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

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I:\MEPC\60\2-2.doc 

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

60th session 

Agenda item 2 

MEPC 60/2/2

 20 August 2009

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Application for Final Approval of the JFE Ballast Water Management System 

(JFE-BWMS) that makes use of ìTG BallastcleanerÆ and TG EnvironmentalguardÆî 

Submitted by Japan 

SUMMARY

Executive summary: This document contains non-confidential information related to the 

application for Final Approval of the JFE Ballast Water Management 

System (JFE-BWMS) that makes use of ìTG BallastcleanerÆ and 

TG EnvironmentalguardÆî in accordance with the ìProcedure for 

approval of Ballast Water Management Systems that make use of 

Active Substances (G9)î adopted by resolution MEPC.169(57) 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 6 

Related documents: BWM/CONF/36; MEPC 57/21, MEPC 57/2/8, MEPC 58/2/7 and 

BWM.2/Circ.18 

Introduction 

1 Regulation D-3 in the Ballast Water Management Convention (BWM Convention) 

requires that Ballast Water Management Systems, which make use of Active Substances, be 

approved by IMO based on a procedure developed by the Organization. 

2 MEPC 57 adopted resolution MEPC.169(57) ìProcedure for approval of Ballast Water 

Management Systems that make use of Active Substances (G9)î. Section 8 of Procedure (G9) sets 

out the methodology to be followed for the approval of Active Substances and requests IMO to 

establish a Technical Group (the GESAMP-Ballast Water Working Group) for reviewing the 

proposals submitted by Administrations and reporting to the Organization on its findings. 
MEPC 60/2/2 - 2 - 

I:\MEPC\60\2-2.doc 

3 Basic Approval of this system has been granted by MEPC 58 (see document 

MEPC 58/23, paragraph 2.6.1). 

4 According to BWM.2/Circ.18, proposals for approval of Ballast Water Management 

Systems that make use of Active Substances are to be submitted to the Marine Environment 

Division of the Organization and to be reviewed by the GESAMP-Ballast Water Working Group. 

In the meantime, a document on the proposal for approval containing all the non-confidential 

data related to the respective Active Substance needs to be submitted to MEPC 60. 

5 Japan therefore submits the non-confidential part of the applicantís dossier in the annex 

of this document to the Organization for evaluation according to Procedure (G9). The complete 

dossier will be made available to the experts of the GESAMP-Ballast Water Working Group with 

the understanding of confidential treatment. 

Action requested of the Committee 

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

***
MEPC 60/2/2 

I:\MEPC\60\2-2.doc 

ANNEX 

NON-CONFIDENTIAL INFORMATION ON THE JFE BALLAST WATER 

MANAGEMENT SYSTEM THAT MAKES USE OF ìTG BALLASTCLEANERÆ

AND TG ENVIRONMENTALGUARDÆî (JAPAN) 

1 PREFACE 

The application for Basic Approval was made by TG Corporation, which is a member of the 

Toagosei Group. However, at that time, tasks related to the onboard installation and operation of 

the ballast water management system (BWMS) as a whole were evaluated considering the case of 

installation of a system manufactured by JFE Engineering Corporation, and this basic application 

was approved. 

Based on this, in this application for Final Approval, the basic system concept is proposed both 

by JFE Engineering Corporation as the BWMS maker and TG Corporation as the chemical 

manufacturer, as a compound process for treatment employing the chemicals approved in the 

Basic Approval. 

This summary presents an outline of the system, and the newly added content of the methodology 

(BWM.2/Circ.13, 10 June 2008) adopted during MEPC 58 focusing around the results of the 

land-based tests. 

In the process of BWMS development and the preparation of proposal for approval, in addition to 

the BWMS maker, JFE Engineering Corporation, and the chemical manufacturer, the Toagosei 

Group, development was carried out through joint development, joint testing, and onboard 

evaluations of the individual elements of the technology with a shipyard in the JFE Group, and 

others. The land-based tests were contracted out to the Norwegian company Ballast Tech NIVA, 

which has an extensive record of tests for BWMS. 

At the same time, Quality Assurance and Quality Control related to inspections were conducted 

by establishing a committee including members of all of the companies concerned, and clarifying 

the system of responsibility for approvals and implementation. 

2 GENERAL 

2.1 Introduction 

In the application for Basic Approval, the TRO concentration in the ballast water at the maximum 

chemical injection rate was set at 30 mg/L. However, from the viewpoint of reducing the 

by-products of this process, it has become clear through experimental research that the maximum 

chemical injection rate of 20 mg/L is acceptable as a rate that satisfies the D-2 standard and is 

also compatible with environmental needs. Therefore, in the land-based tests and evaluation for 

Final Approval, the maximum concentration was set at 20 mg/L. 

However, if it can be confirmed in the future in onboard tests, etc., that the D-2 standard can be 

satisfied with a lower injection concentration than 20 mg/L, efforts will be made to further reduce 

the injection concentration, as the effect on aquatic organism can also be reduced. 
MEPC 60/2/2 

ANNEX 

Page 2 

I:\MEPC\60\2-2.doc 

2.2 Outline of Ballast Water Treatment System 

Considering the D-2 standard and Guidelines (G8) and Procedure (G9), a hybrid treatment 

system was adopted in the JFE-Ballast Water Management System (JFE-BWMS), comprising a 

ìprecision filter,î the Active Substances ìTG BallastcleanerÆ,î and the ìphysical action of 

mixing generated by Venturi tubesî inserted in the main piping route downstream from the 

position where the Active Substances is injected. 

Treatment begins during uptake of ballast water. Although the concentration is low, during 

voyages, TG BallastcleanerÆ is left in the ballast tanks in order to prevent regrowth and hatching 

of egg of marine organisms. On the other hand, when ballast water is discharged during loading 

in a port, the toxicity of the Total Residual Oxidant (TRO) in the treated ballast water is 

detoxified using TG EnvironmentalguardÆ, which is a reducing agent. Because cargo handling 

patterns and sailing time differ greatly, depending on the type of ship, this is done to provide a 

function which ensures that non-toxic ballast water is always discharged when taking on or 

discharging ballast water, corresponding to the cargo handling pattern and sailing time. 

Figure 1 shows the conceptual flow of the JFE-BWMS. Seawater is taken up from the sea chest 

by the ballast pump, and then passes through a strainer and precision filter. Plankton and 

particles of suspended solids (SS) with a minimum size of 50 μm or larger are captured by the 

filter element and rapidly returned to their original habitat or the waters where they were found 

by way of the backwash discharge pipe, together with the backwash water collected by the 

backwash function of the precision filter element, which is performed continuously during 

ballasting. Because TG BallastcleanerÆ is injected after this filtration process, this backwash 

water of filter element does not contain TG BallastcleanerÆ, and thus has no effect on the marine 

environment. 

Because the filtered seawater has a lower content of organic matter (including living organisms) 

and suspended solids than raw seawater, the disinfection/biocide effect can be realized with a 

smaller amount of chemical than if TG BallastcleanerÆ is added directly to the raw seawater. 

TG BallastcleanerÆ acts on the living organisms which have passed through the filter element, 

and also reacts with soluble organic and inorganic substances. Accordingly, with the 

JFE-BWMS, it is possible to deactivate the living organisms with a smaller amount of 

TG BallastcleanerÆ, and only a smaller amount of TG BallastcleanerÆ is necessary. 

The seawater, including living organisms into which TG BallastcleanerÆ is injected, flows into 

the Venturi tubes. The rapid agitation/mixture of the chemicals is performed by vortices 

generated in the expansion portion at downstream of the throat during flowing through the 

Venturi tubes and thus also has an effect, which enables the Active Substances to deactivate 

living organisms more effectively. 

The treated water after passing through this mixing process flows into the ballast water tank. 

A certain concentration of TG BallastcleanerÆ remains in the ballast water tank, and has the 

function of preventing re-growth of organisms and hatching of eggs in the tank. 
MEPC 60/2/2 

ANNEX 

Page 3 

I:\MEPC\60\2-2.doc 

Figure 1: Basic concept of JFE-BWMS 

In many cases, although the concentration is generally low, residual Active Substances may 

remain at the time where the ballast water is discharged. During international voyages, 

particularly with short sailing times, there is a possibility that a high concentration of a toxic 

Active Substances may remain, and this can be expected to have harmful effects on the natural 

ecosystem in the receiving waters if it is discharged from the ship without proper treatment. In 

order to solve this problem, the TRO is discharged from the ship after being detoxified by 

neutralization/reduction by TG EnvironmentalguardÆ, which is a reducing agent. Because the 

reductant TG EnvironmentalguardÆ is injected on the upstream side of the ballast pump during 

discharge of the ballast water, it is completely mixed by the high speed rotation of the pump 

impeller while passing through the pump so that the reduction reaction with the TRO is 

completed immediately in the ballast water discharge pipe line, ensuring that the TRO is 

completely eliminated before the water is discharged from the ship. 

2.2.1 System concept 

In the JFE-BWMS, when the ballast tanks are filled with seawater, etc., (this operation is referred 

to as ìballastingî), the amount of TG BallastcleanerÆ injected into the water is controlled so that 

the TRO concentration in the ballast water immediately after treatment will conform to the set 

value using a TRO meter (Total Residual Oxidant Meter) in order to hold the concentration 

of TG BallastcleanerÆ after injection to the lowest possible level. 
MEPC 60/2/2 

ANNEX 

Page 4 

I:\MEPC\60\2-2.doc 

Based on the TG BallastcleanerÆ injection rate, Free Available Chlorine (FAC) is set with the 

maximum of 20 mg/L as an upper limit. Control values are set so that the operation of the 

system is stopped if FAC exceeds this upper limit value. Furthermore, in ordinary operation, the 

system is set so that the TRO concentration will reach approximately 10 mg/L one minute after 

injection of TG BallastcleanerÆ. 

When treated ballast water is discharged (hereinafter referred to as ìdeballastingî), the TRO 

concentration in the ballast water is measured using the TRO Meter, and an amount of 

TG EnvironmentalguardÆ greater than that necessary to completely neutralize/reduce the 

measured concentration is injected by arranging ìmulti-point injection nozzlesî in the ballast 

water piping on the upstream side of the ballast pump. Complete mixing is achieved using the 

mixing effect of the turbulent flow generated by the rotating impeller of the pump when the water 

passes through the ballast pump on the downstream side from these nozzles. Furthermore, in 

order to confirm that the discharge has been completely neutralized/reduced, monitoring of 

complete neutralization/reduction is performed using a high resolution TRO Meter, which is 

capable of measuring reduction condition. 

2.2.2 Composition and roles of equipment 

JFE-BWMS comprises a power control panel, ballast pump operation panel, chemical injection 

pump operation panel, and BWMS control panel. Although these panels are installed at machine 

side, remote operation panels are also provided, enabling remote operation from the ballast 

control room and other locations. The operating data acquisition function and the report 

preparation function are used to store and analyse operating data and output ñ the necessary items 

requested in Guidelines (G8) in the form of reports. 

2.2.3 Injection system of chemicals 

The injection of TG BallastcleanerÆ during ballasting and the injection of TG EnvironmentalguardÆ

for neutralization/reduction treatment of TRO at the time of ballast discharge, are controlled so as 

to achieve the set TRO concentration by changing the rotational speed of the chemical injection 

pump drive motor with an inverter using the measured value of the TRO concentration. 

Furthermore, because it is necessary to change the injection flow rate corresponding to the 

fluctuations in the flow rate in the main ballast line in order to secure a uniform chemical 

injection concentration, a flow meter is provided for this purpose. 

During deballasting, a TRO Meter is used to confirm that the TRO concentration in the ballast 

water has been completely neutralized/reduced. A TRO Meter with a measurement range 

of 0-30 mg/L is used in order to measure the TRO in the ballast tanks. A high resolution 

TRO Meter with a measurement range of -0.2 to 3 mg/L had been developed and was used to 

confirm that the value of TRO concentration of the ballast water after neutralization/reduction 

(secondary treated water) is 0 or less. The concentration meter has the capability to measure to a 

reducing condition, and outputs minus values at reducing condition. 

TG EnvironmentalguardÆ is injected via the chemical injection nozzles in the piping on the 

upstream side of the ballast pump at a flow rate, which secures the necessary concentration for 

complete neutralization/reduction of the TRO concentration measured immediately after the 

ballast water leaves the ballast tanks, and is mixed as it passes through the pump. 
MEPC 60/2/2 

ANNEX 

Page 5 

I:\MEPC\60\2-2.doc 

The neutralization/reduction reaction velocity of TG BallastcleanerÆ and TG EnvironmentalguardÆ is 

extremely fast. Because these substances are completely mixed by the turbulent flow generated 

by the pump impeller as they pass through the ballast pump, the reaction is 100% complete in the 

ballast water piping. Accordingly, the ballast water does not contain any TRO when discharged, 

and thus has no adverse effect on the external environment. 

2.3 Additional Data Sets requested at time of Basic Approval 

Detailed replies are given in the assessment report on the items which were pointed out in the 

GESAMP-BWWG report of its 6th meeting (MEPC 58/2/7, annex 5) as requiring further 

clarification in the Final Approval process. The requests by GESAMP-BWWG and the replies 

are shown briefly, as follows: 

.1 Considering corrosion, the Group agreed that the applicantís response was 

insufficient to quantitatively assess the corrosion impact to relevant metallic and 

non-metallic materials likely to be used in ballast water tanks, piping and fixtures. 

For non-metallic gasket materials, the applicant responded that tests were not 

started since they have sufficient information for suitable materials but no details 

or data were provided. 

Reply: The data are stated briefly in 7.1.1.5 of this summary, and additional corrosion 

tests necessary for evaluation were performed. (The detailed data are given in the 

confidential part of the assessment report.) 

.2 The applicant should provide appropriate QAs and QCs and indicate why there are 

different detection limits for the same substance being analysed. 

Reply: In order to ensure Quality Assurance/Quality Control for chemical experiments 

and chemical analyses when applying for Final Approval, a decision was made to 

organize a Quality Assurance Committee including members of all related 

companies, and to carry out all drafting and implementation of plans and reporting 

and verification of the results in accordance with a Quality Assurance Project Plan 

(QAPP) audited and approved by the Committee. 

Regarding detection limits, these were unified simultaneously with the 

improvement of making lower detection limits. When some substances have 

different limit values, the reason for this is described separately. 

.3 Further measurement and analysis of discharge concentration of THMs and HAAs 

with adequate QA/QC should be taken during the full-scale land-based test before 

the submission for Final Approval. 

Reply: As mentioned in .2 above, for the application for Final Approval, appropriate 

Quality Assurance/Quality Control were performed in accordance with the QAPP, 

and this obligation was also imposed in commissioned tests (e.g., test contracted 

out to Ballast Tech ñNIVA AS). 

Standard Operation Procedures (SOP) which are capable of assuring quality were 

prepared for all tests, and audits as to whether the test were carried out as specified 

in the SOP were carried out in accordance with the quality assurance system. 
MEPC 60/2/2 

ANNEX 

Page 6 

I:\MEPC\60\2-2.doc 

.4 The chemical analyses for THMs were not performed under adequate QAPPs and 

so recommended that all chemical measurement and analyses should be performed 

under QAPPs. 

Reply: As mentioned in .2 and .3 above for the application for Final Approval, measurements 

and analyses of all chemical substances were conducted based on the QAPP. 

.5 Final Approval submission should provide full details of the dosing control 

arrangements so as to ensure certainty of maintaining specified dosage levels of 

Active Substances. 

Reply: During ballasting, injection control of TG BallastcleanerÆ is performed. 

Regarding TG BallastcleanerÆ injection control, at a set after the start of 

operation of the JFE-BWMS, a set amount of TG BallastcleanerÆ corresponding 

to a free available chlorine (FAC) concentration of 20 mg/L is injected. 

Thereafter, the TG BallastcleanerÆ supply rate is controlled so that the value of 

the residual chlorine concentration in the ballast water will fall within a target 

range of residual chlorine concentrations which has been set in advance. 

On the other hand, during deballasting, discharge neutralization control is 

performed using the chemical TG EnvironmentalguardÆ. 

In discharge neutralization control using TG EnvironmentalguardÆ at a set time after 

the start of operation of the JFE-BWMS, a set amount of TG EnvironmentalguardÆ, 

which will neutralize the 20 mg/L FAC concentration of TG BallastcleanerÆ that 

was supplied during ballasting, is injected. Thereafter, the supply rate of 

TG EnvironmentalguardÆ necessary for neutralization is calculated and adjusted 

based on the residual chlorine concentration value in the ballast water at the outlet 

of the ballast tank, and the ballast water is discharged into the sea after 

neutralization/reduction treatment. 

Those are brief explanation of control system and more details of the control 

system are explained in 2.2.3 above. 

.6 The Group was satisfied that the flow diagram provided was suitable for Basic 

Approval. It is appreciated that further details for evaluation be supplied for 

review during any Final Approval. 

Reply: The piping system diagram, system composition diagram, single line diagram 

(skeleton diagram), control flowchart, and protective interlock diagram of the 

JFE-BWMS and the operational procedure of the JFE-BWMS are described in the 

confidential part of the assessment report. 

.7 The applicant indicated to continue gathering information related to the two 

chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no 

additional data were to be found, they would carry out further algal tests as required. 

Reply: As data on dibromochloroacetic acid and bromodichloroacetic acid were required 

in the the GESAMP-BWWG report (MEPC 58/2/7, annex 5, paragraph 2.10), a 

toxicity test (Algal Growth Inhibition Test) was performed, and NOEC was obtained. 

The test results were added to the confidential part of the assessment report. 
MEPC 60/2/2 

ANNEX 

Page 7 

I:\MEPC\60\2-2.doc 

.8 The Group was satisfied that the applicant had given due preliminary 

consideration to the concerns concerning temperature control put forward but 

requested that these safety mitigation measures and requirements should be fully 

detailed in the operating manual presented for any Final Approval. 

Reply: In order to prevent self-degradation of TG BallastcleanerÆ, it is necessary to 

control the temperature to 20°C or less. In onboard tests, the TG BallastcleanerÆ

tank was covered with thermal insulation, and external heat inputs were prevented 

as much as possible. The very small amount of input heat which was transmitted 

through the insulation was radiated to the outside by a water cooling method 

through cooling tubes arranged between the tank wall and the insulation using an 

independently controlled electric chiller. 

Regarding the temperature control procedure with this chiller, temperature control 

is performed automatically when the power is turned on, the set temperature is 

inputted, and operation begins. In the temperature control, cooling operation 

begins when the temperature exceeds the set temperature by 1°C and ends when 

the temperature of 1°C lower than the set temperature, is reached. 

As another possible method, the tank can be installed in an area where it is 

air-conditioned to 20°C or less. 

.9 Whilst recognizing the validity of the pressure monitoring/control, the Group 

considered that further verification of this should be made during the ship board 

testing and included in the documentation for Final Approval. 

Reply: PV(Pressure-vacuum) valves are provided in the chemical storage tanks. When 

the tank internal pressure exceeds the external atmospheric pressure by 100 mmAq, 

PV valve opens and reduces the pressure, and when the internal pressure decreases 

to 100 mmAq less than the external atmospheric pressure, PV valve opens and 

increases the pressure. 

In onboard tests, the internal pressure increased and decreased due to the loading 

and use of the chemicals, respectively. It was confirmed that the PV valves 

operated normally, and the tank internal pressure was kept within the set range. 

Normal operation of the level gauges and high level alarms was also confirmed in 

shipboard experiments. 

.10 The Group is of the opinion that the acute toxicity testing for treated ballast water 

and the information for acute toxicity testing by simulated ballast water in a 

laboratory scale and full-scale land-based system are needed for evaluation. 

In addition, the Group requested that quantification analysis and degradation rates 

of sodium sulphite in various conditions should be carried out for the submission 

for Final Approval. 

Reply: These were performed in land-based tests carried out by Ballast Tech-NIVA. 

The evaluation is described in Chapter 3. 
MEPC 60/2/2 

ANNEX 

Page 8 

I:\MEPC\60\2-2.doc 

.11 The Group recommended that the following human exposure information related 

to TG BallastCleanerÆ should be addressed: 

.1 in advance identification of all leaking points; these are to be considered 

critical points for the HSE (due to the corrosive properties of the 

preparation); 

Reply: All locations where leaks can be expected were designated in advance, and 

those positions were indicated on the piping system diagram. 

.2 foreseen safety measures for spills/leaks in the wastewater collection tank; 

Reply: Because the periphery of the tank is surrounded by a coaming, there will 

be no effect on the surrounding area in the unlikely event of a leak. It 

should also be noted that the collected wastewater is discharged 

immediately after confirming with a simple sensor that it does not contain 

residual chlorine, and is not stored in the tank. 

.3 manual handheld (residual chlorine meter) measurements of residual 

chlorine concentration in the waste water tank. 

Reply: The operation procedure for the portable residual chlorine meter was 

attached to the appendix of the assessment report. 

2.4 Identification of chemicals 

The disinfectant/biocidal agent (trade name: TG BallastcleanerÆ), which is used in JFE-BWMS is 

an aqueous solution of sodium hypochlorite (CAS No. 7681-52-9). The content of Free Available 

Chlorine (FAC) consists of two classes: TG BallastcleanerÆ having a FAC concentration of more 

than 5% to 10%, or TG BallastcleanerÆ having a FAC concentration of more than 10% to 13% or less. 

A reducing/neutralizing agent, TG EnvironmentalguardÆ, consists of two classes: an aqueous 

solution with a concentration of 10% to 13%, and a solid form. 

2.5 Definition of Active Substances, other components and Relevant Chemicals 

TG BallastcleanerÆ comprises sodium hypochlorite as an Active Substances (AS) as its main 

component, and sodium chloride and sodium hydroxide as other components (OC), which are 

contained due to the manufacturing method. 

Regarding the second chemical TG EnvironmentalguardÆ, which is used to eliminate the TRO in 

the ballast water including residual chlorines and others, this chemical comprises sodium sulfite, 

which is the other component as its main component, and sodium sulfate as the other component, 

which is contained as a result of the manufacturing process. 

Relevant Chemicals (RC) in this ballast water treatment system are the following 23 chemicals 

which were pointed out in the Basic Approval process by the GESAMP-BWWG: hypochlorous 

acid, chloroform, dichlorobromomethane, dibromochloromethane, bromoform, hypobromous acid, 

sodium hypobromite, bromate ion, monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, 

bromochloroacetic acid, bromodichloroacetic acid, dibromochloroacetic acid, monobromoacetic 

acid, dibromoacetic acid, tribromoacetic acid, chloroacetonitrile, dichloroacetonitrile, 

trichloroacetonitrile, dibromoacetonitrile, bromochloroacetonitrile and monochloramine. 
MEPC 60/2/2 

ANNEX 

Page 9 

I:\MEPC\60\2-2.doc 

A list of chemical identification of the above Active Substances, other components and Relevant 

Chemicals is shown in Table 2.5.1. 

Table 2.5.1: List of Chemical Identification 

Name of chemical 

substance IUPAC CAS No. Molecular 

weight 

Chemical 

formula Structural formula 

Active Substances 

AS Sodium hypochlorite Sodium hypochlorite 

7681-52-

9 74.45 NaClO Na-Cl-O 

Other Components 

OC1 Sodium hydroxide Sodium 

Hydroxide 

1310-73-

2 40.00 NaOH NaOH

OC2 Sodium chloride Sodium Chloride 7647-14-

5 58.44 NaCl NaCl

OC3 Sodium sulfite Sodium Sulfite 7757-83-

7 126.06 Na2SO3

NaO

NaO

S O

OC4 Sodium sulfate Sodium Sulfate 7757-82-

6 142.04 Na2SO4 S

O

O

NaO ONa

Relevant Chemicals 

RC1 Hypochlorous acid Hypochlorous 

acid 

7790-92-

3 84.64 HClO H-O-Cl 

RC2 Chloroform Trichloromethane 67-66-3 119.4 CHCl3 H C

Cl

Cl

Cl

RC3 Dichlorobromo 

methane 

Dichlorobromom

etahne 75-27-4 163.82 CHBrCl2 C Cl

Br

H

Cl

RC4 Dibromochloro 

methane 

Dibromochlorom

ethane 124-48-1 208.27 CHBr2Cl C

Cl

Br

Br

H

RC5 Bromoform Tribromomethane 75-25-2 252.7 CHBr3 H C Br

Br

Br

RC6 Hydrobromous acid Hypobromous 

acid 

13517-

11-8 96.91 HBrO H-O-Br 

RC7 Sodium hypobromite Sodium 

hypobromite 

13824-

96-9 118.89 NaBrO Na-O-Br 

RC8 

Bromate ions (CAS 

No., molar mass, etc., 

are shown at sodium 

bromate.) 

Bromate 7789-38-

0 150.9 NaBrO3 Br

O

O

NaO
MEPC 60/2/2 

ANNEX 

Page 10 

I:\MEPC\60\2-2.doc 

Name of chemical 

substance IUPAC CAS No. Molecular 

weight 

Chemical 

formula Structural formula 

RC9 Monochloro 

acetic acid 

Monochloroacetic acid 79-11-8 94.5 CH2ClC

OOH C

O

Cl

C OH

H

H

RC10 Dichloro 

acetic acid 

Dichloroacetic 

acid 79-43-6 128.9 CHCl2CO

OH C

O

Cl

H C OH

Cl

RC11 Trichloroacetic acid 

Trichloroacetic acid 76-03-9 163.4 CCl3COO

H C

Cl O

Cl

Cl C OH

RC12 Bromochloroacetic acid 

Bromochloroacetic acid 5589-96-

8 173.39 CBrClHCOOH C

O

H C OH

Cl

Br

RC13 Bromodichloroacetic acid 

Bromodichloroacetic acid 71133-

14-7 207.84 CBrCl2C

OOH C

O

C OH

Cl

Cl

Br

RC14 Dibromochloroacetic acid 

Dibromochloroacetic acid 5278-95-

5 138.95 Br2ClCC

OOH C

O

C OH

Br

Cl

Br

RC15 Monobromoacetic acid 

Monobromoacetic acid 79-08-3 138.95 BrCH2C

OOH C

O

C OH

H

H

Br

RC16 Dibromoacetic acid Dibromoacetic 

acid 631-64-1 217.84 CHBr2C

OOH C

O

C OH

Br

H

Br

RC17 Tribromoacetic acid Tribromoacetic 

acid 75-96-7 296.74 Br3CCO

OH C

O

C OH

Br

Br

Br

RC18 Chloroacetonitrile 

Chloroacetonitrile 107-14-2 75.47 CH2ClCN H C C

Cl

N

H

RC19 Dichloroacetonitrile 

Dichloroacetonitrile 3018-12-

0 109.94 CHCl2CN C

Cl

H C

Cl

N

RC20 Trichloroacetonitrile 

Trichloroacetonitrile 545-06-2 154.39 CCl3CN C

Cl

C

Cl

Cl N

RC21 Dibromoacetonitrile 

Dibromoacetonitrile 3252-43-

5 198.84 CHBr2C

N H C C N

Br

Br
MEPC 60/2/2 

ANNEX 

Page 11 

I:\MEPC\60\2-2.doc 

Name of chemical 

substance IUPAC CAS No. Molecular 

weight 

Chemical 

formula Structural formula 

RC22 Bromochloroacetonitrile 

Bromochloroacetonitrile 83463-

62-1 154.39 CHBrClC

N H C C

Cl

N

Br

RC23 Monochloramine Chloramide 10599-

90-3 51.48 NH2Cl N

H

Cl

H

3 TEST RESULTS AND DATA ON TOXICITY 

3.1 Results of land-based test and onboard test 

Land-based test and onboard test were conducted to collect data for evaluating the treatment 

performance of the system and conducting the risk assessment. The following summarizes the 

ballast water management systems used for the land-based and onboard tests and describes the 

results. 

3.1.1 Land-based test 

The land-based test of the ballast water management system was conducted at Ballast Tech NIVA AS 

(called BTN, http://www.ballasttech-niva.no/) in Norway. The 10 land-based test cycles 

including 5 cycles each for brackish water and seawater were conducted in total at a sodium 

hypochlorite concentration of 20 mg/L, the maximum injection concentration converted to 

effective chlorine. A test cycle consisting of the experimental items provided by Guidelines (G8) 

was conducted for brackish water in the operating condition in which the measurement of TRO 

meter is 10 mg/L which is normal operation condition. Verification test to determine whether the 

neutralization/reduction of TRO is completed in the ballast pipe during deballasting was 

performed for all test cycles. 

3.1.1.1 Results of the land-based test 

Chemical and biotic water quality parameters of the test water specified in Guidelines (G8) 

satisfied the reference value in all test cycles of land-based test. Treatment performance of 

organisms such as plankton and bacteria satisfied the D-2 standard in all test cycles. 

The following show the concentration of Relevant Chemicals, and the results of the toxicity tests to 

the five marine organisms for the 4-cycle seawater test and the 4-cycle brackish water test in which 

Relevant Chemicals were analysed. Only the results of the test on the secondary treated ballast 

water after the neutralization/reduction conducted after 5 days (Day 5) are shown in this summary. 

3.1.1.1.1 Analysis of Relevant Chemicals 

Table 3.1.1 shows the mean, standard deviation, and maximum values of relevant chemicals in 

the 4 test cycles for brackish water and 4 test cycles for seawater, respectively, as a summary of 

the results of measurements. 

The analytical values below the detection limit are mentioned as ìLT.DL.î in a note underneath 

the table. 
MEPC 60/2/2 

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In the table, the shade cells are the substances for which analytical values above the detection 

limit were detected. Those detected in the brackish water tests were bromodichloromethane, 

dibromochloro-methane, bromoform (tribromomethane), bromate ion, bromochloroacetic acid, 

and dibromoacetic acid. In addition to these, monobromoacetic acid and tribromoacetic acid 

were detected in the seawater tests. 

Bromoform, which particularly attracted attention, showed a mean of 310 μg/L 

(maximum: 330 μg/L) in the brackish water tests, whereas, in the seawater test, a mean 

of 123 μg/L (maximum: 180 μg/L) was detected. It is considered that the difference of water 

quality in the brackish water and seawater has influence on the test. 

Bromate ion showed a mean of 12.0 μg/L (maximum: 18.0 μg/L) in the brackish water tests, but 

a mean of 34.0 μg/L (maximum: 46.0 μg/L) was detected in the seawater tests. 

Dibromoacetic acid showed a mean of 24.0 μg/L (maximum: 47.0 μg/L) in the brackish water 

tests, but a mean of 5.8 μg/L (maximum: 8.7 μg/L) was detected in the seawater tests. 

Table 3.1.1: Analytical values of Relevant Chemicals in the land-based test 

maximum

value

mean

value

standard

deviation

maximum

value

mean

value

standard

deviation

μg/l μg/l μg/l μg/l μg/l μg/l μg/l

RC2 Chloroform 0.1 LT.DL.* LT.DL LT.DL. - LT.DL. LT.DL. LT.DL. -

RC3 Bromodichloromethane 0.1 0.88 0.81 0.08 3,4,5,6 0.70 0.33 0.25 7,8,9,10

RC4 Dibromochloromethane 0.1 16.00 13.00 2.16 3,4,5,6 6.60 4.50 1.45 7,8,9,10

RC5 Bromoform 0.1 330.00 310.00 21.60 3,4,5,6 180.00 122.50 38.62 7,8,9,10

RC6 Hydrobromous acid - -

RC7 Sodium hypobromate - -

RC8 Bromate ion 1.0 18.00 12.00 7.62 3,4,6 46.00 34.00 14.45 7,8,9,10

RC9 Monochloroacetic acid 0.5 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC10 Dichloroacetic acid 0.3 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC11 Trichloroacetic acid 0.2 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC12 Bromochloroacetic acid 0.1 0.47 0.39 0.08 3,4,5,6 0.43 0.24 0.17 9,10

RC13 Bromodichloroacetic acid 0.1 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC14 Dibromochloroacetic acid 0.1 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC15 Bromoacetic acid 0.2 LT.DL. LT.DL. LT.DL. - 5.70 1.58 2.75 7

RC16 Dibromoacetic acid 0.1 47.00 23.98 19.06 3,4,5,6 8.70 5.80 2.97 7,8,9,10

RC17 Tribromoacetic acid 0.1 LT.DL. LT.DL. LT.DL. - 0.10 0.10 0.00 9,10

RC18 Chloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC19 Dichloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC20 Trichloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC21 Dibromoacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC22 Bromochloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -

RC23 Monochloroamine - -

* : LT.DL.. = less than detection limit

Bold character indicate the measured maximum value

Detected substances are indicated in the shaded cells

Measured as TRO

Haloacetic acids Halo- acetonitriles

Measured as TRO Measured as TRO

Relevant Chemicals

Trihalomethanes Bromate

Measured as TRO

Detection

Limit.

Brackish Water Seawater

Test Cycle 3,4,5,6

Detected

Test

Cycle

Test Cycle 7,8,9,10

Detected

Test

Cycle

Class

No. Name of

chemical species

3.1.1.1.2 Biological parameters 

The results of the toxicity test conducted on the 5 types of marine organisms are shown below. In 

this table, TGBC and TGEG are abbreviations of TG BallastcleanerÆ and TG EnvironmentalguardÆ, 

respectively. 
MEPC 60/2/2 

ANNEX 

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A. Results of the growth inhibition test on marine algae (Skeletonema costatum) 

Table 3.1.2 shows the values of EC10 and EC50 obtained from the growth inhibition test. 

These results indicate that the effect on growth inhibition was not seen except in the case of 66% 

of EC10 on Day 5 during the test cycle 1 and 100% of EC10 on Day 5 during the test cycle 2. 

Table 3.1.2: Results of the growth inhibition test on marine algae (Skeletonema costatum) 

Test 

cycle 

Test 

water 

Day 

No. Water condition EC10 (%) EC50 (%) 

0 Immediately after TGBC injection 2.0 2.3 1 Seawater 5 After TGEG neutralization 66 >100 

0 Immediately after TGBC injection 1.0 1.4 2 Brackish 

water 5 After TGEG neutralization 100 >100 

0 Immediately after TGBC injection 1.9 1.8 3 Brackish 

water 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 3.1 3.4 4 Brackish 

water 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 3.7 4.4 5 Brackish 

water 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 1.5 1.7 6 Brackish 

water 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 0.98 0.95 7 Seawater 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 0.15 0.27 8 Seawater 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection >1.8 >1.8 9 Seawater 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 0.42 0.70 10 Seawater 5 After TGEG neutralization >100 >100 

0 Immediately after TGBC injection 1.9 1.7 11 Brackish 

water 5 After TGEG neutralization >100 >100 

Note: (ì>100%î means that no effect was seen in the test using the raw water for the secondary 

treated ballast water.) 

B. Results of the acute toxicity test to marine copepods (Acartia tonsa) 

Results of the acute toxicity test to marine copepods (Acartia tonsa) are shown in Table 3.1.3. 

Table 3.1.3: Acute toxicity test on Acartia tonsa, a type of marine copepods 

Acute toxicity test on invertebrate (Acartia tonsa) 

Test cycle Test water Collection 

date 

Test result 

48H-NOEC % Comment 

8 Seawater 2009.02.25 >100 % 

The death rate was zero in all test 

concentrations up to the 100% 

concentration of the secondary treated 

water. 
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C. Reproduction toxicity (chronic toxicity) to Nitocra spinipes, a type of marine copepods 

Reproduction toxicity (chronic toxicity) to Nitocra spinipes, a type of marine copepods is shown 

in the Table 3.1.4. 

Table 3.1.4: Results of the chronic toxicity test on Nitocra spinipes, a type of marine 

copepods 

Results of reproducible toxicity test (chronic toxicity test) on Nitocra spinipes, a type of marine 

copepods 

Test cycle Test water Collection 

date 

Test result 

14d-NOEC % Comment 

3, 4 Brackish 

water 

2009.01.19 

2009.01.26 >100 % No significant effect was seen on 

reproducibility. 

D. Oyster embryo 

Chronic toxicity test was conducted on oyster embryo. Table 3.1.5 shows the results. No effect 

was seen at all concentrations. 

Table 3.1.5: Results of the chronic toxicity test on oyster embryo 

E Acute toxicity to juvenile turbot (Scophthalmus maximus) 

Acute toxicity to juvenile turbot (Scophthalmus maximus) is shown in Table 3.1.6. 

Table 3.1.6: Results of the acute toxicity test on fish 

Results of the acute toxicity test on fish (juvenile turbot) 

Test cycle Test water Collection date 

Test result 

96H-NOEC 

(%) 

Comment 

6 Brackish 

water 2009.02.09 >100 % The limit test showed no effect 

7 Seawater 2009.02.16 >100 % The limit test showed no effect 

Results of the chronic toxicity test on oyster embryo 

Test cycle Test water Collection 

date 

Test result 

48H-LC50

(%) 

Test result 

48H-NOEC 

(%) 

Comment 

3 Brackish 

water 2009.01.19 >100 % ≥ 100 % No effect was seen at all 

concentrations. 

7 Seawater 2009.02.16 >100 % ≥ 100 % Ditto 
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F. Chronic toxicity to juvenile turbot (Scophthalmus maximus) 

Chronic toxicity to juvenile turbot (Scophthalmus maximus) is shown in Table 3.1.7. 

Table 3.1.7: Results of the chronic toxicity test on fish 

Results of the acute toxicity test on fish (juvenile fish) 

Test cycle Test water Collection date Test result 

28d-NOEC 

(%) 

Comment 

3-6 Brackish 

water 

2009.01.19 

-2009.02.17 >100 %

 The limit test showed no effect. 

Lack of weight increase at controlled 

section. 

7-10 Seawater 2009.02.16 

-2009.03.17 >100 % The limit test showed no effect. 

G. Chronic toxicity on Brachiomus plicatilis using a reproduction test 

Chronic toxicity on Brachiomus plicatilis, a type of marine rotatoria, tested using a reproduction 

test is shown in Table 3.1.8. 

Table 3.1.8: Results of the chronic toxicity test on marine rotatoria 

Reproduction test using marine rotatoria (Brachiomus plicatilis)(chronic toxicity) 

Test cycle Test water Collection date Test result 

LC50 (%) 

Test result 

NOEC (%) Comment 

5 Brackish 

water 2009.01.26 >100 % ≥ 100 % No effect was seen at all 

concentrations. 

10 Seawater 2009.03.09 >100 % ≥ 100 % No effect was seen at all 

concentrations, 

The following conclusion was obtained from the results of these toxicity tests: 

In the growth inhibitory experiments using Skeletonema costatum, only two out 

of 11 cases exhibited minor effects as measured utilizing EC10. No effects were 

observed in other organisms and in other test conditions. These results demonstrate 

ballast water after neutralization/reduction treatment in the present system has no effect 

against aquatic organisms. 

3.1.1.2 Neutralization verification experiments 

In this system, since a larger amount of TG EnvironmentalguardÆ than what is stoichiometrically 

needed is injected to neutralize/reduce TRO completely, the discharge water contains a slightly 

excessive amount of sodium sulfite. Because reduction speed with TRO is extremely high, ballast 

water is completely neutralized and reduced in the piping if the stirring after injection is sufficient. 

To validate the above, ballast water is sampled from the lower side of piping below the nozzle 

where TG EnvironmentalguardÆ is injected to. The fact that TRO is less than 0.02 mg/L was 

confirmed after TRO analysis using a newly developed ìhigh resolution absorption photometryî 

with a detection limit of 0.0012 mg/L and a lower quantification limit of 0.004 mg/L. 
MEPC 60/2/2 

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The reduction of dissolved oxygen concentration of ballast water before and after 

neutralization/reduction treatment during deballasting is confirmed to be at only about 10%. 

Therefore, it was concluded that it has no effect of reduction of dissolved oxygen against living 

organisms. 

3.1.2 Onboard test (Reference data) 

Although the main subject of this application is the risk assessment using the data obtained in the 

land-based test, a voluntary onboard test was conducted in order to obtain data for the case in 

which this system is actually operated on a ship. 

The ship used in the onboard test was a Box Shape Bulker with a dead weight of 46,882MT. 

This ballast water treatment system was installed only in the ballast piping system on the left side 

of the ship when the ship was newly constructed. 

As a result of this experiment, it was possible to confirm that this system conforms to the D-2 

performance standard contained in the Ballast Water Management Convention, including cases in 

which ballasting and deballasting operations are performed with actual ballast tanks. The 

experiment also confirmed that neutralization and reduction treatment during discharge are 

performed in the same manner as in the land-based test, and furthermore, the species of Relevant 

Chemicals contained in the discharged ballast water after neutralization are the same, and their 

concentrations are lower than the maximum values in the land-based test. 

3.2 Methods of analysing environmental concentration 

In this system, control of injection rates related to chemicals, measurements of TRO, and analysis 

to confirm complete neutralization and reduction are performed as follows. 

3.2.1 Analytical method for TRO 

(TRO: hypochlorite, hypochlorous acid, hypobromite, hypobromous acid, and monochloramine) 

The analytical methods used were the ordinary N, N-Diethyl-P-Phenylenediamine method (DPD); 

(lower detection limit: 0.02 mg/L) and, as a high resolution analytical method (lower detection 

limit: 0.0012mg/L) for detection of TRO in low concentrations after neutralization treatment, a 

method in which the optical path length in the DPD method was 5 cm or longer. 

These methods were also used in calibration of the TRO meters used in chemical injection 

control and monitoring of TRO neutralization and reduction. 

3.2.2 Analytical method for bromate

The analysis is obtained by a post-column method using an ion chromograph. The lower 

detection limit is on the order of 1 μg/L. 

3.2.3 Analytical method for trihalomethanes, haloacetic acids, and haloacetonitriles

The analysis of trihalomethanes and haloacetonitriles in seawater was performed in accordance 

with Japanís Tap Water Test Method. Measurements were made using a purge-and-trap gas 

chromatograph/mass spectrometer (GC/MS). The lower detection limit is on the order of 1 μg/L. 
MEPC 60/2/2 

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In the analysis of haloacetic acids, tert-butyl methyl ether extraction was performed, and 

measurements were made with a GC/MS following methylation with diazomethane. 

For the haloacetonitriles, tert-butyl methyl ether extraction was performed, and measurements 

were made with a GC/MS. 

3.3 Quality Assurance and Quality Control 

For reliable implementation of Quality Assurance/Quality Control (QA/QC) in chemical experiments 

and chemical analyses for resolving the main chemical items related to this application, a Quality 

Assurance Committee including members of all the companies concerned was established, and 

the system for audits/approvals and responsibility for implementation was clarified. 

3.3.1 QA/QC system 

All drafting and implementation of plans and reporting and verification of the results were 

performed in accordance with the Quality Assurance Project Plan (QAPP) audited and approved 

by the Quality Assurance Committee. 

3.3.2 QA/QC

In this application, appropriate QA/QC were performed in accordance with the Quality 

Assurance Project Plan (QAPP) and the Standard Operation Procedures (SOP), and the same 

obligation was also imposed in commissioned tests (e.g., Ballast Tech-NIVA). 

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

sensitive and representative organisms 

In this section, only data of the influence on aquatic organisms are shown. The evaluation of 

each item is described in Chapter 6. 

3.4.1 Acute aquatic toxicity 

3.4.1.1 Active Substances 

The object of study as an Active Substances is sodium hypochlorite, which is the main 

component of TG BallastcleanerÆ. 

Because the sodium hypochlorite (NaClO) contained in TG BallastcleanerÆ partially forms 

hypochlorous acid (HClO) in ballast water, the acute toxicity value for the most sensitive species 

in free chlorine is for the Water flea (Ceriodaphnia dubia), which shows LC50 24 h with a 

concentration of 0.005 mg/L 1. The acute toxicity of many life forms is between 0.01 and 0.1 mg/L. 

3.4.1.2 Other components 

The other components are sodium hydroxide (NaOH), sodium chloride (NaCl), sodium sulfite 

(Na2SO3) and sodium sulfate (Na2SO4). Sodium chloride is the main component of ballast water 

(seawater) and as sodium hydroxide exists only in a trace amount, sodium hydroxide does not 

cause changes in the pH of seawater. Therefore, these two substances were excluded from the 

scope of study in this section. Sodium sulfite, which is the main component of 

TG EnvironmentalguardÆ, and sodium sulfate were considered as object substances. 
MEPC 60/2/2 

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Sodium sulfite, which is the main component of TG EnvironmentalguardÆ, reduces and 

neutralizes TRO in disinfected seawater, thereby completely eliminating this substance. The 

unreacted sodium sulfite reacts with the dissolved oxygen in the disinfected ballast water, 

forming sodium sulfate, and is released into the ballast-water discharge waters. 

The acute toxicity for aquatic organisms is described as follows: the most sensitive species of 

aquatic life for sodium sulfite at 16-32 mg/L (as SO3-S) 2 are Green algae (Chlamydomonas 

reinhardtii) EC50 8.9 h, (Chlorella vulgaris) EC50 6.4 h, and (Scenedesmus basiliensis) EC50 8.2 h. 

On the other hand, the most sensitive species for sodium sulfate is the aquatic plant Diatom 

(Nitzschia linearis), which showed TLm 120 h = 1,900 mg/L 3. 

3.4.1.3 Relevant Chemicals 

Substances in this summary is limited to 8 types of Relevant Chemicals detected in the landbased test, among which most sensitive species from the acute toxicity test are described. Other 

Relevant Chemicals are described in the full text or in the appendix 1 (Key Data). 

Data on the toxity of RC12-bromochloroacetic acid is not available and was substituted by the 

data of dibromochloroacetic acid which has higher toxicity based on the chemical structure. 

Table 3.4.1: Acute toxicity of most sensitive species for Relevant Chemicals by class 

Class Species End point Period Concentration 

(mg/L) Reference 

RC3 Dichlorobromomethane 

 

Other life forms 

(ciliates) (Tetrahymena pyriformis) EC50 

Growth rate 24h 240 

Y.Yoshioka 

et al.

(1985) 

RC4 Dibromochloromethane 

Other organisms 

(ciliates) 

Ciliate 

(Tetrahymena pyriformis) EC50

24h 

(Growth 

rate) 

65 

Y.Yoshioka 

et al.

(1985) 

RC5 Bromoform (tribromomethane) 

Fish (seawater 

acclimation) 

Sheepshead minnow 

(Cyprinodon variegatus) LC50 96h 7.1 G.S.Ward et al.

(1981) 

RC8 Sodium bromate 

Invertebrate 

(molluscan) 

Pacific Oyster 

(Crassostrea gigas) LC50 96h >30 E.A. Crecelius

RC12 Bromochloroacetic acid 

 - - - - No data 

RC15 Monobromoacetic acid 

Aquatic plants 

(algae) 

Green algae 

(Scenedesmus 

subspicatus) 

EμC50 

Growth rate 72h 1.4 R. Kuhn et al. 

(1990) 

RC16 Dibromoacetic acid 

Fish Fathead minnow 

(Pimephales promelas) LC50 96h 69 M.A. Mayes et al. (1985) 

RC17 Tribromoacetic acid 

Fish Java medaka 

(Oryzias javanicus) LC50 96h 101 Appendix 13 9
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3.4.2 Chronic aquatic toxicity 

The chemical substances examined in section 3.4.1 were also the objects of this section. 

3.4.2.1 Active Substances 

The object of study as an Active Substances is sodium hypochlorite, which is the main 

component of TG BallastcleanerÆ. 

Because the sodium hypochlorite contained in TG BallastcleanerÆ partially forms hypochlorous 

acid (HClO) in ballast water, the chronic toxicity results for the most sensitive species in free 

chlorine was Cladoceran (Daphnia magna), NOEC 14d = 2-4 μg/L10. Thus, other genera, not 

limited to the water flea, showed toxicity values on the order of 10 μg/L. 

3.4.2.2 Other Components 

Although a search of the literature was carried out, chronic toxicity values for sodium sulfite and 

sodium sulfate could not be obtained. 

Sodium sulfite, which is the main component of TG EnvironmentalguardÆ, changes to sodium 

sulfate, and the second main component of seawater, in a short period of time (15 minutes: 

materials were submitted at time of Basic Approval). Therefore, it is judged that no chronic 

toxicity exists. 

3.4.2.3 Relevant Chemicals 

Eight limited kinds of Relevant Chemicals, which were detected in the land-based tests are 

described in this summary. 

It was not possible to find chronic toxicity data for RC3-bromodichloromethane, 

RC4-dibromochloromethane, RC8-bromate ion, RC12-bromochloroacetic acid, and 

RC17 tricbromoacetic acid. The evaluations of the chronic toxicities of bromodichloromethane 

and dibromochloromethane were performed using data for bromoform, based its structural 

relationship with the aforementioned substances. 

The chronic toxicity values for bromate ion, bromochloroacetic acid, and tribromoacetic acid 

were evaluated considering a safety factor in the acute toxicity values.

Table 3.4.2: Chronic toxicity of most sensitive aquatic life in Relevant Chemicals by class 

Class Species End 

point Period Concentration(mg/L) Reference 

RC5 Bromoform (tribormomethane) 

Fish 

Sheepshead minnow 

(Cyprinodon 

variegatus)

NOEC 4d 2.9 

P.T. Heitmuller 

et al. 

(1981) 

RC15 Monobromoacetic acid 

Invertebrate 

(crustaceans) 

Water flea 

(Daphnia magna) NOEC 21d 3.2 R.Kuhn et al. 

(1989) 
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3.4.3 Endocrine disruption 

The applicants confirmed that the Active Substances, four other chemical substances, 

and 23 Relevant Substances related to TG BallastcleanerÆ and TG EnvironmentalguardÆ are not 

included in the Candidate list of 553 substances in the EC report, ìTowards the establishment of a 

priority list of substances for further evaluation of their role in endocrine disruption.î 

In submitting this proposal, the applicants also confirmed that there have been no changes in the 

contents of the above-mentioned report from the time of Basic Approval. 

3.4.4 Sediment toxicity 

For substances which have the potential property of accumulating or adsorbing in large quantity 

in sediments, toxicity with respect to organisms inhabiting sediments will be evaluated. 

As the evaluation standard, Log Kow has been adopted in accordance with the Methodology for 

information gathering and conduct of work of the GESAMP-BWWG (BMW.2/Circ.13, 10 June, 2008), 

by referring Hazardous Substances Data Bank (HSDB), a database of the National Library of 

Medicineís TOXNET system (http://toxnet.nlm.nih.gov/)) and Syracuse Research Corporationís 

database (http://www.srcinc.com/what-we-do/databaseforms.aspx?id=385). 

3.4.5 Bioavailability, biomagnification, and bioconcentration 

Evaluation criteria are the bioconcentration factor (BCF) >2000 obtained in the experiment 

Methodology (BMW.2/Circ.13, 10 June 2008). 

Therefore, these values are cited from HSDB and the Syracuse Research Corporation database. 

3.4.6 Food web and population effects 

Because no data are available, it was evaluated by using the BCF values. 

3.5 Data on mammalian toxicity 

In this section, only data on mammalian toxicity is described, and evaluation for each item is 

described in section 7.2. 

3.5.1 General 

Mammalian and human toxicity by Active Substances, other components and Relevant 

Chemicals in relation to TG BallastcleanerÆ was assessed. 

Subjects evaluated include acute toxicity, effects on skin and eyes, repeated dose toxicity, chronic 

toxicity, developmental and reproductive toxicity, carcinogenicity, mutagenicity and genotoxicity 

and toxicokinetics. Only Active Substances and bromoform, the most concerned chemical in 

Relevant Chemicals, are described in this summary. 
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3.5.2 Acute toxicity 

3.5.2.1 Acute toxicity of Active Substances 

Toxicity in oral dosage of chlorine water (sodium hypochlorite) to rats and toxicity in inhalation 

of sodium hypochlorite in mice are shown in Table 3.5.2.1. 

Table 3.5.2.1: Acute toxicity and LD50 of Active Substances in mammals 

 Value Species Reference/Comments/Justification for missing data 

AS Sodium hypochlorite 

Oral LD50 (mg/L) 1.23-1.46g/kg 

12.5% FAC 

Rat Proposal for the Health Classification and Labelling of 

the ESR substance Sodium Hypochlorite,ECBI/14/05 

Dermal LD50 (mg/L) No data 

Inhalation LC50

(mg/L/4h) 

>10.5mg/L 

air rate 

10 L/min 

Rat IUCLID P.61 (95) 

3.5.2.2 Acute toxicity of Relevant Chemicals 

Toxicity in oral dosage and toxicity in inhalation of bromoform to rats are shown in Table 3.5.2.2. 

Table 3.5.2.2: Acute toxicity and LD50 of bromoform in mammals 

 Value Species Reference/Comments/Justification for missing 

data 

RC5 Bromoform 

Oral LD50 (mg/L) 1,147 mg/kg Rat female HSDB(2005)

Dermal LD50 (mg/L) No Data

Inhalation LC50

(mg/L/4h) 

No Data Can be substituted with data for chloroform, which 

displays high volatility. 

3.5.3 Effects on skin and eye 

3.5.3.1 Effects of Active Substances on skin and eye 

Exposure to sodium hypochlorite in a percent range caused skin and eye irritation, but no effect 

was observed in the concentration of general use (10-100 ppm as free available chlorine). 

3.5.3.1.1 Skin and eye irritation 

(Effects will be described depending on a level of free available chlorine.) 

A. Case of 10% free available chlorine or higher 

A study by Colgate-Palmolive Company (1985) indicates exposure of 12.7% hypochlorite caused 

only mild irritation of normal or scratched skin of rabbits. Duprat (1974) found exposure 

of 12.5% hypochlorite caused severe skin irritation in rabbits, but concluded this irritation does 

not correspond to corrosive effects according to EU criteria. In eye irritation (including corrosive 

effects), corrosive effects on eye were demonstrated at the concentration of 14.25% (Grant, 1962) 

and 12.7% (Colgate-Palmolive, 1985). 
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B. Case of an aqueous solution of 5-10% free available chlorine 

Osterberg (1977) reported significant irritation effects were not observed in skin irritation of 

animals exposed to about 5% solution as well as Nixon (1975) found very minor irritation to 

rabbits in toxicity test. However, the exposure to 5% solution or higher caused human skin 

irritation (Nixon, 1975). 

3.5.3.1.2 Skin sensitization

Skin sensitization was not found in an animal test with an 8% hypochlorite solution according to 

a standard sensitization procedure. There are a few reports on cases of allergic contact dermatitis 

caused by skin sensitization to the hypochlorite and conclusive agreement has not been reached yet. 

No skin sensitization of sodium hypochlorite has been proposed based on these collected data. 

3.5.3.2 Effects of other components on skin and eye 

Irritation of the skin and eyes by sodium hydroxide is extremely strong. 

Regarding irritation of the skin and eyes by sodium sulfite, although based on limited study, the 

results have shown that this substance is not a strong irritant. Descriptions of the skin 

sensitization of sodium sulfite were not found in IUCLID or HSDB. 

With sodium sulfate, no irritation was observed, even when 500 mg was applied in a rabbit test. 

Regarding irritation of the eyes, the description states that this chemical causes very slight 

irritation in cases where it actually penetrates the eyes, but the affected part recovers. Although 

no direct data were available for sensitization by sodium sulfate, as noted in the table, OECD 

SIDS has rejected the possibility that sodium sulfate causes increased sensitization. 

3.5.3.3 Effects of Relevant Chemicals on skin and eye 

Table 3.5.3.1: Effects of bromoform on skin and eye 

Species Method Results 

(including scores where available) 

Reference/Comments/ 

Justification 

for missing data 

RC5 Bromoform 

Skin Rabbit Single doses of 2,000mg/kg under a cuff

on the intact skin of rabbits were 

survived by two rabbits treated with 

undiluted bromoform. 

HSDB(2005) 

Eye Rabbit The undiluted liquid was moderately 

irritating to rabbit eyes. Healing 

appeared complete in 1 to 2 days. 

HSDB(2005)

3.5.4 Repeated dose toxicity tests 

3.5.4.1 Repeated dose toxicity of Active Substances 

Repeated dose toxicity of the Active Substances in mammals was not available in the data listed 

in NOAEL. 
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3.5.4.2 Repeated dose toxicity of Relevant Chemicals 

NOEL data was obtained on RC3-Dichlorobromomethane, RC4-Dibromochloromethane, 

RC-Bromoform, and RC16-Dibromoacetic acid, and listed in the tables below. 

Table 3.5.4.1: Repeated dose of RC3-Dichlorobromomethane 

Exposure Route Oral administration 

Exposure Duration 102 weeks 

Exposure dose 0, 25, or 50 mg/kg/day 

Species 50 male B6C3F1 mice 

Method Gavage 

Results renal cytomegaly in male mice, an effect considered minimal in the 

absence of data demonstrating renal functional impairment 

NOAEL 1.79 mg/kg/day 

= LOAEL 17.9 mg/kg/day (25 mg/kg/day x 5 days/7 days) x 0.1 

NOEL No description 

Reference/Comments/ 

Justification for missing data EPA IRIS (2008) 

Table 3.5.4.2: Repeated dose of RC4-Dibromochloromethane 

Exposure Route Oral administration 

Exposure Duration 13 weeks 

Exposure dose 0, 15, 30, 60, 125, or 250 mg/kg 

Species Fischer-344 rats and B6C3F1 mice 

Method Fischer-344 rats and B6C3F1 mice were administered 0, 15, 30, 60, 125, 

or 250 mg/kg chlorodibromomethane for 13 weeks by gavage. 

Results A Fisher Exact test showed that incidences of these liver lesions at doses 

of 60 mg/kg/day or above were elevated relative to the vehicle controls, 

thus 30 mg/kg/day is the NOEL. 

NOAEL 21.4 mg/kg/day

NOEL No description 

Reference/Comments/ 

Justification for missing data EPA IRIS (2008) 

Table 3.5.4.3: Repeated dose of RC5-Bromoform 

Exposure Route Oral 

Exposure Duration 13w 

Exposure dose 0, 12, 25, 50, 100, 200 mg/kg/day (5 days/week) 

Species Rat 

Method Gavage Bioassy 

Results Hepatocellular vacuolization was observed in most male rats (10/l0 at 

200 mg/kg, 8/10 at 100 mg/kg, 8/10 at 50 mg/kg, 5/10 at 25 mg/kg, 6/10 

at 12 mg/kg, and 3/10 vehicle controls). 

NOAEL 17.9 mg/kg/day (converted from 25mg/kg/day)

NOEL No description 

Reference/Comments/ 

Justification for missing data EPA IRIS (2008) 
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Table 3.5.4.4: Repeated dose of RC16-Dibromoacetic acid 

Exposure Route Oral (Gavage) 

Exposure Duration 2 to 79days 

Exposure dose No description 

Species Rats 

Method Rats were gavaged daily for 2 to 79 d with a by-product of water 

disinfection, dibromoacetic acid (DBAA). 

Results No abnormalities were detected at the dosage of 2 mg/kg. The changes 

suggest that the testicular effects of DBAA are sequelae to structural 

and/or functional changes in the Sertoli cell. 

NOAEL 2 mg/kg/day

NOEL No description 

Reference/Comments/ 

Justification for missing data HSDB(2009) 

3.5.5 Chronic Toxicity 

3.5.5.1 Chronic toxicity of Active Substances 

NOAEL data were obtained and listed in the table below. 

Table 3.5.5.1: Chronic toxicity of AS-Sodium hypochlorite 

Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose 0, 70, 140, 275 mg/L 

Species F344 rats 

Method Drinking water 

Results No effects seen at 14 and 66 weeks. 

NOAEL 14.4 mg/kg/day

NOEL No description 

Reference/Comments/ 

Justification for missing data

Proposal for the Health Classification and Labelling of the ESR subtance 

Sodium Hypochlorite,ECBI/14/05 

3.5.5.2 Chronic toxicity of Relevant Chemicals 

NOAEL data of RC8-bromate ion were obtained and listed in the table below. 

Table 3.5.5.2: Chronic toxicity of RC8-Bromate ion 

Exposure Route Oral 

Exposure Duration 100 weeks 

Exposure dose 0, 1.1, 6.1, 12.9, and 28.7 mg BrO3

-

/kg-day 

Species F344 rat male 

Method Drinking water 

Results Nonneoplastic kidney lesions were observed in rats. Although the 

severity of chronic nephropathy was comparable between control and 

treated rats, there was a significant dose-dependent increase in the 

incidence of urothelial hyperplasia in rats in dose groups of 6.1 mg/kgday and higher. 

NOAEL 1.1 mg BrO3

-

/kg-day (converted from 1.5 mg KBrO3/kg-day) 

NOEL No description 

Reference/Comments/ 

Justification for missing data EPA IRIS (2001) 
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3.5.6 Developmental and reproductive toxicity 

3.5.6.1 Developmental and reproductive toxicity of Active Substances 

Data on developmental and reproductive toxicity of sodium hypochlorite is limited, but there is 

no direct evidence to indicate the adverse effect of sodium hypochlorite on development and 

reproduction. Similarly, there is no evidence of adverse effect in an epidemiological study on 

people drinking chlorinated water. These studies indicate sodium hypochlorite should not be 

classified into the substances adversely affecting reproduction. 

3.5.6.2 Developmental and reproductive toxicity of Relevant Chemicals 

An example for the case of bromoform is shown below. 

Table 3.5.6.1: Developmental and reproductive toxicity of RC5-bromoform 

Exposure Route Injection 

Exposure Duration 10 days 

Exposure dose 100-200 mg/kg/day 

Species Guinea pig 

Method Injection of 100-200 mg/kg/day to Guinea pig for 10 days 

Results Pathological change in kidney and liver 

NOAEL No description 

NOEL No description 

Reference/Comments/ 

Justification for missing data HSDB (2005) 

3.5.7 Carcinogenicity 

3.5.7.1 Carcinogenicity of Active Substances 

In a study on carcinogenicity of the drinking water in rats and mice, there was no evidence to 

demonstrate the incidence of tumor increase by Active Substances. Available data do not indicate 

that sodium hypochlorite has to be classified as carcinogenic. International Agency for Research 

on Cancer (IARC) presumes sodium hypochlorite belongs to Group 3 (not classifiable as 

carcinogenic to human). Sodium hypochlorite is therefore not treated as carcinogenic. 

3.5.7.2 Carcinogenicity of Relevant Chemicals 

Data on bromoform is listed in below. 

Table 3.5.7.1: Carcinogenicity of RC5-Bromoform 

Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

F344/N rats 2 yr gavage studies There was no evidence of carcinogenic 

activity for male B6C3F1 mice given 50 or 

100 mg/kg bromoform or for female B6C3F1 

mice given 100 or 200 mg/kg; male mice 

might have been able to tolerate a higher 

dose. Survival of female mice was reduced, 

partly due to a utero-ovarian infection

HSDB(2005) 
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3.5.8 Mutagenicity and genotoxicity 

3.5.8.1 Mutagenicity and genotoxicity of Active Substances 

There was some data indicating in vitro mutagenic activity of sodium hypochlorite, but a detailed in 

vivo study using mice indicates this substance has no mutagenic activity (Hayashi et al., 1988). 

Other in vivo study also showed no mutagenic effect of this substance. These data related to 

genetic toxicity of sodium hypochlorite did not indicate the final conclusion15, but further data 

would not be required based on no effects on carcinogenicity. Data obtained indicate sodium 

hypochlorite does not exhibit mutagenicity so that this substance is not classified as mutagenic. 

3.5.8.2 Mutagenicity and genotoxicity of Relevant Chemicals 

A case of bromoform is described in table below. 

Table 3.5.8.1: Mutagenicity and genotoxicity of bromoform 

Species Method Details Results Reference/ 

Comments/ 

Justification for 

missing data 

Aroclorinduced rat 

liver S9 

fraction 

Based on preliminary bacterial 

toxicity determinations, 

bromoform was evaluated for 

mutagenicity at concentrations 

of 5, 10, 50, 100, 500, and 1000 

ug/plate using the direct plate 

incorporation method. 

The mutagenicity of bromoform was 

also tested for mutagenicity in 

Salmonella tester strains TA98, 

TA100 and TA1535, both with and 

without metabolic activation at dose 

levels of 0.02, 0.05, 0.1, and 0.2 

ml/dessicator. In this study, 

bromoform caused a reproducible 

positive response in all three strains. 

HSDB(2005) 

3.5.9 Toxicokinetics 

3.5.9.1 Toxicokinetics of Active Substances 

No data existed. 

3.5.9.2 Toxicokinetics of Relevant Chemicals 

An example of bromoform is described in the table below. 

Table 3.5.9.1: Toxicokinetics of RC5-Bromoform

Species Observation/Remarks 

Reference/ 

Comments/ 

Justification for 

missing data 

No description Bromoform metabolized to carbon monoxide by hepatic microsomal 

mixed function oxidases. HSDB(2005) 
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4 USE OF ACTIVE SUBSTANCES AND CHEMICALS 

4.1 Method of using chemicals 

Usage of TG BallastcleanerÆ and TG EnvironmentalguardÆ was described in ìOnboard 

instruction manual of chemicalsî supplied separately by the chemical producer. 

4.2 Chemical Supply System 

The system shall be supplied with the chemicals TG BallastcleanerÆ and TG 

EnvironmentalguardÆ produced and quality-assured by Toagosei Co., Ltd. and the supply 

network. 

4.3 Chemical supply method 

The chemicals shall be safely and securely supplied to chemical storage tanks on the ship 

equipped with the system by using small containers made of proper materials, tank trucks, and 

small chemical tankers. 

5 MATERIAL SAFETY DATA SHEETS (MSDS) 

The material safety data sheets (MSDS) for TG BallastcleanerÆ and TG EnvironmentalguardÆ

have been revised from the Basic Approval version in accordance with GHS classification. 

Details are shown in appendix of the assessment report. 

6 RISK CHARACTERIZATION 

6.1 Screening for persistency, bioaccumulation and toxicity 

Risk evaluations in connection with persistence, bioaccumulation and toxicity were conducted 

for the chemicals detected in the land-based tests (treated ballast water after 

neutralization/reduction). The chemicals detected in those land-based tests and their measured 

maximum concentrations are shown below in Table 6.1.1. 

Table 6.1.1: Chemicals detected in land-based test and their maximum concentrations 

Chemical Measured maximum concentration (mg/L) 

RC3 Dichlorobromomethane 0.88×10-3

RC4 Dibromochlormethane 16×10-3

RC5 Bromoform 330×10-3

RC8 Bromate 46×10-3

RC12 Bromochloroacetic acid 0.47×10-3

RC15 Monobromoacetic acid 5.7×10-3

RC16 Dibromoacetic acid 47×10-3

RC17 Triibromoacetic acid 0.1×10-3
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It should be noted that sodium sulfite, which is the main component of TG EnvironmentalguardÆ

and is classified as an Other Component, rapidly changes to sodium sulfate by reaction with 

dissolved oxygen that exists in the surface layer water. Accordingly, for sodium sulfite, it is 

appropriate to evaluate only acute toxicity for aquatic life. 

Regarding sodium sulfate, which forms by decomposition of sodium sulfite, the sulfuric acid ion 

concentration calculated from the composition of general seawater is 2,701mg/kg, whereas the 

sulfuric acid ion concentration contributed by ballast water treated with sodium sulfite 

is 24.8 mg/L, and thus is approximately 1/100 of the concentration that naturally exists in 

seawater. Although there is considered to be no risk of effects on aquatic environments into 

which treated ballast water is discharged, the acute toxicity of this chemical will be evaluated. 

6.1.1 Persistency 

Degradation of the object chemical substances occurs by abiotic degradation (hydrolysis) and biotic 

degradation (aerobic degradation and anaerobic degradation). However, because the amount of 

micro-organisms necessary to demonstrate the degradation capacity in the judgment criteria 

(half-life in seawater of 60 days or less) does not exist in ballast water or in waters where ballast 

water is discharged, biotic degradation virtually cannot be expected. Accordingly, because abiotic 

degradation (hydrolysis) is the main reaction, all of the object chemicals were determined to be 

persistent (Yes), based on the criterion for persistency (half-life in seawater exceeds 60 days). 

6.1.2 Bioaccumulation 

Object chemical substances are determined to be non-bioaccumulative as the log Pow is less than 

three for all compounds. 

6.1.3 Toxicity tests 

6.1.3.1 Acute toxicity 

Acute toxicity of object chemical substances against aquatic organisms is listed in the 

aforementioned Table 3.4.1. 

Because sodium sulfite, which is an other component of TG EnvironmentalguardÆ, is added in a 

quantity greater than the equivalent amount necessary to reduce all of the residual chlorine, 

excess sodium sulfite remains in the treated ballast water and is discharged into the waters during 

deballasting. The water into which the treated ballast water is discharged is the surface layer 

water. The remaining sodium sulfite from the reaction with TRO reacts with the dissolved 

oxygen that exists in the surface layer of the water and is rapidly oxidized to sodium sulfate. 

Accordingly, based on this property of sodium sulfite, it is appropriate to evaluate only acute 

toxicity for aquatic life, and evaluation based on the PEC/PNEC ratio will be performed. 

Sodium sulfite reacts with dissolved oxygen to form sodium sulfate. This reaction was 

confirmed at the time of Basic Approval, and the fact that it is almost consumed within 15 

minutes was shown. 

From the above fact, it is considered that all of the sodium sulfite, which is added in an excess 

quantity forms sodium sulfate within 15 minutes after deballasting in the treated ballast water and 

seawater. In the above-mentioned land-based tests, it has been confirmed that it does not affect 

dissolved oxygen. 
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6.1.3.2 Chronic toxicity 

The chronic toxicity values of the object chemicals for aquatic life obtained from the database, as 

shown in the previous Table 3.4.2, were RC5-bromoform, 2.9 mg/L and RC15-monobromoacetic 

acid, 3.2 mg/L. As these values greatly exceeded the T criterion, NOEC<0.01mg/L, in the 

PBT criteria, chronic toxicity was determined to be No (no chronic toxicity). 

Chronic toxicity data were not obtained on RC3-dichlorobromomethane, 

RC4-dibromochloromethane, RC12-bromochloroacetic acid, RC16-dibromoacetic acid, 

RC17-tribromoacetic acid, and RC8-bromate ion. NOEC 0.01 mg/L or more can be expected, as 

those acute toxicity values listed in Table 3.4.1 are 1.0 mg/L level or more. Therefore, the 

evaluations were NO (does not display chronic toxicity). 

6.1.4 Evaluation by PBT Criteria 

The results up to this point for the respective substances were arranged according to the PBT 

criteria as shown in Table 6.1.2. 

Table 6.1.2: PBT criteria for 8 chemical substances 

 Object chemical 

substances of PBT 

criteria 

Persistence 

P (Yes or No)

Bioaccumulation 

B (Yes or No) 

Toxicity 

T (Yes or No)

OC Sodium hypochlorite No No No 

RC3 Dichlorobromomethane Yes No No 

RC4 Dibromochloromethane Yes No No 

RC5 Bromoform Yes No No 

RC8 Sodium bromate Yes No No 

RC12 Bromochloroacetic acid Yes No No 

RC15 Monobromoacetic acid Yes No No 

RC16 Dibromoacetic acid Yes No No 

RC17 Triibromoacetic acid Yes No No 

Substances which are evaluated ìYesî for all of the items Persistence, Bioaccumulation, and 

Toxicity in this table are identified as PBT substances. 

As shown in the table, all of the chemicals are not PBT substances. However, for chemical 

substances which are evaluated as displaying persistence, PEC/PNEC values were calculated in 

order to evaluate the effects on the aquatic environment, and this evaluation was made. 

6.1.5 Evaluation by PEC/PNEC 

The PEC/PNEC ratio was evaluated using the acute toxicity data for the aquatic organisms 

against the target substance, the maximum concentration of the target substance detected in the 

land-based test, and the MAM-PEC Model to calculate the degree of dilution of ballast water in 

the port. The input data used in MAM-PEC Model assumes higher ballast water amount so as 

not to underestimate actually discharged ballast water in a year in the Rotterdam port. 

The chemical species for which PEC/PNEC calculations were made were the 9 species of 

dichlorobromomethane, dibromochloromethane, bromoform, bromochloroacetic acid, 

monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, bromate ion, and sodium sulfite. 
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Because the acute toxicity values were used, the factor 1000 was taken from Table 2 in the 

Methodology (BWM.2/Circ.13, 10 June 2008) and was selected as the assessment factor for use 

in the calculations. 

An average GRT in the table is recalculated for daily basis to generate 1,067 kt/day for the 

number of arriving ships, which is then multiplied by 0.5 for a ratio of the ballast water 

discharging ship for evaluation, resulting in a GRT of 533.5 kt/day. Using the above calculation 

results in 280.1 kt/day for the amount of ballast water per day. 

The values of predicted environmental concentration (PEC) obtained by dividing the maximum 

measured value obtained in the land-based test by the dilution factor obtained from the 

aforementioned MAM-PEC Model, the predicted no-effect concentration (PNEC) obtained by 

dividing each maximum acute toxicity value by the assessment factor of 1000, and the obtained 

PEC/PNEC ratio are shown in Table 6.1.3. As the evaluation standard, PEC/PNEC>1 is 

considered to indicate that the substance has an effect on aquatic life. 

As a result, all of the substances to be designated as evaluation object were determined as having 

no effect on aquatic life. 

Table 6.1.3: PEC/PNEC values 

Yes: Effect on aquatic organism, No: No effect on aquatic organism 

Test substance Species Dilution 

factor 

Maximum 

measured 

value 

PEC PNEC PEC/ 

PNEC Evaluation 

 ( ) mg/L (mg/L) ( ) mg/L 

RC3 

Dichlorobromo- 

-methane 

Other life forms 

(Ciliates) 

(Tetrahymena 

pyriformis) 

379 0.88×10-3 0.00232 

×10-3

240×10-3 9.7 

×10-6

No 

RC4 

Dibromochloro- 

-methane 

Other life forms 

(Ciliates) 

(Tetrahymena 

pyriformis) 

465 16×10-3 0.0344 

×10-3

65×10-3 5.3 

×10-4

No 

RC5 

Bromoform 

Fish (acclimatization 

to seawater) 

Sheepshead minnow 

(Cyprinodon 

variegatus) 

418 330×10-3 0.789 

×10-3

7.1×10-3 0.111 No 

RC8 

Sodium bromate 

Mollusks 

Pacific oyster 

(Crassostrea gigas) 

184 46×10-3 0.250 

×10-3

25.4×10-3 0.0098 No 

RC12 

Bromochloroacetic 

acid 

Not possible to obtain 

data. 

Based on structure, 

substituted with high 

toxicity 

bromodichloroacetic 

acid. 

182 0.47×10-3 0.00258 

×10-3

53×10-3 4.9 

×10-5

No 
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Test substance Species Dilution 

factor 

Maximum 

measured 

value 

PEC PNEC PEC/ 

PNEC Evaluation 

 ( ) mg/L (mg/L) ( ) mg/L 

RC15 

Monobromoacetic 

acid 

Aquatic plant (algae) 

Green algae 

(Scenedesmus 

subspicatus) 

182 5.7×10-3 0.0313 

x10-3

1.4 

x10-3

0.022 No 

RC16 

Dibromoacetic 

acid 

Fish 

Fathead minnow 

(Pimephales 

promelas) 

182 47×10-3 0.258 

×10-3

69 

×10-3

3.74 

×10-3

No 

RC17 

Tribromoacetic 

acid 

Fish 

Java medaka 

(Oryzias javanicus) 

182 0.1×10-3 0.55x10-6 101x10-3 5.4x10-6 No 

OC3 

Sodium sulfite 

Aquatic plant (algae) 

Green algae 

(Chlamydomonas 

reinhardtii, 

Chlorella vigaris, 

Scenedemus 

basiliensis) 

442656 22 0.0497 

×10-3

63 

×10-3 

*1 

0.00080 

(Short 

term) 

No 

Note: 1: Method of calculating PNEC for sodium sulfite 

PNEC: The most sensitive species used for sodium hypochlorite is Aquatic plant (algae) (Chlamydomonas 

reinhardtii, Chlorella vilgaris, Scenedesmus basiliensis), EC50, 6.4 h-8.9 h, 16-32 mg/L (as SO3-S).

Accordingly, the value is 40 mg/L (=(16 x 80)/32) as SO3, that is, 63 mg/L (=(16 x 126)/32) as sodium sulfite. 

PNEC is obtained by dividing this value by the above-mentioned assessment factor of 1000, the result being 

PNEC=63 μg/L. 

6.2 Evaluation of treated ballast water 

6.2.1 Results and evaluation of land-based tests 

The land-based tests of this ballast water treatment system were performed at Ballast Tech NIVA AS

in Norway. The location of the experiments was an experimental station in Solbergstrand, which

is approximately 30 km south of Oslo. Land-based tests comprised a total of 10 cycles were

conducted consisting of 5 cycles each with brackish water and seawater. 

During the period when the land-based tests were performed, this ballast water treatment system 

operated smoothly. All equipment in the injection of TG BallastcleanerÆ, the neutralization 

process using TG EnvironmentalguardÆ etc., including concentration control, operated as 

expected. 

Various types of measurements were performed. The operation of the treatment system was 

smooth, and also satisfied the treatment effect as judged by the D-2 standard. Measurements of 

the environmental risk of Relevant Chemicals were also performed, and various data contributing 

to the study of risk were collected. 
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.1 Treatment rate: 

- The test water treatment rate was at the set value of 350 m3

/h and satisfied the test 

condition. 

.2 Water quality items: 

- The water quality of the test water was water temperature: 0.15-5.1°C, 

pH: 7.95-8.6, DO: 8.8-11.8 mg/L, salinity: 20.6-21.5 (PSU, in tests of brackish 

water) and 32.1-33.6 (PSU, in tests of seawater). Although the tests were 

performed under rather low water temperature conditions, there were no items that 

showed abnormal values. 

In both the brackish water tests and the seawater tests, the values of DOC, POC, 

and TSS all exceeded the levels specified in the Guidelines (G8), and tests 

succeeded. 

.3 Relevant Chemicals: 

- Analysis of Relevant Chemicals was performed for the 23 substances designated 

by the GESAMP-BWWG.. 

As a result, 8 items shown in Table 6.1.1 were detected, and these were studied 

respectively as objects of risk assessment. 

.4 Analysis of chemical activity: 

- For the trihalomethanes, etc., time-dependent change was analysed up to 48 hours 

immediately after neutralization. As a result, the trihalomethanes showed a 

tendency to decrease slightly after neutralization treatment. Bromate ion showed 

virtually no change. In brackish water, the halogenated acetic acids showed a 

peak after 2−4 hours, and a decreasing tendency thereafter. In seawater, these 

substances showed a peak after 24 hours, followed by a decreasing tendency. 

.5 D-2 standard biological items: 

- As results of the measurements of L and S size aquatic organisms and bacteria, the 

D-2 standards were fullfiled in all tests. 

.6 Toxicity tests: 

- The toxicity tests, which were performed included a growth inhibition test for 

diatoms, acute toxicity test for crustaceans, reproduction effect test for 

crustaceans, acute toxicity test for oyster embryos, acute toxicity and chronic 

toxicity tests for juvenile fish, and a reproduction effect test for rotifers. 

Summarizing the results as a whole, in these toxicity tests, the deballast water 

after neutralization treatment can be evaluated as displaying no toxicity. 

However, effects of the treated water could be seen in one test item. It was the 

growth inhibition test of the diatom Skeletonema costatum. In 2 of 11 cases, 

values of 66% and 100% were measured for EC10. (In all other cases, they 
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were >100%.) However, it is difficult to say that there was any large effect, as the 

value when calculated as EC50 was >100%, and the value of 66% also shows no 

effect when diluted by 2 times. Because no effects were observed with the 

exceptions of this item, the effect on aquatic life of the deballast water treated with 

this system is considered to be extremely slight. 

.7 Confirmation of neutralization 

- With this system, ballast water is discharged after neutralization of the TRO. The 

TG EnvironmentalguardÆ used in neutralization is added in an excess quantity. 

Confirmation of neutralization was performed by a residual chlorine sensor 

incorporated in the system. However, in the land-based tests, these results were 

verified by manual analysis. The DPD method was used. In measurements 

using an absorption spectroscopy (manufactured by HACH), the detection limit 

was 0.02 mg/L, and it was not possible to confirm reductions below this level. 

Therefore, neutralization was confirmed by also using a high resolution absorption 

spectroscopy measurement method with detection limit of 0.0012 mg/L, using an 

absorption spectroscope with a 5 cm cell length. The complete neutralization was 

successfully confirmed, and satisfactory result was obtained. 

.8 Reduction of dissolved oxygen concentration in discharged water 

- Theoretically, it can be judged that the reduction of dissolved oxygen by 

TG EnvironmentalguardÆ (main component: sodium sulfite), which is added in an 

excess amount in the neutralization process, is minimal. However, because there 

were misgivings regarding the effect of TG EnvironmentalguardÆ on the dissolved 

oxygen in environmental waters, the actual values were measured. As a result, the 

difference in dissolved oxygen before and after neutralization was judged to be 

very slight. 

6.2.2 Evaluation of onboard tests 

Voluntary onboard tests were carried out twice. Due to the small amount of the S size (10 μm to 

less than 50 μm) existing in these tests, the tests were not completely consistent with the official 

test cycle. However, results, which satisfied the D-2 standard, were obtained from measurements 

of aquatic organism of the L size (50 μm and larger) and S size. The evaluation of bacteria is 

omitted because these were qualitative tests. 

It was confirmed that neutralization and reduction treatment during discharge are performed in 

the same manner as in the land-based test and, furthermore, the species of Relevant Chemicals 

contained in the discharged ballast water after neutralization are the same and their 

concentrations are lower than the maximum values in the land-based test. 

6.2.3 Determination of holding time 

Holding time is not necessary before discharge of the treated ballast water because no TRO in the 

ballast water is discharged outboard in this ballast water treatment system by being instantly 

reduced and neutralized by sodium sulfite immediately prior to discharge. 
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6.3 Risk characterization and analysis 

6.3.1 Reaction with organic matter 

The Relevant Chemicals detected in the land-based test and their concentrations are shown in 

Table 6.1.1. The following evaluations were conducted. 

6.3.2 Characterization of degradation routes and rates 

Degradation of the object chemical substances occurs by abiotic degradation (hydrolysis) and 

biotic degradation (aerobic degradation and anaerobic degradation). However, because abiotic 

degradation (hydrolysis) is the main reaction, all of the chemicals, which were subject to 

evaluation, were determined to be persistent ìYesî. 

6.3.3 Prediction of discharge and environmental concentration 

The predicted environmental concentration (PEC) at the Port of Rotterdam was calculated using 

the maximum concentrations detected in the land-based test and a MAM-PEC Model for 

obtaining the degree of dilution of the ballast water in the harbour. 

6.3.4 Evaluation of potential for bioaccumulation 

The substances of concern were evaluated as having no effects, as BCF<2000 or LogKow<3 for 

all of the substances. 

6.3.5 Environmental assessments 

Because all of the substances of concern displayed BCF<500 and have low bioaccumulation potential, 

assessment of secondary poisoning of top predators such as mammals, birds, etc., is not necessary. 

All of the substances of concern also displayed Koc<500 and have low potential to partition into 

sediments; therefore, assessment of effects on sediment species is not necessary. 

6.3.6 Effect on aquatic organisms 

The evaluation criterion value (PEC/PNEC) based on PEC (Predicted Environmental Concentration), 

which is obtained by dividing the maximum measured values obtained in the land-based test by the 

dilution factor obtained with the MAM-PEC model, and thePredicted No-Effect Concentration 

(PNEC), which is obtained by dividing the respective maximum acute toxicity values by an 

assessment factor of 1000, was <1 for all of the chemical substances which were objects of 

evaluation. Therefore, all of the chemicals were evaluated as having no effect on aquatic life. 

6.3.7 Effect of sediment species 

The substances of concern were evaluated as having no effect because LogKow<3 in all cases. 

6.3.8 Effect on mammalian species 

NOAEL was described, this being necessary in evaluations by the Margin of Safety (MOS), as 

described in section 3.5 above. Regarding toxicokinetics, the results of a search of databases were 

shown in the section 3.5 above. However, it was not possible to obtain data that could be evaluated. 
MEPC 60/2/2 

ANNEX 

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6.3.9 Comparison of effect Assessments and discharge toxicity 

A toxicity test of the discharge water during deballasting in the land-based test was performed 

using the 5 species shown in 3.1.1.1, and it was confirmed that the discharge water displays no 

acute toxicity or chronic toxicity. Because this does not contradict the results for the acute 

toxicity and chronic toxicity of the individual substances in section 3.4, a more detailed 

evaluation of effects is not necessary. 

Regarding dissolved oxygen in the land-based test and environmental waters, judging from the 

measured values obtained in the land-based test, any effects are extremely slight. 

7 RISK ASSESSMENT 

7.1 Risks to ship safety 

7.1.1 Effects on ship hull and safety 

Figure 2 summarizes the systems for supplying TG BallastcleanerÆ and TG EnvironmentalguardÆ

used for ballast water treatment (JFE-BWMS). 

Figure 2: Diagram of TG BallastcleanerÆ and TG EnvironmentalguardÆ supply systems 

7.1.1.1 Effects on hull 

The past durability tests on coating have proved that the concentration of a solution injected into 

ballast tanks has no effect on the hull and pipes as measures such as epoxy lining or coating are 

taken to protect them from the corrosion caused by treated ballast water. 

Pumps and valves are operated by the remote auto-controller 
MEPC 60/2/2 

ANNEX 

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Since TG EnvironmentalguardÆ is only limited to the reaction of the reduction of 

TG BallastcleanerÆ and the consumption of dissolved oxygen, it has no effect on the hull and 

ballast water pipes where treated ballast water flows. 

7.1.1.2 Effects on ballast tanks 

The surfaces (for tank inner surfaces) must be coated or lined (for pipes) with chlorine- and salt 

water-resistant epoxy resins and other materials to protect ballast tanks from corrosion. 

7.1.1.3 Effects on hull plates 

During deballasting, residual chlorine disappears and TG EnvironmentalguardÆ becomes somewhat 

excessive. At that time, TG EnvironmentalguardÆ acts as a reducing agent of residual chlorine in 

treated ballast water and its reducing power is stronger than those of transition metals such as 

iron and zinc. It has therefore no effect on the outside plating of the ship made of steel plates. 

7.1.1.4 Measures related to ballast water management system 

Possible leakage places such as the surrounding of chemical storage tanks were chosen and 

proper measures such as coaming were taken. 

7.1.1.5 Countermeasures for corrosion 

Since sodium hypochlorite, which is the main component of TG BallastcleanerÆ, is a corrosive 

substance, the risk of corrosion of the parts directly touching treated ballast water such as ballast 

tanks and pipes is likely to increase compared to the normal case of ballasting with seawater. 

Corrosion tests were conducted to quantitatively understand the effects on the following parts of 

the hull related to the taking and discharging of ballast water: 

.1 Coated steel plates: 

 - used for the inner surfaces of ballast tanks and ballast pipings 

.2 Uncoated steel plates: 

 - Bulk carriers sometimes take seawater into their cargo holds in heavy ballast 

condition. 

.3 Galvanized steel pipe: 

 - used for parts of ballast pipings 

.4 Zinc electrode for electric corrosion protection: 

 - used for electrolyte corrosion protection in ballast tanks 

.5 Gasket: 

 - used for the flanged joints of ballast pipings 
MEPC 60/2/2 

ANNEX 

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.6 Constituent material for butterfly valve: 

 - Material constituting the butterfly valve used in the ballast piping 

.7 Rubber material for valve sealing: 

 - used for ballast piping valves 

Most of the inner surfaces of ballast tanks and ballast pipes are epoxy resin coated. Existing 

ships and new ships mostly use tar epoxy paints and modified epoxy paints, respectively. Using 

these two types of paints with a film thickness of about 250 μm to 300 μm, ìcoating durability 

testsî and ìsimulated defective coating durability testsî were conducted. 

Since bulk carriers sometimes take seawater into their cargo holds in heavy ballast condition and 

their uncoated steel plates have chances to touch ballast water, uncoated steel plates were tested. 

We also tested galvanized steel pipes, which are occasionally used for parts of ballast water pipes. 

For comparison, natural seawater and the simulated ballast water made of natural seawater and 

TG BallastcleanerÆ with a concentration of 20 mg/L (upper injection limit concentration) were used. 

Assuming an actual uptaking and discharging pattern of ballast water, we set an effective concentration 

of initially injected chloride at 20 mg/L, left the specimens in the air for 3 days after soaking them 

in the solution for 7 days, and again injected TG BallastcleanerÆ to a concentration of 20 mg/L. 

Experiments were conducted by repeating this cycle of 10 days 18 times for 180 days. 

As a result, the difference between the seawater environment and the natural seawater 

environment had no significant effect on the potentials. 

7.1.2 Chemical supply system 

7.1.2.1 Chemical supply equipment 

TG BallastcleanerÆ and TG EnvironmentalguardÆ are supplied to ballast pipes from their 

chemical storage tanks by remotely controlling the valves and pumps. Crew has hence no 

chances of touching the chemicals during normal ballast water treatment operation. 

7.1.2.2 Chemical storage requirements 

Chemicals are supplied to their storage tanks on the ship from a tank truck on land or a chemical 

supply boat anchored close aboard the ship when the ship is moored. 

7.1.2.3 Chemical storage tanks 

Materials for the TG BallastcleanerÆ storage tank shall be steel plates coated or lined with 

polypropylene, polyethylene, or polyvinyl chloride, or Titanium and Titanium alloy plates. 

Materials for the TG EnvironmentalguardÆ storage tank shall be steel plates coated or lined with 

polypropylene, polyethylene, or polyvinyl chloride, stainless steel plates. 

7.1.2.4 Flash point/ignition temperature of chemicals 

Both chemicals have no danger of self-ignition. 
MEPC 60/2/2 

ANNEX 

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7.1.3 Chemical management methods 

7.1.3.1 Management method for TG BallastcleanerÆ 

If TG BallastcleanerÆ is stored at a high temperature, its main component sodium hypochlorite 

partly decomposes into sodium chloride and oxygen. The liquid temperature needs to be kept 

at 20°C or less to inhibit the decomposition. Measures, such as installing an equipment to 

directly cool the storage tank or placing the tank in an air-conditioned compartment, shall be taken. 

TG BallastcleanerÆ freezes when cooled at 0°C or less. The frozen chemical causes pipes to clog 

and the inner pressures to increase, leading to possible pipe rupture. The temperature hence shall 

be kept at 0°C or higher by wrapping insulating material around the pipe. 

7.1.3.2 Management method for TG EnvironmentalguardÆ

When TG EnvironmentalguardÆ is used in a cold region, the chemical freezes. The liquid 

temperature hence shall be kept at 0°C or higher, taking measures such as covering the container 

with insulating materials. 

7.1.3.3 Precautions in handling of chemicals 

Since TG BallastcleanerÆ is a strong alkali reactive chemical, it needs to be handled with the 

greatest care referring to the instruction manual (for example, operation supplying the chemical 

to the ship). 

7.1.4 Health risk to crew and deck personnel 

7.1.4.1 Effects on health of crew and deck personnel 

Since the ballast water control system installed on the ship is remotely operated, human exposure 

to chemical substances is hardly probable during ballast water treatment operation on the ship. 

7.1.4.2 Crew and deck personnel exposure scenarios 

No human exposure occurs under normal operation. 

7.1.4.3 Response to leaks 

When chemical leakage occurs, the main valve of the chemical storage tank concerned shall be 

immediately closed. When a small quantity of TG BallastcleanerÆ leaks on the floor in a 

coaming, the leaked liquid shall be washed out to the wastewater collection tank after diluting it 

with a large quantity of general service water. In the case of a large quantity of leakage, the 

leaked liquid shall be washed out to the wastewater collection tank after neutralizing and 

reducing it with TG EnvironmentalguardÆ for the reduction of TB BallastcleanerÆ. The crew 

engaged in the washing operation shall wear safety glasses and a disaster-prevention mask, 

protective equipment, and protective gloves. 

Although TG BallastcleanerÆ is a safe chemical, it produces chlorine when contacting acids, and 

hence chemical products such as acids shall not be stored near the chemical tank and the supply 

line. Bulletin boards shall be placed in working spaces to call attention to the safety of this 

operation. 
MEPC 60/2/2 

ANNEX 

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7.1.4.4 Response during emergency stops and power outages 

The following are emergency shutdown and power failure response procedures: 

Emergency shutdown: 

- When emergency shutdown is needed, injection pumps shall be immediately 

stopped at the machine side or through remote control to discontinue the injection 

of TG BallastcleanerÆ into ballast water. 

Power outage response: 

- When power outage occurs, the whole system of both TG BallastcleanerÆ and 

TG EnvironmentalguardÆ supply lines shall be stopped to prevent uncontrollable 

chemicals from flowing into ballast tanks and discharge area. A safety device 

such as the one needing resetting shall be installed in the system for the case of 

restarting the system after power return. 

7.1.4.5 Response during supply of chemicals 

When supplying TG BallastcleanerÆ or TG EnvironmentalguardÆ to their chemical storage tanks 

on the ship, operation shall be carried out following the instructions in the manual. 

7.1.4.6 Response during inspections and maintenance 

The daily inspection of chemical tanks shall be carried out to check leakage and damage to 

equipment, taking account of the safety of crew according to the manual. 

The repair of chemical tanks shall be carried out following the instructions in the manual on the 

washing and ventilation in the tanks, protective clothing, etc., to prevent crew and personnel from 

exposure to chemicals. 

7.1.5 Crew safety 

If the ballast water treatment system is normally operated and adequately maintained, the safety 

of crews can be provided. 

7.2 Risk to human health 

This section will study the risk to human health of the chemicals related to the JFE-BWMS, the 

treated ballast water which is stored in the ballast tanks before neutralization (primary treatment 

water), and the treated ballast water which is discharged from the ship after neutralization 

(secondary treatment water). 

The study of risk will be carried out in four stages, as follows: 

.1 Designation of the chemical substances which are objects of study. 

.2 Designation of the toxicities of the respective chemical substance. 

.3 Designation of the exposure level (concentration and duration or frequency) for 

the respective chemical substances. 

.4 Quantification of risk using these data. 
MEPC 60/2/2 

ANNEX 

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Predictions of exposure levels were made by calculation of the Margin of Safety (MOS) by the 

following formula, using the simulation program EUSES 2.1 for Human Exposure Scenario (HES). 

_ ( / / )

( / / )

Exposurel Level mg kg d

NOAEL mg kg d MOS =

Comparing the MOS obtained here and MOSref, this toxicity is allowable in cases greater than 

this; in other words, it is considered safe. As MOSref, 100 is generally used (this being the 

product of 10, representing the difference between humans and the species for which toxicity 

values were obtained, and 10, representing individual differences in humans). 

7.2.1 Exposure assessment 

.1 The chemical substances which are objects of study are the substances contained 

in the following liquids. 

.1 Chemicals (TG BallastcleanerÆ, TG EnvironmentalguardÆ) 

.2 Treated ballast water which has been treated by the BWMS and is stored in 

the ballast tanks before neutralization (primary treatment water) 

.3 Treated ballast water which has been withdrawn from the ballast tanks and is 

discharged from the ship after neutralization (secondary treatment water). 

.2 Classified in terms of the persons who are objects of study and exposure routes, 

the following two categories are considered. 

.1 Persons on onboard (crew, 8 hours/day x 5 days/week) 

 Exposure routes: Normally, respiration and dermal contact 

.2 General public (persons in port while ship is at anchor, persons in area near 

shore) 

Exposure routes: Oral ingestion, respiration and derm

.3 Condition of BWMS 

al contact. 

A summary of the individual operations studied for human risk on these liquids is shown in 

Table 7.2.1. 

Table 7.2.1: Individual operations studied for human risk and object liquids 

Crew General population 

(a) Normal operation (ballasting) B -- 

(a) Normal operation (deballasting) -- C 

(b) Resupply of chemicals A -- 

(c) Equipment breakdown A -- 

(d) Ship accident or other emergency A -- 

(e) Maintenance of ballast tanks and equipment A and B -- 

Here, A: Chemicals (TG BallastcleanerÆ, TG EnvironmentalguardÆ) 

 B: Treated ballast water store in ballast tanks before neutralization 

 C: Treated ballast water discharged from ship after neutralization
MEPC 60/2/2 

ANNEX 

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7.2.2 Human health effects 

In the land-based tests, 23 species of Relevant Chemicals contained in the treated ballast water 

were analysed. A total of 9 chemical substances, including sodium hypochlorite, which is Active 

Substance, and sodium sulfite, which is other component, in addition to 8 chemical substances 

detected in therein, were identified as objects of the following study of human health risk. 

7.2.3 Human Exposure Scenarios (HES) 

The single operation conditions recommended by the GESAMP-BWWG (MEPC 58/2/7, annex 5, 

paragraph 2.15.1 (A) and studied here were as follows: 

.1 Resupply of chemicals 

.2 Ballasting (taking on ballast water) 

.3 Deballasting (discharging ballast water) 

.4 Inspection and maintenance of equipment and chemical tanks 

.5 Inspection and maintenance of ballast tanks 

.6 Trouble and emergency states (concretely, this assumes breakdowns of the 

system and accidents) 

7.2.3.1 Exposure scenario during ballast water uptake and ballast tank maintenance 

Exposure levels for the Active Substance, sodium hypochlorite and the 8 Relevant Chemicals 

shown in Table 7.2.2 were estimated using EUSES 2.1, and were then used to determine risk. 

The oral NOAEL and inhalation NOAEL of the chronic toxicity of these chemical substances is 

shown in Table 7.2.2. 

The equation mentioned in EUSES 2.1 Background Report, Model Calculation, page III, and the 

conversion default values were used for converting the oral NOAEL to inhalation NOAEL. In 

the general population, IHair (respiration rate) is 20m3

/day, however, because a value of 10m3 for 

one 8-hour day was shown for personnel, this value was followed here. 

Table 7.2.2: Concentration contained in treated ballast water in land-based tests (μg/L) 

No. Chemical substances Oral NOAEL 

(mg/kg/d) 

Inhalation 

NOAEL(mg/m3

) 

Reference 

AS Sodium hypochlorite 14.4 50.4 ECBI/14/05 

RC3 Dichlorobromomethane 1.79 6.26 EPA IRIS 

RC4 Dibromochloromethane 21.4 74.9 EPA IRIS 

RC5 Tribromomethane 17.9 62.7 EPA IRIS 

RC8 Bromate 1.1* 3.85 EPA IRIS 

RC12 Bromochloroacetic acid 2* 7 - 

RC15 Monobromoacetic acid 2 7 - 

RC16 Dibromoacetic acid 2 7 HSDB 

RC17 Tribromoacetic acid 2* 7 - 

Note: * Because no NOAEL data were available for bromochloroacetic acid, monobromoacetic acid, and 

tribromoacetic acid, the NOAEL data for dibromoacetic acid, which is considered to have stronger 

toxicity, were substituted for these substances. 
MEPC 60/2/2 

ANNEX 

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I:\MEPC\60\2-2.doc 

The maximum concentration of sodium hypochlorite in the treated ballast water in the ballast 

tanks (primary treatment water) is 20 mg/L. However, the crews on onboard are not exposed to 

the treated ballast water as the ballast water piping and the ballast tanks form a closed loop. In 

the ballast tanks, ventilation vents are provided in order to keep the air pressure in the tank head 

space at the same level as the atmosphere, and the vent holes are normally on the deck. Because 

the air in the ballast tanks is discharged from these vents during ballasting, the effect on human 

health during this operation was studied by the following method. 

When the ship takes on ballast water, the air in the ballast tank head space is discharged outside 

of the ship through vents installed on the deck, etc., as the water level in the ballast tanks rises. 

Because exposure on deck is limited to mooring work when berthing and deberthing, the worst 

case is airborne exposure in the ballast tank head space during internal inspection work in the 

ballast tanks, which is performed with a frequency of approximately one time in 6 months. 

Using the assumed exposure time of 8 hours per month which was calculated based on the 

hearing results with domestic shipping companies and the maximum concentration detected in 

the land-based tests as input data, the human health risk was studied by calculations 

using EUSES 2.1. The calculated results of the obtained RCR (Risk Characterization Ratio 

= MOS/MOSref) are shown in Table 7.2.3. Because the result is larger than 1, it can be judged 

that there is no health risk to humans, and it is not necessary for the crew to wear personal 

protective equipment (PPE). 

Table 7.2.3: Health risk to crew of remaining water in ballast tank (primary treatment water) 

No. Test substance MOS MOSref RCR(MOS/MOSref) 

AS Sodium hypochlorite 1870 100 18.7 

RC3 Dichlorobromomethane 1640 100 16.4 

RC4 Dibromochloromethane 2930 100 29.3 

RC5 Tribromomethane 174 100 1.74 

RC8 Bromate ion 5000 100 50 

RC12 Bromochloroacetic acid 3.291x106 100 3.29x106

RC15 Monobromoacetic acid 9.21x107 100 9.21x105

RC16 Dibromoacetic acid 1.65x107 100 1.65x105

RC17 Tribromoacetic acid 1.02x1010 100 1.02x108

7.2.3.2 During ballast water discharge 

A EUSES 2.1 simulation was performed to consider exposure of the general population to 

bromoform, bromate ion, bromochloroacetic acid, monobromoacetic acid, and dibromoacetic 

acid. 

The calculated results of the obtained Risk Characterization Ratio (RCR) = MOS/MOSref) are 

shown in Table 7.2.4. Because the result is larger than 1, it can be judged that there is no health 

risk to humans, and risk control measures are not necessary. 
MEPC 60/2/2 

ANNEX 

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Table 7.2.4: Health risk to general public of discharged ballast water 

(secondary treatment water) 

Risk Characterization Ratio (MOS/MOSref) 

Local Regional No. Chemical substance 

Inhalatory Total 

Exposure 

Inhalatory Total 

Exposure 

RC3 Dichlorobromomethane 9.16 x106

 5.92 x106 9.48 x106 6.55x106

RC4 Dibromochloromethane 1.27x107

 3.01 x106 1.29 x107 3.38x106

RC5 Tribromomethane 4.89x105

 9.85x104 4.96x105 1.11x105

RC8 Bromate ion 1.58x1010 9.41x104

 6.24x1012 1.06x105

RC12 Bromochloroacetic acid 1.50x109

 1.32x107 1.58x109 1.46x107

RC15 Monobromoacetic acid 1.85x108

 1.87x105 2.01x108 1.89x105

RC16 Dibromoacetic acid 1.20x106

 1.56x105 1.25x108 1.79x105

RC17 Tribromoacetic acid 5.60x1012 5.60x107

 9.66x1012 6.11x107

7.2.3.3 Replenishment of chemicals and inspections and maintenance of equipment and 

chemical tanks 

It is necessary to conduct advance safety training for crew members using the Userís Manuals 

and Material Safety Data Sheets provided by the manufacturer of the chemicals. Safety is also 

secured by crew wearing personal protective equipment (PPE) during work. 

7.2.3.4 Inspections and maintenance of ballast tanks 

In cases where personnel enter ballast tanks, safety management is performed in accordance with 

a manual. There are no health-related problems for personnel under the condition that work is 

performed 8 hours/month, and it can be judged that wearing PPE is not necessary. However, in 

cases where work may exceed this frequency, in addition to securing safety by wearing PPE, it is 

desirable to wear an in-line mask or oxygen tank, particularly in cases where protection against 

inhalation is necessary. In the MOS calculation by EUSES 2.1, a condition, in which 

considerable time has passed since air was taken into the ballast tank, and the air and ballast 

water have reached a state of equilibrium, was calculated as the worst case. However, in cases 

where personnel actually enter ballast tanks to perform maintenance, etc., it can be assumed that 

virtually all of the air in the tank has been replaced with fresh air as a result of complete 

discharge of the ballast water immediately before the personnel enter the tank. Therefore, in the 

operational aspect, there are considered to be no safety-related problems even if personnel do not 

wear PPE. 

Normally, when entering a ballast tank for maintenance or other reasons, safety is further secured 

by performing gas detection and oxygen starvation measurements in the tank, and personnel enter 

the tank only after ventilation measures are taken. 

7.2.3.5 Malfunctions and accidents 

In the event of a chemical leak, clean-up work for TG BallastcleanerÆ and 

TG EnvironmentalguardÆ is performed. In this work, crew must wear the protective glasses or 

protective masks, rubber gloves, rubber boots, helmets, and other PPE and protective clothing 

specified in those paragraphs. 
MEPC 60/2/2 

ANNEX 

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7.3 Risk to water environment 

The assessment in the previous sections showed that involved substances are not PBT substance, 

and the PEC/PNEC ratios do not exceed 1. It is, therefore, judged that further assessment is not 

necessary. 

8 CONCLUSIONS 

Test results and evaluations up to the preceding chapters are summarized as follows. 

.1 The present system for treating ballast water has been smoothly operated for the 

land-based test and all equipment have been operated as planned in the injection 

of TG BallastcleanerÆ including controlling the concentration and the 

neutralization with TG EnvironmentalguardÆ. 

.1 The amount of test water treated was 350 m3/hr as a set value, satisfying 

the test conditions. 

.2 There were no test terms showing abnormality in the quality of test water. 

All of DOC, POC, and TSS values in tests of brackish water and seawater 

exceeded the standard specified by Guidelines (G8), thus meeting the test 

requirements. 

.3 Twenty-three substances specified by the GESAMP-BWWG were analysed 

as Relevant Chemicals. Following analysis of the results, 8 substances in 

the test required further evaluation for risk assessment. 

.4 Aquatic organisms, both large and small in size, as well as bacteria were 

tested in biological terms for the D-2 standard of ballast water. All tests 

results met the specified D-2 standard. 

.5 Toxicity tests performed included measuring the growth inhibition of 

Skeletonema costatum, acute toxicity to marine copepods, effects on the 

reproduction of marine copepods, chronic toxicity to oyster embryo, acute 

toxicity and chronic toxicity to juvenile fish, effects on reproduction of 

Rotifera (Brachinonus plicatilis), respectively. 

 After reviewing overall results, these toxicity tests demonstrate neutralized 

deballasted water is not toxic. 

.6 In the present system, the DPD method was used to confirm if the 

neutralization were completed, while the TRO is neutralized to be released 

into the aquatic environment. Using the absorbance method (by a 

spectrophotometer from Hach Co.), a detection limit was determined to 

be 0.02 mg/L. Hence, in conjunction, ìhigh resolution absorption 

spectroscopyî with an optical path of 5 cm was used to extend the 

detection limit to 0.0012 mg/L to confirm full neutralization. The 

measurement results were satisfactory. 
MEPC 60/2/2 

ANNEX 

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.7 The concentration of dissolved oxygen in discharged water was actually 

measured. Results demonstrate the difference of the dissolved oxygen 

concentration before and after neutralization was found to be in the level 

where no problem exists. 

.2 Although the main subject of this application is the risk assessment using the data 

obtained from the land-based test, a voluntary onboard test was conducted by 

actually operating the system onboard and performing ballasting and deballasting 

operations on actual ballast tanks to check the accordance of the system with the 

D-2 standard and to find the values of chemical by-products. 

Results of the voluntary onboard test are as follows: 

.1 Results of the neutralization/reduction of TRO: 

The time series data on the change in TRO in the monitoring data of TRO 

during the neutralization/reduction process conducted using the system in 

the onboard test started to show negative values indicating a reduced state 

immediately after the injection. The confirmed value with the ORP meter, 

which was installed to check TRO twice during deballasting in the onboard 

test, represents satisfactory results. 

.2 Results of chemical analysis: 

The detected values for byproducts were lower than those for the landbased test, indicating that there is no problem. 

.3 Results of biological analysis: 

Due to the small amount of the S size (10 μm to less than 50 μm) existing 

in these tests, the tests were not completely consistent with the official test 

cycle. However, results, which satisfied the D-2 standard were obtained 

from measurements of aquatic organism of the L size (50 μm and larger) 

and S size. 

.3 Persistency, bioaccumulability, and toxicity were evaluated for the chemical 

substances detected in the above land-based test (treated ballast water) to confirm 

that all of these chemical substances are not the persistent, bioaccumulative, and 

toxic (PBT) substance. 

.4 To evaluate the effects on the aquatic environment, values of PEC/PNEC were 

further calculated to be 1 or less in all cases, thus indicating there is no risk to the 

aquatic environment. 

.5 We estimated there are no effects on the bottom sediment because logKow is less 

than three. 

.6 Concerning the effects on mammals, oral NOAEL of mammals were investigated. 

Data on toxicokinetics are also described. 
MEPC 60/2/2 

ANNEX 

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.7 As effects of chemicals associated with the BWMS, treated ballast water before 

neutralization (primary treated water) and stored in a ballast tank, and treated ballast 

water after neutralization and discharged overboard (secondary treated water) on 

human health were evaluated, the obtained RCR (MOS/MOSref) was higher than 1 

in all cases, thus we estimated there is no risk. 

.8 If it can be confirmed in land-based tests carried out in the future that the D-2 

standard can be satisfied with a lower injection concentration, it will be possible 

not only to reduce bromoform, but also to reduce the effects on aquatic organisms 

due to the Relevant Chemicals as a whole. Therefore, continuing efforts will be 

made to further reduce the injection concentration. 

REFERENCES 

1 P.A. Taylor, ìAn Evaluation of the Toxicity of Various Forms of Chlorine to 

Ceriodaphnia dubia,î Environ Toxicol. Chem. 12, 1993. 

2 IUCLID DATASET (2000), Sodium Sulfite. 

3 R. Patrich, J. Cairns Jr., and A. Scheier, ìThe relative sensitivity of diatoms, snails, and 

fish to twenty common constituents of industrial wastesî, The Progessive Fish-Cultirist,

1968. 

4 Y. Yoshioka, Y. Ose and T. Sato, ìTesting for the Toxicity of Chemicals with 

Tetrahymena pyriformis.î Sci. Total Environ. 43, 1985. 

5 G.S. Ward, P.R. Parrish and R.A. Rigby, ìEarly life stage toxicity tests with a saltwater fish: 

Effects of eight chemicals on survival, growth, and development of sheepshed minnows 

(Cyprinodon variegates)î, Journal of Toxicology and Environmental Health, 8, 1981. 

6 E.A. Crecelius, ìMeasurements of oxidants in ozonized seawater and some biological 

reactionî Journal Fish Research Board Canada, 36, 1979. 

7 R. Kuhn and M. Pattard, ìResults of the harmful effects of water pollutants to green algae 

(Scenedesmus subspicatus) in the cell multiplication inhabitation testî,Wat. Res. 24, 1990. 

8 M.A. Mayes, F.A. Blanchard, D.L. Hopkins and I.T. Takahashi, ìStatic acute toxicity of 

dibromonitrilopropionamide and selected degradation products to the fathead minnow 

(Pimephales Promelas Rafinesque)î, Environmental Toxicology and Chemistry, 4, 1985. 

9 Appendix 13: (Chronic toxicity test). 

10 J.W. Arthur, et al., ìComparative Toxicity of Sewage-Effluent Disinfection to Freshwater 

Aquatic Lifeî, PB-248 653, U.S. EPA, 1975. 

11 Unpublished paper: K. Hayashi, ìBehavior of Sodium sulfite in Seawaterî. 

12 P.T. Heitmuller, T.A. Hollister and P.R. Parrisk, ìAcute toxicity of 54 industrial 

chemicals to Sheephead Minnows (Cyprinodon variegates) Bull. Environm. Contam. 

Toxicol. 27, 1981. 
MEPC 60/2/2 

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13 R. Kuhn, M. Pattard, K. Peynak and A. Winter, ìResults of the Harmful effects of water 

pollutants to Daphnia Magna in the 21 days reduction testî, Wat. Res. 23, (4), 1989. 

14 EUROPEAN COMMISSION DG ENV, ìTowards the establishment of a priority list of 

substances for further evaluation of their role in endocrine disruptionî, 2000. 

15 ìProposal for Health Classification and Labelling of the ESR substance Sodium 

Hypochloriteî ECBI/14/05. 

16 IUCLID DATASET (2000), Sodium Hypochlorite. 

17 Hazardous Substances Date Bank (HSDB), a database of the National Library of 

Medicineís TOXNET system ìTRIBROMOMETHANEî 20050623 on March 3, 2009. 

18 IUCLID DATASET (2000), Sodium Sulfite. 

19 ìOECD SIDS Initial Assessment Report: Sodium sulfateî SIAM 20, 19-22 April 2005. 

20 EPA IRIS: Toxicological review of Bromodichloromethane, January 11th, 2008. 

21 EPA IRIS: Toxicological review of Dibromochloromethane, January 11th, 2008. 

22 EPA IRIS: Toxicological review of Bromoform, January 11th, 2008. 

23 Hazardous Substances Date Bank (HSDB), a database of the National Library of 

Medicineís TOXNET system ìDIBROMOACETIC ACIDî 20090105 on March 3, 2009. 

24 EPA IRIS: Toxicological review of Bromate, March 2001. 

25 J Floor Anthoni, ìThe chemical composition of seawaterî, 

http://www.seafriends.org.nz/oceano//seawater.htm

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