GreenScreenTM Assessment For For Zinc Borate PDF
GreenScreenTM Assessment For For Zinc Borate PDF
GreenScreenTM Assessment For For Zinc Borate PDF
O O O
Zn O
B B
3
2
For
Inorganic
Chemicals
and
relevant
particulate
organics
(if
not
relevant,
list
NA)
Define
Form
&
Physiochemical
Properties
1. Particle
size
(e.g.
silica
of
respirable
size)
–
8-‐20
µm
(mean)
(for
2ZnO.3B2O3.3.5H2O;
EPA,
1991).
2. Structure
(e.g.
amorphous
vs.
crystalline)
–
white
and
granular
(for
2ZnO.3B2O3.3.5H2O;
EPA,
1991).
1
Every
chemical
in
a
material
or
formulation
should
be
assessed
if
it
is:
1. intentionally
added
and/or
2. present
at
greater
than
or
equal
to
100
ppm.
3. Mobility
(e.g.
Water
solubility,
volatility)
–
water
solubility
for
zinc
borate
at
23°C
is
very
low
(0.1%
at
pH
5
and
7,
and
0.03%
at
pH
9),
(EPA,
1991).
Volatility
and
vapor
pressure
have
not
been
identified,
however
based
on
physical
state
(solid)
and
high
melting
point
of
980°C
(HSDB),
vapor
pressure
is
expected
to
be
negligible,
and
volatility
is
not
expected.
4. Bioavailability
–
Empirical
data
examining
bioavailability
of
zinc
borate
were
not
identified.
In
the
acidic
environment
of
the
stomach,
zinc
borate
is
anticipated
to
dissociate
into
the
zinc
ion
/
zinc
chloride
(ZnCl2)
and
3-‐
boric
acid/borate
ion
(BH3O3/BO3 ).
Systemic
bioavailability
of
ingested
zinc
ranges
from
20
to
30%
(ATSDR,
2005);
whereas
gastrointestinal
absorption
of
borates
is
>90%
(USDA,
2006).
Acute
oral
toxicity
data
suggest
that
zinc
borate
is
less
toxic
than
its
presumed
dissociation
products.
Quantitative
studies
regarding
absorption
of
zinc
and
zinc
compounds
after
inhalation
exposure
in
humans
are
limited
(ASTDR,
2005).
Inhalation
of
borate
dust
can
result
in
some
absorption
of
boron
(USDA,
2006).
Studies
are
very
limited
regarding
the
absorption
of
zinc
through
the
skin
(ATSDR,
2004).
Borates
are
not
readily
absorbed
through
intact
skin
but
are
more
quickly
absorbed
across
abraded
skin
(USDA,
2006).
Identify
Applications/Functional
Uses:
(E.g.
Cleaning
product,
TV
casing)
1. Fungicide
(EPA,
1991)
2. Fire
retardant
with
interior
applications
such
as
PVC
carpet
backing,
shower
curtains,
wall
coverings,
etc.,
and
exterior
uses
in
PVC
tenting
and
awnings,
polyolefin
wire
and
cable
coverings,
etc.
Application
rates
vary,
typical
use
levels
in
plastics
is
3-‐30
parts
product
per
hundred
parts
resin
,
and
in
coatings
is
1.25-‐3.0
lb/gal
(EPA,
1991).
2
GreenScreen
Rating :
Zinc
borate
was
assigned
a
Benchmark
Score
of
1
based
on
high
concern
level
for
reproductive
and
developmental
toxicity.
Zinc
borate
also
has
a
very
high
concern
level
for
environmental
2
persistence
and
very
high
concern
for
chronic
aquatic
toxicity
of
zinc
borate,
and
high
or
moderate
concern
level
for
respiratory
sensitization
of
zinc
oxide
as
a
potential
combustion
or
biodegradation
product.
A
data
gap
exists
for
neurotoxicity.
Group
I
Human
Group
II
and
II*
Human
Ecotox
Fate
Physical
2
C
M
R
D
E
AT
ST
N
SnS*
SnR*
IrS
IrE
AA
CA
P
B
Rx
F
R R
S
S
*
*
H
or
H
L
M
H
H
M
L
L
L
M
vH
vH
L
L
L
D
M
D D M
or
vH
G
G
G
Note:
Hazard
levels
(Very
High
(vH),
High
(H),
Moderate
(M),
Low
(L),
Very
Low
(vL))
in
italics
reflect
estimated
values
and
lower
confidence.
Hazard
levels
in
BOLD
font
reflect
values
based
on
test
data
(See
Guidance).
For
the
purposes
of
this
report,
hazard
levels
derived
from
test
data
on
boric
acid
or
zinc
salts
were
given
a
high
level
of
confidence.
Data
on
analogs
or
predicted
data
were
given
a
low
level
of
confidence.
2
For
inorganic
chemicals
with
low
human
and
ecotoxicity
across
all
hazard
endpoints
and
low
bioaccumulation
potential,
persistence
alone
will
not
be
deemed
problematic.
Inorganic
chemicals
that
are
only
persistent
will
be
evaluated
under
the
criteria
for
Benchmark
4.
Transformation
Products
and
Ratings:
Identify
relevant
fate
and
transformation
products
(i.e.,
dissociation
products,
transformation
products,
valence
3
states)
and/or
moieties
of
concern
On
Green
Transformation
Transformation
CPA
Functional
Use
Life
Cycle
Stage
CAS
#
Screen
Pathway
Products
Red
5
4 Rating
List ?
Boric
acid/
borate
10043-‐
Flame
Biotrans-‐ ion
35-‐
End
of
Life
3-‐ Y
1
Retardant
formation
(BH3O3/BO3 )
3/3920
MW
=
59g/mol
1-‐27-‐9
+2
Flame
Biotrans-‐ Zinc
(Zn )
23713-‐
End
of
Life
N
Retardant
formation
MW=65g/mol
49-‐7
Zinc
hydroxide
Flame
Biotrans-‐ 20427-‐
End
of
Life
[Zn(OH)2]
N
Retardant
formation
58-‐1
MW=
99g/mol
Flame
Biotrans-‐ zinc
chloride
(ZnCl2)
7646-‐
End
of
Life
N
Retardant
formation
MW=136g/mol
85-‐7
Flame
Biodegradation
Zinc
oxide
(ZnO);
1314-‐
End
of
Life
N
Retardant
or
Combustion
MW=81g/mol
13-‐2
• Chemical
reactions
of
zinc
borate
can
form
a
composite
of
oxides
of
zinc
and
boron.
Both
occur
naturally
in
soil
and
are
essential
plant
nutrients.
They
are
also
artificially
added
to
agricultural
crops
(EPA,
1991).
Introduction
Since
toxicity
data
for
zinc
borate
were
limited,
potential
hazards
are
inferred
through
knowledge
of
its
potential
byproducts
or
dissociation
products,
such
as
zinc
(as
various
salts)
and
boron
(as
borate/boric
acid).
Zinc
is
an
essential
nutrient
that
is
integral
to
many
physiological
processes.
Boron
is
a
trace
element
for
which
essentiality
is
suspected
but
has
not
been
directly
proven
in
humans
(EPA,
2004).
If
incidental
ingestion
of
zinc
borate
occurs
during
treated-‐product
use,
zinc
borate,
zinc
chloride
and
borate/boric
acid
may
be
of
exposure
concern..
Under
physiological
conditions,
the
acidic
environment
of
the
stomach
is
likely
to
facilitate
solubility
of
the
zinc
borate
complex
and
its
dissociation
into
zinc
(i.e.
ionic
or
as
the
chloride
salt)
and
borate/boric
acid.
Although
there
are
limited
empirical
systemic
toxicity
data
for
zinc
chloride,
zinc
is
an
essential
nutrient
and
tolerable
upper
intake
levels
for
zinc
range
from
4
mg/day
in
infants
(0-‐6
months)
to
40
mg/day
for
elderly,
pregnant
or
lactating
women
(NRC,
2001;
NRC,
2004).
Tolerable
upper
intake
levels
of
25
mg/day
for
adults
(including
pregnant
and
lactating
women)
and
7
mg/day
for
children
ages
1
to
3
years
have
also
been
recommended
(European
Commission,
2003).
Further,
the
European
Population
Reference
Intake
(PRI)
for
zinc
for
adult
males
and
females
is
9.5
mg/day
and
7.0
mg/day,
respectively
(European
Commission,
2003).
Thus,
it
is
unlikely
that
incidental
ingestion
of
zinc
borate
from
its
commercial
use
as
a
flame
retardant
will
result
in
systemic
3
A
moiety
is
a
discrete
chemical
entity
that
is
a
constituent
part
or
component
of
a
substance.
A
moiety
of
concern
is
often
the
parent
substance
itself
for
organic
compounds.
For
inorganic
compounds,
the
moiety
of
concern
is
typically
a
dissociated
component
of
the
substance
or
a
transformation
product.
4
The
CPA
“Red
List”
refers
to
chemicals
1.
flagged
as
Benchmark
1
using
the
GreenScreen™
List
Translator
or
2.
flagged
as
Benchmark
1
or
2
using
the
GreenScreen™
List
Translator
and
further
assessed
and
assigned
as
Benchmark
1.
The
most
recent
version
of
the
GreenScreen™
List
Translator
should
be
used.
5
The
way
you
conduct
assessments
for
transformation
products
depends
on
the
Benchmark
Score
of
the
parent
chemical
(See
Guidance).
zinc
exposure
that
exceeds
these
recommended
tolerable
intake
levels.
With
respect
to
the
boron
(as
borate
or
boric
acid)
moiety,
identified
toxicity
data
are
discussed
in
each
respectively
section.
Although
the
zinc
borate
complex
may
be
an
exposure
concern
for
a
handler
of
powderorliquid
formulations
in
manufacturing
and
commercial
settings
(inhalation
concerns
for
workers
spraying
paint/coatings),
it
is
unclear
whether
the
parent
compound
or
its
potential
biotransformation
products
(such
as
zinc
ion
or
borate/boric
acid)
would
be
of
greater
toxicological
concern
following
inhalation
exposure.
Similar
to
incidental
oral
exposure,
it
is
unlikely
that
incidental
inhalation
of
zinc
borate
from
its
manufacture
or
commercial
use
as
a
flame
retardant
will
result
in
systemic
zinc
exposure
that
exceeds
the
recommended
tolerable
intake
levels
described
previously.
With
respect
to
the
boron
(as
borate
or
boric
acid)
moiety,
available
data
were
insufficient
to
serve
as
the
basis
for
characterizing
potential
risk
(EPA,
2004).
However,
since
boron
is
absorbed
following
inhalation
exposure,
is
uniformly
distributed
in
soft
tissues
as
boric
acid,
and
is
not
metabolized,
route-‐specific
differences
in
systemic
targets
are
not
anticipated
(EPA,
2004).
Therefore,
systemic
target
tissues
identified
in
oral
studies
comprise
the
potential
systemic
targets
following
inhalation
exposure.
Although
dermal
contact
of
zinc
borate
with
healthy
skin
is
not
anticipated
to
result
in
appreciable
dermal
absorption,
contact
with
damaged
skin
may
increase
the
potential
for
absorption
and/or
for
skin
irritation.
Boron
is
a
naturally-‐occurring
element
that
is
widespread
in
the
environment
and
always
found
chemically
bound
to
oxygen,
usually
as
alkali
or
alkaline
earth
borates,
or
as
boric
acid
(EPA,
2004).
Thus,
dose
levels
of
borates
can
be
expressed
in
terms
of
Boron
equivalents
(B)
based
on
the
fraction
of
B
on
a
molecular
weight
basis.
The
B
equivalents
used
are
a
generic
designation
rather
than
a
designation
of
the
element
B.
When
the
boron
moiety
of
zinc
borate
served
as
the
basis
of
the
hazard
score,
the
B
dose
was
back-‐calculated
to
a
zinc
borate
dose.
Likewise,
when
the
zinc
moiety
served
as
the
basis
of
the
hazard
score,
the
Zn
dose
was
back-‐calculated
a
zinc
borate
dose.
The
dose
expressed
as
mg/kg
zinc
borate
was
used
to
compare
to
GHS
or
DfE
criteria.
Chemical
Structure
of
Surrogate
Chemical
Name
(CAS
#)
Zinc
borate
can
exist
in
various
hydration
states
that
according
to
CEFIC-‐EFRA
(2006)
include:
• Zinc
borate
Firebrake®
ZB
(2ZnO.3B2O3.3.5H20),
CAS
#
138265-‐88-‐0
• Zinc
borate
Firebrake®
500
(2ZnO.3B2O3),
CAS#
1338265-‐88-‐0
• Zinc
borate
Firebrake®
415
(4ZnO.B2O3.H20),
CAS#
149749-‐62-‐2
• ZB-‐467
(4ZnO.6B2O3.7H2O),
CAS#
1332-‐07-‐6
• ZB-‐223
(2ZnO.2B2O3.3H2O),
CAS#
1332-‐07-‐6
Group
I
Human
Health
Effects
(Group
I
Human)
Carcinogenicity
(C)
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Low
for
carcinogenicity
based
on:
negative
results
in
two
chronic
studies
on
boricacid.
Authoritative
and
Screening
Lists:
• Zinc
borate,
zinc,
zinc
hydroxide,
zinc
chloride
and
zinc
oxide
were
all
classified
as
Group
D
-‐
Not
classifiable
as
to
human
carcinogenicity
(EPA,
2004).
Zinc
borate
data:
• Carcinogenicity
data
were
not
identified
for
zinc
borate
(CAS
#1332-‐07-‐6).
Zinc
salts
and
Boric
acid
data:
• No
adequate
experimental
evidence
has
been
found
to
indicate
that
zinc
salts
administered
orally
or
parenterally
are
tumorigenic
(WHO/IPCS,
2001).
• Carcinogenic
effects
were
not
observed
in
2-‐year
and
38-‐week
feeding
studies
on
boric
acid
or
sodium
borate
in
rats
and
dogs
treated
with
up
to
1170ppm
B.
This
corresponds
to
approximately
213-‐333mg
B03/kg-‐day.
and
340-‐532mg
3ZnO.2B2O3./kg-‐day
based
on
boron
equivalents.
(Weir
and
Fisher,
1972).
• Carcinogenicity
was
not
observed
in
a
2-‐year
National
Toxicology
Program
(NTP,
1987)
dietary
study
in
mice
at
boric
acid
doses
up
the
highest
dietary
dose
of
5,000
ppm
boric
acid
(550
mg
boric
acid/kg-‐day
or
96
mg
B/kg-‐
day
as
estimated
by
IRIS),
which
is
on
a
boron
equivalent
basis
approximately
837mg
3ZnO.2B2O3/kg-‐day.
Mutagenicity/Genotoxicity
(M)
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Moderate
for
mutagenicity/genotoxicity
based
on:
positive
results
for
zinc
chloride
in
an
in
vivo
chromosomal
aberration
assay.
Authoritative
and
Screening
Lists:
• Zinc
Chloride
(CAS#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
2
for
Germ
Cell
Mutagenicity
(NITE,
2011).
This
translates
to
a
Moderate
concern
for
mutagenicity.
Zinc
Borate
Data:
• Zinc
borate
(CAS#
138265-‐88-‐0)
was
negative
in
Salmonella
reverse
mutation
(Ames)
assay
when
tested
with
and
without
metabolic
activation
(EPA,
1991).
• The
weak
positive
observed
for
zinc
borate
(CAS#
149749-‐62-‐2)
in
a
chromosomal
aberration
assay
in
Chinese
hamster
lung
cells
was
attributed
to
high
zinc
concentrations
in
the
media
(Hubbard,
1998),
which
are
not
physiologically
relevant.
Boric
Acid
and
Zinc
Salts
Data:
• Boric
acid
tested
with
and
without
metabolic
activation
was
not
mutagenic
in
the
Salmonella/microsome
assay
to
strains
TA98,
TA100,
TA1535
or
TA1537.
Boric
acid
was
negative
in
the
mouse
lymphoma
assay
and
did
not
induce
sister-‐chromatid
exchanges
or
chromosomal
aberrations
in
Chinese
hamster
ovary
cells
(NTP,
1987).
• The
weight
of
evidence
from
a
variety
of
test
systems
suggests
that
zinc
is
not
mutagenic
but
there
are
indications
of
some
weak
clastogenic
effects
(WHO/IPCS,
2001).
• Zinc
chloride
was
not
mutagenic
to
mouse
lymphoma
cells
(ECHA,
2011a).
• In
an
in
vivo
chromosomal
aberration
assay
zinc
chloride
caused
severe
chromosomal
anomalies,
particularly
in
animals
kept
on
a
low
calcium
diet
under
the
conditions
of
the
test
(ECHA,
2011b).
• In
an
in
vivo
bone
marrow
chromosomal
aberration
test
zinc
chloride
was
a
potent
clastogen
(ECHA,
2011c).
• Zinc
is
not
considered
to
be
genotoxic
in
vivo
(Hubbard,
1998).
Reproductive
Toxicity
(R)
Score
(H,
M,
or
L):
Zinc
borate
was
assigned
a
score
of
High
for
reproductive
toxicity
based
on:
known
concern
for
reproductive
effects
for
boric
acid.
Note:
the
Green
Screen
does
not
use
guidance
values
for
reproductive
toxicity,
therefore
a
dose
adjustment
for
zinc
borate
was
not
applied
here
and
the
zinc
borate
as
a
whole
is
considered
a
High
for
reproductive
toxicity
based
on
boric
acid.
If
cutoff
values
were
applied,
zinc
borate
may
earn
a
lower
score.
For
example,
a
similar
tool,
the
US
EPA’s
Design
for
the
Environment
Alternatives
Assessment
Criteria
for
Hazard
Evaluation
(EPA,
2011),
uses
guidance
values
of
<50mg/kg-‐day
for
High
concern;
50-‐250mg/kg-‐day
for
Moderate
concern;
>250-‐
1000mg/kg-‐day
for
Low
concern;
>1000mg/kg-‐day
for
Very
Low
concern.
Under
these
criteria
zinc
borate
would
be
assigned
a
score
of
Moderate
considering
the
NOAEL
of
105mg
zinc
borate/kg-‐day
based
on
B
equivalents.
Authoritative
and
Screening
Lists:
• Boric
Acid
(CAS
#s
10043-‐35-‐3
and
11113-‐50-‐1)
are
both
classified
as
Category
2
for
reproductive
toxicity
under
EU
CMR
(ECHA,
2011).
• Boric
Acid
(CAS
#s
10043-‐35-‐3
and
11113-‐50-‐1)
carry
an
EU
Risk
Phases
R60
code.
This
translates
to
High
concern
for
reproductive
toxicity
(ECHA,
2011).
• Boric
Acid
(CAS
#
10043-‐35-‐3)
is
Classified
by
GHS
Japan
as
GHS
category
1B
for
reproductive
toxicity.
This
translates
to
High
concern
for
reproductive
toxicity
(NITE,
2011).
• Boric
Acid
(CAS
#
10043-‐35-‐3)
is
Classified
by
GHS
New
Zealand
as
Category
6.8B
(GHS
Category
2)
for
reproductive
or
developmental
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Moderate
concern
for
reproductive
toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
2
for
reproductive
toxicity
(NITE,
2011).
This
translates
to
a
Moderate
concern
for
reproductive
toxicity.
Zinc
Borate
Data:
• Studies
assessing
potential
reproductive
toxicity
for
zinc
borate
(CAS
#1332-‐07-‐6)
were
not
identified.
Boric
Acid
and
Zinc
Salts
Data:
• Reproductive
toxicity
is
a
concern
for
boron
(from
boric
acid
or
borate)
exposure
and
dogs
were
the
most
sensitive
species
evaluated
(EPA,
2004).
A
2-‐year
systemic
toxicity
study
in
Sprague-‐Dawley
rats
and
Beagles
treated
with
a
diet
containing
borax
and
boric
acid
at
117,
350
and
1170ppm
as
boron
equivalent
or
58,
117
and
350ppm
as
boron
equivalent
respectively,
reported
testicular
effects,
and
was
subsequently
followed
by
a
38-‐week
study
with
Beagles
treated
with
borax
and
boric
acid
in
the
diet
at
1170ppm
for
further
examination
of
testicular
effects
(Weir
and
Fisher,
1972).
Both
species
showed
no
clinical
or
histological
alterations
at
doses
up
to
350ppm.
At
1170ppm
caused
testicular
atrophy
in
rats
and
dogs
and
spermatogenic
arrest
in
dogs.
Weir
and
Fisher
(1972)
continued
with
a
three
generation
reproductive
toxicity
study
in
Rats
treated
with
Borax
or
Boric
acid
at
117,
350
and
1170ppm
as
boron
equivalent
in
the
diet.
No
adverse
effects
were
observed
at
117
and
350ppm
boron
and
rats
at
the
high
dose
level
were
sterile
due
to
lack
of
viable
sperm
and
evidence
of
decreased
ovulation.
In
both
studies,
for
dogs,
the
NOAEL
=
350ppm
Boron
LOAEL
=
1170ppm
boron
(NOAEL
=
8.8mg
B/kg-‐day;
LOAEL
=
29.2mg
B/kg-‐day
as
cited
in
EPA
IRIS,
2004).
In
boron
equivalents,
the
NOAEL
corresponds
to
approximately
48mg
B03/kg-‐day
and
75mg
3ZnO.2B2O3./kg-‐day.
Although
these
studies
had
numerous
deficiencies,
they
are
the
most
conservative
reproductive
NOAEL
and
LOAEL
amongst
the
available
studies.
Note:
A
reproductive
NOAEL
of
75mg
zinc
borate/kg-‐day
is
considered
a
“Moderate”
concern
according
to
the
EPA’s
Design
for
the
Environment
Alternatives
Assessment
Criteria
for
Hazard
Evaluation
(EPA,
2011).
• Reproductive
and
systemic
toxicity
studies
have
identified
the
testis
as
a
sensitive
target
of
boron
toxicity
in
rats
and
mice,
although
at
higher
doses
than
in
the
dog
study
(Weir
and
Fisher,
1972;
Seal
and
Weeth,
1980;
NTP,
1987;
Fail
et
al.,
1991,
as
reviewed
by
EPA,
2004).
Testicular
effects
included
reduced
organ
weight
and
organ:body
weight
ratio,
atrophy,
degeneration
of
the
spermatogenic
epithelium,
impaired
spermatogenesis,
reduced
fertility,
and
sterility
(Weir
and
Fisher,
1972;
Seal
and
Weeth,
1980;
NTP,
1987;
Fail
et
al.,
1991;
Dixon
et
al.,
1979;
Linder
et
al.,
1990;
Treinen
and
Chapin,
1991;
Ku
et
al.,
1993a;
Ku
et
al.,
1993b
as
reviewed
by
EPA,
2004).
• A
human
study
of
occupational
exposure
to
borate
dust
(as
the
sodium
salt)
showed
no
adverse
effect
on
some
reproduction
parameters
(Whorton
et
al.,
1994).
• No
effect
on
testicular
development
was
seen
in
rats
fed
zinc
chloride
at
up
to
500
mg/kg-‐day
from
8
weeks
of
age
until
weanlings
(Evenson
et
al.,
1993).
DevelopmentalToxicity
incl.
developmental
neurotoxicity
(D)
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
High
for
developmental
toxicity
based
on:
known
concern
for
developmental
toxicity
for
boric
acid.
Note:
the
Green
Screen
does
not
use
guidance
values
for
developmental
toxicity,
therefore
a
dose
adjustment
for
zinc
borate
was
not
applied
here
and
the
zinc
borate
as
a
whole
is
considered
a
High
for
developmental
toxicity
based
on
boric
acid.
If
cutoff
values
were
applied,
zinc
borate
may
earn
a
lower
score.
For
example,
a
similar
tool,
the
US
EPA’s
Design
for
the
Environment
Alternatives
Assessment
Criteria
for
Hazard
Evaluation
(EPA,
2011),
uses
guidance
values
of
<50mg/kg-‐day
for
High
concern;
50-‐250mg/kg-‐day
for
Moderate
concern;
>250-‐
1000mg/kg-‐day
for
Low
concern;
>1000mg/kg-‐day
for
Very
Low
concern.
Under
these
criteria
zinc
borate
would
be
assigned
a
score
of
Moderate
considering
the
NOAEL
of
105mg
zinc
borate/kg-‐day
based
on
B
equivalents.
Authoritative
and
Screening
Lists:
• Boric
Acid
(CAS#s
10043-‐35-‐3
and
11113-‐50-‐1)
carries
an
EU
Risk
Phrase
of
R61.
This
translates
to
High
concern
for
developmental
toxicity
(ECHA,
2011).
Zinc
Borate
Data:
• Studies
assessing
potential
developmental
toxicity
of
zinc
borate
(4ZnO.6B2O3.7H2O
or
2ZnO.2B2O3.3H2O,
CAS
#1332-‐07-‐6)
were
not
identified.
Boric
acid
and
Zinc
Salts
Data:
• Developmental
toxicity
is
the
critical
effect
of
boron
(from
boric
acid
or
borate)
exposure
and
rats
were
the
most
sensitive
species
evaluated
(EPA,
2004).
A
chronic
reference
dose
(RfD)
of
0.2
mg/kg-‐day
for
boron
(from
boric
acid
and
borates)
was
derived
based
on
a
benchmark
dose
(BMDL)
of
10.3
mg
B/kg-‐day
for
a
5%
decrease
in
fetal
weight
from
two
developmental
toxicity
studies.
A
composite
uncertainty
factor
of
66
was
applied
to
the
BMDL
and
this
uncertainty
factor
considered
both
toxicokinetic
and
toxicodynamic
differences
between
humans
(intraspecies
extrapolation)
and
between
humans
and
rats
(interspecies
extrapolation).
The
resulting
chronic
RfD
was
0.2
mg
B/kg-‐day.
• The
BMDL05
of
10.3
mg
B/kg-‐day
estimated
by
EPA
(2004)
based
partly
on
the
Price
et
al.
(1996a,
1994)
study
is
supported
by
the
NOAEL
of
9.6
mg
B/kg-‐day
from
the
Price
et
al.
(1996a,
1994)
study.
When
expressed
on
a
boron
equivalent
molecular
weight
basis
9.6mg
B/kg-‐day
corresponds
to
a
NOAEL
of
approximately
52mg
B03/kg-‐day
(mw
=
59)
and
84mg
3ZnO.2B2O3/kg-‐day
(MW=
187).
These
studies
do
not
appear
to
have
any
major
deficiencies
with
respect
to
current
developmental
toxicity
testing
guidelines,
recognizing
that
the
study
authors
did
not
cite
a
specific
protocol.
Note:
A
developmental
NOAEL
of
84
mg/kg-‐day
is
considered
a
“Moderate”
concern
according
to
the
EPA’s
Design
for
the
Environment
Alternatives
Assessment
Criteria
for
Hazard
Evaluation
(EPA,
2011).
• Intraperitoneal
injection
of
zinc
chloride
at
12.5,
20.5
or
25
mg/kg-‐day
on
GD
8,
9,
10
or
11
was
associated
with
a
dose-‐related
increase
in
skeletal
defects,
usually
ripple
ribs
at
all
doses
(Chang
et
al.,
1977).
The
intraperitoneal
exposure
route
is
not
directly
relevant
to
oral
exposure.
• Dose-‐related
reductions
in
pup
body
weight
and
some
changes
in
iron
and
copper
distribution
were
seen
in
the
offspring
of
rats
fed
zinc
oxide
at
0.25
or
0.5%
Zn
(estimated
to
result
in
approximately
250
or
500
mg
Zn/kg-‐day
which
corresponds
on
a
zinc
equivalent
basis
to
approximately
492
or
983mg
3ZnO.2B2O3./kg-‐day)
during
gestation
and
14
days
of
lactation
(Ketcheson
et
al.,
1969).
Since
no
NOAEL
was
identified
in
this
study,
a
concern
level
cannot
be
derived.
Endocrine
Activity
(E)
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Moderate
for
endocrine
activity
based
on:
boric
acid
listed
as
a
substance
of
“Medium
concern”
on
the
EU
ED
list.
Authoritative
and
Screening
Lists:
• Boric
acid
(10043-‐35-‐3,
11113-‐50-‐1
and
39201-‐27-‐9)
is
listed
as
a
category
1
substance
of
“Medium
concern”
on
European
Union
Priority
List
of
suspected
endocrine
disruptors
(Petersen
et.
al.,
2007).
This
translates
to
a
Moderate
or
High
concern
for
endocrine
activity.
Zinc
Borate
Data:
• Studies
assessing
potential
endocrine
activity
for
any
zinc
borate
compound
were
not
identified.
Boric
Acid
and
Zinc
Salts
Data:
• Results
of
systemic,
reproductive
and
developmental
toxicity
studies
for
zinc
or
borate
salts
do
not
suggest
that
exposure
to
zinc
borate
is
of
potential
concern
for
endocrine
disruption.
Group
II
and
II*
Human
Health
Effects
(Group
II
and
II*
Human)
Note:
Group
II
and
Group
II*
endpoints
are
distinguished
in
the
v
1.2
Benchmark
system.
For
Systemic
Toxicity
and
Neurotoxicity,
Group
II
and
II*
are
considered
sub-‐endpoints
and
test
data
for
single
or
repeated
exposures
may
be
used.
If
data
exist
for
single
OR
repeated
exposures,
then
the
endpoint
is
not
considered
a
data
gap.
If
data
are
available
for
both
single
and
repeated
exposures,
then
the
more
conservative
value
is
used.
Acute
Mammalian
Toxicity
(AT)
Group
II
Score
(vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Low
for
acute
mammalian
toxicity
based
on:
low
concern
levels
for
oral,
dermal
and
inhalation
acute
toxicity
for
zinc
borate.
Authoritative
and
Screening
Lists:
• Boric
Acid
(CAS
#10043-‐35-‐3)
is
classified
by
GHS
Japan
as
GHS
Category
5
for
acute
oral
toxicity
(NITE,
2011).
This
translates
to
a
Low
concern
for
acute
mammalian
toxicity.
• Boric
Acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
New
Zealand
as
6.1E
(GHS
Category
5)
for
acute
oral
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Low
concern
for
acute
mammalian
toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
carries
an
EU
H-‐Statement
of
H302
(ECHA,
2011).
This
translates
to
a
Moderate
concern
for
acute
mammalian
toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
carries
an
EU
Risk
Phrase
of
R22(ECHA,
2011).
This
translates
to
a
Moderate
or
High
concern
for
acute
mammalian
toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
4
for
acute
oral
toxicity
and
Category
1-‐5
for
acute
inhalation
toxicity-‐dust
(NITE,
2011).
This
translates
to
a
Moderate
concern
for
acute
oral
mammalian
toxicity
and
unknown
concern
for
inhalation
toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
New
Zealand
as
6.1C
(GHS
Category
3)
for
acute
oral
toxicity
and
category
6.1E
(GHS
Category
5)
for
acute
inhalation
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
High
concern
for
acute
oral
toxicity
and
a
Low
concern
for
acute
inhalation
mammalian
toxicity.
• Zinc
Oxide
(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
Japan
as
GHS
Category
5
for
acute
inhalation
toxicity
(NITE,
2011).
This
translates
to
a
Low
concern
for
acute
inhalation
mammalian
toxicity.
Zinc
Borate
Data:
• LD50
or
LC50
values
for
zinc
borate
(CAS
#1332-‐07-‐6)
were
not
identified.
• Rat
oral
LD50
(males
only)
for
zinc
borate
(2ZnO3B2O33.5H2O,
CAS#138265-‐88-‐0)
is
>
10
g/kg
(EPA,
1991;
Hubbard,
1998).
• Rat
oral
LD50
for
zinc
borate
(4ZnOB2O3H2O,
CAS#149749-‐62-‐2)
is
>
5
g/kg
(Hubbard,
1998).
• The
rat
4-‐hr
LC50
for
zinc
borate
(4ZnOB2O3H2O,
CAS#149749-‐62-‐2)
is
>4.95
mg/m3(Hubbard,
1998).
• Albino
rabbit
dermal
LD50for
zinc
borate
(2ZnO.3B2O3.3.5H2O,
CAS
#138265-‐88-‐0)
is
>
10
g/kg
(EPA,
1991;
Hubbard,
1998).
• Albino
rabbit
dermal
LD50
for
zinc
borate
(4ZnOB2O3H2O,
CAS#149749-‐62-‐2)
is
>2
g/kg
(Hubbard,
1998).
• Based
on
LD50
values
for
acute
oral
and
dermal
toxicity,
zinc
borate
was
considered
a
Pesticide
Toxicity
Category
III
or
IV
(EPA,
1991),
respectively,
which
means
it
is
considered
to
have
Low
Toxicity
or
Very
Low
Toxicity,
respectively
(NPIC,
2008).
Boric
Acid
and
Zinc
Salts
Data:
• Boric
Acid
(CAS
No.
10043-‐35-‐3)
has
a
rat
oral
LD50
value
of
2660
–
4100
mg/kg
(Pfeiffer
et
al.,
1945
and
Weir
and
Fisher,
1972)
equivalent
to
~4245
–
6541
mg/kg
3ZnO.2B2O3
on
a
B
equivalent
basis.
• Zinc
Chloride
(CAS
No.
7646-‐85-‐7)
has
a
mouse
oral
LD50
value
of
1260
mg/kg
in
an
OECD
401
test
and
a
SD
Rat
oral
LD50
value
of
1100
mg/kg
in
an
OECD
401
test
(ECHA,
2011d).
These
values
convert
to
LD50s
of
approximately
1510
and
1730mg
3ZnO.2B2O3./kg
(zinc
equivalent
basis).
3
• Zinc
Chloride
(CAS
No.
7646-‐85-‐7)
has
a
female
SD
Rat
inhalation
LC50
value
of
2000
mg/m
or
2
mg/L
with
a
median
diameter
of
2.3µm
(ECHA,
2011e).
This
value
corresponds
to
approximately
2.75
mg/L
3ZnO.2B2O3
/kg
(zinc
equivalent
basis).
Systemic
Toxicity/Organ
Effects
incl.
immunotoxicity
(ST)
Group
II
Score
(single
dose:
vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
DG
for
systemic
toxicity/organ
effects-‐single
exposure,
based
on:
a
lack
of
relevant
data.
Screening
lists
indicate
very
high
concern
level
for
boric
acid,
zinc
oxide
and
zinc
chloride
for
single
exposure,
however
no
data
were
found
to
support
that
assignment
and
to
enable
conversions
on
a
zinc-‐
or
boron-‐
equivalent
basis
to
zinc
borate
concern
levels.
Group
II*
Score
(repeated
dose:
H,
M
or
L);
Zinc
borate
was
assigned
a
score
of
Moderate
for
systemic
toxicity/organ
effects-‐repeated
exposure,
based
on:
NOAELs
for
zinc
salts,
which,
when
converted
to
zinc
borate
on
a
zinc
equivalent
basis,
translate
to
moderate
or
low
levels
of
concern.
Authoritative
and
Screening
Lists:
• Boric
Acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
Japan
as
Category
1
(oral)
and
category
3
(inhalation)
for
target
organ
toxicity,
single
exposure
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
Systemic
Toxicity.
• Boric
Acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
Japan
as
a
Category
1
for
target
organ
toxicity
repeated
exposure
(NITE,
2011).
This
translates
to
a
High
concern
for
Systemic
Toxicity.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
target
organ
toxicity
single
exposure
(respiratory,
liver
and
pancreas)
and
repeated
exposure
(Lung,
Liver)
(NITE,
2011).
This
translates
to
a
High
or
Very
High
concern
for
Systemic
Toxicity.
• Zinc
Oxide(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
target
organ
toxicity
single
exposure
(inhalation,
systemic
toxicity)
and
repeated
exposure
(inhalation,
Lung)
(NITE,
2011).
This
translates
to
a
High
or
Very
High
concern
for
Systemic
Toxicity.
Zinc
Borate
Data:
• Studies
assessing
the
systemic
toxicity
of
zinc
borate
(CAS
#1332-‐07-‐6)
were
not
identified.
Boric
acid
and
Zinc
Salts
Data:
• Inhaled
zinc
oxide
is
of
theoretical
exposure
potential
as
a
result
of
combustible
zinc
borate.
Zinc
oxide
does
not
produce
lung
damage
even
when
administered
at
relatively
high
concentrations
(WHO/IPCS,
2001).
• Borax
and
boric
acid
was
administered
to
rats
and
dogs
in
a
2-‐year
and
38
week
study
(Weir
and
Fisher
1972).
See
the
summary
of
this
study
under
the
reproductive
toxicity
section.
The
dog
NOAEL
of
8.8mg
B/kg-‐day
was
equivalent
in
boron
equivalents
to
approximately
75mg
3ZnO.2B2O3/kg-‐day.
This
corresponds
to
a
Moderate
concern
for
Systemic
Toxicity.
• Boric
Acid
was
evaluated
in
14-‐day,
13-‐week
and
2-‐year
studies
in
B6C3F1
mice
(NTP
1987).
In
the
14-‐day
studies,
mortality
occurred
in
mice
fed
doses
over
25,000ppm
boric
acid
in
feed.
No
compound
related
gross
pathologic
or
histopathologic
effects
were
observed
in
mice
exposed
up
to
12,500ppm
boric
acid.
In
the
13
week
study,
mortality
occurred
in
1/10
female
and
8/10
males
at
the
20,000ppm
level
and
1/10
male
at
the
10,000ppm
level.
At
20,000ppm
testicular
atrophy
occurred
in
8/10
male
mice,
hyperkeratosis
and
acanthosis
of
the
stomach
in
8/10
male
and
3/9
female
mice
and
extramedullary
hematopoiesis
of
the
spleen
in
all
male
and
female
mice.
In
the
2
year
assay,
groups
of
50
male
and
50
female
rats
were
treated
with
0,
2500
or
5000ppm
boric
acid
in
feed.
Male
mice
showed
reduced
survival
at
both
dose
levels.
Body
weight
gain
was
reduced
in
both
sexes
after
week
30.
No
compound
related
clinical
signs
were
reported.
At
the
high
dose
male
mice
showed
increased
incidence
of
testicular
atrophy
and
interstitial
cell
hyperplasia.
Low
dose
males
also
showed
increased
testicular
atrophy.
Low
dose
males
showed
increases
in
incidences
of
hepatocellular
carcinomas
or
adenomas
and
an
increased
incidence
of
subcutaneous
tissue
tumors.
These
effects
were
not
dose
related
and
were
within
the
historical
control
range.
The
authors
concluded
that
the
tumors
were
not
considered
to
be
related
to
the
administration
of
boric
acid.
The
LOAEL
was
2500ppm,
the
NOAEL
was
<2500ppm
boric
acid
(225mg
boric
acid/kg-‐day
or
48
mg
B/kg-‐day
as
estimated
by
IRIS),
and
418mg
3ZnO.2B2O3./kg-‐day
in
boron
equivalents.
• Zinc
chloride
was
administered
to
Wistar
rats
orally
at
a
concentration
of
11.7-‐12.8
mg
Zn/kg-‐day
daily
for
28
days.
This
study
only
measured
haematological
effects.
Significant
increase
in
percentage
of
recticulocytes
and
polychromatophilic
erythrocytes
and
statistically
significant
decrease
in
the
erythrocyte
count
and
haemoglobin
level
in
the
peripheral
blood
was
observed.
No
major
changes
in
the
percentage
composition
of
bone
marrow
cells
between
the
control
and
treated
animals
were
observed.
The
LOEL
was
11.7-‐12.8mg
Zn/kg-‐
day
or
in
zinc
equivalents,
~23mg
3ZnO.2B2O3/kg-‐day
(ECHA,
2011f).
• Zinc
oxide
was
administered
to
male
and
female
ferrets
(3-‐5/group)
at
0,
500,
1500
or
3000
mg
zinc
oxide/kg
feed
(equivalent
to
be
0,
81.3,
243.8
or
487.5
mg
ZnO/kg
bw,
respectively)
for
180
days.
All
high
dose
animals
died
within
13
days.
At
the
mid
dose
level
the
animals
(n=4)
were
killed
on
days
7,
14
and
21
and
showed
severe
to
mild
diffuse
nephrosis,
extramedullary
haematopoesis
in
the
spleen,
macrocytic
hypochromic
anaemia
and
an
increased
in
level
of
zinc
in
the
liver
and
kidney
tissue.
At
the
lowest
dose
level
the
animals
(n=3)
were
killed
on
days
48,
138
and
191,
respectively.
No
clinical
signs
of
toxicity
or
pathological
changes
were
seen,
apart
from
an
extramedullary
heamatopoiesis
in
the
spleen.
The
authors
do
not
state
a
LOAEL
or
NOAEL.
If
the
NOAEL
is
assumed
to
be
500ppm
or
81.3mg
ZnO/kg-‐day
this
is
equivalent
on
a
zinc
basis
to
~128
mg
3ZnO.2B2O3/kg-‐day
(ECHA,
2011g).
• In
an
EU
Risk
Assessment
Report
on
Zinc
Chloride
(2004),
analogs
zinc
oxide,
zinc
sulfate
and
zinc
monoglycerolate
were
considered
as
analogs
for
zinc
toxicity.
The
lowest
oral
NOAEL
was
from
a
13-‐week
study
in
rats
with
a
NOAEL
of
31.52mg
zinc
monoglycerolate/kg-‐day
(13.26
mg
Zn/kg-‐day)
which
calculates
on
a
zinc
equivalent
basis
to
~26mg
3ZnO.2B2O3/kg-‐day
(EU
RAR,
2004).
Neurotoxicity
(N)
Group
II
Score
(Single
Dose
vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
DG
for
neurotoxicity-‐single
exposure,
based
on:
a
lack
of
relevant
data.
Group
II
*Score
(Repeated
Dose
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
DG
for
neurotoxicity-‐repeated
exposure,
based
on:
a
lack
of
relevant
data.
Authoritative
and
Screening
Lists:
• Zinc
borate,
boric
acid
and
zinc
salts
were
not
found
on
relevant
screening
or
authoritative
lists.
Zinc
Borate
Data:
• Studies
designed
to
assess
the
potential
neurotoxicity
of
any
zinc
borate
compound
were
not
identified.
Boric
Acid
and
Zinc
Salts
Data:
• Although
neurological
effects
were
noted
in
human
case
reports
after
ingestion
of
high
levels
of
boron
(EPA,
2004),
animal
data
are
limited
to
increased
brain
succinate
dehydrogenase
activity
after
10-‐14
weeks
of
oral
exposure
to
sodium
tetraborate,
equivalent
to
20.8
mg
B/kg-‐day
(Settimi
et
al.,
1982-‐
as
reviewed
by
EPA,
2004).
• There
is
an
uncertainty
about
neurological
effects
at
lower
boron
doses
and
other
than
acute
duration
because
no
data
are
available
(EPA,
2004).
This
is
identified
as
an
area
where
further
research
may
be
beneficial.
• Chronic
studies
with
boric
acid
in
rats
(Weir
and
Fisher,
1972)
and
mice
(NTP,
1987)
failed
to
identify
clinical
signs
or
histopathological
changes
indicative
of
neurotoxicity,
however,
comprehensive
neurological
evaluations
were
not
conducted.
Skin
Sensitization
(SnS)
Group
II*
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Low
for
skin
sensitization
based
on:
negative
results
in
skin
sensitization
tests
on
zinc
borate.
Authoritative
and
Screening
Lists:
• Zinc
borate,
boric
acid
and
zinc
salts
were
not
found
on
relevant
screening
or
authoritative
lists.
Zinc
Borate
Data:
• Skin
sensitization
has
not
been
observed
for
any
borate
compound
that
has
been
tested
for
such
effects
(Hubbard,
1998),
including
zinc
borate
(2ZnO.3B2O3.3.5H20,
CAS
#
138265-‐88-‐0;
Kreuzmann,
1990-‐
as
reviewed
by
Hubbard,
1998).
Boric
Acid
and
Zinc
Salts
Data:
• No
information
assessing
the
potential
for
skin
sensitization
was
identified
for
zinc
or
its
salts
other
than
zinc
borate.
• Boric
acid
(CAS
#
10043-‐35-‐3)
was
not
sensitizing
in
guinea
pigs
per
OECD
406
(ECB,
2000).
Respiratory
Sensitization
(SnR)
Group
II*
Score
(H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
High
or
Moderate
for
respiratory
sensitization
based
on:
AOEC’s
“Rs”
code
for
zinc
oxide.
Authoritative
and
Screening
Lists:
• Zinc
oxide
(CAS
No.
1314-‐13-‐2)
carries
an
“Rs”
on
the
AOEC
Asthmagen
list
(AOEC,
2011).
This
translates
to
a
High
or
Moderate
concern
for
Respiratory
Sensitization.
Zinc
Borate
Data:
• Although
occasional
mild
irritation
effects
to
the
nose
and
throat
may
occur
from
inhalation
of
zinc
borate
3
dust
at
levels
greater
than
10
mg/m
(Borax,
2000),
studies
designed
to
assess
potential
respiratory
sensitization
associated
with
exposure
to
any
zinc
borate
compound
were
not
identified.
• An
EU
Risk
Assessment
Report
on
Zinc
Oxide
indicated
no
data
are
available
for
respiratory
sensitization
(ECB,
2004),
andno
other
data
for
respiratory
sensitization
were
identified
for
zinc
oxide.
Therefore
no
modification
was
made
to
the
initial
assignment
of
a
High
or
Moderate
concern
level
for
zinc
borate
based
on
the
“Rs”
code
for
Zinc
Oxide
on
the
AOEC
Asthmagen
List.
Skin
Irritation/Corrosivity
(IrS)
Group
II
Score
(vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Low
for
skin
irritation/corrosivity
based
on:
low
concern
for
irritation
from
zinc
borate.
Authoritative
and
Screening
Lists:
• Boric
acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
Japan
as
GHS
category
2
for
Skin
Irritation
which
translates
to
a
High
concern
for
skin
irritation
(NITE,
2011)
• Boric
acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
New
Zealand
as
Category
6.3B
(GHS
Category
3)
for
skin
irritation
(New
Zealand
EPA,
2011).
This
translates
to
a
Moderate
concern
for
skin
irritation.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
carries
an
EU
H-‐Statement
of
H314
(ECHA,
2011).
This
translates
to
a
Very
High
concern
for
Skin
irritation.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
carries
an
EU
Risk
Phrase
of
R34
(ECHA,
2011).
This
translates
to
a
Very
High
concern
for
Skin
irritation.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
a
DOT
hazard
Class
8
(DOT,
2011).
This
translates
to
a
High
concern
for
Skin
irritation.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
1A-‐1C
for
skin
irritation
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
Skin
irritation.
• Zinc
Chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
New
Zealand
as
8,2C
(GHS
Category
1C)
for
skin
irritation
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
Skin
irritation.
Zinc
Borate
Data:
• Zinc
borate
(unspecified
CAS#)
does
not
cause
irritation
to
intact
skin
(Borax,
2000)
• Zinc
borate
(unspecified
CAS#)
was
not
irritating
to
Albino
rabbits
in
a
primary
dermal
irritation/corrosivity
study
(EPA,
1991).
Boric
Acid
and
Zinc
Salts
Data:
• 1
%
w/v
zinc
chloride
was
found
to
be
moderately
irritating
to
guinea-‐pig
skin
(ECHA,
2011h).
• 1
%
w/v
zinc
chloride
was
found
to
be
severely
irritating
to
rabbit
skin
or
mouse
skin
(ECHA,
2011h).
Eye
Irritation/Corrosivity
(IrE)
Group
II
Score
(vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Moderate
for
eye
irritation/corrosivity
based
on:
data
indicating
zinc
borate
can
be
mildly
irritating
to
the
eyes.
Authoritative
and
Screening
Lists:
• Boric
acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
Japan
as
GHS
category
2A-‐2B
for
Eye
Irritation
which
translates
to
a
High
or
Moderate
concern
for
eye
irritation
(NITE,
2011)
• Boric
acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
New
Zealand
as
Category
6.4A
(GHS
Category
2A
or
2B)
for
eye
irritation
(New
Zealand
EPA,
2011).
This
translates
to
a
Moderate
or
High
concern
for
eye
irritation.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
eye
irritation
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
eye
irritation.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
New
Zealand
as
8.3A
(GHS
Category
1)
for
eye
irritation
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
eye
irritation.
Zinc
Borate
Data:
• Since
many
years
of
occupational
exposure
to
zinc
borate
(unspecified
CAS#)
suggest
no
adverse
effects
on
human
eyes,
it
is
not
considered
to
be
a
human
eye
irritant
in
normal
industrial
use
(Borax,
2000).
• While
U.S.
EPA
(1991)
reported
that
other
zinc
borate
compounds
(unspecified
but
not
CAS#1332-‐07-‐6)
were
irritating
to
Albino
rabbit
eyes
since
mild
conjunctivitis
was
observed,
zinc
borate
(4ZnO.B2O3.H20,
CAS
#149749-‐62-‐2)
was
not
irritating
to
rabbit
eyes
(Cerven,
1992-‐
as
reviewed
by
Hubbard,
1998).
Boric
Acid
and
Zinc
Salts
Data:
• Boric
acid
was
evaluated
in
OECD
405
in
rabbit
eyes.
It
was
classified
as
not
irritating
Toxicity
Category
III
-‐
corneal
involvement
or
irritation
clearing
in
7
days
or
less
(ECHA,
2011i).
• Anhydrous
boric
acid
was
an
ocular
irritant
when
applied
directly
to
the
eyes
of
rabbits.
The
irritation
was
reversible
after
24
h
with
a
return
to
near
normal
by
72
h
after
exposure
to
the
test
article
(ECHA,
2011i).
• Boric
acid
(100mg)
applied
to
rat
eyes
resulted
in
mild
to
moderate
erythema
which
subsided
by
Day
4.
The
test
substance
was
classified
as
non-‐irritating
(ECHA,
2011i).
Ecotoxicity
(Ecotox)
Acute
Aquatic
Toxicity
(AA)
Score
(vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
High
or
Very
High
for
acute
aquatic
toxicity
based
on:
a
score
of
Very
High
is
possible
based
on
the
R-‐phrase
R50/53
assigned
to
zinc
borate,
however
data
on
aquatic
toxicity
indicates
High
concern
may
be
more
accurate.
Authoritative
and
Screening
Lists:
• Boric
acid
(CAS
#
10043-‐35-‐3)
is
classified
by
GHS
New
Zealand
as
Category
9.1D
(GHS
Category
2
or
3)
for
aquatic
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Moderate
or
High
concern
for
acute
aquatic
toxicity.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
acute
and
chronic
aquatic
toxicity
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
New
Zealand
as
9.1A
(GHS
Category
1)
for
aquatic
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
oxide
(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
New
Zealand
as
9.1A
(GHS
Category
1)
for
aquatic
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
oxide
(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
aquatic
toxicity
acute
&
chronic
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
Zinc
Borate
Data:
• Zinc
borates
are
classified
as
Dangerous
to
the
Environment,
with
the
EU
Risk
Phrases
of
R50/R53,
Very
toxic
to
aquatic
organisms/May
cause
long-‐term
effects
in
the
aquatic
environment.
However,
both
boron
and
zinc
are
essential
micronutrients
for
the
healthy
growth
of
plants
and
other
aquatic
organisms
(CEFIC-‐EFRA,
2006).
• 96-‐hr
LC50
to
Lepomismacrochirus
(bluegill
sunfish)
under
static
conditions
was
>335
ppm.
(ECOTOX,
2000)
• 96-‐hr
LC50
S.
gairdneri
(rainbow
trout)
under
static
conditions
was
2.4
mg/L
(Borax,
1992,
2000).
• Boric
acid
–
zinc
salt
(CAS
#
not
specified)
48-‐hr
EC50
in
Daphnia
magna
=
75
mg/L
(ECOTOX,
2000).
• Data
supporting
R50/53
could
not
be
identified;
the
above
noted
LC/EC50s
support
a
GHS
classification
2.
Other
• In
avian
dietary
studies,
the
LC50
of
zinc
borate
in
mallard
ducklings
(Anasplatyrhynchos)
was
>
5620
ppm
(EPA,
1991).
Chronic
Aquatic
Toxicity
(CA)
Score
(vH,
H,
M
or
L):
Zinc
borate
was
assigned
a
score
of
Very
High
for
chronic
aquatic
toxicity
based
on:
R50/53
code
for
zinc
borate.
Authoritative
and
Screening
Lists:
• Zinc
powder
(CAS
#
7440-‐66-‐6),
zinc
chloride
(CAS
#
7646-‐85-‐7)
and
zinc
oxide
(CAS
#
1314-‐13-‐2)
all
carry
EU
Risk
Phrases
of
R50/53
phrases
(ECHA,
2011).
This
translates
to
a
Moderate
concern
for
chronic
aquatic
toxicity.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
acute
and
chronic
aquatic
toxicity
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
chloride
(CAS
#
7646-‐85-‐7)
is
classified
by
GHS
New
Zealand
as
9.1A
(GHS
Category
1)
for
aquatic
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
oxide
(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
New
Zealand
as
9.1A
(GHS
Category
1)
for
aquatic
toxicity
(New
Zealand
EPA,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
• Zinc
oxide
(CAS
#
1314-‐13-‐2)
is
classified
by
GHS
Japan
as
GHS
Category
1
for
aquatic
toxicity
acute
&
chronic
(NITE,
2011).
This
translates
to
a
Very
High
concern
for
acute
and
chronic
aquatic
toxicity.
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Corporation.
1992.
Initial
submission:
zinc
borate:
20
mule
team
firebrake
-‐
acute
toxicity
to
rainbow
trout
(Oncornhynchusmykiss)
under
stat
conditions
(Final
report)
with
cover
letter
dated
052192.
EPA/OTS;
Doc
#88-‐
920003286.
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Appendix
1
Modeling
Results
EPI
Suite
and
ECOSAR
modeling
results
were
not
used
because
these
modeling
programs
and
not
currently
suitable
for
inorganic
compounds.