Page
1
of
20
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
July
24,
2002
MEMORANDUM
FROM:
Kathryn
Boyle,
CoChair
IIFG
and
Kerry
Leifer,
CoChair
IIFG
TO:
Robert
Forrest,
Chief
Minor
Use,
Inerts,
and
Emergency
Response
Branch
SUBJECT:
IIFG
Decision
Documents
on
Reassessing
Exemptions
from
the
Requirement
of
a
Tolerance
for
the
Mineral
Acids
(Hydrochloric,
Carbonic,
Phosphoric,
and
Sulfuric)
and
their
Ammonium,
Calcium,
Ferrous,
Ferric,
Magnesium,
Potassium,
Sodium,
and/
or
Zinc
Salts
Collectively
these
Decision
Documents
cover
four
mineral
acids
and
the
salts
of
these
acids.
The
individual
Decision
Documents
are:
(1)
Hydrochloric
Acid
and
Salts,
(2)
Salts
of
Carbonic
Acid,
(3)
Phosphoric
Acid
and
Salts,
and
(4)
Sulfuric
Acid
and
Salts.
The
Inert
Ingredient
Focus
Group
reassessment
is
based
on
various
conclusions
of
the
FAO/
WHO
Joint
Expert
Committee
on
Food
Additives,
conclusions
of
various
FDA
GRAS
(Generally
Recognized
As
Safe)
Assessments,
information
previously
used
by
OPP
as
part
of
the
reregistration
process,
and
other
information
available
on
government
websites.

In
total
46
exemptions
from
the
requirement
of
a
tolerance
in
40
CFR
180
are
reassessed.
This
total
consists
of
18
in
the
phosphoric
acid
document,
nine
in
the
hydrochloric
acid
document,
six
in
the
carbonic
acid
document,
and
13
in
the
sulfuric
acid
document.
Page
2
of
20
INERT
INGREDIENT
FOCUS
GROUP
DECISION
DOCUMENT
for
Hydrochloric
Acid
and
Salts
Petition
No.:
no
Tolerance
Reassessments?:
yes
Chemical
Category/
Group:
mineral
acid
and
salts
The
following
describes
the
various
ways
that
hydrochloric
acid
and
its
salts
are
used.

Table
1:
Use
Pattern
(pesticidal
­
inert
ingredient)

Chemical
Name
PC
Code
40
CFR
180.1001
Inert
Use
Pattern
(Pesticidal)
Current
Inert
List
hydrochloric
acid
045901
845901
(c)
solvent,
neutralizer
3
ammonium
chloride
900327
(c)
intensifer,
fire
suppressant
4B
calcium
chloride
875605
(c),
(e)
stabilizer
4B
ferric
chloride
834901
(d)
limitation
of
2%,
suspending,
dispersing
agent
4B
magnesium
chloride
013902
813902
(c)
safener
4B
potassium
chloride
813904
(c)
solid
diluent,
carrier
4B
sodium
chloride
800012
(c)
solid
diluent,
carrier
4A
There
is
also
a
tolerance
exemption
for
sodium
chloride
in
40
CFR
180.2.

Use
Pattern:
(pesticidal
­
active
ingredient)

At
this
time,
only
hydrochloric
acid
and
magnesium
chloride
are
used
as
active
ingredients.
Page
3
of
20
Hydrochloric
acid
is
used
as
a
disinfectant
in
48
products.
Many
of
these
products
are
toilet
bowl
cleaners,
with
concentrations
of
hydrochloric
acid
ranging
from
9.5
to
60%.
However,
potable
human
drinking
water
systems,
meat
and
poultry
processing
plants,
and
hospitals
are
also
use
sites.
Magnesium
chloride
is
used
as
an
herbicide
at
iceplants
in
only
one
product.
There
are
no
longer
any
EPA­
registered
active
ingredient
uses
for
any
of
the
other
above­
listed
chloride
salts.

Table
2:
Use
Pattern
(FDA
GRAS)

Chemical
GRAS
Citation
GRAS
Uses
hydrochloric
acid
21
CFR
182.1057
neutralizing
agent
ammonium
chloride
21
CFR
184.1138
dough
strengthener,
flavor
enhancer,
leavening
agent,
processing
aid
calcium
chloride
21
CFR
184.1193
anticaking
agent,
antimicrobial
agent,
curing
or
pickling
agent,
firming
agent,
flavor
enhancer,
humectant,
nutrient
supplement,
pH
control
agent,
processing
aid,
stabilizer
and
thickener,
surface­
active
agent,
synergist,
texturizer
ferric
chloride
21
CFR
184.1297
flavoring
agent
magnesium
chloride
21
CFR
184.1426
flavoring
agent
and
adjuvant,
nutrient
supplement
potassium
chloride
21
CFR
184.1622
flavor
enhancer,
flavoring
agent,
nutrient
supplement,
pH
control
agent,
stabilizer
or
thickener
Ammonium
chloride
and
calcium
chloride
also
have
uses
in
food
contact
surface
sanitizing
solutions
under
21
CFR
178.1010.
Page
4
of
20
Table
3:
Use
Pattern
(non­
pesticidal):

Chemical
Uses
hydrochloric
acid
in
the
production
of
chlorides;
refining
ore
in
the
production
of
tin
and
tantalum;
to
neutralize
basic
systems;
laboratory
reagent;
hydrolyzing
of
starch
and
proteins
in
the
preparation
of
various
food
products;
pickling
and
cleaning
of
metal
products;
as
catalyst
and
solvent
in
organic
synthesis;
for
oil­
and
gas­
well
treatment;
in
removing
scale
from
boilers
and
heat­
exchange
equipment;
pharmaceutic
aid
(acidifier).
ammonium
chloride
solutions
for
eye
irrigation,
fertilizer,
dyeing,
electroplating,
safety
explosives,
lustering
cotton,
washing
powders,
electrolyte
for
dry
cell
batteries,
soldering,
metal
and
refinishing
flux,
galvanizing
calcium
chloride
used
for
antifreeze
and
refrigerating
solution,
in
fire
extinguishers,
to
preserve
wood
and
stone,
ice
manufacturing,
glues,
cements,
fireproofing
fabrics,
automobile
antifreeze
mixtures,
to
melt
ice
and
snow,
as
coagulant
in
rubber
manufacturing,
as
size
in
admixture
with
starch
paste,
in
concrete
mixes
to
give
quicker
initial
set
and
greater
strength,
freezeproofing
of
coal
and
ores,
dust
control
on
unpaved
roads,
sizing
and
finishing
cotton
fabrics,
as
brine
for
filling
inflatable
tires
on
tractors
to
increase
traction.
ferric
chloride
treatment
of
sewage
and
industrial
wastes;
etching
agent
for
engraving,
photography,
and
printed
circuitry;
condensation
catalyst
in
Friedel­
crafts
reactions;
mordant;
oxidizing,
chlorinating,
and
condensing
agent;
disinfectant;
pigment;
feed
additive;
water
purification.
magnesium
chloride
source
of
magnesium
metal,
chemical
intermediate
for
magnesium
oxychloride
for
cement,
catalyst,
flocculating
agent,
agent
in
fire
extinguishers,
agent
in
textile
and
paper
manufacturing,
component
for
ceramics,
fireproofing
agent
for
wood,
component
of
refrigerating
brines
potassium
chloride
fertilizer
component
(primary
plant
nutrient);
chemical
intermediate
in
production
of
other
potassium
salts;
photography;
medical
uses
both
orally
and
intravenously
for
treating
potassium
depletion
states;
dietary
supplement.
sodium
chloride
In
the
production
of
chemicals
(sodium
hydroxide,
soda
ash,
hydrogen
chloride,
chlorine,
metallic
sodium),
ceramic
glazes,
metallurgy,
curing
hides,
food
preservative,
food
seasoning,
mineral
waters,
soap
manufacture
(salting
out),
home
water
softeners,
highway
deicing,
regeneration
of
ion­
exchange
resins,
photography,
herbicide,
fire
extinguishing,
nuclear
reactors,
mouthwash,
medicine
(heat
exhaustion
­
intravenous
solutions
for
fluid
replacement),
saline
solutions
for
eye
washes
and
contact
lens
solutions,
salting
out
dyestuffs,
supercooled
solutions.

It
should
be
noted
that
ammonium
chloride
and
potassium
chloride
have
uses
as
fertilizers.
Plants
need
various
elements
(metals
and
non­
metals)
for
proper
growth.
Especially
for
agricultural
crops,
plants
are
supplied
these
elements
as
part
of
chemical
fertilizers.
The
most
important
elements
for
plant
growth
are
nitrogen,
phosphorus,
and
potassium.
Other
metals
needed
in
the
soil
for
plant
up­
take
are
calcium,
magnesium,
iron,
and
trace
elements
such
as
zinc.
Both
potassium
chloride
and
ammonium
chloride
are
intentionally
added
to
growing
agricultural
crops
as
needed
to
promote
plant
growth.
Page
5
of
20
Page
6
of
20
Assessment
of
Hydrochloric
Acid
and
its
Salts
Hydrochloric
acid
and
its
ammonium,
sodium,
potassium,
calcium,
magnesium,
and
iron
salts
are
being
assessed
as
a
group
due
to
their
chemical
similarities.
Due
to
its
acidic
nature
the
toxicity
of
hydrochloric
acid
will
be
different
from
those
of
the
more
neutral
chloride
salts.
However,
the
chloride
salts
all
contain
the
chloride
ion
and
thus
share
some
common
chemistries.
A
major
focus
of
this
assessment
is
the
work
previously
performed
by
FDA
in
assessing
the
safety
of
these
chemicals
as
food
additives.

1.
Physical/
Chemical
Properties:

The
physical
and
chemical
properties
of
hydrochloric
acid
and
its
various
salts
are
described
in
the
May
7,
2002
EFED
Assessment.
See
attached.

2.
Information
Sources:

The
following
information
was
used
in
performing
this
assessment.
The
available
information
consisted
of
information
retrieved
from
various
websites,
such
as:
°EPA(
www.
epa.
gov),
°NIOSH,(
www.
cdc.
gov/
niosh/
ipcsneng/
neng1184.html),
(www.
cdc.
gov/
niosh/
ipcsneng/
neng1051.html),
(www.
cdc.
gov/
niosh/
ipcsneng/
neng0764.html),
(www.
cdc.
gov/
niosh/
npg/
npgd0229.html),
and
(www.
cdc.
gov/
niosh/
npg/
npgd0346.html)
°
TOXNET
(
www.
toxnet.
nlm.
nih.
gov.),
°WHO(
www.
inchem.
org/
documents/
jecfa/
jecmono/
v05je83.htm)
and
(www.
inchem.
org/
documents/
jecfa/
jecmono/
40abcj43.htm)

Various
FDA
GRAS
Assessments
were
used,
as
well
as,
the
FAO/
WHO
Assessments.

3.
NIOSH
(National
Institute
for
Occupational
Safety
and
Health)

The
NIOSH
Pocket
Guide
for
hydrogen
chloride
indicates
that
hydrogen
chloride
is
a
colorless
to
slightly
yellow
gas
with
a
pungent,
irritating
odor.
It
is
nonflammable.
Additional
information
on
the
NIOSH
web­
site
included
the
Occupational
Health
Guideline
for
Hydrogen
Chloride.
Hydrogen
chloride
gas
irritates
the
eyes,
mucous
membranes,
and
skin.
The
current
OSHA
standard
for
hydrogen
chloride
is
a
ceiling
of
7
mg/
m
3
.
Ingestion
of
hydrochloric
acid
can
cause
severe
burns
of
the
mucous
membranes
of
the
mouth,
esophagus,
and
stomach.

The
NIOSH
International
Chemical
Safety
Cards
for
magnesium
and
calcium
chloride
indicate
that
TLVs
(Threshold
Limit
Values)
have
not
been
established.
Both
chemicals
can
irritate
the
skin
and
the
respiratory
tract,
and
when
dissolved
in
water
liberate
a
considerable
amount
of
heat.
Page
7
of
20
According
the
International
Chemical
Safety
Card
for
ammonium
chloride,
the
substance
irritates
the
eyes,
the
skin
and
the
respiratory
tract.
The
TLV
is
established
only
for
the
fume.

The
NIOSH
International
Chemical
Safety
Cards
for
iron
salts
(soluble,
as
Fe)
which
includes
ferric
chloride
indicates
an
exposure
limit
of
1
mg/
m
3
(time
weighted
average).

4.
Acid
Characteristics
An
acid
is
a
substance
that
when
dissolved
in
water
yields
H
+
ions.
The
increase
of
the
concentration
of
the
H
+
ions
lowers
the
pH.
Mineral
acids
contain
a
non­
metal
such
as
phosphorus,
nitrogen,
sulfur,
or
chlorine
which
may
or
may
not
be
combined
with
oxygen.
When
combined
with
oxygen,
these
anions
can
be
referred
to
as
oxyanions.
Strong
acids
are
those
acids
that
when
dissolved
completely
transfer
their
H
+
ions
to
water.
Hydrochloric
acid
is
an
example
of
a
strong
acid.

5.
Cations:
Sodium,
Potassium,
Calcium,
Magnesium,
and
Iron
Generally,
a
salt
of
a
strong
acid,
such
as
hydrochloric
acid,
when
dissolved
in
water
dissociates
to
yield
the
chloride
ion
(an
anion,
which
is
negatively
charged)
and
a
positively
charged
cation.
In
the
human
body,
these
salts
tend
to
dissociate
and
thus,
for
the
most
part,
react
in
the
body
as
the
anion
and
the
cation.

Metals
such
as
calcium,
sodium,
magnesium,
potassium,
and
iron
are
also
required
for
proper
functioning
of
human
biological
systems.
For
risk
assessment
purposes
an
important
feature
of
these
metals
is
that
overall
the
body
does
have
an
effective
means
of
processing
them.
The
primary
means
of
exposure
to
these
cations
is
ingestion.
Four
of
the
most
common
cations
required
for
functioning
of
human
biology
are:
sodium,
potassium,
calcium
and
magnesium.
Chemically,
sodium
and
potassium
belong
to
the
same
chemical
family:
calcium
and
magnesium
belong
to
a
different
chemical
family.

Sodium:

The
average
human
body
burden
of
sodium
is
approximately
20
grams
(g)
for
a
70
kilogram
(kg)
adult.
The
sodium
cation
is
necessary
for
the
nerves
and
muscles
to
function
properly.
It
is
the
principal
cation
of
extracellular
fluid,
and
helps
to
maintain
the
body's
water
balance.
These
electrolytes,
the
electrically
charged
ions
in
the
body
fluids,
consist
to
a
great
extent
of
sodium
and
potassium.
There
is
no
Recommended
Dietary
Allowance
(RDA)
for
sodium.

Potassium:

The
average
human
body
burden
of
potassium
is
approximately
140
g
for
a
70
kg
adult.
The
potassium
cation
is
important
in
regulating
blood
pressure,
regulating
cellular
water
content,
Page
8
of
20
maintaining
proper
pH
balance,
and
transmission
of
nerve
impulses.
It
helps
to
regulate
the
electrical
activity
of
the
heart
and
muscles.
The
potassium
RDA
is
900
mg/
day.

Calcium:

The
average
human
body
burden
of
calcium
is
approximately
1
kg
for
a
70
kg
adult;
or
1/
70th
of
our
weight
is
calcium.
The
calcium
cation
is
necessary
for
bone
and
teeth
formation.
It
is
also
important
for
the
proper
functioning
of
nerves,
enzymes,
and
muscles,
and
plays
a
role
in
blood
clotting
and
the
maintenance
of
cell
membranes.
The
RDAs
for
calcium
are
1000
mg/
day
for
adults
aged
19
to
50
years
and
1200
mg/
day
for
individuals
older
than
50
years.

Magnesium:

The
average
human
body
burden
of
magnesium
is
approximately
20
g
for
a
70
kg
adult.
The
magnesium
cation
is
also
used
in
building
bones.
It
plays
a
role
in
releasing
energy
from
muscles
and
regulating
body
temperature.
The
RDA
for
magnesium
is
310
to
320
mg/
day
for
adult
females
and
400
to
420
mg/
day
for
adult
males
with
the
RDA
increasing
with
increasing
age.

Iron:

Another
common
metal
cation
that
is
needed
for
functioning
of
human
biology,
but
in
smaller
amounts
often
referred
to
as
trace,
is
iron.
The
human
body
burden
of
iron
is
approximately
4.1
g
for
a
70
kg
adult.
Iron
functions
as
a
carrier
of
oxygen.
The
hemoglobin
molecule
in
blood
transports
oxygen
from
the
lungs
to
the
cells.
The
myoglobin
molecule
supplies
oxygen
to
muscle
cells.
Iron
deficiency
is
characterized
by
anemia,
stunted
growth,
fatigue,
and
lowered
resistance
to
infection.
The
RDAs
for
iron
are
10
mg/
day
[0.14
mg/
kg/
day
for
an
adult
(70
kg)
male
(25
to
50
years)]
and
15
mg/
day
[0.
25
for
an
adult
(60
kg)
female
(19
to
50
years)].
Pregnant
and
nursing
woman
have
increased
requirements
for
iron.

Dietary
iron
is
poorly
absorbed.
The
intestinal
mucosa
is
a
limiting
factor
in
iron
absorption.
Normal
absorption
is
about
1
mg/
day
in
an
adult
male,
and
about
1.4
mg/
day
in
an
adult
female.
Absorption
occurs
in
the
divalent
(ferrous)
form,
which
must
then
be
oxidized
to
the
trivalent
(ferric)
form
for
use.
Acute
toxicity
of
iron
ingested
from
normal
dietary
sources
has
not
been
reported.
However,
death
especially
in
young
children
has
resulted
from
ingestion
of
large
overdoses
of
medicinal
iron.
(doses
ranging
from
40
to
1600
mg/
kg
­
average
900
mg/
kg).
It
is
noted
that
the
iron
from
ferric
salts
is
less
well
absorbed
than
that
from
ferrous
salts.

6.
Ammonium
Salt:

Ammonium
chloride
dissociates
to
the
chloride
anion
and
the
positively
charged
ammonium
cation
(NH4
+
).
Humans
cannot
convert
atmospheric
nitrogen
to
any
form
that
can
be
used
as
part
of
any
of
the
various
metabolic
cycles.
Therefore,
reduced
nitrogen
(NH4
+
)hasto
Page
9
of
20
enter
the
body
from
an
outside
source.
These
sources
are
the
nitrogen­
containing
amino
acids
in
protein
which
are
consumed
daily
as
part
of
the
diet.
Although
the
human
body
can
produce
some
amino
acids,
ten
amino
acids
are
considered
"essential"
amino
acids,
i.
e.,
they
must
be
consumed
in
the
diet.

Generally
the
body
works
to
maintain
a
balance
of
nitrogen
intake
and
nitrogen
excretion.
The
estimated
daily
ammonia
intake
through
food
and
drinking
water
is
18
mg.
In
contrast,
4000
mg
of
ammonia
per
day
are
produced
endogenously
in
the
human
intestine.

Ammonia
and
the
ammonium
ion
are
integral
components
of
normal
human
metabolic
processes.
Ammonia
is
released
following
deamination
that
occurs
when
protein
is
used
by
the
body
for
energy
production.
The
liver
converts
ammonia
via
the
urea
cycle
into
urea.
According
to
FDA
in
the
"Evaluation
of
the
Health
Aspects
of
Certain
Ammonium
Salts
as
Food
Ingredients"
(1974),
"the
normal
liver
so
readily
detoxifies
ammonium
ion
from
alimentary
sources
that
blood
concentrations
of
ammonium
salts
do
not
rise
to
the
levels
necessary
to
evoke
toxic
response."
Approximately
80%
of
the
body's
excess
nitrogen
is
eliminated
through
the
kidneys
as
urea,
approximately
25
to
30
grams
per
day.
Page
10
of
20
7.

Toxicological
Profile
Table
With
the
exception
of
the
information
in
IRIS
(Integrated
Risk
Information
System),
the
Agency
has
not
reviewed
any
of
the
toxicological
studies
in
the
following
table
for
hydrochloric
acid
or
any
of
its
salts.
The
reviews
of
these
studies
were
obtained
from
Toxnet,

as
well
as
other
government
websites.
Table
4:

Toxicological
Profile
Chemical
Toxicity
Other
Information
Hydrochloric
Acid
Severely
corrosive
by
all
routes
as
1N
solution;
IRIS
RfC
=

2
x
2
­2
mg/
m
3
based
on
hyperplasia
of
nasal
mucosa,
larynx
and
trachea
in
rat
chronic
inhalation
study;
LOAEL
=

15
mg/
m
3
(10ppm);
Chemical
has
no
systemic
toxicity
associated
with
exposure
except
the
acute
effects
of
corrosion/
irritation
depending
upon
the
pH
of
the
solution.

CERCLA
Reportable
Quantity:
greater
than
10
lb
(4.
54
kg);
Hazardous
Air
Pollutant
(HAP)

chemical;
1995
production
7.

33
billion
lbs;
Ammonium
Chloride
Mild
skin
and
respiratory
system
irritant;
Dust
irritating
to
eyes;
Ingestion
of
40
to
50
g
over
a
short
period
would
be
expected
to
exhaust
available
body
buffers
of
the
average
adult
and
produce
potentially
fatal
acidosis.

Mild
acidosis
occurs
at
a
dose
of
2
g;
One
sixth
molar
ammonium
chloride
was
given
to
mice
orally
in
the
drinking
water
after
day
7
during
pregnancy
and
although
the
offspring
were
small
sized
no
congenital
defects
were
found;
Absorbed
almost
100%

in
the
gastrointestinal
tract
CERCLA
Reportable
Quantity:
greater
than
5000
lb
(2270
kg);
Page
11
of
20
Magnesium
Chloride
Rat
oral
LD50
=

2800
mg/
kg;

signs:

convulsions,
changes
in
respiration
and
cardiac
function;
Drug
use
as
electrolyte
replenisher
in
hemadialysis
and
peritoneal
dialysis
fluid;
Cathartic;
90­
day
study
in
rats
with
magnesium
chloride
hexahydrate
doses

0,

0.
1,

0.
5,

2.

5%

in
diet
­NOAEL
=

2.

5%

(highest
dose
tested
(HDT));
Developmental
study
in
rats
with
magnesium
chloride
hexahydrate
­doses:

0,

200,
400,

800mg/
kg/
day
NOAEL=
800mg/
kg/
day
(HDT);
Carcinogenicity
study
in
mice
with
magnesium
chloride
hexahydrate
­doses
0,

0.5,
2%

in
diet
for
96
wks–
not
carcinogenic
Deliquescent
US
production
1972
8.6
x
10
11
grams
Calcium
Chloride
Rat
oral
LD50
=

1000
mg/
kg;
Mouse
LD50
=

1940
mg/
kg;
Anhydrous
form
irritating
to
skin,
eyes
and
mucus
membranes
Hygroscopic;
Liberates
heat
during
water
absorption
and
on
dissolution;
US
production
1993
1.4
billion
lbs
Ferric
Chloride
Rat
oral
LD50
=

0.
5­
5
g/

kg
added
to
bottled
water;
Skin,
eye
and
mucous
membrane
irritant;
Carcinogenicity
study
in
rats
at
doses
of
0,

0.

25,

0.

5%

in
drinking
water
was
negative;
Excess
ingestion
of
iron
produces
liver
toxicity;
Acute
ingestion
of
0.
5
g
of
iron
produces
severe
toxicity
Hygroscopic;
CERCLA
Reportable
Quantity:
greater
than
100
lb
(45.
4
kg);
US
production
1.
2
x
10
11
grams;
iron
drinking
water
guideline
300
ug/
L
Page
12
of
20
Potassium
Chloride
Rat
oral
LD50
=

2600
­

3020
mg/
kg;
Mild
eye
irritation
for
rabbits;
Irritating
to
skin
and
mucous
membranes;
Commercial
dietary
salt
substitute;

US
production
1980
=

3
x
10
12
grams;
OSHA
PEL
=

15
mg/
m
3
,

5
mg/
m
3
for
respirable
particles
Sodium
Chloride
Skin,
eye
and
mucous
membrane
irritant;
Affects
blood
pressure
in
humans;
Average
daily
intake
of
US
citizens
10­
12
g/

day
with
3
g
occurringnaturally,3
g
added
incooking,
4­6
g
inprocessed
foods
Common
table
salt,
sea
salt
Page
13
of
20
8.
OPP
REDs
(Reregistration
Eligibility
Decision
Document)

Mineral
Acid
RED
The
following
information
on
the
acute
toxicity
of
hydrochloric
acid
was
in
the
1993
RED:
The
oral
LD50
is
1000
mg/
kg,
toxicity
category
III.
The
dermal
LD50
is
>
2000
mg/
kg,
toxicity
category
III.
Hydrochloric
acid
is
toxicity
category
I
for
eye
and
dermal
irritation.
No
other
toxicological
data
were
required
based
on
the
use
patterns
at
the
time
of
the
RED
and
the
corrosiveness
shown
in
the
acute
studies
for
dermal
and
eye
irritation.

Inorganic
Halide
RED
This
1993
RED
included
sodium
chloride.
The
oral
LD50
(rat)
is
3000
mg/
kg,
toxicity
category
III.
Sodium
chloride
was
classified
as
moderate,
toxicity
category
III
for
eye
irritation,
and
mild,
toxicity
category
IV
for
skin
irritation.
Because
of
its
abundance
in
the
environment
and
low
toxicity
to
humans,
no
additional
toxicity
data
were
required.

9.
FDA
GRAS
(Generally
Recognized
As
Safe)
Assessments
Hydrochloric
Acid
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Hydrochloric
Acid
as
a
Food
Ingredient"
(1979).
Hydrochloric
acid
has
a
variety
of
FDA
approvals
for
food
additive
use.
"Food
stuffs
to
which
hydrochloric
acid
has
been
added
expose
consumers
predominantly
to
chloride
ions
and
other
chemical
products
resulting
from
its
reaction
to
chloride
ions
and
other
chemical
products
resulting
from
its
reaction
with
neutralizing
agents
or
chemicals
in
the
food.
Free
hydrochloric
acid
would
be
expected
to
be
present
in
only
minute
amounts,
if
at
all."

The
human
stomach
normally
contains
sufficient
hydrochloric
acid
to
maintain
the
pH
of
gastric
juice
at
1.5
to
2.
5.
The
introduction
of
any
hydrochloric
acid
into
the
stomach
proportionally
depresses
the
secretion
of
the
acid
by
the
stomach.

According
to
FDA:

"Hydrochloric
acid
in
concentrated
form
is
a
strongly
corrosive
agent
and
the
consequences
of
exposure
to
it
are
well­
known.
However,
as
it
is
used
in
food
processing,
or
as
a
food
additive
to
adjust
the
pH,
hydrochloric
acid
is
neutralized
or
buffered
by
the
food
to
which
it
is
added.
Thus,
human
consumption
is
not
of
the
acid,
but
of
the
chloride
ion
in
the
salts
formed
in
the
neutralization
process.....
There
is
no
evidence
in
the
available
information
on
hydrochloric
acid
that
demonstrates
or
suggests
reasonable
grounds
to
suspect
a
hazard
to
the
public
when
it
is
used
at
levels
that
are
now
current
or
that
might
reasonably
be
expected
Page
14
of
20
in
the
future."

Ammonium
Chloride
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Certain
Ammonium
Salts
as
Food
Ingredients"
(1974).

"Ammonia
and
ammonium
ion
are
integral
components
of
normal
metabolic
processes
and
play
an
essential
role
in
the
physiology
of
man.
Although
there
have
been
no
significant
feeding
studies
specifically
designed
to
ascertain
the
safety
threshold
of
ammonium
compounds
as
food
ingredients,
numerous
metabolic
studies
have
been
reported
in
the
scientific
literature.
Extrapolation
of
these
findings
to
the
concentrations
of
ammonium
compounds
normally
present
in
foods
does
not
suggest
that
there
would
be
untoward
effects
at
such
levels."

Calcium
Chloride
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Certain
Calcium
Salts
as
Food
Ingredients"
(1975).
The
estimated
per
capita
daily
intake
of
calcium
chloride
is
160
mg.
Both
the
calcium
and
the
chloride
are
common
constituents
of
food
and
are
metabolized
by
the
normal
metabolic
processes
in
humans.

Magnesium
Chloride
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Magnesium
Salts
as
Food
Ingredients"
(1976).
Magnesium
is
(1)
a
dietary
essential,
(2)
involved
in
many
metabolic
reactions,
(3)
important
in
electrolyte
balance,
and
(4)
present
in
fruits,
vegetables,
grains,
milk,
meat
and
fish.
No
chronic
toxicity
data
were
available.
The
"status
of
magnesium
as
a
ubiquitous
and
essential
dietary
ingredient
for
the
maintenance
of
homeostatic
and
bioenergetic
mechanisms
leads
to
the
opinion
that
none
of
the
available
evidence
suggests
any
probable
hazard
when
any
of
the
GRAS
compounds
of
magnesium
is
used
as
a
food
ingredient."
The
conclusion
was
reached
that
there
was
no
available
information
on
magnesium
chloride
to
demonstrate,
or
suggest
"reasonable
grounds
to
suspect,
a
hazard
to
the
public
when
...
used
at
levels
that
are
now
current
and
in
the
manner
now
practiced,
or
which
might
reasonably
be
expected
in
the
future."

Potassium
Chloride
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Sodium
Chloride
and
Potassium
Chloride
as
Food
Ingredients"
(1979).
The
concentration
of
potassium
in
blood
serum
is
maintained
normally
between
3.
5
and
5
meq/
L.

"The
available
evidence
indicates
that
in
normal
individuals
potassium
chloride
is
well
tolerated,
and
that
metabolism
quickly
and
efficiently
adjusts
potassium
in
the
Page
15
of
20
body
to
narrow
homeostatic
levels.
Certain
health
conditions
are
known
to
affect
the
normal
homeostatic
control
of
sodium
and
potassium
in
the
body
to
narrow
homeostatic
levels.
Certain
health
conditions
are
known
to
affect
the
normal
homeostatic
control
of
sodium
and
potassium
metabolism,
and
patients
with
these
conditions
must
adjust
their
diets
to
avoid
proscribed
electrolyte
intakes.
Water
intake,
efficiency
of
the
kidney,
and
the
ratio
of
sodium
to
potassium
in
the
diet
are
interrelated
factors
that
must
be
evaluated
in
considering
the
health
aspects
of
changing
the
relative
intakes
of
sodium
chloride
and
potassium
chloride."

It
was
concluded:

"There
is
no
evidence
in
the
available
information
on
potassium
chloride
that
demonstrates
or
suggests
reasonable
grounds
to
suspect
a
hazard
to
the
public
when
it
is
used
at
levels
that
are
now
current
or
that
might
reasonably
be
expected
in
the
future."

Sodium
Chloride
The
FDA
Assessment
is
titled
"Evaluation
of
the
Health
Aspects
of
Sodium
Chloride
and
Potassium
Chloride
as
Food
Ingredients"
(1979).
Sodium
chloride,
commonly
known
as
table
salt,
occurs
abundantly
in
nature,
in
sea
water
and
mineral
springs,
and
in
large
underground
deposits.
The
mineral
form
is
called
halite.
It
is
a
food
ingredient
and
has
historically
been
considered
an
essential
part
of
the
diet.
The
body
must
have
some
sodium.
The
human
body
has
a
homoeostatic
control
to
maintain
the
proper
balance
of
sodium,
potassium.
and
chlorine
in
the
human
body.
The
concentration
of
sodium
in
blood
serum
is
maintained
normally
between
136
to
145
meq/
L.
That
of
chlorine
is
96
to
106
meq/
L.

The
American
diet
is
considered
to
contain
an
abundance
of
salt
which
if
consumed
in
excess,
may
have
adverse
health
consequences.
In
fact,
treatment
of
certain
diseases
such
as
hypertension
can
require
restriction
of
salt
intake.
Acute
and
chronic
toxic
effects,
including
death,
can
occur
when
salt
is
ingested
in
excessive
amounts.
There
is
no
daily
requirement
for
salt,
as
it
would
be
a
level
highly
dependent
all
dietary
sources,
the
level
of
potassium
and
the
sodium
to
potassium
ratio
in
the
diet,
and
health
conditions
such
as
sweating.

The
Assessment
considers
that
the
consumption
of
sodium
chloride
in
the
aggregate
should
be
lowered
in
the
United
States.
The
Assessment
concluded:
"The
evidence
on
sodium
chloride
is
insufficient
to
determine
that
the
adverse
effects
reported
are
not
deleterious
to
the
health
of
a
significant
proportion
of
the
public
when
it
is
used
at
levels
that
are
now
current
and
in
the
manner
now
practiced."

10.
FAO/
WHO
Expert
Committee
on
Food
Additives
Page
16
of
20
WHO
has
performed
two
assessments:
hydrochloric
acid
in
1966
and
calcium
acetate,
chloride,
gluconate,
and
sulfate
in
1973.

Both
assessments
discussed
that
from
a
toxicological
point
of
view,
there
were
no
concerns
for
the
chloride
ion.
It
was
considered
to
be
naturally­
occurring
and
a
normal
participant
of
animal
and
human
metabolism.

11.
Human
Health
Hazard
Characterization:

Hydrochloric
acid
in
its
concentrated
form
is
highly
corrosive.
Due
to
this
property
toxicity
testing
can
only
be
performed
on
dilute
concentrations
or
on
neutralized
forms
of
the
acid
such
as
a
salt.
The
consequences
of
acute
exposure
to
hydrochloric
acid
are
well­
understood.
Dermal
exposure
can
lead
to
burns.
Exposure
to
the
gas
can
cause
severe
irritation
of
the
upper
respiratory
tract.

Exposure
to
hydrochloric
acid
in
pesticide
products
as
an
inert
ingredient
would
be
in
the
role
of
a
pH
adjuster.
This
is
indicative
of
the
use
of
small
amounts
of
hydrochloric
acid
that
are
incorporated
in
a
pesticide
product
to
lower
the
pH
.
After
the
pH
adjustment
is
performed,
the
hydrochloric
acid
would
be
neutralized.
As
an
active
ingredient
hydrochloric
acid
is
subject
to
FIFRA
(Federal
Insecticide,
Fungicide,
and
Rodenticide
Act)
registration
requirements
and
various
labeling
language
as
specified
in
the
RED.
Hydrochloric
acid,
whether
used
as
an
inert
or
an
active
ingredient,
must
be
used
and
applied
according
to
good
manufacturing
or
good
agricultural
practices.
However,
there
are
no
significant
adverse
effects,
to
the
general
public
or
any
population
subgroup
from
consumption
of
residues
of
hydrochloric
acid
resulting
from
pesticide
product
uses.

As
a
group
salts
of
hydrochloric
acid
constitute
a
group
of
chemicals
with
many
uses
including
direct
use
in
the
food
supply.
In
particular
sodium
chloride,
common
table
salt,
can
be
purchased
and
used
by
the
public
in
the
amounts
specifically
chosen
for
their
individual
wants
and
desires.
According
to
the
information
available
to
the
Agency,
sodium
chloride
used
in
food
processing
results
in
consumption
of
4
to
6
grams
of
sodium
chloride
in
the
average
diet
per
day.
The
average
individual
adds
up
to
another
3
grams
of
sodium
chloride
during
cooking
and
at
the
table.

The
available
toxicity
data
indicates
that
the
human
body
metabolizes
chloride,
ammonium,
calcium,
iron,
magnesium,
potassium,
and
sodium
ions
through
well­
understood
pathways.
In
fact,
all
are
necessary
human
nutrients.
Various
salts
of
hydrochloric
acid
have
been
used
in
the
food
supply
for
a
number
of
years.
There
are
no
available
data
to
indicate
any
significant
adverse
effects
to
the
general
public
or
any
population
subgroup
from
consumption
of
residues
of
the
ammonium,
calcium,
iron,
magnesium,
potassium,
and
sodium
salts
of
hydrochloric
acid
resulting
from
pesticide
product
uses.
Page
17
of
20
Given
the
long
history
of
safe
use,
the
available
toxicity
data,
an
understanding
of
the
human
body's
ability
to
metabolize
these
chemicals,
and
the
evaluations
by
FDA
and
WHO,
the
IIFG
believes
that
ammonium,
sodium,
potassium,
magnesium,
calcium
and
iron
chloride
are
of
low
oral
toxicity.

12.
Type
of
Risk
Assessment/
Risk
Characterization:

The
toxicity
of
these
chemicals
derives
from
the
irritation
and
caustic
effects;
therefore,
a
qualitative
assessment
for
all
pathways
of
human
exposure
(food,
drinking
water,
and
residential)
is
appropriate.

Given
the
widespread
occurrence
of
hydrochloric
acid
and
its
ammonium,
calcium,
iron,
magnesium,
potassium,
and
sodium
salts
in
the
existing
food
supply,
the
amounts
that
may
be
present
in
food
as
a
result
of
the
use
of
these
chemicals
in
a
pesticide
product
would
not
be
expected
to
significantly
increase
the
existing
amounts
in
the
food
supply.
There
is
no
available
information
on
any
of
the
salts
of
hydrochloric
acid
considered
in
this
document
indicative
of
a
human
health
hazard
resulting
from
the
EPA­
regulated
uses
as
well
as
the
FDA
GRAS
uses
to
the
general
public
or
any
population
subgroup.
No
additional
information
are
needed
to
assess
the
safety
of
hydrochloric
acid
and
its
salts.

13.
Sensitivity
of
Infants
and
Children:

Due
to
its
acidic
nature,
its
corrosive
potential,
there
is
high
acute
toxicity
for
hydrochloric
acid.
Hydrochloric
acid
must
be
used
in
pesticide
products
according
to
good
manufacturing
or
good
agricultural
practices.
The
ammonium,
calcium,
iron,
magnesium,
potassium,
and
sodium
salts
of
hydrochloric
acid
have
low
toxic
potential.
At
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children.
A
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

14.
Environmental
Fate
and
Ecotoxicity
Assessment/
Characterization:

In
general,
the
constituents
of
the
mineral
acids,
such
as
hydrochloric
acid,
are
commonly
found
in
soil
and
water
in
the
environment
suggesting
that
releasing
low
levels
of
these
chemicals
would
not
normally
be
expected
to
adversely
effect
wildlife
or
water
resources.
Large
releases
may
adversely
affect
wildlife
and
water
resources
either
directly
or
indirectly.
Direct
effects
may
result
from
exceeding
toxicity
thresholds
of
specific
chemicals.
Indirect
effects
may
be
manifested
through
disrupting
ecosystems
through
altering
pH
or
increasing
availability
of
algal
nutrients.

Hydrochloric
acid
is
a
strong
acid.
The
magnitude
of
the
pH
changes,
and
thus
the
magnitude
of
effects,
would
depend
on
a
number
of
factors
including
the
amount
of
material
released
and
the
buffering
capacity
of
the
exposed
soil
or
water.
Normal
aquatic
pHs
range
from
Page
18
of
20
5
to
9.
EPA's
Office
of
Water
recommended
water
quality
criteria
for
pH
are
6.
5
to
9
for
freshwater
and
6.
5
to
8.5
for
saltwater.
At
higher
or
lower
pH
aquatic
life
is
expected
to
be
adversely
impacted.
In
addition,
rapid
changes
in
pH
can
also
be
detrimental
to
aquatic
life.
Hydrochloric
acid
is
not
expected
to
be
persistent
in
the
environment.
Instead
it
is
expected
to
dissociate,
react
with
organic
or
inorganic
materials,
and
complex
with
ionic
substrates.

Hydrochloric
acid
salts
dissociate
in
water
resulting
in
a
positively
charged
(cationic)
metal
in
solution.
Dissociation
is
frequently
dependent
on
pH,
with
lower
(more
acidic)
pHs
resulting
in
higher
levels
of
dissociation
and
greater
solubility.
Aquatic
toxicity
of
metals
varies
with
the
species
of
metal
and
its
concentration.
EPA's
freshwater
water
quality
criteria
for
iron
is
1
ppm
implying
relatively
low
toxicity.
Metals
do
not
degrade
and
thus
are
permanent
in
the
environment.
They
are
likely
to
dissipate
by
being
sequestered
in
soil,
sediment,
and
plants.

15.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
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
chemical's
residues
and
"other
substances
that
have
a
common
mechanism
of
toxicity."
The
chemicals
considered
in
this
document
are
structurally
related;
however,
all
of
the
salts
are
low
toxicity
chemicals.
Therefore,
the
resultant
risks
separately
and/
or
combined
should
also
be
low.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
these
pesticide
chemicals
have
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
these
pesticide
chemicals
in
a
cumulative
risk
assessment.

16.
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,
and
to
infants
and
children
from
aggregate
exposure
to
residues
of
hydrochloric
acid
and
its
ammonium,
sodium,
potassium,
calcium,
magnesium,
and
iron
salts.
Therefore,
the
following
exemptions
from
the
requirement
of
a
tolerance
are
reassessed:
In
40
CFR
180.2
sodium
chloride.
In
40
CFR
180.1001
(c)
ammonium
chloride,
calcium
chloride,
hydrochloric
acid,
magnesium
chloride,
potassium
chloride,
and
sodium
chloride.
In
40
CFR
180.1001
(d)
ferric
chloride.
In
40
CFR
180.1001
(e)
calcium
chloride.

17.
List
Reclassifications:

The
following
List
reclassifications
are
made
or
confirmed:

Hydrochloric
acid:
List
4B.
With
the
restriction
of
use
as
a
solvent,
pH
adjuster,
neutralizing
agent.
Ammonium
chloride:
List
4B
Page
19
of
20
Calcium
chloride:
List
4B
Ferric
chloride:
List
4B,
current
limitation
remains
in
place.
Magnesium
chloride:
List
4B
Potassium
chloride:
List
4A
considering
its
use
as
a
salt
substitute
Sodium
chloride:
List
4A
considering
its
use
as
common
table
salt
The
following
table
lists
the
various
chemical
names,
CAS
Reg.
No.,
and
CAS
Index
Names
that
will
be
used
for
listing
in
40
CFR.
180.
Note
that
both
the
anhydrous
and
the
hydrated
forms
are
included.
The
Agency
sees
no
reason
to
distinguish
between
these
chemicals
given
that
the
only
difference
is
the
attachment
of
the
water
molecules.

Chemical
Name
CAS
Reg.
No.
Chemical
Abstracts
Index
Name
Hydrochloric
acid
7647­
01­
0
Hydrochloric
acid
(6CI,
7CI,
8CI,
9CI)

Ammonium
chloride
12125­
02­
9
Ammonium
chloride
((
NH4)
Cl)
(9CI)

Calcium
chloride
10043­
52­
4
Calcium
chloride
(CaCl2)
(9CI)

Calcium
chloride
hydrate
(CaCl2.
1/
3H2O)
56073­
24­
6
Calcium
chloride
(CaCl2),
hydrate
(3:
1)
(9CI)

Calcium
chloride,
hydrate
(8CI)
22691­
02­
7
Calcium
chloride
(CaCl2),
hydrate
(9CI)

Calcium
chloride
dihydrate
10035­
04­
8
Calcium
chloride
(CaCl2),
dihydrate
(9CI)

Calcium
chloride
hexahydrate
7774­
34­
7
Calcium
chloride
(CaCl2),
hexahydrate
(9CI)

Calcium
chloride
monohydrate
13477­
29­
7
Calcium
chloride
(CaCl2),
monohydrate
(9CI)

Ferric
chloride
7705­
08­
0
Iron
chloride
(FeCl3)
(8CI,
9CI)

Ferric
chloride
monohydrate
60684­
13­
1
Iron
chloride
(FeCl3),
monohydrate
(9CI)

Ferric
chloride
dihydrate
54862­
84­
9
Iron
chloride
(FeCl3),
dihydrate
(9CI)

Iron
III
chloride
hexahydrate
10025­
77­
1
Iron
chloride
(FeCl3),
hexahydrate
Ferric
chloride
dodecahydrate
58694­
80­
7
Iron
chloride
(FeCl3),
dodecahydrate
(9CI)

Ferric
chloride
nonahydrate
58694­
79­
4
Iron
chloride
(FeCl3),
nonahydrate
(9CI)

Ferric
chloride
sesquihydrate
115321­
78­
3
Iron
chloride
(FeCl3),
hydrate
(2:
3)
(9CI)

Ferric
chloride
trihydrate
58694­
75­
0
Iron
chloride
(FeCl3),
trihydrate
(9CI)

Magnesium
chloride
7786­
30­
3
Magnesium
chloride
(MgCl2)
(9CI)

Magnesium
chloride
hexahydrate
7791­
18­
6
Magnesium
chloride
(MgCl2),
hexahydrate
(9CI)

Potassium
chloride
7447­
40­
7
Potassium
chloride
(KCl)
(9CI)
Page
20
of
20
Sodium
chloride
7647­
14­
5
Sodium
chloride
(NaCl)
(9CI)

Attachment:

EFED
Review
of
Mineral
Acids
(Birchfield;
May
7,
2002)
