
a.
i.)
is
used
in
restaurants
and
bars
on
food­
contact
surfaces
as
well
as
to
sanitize
glassware
and
utensils.
Because
the
uses,
concentrations,
and
exposed
individuals
associated
with
these
three
products
will
be
different,
all
of
these
labels
were
considered
in
the
exposure
assessment.

The
Army
label
(
Reg.
No.
40510­
1)
states
that
the
product
can
be
used
"
for
disinfection
of
mess
gear,
fresh
fruits,
and
vegetables."
The
labels
for
the
latter
products
selected
for
examination
state
that
the
product
is
a
food­
contact
sanitizer
for
use
on
hard,
non­
porous
inanimate
surfaces
in
homes,
offices,
schools,
bars,
and
restaurants,
as
well
as
bar
and
restaurant
glassware
and
utensils.
Although
there
are
non­
food
contact
uses,
as
well
as
other
food­
contact
use
sites
(
i.
e.
food
processing
plants)
on
other
labels,
the
concentration
of
active
ingredient
in
those
products
(
once
diluted
according
to
label
directions)
are
lower
than
that
for
Reg.
No.
8160­
1.
It
is
assumed
that
exposure
from
the
restaurant
use
that
was
assessed,
which
includes
infants
and
children
with
chronic
exposure,
represents
the
high­
end
exposure
and
is,
therefore,
representative
of
these
other
uses,
excluding
to
sanitize
glassware
and
utensils.

Based
on
the
information
provided
on
the
labels,
the
following
scenarios
were
chosen
for
consideration
in
this
human
health
risk
assessment:

$
Dermal/
inhalation
exposure
due
to
ungloved
workers
in
the
Army
using
the
product
to
disinfect
mess
kits,
fruits,
and
vegetables
(
19.3%
a.
i.
product);

$
Dermal/
inhalation
exposure
due
to
ungloved
workers
at
restaurants/
bars
using
the
product
to
sanitize
surfaces
and
food
utensils
(
18.7%
product);

$
Dietary
exposure
due
to
ingestion
of
residues
left
on
treated
food
utensils
and
due
to
ingestion
of
residues
from
washed
fruits
and
vegetables
(
19.3%
product);
and,

$
Dietary
exposure
due
to
ingestion
of
residues
left
on
treated
food
utensils
and
due
to
ingestion
of
residues
that
were
transferred
to
food
when
prepared
on
treated
surfaces
(
18.7%
and
18%
products,
respectively).
Page
13
of
38
5.1
Occupational
Exposure
Assessment
5.1.1
Inhalation
and
Dermal
Exposure
for
Army
Workers
Estimates
of
inhalation
and
dermal
risk
were
calculated
for
ungloved
occupational
workers
in
the
army
using
the
product
to
disinfect
mess
kits,
fruits,
and
vegetables.
To
disinfect
mess
kits,
the
label
(
Reg.
No.
40510­
1)
for
the
19.3%
product
states
that
4.77
oz.
of
the
chemical
powder
is
to
be
poured
into
a
25­
gallon
container
of
water
(
i.
e.,
0.0276%
a.
i.
in
the
diluted
solution)
and
that
two
containers
(
25
gallons
each)
should
be
prepared
(
4.77
oz.
product/
packet
x
2
packets
x
19.3%
a.
i.
x
1
lb./
16
ozs.
=
0.115
lbs
a.
i.
in
diluted
solution).
Mess
kits
that
have
been
washed
are
to
be
rinsed
twice 
once
in
the
first
container,
and
then
again
in
the
second 
and
then
allowed
to
air
dry.
The
50
gallons
used
should
be
sufficient
to
treat
100
mess
kits.

To
disinfect
fruits
and
vegetables,
the
label
for
the
19.3%
product
states
that
4.77
oz
of
the
chemical
powder
is
to
be
poured
into
a
20­
gallon
container
of
water
(
i.
e.,
0.0344%
a.
i.
in
the
diluted
solution),
and
that
two
containers
(
20
gallons
each)
should
be
prepared.
Unpeeled
fruits
and
vegetables,
with
bruised
leaves
removed,
are
to
be
washed
thoroughly
in
the
first
container,
then
are
to
be
completely
immersed
in
the
second
container
and
allowed
to
soak
for
10
minutes.
After
the
soaking
time,
the
product
is
to
be
rinsed
with
potable
water.

This
exposure
scenario
can
be
divided
into
three
parts:

$
The
worker
opening
the
packets
and
pouring
two
4.77
oz.
packets
of
the
chemical
into
water,

$
The
worker
dipping
mess
kits
into
the
diluted
solution,
and
$
The
worker
dipping
fruits
and
vegetables.

To
calculate
the
risks
associated
with
this
type
of
exposure,
the
following
assumptions
were
used:

$
It
is
assumed,
for
this
assessment,
that
two
4.77
oz.
packets
are
sufficient
for
the
needs
of
an
individual
worker
in
a
kitchen
per
day,
either
washing
mess
kits
or
washing
fruits
and
vegetables.

$
To
model
opening
the
packet
and
pouring
the
contents,
surrogate
data
from
the
Chemical
Manufacturers
Association
(
MRID
42587501)
were
used.
CMA
data
exists
for
`
solid
pour'
scenarios,
which
entails
a
worker
transferring
powder
from
large
shipping
containers
to
smaller
containers
for
measuring
and
pouring.
The
quantities
of
powder
used
in
the
CMA
studies
are
much
greater
than
the
quantities
of
trichloromelamine
that
will
be
used
in
this
scenario.
However,
for
lack
of
better
data,
the
CMA
data
were
used.

$
To
calculate
the
inhalation
exposure
associated
with
standing
over
the
containers
and
washing
mess
kits,
fruits,
and
vegetables,
surrogate
data
from
CMA
were
used.
CMA
data
exist
for
`
wiping'
scenarios,
which
entails
a
worker
applying
a
chemical
to
surfaces
and
then
wiping
them.
Although
the
representativeness
of
the
CMA
scenario
for
wiping
is
uncertain,
no
better
surrogate
data
currently
exists.
Page
14
of
38
$
To
calculate
the
dermal
exposure
for
a
worker
treating
mess
kits,
fruits,
and
vegetables,
the
DERMAL
model
was
used.
According
to
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
"
The
DERMAL
model
was
developed
by
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
to
support
the
assessment
of
new
chemicals
under
Premanufacture
Chemicals
under
the
Toxic
Substance
Control
Act.
DERMAL
is
used
primarily
in
screening­
level
assessments
of
dermal
exposure
to
the
components
of
consumer
products"
(
U.
S.
EPA,
1997).
The
DERMAL
model
calculates
exposures
to
wet
surfaces
for
the
whole
day.
In
actual
practice,
it
is
unlikely
that
workers
would
have
their
hands
wet
with
the
dilute
trichloromelamine
solution
for
the
entire
day.
The
DERMAL
model
requires
that
a
weight
fraction
be
used
as
a
user
input.
Other
inputs
include
surface
area
to
body
weight
ratio
(
SA/
BW)
and
the
amount
of
chemical
retained
on
skin.

The
calculations
and
results
for
exposures
and
risks
to
Army
workers
are
shown
in
Tables
5
­
7.
As
all
MOEs
are
greater
than
the
target
MOE
of
100,
no
risks
of
concern
are
identified
for
the
tasks
conducted
in
mess
halls.
However,
as
the
inhalation
MOE
of
660
for
either
washing
mess
kits
or
fruits
and
vegetables
falls
below
the
MOE
of
1000,
when
the
additional
route­
toroute
extrapolation
uncertainty
factor
is
applied,
an
inhalation
study
would
be
required
to
confirm
these
findings.

The
combined
MOE
for
both
dermal
and
inhalation
exposure
for
both
the
opening
and
pouring
of
packets
and
washing
mess
kits
is
160,
as
is
the
combined
MOE
for
the
opening
and
pouring
of
packets
and
washing
fruits
and
vegetables
(
Table
7).
As
a
conservative
measure,
it
is
assumed
that,
because
this
is
potentially
a
small­
scale
process,
one
person
could
mix
the
solution
and
use
it
immediately
after.
These
combined
risks
are
greater
than
the
target
MOE
of
100
and,
therefore,
not
of
concern.
Page
15
of
38
Table
5.
Inhalation
and
Dermal
Exposure
Calculations
for
Opening
and
Pouring
Packet
and
Inhalation
Exposure
Calculations
for
Standing
Over
Containers
While
Washing
Mess
Kits,
Fruits,
and
Vegetables
(
19.3%
a.
i.
Product)

Exposure
Scenario
Clothing
and
PPE
Parameters
Dermal
Unit
Exposurea
(
mg/
lb
a.
i.)
Inhalation
Unit
Exposurea
(
mg/
lb
a.
i.)
Daily
Amount
Usedb
(
lb
a.
i.)
Daily
Dermal
Dosec
(
mg/
kg/
day)
Daily
Inhalation
Dosec
(
mg/
kg/
day)
MOE
Opening
and
Pouring
Two
Packets
(
Solid
Pour
of
Powder)
76.2
0.0412
0.115
0.125
6.77x10­
5
Dermal
=
240
Inhalation
=
440,000
Exposure
For
Washing
Mess
Kits
or
Fruits
and
Vegetables
(
Wiping)
Long
sleeved
shirt
and
pants,
no
gloves
NAd
27.7
0.115
NAd
4.55x10­
2
Inhalation
=
660
a
Unit
Exposure
data
from
CMA.

b
4.77
oz.
product/
packet
x
2
packets
x
19.3%
a.
i.
x
1
lb./
16
ozs.
=
0.115
lbs
a.
i.
in
diluted
solution
(
Reg
No.
40510­
1)

c
Daily
dose
=
Daily
Amt.
Used
(
lb
a.
i.)
*
Unit
Exposure
(
mg/
lb
a.
i.)
/
70
kg
body
weight.

d
Not
Applicable.
For
the
washing
of
mess
kits,
fruits,
and
vegetables,
dermal
doses
were
calculated
using
a
different
method.
These
calculations
are
shown
in
Table
5.

NOAEL
=
30
mg/
kg/
day;
MOE
=
NOAEL/
Exposure
Dermal
absorption
is
assumed
to
be
100%

Target
MOE=
100
Page
16
of
38
Table
6.
Dermal
Exposure
Calculations
for
Washing
Mess
Kits
and
Fruits
and
Vegetables
(
19.3%
a.
i.
Product)

Value
Parameter
Mess
Kits
Fruits
and
Vegetables
Rationale
Weight
Fraction
of
Chemical
in
Product
2.76x10­
4
3.45x10­
4
Based
on
maximum
use
rate
listed
on
product
label
Skin
Surface
Area/
Body
Weight
Ratio
18.8
cm2/
kg
High­
end
ratio
(
90th
percentile)
default
value
for
hands
(
DERMAL
model)

Film
Thickness
2.14x10­
3
cm
Default
value
(
DERMAL
model)
for
cleaning
products
Density
of
Formulation
1.040
g/
cm3
Default
value
(
DERMAL
model)
for
cleaning
products
Dilution
Fraction
1.000
Default
value
(
DERMAL
model)

Calculated
Results
Potential
Dermal
Dose
Rate
0.0058
mg/
kg/
day
0.0072
mg/
kg/
day
Dermal
MOE
5200
4200
DERMAL
Model
Results
Divided
by
2
(
Half­
day
Exposure)

Target
MOE
=
100
Weight
Fraction
=
%
a.
i.*
(
oz.
product
used/
gallons
water
used
for
dilution)
*
(
1/
density
of
water),
where:
2
Packets
of
4.77
oz
each
were
diluted
in
two
20
(
fruits
and
vegetables)
or
two
25
(
mess
kits)
gallon
containers
(
one
packet
per
container)
of
water
(
EPA
Reg.
No.
40510­
1).
Density
of
Water
=
133.5
oz./
gal
Table
7.
Combined
Exposure
and
Risk
for
Opening
and
Pouring
plus
Washing
Mess
Kits
or
Fruits
and
Vegetables
Exposure
Scenario
Daily
Dermal
Dose
(
mg/
kg/
day)
Daily
Inhalation
Dose
(
mg/
kg/
day)
Dermal
MOE
Inhalation
MOE
Aggregate
MOE
Opening
and
Pouring
Two
Packets
(
Solid
Pour
of
Powder)
&
Washing
Mess
Kits
0.131
4.56x10­
2
230
660
170
Opening
and
Pouring
Two
Packets
(
Solid
Pour
of
Powder)
&
Washing
Fruits
and
Vegetables
0.132
4.56x10­
2
230
660
170
5.1.2
Inhalation
and
Dermal
Exposure
for
Commercial/
Institutional
Workers
Estimates
of
inhalation
and
dermal
risk
were
calculated
for
ungloved
workers
at
restaurants/
bars
using
the
product
to
sanitize
surfaces.
The
label
for
the
18.7%
product
(
Reg.
No.
65169­
1)
states
that
one
0.25
oz.
packet
of
the
chemical
powder
is
to
be
poured
into
three
gallons
of
water
(
i.
e.,
0.0117%
a.
i.
in
the
diluted
solution).
Glassware
that
has
been
washed
with
soap
and
water
is
immersed
into
this
solution
for
at
least
two
minutes
and
then
allowed
to
air
dry.
Alternatively,
the
solution
can
be
used
to
wipe
surfaces
such
as
countertops.
Page
17
of
38
This
exposure
scenario
can
be
divided
into
three
parts:

$
The
worker
opening
the
packet
and
pouring
the
contents
into
the
water,

$
The
worker
dipping
food
utensils
into
the
diluted
solution,
and
$
The
worker
using
the
diluted
solution
to
wipe
countertops.

To
calculate
the
risks
associated
with
this
type
of
exposure,
the
following
assumptions
were
used:

$
The
label
states
that
additional
quantities
should
be
used
if
the
diluted
solution
falls
below
100
ppm
available
chlorine.
It
is
assumed,
for
this
occupational
assessment,
that
the
available
chlorine
does
not
fall
over
the
course
of
a
day,
and
that
0.25
oz.
in
three
gallons
of
water
for
each
activity
(
sanitizing
utensils
and
wiping
countertops)
is
sufficient
for
the
needs
of
one
worker
in
a
restaurant
per
day.

$
To
model
opening
the
packet
and
pouring
the
contents,
surrogate
data
from
the
Chemical
Manufacturers
Association
(
MRID
42587501)
were
used.
CMA
data
exists
for
`
solid
pour'
scenarios,
which
entails
a
worker
transferring
powder
from
large
shipping
containers
to
smaller
containers
for
measuring
and
pouring.
The
quantities
of
powder
used
in
the
CMA
studies
are
much
greater
than
the
quantities
of
trichloromelamine
that
will
be
used
in
this
scenario.
However,
for
lack
of
better
data,
the
CMA
data
were
used.

$
To
model
the
worker
treating
food
utensils,
the
DERMAL
model
was
used.
According
to
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
"
The
Dermal
model
was
developed
by
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
to
support
the
assessment
of
new
chemicals
under
Premanufacture
Chemicals
under
the
Toxic
Substance
Control
Act.
DERMAL
is
used
primarily
in
screening­
level
assessments
of
dermal
exposure
to
the
components
of
consumer
products"
(
U.
S.
EPA,
1997).
The
DERMAL
model
calculates
exposures
to
wet
surfaces
for
the
whole
day.
In
actual
practice,
it
is
unlikely
that
workers
would
have
their
hands
wet
with
the
dilute
trichloromelamine
solution
for
the
entire
day.
The
DERMAL
model
requires
that
a
weight
fraction
be
used
as
a
user
input.
Other
inputs
include
surface
area
to
body
weight
ratio
(
SA/
BW)
and
the
amount
of
chemical
retained
on
skin.

$
For
inhalation
exposure,
it
is
assumed
that
the
pathway
through
which
the
chemical
is
inhaled
when
standing
over
a
bucket
of
solution
is
similar
to
the
pathway
when
using
the
chemical
as
a
wiping
agent.
The
amount
of
exposure
is
assumed
to
be
the
same
from
that
calculated
for
wiping
since
the
same
amount
of
solution
is
used
in
treating
food
utensils
and
wiping
(
3
gallons).

$
To
model
the
wiping
of
surfaces
with
the
diluted
solution,
surrogate
data
from
the
Chemical
Manufacturers
Association
(
MRID
42587501)
were
used.

The
calculations
and
results
are
shown
in
Tables
8
­
10.
As
all
MOEs
are
greater
than
the
target
MOE
of
100,
no
risks
of
concern
are
identified
for
the
tasks
conducted
in
restaurants
and
Page
18
of
38
bars.
The
combined
MOE
for
both
dermal
and
inhalation
exposure
for
both
the
opening
and
pouring
of
packets
and
wiping
countertops
is
240,
and
the
combined
MOE
for
the
opening
and
pouring
of
packets
and
washing
utensils
is
2500
(
Table
10).
As
a
conservative
measure,
it
is
assumed
that,
because
this
is
potentially
a
small­
scale
process,
one
person
could
mix
the
solution
and
use
it
immediately
after.
The
combined
risks
from
these
exposures
are
below
the
Agency's
level
of
concern.
Page
19
of
38
Table
8.
Exposure
Calculations
for
Opening
and
Pouring
Packet
and
Wiping
Countertops
Exposure
Scenario
Clothing
and
PPE
Parameters
Dermal
Unit
Exposurea
(
mg/
lb
a.
i.)
Inhalation
Unit
Exposurea
(
mg/
lb
a.
i.)
Daily
Amount
Usedb
(
lb
a.
i.)
Daily
Dermal
Dosec
(
mg/
kg/
day)
Daily
Inhalation
Dosec
(
mg/
kg/
day)
MOE
Opening
and
Pouring
Packet
(
Solid
Pour)
76.2
0.0412
0.00292
3.18x10­
3
1.72x10­
6
Dermal
=
9400
Inhal.=
1.7x107
Wiping
Countertops
(
Wiping)
Long
sleeved
shirt
and
pants,

no
gloves
2870
27.7
0.00292
1.20x10­
1
1.16x10­
3
Dermal
=
250
Inhal.
=
26,000
a
Unit
Exposure
data
from
CMA.

b
0.25
oz.
product/
packet
x
18.7%
a.
i.
x
1
lb./
16
ozs.
=
0.00292
lbs
a.
i.
in
diluted
solution
(
Reg.
No.
65169­
1)

c
Daily
dose
=
Daily
Amount
Used
(
lb
a.
i.)
*
Unit
Exposure
(
mg/
lb
a.
i.)
/
70
kg
body
weight
MOE=
NOAEL/
Exposure;
NOAEL
=
30
mg/
kg/
day.

Dermal
absorption
is
assumed
to
be
100%.

Target
MOE=
100
Page
20
of
38
Table
9.
Exposure
Calculations
for
Treating
Food
Utensils
Parameter
Value
Rationale
Weight
Fraction
of
Chemical
in
Product
1.17x10­
4
Based
on
maximum
use
rate
listed
on
product
label
Skin
Surface
Area/
Body
Weight
Ratio
18.8
cm2/
kg
High­
end
ratio
(
90th
percentile)
default
value
for
hands
(
DERMAL
model)

Film
Thickness
2.14x10­
3
cm
Default
value
(
DERMAL
model)
for
cleaning
products
Density
of
Formulation
1.040
g/
cm3
Default
value
(
DERMAL
model)
for
cleaning
products
Dilution
Fraction
1.000
Default
value
(
DERMAL
model)

Calculated
Results
Potential
Dermal
Dose
Rate
4.88x10­
3
mg/
kg/
day
Dermal
MOE
6100
DERMAL
model
Inhalation
Dose
Rate
1.16x10­
3
mg/
kg/
day
Inhalation
MOE
26,000
Same
as
the
inhalation
dose
rate
for
wiping
Target
MOE
=
100
Weight
Fraction
=
%
a.
i.*
(
oz.
product
used/
gallons
water
used
for
dilution)
*
(
1/
density
of
water),
where:
0.25
oz.
was
diluted
in
3
gallons
of
water
(
EPA
Reg.
No.
65169­
1)
Density
of
Water
=
133.5
oz./
gal
Table
10.
Combined
Exposure
and
Risk
for
Opening
and
Pouring
plus
Wiping
Countertops
or
Treating
Utensils
Exposure
Scenario
Daily
Dermal
Dose
(
mg/
kg/
day)
Daily
Inhalation
Dose
(
mg/
kg/
day)
Dermal
MOE
Inhalation
MOE
Aggregate
MOE
Opening
and
Pouring
Packet
(
Solid
Pour)
&
Wiping
Countertops
1.23x10­
1
1.16x10­
3
240
26,000
240
Opening
and
Pouring
Packet
(
Solid
Pour)
&
Treating
Utensils
8.06x10­
3
1.16x10­
3
3700
26,000
3200
5.2
Residential
Exposure
Assessment
A
separate
residential
risk
assessment
was
not
performed,
as
the
assessment
for
occupational
handlers
in
restaurants
is
considered
to
be
a
conservative
and
protective
surrogate
for
residential
uses.
Since
a
higher
application
rate
is
found
on
the
label
used
to
calculate
occupational
risks,
these
values
are
used
to
represent
residential
risks
in
the
aggregate
assessment
and
are
an
overestimate
of
the
residential
exposures
and
risks.
These
values
are
not
being
refined
because
the
assessment
shows
no
risks
of
concern.
Page
21
of
38
5.3
Dietary
Exposure
Assessment
5.3.1
Dietary
Assessment
for
Army
Mess
Hall
Patrons
Patrons
of
a
mess
hall
using
the
chemical
may
have
dietary
exposure
to
the
chemical
via
two
routes:

$
The
diluted
solution
of
this
chemical
is
used
as
a
"
last
tank"
for
washing
mess
kits.
That
is
to
say,
mess
kits
that
have
been
washed
with
soap
and
water
are
then
dipped
in
the
solution,
air
dried,
and
then
reused.
Patrons
of
the
mess
hall
may
ingest
residues
of
the
chemical
left
on
plates,
forks,
glasses,
and
other
food
utensils.

$
The
diluted
solution
of
this
chemical
is
used
as
a
disinfectant
on
fruits
and
vegetables,
which
are
washed
in
the
solution
and
then
soaked
in
the
solution
for
10
minutes
and
rinsed
with
potable
water.

These
two
assessments
have
been
performed
separately,
and
then
combined
to
determine
a
total
dietary
intake
associated
with
patrons
of
a
mess
hall
that
uses
the
chemical
for
mess
kits,
fruits,
and
vegetables.

To
calculate
the
EDI
associated
with
use
of
a
trichloromelamine
product
as
a
mess
kit
disinfectant,
a
number
of
assumptions
have
been
made
based
on
the
FDA
guidelines
(
FDA,
2003).

$
When
a
surface
is
treated
with
a
disinfectant,
a
quantity
of
the
disinfectant
remains
on
the
surface.
The
FDA
recommended
worst­
case
concentration
for
this
quantity
is
1
mg
of
solution
per
square
centimeter
of
treated
surface
area.
In
the
absence
of
any
other
data,
this
value
has
been
used.

$
The
FDA
suggests
that,
as
a
worst­
case
scenario,
all
food
that
an
individual
consumes
will
come
into
contact
with
4000
cm2
of
sanitized
non­
porous
food­
contact
surfaces.
This
contact
area
represents
all
the
surface
area
from
silverware,
china,
and
glass
used
by
a
person
who
regularly
eats
three
meals
per
day
at
an
institutional
or
public
facility.

$
FDA
calculations
assume
that
100%
of
the
active
material
present
on
food
contact
surfaces
will
migrate.
This
represents
a
worst
case
scenario.

For
calculating
exposure
associated
with
use
of
a
trichloromelamine
product
as
a
fruit
and
vegetable
disinfectant,
the
following
assumptions
were
used:

$
The
following
equation
was
used
to
calculate
the
EDI:

 
=
i
i
i
Q
C
EDI
Page
22
of
38
Where:

EDI
=
Estimated
Daily
Intake
of
trichloromelamine
associated
with
ingestion
of
washed
fruits
and
vegetables
(
mg/
day),
i
=
Type
of
fruit
or
vegetable,
Ci
=
Concentration
of
chemical
residue
on
food
type
i
(
mg/
kg),
and
Qi
=
Quantity
of
food
type
i
eaten
by
a
person
per
day
(
kg/
day).

$
Ideally,
to
determine
Ci,
data
from
a
study
showing
the
amount
of
trichloromelamine
absorbed
would
be
used.
This
study
would
replicate
the
conditions
described
in
the
product
label
and
would
consider
a
variety
of
fruits
and
vegetables,
including
foods
with
a
variety
of
skin
textures,
surface
area/
volume
ratios,
and
chemical
compositions.
No
such
study
was
available.
Instead,
data
were
used
from
an
EPA
review
of
the
use
of
sodium
lauryl
sulfate
(
SLS)
on
fruits
and
vegetables
as
a
disinfectant
(
EPA,
2000).
Fruits
and
vegetables
were
to
be
sprayed
with
enough
SLS
solution
to
`
cover'
them,
rubbed
for
30
seconds,
and
then
rinsed
with
water.
Use
of
the
SLS
product
differs
from
the
use
specified
for
the
trichloromelamine
product.
The
SLS
solution
is
sprayed
on
foods
and
rubbed
for
30
seconds.
For
the
trichloromelamine
product,
foods
are
washed
in
a
container
of
the
solution,
and
then
soaked
for
10
minutes
in
another
container
of
the
solution.
SLS
also
differs
chemically
from
trichloromelamine,
and
it
is
not
clear
that
the
absorption
kinetics
of
SLS
on
fruits
and
vegetables
would
be
similar
to
those
of
trichloromelamine.
However,
for
lack
of
better
data,
this
review
was
used.
SLS
residue
data
were
collected
for
the
following
foods:
apples,
pears,
cherries,
grapes,
cucumbers,
squash,
peppers,
tomatoes,
potatoes,
spinach,
and
strawberries.
These
foods
were
sprayed
with
the
SLS
product,
rubbed
for
30
seconds,
then
rinsed
with
water
for
10
seconds
(
20
seconds
for
grapes).
EPA
noted
a
number
of
concerns
with
this
study,
including
the
fact
that
the
rinse
times
used
were
excessively
long,
and
that
the
analytical
method
used
in
the
study
was
not
adequately
validated.
The
food
concentrations
in
the
SLS
study
were
reported
in
terms
of
ppm
SLS.
Values
of
ppm
trichloromelamine
were
determined
by
dividing
the
weight
fraction
of
the
trichloromelamine
dilute
solution
(
0.0345%
a.
i.)
by
the
weight
fraction
of
the
SLS
product
(
reported
in
MRID
45012316
as
0.2%
SLS),
and
then
multiplying
by
the
SLS
concentrations
reported.

$
Values
of
Qi
were
determined
using
data
from
the
Continuing
Survey
of
Food
Intakes
by
Individuals
(
CSFII).
Data
were
available
both
for
adult
food
consumption
(
Wilson
et
al.,
1997)
and
for
children
(
USDA,
1999).
For
the
purposes
of
this
assessment,
two
populations
were
examined:
adult
males
(
20
and
older)
and
adult
females
(
20
and
older).
It
is
assumed
that
children
are
not
eating
at
mess
halls.
Data
regarding
consumption
of
fruit
juices
and
dried
fruits
have
not
been
used.
Mean
consumption
rates
were
used
for
each
population.
The
dietary
intake
for
fruits
and
vegetables
is
limited
to
subset
of
the
general
population,
specifically
members
of
the
army;
since
this
subpopulation
is
not
representative
of
the
general
population,
the
90th
percentile
was
not
used
to
calculate
dietary
risk.
It
has
been
assumed
that
all
vegetables
consumed
have
been
washed
using
the
product.
This
is
a
conservative
assumption;
people
may
also
obtain
fruits
and
vegetables
from
unwashed
sources,
including
canned
or
frozen
foods.
Page
23
of
38
The
calculations
of
the
estimated
daily
intakes
are
shown
in
Tables
11­
13.
Summary
calculations
for
all
dietary
exposures
are
presented
at
the
end
of
this
section.
The
total
dietary
exposure
from
eating
fruits
and
vegetables
and
using
mess
kits
treated
with
trichloromelamine
is:

0.00282
mg/
kg/
day
+
1.104
mg/
day
/
70
kg
=
0.0186
mg/
kg/
day
(
adult
male)
0.00290
mg/
kg/
day
+
1.104
mg/
day
/
60
kg
=
0.0213
mg/
kg/
day
(
adult
female)
Page
24
of
38
Table
11.
Calculations
of
EDI
for
Adult
Males
(
Age
20
Years
and
Older)
Consuming
Washed
Fruits
and
Vegetables
(
19.3%
Product)

Food
Concentrationa
(
mg
a.
i./
kg
food)
Food
Ingestedb
(
g
food/
day)
Active
Ingredient
Ingestedc
(
mg/
day)
EDId
(
mg/
kg/
day)

Applese
0.0345
17
0.000586
0.0000083
Bananase
0.0345
19
0.000656
0.0000094
Melons
and
Berriesf
0.552
17
0.00938
0.000134
Other
fruitsf
0.552
20
0.011
0.000157
Potatoes
0.138
79
0.0109
0.000156
Dark
Green
Vegetablesg
1.73
14
0.0242
0.000346
Deep
Yellow
Vegetablesh
0.069
8
0.000552
0.0000079
Tomatoes
0.0518
37
0.00191
0.0000273
Lettuce,
Lettuce­
Based
Saladsg
1.73
20
0.0345
0.000493
Green
Beansi
0.138
9
0.00124
0.0000177
Corn,
Green
Peas,
Lima
Beansi
0.138
16
0.00221
0.0000316
Other
Vegetablesg
1.73
58
0.10034
0.00143
Total:
314
0.197
0.00282
a
Values
of
ppm
Trichloromelamine
were
determined
by
dividing
the
weight
fraction
of
the
trichloromelamine
dilute
solution
(
0.0334%
a.
i.)
by
the
weight
fraction
of
the
SLS
product
(
reported
in
MRID
45012316
as
0.2%
SLS),
and
then
multiplying
by
the
SLS
concentrations
reported
in
EPA
(
2000).
The
types
of
foods
examined
in
the
SLS
study
did
not
match
exactly
those
types
examined
in
CSFII.
See
footnotes
for
individual
food
types
for
more
information.
b
Sources:
Wilson
et
al.,
1997;
USDA,
1999.
c
Active
Ingredient
Ingested
(
mg/
day)
=
Concentration
(
mg
a.
i./
kg
food)
*
Food
Ingested
(
g
food/
day)
/
(
1000
g/
kg)
d
Estimated
Daily
Intake
(
mg/
kg/
day)
=
Active
Ingredient
Ingested
(
mg/
day)
/
Adult
Male
Body
Weight
(
70
kg)
e
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
apples
and
pears
(
one
category)
were
used
to
determine
concentrations
for
apples
and
bananas.
f
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
strawberries
were
used
to
determine
concentrations
for
melons,
berries
and
other
fruits.
The
SLS
concentrations
for
strawberries
were
the
highest
reported
for
fruits,
and
therefore
the
use
of
this
number
for
other
fruits
is
most
likely
conservative.
g
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
spinach
were
used
to
determine
concentrations
for
dark
green
vegetables,
lettuce,
and
other
vegetables.
The
SLS
concentrations
for
spinach
were
the
highest
reported
for
vegetables,
and
therefore
the
use
of
this
number
for
other
vegetables
is
most
likely
conservative.
h
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
cucumbers,
melons,
and
squash
(
one
category)
were
used
to
determine
concentrations
for
deep
yellow
vegetables.
i
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
potatoes
were
used
to
determine
concentrations
for
green
beans,
corn,
green
peas,
and
lima
beans.
Page
25
of
38
Table
12.
Calculations
of
EDI
for
Adult
Females
(
Age
20
Years
and
Older)
Consuming
Washed
Fruits
and
Vegetables
(
19.3%
Product)

Food
Concentrationa
(
mg
a.
i./
kg
food)
Food
Ingestedb
(
g
food/
day)
Active
Ingredientc
Ingested
(
mg/
day)
EDId
(
mg/
kg/
day)

Applese
0.0345
17
0.000587
9.8x10­
6
Bananase
0.0345
17
0.000587
9.8x10­
6
Melons
and
Berriesf
0.552
18
0.00994
0.00017
Other
fruitsf
0.552
20
0.0110
0.00018
Potatoes
0.138
51
0.00704
0.00012
Dark
Green
Vegetablesg
1.73
14
0.0242
0.000400
Deep
Yellow
Vegetablesh
0.069
10
0.000690
0.0000100
Tomatoes
0.0518
28
0.00145
0.0000200
Lettuce,
Lettuce­
Based
Saladsg
1.73
17
0.0293
0.000490
Green
Beansi
0.138
8
0.00110
0.0000200
Corn,
Green
Peas,
Lima
Beansi
0.138
11
0.00152
0.0000300
Other
Vegetablesg
1.73
50
0.0863
0.00144
Total:
261
0.174
0.0029
a
Values
of
ppm
Trichloromelamine
were
determined
by
dividing
the
weight
fraction
of
the
trichloromelamine
dilute
solution
(
0.0334%
a.
i.)
by
the
weight
fraction
of
the
SLS
product
(
reported
in
MRID
45012316
as
0.2%
SLS),
and
then
multiplying
by
the
SLS
concentrations
reported
in
EPA
(
2000).
The
types
of
foods
examined
in
the
SLS
study
did
not
match
exactly
those
types
examined
in
CSFII.
See
footnotes
for
individual
food
types
for
more
information.
b
Sources:
Wilson
et
al.,
1997;
USDA,
1999.
c
Active
Ingredient
Ingested
(
mg/
day)
=
Concentration
(
mg
a.
i./
kg
food)
*
Food
Ingested
(
g
food/
day)
/
(
1000
g/
kg)
d
Estimated
Daily
Intake
(
mg/
kg/
day)
=
Active
Ingredient
Ingested
(
mg/
day)
/
Adult
Female
Body
Weight
(
60
kg)
e
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
apples
and
pears
(
one
category)
were
used
to
determine
concentrations
for
apples
and
bananas.
f
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
strawberries
were
used
to
determine
concentrations
for
melons,
berries
and
other
fruits.
The
SLS
concentrations
for
strawberries
were
the
highest
reported
for
fruits,
and
therefore
the
use
of
this
number
for
other
fruits
is
most
likely
conservative.
g
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
spinach
were
used
to
determine
concentrations
for
dark
green
vegetables,
lettuce,
and
other
vegetables.
The
SLS
concentrations
for
spinach
were
the
highest
reported
for
vegetables,
and
therefore
the
use
of
this
number
for
other
vegetables
is
most
likely
conservative.
h
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
cucumbers,
melons,
and
squash
(
one
category)
were
used
to
determine
concentrations
for
deep
yellow
vegetables.
i
Because
the
food
types
from
EPA
(
2000)
did
not
exactly
match
those
from
CSFII,
SLS
concentrations
for
potatoes
were
used
to
determine
concentrations
for
green
beans,
corn,
green
peas,
and
lima
beans.
Page
26
of
38
Table
13.
Calculations
of
EDI
for
Use
of
Trichloromelamine
Products
on
Mess
Kits
(
19.3%
a.
i.
Product)

Parameter
Value
Rationale
Residual
Solution
on
Surface
1
mg/
cm2
FDA
worst­
case
assumption
Area
of
Treated
Surface
4,000
cm2
100%
and
50%
of
FDA
worst­
case
assumption
for
food
utensils
Percent
Active
Ingredient
0.0276%
Diluted
Solution
concentration,
based
on
maximum
concentration
listed
on
product
label
(
4.77
oz
in
25
gal
water)

Calculated
Results
Estimated
Daily
Intake
1.104
mg/
person/
day
EDI
=
(
Resid.
Solution)
*
(%
a.
i.)
/
100
*
(
Surface
Area)

5.3.2
Dietary
Assessment
for
Restaurant/
Bar
Patrons
Patrons
of
a
restaurant/
bar
using
the
chemical
may
have
dietary
exposure
to
the
chemical
via
two
routes:

$
The
diluted
solution
of
this
chemical
is
used
as
a
"
last
tank"
for
washing
food
utensils.
That
is
to
say,
food
utensils
that
have
been
washed
with
soap
and
water
are
then
dipped
in
the
solution,
air
dried,
and
then
reused.
Patrons
of
the
restaurant/
bar
may
ingest
residues
of
the
chemical
left
on
plates,
forks,
glasses,
and
other
food
utensils.
This
analysis
is
based
on
EPA
Reg.
No.
65169­
1.

$
The
diluted
solution
of
this
chemical
is
used
as
a
sanitizer
on
food
contact
surfaces,
such
as
countertops.
The
diluted
solution
is
wiped
across
surfaces,
which
are
then
allowed
to
air
dry.
The
residues
on
these
food
preparation
surfaces
may
be
transferred
to
food,
which
is
then
ingested
by
the
patrons.
For
purposes
of
this
assessment,
use
of
trichloromelamine
as
a
food­
contact
sanitizer
in
restaurants
will
also
be
representative
of
trichloromelamine
exposures
in
the
home.
The
food­
contact
surface
analysis
is
based
on
EPA
Reg.
No.
8160­
1.

These
two
assessments
have
been
performed
separately,
and
then
combined
to
determine
a
total
dietary
intake
associated
with
patrons
of
a
restaurant
that
uses
the
chemical
for
both
food
utensils
and
food
preparation
surfaces.

To
calculate
the
EDI
associated
with
use
of
a
trichloromelamine
product
as
a
food
utensil
sanitizer,
a
number
of
assumptions
have
been
made
based
on
the
FDA
guidelines
(
FDA,
2003).

$
When
a
surface
is
treated
with
a
disinfectant,
a
quantity
of
the
disinfectant
remains
on
the
surface.
The
FDA
recommended
worst­
case
concentration
for
this
quantity
is
1
mg
of
solution
per
square
centimeter
of
treated
surface
area.
In
the
absence
of
any
other
data,
this
value
has
been
used.
Page
27
of
38
$
The
FDA
suggests
that,
as
a
worst­
case
scenario,
all
food
that
an
individual
consumes
will
come
into
contact
with
4000
cm2
of
sanitized
non­
porous
food­
contact
surfaces.
This
contact
area
represents
all
the
surface
area
from
silverware,
china,
and
glass
used
by
a
person
who
regularly
eats
three
meals
per
day
at
an
institutional
or
public
facility.

$
FDA
calculations
assume
that
100%
of
the
active
material
present
on
food
contact
surfaces
will
migrate.
This
represents
a
worst
case
scenario.

For
use
of
a
trichloromelamine
product
as
a
countertop
disinfectant,
the
same
assumptions
as
listed
above
were
used,
and
one
additional
assumption
was
added:

$
The
amount
of
countertop
surface
area
that
comes
in
contact
with
food
should
be
much
smaller
than
the
amount
of
food
utensil
area
that
comes
into
contact
with
food.
As
a
conservative
estimate,
it
is
assumed
that
50%
of
the
FDA
value,
or
2000
cm2
of
treated
surface
area,
comes
into
contact
with
an
individual's
food
per
day.

For
both
assessments,
the
product
with
highest
percent
of
the
active
ingredient
in
solution
(
as
diluted
per
label
instructions)
was
used
to
estimate
the
worst
case
scenario.
However,
two
labels
(
Reg.
Nos.
6198­
3
and
70627­
26)
state
that
additional
quantities
should
be
used
if
the
diluted
solution
falls
below
100
ppm
available
chlorine
and
list
the
amount
of
product
required
to
achieve
200
ppm
available
chlorine.
Although
the
Agency
does
not
believe
that
these
higher
concentrations
will
be
used
often,
as
a
conservative
measure,
they
are
assessed
as
an
acute
exposure.

The
calculation
of
the
estimated
daily
intakes
is
shown
in
Table
14.
The
total
amount
of
dietary
intake
associated
with
a
restaurant
using
a
trichloromelamine
product
as
both
a
food
utensil
sanitizer
and
a
countertop
disinfectant
is
1.42
mg/
day
(
acute
exposure)
and
0.806
(
chronic
exposure).
Hence,
the
total
dietary
exposure
is:

1.42
mg/
70
kg/
p/
d
=
0.0203
mg/
kg/
day
(
adult
male,
acute
exposure)
1.42
mg/
60kg/
p/
d
=
0.0237
mg/
kg/
day
(
adult
female,
acute
exposure)
1.42
mg/
15
kg/
p/
d
=
0.0948
mg/
kg/
day
(
child,
acute
exposure)

0.806
mg/
70
kg/
p/
d
=
0.0115
mg/
kg/
day
(
adult
male,
chronic
exposure)
0.806
mg/
60kg/
p/
d
=
0.0134
mg/
kg/
day
(
adult
female,
chronic
exposure)
0.806
mg/
15
kg/
p/
d
=
0.0537
mg/
kg/
day
(
child,
chronic
exposure)
Page
28
of
38
Table
14.
Calculations
of
EDI
for
Use
of
Trichloromelamine
Products
in
Restaurants
Value
Parameter
Food
Utensil
Countertop
Rationale
Residual
Solution
on
Surface
1
mg/
cm2
FDA
worst­
case
assumption
Area
of
Treated
Surface
4,000
cm2
2,000
cm2
100%
and
50%
of
FDA
worst­
case
assumption
for
food
utensils
Percent
Active
Ingredient
(
acute
exposure)
0.0237%
0.0237%
Diluted
solution
concentration,
based
on
maximum
concentration
listed
on
product
label
(
Reg.
No.
6198­
3)

Percent
Active
Ingredient
(
chronic
exposure)
0.0117%
0.0169%
Diluted
solution
concentration,
based
on
maximum
concentration
listed
on
product
label
(
Reg.
No.
65169­
1
for
utensils
and
Reg.
No.
8160­
1
for
countertops)

Calculated
Results
Estimated
Daily
Intake
(
Acute)
0.948
mg/
person/
day
0.474
mg/
person/
day
EDI
=
(
Resid.
Solution)
*
(%
a.
i.)
/
100
*
(
Surface
Area)

Estimated
Daily
Intake
(
Chronic)
0.468
mg/
person/
day
0.338
mg/
person/
day
EDI
=
(
Resid.
Solution)
*
(%
a.
i.)
/
100
*
(
Surface
Area)

Table
15
summarizes
the
dietary
exposure
and
risks
for
trichloromelamine.
As
the
%
PAD
does
not
exceed
100%,
the
dietary
risks
from
both
acute
and
chronic
exposure
to
trichloromelamine
fall
below
the
Agency's
level
of
concern.

Table
15.
Summary
of
Dietary
Exposure
and
Risk
Population
EDIa
(
mg/
kg/
day)
%
PADb
Army
Fruits/
Vegetables
Mess
Kits
Total
Acute
Chronic
Adult
Males
0.00282
0.0158
0.0186
6.20%
18.6%

Adult
Females
0.00290
0.0184
0.0213
7.10%
21.3%

Restaurant/
Bar
(
Acute)

Food
Utensil
Countertop
Total
Acute
Adult
Males
0.0135
0.00677
0.0203
6.77%

Adult
Females
0.0158
0.0079
0.0237
7.90%

Children
0.0632
0.0316
0.0948
31.6%

Restaurant/
Bar
(
Chronic)

Food
Utensil
Countertop
Total
Chronic
Adult
Males
0.00669
0.00483
0.0115
11.5%

Adult
Females
0.00780
0.00563
0.0134
13.4%

Children
0.0312
0.0225
0.0537
53.7%
EDI=
Estimated
Daily
Intake;
PAD=
Population
Adjusted
Dose
(
acute
or
chronic)
a
EDI=
Intake
(
mg/
person/
day)/
BW
(
adult
male=
70kg,
adult
female=
60kg,
and
child=
15kg)
b
%
PAD
=
EDI/
aPAD
or
cPAD
*
100,
where
aPAD=
0.3
mg/
kg/
day
and
cPAD=
0.1
mg/
kg/
day
Page
29
of
38
6.0
AGGREGATE
RISK
ASSESSMENT
In
accordance
with
the
policy
of
the
Office
of
Pesticide
Programs
(
OPP),
aggregate
risk
assessments
are
typically
considered
for
acute
and
chronic
dietary
exposure
(
which
includes
diet
+
drinking
water
exposure)
and
for
short­,
intermediate­,
and
long­
term
exposures,
which
usually
include
the
dietary
exposure
and
any
residential
exposures
that
can
be
thought
of
as
reasonably
occurring
together.
These
aggregate
assessments
can
be
performed
for
both
non­
cancer
and
cancer
as
needed.
In
the
case
of
trichloromelamine,
a
cancer
aggregate
assessment
is
not
needed,
as
it
has
been
determined
by
the
Health
Effects
Division
that
"
humans
are
not
likely
to
be
exposed
to
the
high
doses
of
melamine
that
produce
the
urinary
tract
toxicity
that
precedes
and
seems
to
lead
to
the
carcinogenic
response
in
rats."
For
non­
cancer
aggregate
assessment,
there
is
no
need
for
an
acute
and
chronic
dietary
aggregate
assessment,
as
the
uses
of
trichloromelamine
have
been
determined
to
have
no
impact
on
surface
or
ground
water
and
the
dietary
risk
calculations
estimated
in
this
chapter
will
characterize
the
total
dietary
risk
of
trichloromelamine.
In
the
case
of
short­,
intermediate­,
and
long­
term
aggregate
assessments,
the
following
aggregate
assessments
were
performed
for
adults
exposed
to
trichloromelamine:
dietary
exposure
from
eating
food
that
has
come
into
contact
with
treated
surfaces,
utensils,
and
glassware;
dermal
and
inhalation
exposure
from
opening
and
pouring
of
the
trichloromelamine
product
in
residential
settings;
and
dermal
and
inhalation
exposure
from
wiping
the
countertop
in
residential
settings.
No
aggregate
assessment
was
performed
for
children
as
they
are
not
likely
to
have
non­
dietary
exposures.
Further,
the
residential
exposure
scenarios
associated
with
trichloromelamine
uses
do
not
involve
long­
term
exposures,
only
short­
and
intermediate­
term
exposures.

For
the
short­
and
intermediate­
term
aggregate
risk
assessment,
the
oral,
dermal,
and
inhalation
exposures
were
combined,
due
to
the
common
endpoint
(
all
from
the
subchronic
study)
defining
the
toxicity
by
these
routes.
The
values
used
for
dermal
and
inhalation
exposures
are
derived
from
a
label
(
Reg.
No.
65169­
1)
intended
mainly
for
use
in
occupational
settings.
However,
as
this
product
had
the
highest
use
rates
(
Section
5.1.2)
and
the
mixing/
loading
and
application
on
food­
contact
surfaces
in
restaurants
is
assumed
to
be
representative
of
hard
surface
uses
in
homes,
these
values
are
used
here
and
are
a
slight
overestimate
of
the
residential
exposures
and
risks.
These
values
are
not
being
refined
because
the
assessment
shows
no
risks
of
concern.
Aggregate
MOE
calculations
were
performed
using
the
Aggregate
Risk
Index
method
(
EPA,
2001).
As
shown
in
Table
16,
no
aggregate
risks
of
concern
were
identified
for
either
males
or
females,
as
the
ARI
value
is
above
1
for
both.
Page
30
of
38
Table
16.
Summary
of
Short­
and
Intermediate­
Term
(
ST/
IT)
Aggregate
Exposure
and
Risk
Calculations
Population
Chronic
Food
Exposure
mg/
kg/
day
(
MOE)
Opening
and
Pouring
Inhalation
Exposure
mg/
kg/
day
(
MOE)
Opening
and
Pouring
Dermal
Exposure
mg/
kg/
day
(
MOE)
Wiping
Inhalation
Exposure
mg/
kg/
day
(
MOE)
Wiping
Dermal
Exposure
mg/
kg/
day
(
MOE)
Aggregate
Risk
Index
Adult
Males
0.0115
(
2610)
1.72x10­
6
(
1.7x107)
3.18x10­
3
(
9400)
1.16x10­
3
(
26,000)
1.20x10­
1
(
250)
1.89
Adult
Females
0.0134
(
2240)
1.72x10­
6
(
1.7x107)
3.18x10­
3
(
9400)
1.16x10­
3
(
26,000)
1.20x10­
1
(
250)
1.83
ARI
=
1/
((
UF1/
MOE1)
+
(
UF2/
MOE2)
+
(
UF3/
MOE3)
+
 ),
where
the
UF
=
300
for
chronic
dietary
exposure
and
100
for
inhalation
and
dermal
exposures.

7.0
CUMULATIVE
EXPOSURE
FQPA
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non­
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.

AD
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
RED
for
trichloromelamine
because
AD
has
not
yet
initiated
a
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
trichloromelamine.
For
purposes
of
this
RED,
EPA
has
assumed
that
trichloromelamine
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.

On
this
basis,
the
Registrant
must
submit,
upon
EPA's
request
and
according
to
a
schedule
determined
by
the
Agency,
such
information
as
the
Agency
directs
to
be
submitted
in
order
to
evaluate
issues
related
to
whether
trichloromelamine
shares
a
common
mechanism
of
toxicity
with
any
other
substance
and,
if
so,
whether
any
tolerances
for
trichloromelamine
need
to
be
modified
or
revoked.
If
AD
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
trichloromelamine,
AD
will
perform
aggregate
exposure
assessments
on
each
chemical
and
will
begin
to
conduct
a
cumulative
risk
assessment.

The
Health
Effects
Division,
Office
of
Pesticide
Programs,
has
recently
developed
a
framework
proposed
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
was
issued
for
public
comment
on
January
16,
2002
(
67
FR
2210­
2214)
and
is
available
from
the
OPP
Website
at:
Page
31
of
38
http://
www.
epa.
gov/
pesticides/
trac/
science/
cumulative_
guidance.
pdf.
In
the
guidance,
it
is
stated
that
a
cumulative
risk
assessment
of
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
will
not
be
conducted
until
an
aggregate
exposure
assessment
of
each
substance
has
been
completed.

Before
undertaking
a
cumulative
risk
assessment,
AD
will
follow
procedures
for
identifying
chemicals
that
have
a
common
mechanism
of
toxicity
as
set
forth
in
the
"
Guidance
for
Identifying
Pesticide
Chemicals
and
Other
Substances
that
Have
a
Common
Mechanism
of
Toxicity"
(
64
FR
5795­
5796,
February
5,
1999).

8.0
ECOTOXICOLOGY
AND
ENVIRONMENTAL
RISK
ASSESSMENT
8.1
Ecological
Hazard
Information
regarding
the
potential
ecotoxicity
of
trichloromelamine
is
shown
in
Table
17.
Because
the
use
of
trichloromelamine
is
limited
to
use
as
a
food
surface
disinfectant
in
restaurants
and
similar
establishments,
trichloromelamine
is
not
expected
to
enter
the
environment
and
risk
to
terrestrial
and
aquatic
organisms
is
not
expected
due
to
the
lack
of
exposure.

Although
the
information
currently
available
regarding
melamine
toxicity
is
insufficient
for
a
hazard
assessment,
an
Agency
memorandum
notes
that
there
is
sufficient
evidence
to
conclude
that
melamine
may
be
chronically
toxic
to
fish
and
invertebrates,
causing
adverse
effects
on
reproduction
and
embryonic
development.
It
was
noted
that
melamine
may
be
more
toxic,
chronically,
than
the
data
reviewed
indicate
(
EPA,
1983).

FDA
conducted
a
review
of
a
number
of
acute
toxicity
studies
for
melamine
(
EPA,
1983).
The
FDA
concluded
that,
although
there
is
insufficient
evidence
to
determine
the
potential
environmental
toxicity
of
melamine,
there
is
basis
for
concern,
due
to
the
structureactivity
relationship
(
SAR)
of
melamine
to
meta­
phenylenediamine,
and
the
readily
available
studies
on
melamine's
reproductive
effects
on
embryonic
development
to
fish
and
invertebrates.
Based
on
SARs
of
melamine
to
meta­
phenylenediamine,
the
96­
hour
EC50
for
melamine
for
green
algae
is
expected
to
be
2.4
mg/
L.
The
LC50
for
daphnids
is
expected
to
be
5.9
mg/
L,
and
the
MATC
is
expected
to
range
between
0.05
and
0.09
mg/
L.
Page
32
of
38
Table
17.
Summary
of
Ecotoxicity
Data
(
Trichloromelamine)

Endpoint
Type
Species
Results
Reference/
MRID#

Acute
Avian
Oral
Bobwhite
quail
(
Colinus
virginianus)
LD50
>
5,000
mg/
kg
NOEC
=
5,000
mg/
kg
42250801
Acute
Avain
Diet
Bobwhite
quail
(
Colinus
virginianus)
LD50
>
2,150
mg/
kg
42280801
Acute
Avain
Diet
Mallard
duck
(
Anas
platyrhynchos)
LC50
>
5,000
mg/
kg
NOEC
=
2,500
mg/
kg
42247401
Acute
Fish
Toxicity
Bluegill
sunfish
(
Lepomis
macrochirus)
LC50
=
4.5
mg/
L
NOEC
=
1.0
mg/
L
41934901
Acute
Fish
Toxicity
Rainbow
Trout
LC50
=
4.0
mg
a.
i./
L
NOEC
=
0.56
mg
a.
i./
L
42010601
Acute
Aquatic
Invertebrate
Toxicity
Daphnia
EC50
=
0.80
mg
ai/
L
NOEC
=
0.32
mg
ai/
L
42020801
8.2
Environmental
Fate
According
to
EPA's
EPI
Suite
database
used
by
OPPTS,
a
linear
model
on
biodegradability
predicts
that
trichloromelamine
has
a
high
probability
of
biodegrading
in
water
within
hours.
The
half­
life
in
air
for
trichloromelamine,
as
determined
through
mediation
of
the
hydroxy
radical
in
the
atmosphere,
is
about
16
days
(
based
on
a
12­
hour
day),
and
it
appears
to
be
moderately
persistent
in
the
atmosphere
(
EPA,
2005).

The
half­
life
of
trichloromelamine
in
soils
has
been
estimated
to
be
about
38
days
and
150
days
in
sediments.
With
an
estimated
Koc
of
150,
it
is
likely
to
be
immobile
and
persistent
in
soils
and
sediments
and
may
not
pose
a
concern
for
groundwater
contamination.
However,
as
trichloromelamine
is
immobile,
it
may
pose
a
concern
for
surface
water
contamination
due
to
soil
erosion.
Because
use
of
trichloromelamine
is
limited
to
use
as
a
food
and
food­
contact
surface
sanitizer
in
restaurants
and
similar
establishments,
and
in
Army
mess
halls,
trichloromelamine
is
not
expected
to
enter
the
environment
and
exposure
to
soil
and
water
should
be
minimal.

8.3
Environmental
Exposure
and
Risk
Characterization
Environmental
exposure
modeling
was
not
conducted
for
trichloromelamine.
The
use
patterns
are
not
likely
to
result
in
significant
outdoor
exposure.
The
uses
of
trichloromelamine
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur.
However,
the
high
toxicity
of
trichloromelamine
to
freshwater
organisms
is
of
concern
in
the
event
of
a
spill
or
misuse
of
the
product.
Product
labeling
should
indicate
that
the
chemical
is
toxic
to
aquatic
invertebrates,
and,
if
more
than
50
pounds
or
5
gallons
of
product
is
sold
in
one
package,
that
discharge
into
water
should
not
occur
except
in
accordance
with
NPDES
requirements.
Page
33
of
38
8.4
Listed
Species
Considerations
Section
7
of
the
Endangered
Species
Act,
16
U.
S.
C.
Section
1536(
a)(
2),
requires
all
federal
agencies
to
consult
with
the
National
Marine
Fisheries
Service
(
NMFS)
for
marine
and
anadromous
listed
species,
or
the
United
States
Fish
and
Wildlife
Services
(
FWS)
for
listed
wildlife
and
freshwater
organisms,
if
they
are
proposing
an
"
action"
that
may
affect
listed
species
or
their
designated
habitat.
Each
federal
agency
is
required
under
the
Act
to
insure
that
any
action
they
authorize,
fund,
or
carry
out
is
not
likely
to
jeopardize
the
continued
existence
of
a
listed
species
or
result
in
the
destruction
or
adverse
modification
of
designated
critical
habitat.
To
jeopardize
the
continued
existence
of
a
listed
species
means
"
to
engage
in
an
action
that
reasonably
would
be
expected,
directly
or
indirectly,
to
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
the
species."
50
C.
F.
R.
§
402.02.

To
facilitate
compliance
with
the
requirements
of
the
Endangered
Species
Act
subsection
(
a)(
2)
the
Environmental
Protection
Agency,
Office
of
Pesticide
Programs
has
established
procedures
to
evaluate
whether
a
proposed
registration
action
may
directly
or
indirectly
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
any
listed
species
(
EPA
2004a).
After
the
Agency's
screening­
level
risk
assessment
is
performed,
if
any
of
the
Agency's
Listed
Species
LOC
Criteria
are
exceeded
for
either
direct
or
indirect
effects,
a
determination
is
made
to
identify
if
any
listed
or
candidate
species
may
co­
occur
in
the
area
of
the
proposed
pesticide
use.
If
determined
that
listed
or
candidate
species
may
be
present
in
the
proposed
use
areas,
further
biological
assessment
is
undertaken.
The
extent
to
which
listed
species
may
be
at
risk
then
determines
the
need
for
the
development
of
a
more
comprehensive
consultation
package
as
required
by
the
Endangered
Species
Act.

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
1/
23/
04,
Appendix
A,
Section
IIB,
pg.
81).
Chemicals
in
these
categories
therefore
do
not
undergo
a
full
screening­
level
risk
assessment,
and
are
considered
to
fall
under
a
"
no
effect"
determination.
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
trichloromelamine,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.
Page
34
of
38
7.0
REFERENCES
Submitted
Studies:

MRID
Citation
41934901
Bowman,
J.
(
1986)
Acute
Toxicity
of
Trichloromelamine
to
Bluegill
Sunfish
(
Lepomis
macrochirus):
Lab
Project
Number:
34811.
Unpublished
study
prepared
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ABC
Labs,
Inc.
17
p.

42010601
Bowman,
J.
(
1986)
Acute
Oral
Toxicity
Trichloromelamine
to
Rainbow
Trout
(
Salmo
gairdneri):
Lab
Project
Number:
34812.
Unpublished
study
prepared
by
Analytical
Bio­
chemistry
Laboratories,
Inc.
17
p.

42020801
Burgess,
D.;
Frazier,
S.;
Schoen,
L.
(
1991)
Acute
Toxicity
Trichloromelamine
to
Daphnia
magna:
Lab
Project
Number:
34813.
Unpublished
study
prepared
by
ABC
Laboratories,
Inc.
15
p.

42021701
Cifone,
M.
(
1986)
Evaluation
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Trichloromelamine
in
the
Rat
Hepatocyte
Unscheduled
DNA
Synthesis
Assay:
Lab
Project
Number:
20991
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
25
p.

42021801
Ivett,
J.
(
1986)
Clastogenic
Evaluation
of
Trichloromelamine
in
an
In
Vitro
Cytogenic
Assay
Measuring
Chromosomal
Aberration
Freq­
uencies
in
Chinese
Hamster
Ovary
(
CHO)
Cells:
Lab
Project
Number
:
20990.
Unpublished
study
prepared
by
Hazelton
Laboratories
America,
Inc.
33
p.

42131101
Leifheit,
B.
(
1990)
Product
Chemistry
for
Trichloromelamine,
Technical
Grade.
Unpublished
study
prepared
by
Drackett
Co.
8
p.

42148801
Jagannath,
D.
(
1987)
Evaluation
of
Trichloromelamine,
(...)
in
Ames
Salmonella/
Microsome
Reverse
Mutation
Assay:
Lab
Project
Number:
20988.
Unpublished
study
prepared
by
Hazleton
Labs.,
America,
Inc.
26
p.

42247401
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
8­
Day
Acute
Dietary
LC50
Study
in
Mallard
Ducklings:
Lab
Project
Number:
88
DC
109.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
26
p.

42250801
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
21­
Day
Acute
Dietary
LD50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
BLAL
88
QD
109.
Unpublished
study
prepared
by
Bio­
Life
Assocs.
31
p.

42280801
Fletcher,
D.;
Pedersen,
C.
(
1988)
Trichloromelamine:
8­
Day
Acute
Dietary
LC50
Study
in
Bobwhite
Quail:
Lab
Project
Number:
BLAL
88
QC
110.
Unpublished
study
prepared
by
Bio­
Life
Associates,
Ltd.
25
p.
Page
35
of
38
42283401
DBK
Incorporated
(
1992)
Trichloromelamine
&
DBK
Food
Contact
Sanitizer:
Product
Chemistry
Data.
Unpublished
study.
35
p.

42385101
Schneder,
D.
(
1992)
Trichloromelamine­­
Efficacy
Data
"
Replacement
Study":
Lab
Project
Number:
TCM­
EFF.
Unpublished
study
prepared
by
H
&
S
Chemical
Co.
Inc.
25
p.

42587501
Popendorf,
W.;
Selim,
M.;
Kross,
B.
(
1992)
Chemical
Manufacturers
Association
Antimicrobial
Exposure
Assessment
Study:
Second
Replacement
to
MRID
41761201:
Lab
Project
Number:
Q626.
Unpublished
study
prepared
by
The
University
of
Iowa.
316
p.

43064301
Michie,
M.
(
1989)
Trichloromelamine­­
90­
Day
Subchronic
Study
in
Rats:
Lab
Project
Number:
75­
51­
0743­
88:
40­
0743­
88.
Unpublished
study
prepared
by
U.
S.
Army
Environmental
Hygiene
Agency.
1177
p.

43159901
Glaza,
S.
(
1994)
Acute
Dermal
Toxicity
Study
in
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102386:
TP3016.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
31
p.

43159902
Glaza,
S.
(
1994)
Primary
Eye
Irritation
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102388:
TP3015.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
26
p.

43159903
Glaza,
S.
(
1994)
Primary
Dermal
Irritation
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rabbits:
Final
Report:
Lab
Project
Number:
HWI
31102387:
TP3014.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
24
p.

43159904
Glaza,
S.
(
1994)
Dermal
Sensitization
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Guinea
Pigs­­
Closed
Patch
Technique:
Final
Report:
Lab
Project
Number:
HWI
31102389:
TP2008.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
38
p.

43165701
Glaza,
S.
(
1994)
Acute
Oral
Toxicity
Study
of
Trichloromelamine
(
TCM),
#
14468W46
in
Rats:
Final
Report:
Lab
Project
Number:
HWI/
31102385.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
44
p.

43350301
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
61­
3:
Product
Chemistry:
Lab
Project
Number:
TCM­
61­
3.
Unpublished
study
prepared
by
H&
S
Chemical
Co.,
Inc.
5
p.

43350302
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
62­
1,2:
Product
Chemistry:
Lab
Project
Number:
TCM­
62­
1,2.
Unpublished
study
prepared
by
H&
S
Chemical
Co.,
Inc.
6
p.
Page
36
of
38
43350303
Schneider,
D.
(
1994)
Trichloromelamine­­
Series
63­
9,
10,
11:
Product
Chemistry:
Lab
Project
Number:
TCM­
63­
9,
10,
11.
Unpublished
study
prepared
by
H&
S
Chemical
Co.,
Inc.
8
p.

43368501
Viau,
A.
(
1994)
An
Evaluation
of
the
Acute
Toxicity
of
Inhaled
Trichloromelamine
Dry
Powder
Formulation
in
the
Albino
Rat:
Lab
Project
Number:
90906.
Unpublished
study
prepared
by
Bio­
Research
Lab.,
Ltd.
190
p.

43395401
Lee,
H.
(
1994)
Physical
and
Chemical
Characteristics
of
Trichloromelamine:
Lab
Project
Number:
7673/
09/
08/
A1:
233A1.
Unpublished
study
prepared
by
S.
C.
Johnson
&
Son,
Inc.
17
p.

43614301
Tyl,
R.;
Marr,
M.;
Myers,
C.
(
1995)
Developmental
Toxicity
Evaluation
of
Trichloromelamine
Administered
by
Gavage
to
New
Zealand
White
Rabbits:
Final
Report:
Lab
Project
Number:
65C­
5742­
300/
400.
Unpublished
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prepared
by
Research
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215
p.

43614302
Tyl,
R.;
Marr,
M.;
Myers,
C.
(
1995)
Developmental
Toxicity
Evaluation
of
Trichloromelamine
Administered
by
Gavage
to
CD
(
Sprague­
Dawley)
Rats:
Final
Report:
Lab
Project
Number:
65C­
5742­
100/
200.
Unpublished
study
prepared
by
Research
Triangle
Institute.
246
p.

45012316
Walls,
C.;
Watters,
J.
(
1999)
Exposure
and
Risk
Assessments
for
Sodium
Lauryl
Sulfate:
Lab
Project
Number:
99­
02:
99­
01.
Unpublished
study
prepared
by
Novigen
Sciences,
Inc.
153
p.

Memos,
Open
Literature,
and
Websites:

Environmental
Protection
Agency,
1983.
Meeting
with
FDA
Toxicology
Department
concerning
their
evaluation
of
pituitary
tumor
incidence
in
male
Fischer
344
rats
and
bone
marrow
leukemia
incidence
in
female
F
344
rats
in
the
30­
month
melamine
study
submitted
by
American
Cyanamin
(
1983).
Memorandum
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