File No: NA/932
May 2001
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
2-Butenedioic acid (2Z)-, ammonium salt, homopolymer, hydrolysed, sodium salts
(Polyaspartic acid, sodium salts)
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) and Regulations. This legislation is an Act of the
Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) is administered by the National Occupational Health and Safety Commission
which also conducts the occupational health & safety assessment. The assessment of environmental
hazard is conducted by the Department of the Environment and the assessment of public health is
conducted by the Department of Health and Aged Care.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be inspected by
the public at the Library, National Occupational Health and Safety Commission, 92-94 Parramatta
Road, Camperdown NSW 2050, between the following hours:
Monday - Wednesday 8.30 am - 5.00 pm
Thursday 8.30 am - 8.00 pm
Friday 8.30 am - 5.00 pm
Copies of this full public report may also be requested, free of charge, by contacting the
Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone: (61) (02) 9577 9514 FAX (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
TABLE OF CONTENTS
FULL PUBLIC REPORT...........................................................................................................3
1. APPLICANT ..................................................................................................................3
2. IDENTITY OF THE CHEMICAL.................................................................................3
3. POLYMER COMPOSITION AND PURITY................................................................4
4. PHYSICAL AND CHEMICAL PROPERTIES.............................................................5
4.1 Comments on Physico-Chemical Properties ..........................................................5
5. USE, VOLUME AND FORMULATION......................................................................6
6. OCCUPATIONAL EXPOSURE ...................................................................................7
7. PUBLIC EXPOSURE ....................................................................................................8
8. ENVIRONMENTAL EXPOSURE................................................................................8
8.1 Release ...................................................................................................................8
8.2 Fate .........................................................................................................................9
9. EVALUATION OF TOXICOLOGICAL DATA.........................................................10
9.1 Acute Toxicity......................................................................................................10
9.1.1 Oral Toxicity ................................................................................................10
9.1.2 Dermal Toxicity ...........................................................................................10
9.1.4 Skin Irritation ...............................................................................................11
9.1.5 Eye Irritation.................................................................................................11
9.1.6 Skin Sensitisation .........................................................................................12
9.2 Genotoxicity .........................................................................................................12
9.2.1 Salmonella typhimurium Reverse Mutation Assay ......................................12
9.3 Toxicological hazards of constituents, impurities, additives and adjuvants ........13
9.4 Overall Assessment of Toxicological Data ..........................................................13
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS .............................................14
11. ASSESSMENT OF ENVIRONMENTAL HAZARD .............................................14
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS .................................................................................................................15
12.1. Occupational health and safety.........................................................................16
12.2. Public Health ....................................................................................................16
13. RECOMMENDATIONS .........................................................................................16
14. MATERIAL SAFETY DATA SHEET....................................................................17
15. REQUIREMENTS FOR SECONDARY NOTIFICATION ....................................17
16. REFERENCES.........................................................................................................17
NA/932
FULL PUBLIC REPORT
2-Butenedioic acid (2Z)-, ammonium salt, homopolymer, hydrolysed, sodium salts
(Polyaspartic acid, sodium salts)
1. APPLICANT
Bayer Australia Limited of 633-647 Springvale Road, Mulgrave North Victoria 3170 (ACN
000 691 690) has submitted a limited notification statement in support of their application for
an assessment certificate for `Polyaspartic acid, sodium salts'.
The notifier has not claimed any information to be exempt from publication in the Full Public
Report.
2. IDENTITY OF THE CHEMICAL
Chemical name: 2-butenedioic acid (2Z)-, ammonium salt, homopolymer, hydrolysed,
sodium salts
CAS number: 181828-06-8
Marketing names: polyaspartic acid sodium salt TP OC 1001 (for the powder),
polyaspartic acid sodium salt TP OC 1401 (for the solution)
Molecular formula: [C4H4NO3Na]x
Structural formula:
O O O O
O Na
NH O Na O Na
O Na O Na
NH NH
H2N
O O O O
n
Reactive functional groups:
The notified polymer contains one terminal amine group (high concern) and multiple
carboxylate groups (as the sodium salt, low concern) per polymer molecule.
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Functional group equivalent weight (FGEW):
1151 (for the amine group)
Molecular weight (MW):
Number-average Weight-average % MW < 1000 % MW < 500 Method
MW MW
1151-1259 2380-2505 20 % (approx.) 8 % (approx.) GPC
Structural identification method: IR
Peaks at: 3410(br), 3070, 2930, 1600, 1540, 1400, 1310, 1240, 1200, 1120 cm-1
3. POLYMER COMPOSITION AND PURITY
Polymer constituents
Constituent CAS no. % weight % residual
2-butenedioic acid 39444-67-2 92.7 information not
ammonium salt homopolymer available
sodium hydroxide 1310-73-2 7.3 information not
available
Purity (%): 83%
Hazardous impurities:
Chemical name Synonym CAS no. % weight
2-butenedioic acid (Z)- maleic acid 110-16-7 0.1
2-butenedioic acid (E)- fumaric acid 110-17-8 0.2
Non-hazardous impurities at 1% by weight or more:
Chemical name Synonym CAS no. % weight
water 7732-18-5 11.5
DL-aspartic acid DL-asparaginic acid 617-45-8 3.1
unknown impurities 2.1
Additives/adjuvants:
None stated
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4. PHYSICAL AND CHEMICAL PROPERTIES
Property Result Comments
white powder; orange to
Appearance
brown liquid (solution)
decomposes at 140oC
not determined
Melting point
100oC solution (for water)
Boiling point
powder: 675 kg/m3
Density
solution: 1300 kg/m3
not volatile
Vapour Pressure
> 1000 g/L at 25oC
Water solubility
Log Pow = -2.4
Partition coefficient
not determined
Adsorption/desorption
> 600 祄 0.1-1 %
Particle size
315-600 祄 0.8-8 %
200-315 祄 11-14 %
100-200 祄 65-67 %
28-100 祄 1.1-5.8%
< 28 祄 0.05-0.4 %
not flammable
Flammability
not expected to self ignite
Autoignition
temperature
not expected to be powder may result in dust
Explosive properties
explosive explosions if dusts allowed to
form
not expected to degrade the powder may react with strong
Stability/reactivity
under ambient conditions oxidising agents
or undergo hazardous
polymerisation
pKa = 4.87
Dissociation constant
not determined no groups are expected to
Hydrolysis
hydrolyse under normal
environmental conditions
4.1 Comments on Physico-Chemical Properties
The vapour pressure could not be determined because the notified polymer decomposed
during the test (Bayer AG ZF-Zentrale Analytik 2000).
The water solubility was determined using a bending vibration method (Bayer AG ZF-
Zentrale Analytik 1999a). The relative density of a solution containing the notified polymer
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was determined using an oscillating densitometer as described in OECD TG 109. The
solubility of a compound is determined once the density of a saturated solution of known
volume is obtained. The notified polymer (60 g) was added to a buffered solution (20 mL)
and the resulting viscous paste was stirred at 23oC. An U-formed tube, which can be made to
vibrate, was calibrated with two liquids of known density. A known amount of the polymer
paste (0.7 mL) was added to the U-formed tube and the density of the sample determined.
This method indicated that the solubility of the notified polymer is > 1000 g/L.
The notified polymer contains amide linkages that could be expected to undergo hydrolysis
under extreme pH conditions. However, in the environmental pH range of 4 to 9, significant
hydrolysis is unlikely to occur.
The partition coefficient was determined using a shake flask method (Bayer AG ZF-Zentrale
Analytik 1999b). The log P of the notified polymer is -2.4. This equates to a P value of 3.98 ?br>
10-3 which indicates that the notified polymer may be considered to be hydrophilic.
No adsorption/desorption tests were conducted for this notification. The notified polymers
partition coefficient would suggest that the notified polymer is not expected to adsorb to
organic matter in soil or sediments. However, polyanionic compounds and polymers are
known to absorb to soils and sediments, through their ability to chelate to metals.
Although no dissociation tests were conducted, based on the dissociation constant of
propionic acid, the notifier expects that the notified polymer to have a pKa of approximately
4.87.
5. USE, VOLUME AND FORMULATION
Use:
The notified polymer will be used by manufacturing companies as an ingredient in liquid
formulations that are used within the water treatment industry. The products will be used by
industrial/commercial customers within cooling and heating systems where they act as scale
inhibitors to prevent deposits on cooling or heating circuits.
Manufacture/Import volume:
The notified polymer is not manufactured in Australia. It is imported either as a powder
(83 % pure notified polymer), in 160 kg plastic-lined fibre drums and 60 kg plastic drums, or
as a 40 % aqueous solution in 1250 kg tank containers, 230 kg rolling drums or 250 kg
polyethylene bunghole containers.
The total maximum quantity to be imported annually for the first five years is 10 tonnes per
annum.
Formulation details:
Both the powder and aqueous forms of the polymer will be reformulated within Australia to
produce water treatment products containing between 5 and 30 % notified polymer. Products
will be contained within 20 or 200 L drums, or 1500 L IBCs. Typically, at customer sites the
water treatment product containing the notified polymer will be pumped from a storage
container to the process stream via a feed (transfer) system.
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6. OCCUPATIONAL EXPOSURE
Exposure Exposure details Controls indicated by notifier
route
Transport and Storage (2-3 hours/day, 12-15 days/year)
Waterside unloading (2-3 workers)
Dermal or The imported containers will be None indicated
inhalation transferred from ships to road trucks.
Exposure is only likely following
accidental spills or leaks.
Transport and storage (3-4 workers)
Dermal or Containers will be stored under cover. None indicated
inhalation No repackaging will occur prior to
reformulation. Exposure is only likely
following accidental spills or leaks.
Formulation (6-20 workers, 8 hours/day, 100-150 days/year)
Transfer from import containers
Dermal or Manual handling is minimised by the Processes are automated. Also
inhalation use of metered dose pumps to transfer reformulation workers will wear
the polymer, in liquid or powder form, impervious gloves, overalls, eye
to 7000 L mixing tanks. Exposure may protection, safety boots and dust-
occur during connection and masks if necessary.
disconnection of pumping equipment.
Mixing
Dermal or Other ingredients are added by Local and general ventilation are
inhalation automated procedures and the mixing used. Also reformulation workers
tanks are sealed. will wear impervious gloves,
overalls, eye protection, safety
boots and dust-masks if necessary.
Dispensing
Dermal Product is dispensed automatically via Dispensing processes are
hoses into 20 or 200 L drums, or automated. Also, reformulation
1500 L IBCs. Exposure may occur workers will wear impervious
during the manual closing of gloves, overalls, eye protection,
containers. safety boots and dust-masks if
necessary.
End use (50-100 workers)
Plant operators
Dermal End users may dilute the products Typically plant operators are
further. Operators (1-2 per site) may required wear impervious gloves,
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be exposed (once per day for 0.5-1 overalls and eye protection during
hour/day) to a maximum concentration connection and disconnection of
of 30 % notified polymer, when feed lines.
removing container bungs or lids and
during connection of pumping
equipment.
7. PUBLIC EXPOSURE
Public exposure to the notified polymer as imported, transported and stored will only occur
with rupture of containers as a result of an accident. There is negligible public exposure due
to factory processing and from waste product.
The notified polymer is not available for sale to the public. Industrial use may lead to release
into the environment through leakage of storage containers and spillage of product at a
maximum of 30 % of the notified polymer, or from cooling system discharge, manual system
blowdown, and cooling tower drift at typical concentrations of 10 ppm. Public exposure will
be limited and at very low concentrations, as the release will be into treatment systems that
will further dilute the polymer or into the atmosphere away from normal public access and
will thus be dispersed by the air.
8. ENVIRONMENTAL EXPOSURE
8.1 Release
After importation, the notified polymer will be transported via road without repackaging. The
notifier expects that approximately 0.5 % of the total import volume will be released through
spills prior to reformulation. This equates to a loss of 50 kg per annum of the notified
polymer. The notifier estimates that 1 % of the notified polymer may be lost during
formulation which would equal 100 kg per annum.
The notifier estimates that approximately 1 % or 100 kg per annum of the notified polymer
will remain as residues in the importation drums. The import and reformulation drums
containing residues will be disposed of by licensed waste disposal contractors. The IBCs are
expected to be washed and drained thoroughly before reuse.
The notified polymer will be used for the treatment of water contained in closed systems at
the end use site. During the water treatment, the efficacy of treatment polymer diminishes and
new water treatment solution is continually added to the system. A continual bleeding and
discharge of the treated water compensates replenishment of the polymer in the system.
The majority of the notified polymer will be released to the environment in this way as well
as when cooling systems undergo either short-term manual system blowdown (BD) or total
shut-down and are cleaned.
For example, the notifier indicates that the volume of purge or blowdown from a small site
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with a BD of 0.5 tonnes per hour with only one cooling tower would be approximately 4.5
ML/year. The quantity of the notified polymer released would be 22.5 kg/year. A large
cooling plant system would have a BD of 21 tonnes per hour, which is equivalent to 170
ML/year. This equates to a release of approximately 850 kg/year of the notified polymer after
on-site treatment.
The notifier indicates that most cooling towers operate with a maximum drift of 0.002% of
the recirculation rate. The recirculation rate in a small site cooling tower may be 900
tonnes/hour. Assuming a 5 ppm concentration of notified polymer in the cooling tower, 9
g/hour or 79 kg/year would be lost due to drift. In a larger system the recirculation rate is in
the order of 9000 tonnes/hour and this would result in 790 kg/year of notified polymer being
released due to drift.
8.2 Fate
The notifier indicates that empty drums and their residues will be sent to either licensed drum
reconditioners or the drums disposed of directly to a licensed landfill site. Presumably, drum
reconditioners will also dispose of solid residue from drums to licensed waste landfill sites.
While not specifically indicated by the notifier, presumably washings from pipes and mixing
equipment will be use in the formulation of the next batch of water treatment solution.
The notifier has provided the results of a ready biodegradation test in an aerobic aqueous
media following modified OECD screening test, OECD TG 301B (Bayer AG, Institut f黵
Umweltanalyse 1997a). The biodegradation was determined by the measurement of dissolved
organic carbon produced after the medium was inoculated with a mixed population of aquatic
microorganisms and stored in the dark at 24oC for 28 days. Aniline was used as the standard
material. The results indicated that 68 % of the polymer had degraded over this time, while
100 % of the standard degraded in 14 days. The results indicate that polyaspartic acid is not
readily biodegradable as < 70 % had degraded within 10 days of 10 % having been reached.
During use the notifier indicates that the feed rate will be adjusted to maintain a concentration
of up to 5 ppm of the active notified polymer in the cooling water system. The cooling tower
concentrations of the notified polymer are, therefore, expected to be less that 5 ppm.
The notifier indicates that typically cooling water represents about 60 % of the total effluent
volume discharged from a facility. The remaining water comes from boiler and process
streams. The concentration of the notified polymer in the plant effluent would, therefore, be
about 3 ppm. If a secondary effluent plant is used prior to discharge, the notifier estimates that
this would involve a ten-fold dilution and 50 % of the notified polymer is expected to be
removed through the waste treatment facilities as sludge and disposed of to landfill.
Discharge from the plant would, therefore, contain < 0.2 ppm notified polymer. Subsequent
treatment at local sewage treatment plants would further dilute and remove the notified
polymer to very low concentration levels (< 0.02 ppm).
Based on these assumptions, it is expected that some of the notified polymer will find its way
to landfill. Here it will be adsorbed to soil and sediment and be immobile due to its
polyanionic nature. It should not bioaccumulate (Connell 1990) as the polymer is water
soluble with a very low log Pow value.
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9. EVALUATION OF TOXICOLOGICAL DATA
9.1 Acute Toxicity
Summary of the acute toxicity of Polyaspartic acid, sodium salts
Test Species Outcome Reference
acute oral toxicity rat LD50>2000mg/kg Stropp, 1999a
acute dermal toxicity rat LD50>2000mg/kg Stropp, 1999b
skin irritation rabbit non-irritant Stropp, 1998a
eye irritation rabbit non-irritant Stropp, 1998b
skin sensitisation guinea pig non-sensitiser Stropp, 1999c
9.1.1 Oral Toxicity (Stropp, 1999a)
Species/strain: rat/Wistar
Number/sex of animals: 3/sex
Observation period: 14 days
Method of administration: gavage; 2000 mg/kg, as a 42.8 % aqueous solution
Test method: OECD TG 423 (Acute Toxic Class), Limit test
Mortality: none
Clinical observations: no signs of toxicity were observed
Morphological findings: no treatment-related macroscopic findings were observed
LD50: >2000 mg/kg
Result: the notified polymer was of very low acute oral toxicity in
rats
9.1.2 Dermal Toxicity (Stropp, 1999b)
Species/strain: rat/Wistar
Number/sex of animals: 3/sex
Observation period: 14 days
Method of administration: 2400 mg/kg under occlusive dressing for 24 hours, as a
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42.8 % aqueous solution
Test method: OECD TG 402
Mortality: none
Clinical observations: no signs of local or systemic toxicity were observed
Morphological findings: no treatment-related macroscopic findings were observed
Comment: the test method was modified in that a reduced number of
animals were used
LD50: > 2400 mg/kg
Result: the notified polymer was of low dermal toxicity in rats
9.1.4 Skin Irritation (Stropp, 1998a)
Species/strain: rabbit/Himalayan
Number/sex of animals: 3 males
Observation times: 60 min, 24, 48 and 72 hours
Method of administration: 0.5 mL notified polymer, in a 42.8 % aqueous solution,
under semi-occlusive dressing for 4 hours
Test method: OECD TG 404
Comment: no signs of erythema or oedema were seen in any of the
animals at any of the observation times
Result: the notified polymer was not irritating to the skin of rabbits
9.1.5 Eye Irritation (Stropp, 1998b)
Species/strain: rabbit/Himalayan
Number/sex of animals: 3 males
Observation times: 60 min, 24, 48 and 72 hours
Method of administration: 0.1 mL of 42.8 % aqueous solution placed into conjunctival
sac of one eye of each animal
Test method: OECD TG 405
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Comment: no signs of irritation of the cornea, iris or conjunctivae were
observed in any animal at any of the observation times
Result: the notified polymer was not irritating to the eyes of rabbits
9.1.6 Skin Sensitisation (Stropp, 1999d)
Species/strain: guinea pig/Hsd Poc:DH
Number of animals: 10 test and 5 control animals
Induction procedure:
test group: Three pairs of intradermal injections, of 0.1 mL volume,
day 0 were made in the scapular region:
?FCA diluted 1:1 with physiological saline
?5 % notified polymer in physiological saline
?5 % notified polymer in FCA
day 7 0.5 mL of 100 % notified polymer applied topically, under
occlusive dressings for 48 hours, to same skin area
Challenge procedure:
day 21 0.5 mL of 25 % notified polymer was applied topically to
dorsal and flanks for 24 hours under occlusive dressing
Test method: OECD TG 406
Challenge outcome:
Test animals Control animals
Challenge
concentration 48 hours* 48 hours
25% 0/10** 0/5
* time after patch removal
** number of animals exhibiting positive response
Result: the notified polymer was not sensitising to the skin of guinea
pigs
9.2 Genotoxicity
9.2.1 Salmonella typhimurium Reverse Mutation Assay (Herbold, 1999)
Strains: TA 98, TA 100, TA102, TA1535, TA 1537
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Metabolic activation: Aroclor-induced rat liver S9
50 ?5000 礸/plate
Concentration range:
Test method: OECD TG 471 (plate incorporation method)
Comment: the independent repeat test was performed using a 20 minute
pre-incubation period; there were no signs of toxicity to any
of the test strains at any of the concentrations employed
solvent control plates gave counts in the expected range and
positive controls produced significant increases in the
revertant counts
Result: the notified polymer was non mutagenic under the
conditions of the test
9.3 Toxicological hazards of constituents, impurities, additives and adjuvants
The health hazards of the constituents and hazardous impurities, additives and adjuvants are
tabulated below.
Chemical Health hazards (NOHSC, 1999a) Regulatory controls
Hazardous impurities :
R36/37/38: irritating to eyes, skin
maleic acid none
and respiratory tract (at > 20 %)
R22: harmful if swallowed (> 25 %).
fumaric acid none
R36: irritating to eyes (at > 20 %)
9.4 Overall Assessment of Toxicological Data
The notified polymer is a polymer of low reactivity and high molecular weight. It is of very
low and low acute oral and dermal toxicity, respectively, with LD50 values > 2400 and > 2000
mg/kg, respectively, being obtained in rodent studies. It is not a skin or eye irritant or a skin
sensitiser according to standard toxicity studies. Neither does it induce gene mutations in a
standard Ames test.
According to the available data the notified polymer is not classified as a hazardous substance
according to the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC,
1999b).
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10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
Test Species Results
96 h Acute Toxicity Zebra fish 3160 mg/L < LC50 > 10000 mg/L
Brachydanio rerio NOEC = 3160 mg/L
48 h Acute Toxicity Daphnia magna EC50 = 3536 mg/L
72 h Algal Growth Scenedesmus subspicatus 72 h EbC50 = 528 mg/L
Inhibition 72 h ErC50 = 1070 mg/L
* NOEC - no observable effect concentration
The tests on fish (Bayer AG, Institut f黵 Umweltanalyse 1997b) were performed using a static
methodology. Observations were performed at 2, 24, 48, 72 and 96 hours. The test was
performed using ten specimen fish per test concentration at a temperature of 21oC. The tests
were conducted using nominal concentrations of 3160 and 10000 mg/L. The results of the
definitive study showed that no mortalities or sublethal effects were observed in the test
vessel containing 3160 mg/L of the notified polymer. After 96 h, 80 % mortality was
observed at a test concentration of 10000 mg/L. The 96-hour LC50 for the notified polymer to
Brachydanio rerio is therefore between 3160 and 10000 mg/L.
The immobilisation tests with Daphnia magna (Bayer AG, Institut f黵 Umweltanalyse 1997c)
were also performed under static conditions with observations performed at 24 and 48 hours.
The test was performed using 10 daphnids per flask at a temperature of 20oC. The tests were
conducted using nominal concentrations of 625, 1250, 2500, 5000 and 10000 mg/L. After 48
h, no immobilised daphnids were observed in the test vessels with less than 2500 mg/L of the
notified polymer and 100 % mortality was observed after 48 h at test concentrations above
5000 mg/L. The 48-hour EC50 for the notified polymer to Daphnia magna is 3536 mg/L of
the notified polymer.
Algae were exposed to the test substance at concentrations of 125, 395, 1248 and 3959 mg/L
for 72 h at 24癈 under constant illumination and shaking (Bayer AG, Institut f黵
Umweltanalyse 1997d). After 72 h, the percentage inhibition of biomass for the test vessels
containing 125, 395, 1248 and 3959 mg/L of the notified polymer was 2.3, 48.1, 84.3 and
92.2 %, respectively, and the percentage inhibition of growth rate was 0, 25.0, 66.7 and
66.7 %, respectively. The 72 h EbC50 and ErC50 for the notified polymer to Scenedesmus
subspicatus is 528 mg/L and 1070 mg/L, respectively.
The ecotoxicity data indicates the notified polymer is practically non-toxic to fish, daphnia
and algae.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The intended use pattern of the notified polymer is expected to result in the majority of the
polymer being eventually released to the environment. However, this will be in dilute manner
as the notified polymer contained within the water treatment solution released from cooling
towers will be at a low concentration. The notifier expects further dilution as well as
adsorption will occur at on-site treatment plants. Discharge from the on-site treatment sites is
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expected to contain the notified polymer at a concentration of < 0.05 ppm. Subsequent
treatment at local sewage treatment plants would further dilute and remove the notified
polymer to very low concentration levels. If the notified polymer is used at other sites that do
not have on-site treatment plants then environmental exposure is still expected to be low
since the polymer is only expected to be used at a maximum concentration of 5 ppm.
Furthermore, the ecotoxicity data provided indicates the notified polymer is practically non-
toxic to fish, daphnia and algae and more than 3 orders of magnitude difference in predicted
levels compared with toxic levels.
In a worst case based on maximum annual imports of 10 tonnes per annum, all of which is
released to sewer and assuming that none is removed during sewage treatment processes,
assuming a national population of 18,000,000 and that each person contributes an average
150 L/day to overall sewage flows, the predicted concentration in sewage effluent on a
nationwide basis is estimated as 2.2 mg/L.
Amount of Polyaspartic Acid entering sewer annually 6000 kg
Population of Australia 18 million
Amount of water used per person per day 150 L
Number of days in a year 365
Estimated PEC 2.2 mg/L (2.2 ppm)
When released to receiving waters the concentration is generally understood to be reduced by
a further factor of at least 10, and so the Predicted Environmental Concentration (PEC) is
around 0.2 mg/L. If the notified polymer were to be used in one major capital city, such as
Sydney (pop. 3500000), the PEC in the receiving waters would be 11.4 mg/L.
The nationwide and larger cities PEC estimates indicate that after discharge to receiving
waters the environmental concentration of the notified polymer will be 3 orders of magnitude
less than the demonstrated toxicity to the Daphnia (EC50 = 3536 mg/L).
Wastes containing the notified polymer including residues from imported drums, from
formulation and sludge will be disposed of in landfill and are expected to be immobile. Even
though the notified polymer is soluble in water, it will adsorbed to soil and sediment due to its
high molecular weight and polyanionic nature.
Therefore, the environmental exposure and overall environmental hazard from the notified
polymer is expected to be low.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
The notified polymer is of very low and low acute oral and dermal toxicity, respectively.
Toxicity of inspirable dust, if formed, is also expected to be low. It is not a skin or eye irritant
and is not a skin sensitiser. A bacterial gene mutation study demonstrates that mutagenicity is
not expected to occur. The notified polymer is not flammable, nor is it expected to self ignite
or be explosive.
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12.1. Occupational health and safety
Imported containers of the notified polymer in either powder or aqueous formulation will not
be opened until arrival at formulation facilities. Therefore exposure of transport and storage
workers to the notified polymer will only occur in the event of accidental spillage.
Dermal and/or inhalation exposure to the aqueous solution and the powder may occur during
the connection and disconnection of transfer pumping equipment used in the (otherwise
automated) formulating processes. Dermal exposure to the aqueous solution may similarly
occur during the largely automated dispensing operation. However the extra controls
specified in the notification (wearing of impervious gloves, overalls, eye protection, dust
masks etc) will provide adequate protection against the low toxicity polymer.
Dermal exposure may occur to the formulated polymer, at a maximum concentration of 30 %,
when opening product containers, during diluting procedures and when connecting and
disconnecting pumping equipment to feed the product into water systems. However, the
notifier has stated that typically plant operators are required to wear impervious gloves,
overalls and eye protection during connection and disconnection of feed lines. Such controls
are considered sufficient to protect the workers against the low toxicity polymer.
Exposure to the low toxicity notified polymer is expected to be limited such that there are no
concerns for health and safety during the occupational handling of the polymer. No specific
risk reduction measures are necessary.
12.2. Public Health
The notified polymer is not available for sale to the public. Releases from industrial use will
have very low concentrations of the polymer (10 ppm) and these will be further diluted in the
atmosphere or sewerage system. Release from cooling towers, which are located away from
normal public access (e.g. on building roofs), allows dispersion of the polymer in the
atmosphere. Releases from boiler systems are unlikely to occur in publicly frequented areas.
These exposures are unlikely to pose a significant hazard to human health.
13. RECOMMENDATIONS
To minimise occupational exposure to polyaspartic acid, sodium salts the following
guidelines and precautions should be observed:
Spillage of the notified polymer should be avoided. Spillages should be cleaned up
?br>
promptly with absorbents (for the liquid) or swept up (for the powder) and put into
containers for disposal;
A copy of the MSDS should be easily accessible to employees.
?br>
If products containing the notified polymer are hazardous to health in accordance with the
NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999b),
workplace practices and control procedures consistent with State and Territory hazardous
substances regulations must be in operation.
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14. MATERIAL SAFETY DATA SHEET
MSDS for the notified polymer, in powder and aqueous form, were provided in a format
consistent with the National Code of Practice for the Preparation of Material Safety Data
Sheets (1994).
These MSDS were provided by the applicant as part of the notification statement. They are
reproduced here as a matter of public record. The accuracy of this information remains the
responsibility of the applicant.
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, the director must be informed if any of the circumstances stipulated under
subsection 64(2) of the Act arise, and secondary notification of the notified polymer may be
required. No other specific conditions are prescribed.
16. REFERENCES
Bayer AG ZF-Zentrale Analytik (1999a) Study Number N 99/0025/02 LEV: Water Solubility,
Leverkusen, Germany, (unpublished report submitted by Bayer).
Bayer AG ZF-Zentrale Analytik (1999b) Study Number N 99/0025/03 LEV: Partition
Coefficient (n-Octanol/water), Leverkusen, Germany, (unpublished report submitted by
Bayer).
Bayer AG ZF-Zentrale Analytik (2000) Study Number 99/021/01: Vapour Pressure, Physical-
Chemical Properties, Leverkusen, Germany, (unpublished report submitted by Bayer).
Bayer AG, Institut f黵 Umweltanalyse (1997a) Study number S1247112: Assessment of ready
biodegradability; Leverkusen, Germany, (unpublished report submitted by Bayer).
Bayer AG, Institut f黵 Umweltanalyse (1997b) Study number 61266359: Acute Fish Toxicity
of Polyaspartic acid, Leverkusen, Germany, (unpublished report submitted by Bayer).
Bayer AG, Institut f黵 Umweltanalyse (1997c) Study number 61266359: Acute Daphnia
Toxicity of Polyaspartic acid, Leverkusen, Germany, (unpublished report submitted by
Bayer).
Bayer AG, Institut f黵 Umweltanalyse (1997d) Study number 61266359: Algal Growth
Inhibition Test, Leverkusen, Germany, (unpublished report submitted by Bayer).
Connell, D.W. (1990). General Characteristics of Organic Compounds Which Exhibit
Bioaccumulation. In: Bioaccumulation of Xenobiotic Compounds. CRC Press, Boca Raton,
USA, pp. 47-57.
9 May 2001
FULL PUBLIC REPORT
NA/932 17/18
Herbold B (1999) Salmonella/Microsome Test Plate Incorporation and Preincubation
Method. Study No. T 4059893, Bayer AG, Toxicology, Friedrich-Ebert-Strasse 217-333, D-
42096 Wuppertal, Report No. 28412
NOHSC (1994) National Code of Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)]. Canberra, Australian Government Publishing Service.
NOHSC (1999a) List of Designated Hazardous Substances [NOHSC:10005(1999)].
Canberra, Australian Government Publishing Service. Canberra.
NOHSC (1999b) Approved Criteria for Classifying Hazardous Substances [NOHSC:1008
(1999)]. Canberra, AusInfo.
Stropp G (1999a) Acute Oral Toxicity Study in Male and Female Wistar Rats. Study No. T
2067559, Bayer AG, Fachbereich Toxikologie, Friedrich-Ebert-Strasse 217-333, D-42096
Wuppertal, Report No. 28384
Stropp G (1999b) Acute Dermal Toxicity Study in Male and Female Wistar Rats. Study No.
T 2067522, Bayer AG, Fachbereich Toxikologie, Friedrich-Ebert-Strasse 217-333, D-42096
Wuppertal, Report No. 28385
Stropp G (1998a) Acute Skin Irritation Test (Patch Test) of Polyasparaginsaure, Na-Salz,
Losung in Rabbits. Study No. T 0067179, Bayer AG Werk Elberfield, Institut fur
Toxikologie, Friedrich-Ebert-Strasse 217-333, D-42096 Wuppertal, Report No. R 7306
Stropp G (1998b) Acute Eye Irritation Study of Polyasparaginsaure, Na-Salz, Losung by
Instillation into the Conjuctival Sac of Rabbits. Study No. T 0067179, Bayer AG Werk
Elberfield, Institut fur Toxikologie, Friedrich-Ebert-Strasse 217-333, D-42096 Wuppertal,
Report No. R 7307
Stropp G (1999c) Study for the Skin Sensitisation Effect in Guinea Pigs. Study No. T
2067630, Bayer AG, Fachbereich Toxikologie, Friedrich-Ebert-Strasse 217-333, D-42096
Wuppertal, Report No. PH-28603
9 May 2001
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