FULL PUBLIC REPORT

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Nov 8, 2013 (3 years and 11 months ago)

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File No:

LTD/
1492


October 2010




NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)



FULL PUBLIC REPORT



Starch Copolymer in Poroseal




This Assessment has been compiled in accordance with the provisions of the
Industrial Chemicals (Notification
and Assessment) Act 1989
(Cwlth)
(the Act) and Regulations. This legislation is an Act of the Commonwealth of
Australia. The National Industrial C
hemicals Notification and Assessment Scheme (NICNAS) is administered
by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational
health and safety. The assessment of environmental risk is conducted by the
Dep
artment of Sustainability,
Environment, Water, Population and Communities
.


For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office
by appointment only at
Level 7, 260 Elizabeth St, SURRY HILLS NSW 201
0
.


This Full Public Report is also available for viewing and downloading from the NICNAS website or available on
request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS
Administration Coordinator at:


Street Ad
dress:


Level 7, 260 Elizabeth St, SURRY HILLS NSW 2010
, AUSTRALIA.

Postal Address:


GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.

TEL:




+ 61 2 8577 8800

FAX




+ 61 2 8577 8888

Website:



www.nicnas.gov.au





Director

NICNAS



TABLE OF CONTENTS


F
ULL
P
UBLIC
R
EPORT

................................
................................
................................
................................
..............

3

1.

APPLICANT AND NOTIFICATION DETAILS

................................
................................
....................

3

2.

IDENTITY OF CHEMICAL

................................
................................
................................
...................

3

3.

COMPOSITION
................................
................................
................................
................................
.......

3

4.

PHYSICAL AND CHEMICAL PROPERTIES

................................
................................
.......................

4

5.

INTRODUCTION AND USE INFORMATION

................................
................................
.....................

4

6.

HUMAN HEALTH IMPLICATIONS

................................
................................
................................
.....

5

7.

ENVIRONMENTAL IMPLICATIONS

................................
................................
................................
..

6

8.

CONCLUSIONS AND REGULATORY OBLIGATIONS

................................
................................
.....

9

A
PPENDIX
A:

P
HYSICAL AND
C
HEMICAL
P
ROPERTIES

................................
................................
...........................

11

A
PPENDIX
B:

E
NVIRONMENTAL
F
ATE AND
E
COTOXICOLOGIC
AL
I
NVESTIGATIONS

................................
...............

11

B
IBLIOGRAPHY

................................
................................
................................
................................
......................

16




October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
3

of
16

F
ULL
P
UBLIC
R
EPORT


Starch Copolymer in Poroseal


1.

APPLICANT AND NOTIFICATION DETAILS


A
PPLICANT
(
S
)


M
-
I Australia Pty Ltd (ABN 67 009 214 162)

11/251 Adelaide Terrace

PERTH WA 6000


N
OTIFICATION
C
ATEGORY

Limited: Synthetic polymer with Mn


1000䑡D


E
XEMPT
I
NFORMATION
(S
ECTION
75

OF THE
A
CT
)

Data items and details claimed exempt from publication:
chemical name, other names, CAS number,
molecular and structural formulae, molecular weight, polymer constituents, residual m
onomers/impurities, use
detail
s and

import volume
.



V
ARIATION OF
D
ATA
R
EQUIREMENTS
(S
ECTION
24

OF THE
A
CT
)

Variation to the schedule of data requirements is claimed as follows:
melting point, boiling point, vapour
pressure, hydrolysis as a function of pH, adsorption/desorption, dis
sociation constant, flash point, flammability
limits, autoignition temperature, explosive properties and reactivity.


P
REVIOUS
N
OTIFICATION IN
A
USTRALIA BY
A
PPLICANT
(
S
)


None


N
OTIFICATION IN
O
THER
C
OUNTRIES

EU


2.

IDENTITY OF CHEMICAL


M
ARKETING
N
AME
(
S
)

Poroseal (product cont
aining the notified polymer at 40
-
50%)


M
OLECULAR
W
EIGHT


Mn
>10
,
000 Da
.


A
NALYTICAL
D
ATA


Reference
GPC

spectrum was

provided.


3.

COMPOSITION


D
EGREE OF
P
URITY

>99
%


A
DDITIVES
/A
DJUVANTS


None


L
OSS OF
M
ONOMERS
,

O
THER
R
EACTANTS
,

ADDITIVES
,

I
MPURITIES


None


D
EGRADATION
P
RODUCTS


None






October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
4

of
16

4.

PHYSICAL AND CHEMICAL PROPERTIES

The following information on the physical and chemical properties of the notified polymer is based on the
product Poroseal cont
aining the notified
polymer at 40
-
50% concentration in water. No data were submitted on
the notified polymer itself.


A
PPEARANCE AT
20
º
C

AND
101.3

kPa:
Milky white liquid


Property

Value

Data Source/Justification

Boiling Point

100
o
C
at 101.3 kPa

MSDS

Density

1110

kg/m
3

M
SDS

Vapour Pressure

<1.3x10
-
9

kPa

Estimated based on NAMW > 1
000
Da. (US EPA, 2007)

Water Solubility

Not determined

The notified polymer is reported to be
partly so
l
uble

Hydrolysis as a Function of pH

Not determined

The notified polymer is not expected

to hydrolyse under environmental
conditions

Partition Coefficient

(n
-
octanol/water)

log Pow < 0

Estimated. The notified polymer forms
an emulsion in a water/octanol mixture

Adsorption/Desorption

Not determined

The notified polymer is expected to
adsorb

to soils and sediment based on
its high molecular weight

Dissociation Constant

Not determined

The notified polymer has no
dissociable functions

Particle Size
1

Average
particle size

=
0
.
201 µm

Measured

Flash Point

Not

determined


Expected
to have a
high

flash point
based on molecular weight

Flammability

Not determined

Not expected to be flammable

Autoignition Temperature

Not determined

Not expected to autoignite

Explosive Properties

Not determined

Not expected to be explosive

1

Particle s
ize
measurement relates to the notified polymer in powder form.


D
ISCUSSION OF
P
ROPERTIES


For full details of tests on physical and chemical properties, refer to Appendix A.


Reactivity

The notified polymer is expected to be stable under normal ambient condi
tions.


Dangerous Goods classification

Based on the estimated and submitted

physical
-
chemical data in the above table the notified
polymer

is
not
classified

according to the Australian Dangerous Goods Code (NTC,

20
07). However the data above do

not
address all Dangerous Goods endpoints. Therefore consideration of all endpoints should be undertaken before a
final decision on the Dangerous Goods classification is made by the introducer of the polymer
.


5.

INTRODUCTION AND USE INFORMATION


M
ODE OF
I
N
TRODUCTION OF
N
OTIFIED
C
HEMICAL
(100%)

O
VER
N
EXT
5

Y
EARS

The notified polymer will be imported in a formulat
ion at 40
-
50% concentration in 208

L drums by sea.


M
AXIMUM
I
NTRODUCTION
V
OLUME OF
N
OTIFIED
C
HEMICAL
(100%)

O
VER
N
EXT
5

Y
EARS


Year

1

2

3

4

5

Tonnes

<300

<300

<300

<300

<300


P
ORT OF
E
NTRY

Perth


I
DENTITY OF
M
ANUFACTURER
/R
ECIPIENTS


M
-
I Australia Pty Ltd


October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
5

of
16


T
RANSPORTATION AND
P
ACKAGING

The notified polymer w
ill be imported at 40
-
50% concentration in
water in
208

L drums for use in offshore oil
and gas drilling operations. Once imported, it will be transported to a warehouse in Perth pr
ior to distribution
to customer
s for offshore use.


U
SE


The notified polymer will be used
at
≤5%
=
捯n捥n瑲慴楯n=
慳a 慮= 慤d楴楶攠
for= w慴敲
-
b慳敤= dr楬汩ng= flu楤s= in=
offshor攠o楬⁡nd=gas=dr楬汩ng=op敲慴楯ns.
=
=
=
l
PERATION DESCRIPTION



The
notifi
ed polymer will be imported at 40
-
50% concentration and transported to the notifier’s warehouse for
s瑯r慧攠pr楯r=瑯=d楳瑲楢u瑩tn=to=捵s瑯m敲
’s drilling facilities offshore. At the offshore drilling operations, the
produ捴
=
捯n瑡楮楮g=瑨攠no瑩f楥d=po汹m敲=w楬氠b攠w敩gh敤=慮d=瑲慮sf敲r敤=manu慬ay=瑯
=
愠hopp敲=wh敲攠楴
=
w楬氠be
=
mix敤=慴a愠捯n捥n瑲慴楯n=of=
≤5%
=
w楴h=oth敲=捯mpon敮ts=of=瑨攠dr楬汩ng=fl
u楤s

Th攠dr楬汩ng=flu楤s=w楬氠瑨en=b攠
pump敤=


=
th攠
dr楬氠io汥l
=
and=r整ern敤=瑯=瑨攠surf慣攠in=dr楬汩ng=mud=捵t瑩tgs
.
=
=
6.

HUMAN HEALTH IMPLICATIONS


6.1

Exposure assessment


6.1.1

Occupational exposure


E
XPOSURE
D
ETAILS

Transport and warehousing workers
may come into dermal and ocular contact with the notified polymer
through accidental leaks and spillages of the drums and containers.


During mixing

of the produc
t into drilling fluids, workers will
manually
weigh and transfer the polymer
product

(cont
aining the notified polymer at 40
-
50% concentration)

to

the hopper for mixing

which may lead to
dermal, inhalation and ocular exposure
. Workers will wear appropriate personal protective equipment

(PPE)

such as impermeable gloves, eye protection and coats

t
o minimise dermal and ocular exposure
.
Inhalation
exposure to aerosols of the notified polymer created during the mixing and transfer processes is also possible.
However, this is expected to be
lowered by conducting transfers

in well
-
ventilated areas and/o
r by using local
exhaust
ventilation.
I
nhalation exposure
to vapours of the notified polymer
is not anticipated to be significant
due to
its

low vapour pressure.


W
orkers
may
also
encounter dermal and ocular exposure to

the notified polymer
at
≤5%
=
楮= dr楬i
楮g= mud=
捵瑴tngs=when=they=慲攠r整urned=瑯=瑨攠surf慣e

䡯wev敲,=exposur攠w楬氠l攠minim楳敤=by=th攠use=of=mmb=su捨=慳=
imp敲m敡b汥
=
g汯v敳Ⱐey攠pro瑥捴楯n=慮d=ov敲慬a
s
.
=
=
6.1.2.

Public exposure

The notified
polymer

is intended for industrial use on specific

sites and therefore public exposure is not
anticipated.


6.2.

Human health effects assessment


No toxicity data were submitted

on the notified polymer.


The notified polymer has a high molecular weight (>

10000 Da.) and is not expected to be absorbed via the oral,
dermal or inhalation route.


Health hazard classification

No toxicity data are provided for the notified polymer. Therefore, it
cannot be classified according to the
Approved Criteria for Classifying Hazardous Substances
(NOHSC, 2004).





6.3.

Human health risk characterisation


October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
6

of
16

6.3.1.

Occupational health and safety

Workers may encounter dermal and ocular exposure to the notified polymer (40
-
50%) during
manual
transfer
of the notified polymer to the hopper

for

mixing
and at
≤5%

concentration in drilling mud cuttings when they
are returned to the surface
. The anticipated use of
PPE

such as protective clothing, safety goggles and
impermeable

gloves
during these pr
ocesses
is expected to minimise the potential for dermal and ocular
exposure

and therefore the risk via these routes of exposure is not considered unacceptable
.


The risk posed by inhalation of the notified polymer in aerosol form is uncertain.
I
nhalation
exposure is
expected

to be minimised by the processes taking place in a well
-
ventilated area which may include the use of
local exhaust ventilation.


Overall, the risk presented by the notified
polymer to workers is not consider
ed to be unacceptable, based

on
the
expected
control measures and PPE in use
.


6.3.2.

Public health

The notified polymer is intended only for use at specific industrial sites and as such public exposure to the
notified polymer is not expected.


7.

ENVIRONMENTAL IMPLICATIONS


7.1.

Environmental Exposure & Fate Assessment


7.1.1

Environmental Exposure


R
ELEASE OF
C
HEMICAL AT
S
ITE

The notified polymer will be imported as a component of a finished end
-
use product and will not be
reformulated in Australia. Release to the environment
during shipping, transport and warehousing could occur
through accidental spills or leaks of the drums or containers. During formulation and packaging, spills are
expected to be minimal. When spills occur, they will be contained by diking, collected with a
bsorbent material
and sent to a licensed off site waste disposal centre. Empty drums from import will be sent to drum
reconditioners. Total waste from all sources is expected to constitute approximately 2% of the total import
volume.


R
ELEASE OF
C
HEMICAL
FROM
U
SE

It is assumed that a total of 2000 kg of the notified polymer will be added to drilling muds for each well that is
drilled with the majority added initially and smaller amounts added throughout the drilling operation. All
drilling will be off
-
sho
re and a single drilling operation is expected to last between 1

=
6=w敥ks.=Th攠no瑩晩td=
po汹m敲=wi汬⁢攠us敤=in=w慴敲
-
b慳敤=muds.=aur楮g=g慳=慮d=o楬iw敬氠dr楬汩ng=op敲慴楯ns,=dr楬汩lg=mud=捯n瑡tning=
up=瑯=
≤5%
=
of=瑨攠no瑩f楥i=po汹m敲=wi汬lb攠pump敤=down=th
攠dr楬氠sh慦琠wh敲攠楴ifun捴楯ns=慳a愠捯mbin慴楯n=of=
f楬瑲i瑩tn= 捯n瑲o氬l 捡rr楥i= for= 瑨攠so汩l= 捵瑴tngs,= 慮d= sh慬a= s敡污l琠瑯= m楮im楳攠dr楬汩ng= f汵楤= 汯ss= in瑯= 瑨e=
form慴楯ns=dur楮g=dr楬汩ng=of=d敥p= we汬l.=Th攠dr楬汩ng= mud= wi汬l even瑵慬ly=b攠push敤= ou琠of=
th攠w敬氠and=
瑲慮sf敲r敤=瑯=瑨攠surf慣攠for=so汩ls=pro捥ss楮g.=Th楳=invo汶es=愠sif瑩ng=s瑥t=慬ang=w楴h=汯w=sp敥d=捥n瑲楦ug慴楯n=
楮=ord敲=瑯=r敭ov攠瑨攠dr楬氠捵瑴tngs.=Th攠dr楬汩ng=mud=捯nt慩aing=th攠no瑩f楥i=polym敲=w楬氠b攠r散ov敲敤=慮d=
瑨敮=r数汥n楳h敤=w
楴h=慤d楴楯n慬amud=捯n瑡楮ing=mor攠no瑩f楥i=polym敲=慮d=瑨en=瑲ansferr敤=b慣k=down=in瑯=
瑨攠w敬氮=Th攠dr楬氠捵瑴楮gs=th慴ar数r敳敮琠慢ou琠5
-
N0┠of=瑨攠m慴敲楡氠瑲ansf敲r敤=瑯=瑨攠surf慣攠捯n瑡tn=som攠
慤h敲敤=dr楬汩ng=mud.=䅦瑥t=s数慲慴楯n,=w攠敳瑩m慴攠th慴
=
th攠dr楬氠捵瑴tngs=w楬氠捯n瑡tn=approx業a瑥ty=5
-
N5┠
敮瑲慩a敤=dr楬汩ng= mud=b慳敤=on=愠汩瑥l慴ar攠v慬u攠of=N5┠for=愠wors琠捡s攠and=5┠for= mod敲n=pr慣瑩捥献t=
A汴hough=i琠楳=poss楢汥lfor=cu瑴楮gs=瑯=b攠re
-
inj散瑥t=楮瑯=th攠w敬e=or=捯汬散瑥l=for=on
-
shor攠d楳
pos慬aor=re
-
us攠as=
g敮敲慬af楬氬ii琠wou汤=慰p敡r=瑨慴ath楳=is=no琠gen敲慬ay=pr慣瑩捥t=楮=Aus瑲慬楡a=Cons敱u敮tly,=楮=瑨攠捡s攠of=off
-
shor攠dr楬汩ng,=瑨攠捵t瑩tgs=(and=瑨攠敮瑲慩a敤=mud)=wi汬lb攠d楳捨慲g敤=楮瑯=瑨攠o捥慮.=Thus,=楴i楳=敳瑩m慴敤=th慴=
5┠of=th
攠no瑩f楥i=polym敲=th慴a楳=us敤=in=dr楬汩ng=mud=for=敡捨=w敬e=(N00=kg)=wi汬lb攠r敬敡s敤=楮瑯=th攠o捥an=
w楴h=dr楬氠捵瑴tngs=dur楮g=dr楬汩ng=op敲慴楯ns=off
-
shor攮
=
=
o
ELEASE OF
C
HEMICAL FROM
D
ISPOSAL

After the completion of off
-
shore drilling operations, the

used drilling mud along with the remaining
notified polymer will be discharged into the ocean. For the purposes of assessment, it is assumed that all
of the notified polymer that is not released with the drill cuttings (95% or 1900 kg per well) will be
su
bsequently discharged along with the used mud.


7.1.2

Environmental fate

October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
7

of
16


Water
-
based muds and cuttings containing the notified polymer will be discharged to the ocean. The notified
polymer is reported as being partly soluble in water and therefore some

of the notified polymer will be dispersed
by tidal and ocean currents following mixing of the waste drilling mud and cuttings with sea water around the
discharge point. Most of the polymer is expected to sediment to the sea bed with the cuttings. A study
submitted
by t
he notifier indicates that the notified polymer is inherently biodegradable in seawater. Based on its high
molecular weight, it is expected that the majority of the notified polymer will associate with solids and
sediments, and degrade to wat
er and oxides of carbon. Based on its high molecular weight, the notified polymer
is not expected to bioaccumulate.


For the details of the environmental fate st
udies, refer to Appendix B
.


7.1.3

Predicted Environmental Concentration (PEC)


The notified

polymer was reported as being partly soluble in water, however no quantitative data was pro
vided
to support this. T
herefore
, the

PEC for

the

two
-
worst case scenarios

were calculated
. The first scenario a
PEC
sediment
was calculated assuming that all of the

notified polymer is deposited on the seafloor beneath the
discharge point along with the cuttings and entrained mud. The second scenario a PEC
water,batch

was calculated
assuming a batch
-
wise discharge of the water based mud.


Scenario 1

An estimate of the

PEC
sediment

can be made in accordance with the CHARM model assuming that the greatest
effect of the notified polymer will occur within a radius (r) of 500 m from the discharge line. In this case, the
total volume of sediment affected is πr
2
d. If the depth

of sediment (d) is taken to be 5 cm, the resulting volume
of affected sediment is 39,300 m
3
. If the density of the sediment is approximately 1000 kg/m
3
, then the mass
of affected sediment is 39,300 tonnes. If it is further assumed for a worst case that al
l of the discharged mass
of notified polymer in a batch of used water based mud (2000 kg) is deposited in this layer of sediment, then
the PEC
sediment

for the notified polymer in the benthic system is estimated to be 51 mg/kg.


Scenario 2

In the CHARM
model (Thatcher et al., 2005, p. 23), the PEC for drilling chemicals in seawater resulting from
batch
-
wise discharge of water
-
based muds (PEC
water,batch
/ mg L
-
1
) is calculated using the following equation:







In this
relationship, PEC
water,batch

is related to the amount of chemical discharged (M/kg), the volume of mud
discharged for the specific section drilled (V
m
/m
3
), and the dilution factor for batch
-
wise discharges (D
batch
).
The specific values for volume of mud di
scharged and the dilution factor have not been provided for
operations under Australian conditions. Hence, the default values for V
m

(375 m
3

for a 1500 m drill length)
and D
batch

(7.7 × 10
-
5
) as specified in the CHARM model for the batch
-
wise discharge sce
nario have been used
for this calculation (Thatcher et al., 2005, p. 46). Based on these default values, and the worst case discharge
of 1900 kg of notified polymer in a single batch of used mud, the PEC
water,batch

for the notified polymer is
calculated to

be 0.39 mg/L.


7.2.

Environmental effects assessment


The results from marine ecotoxicological investigations conducted on the notified polymer are summarised in
the table below. Details of these studies can be found in Ap
pendix B
.


Endpoint

Result

Assessment Conclusion

Fish Toxicity




Cyprinodon variegatus
(96 hours)

LC50 > 63.3 mg/L

Potentially harmful

Invertebrate Toxicity



Arcatia tonsa
(48 hours)

EC50 = 311 mg/L

Not harmful

Corophium volutator

(10 days)

LC50 > 72 mg/kg
dry weight
sediment

Not classifiable

Algal Toxicity



3
,
10



batch
m
batch
water
D
V
M
PEC

October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
8

of
16

Skeletonema costatum

(72 hours)

E
r
C50 = 63 mg/L

Harmful


The notified polymer is classified as harmful to aquatic life under the Globally Harmonised System of
Classification and Labelling of Chemicals (United
Nations, 2009). The notified polymer has a low potential to
biodegrade in seawater and has an acute toxicity endpoint < 100 mg/L and therefore it is chronically classified
as harmful to aquatic life with long lasting effects.


Based on the indicated toxicity of the notified polymer to the algae,
Skeletonema costatum
, marine algae are the
most sensitive biota to toxic effects of the notified polymer. The toxicity of the notified polymer to the
sediment dwelling organism,
Corophium volutator,

has been evaluated in an acute toxicity test which found
some toxicity, but only at very high sediment concentrations.


7.2.1

Predicted No
-
Effect Concentration

Ecotoxicity data was provided for pelagic and benthic biota, hence PNECs
were calculated for the sediment and

aquatic compartments. PNEC
aquatic

was based on the endpoint for algae as it was the most sensitive aquatic
species. Since three aquatic ecotoxicological studies were available, an assessment factor of 100 was used givi
ng
a PNEC
aquatic
of 0.63 mg/L. The PNEC
sediment
was based on the only benthic endpoint available (
Corophium
volutator)

and had an assessment factor of 1000 applied. The
PNEC
sediment
was calculated to be 0.072 mg/kg.


7.3.

Environmental risk assessment

The

notified polymer is used for a specific application in the oil and gas
-
drilling industry at off
-
shore sites in
Western Australia. The environmental exposure of the notified polymer is therefore concentrated to one
location. The main route for exposure of
the environment to the notified polymer is through the discharge of
drill cuttings and used drilling muds overboard at off
-
shore drilling sites. All of the notified polymer used in
water
-
based muds is expected to be discharged to the ocean at the completio
n of drilling.


The risk quotient (RQ=PEC/PNEC) has been calculated for the worst case discharge scenario in the aquatic
compartment and is 0.62. However, based on the expected low concentration of the notified polymer in the
water column and its inability

to bioaccumulate, there is a low risk to pelagic biota from this polymer when it is
discharged in mud and cuttings into the ocean.


The majority of discharged mass of this polymer is expected to remain associated with the insoluble minerals
and other
solids discharged overboard, based on the expected partial solubility of the notified polymer in water.
Most of the notified polymer is therefore expected to deposit on the sea floor beneath the discharge point along
with the mud and cuttings.


Based on a
sediment density value of 1000 kg/m
3
, the PNEC value for the formulated product, and, worst case,
a discharge of 2000 kg of notified polymer per well depositing on the sea floor beneath the discharge point, the
mass of sediment required to produce an accep
table level of risk is < 2.78



10

kg (= 2



9

mg ÷ > 0.072
mg/kg), and the volume would be < 2.78



7

m
3

(= < 2



10

kg ÷ 1000 kg/m
3
). If the aerobic zone of the
sediment is assumed to be 5 cm and the release pattern cylindrical into the sediment

(with an affected volume
of πr
2
h), then the use of this notified polymer may have the potential to have an adverse effect on sediment
-
dwelling organisms at a radius up to 13,303 m (= √(2.78



7

m
3
/0.05π)) from the point of release.
=
=
Th攠po瑥t瑩慬timp慣t
=
r慤極s=in=瑨攠慥rob楣i穯n攠of=s敤業en琠for=瑨攠no瑩f楥i=po汹m敲=楳=ov敲=twenty=瑩mes=瑨e=
r慤極s=(500=m)=from=慮=off
-
shor攠dr楬汩ng=汯捡瑩tn=慳aum敤=in=th攠CeAoM=mod敬e=䡯w敶敲,=瑨楳=捡汣u污瑩ln=is=
b慳敤=on=捯ns敲v慴av攠敳eimat敳efor=bo瑨=dis捨慲g攠vo汵m敳
,=瑨攠d数os楴ir慤極s=[mounds=of=cu瑴tngs=慲攠known=
瑯=b攠up=瑯=2=m=h楧h,=for=數amp汥l=楮=瑨攠乗=ph敬f=(p=85,=佩氠慮d=䝡猠mrodu捥rs,=2003)]=and=s敤imen琠瑯x楣楴y.=
Also,=瑨攠d数os楴楯n=of=cu瑴tngs=may=r敳u汴l楮=phys楣慬ismoth敲楮g=of=b敮th楣iorganisms=r敧慲d
汥獳=of=th攠n慴are=
of=瑨攠cu瑴楮gs=(p.=29,=佩氠慮d=䝡猠mrodu捥rs,=2003)=wh楣i,=楮=th楳=捡s攬=wou汤=b攠mor攠l楫敬y=瑯=hav攠慤v敲s攠
敦f散瑳=th慮=any=po瑥n瑩慬⁣hem楣慬i瑯x楣楴y=of=瑨攠no瑩f楥i=po汹m敲.=
=
=
Con捬us楯n
=
B慳敤=on=th攠exp散瑥t=汯w= 捯n捥n瑲慴楯n=of=
th攠no瑩f楥i=polym敲=in=th攠wa瑥t=捯汵mn=and=楴s=in慢楬楴y= 瑯=
b楯慣捵mu污瑥l=瑨敲攠楳=愠汯w=r楳k=瑯=p敬慧楣ib楯瑡tfrom=瑨楳=po汹m敲=when=楴i楳=d楳捨慲g敤=楮=mud=慮d=捵瑴tngs=
楮瑯=瑨攠o捥慮.
=
B慳敤=on=捯ns敲v慴av攠r楳k=an慬yses=for=s敤imen琠organ楳ms=數pos敤
=
瑯=w慴敲=b慳敤=muds,=瑨攠no瑩f楥i=po汹m敲=
楳=no琠exp散瑥t=瑯=have=慤v敲s攠敦f散瑳=on=b敮th楣ib楯瑡=ou瑳楤攠瑨e=imm敤楡瑥=v楣楮ity=of=off
-
shor攠o楬iand=g慳=
s楴敳= fo汬lw楮g= 愠wors琠捡se= d楳捨慲g攠of= th攠muds.= 卯m攠瑲慮s楥i琠瑯x楣i 敦f散瑳= may= o捣ur= b敮敡瑨= t
he=
d楳捨慲ge=po楮琬tbu琠楮=th楳=捡s攠th敳e=慲攠no琠汩k敬y=瑯=be=signif楣int=g楶en=the=po瑥t瑩慬=for=phys楣慬ieff散瑳=on=
October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
9

of
16

biota resulting from deposition of mud and cuttings on the sea floor.


The environmental risks associated with the introduction and int
ended use of the notified polymer are therefore
acceptably low.



8.

CONCLUSIONS AND REGULATORY OBLIGATIONS


Hazard
classification

No toxicity data are provided for the notified polymer. Therefore, it
cannot be classified according to the
Approved Criteria for Classifying Hazardous Substances
(NOHSC, 2004).


The

classification of the notified
polymer

using the Globally Harmonised System for the Classification and
Labelling of Chemicals (GHS) (United Nations 2003) is presented below. This sy
stem is not mandated in
Australia and carries no legal status but is presented for information purposes.



Hazard category

Hazard statement

Environment

Acute


Chronic


Harmful to aquatic life


Harmful to aquatic life with long lasting
effects



Human
health risk assessment

Under the conditions of the occupational settings described, the notified
polymer

is
not considered to pose

an
unacceptable risk to the health of workers.


When used in the proposed manner, the notified
polymer

is
not considered to p
ose

an unacceptable risk to
public health.



Environmental risk assessment

Based on its reported use pattern and low toxicity to marine biota, the notified polymer is not considered to pose
a risk to the environment.


Recommendations


C
ONTROL
M
EASURES

Oc
cupational Health and Safety




Employers should implement the following safe work practices to minimise occupational exposure
during handling of the notified
polymer

as imported at 40
-
50% concentration in the product Starch
Copolymer in Poroseal:



Local
exhaust ventilation




Employers should ensure that the following personal protective equipment is used by workers to
minimise occupational exposure to the notified
polymer

as imported at 40
-
50% concentration in the
product Starch Copolymer in Poroseal and d
uring use at concentration of ≤5%:



Safety gloves



Safety glasses



Overalls




Guidance in selection of personal protective equipment can be obtained from Australian,
Australian/New Zealand or other approved standards.




A copy of the MSDS should be easily
accessible to employees.




If products and mixtures containing the notified
chemical

are classified as hazardous to health in
accordance with the
Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(2004)]
October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
10

of
16

workplace practices and control proce
dures consistent with provisions of State and Territory hazardous
substances legislation must be in operation.


Disposal




The notified
polymer

should be disposed of to landfill.


Emergency procedures




Spills or accidental release of the notified
polymer

should be handled by
physical containment,
collection and subsequent safe disposal
.


Regulatory Obligations


Secondary Notification

This risk assessment is based on the information available at the time of notification. The Director may call for
the reassessment of the chemical under secondary notification provisions based on changes in certain
circumstances. Under Section 64 of the
In
dustrial Chemicals (Notification and Assessment) Act (1989)
the
notifier, as well as any other importer or manufacturer of the notified chemical, have post
-
assessment regulatory
obligations to notify NICNAS when any of these circumstances change. These obl
igations apply even when the
notified chemical is listed on the Australian Inventory of Chemical Substances (AICS).


Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or
manufacturer:


(1)

Under Se
ction 64(1) of the Act; if



the polymer is intended to be introduced in powder form

or


(2)

Under Section 64(2) of the Act; if



the function or use of the
polymer

has changed from
drilling fluid additive
at concentrations ≤5%
for use in offshore oil and gas

drilling operations,

or is likely to change significantly;



the amount of
polymer

being introduced has increased from

300 tonnes
, or is likely to increase,
significantly;



the
polymer

has begun to be manufactured in Australia;



additional information has become available to the person as to an adverse effect of the
polymer

on
occupational health and safety, public health, or the environment.


Material Safety Data Sheet

The MSDS of
a product

containing the notified
polymer

provide
d by the notifier was reviewed by NICNAS. The
accuracy of the information on the MSDS remains the responsibility of the applicant.


October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
11

of
16

A
PPENDIX
A:

P
HYSICAL AND
C
HEMICAL
P
ROPERTIES



Density

1110

kg/m
3





Method

Not provided
.


Test Facility

Confidential


Partition Coefficient (n
-
octanol/water)

log Pow < 0 (estimated)





Method

OECD TG 117 Partition Coefficient (n
-
octanol/water)


Remarks

In a pre
-
screening test the test substance (30
-
60% notified polymer in water) was found to
be unsuitable for HPLC analysis. The test substance was reported to be partly soluble in
water and insoluble in methanol, octanol and the HPLC mobile phase (25% wate
r, 75%
methanol). The test substance formed an emulsion in an octanol/water mix. No
quantitative results were reported. Based on its solubility, the notified polymer was
estimated to have a log Pow < 0.


Test Facility

M
-
I SWACO (2010a)


































A
PPENDIX
B
:

E
NVIRONMENTAL
F
ATE AND
E
COTOXICOLOGICAL
I
NVESTIGATIONS

October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
12

of
16


B.1.1

Environmental Fate


B.1.1. Biodegradability in seawater



T
EST
S
UBSTANCE

Notified polymer (30

=
60┩%in=w慴敲
=
=
=
=
M
ETHOD

OECD TG 306 Biodegradation in seawater:
Closed bottle method

Inoculum

Natural seawater (salinity 31.7‰)
=
bxposur攠m敲楯d
=
28=d慹s
=
䅵x楬楡iy=卯汶ent
=
乯n攠r数or瑥t
=
䅮慬y瑩捡氠䵯n楴ir楮g
=
佸ygen=m整敲
=
oem慲ks=
-
=
䵥thod
=
卥pw慴敲=w慳a捯汬散瑥l=from=愠d数瑨=of=40=m=and=h慤=愠s慬in楴y=of=3N.7


Th攠瑥獴=subs瑡t捥=was=慤d敤=瑯=s敡wa瑥t=瑯=mak攠up=愠捯n捥n瑲慴楯n=of=
2.7=mgLi.=
=
=
=
=
o
ESULTS



Test substance

Sodium benzoate

Day

% Degradation

Day

% Degradation

0

0

0

0

7

19

7

61

14

36

14

74

21

36

21

78

28

36

28

69


Remarks
-

Results

During
the test the temperature was in the range 15
-

20ºC and oxygen
consumption in the control media was 30% of the original amount (day 0)
which are indicative of a valid test. Sodium benzoate degraded >60% in 14
days indicating microbial activity was satisfac
tory. The inhibitory test
resulted in 57% degradation of sodium benzoate after 28 days indicating
there is no interference between the two compounds. No O
2

consumption
was observed during the abiotic test.




C
ONCLUSION

The notified polymer has a low po
tential to biodegrade in seawater.




T
EST
F
ACILITY

M
-
I SWACO (2010b)


B.2.

Ecotoxicological Investigations


B.2.1 Acute toxicity to fish



T
EST
S
UBSTANCE

Notified polymer (30

=
60┩%in=w慴敲
=
=
=
=
M
ETHOD

OECD TG 203 Fish, Acute Toxicity Test

=
卥mi
-
s瑡瑩挠

=
96h= (N993),=
modif楥i=瑯=m慲in攠捯nd楴楯ns.
=
体l䅒=⼠m䅒Cl䴠mro瑯捯ls=on=䵥瑨ods=for=瑨攠T敳瑩ng=of=Chem楣i汳=
啳敤=楮=th攠佦fshor攠fndus瑲y=2006=(体lAo,=2006).
=
印散楥i
=
guv敮楬攠sh敥psh敡d=minnow=(
Cyprinodon variegatus
)

Exposure Period

96 h

Auxiliary Solvent

None reported

Water Hardness

Not reported

Analytical Monitoring

Not reported

Remarks

=
䵥thod
=
Th攠瑥獴=subs瑡t捥=w慳=d楳so汶敤=d楲散瑬y=in瑯=瑥s琠v敳s敬e=w楴h=n慴ar慬=
s敡w慴敲=us敤=慳a瑨攠d楬u瑩tn=m敤極m=(s慬an楴y=㴠3N.5

).=Throughou琠
th攠
s瑵dy=th攠瑥mp敲慴ar攠was=wi瑨in=th攠r慮g攠N9.4=

=
20.7ºC=慮d=p䠠7.8=

=
8.N.=䙩ch=w敲攠only=expos敤=瑯=愠sing汥l捯n捥n瑲慴楯n=of=th攠t敳琠eubs瑡n捥=
(2NN=mgLi).=Th攠瑥獴=慮d=捯n瑲o氠獯汵瑩tns=w敲攠r敮ew敤=慴a48=hours.=
=
=
=
=
o
ESULTS

The concentrations tabulated below are of the test substance (30
-
60%
October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
13

of
16

solution).


Concentration mg/L

Number of Fish

Mortality

Nominal

Actual


0 h

24 h

48 h

72 h

96 h

0

0

10

0

0

0

0

1

211

Not determined

10

0

0

0

0

0


LC50

> 63.3 mg/L at 96 hours

NOEC

63.3 mg/L at 96 hours

Remarks

=
oesul瑳
=
Th攠r敳eons攠of=愠ref敲敮捥=compound=(3,5=d楣i汯roph敮ol)=w慳=found=瑯=
b攠楮=瑨攠慣捥p瑡t汥lr慮g攮=Th攠mor瑡汩ty=of=th攠b污lk=d楤=no琠數捥敤=N0%=
慮d= 瑨攠 d楳so汶敤= oxygen= con捥n瑲慴楯n= w慳a 㸶0┠ of= 慩a= s慴ar慴楯n=
瑨r
oughou琠瑨攠瑥s琮t 䡥n捥= th攠瑥獴= is= 捯ns楤敲敤= v慬楤.= Th敲攠was= no=
慮慬y瑩捡氠 mon楴iring= of= 瑨攠 瑥獴= subs瑡n捥.= Th攠 r敳el瑳= hav攠 b敥n=
捯rr散瑥t=瑯=r敦汥捴l瑨e=po瑥t瑩慬ay=most=d楬i瑥=捯n捥n瑲慴楯n=(30┩%of=瑨e=
no瑩晩td=po汹m敲=in=th攠瑥s琠subs瑡n捥.=Th敳攠
r敳e汴l=do=no琠數捬ud攠瑨e=
possibility that the notified polymer has an LC50 ≤ 100 mg/L which is
瑨攠upp敲=汩m楴i for=捨em楣i汳=捬慳cif楥i=慳ah慲mfu氠瑯=慱u慴楣a汩l攠und敲=
瑨攠 und敲= 瑨攠 d汯b慬ay= e慲mon楳敤= pys瑥m= of= C污ls楦楣i瑩tn= and=
i慢敬汩ng= of= Chem楣慬s
=
(啮楴敤= 乡瑩Nns,= 2009).= A= 捯ns敲v慴ave=
慳aump瑩tn=w慳=瑨敲efor攠mad攠瑨慴a th攠no瑩t楥i=polym敲=楳=po瑥t瑩慬ty=
h慲mfu氠瑯=m慲in攠fish.
=
=
=
=
C
ONCLUSION

The notified polymer is potentially harmful to marine fish.




T
EST
F
ACILITY

M
-
I SWACO (2010c)



B.2.2. Toxicity to sediment dwelling organisms



T
EST
S
UBSTANCE

Notified polymer (30

=
60┩%in=w慴敲
=
=
=
=
M
ETHOD

OSPAR / PARCOM Protocols on Methods for the Testing of Chemicals
Used in the Offshore Industry 2006 (OSPAR, 2006).

Species

Corophium
volutator

Exposure Period

10 days

Auxiliary Solvent

None reported

Water Hardness

Not reported

Analytical Monitoring

None reported

Remarks
-

Method

Dry sediment was spiked with the test substance and further blended into
wet sediment. Seawater was then

carefully poured over the sediment
without any resuspension of the sediment into seawater. Seawater volume
was maintained by replacement of evaporated water with freshwater
purified by reverse osmosis. Each test vessel was aerated. Throughout the
study th
e temperature was 14.7

=
N6.6ºC,=s慬楮ity=w慳a32.4=

=
35.8

,=pe=
was=7.6=

=
8.N=慮d=瑨攠oxygen=s慴ar慴楯n=w慳‾85┮%
=
=
o
ESULTS

The concentrations tabulated below are of the test substance (30
-
60%
solution).


Concentration mg/kg

Number of C. volutator

Mortality

(day 10)

% Mortality

(day 10)

Nominal

Actual




0

0

40

4

10

240

Not determined

20

3

15


LC50

> 72 mg/kg dry weight sediment at 10 days

Remarks
-

Results

No analysis of test solutions was reported. The data were not suitable for
probit
analysis. The results have been corrected to reflect the potentially
most dilute concentration (30%) of the notified polymer in the test
October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
14

of
16

substance.




C
ONCLUSION

The notified polymer may exhibit some toxicity to the sand dwelling
marine amphipod,
Corophium volutator,
at high nominal loadings, but the
toxicity cannot be classified
.




T
EST
F
ACILITY

M
-
I SWACO (2010d)


B.2.3. Acute toxicity to aquatic invertebrates



T
EST
S
UBSTANCE

Notified polymer (30

=
60┩%in=w慴敲
=
=
=
=
M
ETHOD

ISO 14669:1999

Species

Acartia tonsa

Exposure Period

48 hours

Auxiliary Solvent

None reported

Water Hardness

Not reported

Analytical Monitoring

None reported

Remarks
-

Method

Seawater was collected from a depth of 40 m and had salinity of 31.5

=
on=瑨攠捯汬散瑩ln=day.=Throughou琠th攠s瑵dy=瑨攠瑥mp敲慴ar攠w慳aN9.2=

=
20.7ºC,=p䠠w慳a8.N=

=
8.2=慮d=瑨攠oxygen=s慴ur慴楯n=was=㸸0┮%A琠敡捨=
瑥獴=捯n捥n瑲慴楯n=th敲攠w敲攠4=r数汩捡瑥猠w楴h=5=慮im慬s=in=敡捨=vess敬e=
佲g慮isms= w敲攠 慬so= 數pos敤= 瑯= 3,5
-
d楣i汯
roph敮o氠 慳a 瑨攠 瑯x楣=
r敦敲敮捥.
=
=
o
ESULTS

The concentrations tabulated below are of the test substance (30
-
60%
solution).


Concentration mg/L

Number of A. tonsa

Number Dead

Nominal


24 h

48 h

0

20

0

2

100

20

0

0

178

20

0

2

316

20

0

4

563

20

0

1

1001

20

0

7

3,5
-
dichlorophenol

(1 mg/L)

20

16

18


LC50

311 mg/L at 48 h

NOEC

178 mg/L at 48 h

Remarks
-

Results

A sigmoid response curve was observed on
Acartia tonsa

indicating
mortality due to the notified polymer. The results have been corrected to
reflect the potentially most dilute concentration (30%) of the notified
polymer in the test substance. In the control 10% of the animals died
which did not affect the val
idity of the test. The LC50 (48 h) of 3,5
-
dichlorophenol is anticipated to be 1.0 mg/L. At this concentration there
was 80% mortality indicating an acceptable response of organisms.




C
ONCLUSION

The notified polymer is not harmful to marine zooplankton




T
EST
F
ACILITY

M
-
I SWACO (2010e)




B.2.4. Algal growth inhibition test



T
EST
S
UBSTANCE

Notified polymer (30

=
60┩%in=w慴敲
=
=
=
=
M
ETHOD

ISO/DP 10253

October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
15

of
16

Species

Skeletonema costatum

Exposure Period

72 hours

Concentration Range

Nominal:

99
-

1011
mg/L (WAF)

Actual:

Not reported

Auxiliary Solvent

None reported

Water Hardness

Not reported

Analytical Monitoring

None reported

Remarks
-

Method

Seawater was collected from a depth of 40 m and had salinity of 31.1


on the collection day. Throughout the study the temperature was 20


21ºC. At 72 h the pH was 7.6


8.3. The algae was exposed to the
reference chemical 3,5
-
dichlorophenol at a concentration of 1.6 mg/L.




R
ESULTS

The concentrations tabulated below ar
e of the test substance (30
-
60%
solution).


Biomass

Growth

E
b
C50

NOEC

E
r
C50

NOEC

mg/L at 72 h

mg/L

mg/L at 72 h

mg/L

Not calculated

Not calculated

63

Not provided


Remarks
-

Results

The response to the reference chemical was within the range for a valid
test. The test substance had a sigmoid response on
Skeletonema costatum

in the test range. The E
r
C50 was calculated by Probit analysis. It does not
state in the report that particulate

matter (i.e. undissolved notified
polymer) was observed in the WAF. The results have been corrected to
reflect the potentially most dilute concentration (30%) of the notified
polymer in the test substance.




C
ONCLUSION

The notified polymer is not
harmful to marine algae




T
EST
F
ACILITY

M
-
I SWACO (2010f)

October 2010

NICNAS


FULL PUBLIC REPORT: LTD/1492

Page
16

of
16


B
IBLIOGRAPHY

M
-
I SWACO (2010a) An assessment of the water oil distribution for Poroseal. (12 March 2010) Bergen,
Norway, M
-
I SWACO Norge AS. (Unpublished report
provided by notifier).

M
-
I SWACO (2010b) A study of the biodegradation in seawater of: Poroseal using the closed bottle procedure.
(Tes
t Identification: OECD 306.
19 Apr 2010). Bergen, Norway, M
-
I SWACO Norge AS. (Unpublished
report provided by notifier).

M
-
I SWACO (2010c) The acute toxicity of Poroseal to the juvenile marine fish Sheepshead minnow
(
Cyprinodon variegatus

j.) (03 March 2010). Fyllingsdalen, Norway, M
-
I SWACO Norge AS. (Unpublished
report provided by notifier).

M
-
I SWACO (2010d) The acute tox
icity of Poroseal to the sediment reworker
Corophium volutator
.
Fyllingsdalen, Norway, M
-
I SWACO Norge AS. (Unpublished report provided by notifier).

M
-
I SWACO (2010e) The acute toxicity of Poroseal to the marine copepod
Acartia tonsa
(08 Apr 2010)
Fylling
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