I:\MEPC\57\2-2.doc 

For reasons of economy, this document is printed in a limited number. Delegates are 

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INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

57th session 

Agenda item 2 

MEPC 57/2/2

 7 September 2007

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Application for Basic Approval of Active Substances used by Hitachi Ballast Water 

Purification System (ClearBallast)

Submitted by Japan 

SUMMARY

Executive summary: This document contains an application for Basic Approval of Active 

Substances used by Hitachi Ballast Water Purification System 

(ClearBallast) in accordance with the Procedure for approval of ballast 

water management systems that make use of Active Substance (G9) 

adopted by resolution MEPC.126(53). Relevant documents and the 

complete dossier have been provided to Marine Environment Division 

of the Organization for review by the GESAMP-Ballast Water 

Working Group. 

Action to be taken: Paragraph 5 

Related documents: BWM/CON/36; MEPC 56/2/2; and BWM.2/Circ.10 

Introduction 

1 The Ballast Water Management Convention (BWM Convention), in its regulation D-3.2, 

provides that ballast water management systems which make use of Active Substances, to 

comply with the Convention, shall be approved by IMO based on a procedure developed by the 

Organization. 

2 MEPC 53 adopted, by resolution MEPC.126(53), the ëProcedure for approval of ballast 

water management systems that make use of Active Substances (G9)í. Section 8 of the Procedure 

sets out the methodology to be followed for the approval of such systems and requests IMO to 

establish a Technical Group (the GESAMP-Ballast Water Working Group) to review the 

proposals submitted by Administrations and report to the Organization on its findings. 

3 This document contains an application for Basic Approval of Active Substances used by 

Hitachi Ballast Water Purification System (ClearBallast) in accordance with the Procedure (G9) 

and its annex provides the non-confidential information on that system. Relevant documents and 

the complete dossier have been submitted to Marine Environment Division of the Organization 

for review by the GESAMP-Ballast Water Working Group. 
MEPC 57/2/2 - 2 - 

I:\MEPC\57\2-2.doc 

4 The Hitachi Ballast Water Purification System (ClearBallast) holds excellence in 

treatment capability and is safe not only to ships and crew but also to the environment. 

Action requested of the Committee 

5 The Committee is invited to consider the proposal for approval and decide as appropriate. 

*** 
MEPC 57/2/2 

I:\MEPC\57\2-2.doc 

ANNEX 

INFORMATION FOR BASIC APPROVAL OF ACTIVE SUBSTANCES USED BY 

HITACHI BALLAST WATER PURIFICATION SYSTEM (CLEARBALLAST)

This report is structured in accordance with the headlines in the ìProcedure for approval of 

ballast water management systems that make use of Active Substances (G9)î. 

1 INTRODUCTION 

The purpose of this document is to clarify management responsibilities to the authorities 

concerned by providing data. Furthermore, the document describes Hitachi Ballast Water 

Purification System and its impact on the environment. This system uses coagulation magnetic 

separation as the major purification method in accordance with the Procedure (G9). 

1.1 Glossary 

Chemical Injector: A device to inject chemicals (triiron tetraoxide, PAC, or PASA), which is a 

part of the Hitachi Ballast Water Purification System. 

Coagulator: A device to transform chemicals into flocs containing SS, plankton, bacteria, and 

so on, which is a part of the Hitachi Ballast Water Purification System. 

Filter Separator: A device which removes flocs from the ballast water using a rotating filter 

drum, as a part of the Hitachi Ballast Water Purification System. 

Floc: Gelatinous matter made up of fine particles such as a suspension colloid in water 

(suspended solids) formed by an inorganic coagulant or high-polymer coagulant. 

Inorganic Coagulant: A chemical containing metallic ions of aluminium or iron that forms a 

larger floc of fine particles dispersed in water such as a suspension colloid by neutralizing the 

charge on their surfaces. 

Magnetic Disk: A component of the magnetic separator of this system. A disk in which 

magnets (permanent magnets) are embedded. 

Magnetic Disk Array: A component of the magnetic separator of this system. An assembly 

consisting of several magnetic disks arranged coaxially. 

Magnetic Separator: A device which removes flocs from the ballast water using a magnetic 

disk array, as a part of the Hitachi Ballast Water Purification System. 

PAC (Poly Aluminium Chloride): An inorganic coagulant consisting of poly aluminium 

chloride and referring to basic aluminium chloride. 

PASA (Poly Acrylamide Sodium Acrylate): A crosslinking chemical consisting of high 

molecular weight polymer particles with a negatively charged surface, which forms a coagulation 

of fine particles suspended in water such as a suspension colloid. It is a kind of Anionic 

High-Polymer Coagulant. 
MEPC 57/2/2 

ANNEX 

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Rotating Filter Drum: A component of the filter separator of this system. A drum with metallic 

or plastic filters attached on the cylindrical frame and that is continuously rotating. 

Sludge Tank: Tank for storing the removed flocs containing chemicals, SS, plankton, bacteria, 

and so on, which is a part of the Hitachi Ballast Water Purification System. 

SS (Suspended Solids): Particulate substances in water that are insoluble to water such as a 

suspension colloid. One of the indices that expresses the extent of suspension in water. 

SS Concentration: Weight of suspended solids contained in 1 L of water in the unit of mg/L. 

1.2 Features of Hitachi Ballast Water Purification System 

The Hitachi Ballast Water Purification System purifies water by removing target organisms and 

other objects using flocculating agents. The system effectively promotes collision between these 

small target organisms and aggregates to form flocs, and separates the floc by magnetic 

separation technology to purify ballast water. The photograph shown in Figure 1-1 is of a 

pilot-scale test set-up of this system. Even when the seawater intake is turbid with SS, this system 

efficiently removes such suspension components as well as bacteria and plankton so that 

transparent, clear treated ballast water is obtained. 

Figure 1-1: Example of Hitachi Ballast Water Purification System 

2 OUTLINE OF HITACHI BALLAST WATER PURIFICATION SYSTEM

2.1 Principle of purification of the system 

This system employs a coagulation magnetic separation method, in which organisms and other 

target objects are coagulated using coagulants and separated by magnetic separation technology. 

Specifically, coagulants and triiron tetraoxide are added to the seawater to form small 

agglomerates of about 1 mm in diameter called flocs, containing plankton, bacteria and sand 

(Figure 2-1). 
MEPC 57/2/2 

ANNEX 

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Figure 2-2 shows the ballast water purification process in this system. First, triiron tetraoxide is 

added to seawater containing plankton, bacteria, and SS. Next, PAC and PASA are added to form 

flocs. These flocs are then separated from the seawater using permanent magnets. Finally, any 

flocs that were not removed by the magnetic separation are removed by filtering to produce 

purified water. 

This coagulation magnetic separation method removes not only plankton and bacteria but also 

sand, mud, and SS contained in the ballast water, thereby reducing mud deposits 

(including muddy sediment such as dead organisms) and alleviating mud removal during ship 

inspections. With this system, the ballast water can be purified either during storage in the ballast 

tank, during intake, or during discharge. Purification during intake is the most effective way to 

ensure that a minimal amount of organisms and SS enter the ballast tanks and thus reduces 

sediment build-up in the tanks. Therefore, most of our attention is focused on the system 

components and operations for purification during intake. 

PAC and PASA are widely used in drinking water purification plants so the safety of these 

chemicals has been confirmed. Triiron tetraoxide, whose composition is Fe3O4, is a natural 

resource that exists broadly in nature, as is generally known. Table 2-1 shows the rated 

concentration of each chemical used in the coagulation magnetic separation method. 

PAC

and

PASA

Triiron tetraoxide Plankton

Bacteria

Figure 2-1: Schematic structure of a floc 

Table 2-1: Rated concentration of each chemical 

Additive agent Additive concentration 

(mg/L) 

Triiron tetraoxide 30 

PAC 5 (as Al) 

PASA 1 
MEPC 57/2/2 

ANNEX 

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Figure 2-2: Outline of process of Hitachi Ballast Water Purification System 

2.2 Specifications of the system 

This section describes the specifications of the major components of the Hitachi Ballast Water 

Purification System described in the preceding section. Figure 2-3 is a schematic diagram of the 

structure of the Hitachi Ballast Water Purification System. 

Since the Hitachi Ballast Water Purification System is automated, no manual operation by the 

crew is required and no dedicated operators for the purification system are necessary. Some 

manual operation is required for the pouring chemicals into the storage tank, preparing for 

unloading the sludge, and unloading the sludge onto land. 

Coagulator Coagulator

Separation of floc containing Separation of floc containing triiron

tetraoxide tetraoxide

Formation and growth Formation and growth

of floc containing of floc containing triiron

tetraoxide tetraoxide

Mixing chemicals, Mixing chemicals,

formation of formation of 

micro floc micro floc

Filter 

separator separator

Retention time Retention time

- 0.5 min 0.5 min

Flash mixer Flash mixer

Separating time Separating time

< 10 sec < 10 sec

Magnetic Magnetic 

separator separator

Retention time Retention time

- 2 min

Flocculation reactor Flocculation reactor

Coagulator Coagulator

Separation of floc containing Separation of floc containing triiron

tetraoxide tetraoxide

Formation and growth Formation and growth

of floc containing of floc containing triiron

tetraoxide tetraoxide

Mixing chemicals, Mixing chemicals,

formation of formation of 

micro floc micro floc

Filter 

separator separator

Retention time Retention time

- 0.5 min 0.5 min

Flash mixer Flash mixer

Separating time Separating time

< 10 sec < 10 sec

Magnetic Magnetic 

separator separator

Retention time Retention time

- 2 min

Flocculation reactor Flocculation reactor

Ballast Ballast

tank

Triiron tetraoxide

PAC

Seawater Seawater

PASA Magnetic disk array

Injection Injection

Injection Injection

Rotating 

filter 

drum

Filter washing spray

Figure 2-3: Schematic diagram of structure of Hitachi Ballast Water Purification 

System 

Seawater Ballast

pump

Magnetic

separator

PASA

Chemical injectors

Filter separator Ballast tank

P

Filter washing water

Residue from filter

P Filter residue tank

Sludge

Sludge tank

Flash

mixer

Flocculation

reactor

Triiron

tetraoxide

&

PAC

Chemical injector

Coagulator
MEPC 57/2/2 

ANNEX 

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2.2.1 Preparation for operation 

Since some manual operation is required for the preparation of the purification operation, this 

section outlines the manual operation for the preparation. 

Seawater

PAC injector

Flash mixer

Storage tank

P

P

M Fresh water

Triiron tetraoxide injector

Storage tank

with auto-feeder Slurry mixer

M:Mixer motor

P:Pump

Injection pump

Injection pump

Flash mixer Flocculation reactor

PASA solution injector

P Solution mixer

Fresh water

M

Storage tank

with auto-feeder

Injection pump

M:Mixer motor

P:Pump

Figure 2-4: Schematic diagrams of chemical injectors 

2.2.2 Chemical injector 

Each chemical injector has a liquid or powder chemical storage tank, a slurry mixer or solution 

mixer, and a liquid chemical injection pump. 

Triiron tetraoxide and PASA are available on the market in powder form while PAC is available 

in liquid form. The two powder chemicals are converted into slurry or solution before injection 

by mixing them with fresh water on the ship. The three chemicals in liquid form are injected into 

the ballast water feed pipes through the injection pumps (Figures 2-2 and 2-3). 

2.2.3 Coagulator 

The coagulator consists of two types of mechanical reactors: a flash mixer and a flocculation 

reactor (see Figure 2-3). The triiron tetraoxide and PAC injected from the chemical injectors are 

uniformly mixed in the flash mixer at high speed. In the process of sending the micro flocs from 

the flash mixer to the flocculation reactor, PASA is added. Agitation is milder in the flocculation 

reactor than in the flash mixer. 
MEPC 57/2/2 

ANNEX 

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In this way, flocs containing triiron tetraoxide and aggregated particles (SS, bacteria, plankton, etc.) 

are formed in the untreated ballast water. Since the floc contains triiron tetraoxide, it is 

magnetically attractive at the next process, magnetic separator. Table 2-2 shows flocculation 

time. 

Table 2-2: Required time for formation of flocs by coagulator 

Item Required time 

Flash mixer 0.5 minutes (for micro floc formation) 

Flocculation reactor 2 minutes (for floc formation) 

(The required time shown in Table 2-2 corresponds to the amount of treatment at 

the rated operation of the ballast pump.) 

2.2.4 Magnetic separator

The magnetic separator consists of a casing that receives the seawater containing flocs 

transferred from the coagulator and a magnetic disk array that removes the flocs magnetically. 

The magnetic disk array consists of multiple magnetic disks in which permanent magnets are 

embedded (see Figure 2-5). While the ballast water is transferred from the coagulator, it flows 

through the magnetic disks, and the flocs are attracted to the magnetic disks. The flocs attached 

to the disks are scraped off with scrapers in the open air and collected as sludge. 

The coagulation magnetic separation method can remove flocs containing triiron tetraoxide 

within several seconds. Residual flocs are removed by filter separator described in the following 

section. 

Treated water Treated water

Magnetic disk array

Sludge

Rotating filter drum

Casing of magnetic separator Casing of filter separator

Coagulator

Magnetic separator Filter separator

Filter washing spray

Figure 2-5: Schematic diagram of magnetic separator and filter separator 

2.2.5 Filter separator

The filter separator consists of a continuously rotating filter drum, a casing, and filter washing 

sprays. The residue collected by filter washing is returned to the ballast water feed pipe before 

the first chemical injection points (see Figure 2-2) and is purified along with the untreated ballast 

water. 
MEPC 57/2/2 

ANNEX 

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2.2.6 Sludge tank 

The method being studied at present, after the temporary storage of flocs as sludge, is to handle 

the sludge on board and then unload it onto land. Since the situation differs from ship to ship, it 

may be necessary to take individual measures. 

The flocs collected in the magnetic separator are automatically transferred to the sludge tank by 

conveyors without any manual handling. The stored sludge is taken out of the ship for unloading 

after sufficient preparation such as transferring to individual containers or removing water, etc. In 

the unloading process, some steps such as transport of the individual containers require manual 

handling. There is no human exposure in the rest of the steps since they are automated. 

2.3 Purification performance of the system 

2.3.1 Quality of water treated by this system 

The quality of the water treated (at a flow rate of 50 m3/h) by the pilot-scale set-up on reclaimed 

land in Tokyo Bay was measured by the amount of zooplankton, phytoplankton, and E. coli it 

contained. The results meet the standards set in regulation D-2 for the discharge of ballast water 

(see Table 2-3). 

Table 2-3: Results of organism removal performance 

Item Unit Untreated 

seawater*

Treated 

seawater Criteria 

Plankton 50μm or larger Viable organisms / m3 67,600 0 <10 

10 - 50μm Viable organisms / ml 92.1 0 <10 

E. coli MPN/100 mL 1,100 2 <250 

Average data in the period from October 2006 to February 2007. 

* Seawater taken from Tokyo Bay. 

The quality of the water treated by this system was also measured by its SS concentration, using 

the same set-up as the organism removal performance test mentioned above. The results show 

that the SS concentration in the treated water of the load test was the same as that of the control 

test (see Table 2-4). 

Table 2-4: Results of SS removal performance 

SS concentration (mg/L) Sample Untreated seawater Treated seawater 

Control 1) 10 < 1 

Load test 2) 50 < 1 

Detection limit: 1mg/L 

1) Actual seawater taken from Tokyo Bay on October 26, 2006. 

2) Kaolin was added to the actual seawater before the treatment. 
MEPC 57/2/2 

ANNEX 

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The following sections explain that the treated water by this system has no environmental and 

ecological risks. 

2.3.2 pH of treated water 

The treatment of seawater by the Hitachi Ballast Water Purification System slightly reduces the 

pH value of the treated water. This pH reduction is caused by reaction of PAC in water. PAC is a 

polybasic polyelectrolyte, and aluminium ions exist as an aqua-complex, [Al(OH2)6]

3+, in which 

six H2O molecules are co-ordinated around the aluminium atom in octahedral configuration. 

The general formula of PAC is expressed by [Al2(OH)nCl6-n]m (n: 1 to 5, m: 1 to 10). PAC reacts 

with calcium carbonate in the untreated water to lower the alkalinity. Therefore, the pH value of 

the water treated by the system will be reduced. 

In this calculation, bicarbonic acid at 140 mg/L, determined from the standard seawater 

composition, is used as the alkalinity of seawater. A pH value of 8.3, which is the intermediate 

pH value of the untreated seawater sampled from the purification experiment carried out in 

Tokyo Bay, is used as the pH of the untreated seawater. In theory, the pH is the lowest when m=1 

and n=1, and it does not become much lower than 7.0. The pH value is 7.2 (for m = n = 1) under 

the condition of 5mg/L used for rated operation. The same results are obtained for m=2 to 10. 

Therefore, it is theoretically impossible for the pH value to become much lower than 7.0.

2.4 Application capacity

The volume of the major components of this system, particularly the volume of the coagulator, 

increases in proportion to the flow rate. This is because the retention time of the ballast water in 

the equipment, which is the treating time, is constant regardless of the flow rate. The treatment 

time of the coagulator and the magnetic separator can be kept constant regardless of the flow 

rate, and the tank volume inside these two devices is proportional to the flow rate of ballast 

water. On the other hand, the process scale of the filter separator is related to filter flux 

(filtration speed) and the flux can be kept constant. The area is proportional to the flow rate of the 

ballast water. 

The equipment can be scaled up or multiple sets of equipment can be installed in accordance with 

the amount of ballast water to be treated. As a result, the commercial process scale would be 

designed at the ranges from 50 to 10,000 m3

/h. 

2.5 Specifications for chemicals 

The following chemicals are used in the Hitachi Ballast Water Purification System. 

2.5.1 Triiron tetraoxide 

.1 Identification of the chemical 

Name of substance (IUPAC): triiron tetraoxide 

Molecular formula or structural formula: Fe3O4

.2 Quality standard for safety of human health 

High purity grade is used. 
MEPC 57/2/2 

ANNEX 

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2.5.2 PAC 

.1 Identification of the chemical 

Name of substance (IUPAC): Basic aluminium chloride 

Molecular formula or structural formula: [Al2(OH)nCl6-n]m (n: 1 to 5, m: 1 to 10) 

.2 Quality standard for safety of human health 

The following requirements relating to impurities specified by ANSI/AWWA 

B408-03 Liquid Polyaluminium Chloride (AWWA, 2004) of the American Water 

Works Association (AWWA) Standard shall be satisfied. The specifications of 

ìJapan Industrial Standard JIS K 1475 for poly aluminium chlorideî (JIS, 1996) 

and ìEuropean Standard EN 883:2004 Chemicals used for treatment of water 

intended for human consumption-Polyaluminium chloride hydroxide and 

polyaluminium chloride hydroxide sulfateî (CEN, 2004) are stricter than that of 

ANSI/AWWA B408-03 Liquid Polyaluminium Chloride. Poly aluminium 

chloride conforming to JIS or EN may be used. 

2.5.3 PASA 

.1 Identification of the chemical 

Name of substance (IUPAC): Acrylamide sodium acrylate copolymer 

Molecular formula or structural formula: 

CH2 CH n CH2 CH m

CONH2 COONa

.2 Quality standard for safety of human health 

The following requirements relating to impurities specified by ANSI/AWWA B453-06 

Polyacrylamide (AWWA, 2006) of the (AWWA, American Water Works 

Association) Standard shall be satisfied. ìJapan Water Works Association 

(JWWA, 1980) standard K 126-1980 for polyacrylamide used for water worksî 

and ìThe European Standard EN 1407:1998 Chemicals used for treatment of 

water intended for human consumption-Anionic and non-ionic polyacrylamidesî 

(CEN, 1998) are similar quality standards. PASA conforming to JWWA or 

EN standard may be used. 

3 HANDLING CHEMICALS ON BOARD SHIP 

This section explains the procedure of loading chemicals onto ship, using chemicals for ballast 

water treatment and unloading sludge from ship to land. 
MEPC 57/2/2 

ANNEX 

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3.1 Carrying-in procedure and mechanism to prevent leakage of chemicals from piping 

3.1.1 Triiron tetraoxide and PASA 

Triiron tetraoxide and PASA powder are loaded onto the designated position on board packed in 

a flexible container. The outlet of the container is connected to the inlet in the carry-in room and 

the triiron tetraoxide and PASA are poured to the onboard each dedicated tank respectively. 

To prevent scattering of the powder, the storage tank and piping equipped with safety valves are 

tightly sealed. An exhaust duct positioned close to the storage tank provides forced ventilation, 

preventing any spilled dust from scattering. 

3.1.2 PAC 

PAC liquid is loaded onto a designated position on board packed in an acid-resistant plastic 

container. The container outlet is connected to the inlet in the carry-in room using an acid-resistant 

hose, and the safety valve is opened to pour the PAC to the on-board PAC storage tank. 

The storage tank is made of plastics or is lined with plastics on the inner surface to prevent 

corrosion of the tank due to contact with the acidic chemical. The feeding pipes connecting the 

PAC storage tank to the ballast water feed pipe are also made of acid-resistant materials, such as 

plastic. If PAC leakage occurs, coamings with a height of about 10 cm around the PAC storage 

tank prevent the spread of the chemicals over the floor, enabling the crew to safely and smoothly 

stop the leakage. In case the system is designed to use PAC in powder form, the storage tank and 

hose connecting the PAC container to the inlet are made of plastics. To prevent the scattering of 

powder, the storage tank and piping equipped with safety valves are tightly sealed. An exhaust 

duct providing forced ventilation is provided close to the storage tank to prevent any dust from 

scattering if the powder spills. 

3.2 Use of chemicals on ship and operation protocol 

The chemicals used in the system are continuously injected from the piping of ballast water 

treatment equipment using three dedicated pumps. They are automatically controlled as part of 

the automated operation of ballast water treatment. Since these chemicals are manually poured 

into the storage tanks by operators or crew, the operators wear goggles, masks, rubber gloves, 

and work clothes in anticipation of accidental chemical dispersion to prevent inhalation and 

adhesion of the dust to the skin. A notice regarding the use of appropriate protective gear is to be 

placed on the injector. 

The flocs collected in the magnetic separator are automatically transferred to the sludge tank by 

the conveyor without any manual handlings. The part related to the sludge is basically covered so 

that the sludge does not scatter. The stored sludge is unloaded from the ship after sufficient 

preparations such as subdividing into individual containers or removing water with drum dryers, 

etc. In the unloading process, some steps partially require manual handling. Since the sludge 

contains chemicals, the operators should wear goggles, rubber gloves, mask, and protective 

clothes. Warnings should be displayed on the devices to emphasize the need to use such safety 

gear. 
MEPC 57/2/2 

ANNEX 

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4 ANALYSIS OF TREATED WATER 

The treated water was tested to determine whether substances derived from the chemicals 

(triiron tetraoxide, PAC, and PASA) used in the purification system were present and also to 

determine if harmful heavy metal were present (CERI, 2007a). All tests were carried out using a 

pilot-scale ballast water purification system (with a flow rate of 50 m3/h) on reclaimed land in 

Tokyo Bay. Actual seawater from Tokyo Bay was treated, and samples of untreated water and 

treated water were analysed. 

4.1 Identification and determination of substances contained in raw and treated water 

4.1.1 Test method 

(1) Samples 

The seawater was treated (marked ì(1)î in this section) at the pilot-scale system mentioned above 

(flow rate of 50 m3/h) that is installed on reclaimed land in Tokyo Bay. The pilot-scale system 

simulates the ballast water purification system. Untreated seawater (marked ì(2)î in this section) 

was pumped in at the location where the test equipment was installed. 

(2) Amounts of additive chemicals 

In this test, the chemicals were added at the rated concentrations (see Table 4-1). 

Table 4-1: Amounts of additive chemicals (rated concentration) 

Additive chemical Addition concentration (mg/L) 

Triiron tetraoxide 30 

PAC 5 (as Al) 

PASA 1 

(3) Water sampling 

Samples of untreated water and treated water were taken from the respective sampling positions 

(see Figure 4-1). 

Figure 4-1: Schematic diagram of water sampling positions 

Tokyo Bay Intake pump Treatment equipment Treated water tank Tokyo Bay

[Sampling the untreated water]

[Sampling treated water]

Taken from the outlet of the rotary filter separator,

which is the final stage of the system.
MEPC 57/2/2 

ANNEX 

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(4) Test item and method 

Elemental analysis was done using inductively coupled plasma atomic emission spectrometry 

(ICP-AES)*. 

Volatile organic compounds: Purge and trap gas chromatograph-mass spectrometry 

pH: JIS K 0102 12.1 Glass-electrode method 

Arsenic: JIS K 0102 61.2 Atomic absorption spectrometry by hydride 

Aluminum: JIS K 0102 58.4 Inductively coupled plasma atomic emission spectrometry 

Manganese: JIS K 0102 56.4 Inductively coupled plasma atomic emission spectrometry 

Acrylamide: Gas chromatograph spectrometry 

Acrylic acid: Gas chromatograph mass spectrometry after solid-phase extraction and 

derivatization 

Total organic carbon: JIS K 0102 22.2 Combustion oxidation-infrared type TOC automatic 

analysis method 

*

 The ICP methods used in JIS K 0102 correspond approximately to ISO 11885:2007; 

Water quality -- Determination of selected elements by inductively coupled plasma optical 

emission spectrometry (ICP-OES). 

Only the aluminium was measured for the samples taken both before and after the filtering with a 

glass and a membrane filter (see Table 4-2 and 4-3). All the other items were analysed for the 

samples taken before the filtering. 

4.1.2 Test results 

(1) Quantitative analysis of harmful heavy metals and water treatment agents 

(acrylamide, acrylic acid, aluminum) 

Table 4-2: Results of quantitative analysis of harmful metals and water treatment agents 

Unit: mg/L 

Sample

Test item 

(1) 

Treated water

(2) 

Untreated water 

detection 

limit 

PH 7.7(23.5oC) 7.9(23.5oC) - 

Arsenic (As) Not detected. 0.001 0.001 

Aluminium (Al) 0.08 Not detected. 0.02 

Manganese (Mn) 0.01 Not detected. 0.01 

Acrylamide monomer Not detected. Not detected. 0.0001

Acrylic acid monomer Not detected. Not detected. 0.0001

Organic carbon (TOC) 1.3 1.3 0.5 

*

 Cadmium(Cd), Lead(Pb), Mercury(Hg), Chromium(VI), and Selenium(Se) were not deteced 

in both of treated water and untreated water. 
MEPC 57/2/2 

ANNEX 

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Table 4-3: Comparison of aluminium content before and after filtration 

Unit: mg/L 

Sample 

Filter treatment 

(1) 

Treated water 

(2) 

Untreated water 

Detection 

limit 

Not filtered* 0.02 ND 0.02 

Glass filter (1 μm)** ND ND 0.02 

Membrane filter (0.45μm) ** ND ND 0.02 

*

 In order to detect total aluminium in the sample (suspended aluminium in solid form and 

dissolved aluminium in ion form) ** In order to detect aluminium ions in the sample 

(2) Qualitative and quantitative analyses of volatile organic compounds (VOCs) 

Quantitative and qualitative analysis was conducted for the VOC compounds. Although scanning 

analysis was also conducted, no differences were detected between treated water and untreated 

water. 

(3) Qualitative analysis of semivolatile organic compounds 

Each sample was extracted with dichloromethane and analysed by scanning measurement on a 

gas chromatograph-mass spectrometer. No substance was detected (detection limit: 0.002 mg/L 

as hexane equivalent). 

(4) Elemental analysis by ICP-AES 

A qualitative analysis was conducted on the treated water to find out whether the elements shown 

in Table 4-4. Since there was hardly any difference between the results of the treated water and 

the untreated water, the treated water does not seem to contain any new elements due to the 

processing of the Hitachi Ballast Water Purification System. 

Table 4-4: Results of elemental analysis by ICP-AES 

Unit: mg/L 

No. Measured element (1) 

Treated water 

(2) 

Untreated water 

Detection 

limit 

1 Sodium (Na) 1,600 2,000 10 

2 Magnesium (Mg) 760 750 0.01 

3 Silicone (Si) 2 2 1 

4 Sulphur (S) 1,300 1,300 10 

5 Potassium (K) 330 330 5 

6 Calcium (Ca) 78 79 0.1 

7 Manganese (Mn) 0.1 Not detected. 0.1 

8 Iron (Fe) Not detected. Not detected. 1 

9 Strontium (Sr) 22 22 0.1 

Remarks: Values are semiquantative (reference values). 
MEPC 57/2/2 

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4.1.3 Amounts of substances derived from additive chemicals in treated water 

Since the Hitachi Ballast Water Purification system uses triiron tetraoxide, PAC, and PASA as 

the chemicals, any iron, aluminium, or acrylamide detected in the treated water could possibly be 

derived from the additive chemicals. 

As shown in Tables 4-2 and 4-3, iron and acrylamide were not detected in either the treated water 

or the untreated water. Aluminium was not detected in the untreated water but 0.08 mg/L was 

detected in the treated water (see Table 4-2). Since 5 mg/L (as Al) of PAC is added, the 

maximum ratio (%) of PAC contained in the treated water can be approximately to be 1.6% of 

the PAC added. 

4.2 Measurement of pH 

4.2.1 Test method 

(1) Samples 

The samples for this test were prepared by purifying seawater using the same equipment as used 

for the identification and determination tests (see Section 4.1.1 (1)). 

(2) Amounts of additive chemicals 

The amounts of chemicals used in this test were double those used under rated operating 

conditions (see Table 4-5). 

Table 4-5: Amounts of additive chemicals 

Additive chemical Additive concentration (mg/L) 

Triiron tetraoxide 60 

PAC 10 (as Al) 

PASA 2 

(3) Method 

The pH measurement was started after the system was launched to make sure all the devices were 

filled with water. Sampling of the treated water and untreated water was 

conducted 16 to 32 minutes after the start-up of treatment in the same way as described in 

Section 4.1.1 (3). 

4.2.2 Results 

The measurement was carried out within 10 minutes of sampling. As described in Section 2.3, 

the pH of the treated water was between 6.9 and 7.4 while the pH of the untreated water was 

between 8.0 and 8.6. Since the equilibrium is assumed to continue after treatment, the pH of the 

treated ballast water should not decrease until it is released (in about two weeks). 
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5 DATA SET 

In this section, the identification of substances used in the Hitachi Ballast Water Purification 

System and the data-set required for section 4.2 of Procedure (G9) are reported. 

As for the data of each substance, international peer reviewed documents, databases, original 

study reports, etc. were searched comprehensively and broadly, and all the available data were 

checked to evaluate their reliability. Only the data judged to be reliable have been adopted for 

this application. 

5.1 Identification of substances or preparation (G9: 4.1)

5.1.1 Preparation (G9: 4.2.2) 

No substance corresponding to the preparation defined by paragraph 2.1.3 of Procedure (G9) is 

included in this system. 

5.1.2 Active Substances 

Triiron tetraoxide, PAC, and PASA correspond to Active Substances (see Table 5-1). In this 

purification system, since almost all the additive agents collected in the flocs are removed 

(see 2.3.1), the amount of Active Substances released into the environment together with the 

treated ballast water is negligible. 

Table 5-1: Active Substances 

Active 

Substance 1 Active Substance 2 Active Substance 3 

Name of 

substance 

(IUPAC) 

Triiron 

tetraoxide 

Basic aluminum chloride Acrylamide sodium acrylate 

coplymer 

Synonym (used 

in this 

document) 

Triiron 

tetraoxide 

PAC PASA 

CAS number 1317-61-9 1327-41-9 25085-02-3 

UN number None None None 

Shipping name None None None 

Molar weight 231.53 Not applicable More than several million 

Empirical 

formula or 

structural 

formula 

Fe3O4 Aln(OH)mCl(3n-m)

0<m<3n 

CH2 CH n CH2 CH m

CONH2 COONa

Purity 100% Percent of content: 10-11% 

of water solution 

(aluminium oxide equivalent) 

90% or more 

Impurity None None Acrylamide monomer: 0.05% 

or less (CAS No. 79-06-1) 

Stabilizers or 

additives 

None None None 
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5.1.3 Relevant Chemicals (G9: 2.1.4) 

Since triiron tetraoxide, PAC, and PASA do not have active functional groups, no by-products 

are generated as a result of a reaction with seawater. Consequently, no substance corresponding 

to a Relevant Chemical exists in this system. 

5.1.4 Other substances 

A substance that corresponds to other substances is acrylamide monomers that remain in PASA 

as an impurity. Although its mass concentration is only 0.05% or less of PASA, a data survey 

was performed. 

5.1.5 Configuration of PAC in water 

Since PAC, which is the Active Substance in this system, can be transformed into water, its 

details are explained below. 

PAC, which is used as an inorganic flocculating agent, is a polybasic polyelectrolyte. In water the 

aluminium ions take the form of the aqua-complex, [Al (H2O)6]

3+, in which six H2O molecules 

are co-ordinated around the aluminium atom in octahedral formation. The general formula of 

PAC is expressed as [Al2(OH)nCl6-n]m (n: 1 to 5, m: 1 to 10). The more detail is described 

in 2.3.2. The composition of this hydroxide is not well-defined, being a gel-like precipitate 

formed by the linkage of Al3+ with OH- and being co-ordinated with many water molecules. 

5.2 Data on effects on aquatic plants, invertebrates and fish, and other biota, including 

sensitive representative organisms (G9: 4.2.1.1) 

Since PAC is dissociated into chloride ions and aluminium ions in an aqueous solution, and the 

aluminium ions exist as an aqua complex, as described before (5.1.5), its form in the water 

depends on pH values. Furthermore, since chloride ions exist in seawater in large amounts, the 

assessment of the ecotoxicity of PAC can be conducted based on the toxicity of aluminium. 

In addition, collecting the data on the toxicity of aluminium ions is limited to the pH range 

of 6.5 to 7.5, which is actually applied in the coagulation sedimentation process of the Hitachi 

Ballast Water Purification System (see 2.3.2). 

5.2.1 Acute aquatic toxicity 

Triion tetraoxide 

For triiron tetra oxide, there is a report on the use of fresh water fish, Japanese dace 

(Leuciscus idus), and the value of 48-h LC0 is > 1,000 mg/L (EU, 2000a). There are no 

corresponding data available for algae and invertebrates. Considering that naturally-occurring 

triiron tetraoxide is abundant in the environment and is not absorbed or accumulated in the body 

due to consisting of water insoluble particles, the toxicity of triiron tetraoxide for algae and 

invertebrates is considered to be very low. 
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PAC 

(1) Toxicity data on PAC is obtained from reports on algae, shellfish and fish. There is a 

report on the acute toxicity of PAC in algae using seaweed, and the 48-h LC50 values 

are 1,500 mg/L and > 10,000 mg/L (growth inhibition as the index), when the pH is not 

adjusted and adjusted to neutral, respectively (Asada Chemical Industry, 2003). 

Regarding the acute toxicity of PAC in shellfish, there is a report on the study of Manila 

clams in which the 48-h LC50 values are 6,800 mg/L and > 10,000 mg/L, when the pH is 

not adjusted and adjusted to neutral, respectively (Asada Chemical Industry, 2003). 

As for the acute toxicity of PAC in fish, there is a report on the study of Oryzias latipes in 

which the 48-h LC50 values are 840 mg/L and > 10,000 mg/L, when the pH is not 

adjusted and adjusted to neutral, respectively (Asada Chemical Industry, 2003). 

(2) Looking at the acute toxicity of PAC, data on water soluble aluminium salts such as 

aluminium chloride can be examined to evaluate the toxicity of PAC in aquatic organisms 

because the salts are dissociated in water and form the same aqua complex as PAC. 

For aluminium ions, toxicity data are reported in invertebrates and fish. 

For the acute toxicity of aluminium ions in invertebrates, the minimum 96-h LC50 value 

is 0.097 mg Al/L for Ctenodrilus serratus, a sand worm marine species 

(IPCS, 1997; Petrich & Reish, 1979). Regarding the acute toxicity of aluminium ions in 

fish, the minimum value of 96-h LC50 in the pH range from 6.5 to 7.5, which is actually 

applied in the ballast water treatment, is 4.25 mg Al/L (pH: 7.4) for Pimephales promelas

(IPCS, 1997). 

PASA 

Acute toxicity data on PASA are reported on invertebrates and fish. There is a report on the acute 

toxicity of PASA in invertebrates in which the fresh water species, Ceriodaphnia dubia is used, 

and the 48-h LC50 value is 218 mg/L (De Rosemond & Liber, 2004). 

Looking at the acute toxicity of PASA, there is a report on the study of the marine species 

Girella punctata, and the 48-h LC50 value is 840 mg/L (Tabata and Ishibashi, 1984). For fresh 

water species, there is a report on the study of Oryzias latipes, Carassius auratus, Cyprinus 

carpio, and Salvelinus namaycush, in which the LC50 values are between 180 and >600 mg/L 

(Dia-Nitrix, 2004; Liver et al., 2005; Tabata and Ishibashi, 1984). Since the data provided by 

Tabata and Ishibashi in 1984 are reliable because the testing methods and conditions are 

described in detail, the original report in Japanese has been translated into English and is listed in 

the References. 

No data on the toxicity in algae are reported. As PASA consists of particles containing high 

molecular weight polymers (several millions or more), it is not absorbed and accumulated in the 

body. The toxicity of PASA in algae is considered to be low, not including any physical harmful 

effect. 
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Acrylamide monomers 

Regarding the acute toxicity of acrylamide monomers in algae, there is a report on the fresh 

water green alga Pseudokirchneriella subcapitata, in which the 72-h EC50 (growth inhibition as 

the index) is 33.8 mg/L (EU, 2002). 

There is a report on the acute toxicity of acrylamide monomers in invertebrates in which the 

marine crustacean, Mysidopsis bahia, is used, and the 96-h LC50 is 78 mg/L (EU, 2002). For fresh 

water fish, there is a report on Daphnia magna and chironomid species, and the 48-h EC50

(swimming inhibition) is 98 mg/L for the former (EU, 2002). 

As for the acute toxicity of acrylamide monomers in fish, the minimum value of 96-LC50 

is 59 mg/L for Danio rerio (Kovriznych & Urbancikova, 2001). 

5.2.2 Chronic aquatic toxicity 

There are no chronic toxicity data available for triiron tetraoxide and PAC in aquatic organisms. 

Naturally occurring triiron tetraoxide is abundant in the environment. Although it is highly 

possible that wild organisms are exposed to this substance, no adverse effects have been 

identified. Therefore, it may be concluded that chronic toxicity of triiron tetraoxide is not 

significant. For PAC, data on water soluble aluminium salts such as aluminium chloride are 

available for the evaluation of the toxicity of PAC in aquatic organisms because the salt 

dissociate in water and form the same aqua- complexes as those formed by PAC. 

PAC 

To evaluate the toxicity of PAC in aquatic organisms, data on water soluble aluminium salts such 

as aluminium chloride can be examined because the salts are dissociated in water and form the 

same aqua complex as PAC. For aluminium ions, chronic toxicity data are reported in 

invertebrates and fish. As for the chronic toxicity of aluminium ions in invertebrates, there is a 

report on Ctenodrilus serratus, a kind of sandworm, in which the 28-day NOEC for reproduction 

is 0.02 mg Al/L (pH: 7.6 - 8.0) (Petrich & Reish, 1979). 

Looking at the chronic toxicity of aluminium ions in fish, there is a report on the fresh water 

species, Salvelinus fontinalis, in which the 60-day NOEC for growth is 0.088 mg Al/L 

(pH: 6.5 - 6.6) (IPCS, 1997). 

PASA 

Data on the chronic toxicity of PASA are reported on fish. 

Regarding the chronic toxicity of PASA in fish, there is a report in which the fresh water species, 

Salvelinus namaycush is used, and the 30-day NOEC for activity is 75 mg/L and that for survival 

and growth is 300 mg/L (Liver et al., 2005). 
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Acrylamide monomers 

Data on the chronic toxicity of acrylamide monomers were gathered because traces of 

unpolymerized acrylamide monomers remain in PASA as an impurity. For acrylamide 

monomers, toxicity data are reported in algae and invertebrates. The chronic toxicity of 

acrylamide monomers in algae is 16 mg/L for a 72-hour NOEC in a growth inhibition test using 

the fresh water green alga, Pseudokirchneriella subcapitata (EU, 2002). There is a report on the 

chronic toxicity of acrylamide monomers in the invertebrate marine species, Mysidopsis bahia, in 

which the 28-day NOEC for death is 2.04 mg/L (Springborn Bionomics, 1985). 

5.2.3 Endocrine disruption

There are no reports of triiron tetraoxide, PAC, PASA, and acrylamide monomers having an 

effect on endocrine disruption in aquatic organisms. None of these substances are listed as 

suspected endocrine disruptors (MOE, 2005). 

5.2.4 Sediment toxicity 

There are no reports of triiron tetraoxide, PAC, or PASA having sediment toxicity. Triiron 

tetraoxide and PAC are inorganic compounds. They are accumulated and presented as triiron 

tetraoxide or aqua-complex ions of aluminium in the sediment. As all these substances are 

naturally occurring elements, the probability of their having an adverse effect on the sediment 

organisms is considered to be low. 

Although PASA is accumulated in the sediment, it is not absorbed or accumulated in the 

sediment organisms because it consists of particles of high molecular weight polymers 

(several million or more). Therefore, the possibility of PASA having an adverse effect on 

sediment organisms is considered to be low. 

Data on the sediment toxicity of acrylamide monomers were gathered because traces of 

unpolymerized acrylamide monomers remain in PASA as an impurity. Since acrylamide is 

biodegraded and mineralized easily, the possibility of acrylamide monomers being accumulated in 

the sediment is low. In addition, although acrylamide monomers are water soluble (204 g/100 mL) 

(IPCS, 2000), both log KOW and soil adsorption coefficient, KOC, are low with values of -1.65 

to -0.67 and 0.195 l/kg, respectively (EU, 2002). Therefore, it is not absorbed or accumulated in the 

sediment and the possibility of adverse effects on sediment organisms is very low. 

5.2.5 Bioconcentration 

For PAC, data on water-soluble aluminium salts such as aluminium chloride may be examined to 

evaluate the bioconcentration of PAC in aquatic organisms because the salts dissociate in water 

and form the same aqua-complexes as those formed by PAC. In a test using Salvelinus fontinalis, 

the value of BCF was 36 at pH 7.2 (Cleveland et al., 1991). Although the concentration 

(0.2 mg/L) in this study was higher than the 60-day NOEC (0.088 mg Al/L) with growth as the 

index (pH 6.5 - 6.6) in the test in which Salvelinus fontinalis was used (see 5.2.2), it is reasonable 

to consider the result of that study, because it indicated no effects at a pH of 7.2. In a test that 

used the marine species, Salmo salar, the BCF values at pH 5.5 were in the range of 76 to 190 

(Buckler et al., 1995). Therefore, the bioconcentration of aluminium ions was low. 

As PASA consists of high molecular weight polymers particles (several millions or more), it 

exhibits no biomembrane permeation and the possibility of its accumulation is low. The BCF 

values in a test using Cyprinus carpio are between 0.23 and 0.41, indicating that the 

bioconcentration of PASA is low (OEC, 2003). 
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For acrylamide monomers, when Cyprinus carpio and Oryzias latipes are exposed to water at 

concentrations of 1 mg/L and 10 mg/L for 20 days, the BCF values are 0.26 and 0.77 for 

Cyprinus carpio and 0.31 and 2.53 for Oryzias latipes (EU, 2002). In an exposure test of 

Oncorhynchus mykiss in water with a concentration of 0.710 mg/L, concentration and excretion 

reached a balance after 72 hours, and the BCF values are 1.44 and 1.65 for the whole body and 

internal organs, respectively (EU, 2002). These results indicate that the bioconcentration of 

acrylamide monomers is low. 

No reports on the bioconcentration of triiron tetraoxide were found. However, because it consists 

of water insoluble particles, triiron tetraoxide is not absorbed or accumulated in living organisms 

and has no bioaccumulation. 

5.2.6 Food web/population effects 

As the bioaccumulation of the chemicals used in this system is low, the possibility of secondary 

poisoning is low and no adverse effects on algae, invertebrates or fish are observed. Therefore, it 

is assumed that none of these substances affect food webs or populations. 

5.3 Data on mammalian toxicity (G9: 4.2.1.2) 

5.3.1 Acute toxicity 

Table 5-2: 50% lethal dose of triiron tetraoxide, PAC, PASA, and acrylamide monomers 

Exposure 

path 

Animal 

species 

End 

point Value Reference 

Triiron tetraoxide 

Oral 

administration 

Rats LD50 >10,000 mg/kg bodyweight EU, 2000a 

PAC 

Oral Mice LD50 Ca. 7,000 mg/kg EU, 2000b 

administration Rats LD50 >2,000 mg/kg bodyweight EU, 2000b 

PASA 

Oral 

administration 

Rats LD50 >4,000 mg/kg bodyweight Cosmetic 

Ingredient 

Review, 2005 

Acrylamide monomers 

Mice, rats, 

rabbits, and 

guinea pigs 

Oral LD50 150 - 180 mg/kg bodyweight ACGIH, 2001a 

administration 

Mice and 

rats 

LD50 107 - 203 mg/kg bodyweight EU, 2002 

Percutaneous 

administration 

Rabbits LD50 About 1,150 mg/kg 

bodyweight 

EU, 2002 

*

 Although no data are available for the dermal route for triiron tetraoxide, PAC, or PASA, 

irritation is not caused by these substances or the extent of irritation is very low 

(see Section 5.3.2). Therefore, acute dermal toxicity is considered to be weak, and only the 

data on oral acute toxicity are described below. 
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5.3.2 Effects on skin and eyes 

Table 5-3: Skin irritation 

Substance Species Method 

Guidelines

Result Reference/ 

Comments

Triiron 

tetraoxide 

Rabbits OECDTG404 No EU, 2000a 

Rabbits OECDTG404 No EU, 2000b 

Rabbits, 

mice, and 

pigs 

Not specified No EU, 2000b 

PAC 

Humans Not specified Yes EU, 2000b 

PASA Rabbits Not specified No Cosmetic Ingredient 

Review, 2005 

Rabbits Not specified No: for uninjured skin 

Very mild erythema and 

edema: for injured skin 

ACGIH, 2001a 

Rabbits Not specified No or quite mild EU, 2002 

Acrylamide 

monomers 

Humans Occupational 

exposure 

Dermal irritation, skin 

separation 

EU, 2002 

Table 5-4: Eye irritation 

Substance Species Method 

Guidelines

Result Reference/ 

Comments

Triiron 

tetraoxide 

No data No data No data It is expected that 

triiron tetraoxide 

causes no chemical 

irritation because of its 

insolubility. 

PAC Rabbits OECDTG404 Mild EU, 2000b 

Humans Not specified Yes EU, 2000b 

PASA Rabbits Not specified Solid: Mild 

5% water solution: No 

Cosmetic Ingredient 

Review, 2005 

Rabbits Not specified 10% water solution: Mild

40% water solution: Yes 

Acrylamide ACGIH, 2001a 

monomers 

Rabbits Not specified Yes EU, 2002 
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5.3.3 Sensitization 

Table 5-5: Skin sensitization 

Substance Species Method 

Guidelines

Sensitizer 

(yes/no)

Reference/ 

Comments

Triiron 

tetraoxide 

Guinea pigs Not specified No EU, 2000a 

PAC Rabbits Not specified No EU, 2000b 

PASA No data No data No It is not expected to exhibit any 

sensitization because it is not 

absorbed in the body due to its 

high molecular weight. 

Acrylamide 

monomers 

Guinea pigs Not specified Yes EU, 2002 

Repeated dose toxicity (subacute/subchronic toxicity). 

5.3.4 Triiron tetraoxide 

There is a report on intracavernous administration in rats over three weeks and intracavernous 

administration in dogs over three weeks which shows that pigment deposition increases in cells 

of the reticuloendothelial system but no injury in tissues occurs (EU, 2000a). Triiron tetraoxide is 

expected to have no adverse effects with repeated dose toxicity (subacute/subchronic toxicity) 

because it consists of insoluble inorganic microparticles which are not absorbed in the body. 

PAC 

In an inhalation exposure test of 22 days in which PAC solutions of 0.34μg/L and 2.5μg/L were 

given to rats 4 hours a day at a frequency of 5 days a week, no toxicity or accumulation in tissues 

were observed (EU, 2000b). 

PASA 

No chronic toxicity was observed in a test in which feedstuffs containing 500 to 50,000 ppm of 

polyacrylamide were given to rats and dogs (Cosmetic Ingredient Review, 2005). PASA is 

expected to have no adverse effects with repeated dose toxicity (subacute/subchronic toxicity) 

because it consists of high molecular weight polymer particles (several million or more) which 

are not absorbed in the body. 

Acrylamide monomers 

According to several tests by peroral administration to laboratory animals, the major toxic effects 

are on the nervous system and male generative organs. In a test in which feedstuffs 

containing 3 to 400 ppm of acrylamide monomers were given to rats for 90 days, neurotoxicity 

appeared at 300 ppm or more, seminiferous epithelium degeneration appeared at 400 ppm, and 

the NOAEL was 110 ppm (corresponding to 5.5 mg/kg bodyweight/ day). In a test in 

which 0.05 to 20 mg/kg bodyweight/day of acrylamide monomers contained in drinking water 

was given to rats for 90 days, neurotoxicity symptoms appeared at 1 mg/kg bodyweight/day or 

more, severe degeneration of peripheral nerves appeared at 20 mg/kg bodyweight/day, and the 
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NOAEL was 0.2 mg/kg bodyweight/day. The value in a peroral administration test for 90 days 

using rats with the minimal change of peripheral nerves as the index was 0.2 mg/kg/day 

(ACGIH, 2001a). 

There is a report of repeated exposure of acrylamide monomers to humans causing adverse 

effects on the central nerve system, such as loss of muscle strength, disturbance of muscle 

co-ordination, gait abnormality, tremor, and hallucination (ACGIH, 2001a). 

5.3.5 Chronic toxicity 

Triiron tetraoxide 

No data on chronic toxicity for laboratory animals are available. Chronic toxicity is not caused in 

humans because humans are only exposed to triiron tetraoxide if an accident occurs when the 

chemical is being brought in, and the duration of exposure is limited to a short period. 

PAC 

In several reports on inhalation exposure using laboratory animals, the accumulation of 

aluminium in the lungs, lymph nodes around the lung alveoli, and adrenal glands, and lung 

disorders are reported. In tests in which rats and guinea pigs were exposed to three levels of PAC 

content, 0.25, 2.5, and 25 mg/m3

 for 6 hours a day at a frequency of five days a week for 

six months, the value of the NOAEL could not be obtained, the LOAEL was 0.25 mg/m3

(EU, 2000b), lung injury occurred at a PAC concentration of 0.25 mg/m3 or more, and an 

increase in weight was suppressed at a concentration of 25 mg/m3. 

PAC is widely used in the municipal purification of water, and no adverse effects to human 

health have been identified. Therefore, the possibility of influence in humans is low. 

PASA 

Several tests have been conducted in which feedstuffs containing 500 to 100,000 ppm of 

polyacrylamide were given to rats for two years. No toxic effects or pathological changes related 

to the administration were observed in any of the tests (Cosmetic Ingredient Review, 2005). 

Regarding chronic toxicity in humans, no adverse effects have been observed on workers 

exposed to dust containing polyacrylamide (1 mg/m3

) over five years or more in polyacrylamide 

manufacturing plants (Cosmetic Ingredient Review, 2005). 

Acrylamide monomers 

There are several reports of tests on laboratory animals by peroral administration, and the major 

toxic effect is on the neural system. ACGIH has set the time-weighted average threshold limit 

value (TLV - TWA) of acrylamide monomers to 0.03 mg/m3 (ACGIH, 2001a). 
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5.3.6 Reproductive/developmental toxicity 

Triiron tetraoxide 

There are no data available on the reproductive and developmental toxicity of triiron tetraoxide. 

Triiron tetraoxide is not expected to have any adverse effects on reproduction and development 

because it consists of insoluble inorganic microparticles which are not absorbed in the body. 

PAC 

There is a report of a decrease in the number of implantations and fetal deaths observed in a 

test in which PAC was given by peroral administration to rats during day 7 to day 19 of 

pregnancy, in which the TDLo was 13,000 mg/kg/day, but further details are unknown 

(EU, 2000b; U.S. NIOSH, 2007). 

PASA 

No effects on reproduction were observed in a three-generation test in which 

feedstuffs containing two levels of polyacrylamide, 500 and 2,000 ppm, were given to rats 

(Cosmetic Ingredient Review, 2005). 

Acrylamide monomers 

There are several reports of reproductive toxicity in peroral administration to laboratory animals, 

and it has been shown that male genital toxicity and male sterility are caused. The value of the 

NOAEL with the effect on fertility potential was 5 mg/kg/day as for rats, and was 9 mg/kg/day as 

for mice (EU, 2002). 

For developmental toxicity, there is a report of acrylamide monomers being given to pregnant 

female animals by peroral administration. Neither fetal toxicity nor teratogenicity is observed 

with a dose that does not cause mother animal toxicity (EU, 2002). 

5.3.7 Mutagenecity/genotoxicity

Triiron tetraoxide 

In an in vitro reverse mutation test using Salmonella typhimurium (Ames test), the results were 

negative regardless of the existence of metabolic activation (EU, 2000a). 

There are no in vivo reports available. Triiron tetraoxide is not expected to exhibit mutagenecity 

(genotoxicity) because it consists of insoluble inorganic microparticles which are not absorbed in 

the body. 

PAC 

Although no reports on mutagenecity and genotoxicity are available, it can be assessed based on 

test data on aluminium chloride and so on, which exhibit behaviour identical to that of PAC in 

living organisms (formation of aqua-complexes). Negative results have been obtained in an 

in vitro reverse mutation test (Ames test) using Salmonella typhimurium with aluminium sulfate 

as the test substance and a gene mutation test using L5178Y cells of the lymphoma of a mouse, 

but positive results have been obtained in a chromosomal aberration test using human leukocytes 

with aluminium sulfate as the test substance (IPCS, 1997). 
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In two in vivo tests, one in which aluminium chloride was given to mice by intraperitoneal 

administration and the other in which aluminium sulfate was given to rats, the induction of 

chromosomal aberrations in marrow cells was observed (IPCS, 1997). 

PASA 

Although no reports on the mutagenicity/genotoxicity of polyacryamide are available, 

since polyacrylamide is not absorbed by the body, it is not expected to exhibit 

mutagenicity/genotoxicity. 

Acrylamide monomers 

Among the in vitro tests, the results of mutation tests using bacteria were negative but the results 

of tests using animal cells were clearly positive in a micronucleus test, unscheduled 

DNA synthesis (UDS) test, and sister chromatid exchange (SCE) test. Acrylamide monomers are 

mutagenic substances that act directly on the target, and there are many pieces of evidence of 

genotoxicity in body cells and generative cells in in vivo tests. In particular, it has been proved 

that transgenerational mutagenicity is induced in generative cells (ACGIH, 2001a; EU, 2002). 

5.3.8 Carcinogenicity 

Triiron tetraoxide 

Several reports on the carcinogenicity of triiron tetraoxide are available, all of which are 

insufficient to assess its carcinogenicity. 

PAC 

Although there are no reports available on the carcinogenicity of PAC, aluminium ions are an 

important factor as to the effects of PAC on living organisms, and the assessment of PAC can be 

implemented on the basis of the carcinogenicity of aluminium compounds that exhibit behaviour 

similar to that of PAC in living organisms. Among such aluminium compounds, several tests 

have been conducted relating to aluminium potassium sulfate. For the two tests in which the 

increase in tumours was observed, since the tests were conducted using a single dose, the dose 

dependency is not clear and nothing is described about the type of tumours or the organs with 

tumours. Therefore, the results of these tests do not support the carcinogenicity. 

PASA 

Several tests have been conducted, in which feedstuffs containing 500 to 100,000 ppm of 

polyacrylamide were given to rats for two years, and feedstuffs containing 500 to 50,000 ppm of 

polyacrylamide were given to dogs also for two years. In both of these tests, no lesions related to 

the administration were observed (Cosmetic Ingredient Review, 2005). 
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Acrylamide monomers 

There has been a test on the carcinogenicity of acrylamide, in which acrylamide monomers were 

given to F344 rats by drinking water administration for two years, and an increase in the 

incidence ratio of tumours in tissues of various organs, such as thyroid gland, adrenal glands, and 

testis was observed. Judging from the types of tumours developed, a relationship with endocrine 

disruption is suggested. Furthermore, a relationship with the development of brain tumours and 

spinal cord tumours is suggested although the evidence is not sufficient. IARC has classified 

acrylamide monomers as Group 2A (probably carcinogenic to humans) (IARC, 1994). 

5.3.9 Kinetics and metabolism 

Triiron tetraoxide 

There is a report that the clearance half-life period of a rat that has inhaled triiron tetraoxide for 

two hours is 47 days (EU, 2000a). 

PAC 

In an inhalation exposure test in which rats were exposed to PAC for 24 months and guinea pigs 

for 21 months, aluminium was mainly accumulated in the lungs in both rats and guinea pigs, 

secondary to the adrenal glands in the rats and to the lymph nodes around the lung alveoli in the 

guinea pigs (EU, 2000b). 

PASA 

In a test in which polyacrylamide was given to rats by peroral administration, most of the 

acrylamide was recovered in feces and bowel contents and was not detected in the tissues, which 

shows that polyacrylamide is not absorbed in the body (Cosmetic Ingredient Review, 2005). 

Acrylamide monomers 

Acrylamide monomers are rapidly absorbed orally and percutaneously by many animals so that 

unchanged substances and metabolites are widely distributed in living organisms. In particular, 

they are distributed to the male reproductive organs and to unborn babies through the placenta. 

In rats and mice, acrylamide monomers are mainly excreted in urine after undertaking 

glutathione conjugation. Absorbed acrylamide monomers are also excreted in exhaled breath as 

carbon dioxide, while only small portion is excreted in feces (EU, 2002). In a test that used rats, 

the selective accumulation in nerve cells was not observed (ACGIH, 2001a). There are only 

limited data on the in vivo fate of acrylamide monomers in humans, and it has been indicated that 

acrylamide is absorbed orally or percutaneously because acrylamide monomer adducts are 

detected in hemoglobin (EU, 2002). 
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5.4 Data on environmental fate and effect under aerobic and anaerobic conditions 

(G9: 4.2.1.3) 

5.4.1 Degradation 

5.4.1.1 Hydrolysis 

Hydrolysis properties do not apply to triiron tetraoxide and PAC because they are inorganic 

compounds. Since the half-life period of acrylamide monomers for hydrolysis is more than one 

year under the conditions of pH 5 to 9 and 55°C, acrylamide monomers are considered not to be 

easily hydrolyzed in environmental water (EU, 2002). Therefore, it is assumed that PASA is 

resistant to hydrolysis, as in the case of acrylamide in environmental water. 

5.4.1.2 Biodegradability 

Biodegradability does not apply to triiron tetraoxide or PAC because they are inorganic 

compounds. Regarding the biodegradability of PASA, there is a report on the degradation rate of 

activated sludge taken from an urban sewage treatment plant using the coulometer method, in 

which PASA was assessed to be non-biodegradable because it was hardly degraded 

after 300 hours (OEC, 2003). 

The biodegradability of acrylamide monomers has been tested based on OECD TG301D. Since 

the biochemical oxygen demand (BOD) values for 28 days under the two levels of the 

concentration of testing substance, 2 mg/L and 5 mg/L, were 100 and 53.3%, respectively, it has 

been determined that acrylamide monomers are easily degraded at lower concentrations 

(<2 mg/L) (EU, 2002). 

5.4.2 Partition coefficient 

A partition coefficient is not applied to triiron tetraoxide or PAC because they are inorganic 

compounds. Further, a partition coefficient is not applied to PASA because it is a high molecular 

weight polymer compound. The octanol/water partition coefficient (log POW) for acrylamide 

monomer is -0.67 to -1.65, and soil adsorption coefficient, KOC, is 0.195 l/Kg (EU, 2002). 

5.4.3 Persistence and identification of main metabolites in relevant media (ballast water, 

marine, and fresh water) 

No generation occurs of degradation products from any of triiron tetraoxide, PAC, and PASA. 

Since acrylamide monomers are resistant to hydrolysis and easily biodegraded and mineralized 

under aerobic conditions, degradation products are not generated. 

5.4.4 Reaction with organic matter 

Triiron tetraoxide, PAC, PASA, and acrylamide monomers all do not generate free radicals, and 

do not react with organic compounds. 
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5.4.5 Potential physical effects on wildlife and benthic habitats 

Triiron tetraoxice, PAC, PASA, acrylamide monomers, and flocs would have no physical effect 

on the habitat of fish species, avian species, marine mammals or benthic organisms. 

5.4.6 Potential residues in seafood 

The substances used in this system do not exhibit bioconcentration and so exhibit no potential 

persistence in seafood. 

5.5 Physical and chemical properties for the Active Substances and preparations and 

treated ballast water (G9: 4.2.1.4) 

Table 5-6 shows the physicochemical properties of triiron tetraoxide, PAC, PASA, acrylamide 

monomers, and treated ballast water. 

Table 5-6: Physicochemical properties 

Triiron 

tetraoxide PAC PASA Acrylamide monomers 

Treated 

ballast 

water 

CAS No. 1317-61-9 1327-41-9 25085-02-3 79-06-1 None 

Melting point 

(°C) 

1,538 1) About -12 2) Not Applicable 84.5 1) NR9)

Boiling point 

(°C) 

Not 

Applicable 

About 103 2) Not Applicable 125 at 3 kPa 1) NR 

Flammability 

(Flash point for 

liquids ; °C) 

Not 

Applicable 

Noncombustible

5)

None#1, 4) 138 (closed 

method) 3)

NR 

Density (20 °C; 

kg/m3

) 

5,200 

(5.2 g/cm3) 

1)

1,340 

(1.34 g/cm3

) 2)

Bulk specific 

gravity; 0.55-0.65 

4)

1,130(1.13 g/cm3) 

3)

NR 

Vapour pressure 

(20 °C; Pa) 

Not 

Applicable 

Non-evaporable 

5)

Non-evaporable #2 1 3) NR 

Vapour density 

(air = 1) 

Not 

Applicable 

Not Applicable Not Applicable 2.46 (calculated 

value) 

NR 

Water solubility Insoluble 6) Soluble1) Mixing with water 

forms highly 

viscous gel-like 

material 4)

2,040,000 (25°C) 

(204 g/100 ml) 3)

NR 

pH in solution NR NR 

4.3 (15%) 1)

NR NR 7 - 7.3 

(see 4.2) 

Dissociation 

constant (pKa) 

Not 

Applicable 

No dissociable 

group 

No dissociable 

group 

No dissociable 

group 

NR 

Oxidationreduction 

potential 

Not 

Applicable 

None 5) None 4) None 7) None 

Corrosivity to 

material or 

equipment 

None Corrosive to 

metals 

None None None 
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Triiron 

tetraoxide PAC PASA Acrylamide monomers 

Treated 

ballast 

water 

Reactivity to 

container 

material 

None None None None NR 

Autoignition 

temperature 

(°C) 

Not 

Applicable 

Noncombustible

5)

None 4) 424 3) NR 

Explosive 

properties 

Not 

Applicable 

None None None 7) NR 

Oxidizing 

properties 

Not 

Applicable 

None 5) None 4) None 7) NR 

Surface tension None Equal to water 

because of 

aqueous 

solution 

None None NR 

Viscosity None 28 mPa.s (25°C) 

2)

Mixing with water 

forms highly 

viscous gel-like 

material 4)

2.71 mPa.s (25°C) 

(50% aqueous 

solution) 8)

1.55cP 

(16°C) 

Thermal 

stability 

Transformed 

into iron 

oxide 

(Fe2O3) by 

heating in 

air1)

Nonflammable Combustible by 

heating at high 

temperature 

Violently 

polymerizes when 

heated to over 

85°C or when 

exposed to of 

light or oxidizing 

agents. 

When heated to 

decomposition, 

fumes and 

nitrogen oxide are 

generated. 3), 8)

NR 

Other physicochemical 

properties 

None None None Because 

acrylamide 

readily 

polymerizes, 

common products 

contain 

polymerization 

inhibitors1)

None 

 1) Merck, 2006, 2) EU, 2000b, 3) IPCS, 2000, 4) Dia-Nitrix, 2004, 5) Asada Chemical Industry,

 2003, 6) Dean,1999, 7) EU, 2002, 8) HSDB, 2007, 9) NR: not required for G9 

 #1 Noncombustible under conditions of normal use (normal pressure, 0-50°C). 

 #2 Non-evaporable under normal pressure and normal temperature because of high molecular 

 weight polymers (several million or more). 
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5.6 Analytical method at environmentally relevant concentration (G9: 4.2.1.5) 

Triiron tetraoxide 

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as 

iron ions. 

PAC 

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as 

aluminum ions. 

PASA 

The sample water is filtered with a membrane filter, and the infrared spectra of the substances on 

the filter paper is analysed by infrared spectrometry (IR). Its spectra are compared with that of 

the standard substance to know whether PASA is present or not. The substances gathered on the 

membrane filter are weighed on a scale to obtain the rough amount of PASA. 

Acrylamide monomers 

Acrylamide monomers in the sample water are brominated using potassium bromide solution and 

potassium bromate solution under acidic conditions to obtain dibromo-derivatives. Excess 

bromine is reduced and eliminated with sodium thiosulfate, and the dibromo-derivatives are then 

extracted with ethyl acetate. Triethylamine is added to the solution to remove hydrogen bromide, 

and the obtained monobromo-derivatives are analysed by gas chromatography (GC). 

6 ECOTOXICITY STUDIES 

In this section, the results of ecotoxicity studies of saltwater representatives for three trophic 

levels (algae, invertebrates and fish) are presented and the hazards of the ballast water treated by 

the Hitachi Ballast Water Purification System to the aquatic organisms are evaluated. 

(Refer to IDEA Consultants, Inc., 2007a; 2007b; 2007c for more details.) 

6.1 Methods of water treatment and water sampling 

6.1.1 Set-up for Hitachi Ballast Water Purification System 

The system used for the test was identical to the one used in section 4 Analysis of treated water 

(see 4.1.1 (1)). 

6.1.2 Amounts of chemicals added to set-up 

In order to evaluate the hazards of Active Substances to aquatic organisms, the substances were 

injected into the raw seawater to produce final concentrations two times higher than those of the 

standardized processing conditions for the Hitachi Ballast Water Purification System (Table 6-1). 
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Table 6-1: Final concentrations of chemicals after injection 

Active Substance Concentration in 

untreated seawater (mg/L) 

Triiron tetraoxide 60 

PAC 10 (as Al) 

PASA 2 

6.1.3 Method of water sampling and water treatment procedure 

Processing of seawater by the set-up was carried out and supplied to the test facility daily from 

the day before the beginning of the toxicity tests to the last day of the tests. Approximately 20 L 

of the treated-seawater was sampled from the effluent in the outfall of the filter-separation unit 

when the processing had been carried out for 16 to 32 minutes (see 4.1.1 (3)). 

6.2 Ecotoxicity testing 

6.2.1 Testing on algae

(1) Test guidelines applied to the study 

The toxicity study in algae was conducted according to the International standard ISO 10253 

ìWater quality ñ Marine algae growth inhibition test with Skeletonema costatum and 

Phaeodactylum tricornutum, Second editionî (2006) and the US EPA guidelines ìShort-term 

Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Marine and 

Estuarine Organisms, Third Editionî (2002). (Refer to IDEA Consultants, Inc., 2007a for more 

details.) 

(2) Test method and conditions 

The marine diatom Skeletonema costatum was selected as the test species for this study, and the 

exposure experiment was conducted under the conditions shown below: 

Type of exposure: Static, continuous shaking at 100 rpm 

Exposure duration: 72 hours 

Number of treatments: 5 treatment groups (1/1-, 1/2-, 1/4-, 1/8-, and 1/16-

groups) and a control group 

Number of replicates: 3 replicates per treatment and 6 replicates for 

control 

Volume of test solution per vessel: 30 mL 

Initial cell density: 0.5 x 104

 cells/mL 

Temperature: 20 ± 2 oC 

Illumination: Cool-white type fluorescent bulbs, continuous at 

7,000 Lux ± 20% 

(3) Results and conclusion 

It is concluded that the ballast water treated by the Hitachi Ballast Water Purification System has 

no toxicity impact on the marine Diatom S. costatum without any dilutions. 
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6.2.2 Testing on invertebrates 

(1) Test guidelines applied to the study 

The toxicity study on invertebrates was conducted according to the modified method reported by 

Anasco et al.

1) and the US-EPA guidelines ìShort-term Methods for Estimating the Chronic 

Toxicity of Effluents and Receiving Waters to Marine and Estuarine Organisms, Third Editionî 

(2002). (Refer to IDEA Consultants, Inc., 2007b for more details.) 

(2) Test method and conditions 

The marine gammarid Hyale barbicornis was used as the test species in this study, and the 

exposure experiment was conducted under the conditions shown below. 

Type of exposure: Semi-static, whole renewal every 24 hours 

Exposure duration: 21 days 

Number of treatments: 5 treatment groups (1/1-, 1/2-, 1/4-, 1/8- and 1/16-groups) 

and a control group 

Number of replicates: 20 replicates per group 

Volume of test solution per vessel: 10 mL 

Test animal: Age; Neonates within 24 hours post-hatch 

Number exposed; 20 animals per group (one animal per vessel) 

Temperature: 24 ± 1oC 

Illumination: Cool-white type fluorescent bulbs, 14-hours 

light/10-hours dark 

Feeding: Artificial flake food Tetra MarineÆ (< 0.5 mm 

crushed pieces), once a day 

(3) Results and conclusion 

It is concluded that the ballast water treated by the Hitachi Ballast Water Purification System has 

no toxicity impact on the marine Gammarid H. barbicornis without any dilutions. 

6.2.3 Testing on fish 

(1) Test guidelines applied to the study 

The toxicity study in fish was conducted in accordance with the OECD guidelines No.210 ìFish, 

Early-life Stage Toxicity Testî (1992) and the US-EPA guidelines ìShortterm Methods for 

Estimating the Chronic Toxicity of Effluents and Receiving Waters to Marine and Estuarine 

Organisms, Third Editionî (2002). (Refer to IDEA Consultants, Inc., 2007c for more details) 

 

1) Anasco N., Takenouchi A., Koyama J., Noro T., Imai S, Uno S. Toxicity of chemicals used to treat ballast waters 

(hydrogen peroxide and sodium hypochlorite) to four marine organisms., terminal report: Toxicity of Hydrogen peroxide and 

sodium hypochlorite to marine organisms, in preparation.
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(2) Test method and conditions 

The saltwater fish Java medaka, Oryzias javanicus, was selected as the test species for this study, 

and the exposure experiment was conducted under the conditions shown below 

Type of exposure: Semi-static, whole renewal every 24 hours 

Exposure duration: From 1 day post-fertilization embryo to 28 days 

post-hatch 

Number of treatments: 5 treatment groups (1/1-, 1/2-, 1/4-, 1/8-, and 1/16-group), 

and a control group 

Number of replicates: 3 replicates per group 

Volume of test solution per vessel: 100 mL (embryonic phase), 

500 mL (post-hatch phase, until 14 days post-hatch), and 

1,000 mL (post-hatch phase, after 14 days post-hatch) 

Test animal: Age; Fertilized eggs 1 day post-fertilization 

Number exposed: 60 eggs per group (20 eggs per vessel) 

Temperature: 26 ± 1 oC 

Illumination: Cool-white type fluorescent bulbs, 14-hours 

light/10-hours dark 

Feeding: Brine shrimp nauplii, once a day 

(3) Results and conclusion 

It is concluded that the ballast water treated by the Hitachi Ballast Water Purification System has 

no toxicity impact on the saltwater fish O. javanicus without any dilutions. 

7 MATERIAL SAFETY DATA SHEET (MSDS) (G9: 4.2.7)

Samples of MSDS for triiron tetraoxide, PAC, and PASA are attached to the original assessment 

report. 
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8 RISK CHARACTERIZATION 

8.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) 

Table 8-1 shows the results of an assessment of PBT. None of the triiron tetraoxide, PAC, PASA, 

and acryamide monomers are classified as PBT substances. 

Table 8-1: Assessment of PBT 

Low degradability (P) Bioaccumulation (B) Toxicity (T) 

 Half-life: 

>60 days in marine water, or 

>40 days in freshwater, or 

>180 days in marine sediment, or 

>120 days in freshwater sediment 

BCF > 2,000 

or 

Log POW ≥ 3 

Chronic NOEC < 

0.01 mg/L 

Triiron 

tetraoxide 

Not applicable* No No 

PAC Not applicable* No No 

PASA Yes No No 

Acrylamide 

monomers 

No No No 

* As described in 5.4.1, biodegradability and hydrolysis do not apply to triiron tetraoxide and 

PAC because they are inorganic compounds. 

8.2 Evaluation of treated ballast water (G9: 5.2) 

To investigate the toxicity of the seawater treated by the Hitachi Ballast Water Purification 

System, ecotoxicity tests were carried out on three types of marine. The seawater was treated 

(at a flow rate of 50 m3/h) by the land-based pilot set-up on reclaimed land in Tokyo Bay which 

simulates the Hitachi Ballast Water Purification System, and was tested by adding twice as much 

of the three chemicals (triiron tetraoxide, PAC, and PASA) compared with rated operation. 

All the ecotoxicity studies with the treated ballast water as a test substance were conducted under 

the conditions specified by the OECD principles of Good Laboratory Practice and were 

performed according to international standards such as OECD test guidelines or US EPA 

guidelines. (For details, see section 6.) 

The above test results show that seawater treated with the addition of chemicals in rated 

operation does not have any adverse effect on marine organisms even if released without 

dilution, because seawater treated with twice as much chemical as in the rated operation does not 

influence marine organisms at all even if released without dilution (100%). 
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8.3 Risk characterization and analysis 

8.3.1 Reaction with organic matter (G9: 4.2.1.3; this report 5.4.4) 

Since triiron tetraoxide, PAC, and PASA all do not generate free radicals, they are not reactive 

with organic matter. 

8.3.2 Characterization of degradation route and rate (G9: 5.3.5) 

Since triiron tetraoxide and PAC are inorganic substances, hydrolysis and biodegradability are 

not applicable. Acrylamide monomers are resistant to hydrolysis but biodegraded in a relatively 

short period. PASA is considered to be resistant to hydrolysis. In addition, PASA is scarcely 

biodegraded in activated sludge after 300 hours and is therefore not biodegradable. 

In the Hitachi Ballast Water Purification System, since almost the entire additive chemicals are 

collected in the flocs, the amount of Active Substances released into the environment together 

with the treated ballast water is negligible. Therefore, the characteristics described here do not 

have a serious environmental effect. 

8.3.3 Prediction of discharge and environmental concentrations

Table 8-2: Summary of predicted discharged concentration PEC 

Predicted concentration at 

discharge (mg/L) 

PEC 

(mg/L) 

Triiron tetraoxide 0.69 <0.69 

PAC 0.15 <0.15 

PAC (aluminium ions) 0.01 <0.00358*

PASA 0.016 <0.016 

Acrylamide monomers 0.00005 <0.00005 

*

 Estimation of environmental concentration based on the MAM-PEC Model. 

The environmental concentration when the treated ballast water is discharged in Rotterdam Port 

was estimated using the MAM-PEC Model (version 1.6). It is assumed that all ships entering 

Rotterdam Port are provided with the Hitachi Ballast Water Purification System. 

The concentration of original aluminium ions in the seawater of Rotterdam Port, which is the 

background concentration, is assumed to be 0.035 mg/L based on the value shown in the 

reference (Kobayashi et al., 2006). Table 8-3 shows the results of the estimation. The average 

concentration in the water is calculated to be 0.00350 mg/L, which is the same as the background 

concentration. Therefore, it is concluded that aluminium ions in the ballast water discharged from 

the Hitachi Ballast Water Purification System do not have an influence on the environmental 

concentration. (CERI, 2007b). 
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Table 8-3: Estimated concentrations in water using MAM-PEC Model 

Item Concentration of Aluminium ions 

(μg/L) 

Maximum concentration 3.58 (0.00358 mg/L) 

Average concentration 3.50 (0.00350 mg/L) 

8.3.4 Assessment of potential for bioaccumulation (G9: 5.3.7) 

As described in section 5.2.5, the substances are not bioaccumulative. 

8.3.5 Effects assessment (G9: 5.3.9) 

Triiron tetraoxide 

The data on ecotoxicity of triiron tetraoxide do not correspond to the GHS acute toxicity hazard 

category. 

PAC 

The data on ecotoxicity of PAC do not correspond to the GHS acute toxicity hazard category. 

PASA 

The data on ecotoxicity of PASA do not correspond to the GHS acute toxicity hazard category. 

Acrylamide monomers 

The data on ecotoxicity of acrylamide monomers correspond to the GHS acute toxicity hazard 

category III (harmful). But, acrylamide monomers contained as an impurity in PASA account 

for 0.05% or less of PASA by weight as given in 2.5. As a result, the acrylamide monomer 

concentration in ballast water is 0.0005 or less mg/L (before magnetic separation). Because the 

acrylamide monomer concentration in the treated water is 0.0001 or less mg/L as given in 4.1.2, 

the risk to aquatic organisms is negligible (see 9.3 for details). 
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8.3.6 Derivation of Predicted No-Effect Concentration (PNEC)

Table 8-4: PNECs 

Toxicity 

(mg/L) 

Assessment 

factor 

PNEC 

(mg/L) 

Triiron 

tetraoxide 

48-h LC0 (acute) > 

1,000 

1000 > 1 PNECshort 

PAC 48-h LC50 (acute) 840 1000 0.84 PNECshort 

96-h LC50 (acute) 0.097 1000 0.003597 a) PAC PNECshort 

(aluminium 

ions) 

28-day NOEC 

(chronic) 

0.02 1000 0.00352 a) PNEClong 

PASA 48-h LC50 (acute) 180 1000 0.18 PNECshort 

30-day NOEC 

(chronic) 

75 100 0.75 PNEClong 

Acrylamide 96-h LC50 (acute) 59 1000 0.059 PNECshort 

monomers 28-day NOEC 

(chronic) 

2.04 100 0.02 PNEClong 

a) The natural background concentration is added. 

Since the PNEClong is smaller than the PNECshort for PAC (aluminium ions), PASA, and 

acrylamide monomers, PNEClong is applied in the PEC/PNEC ratio described in section 9.3.1. 

9 RISK ASSESSMENT 

9.1 Risk to ship safety 

9.1.1 Risk during the storage of chemicals and operation of equipment 

The IBC code is not applied to triiron tetraoxide, PAC, or PASA. 

As seen from the physical properties described in 5.5, triiron tetraoxide, PAC, PASA, and 

acrylamide monomers are not corrosive, do not react with the storage tank, do not ignite 

spontaneously, do not vaporize, and do not have oxidizing properties under the assumed 

on-board circumstances. Therefore, there is no concern that this substance may cause an accident 

such as corrosion, spontaneous ignition, or explosion of the vesselís body and on-board 

structures during the storage or operation of the equipment. 

9.1.2 Risk from the treated ballast water 

The treated ballast water is not corrosive, and the concentrations of volatile and semivolatile 

substances are comparable to those in the seawater of the reference site as described in 4.1.2 (2) 

and 4.1.2 (3). Therefore, there is no concern about accidents occurring in the ballast tank. 
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9.2 Risk to human health (sailors) 

9.2.1 Exposure to humans 

Since the operation of the Hitachi Ballast Water Purification System is automated from the 

chemical injection into the ballast water through to the sludge transfer into the sludge tank, no 

manual operation by the crew is required and no dedicated operators are necessary. 

External to the purifying operation, there are small potential risks of short-time exposure to 

humans because some manual operation is required for pouring the chemicals into the storage 

tank, preparing for unloading the sludge, and actually unloading the sludge onto land. 

When the chemicals are poured into the storage tanks, the transfer is from one closed container to 

another closed container, so the risk of exposure is minimal. The operator must wear safety gear 

such as goggles, rubber gloves, and a mask in anticipation of accidents such as powder being 

scattered. Warnings should be displayed on the equipment of this system to emphasize the need 

to use such safety gear. 

9.2.2 Risk to human health

As described in 5.3, triiron tetraoxide is not a toxic substance. Furthermore, the only operations 

that may cause exposure to humans are the pouring of chemicals into the storage tank, preparing 

for unloading the sludge, and unloading the sludge onto land. In these operations, the potential 

exposure periods are limited and the workers wear protective gear, so there is virtually no risk to 

human health. 

PAC is not toxic, as described in 5.3, but it is an irritant and has been shown to have adverse 

effects in reproductive/developmental toxicity tests on animals. Therefore, the Hitachi Ballast 

Water Purification System minimizes the risk to human health by using PAC conforming to the 

standards for water purification chemicals established by the American Water Works Association 

(AWWA) and by automating the purification operation. The only operations that may cause 

exposure to humans are the pouring of chemicals into the storage tank, preparing for unloading 

the sludge, and unloading the sludge onto land. In these operations, the potential exposure 

periods are limited and exposure is prevented by protective gear. Furthermore, the frequency of 

these operations is limited so there is virtually no risk to human health. 

As described in Section 5.3, PASA is not a toxic substance. The Hitachi Ballast Water 

Purification System minimizes the risk to human health by using PAC conforming to the 

standard for water purification chemicals established by the American Water Works Association 

and by automating the purification operation. The only operations that may cause exposure to 

humans are the pouring of the chemicals into the storage tank, preparing for unloading the 

sludge, and unloading the sludge onto land. In these operations, the exposure periods are limited 

and exposure is prevented by protective gear. Furthermore, the frequency of these operations is 

limited so there is virtually no risk to human health. 

The risk of acrylamide monomers to human health was investigated because traces of 

unpolymerized acrylamide monomers remain in PASA as an impurity. However, the PASA used 

in the system conforms to the standard for water purification chemicals established by the 

American Water Works Association. The level of contamination is 0.05% or less, which has been 

proven safe. It poses virtually no risk to human health. 
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9.3 Risk to aquatic environment 

9.3.1 Assessment by PEC/PNEC ratio

An assessment by PEC/PNEC ratio was carried out on triiron tetraoxide, PAC, PASA, and 

acrylamide monomers. The assessment for PAC was conducted by using the acute toxicity data 

for PAC and aluminium ions and the chronic toxicity data for aluminium ions. 

As derived in 8.3.6, the PNEC values are > 1 mg/L for triiron tetraoxide, 0.84 mg/L for 

PAC, 0.003597 mg /L for PAC (aluminium ions), 0.18 mg/L for PASA, and 0.02 mg/L for 

acrylamide monomers (see Table 8-4). 

As derived in 8.3.3, the PEC values are 0.69 mg/L for triiron tetraoxide, 0.3 mg/L for 

PAC, 0.00358 mg /L for PAC (aluminium ions), 0.016 mg/L for PASA, and 0.00005 mg/L for 

acrylamide monomers (see Table 8-2). 

From the above data, the PEC/PNEC ratio values are derived. The PEC/PNEC ratios are <1 for 

triiron tetraoxide, PAC, PASA and acrylamide monomers, which shows that there is virtually 

no risk to aquatic organisms. 

At this moment, the PEC/PNEC ratio for PAC (aluminium ions) is not low enough to be assessed 

as having no effect on the aquatic environment. However, the analysis of treated water described 

in section 4.1 was carried out before the flocculation technique was fully developed. It has been 

confirmed that the amount of flocs remaining in the water treated by the current improved 

structure is drastically less than the amount remaining in the water treated by the previous 

structures. Since detailed improvements on the equipment are ongoing, new data on water quality 

will be collected and shown in the application for final approval. 

Table 9-1: PEC/PNEC ratio 

PEC 

(mg/L) 

PNEC 

(mg/L) 

PEC/PNEC 

ratio 

Triiron tetraoxide 0.69 > 1 < 0.69 

PAC 0.15 0.84 0.18 

PAC (aluminium ions) 0.00358 0.00352 1.02 

PASA 0.016 0.18 0.09 

Acrylamide monomer 0.00005 0.02 0.0025 

9.3.2 Assessment of treated ballast water by ecotoxicity test (G9: 5.3.14) 

A chronic ecotoxicity test was conducted based on GLP principles and in accordance with test 

guidelines established by OECD, ISO, and USEPA to assess the effects of ballast water treated 

by the Hitachi Ballast Purification System on aquatic organisms (for details, see section 6). 
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As described in 6.1.2, since the concentration of chemicals added was twice that of rated 

concentration, the volume of substances contained in the treated water supplied for the testing 

was twice of the predicted concentration described in 8.3.3. Consequently, the concentrations of 

each substances are expected 1.38 mg/L for triiron tetraoxide, 0.3 mg/L for PAC, 0.02 mg /L for 

aluminium ions, 0.032 mg/L for PASA, and 0.001 mg/L for acrylamide monomers. 

Table 9-2 shows the NOEC values derived from the results of the chronic ecotxicity test. 

The 100% concentration treated ballast water affected none of the organisms examined. Given 

that the quantities of chemicals added in the rated operation of the Hitachi Ballast Purification 

System are half of those added in the test, it is concluded that the treated water under the rated 

conditions has virtually no effect on aquatic organisms. 

Table 9-2: NOEC of treated ballast water 

Test substance 

Classific

ation of 

organism

Organism 

species End point 

Toxicity 

(Maximum no 

observed effect 

concentration)

Algae Skeletonema 

costatum

NOEC for 

72 hrs 100% treated 

ballast water*

Invertebr

ates 

Hyale 

barbicornis

NOEC for 

21 days 

100% treated 

ballast water*

Treated ballast water 

(containing triiron 

tetraoxide; 1.38 mg/L, 

PAC; 0.3 mg/L, 

aluminium ions; 0.02 

mg/L, PASA; 0.032 

mg/L, acrylamide 

monomers; 0.0001 mg/L) 

Fish Oryzias 

javanicus

NOEC for 

40 days 100% treated 

ballast water*

* These findings conclusively demonstrated that ballast water treated by the Hitachi Ballast 

Water Purification System has virtually no impact on aquatic organisms. 
MEPC 57/2/2 

ANNEX 

Page 41 

I:\MEPC\57\2-2.doc 

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