I:\MEPC\61\2-3.doc 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

61st session 

Agenda item 2 

MEPC 61/2/3

17 March 2010

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Application for Basic Approval of the MES Ballast Water Management System 

(FineBallast MF) 

Submitted by Japan 

SUMMARY 

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

to the application for Basic Approval of MES Ballast Water 

Management System (FineBallast MF), in accordance with the 

"Procedure for approval of ballast water management systems that 

make use of Active Substances (G9)" 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; BWM.2/Circ.13 and BWM.2/Circ.24 

Introduction 

1 Regulation D-3.2 of the International Convention for the Control and Management of 

Ships' Ballast Water and Sediments stipulates that ballast water management systems that 

make use of Active Substances to comply with the Convention shall be approved 

by the Organization. 

2 The "Procedure for approval of ballast water management systems that make use 

of Active Substances (G9)" defines the principal aspects to be documented by data or testing 

(MEPC 57/21, annex 1, paragraph 4.2.1) and some basic principles for risk evaluation 

(MEPC 57/21, annex 1, paragraph 5.3). According to section 6 of Procedure (G9), 

the Organization should evaluate the information provided in the application. 

3 According to BWM.2/Circ.24, 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 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 
MEPC 61/2/3 

Page 2 

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data related to the respective ballast water management systems that make use of Active 

Substances needs to be submitted to MEPC 61. 

4 The competent authority in Japan has verified the application dossier, prepared 

by Mitsui Engineering and Shipbuilding Co. Ltd. (MES), and believes it to satisfy the data 

requirements of Procedure (G9). 

5 Japan therefore submits the non-confidential part of the applicant's 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 61/2/3 

Annex, page 1 

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ANNEX 

APPLICATION FOR BASIC APPROVAL OF THE FINEBALLAST MF 

BALLAST WATER MANAGEMENT SYSTEM 

Contents 

1 INTRODUCTION 

1.1 "FineBallast MF" BWMS working principles 

1.2 Description of the "FineBallast MF" BWMS and its components 

1.3 Chemical cleaning 

1.4 Sampling and measurements 

1.5 Quality control and assurance (G9: 4.2.4) 

2 DEFINITIONS 

2.1 Terms and definitions 

2.2 Active Substances 

2.3 Relevant Substances 

3 DATA ON THE EFFICACY OF ORGANISM REMOVAL FROM NATURAL SEAWATER 

3.1 Preparation for the test 

3.2 Test methods 

3.3 Test results 

4 DATA REGARDING EFFECTS ON AQUATIC PLANTS, INVERTEBRATES, FISH 

AND OTHER BIOTA, INCLUDING SENSITIVE AND SIGNIFICANT ORGANISMS 

(G9: 4.2.1.1) 

4.1 Acute aquatic toxicity 

4.2 Chronic aquatic toxicity 

4.3 Endocrine disruption 

4.4 Sediment toxicity 

4.5 Bioavailability/biomagnification/bioconcentration 

4.6 Food web/population effects 

5 DATA ON MAMMALIAN TOXICITY (G9:4.2.1.2) 

5.1 Acute toxicity 

5.2 Effects on eyes and skin 

5.3 Repeated-dose toxicity 

5.4 Chronic toxicity 

5.5 Developmental and reproductive toxicity 

5.6 Carcinogenicity 

5.7 Mutagenicity/genotoxicity 

5.8 Toxicokinetics 
MEPC 61/2/3 

Annex, page 2 

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6 DATA ON ENVIRONMENTAL FATE AND EFFECTS UNDER AEROBIC AND 

ANAEROBIC CONDITIONS (G9: 4.2.1.3) 

6.1 Modes of degradation (biotic; abiotic) 

6.2 Bioaccumulation, partition coefficient, octanol/water coefficient 

6.3 Persistence and identification of the main metabolites in the relevant media 

(ballast water, marine and fresh waters) 

6.4 Reaction with organic matter 

6.5 Potential physical effects on wildlife and benthic habitats 

6.6 Potential residues in seafood 

6.7 Known interactive effects 

7 PHYSICAL AND CHEMICAL PROPERTIES OF THE PREPARATIONS, ACTIVE 

SUBSTANCE, AND TREATED BALLAST WATER, IF APPLICABLE (G9: 4.2.1.4) 

7.1 Physical and chemical properties of the Active Substance 

7.2 Corrosivity 

8 ANALYTICAL METHODS AT ENVIRONMENTALLY RELEVANT CONCENTRATIONS 

(G9: 4.2.1.5) 

9 RISK CHARACTERIZATION 

9.1 Screening for persistency, bioaccumulation and toxicity 

9.2 Toxicity testing of the treated ballast water 

9.3 Risk analysis for aquatic organisms 

10 RISK ASSESSMENT 

10.1 Risk to ship safety 

10.2 Risk to environment 

11 REFERENCES 

12 APPENDICES 

APPENDIX I EXTRACTION OF QAPP 

APPENDIX II CHEMICAL ANALYSIS TEST REPORTS 

APPENDIX III AQUATIC TOXICITY TEST REPORTS 

APPENDIX IV CORROSIVITY TEST REPORTS 

APPENDIX V MODEL ESTIMATION OF H2O2 CONCENTRATION IN AIR IN 

THE WORKING PLACE 

APPENDIX VI REFERENCE ECOTOXICITY DATA ON H2O2 AND CHLOROFORM 

FROM LITERATURES 

APPENDIX VII RISK ASSESSMENT 

APPENDIX VIII EXPERIMENT USING 10% H2O2 AS WEAK SOLUTION FOR THE 

BWMS 

APPENDIX IX MANGANESE ANALYSIS FOR THE BWMS 
MEPC 61/2/3 

Annex, page 3 

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1 INTRODUCTION 

1.1 "FineBallast MF" BWMS working principles 

Ballast water is processed in this system at intake (ballasting) by microfiltration. Organisms 

are completely removed from the ballast water by passing through the membrane in the 

separation removal procedure, requiring no other form of disinfection. "FineBallast MF" 

BWMS is therefore a system that does not use Active Substances in ballast water 

processing. Chemical cleaning by H2O2 which corresponds to an Active Substance is 

necessary for membrane maintenance however. 

1.2 Description of the "FineBallast MF" BWMS and its components 

The "FineBallast MF" BWMS is a complete system and its operation can be divided into 

four components: pre-treatment; microfiltration; H2O2 cleaning of the membrane; and control. 

The "FineBallast MF" BWMS is illustrated schematically in Figure 1.1. 

The system consists of four components as follows (the outline of each component is shown 

in paragraphs 1.2.1 to 1.2.4): 

.1 pre-filter; 

.2 membrane module; 

.3 CIP (cleaning in place) unit; and 

.4 control unit. 

A, B and C in Figure 1.1 denote the samples tested: "A" is influent water before filtration 

which meets IMO requirements, "B" is treated water for ballasting or deballasting, and "C" is 

the detoxified cleaning solution from the CIP unit before ballasting (see section 1.4 for 

sampling strategy details). 

 Figure 1.1: Schematic Process Diagram of the "FineBallast MF" BWMS and 

sampling position (A, B, C) 
MEPC 61/2/3 

Annex, page 4 

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1.2.1 Pre-filter 

The Pre-filter is comprised of a 100~200 μm filter with automatic washing. The filter removes 

larger particles and organisms to prevent blockage of the flow passage. A filter is selected 

properly below pore diameter to block the membrane module flow passage. The filter is fully 

automatic in terms of operation and washing without affecting the filtration process, and 

washing water is returned to the sea in situ. 

1.2.2 Membrane module 

Ballast water is processed by passing through the membrane at intake (ballasting). The 

membrane used with this system possesses an extremely uniform micro pore size, and can 

satisfy the D-2 standard without using Active Substances. The membrane improves the 

ballast water processing module, using two or more modules. The system operates 

automatically, and organisms filtered by the membrane are returned to the sea at regular 

intervals. The membrane module structure is shown in Figure 1.2. 

Figure 1.2: Membrane module design 

1.2.3 The CIP Unit 

The "FineBallast MF" BWMS has a "Cleaning in Place" (CIP) unit using H2O2 to clean out 

organisms adhering to the membrane after ballasting. The CIP-unit feeds a prescribed 

amount of H2O2 to seawater reserved in the membrane unit and starts cleaning. After 

cleaning, the remaining H2O2 in the seawater is detoxified by a catalyst. The CIP unit is 

comprised of an H2O2 feed tank, concentration meter, supply pump, filter, and catalyst unit. 

After ballasting is completed, chemical cleaning is executed automatically during navigation. 

The schematic process diagram of the CIP Unit is shown in Figure 1.3. 
MEPC 61/2/3 

Annex, page 5 

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Figure 1.3: CIP Unit Schematic Process Diagram 

1.2.4 Control unit 

The control unit controls the power supply, the automatic air valve, and the warning alarm for 

all equipment in the "FineBallast MF" BWMS. 

This application for Basic Approval will focus on H2O2 used in the CIP unit. The membrane 

module and other components are not considered to be relevant for Active Substance 

approval. 

1.3 Chemical cleaning 

After each ballasting operation, the membrane module is cleaned with seawater 

containing H2O2. The H2O2 is added into the circulating seawater reserved in the membrane 

module, at a concentration of 15,000 mg/L or less. Chemical cleaning repeats circulation and 

holding for each membrane module for the prescribed time. After the prescribed time 

passes, H2O2 remaining in the seawater is detoxified by a catalyst to less than 1.0 mg/L, and 

this seawater (detoxified cleaning solution) is sent to the ballast tank in the next ballasting 

operation. 

The reserved detoxified cleaning solution volume is smaller than the capacity of each ballast 

tank. For example, in the case of a 56,000 dwt type bulk carrier ship, the detoxified cleaning 

solution would be diluted to over 1/70. 

Test facility operation 

Flow rate 1.2 m 3/h/module 

Chemical cleaning time 12 h 

Detoxification time 6 h 

H2O2 Concentration (maximum) 15,000 mg/L (at cleaning) 

H2O2 Concentration (minimum) Less than 1 mg/L (after detoxification) 

Dilution water Seawater 

Catalyst material Manganese dioxide 

Space velocity below 100 h-1

Method of analysis Titration by 0.001N KMnO4
MEPC 61/2/3 

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1.4 Sampling and measurements 

Sampling locations (A, B and C) are indicated in Figure 1.1. All samples for chemical and 

ecotoxicity analysis (see Table 1.1) were collected in triplicate from untreated water (A), 

treated seawater (B) and detoxified cleaning solution (C). Sample (A) is untreated water for 

use as a control. Sample (B) is treated water to be used in performance analysis, chemical 

analysis, toxicity testing and corrosivity testing, respectively. Sample (C) (washout seawater 

from the CIP unit) is not required by Procedure (G9) either for toxicity tests or chemical 

analysis. However, (C) is used as a worst-case sample for any residual chemical, toxicity and 

corrosivity tests, excluding performance analysis. 

Seawater was sampled according to guidelines in order to be analysed (see Table 1.1): 

- whether water quality in the initial test water (A) meets the chemical and 

biological water quality criteria defined by the IMO; 

- the efficiency of the "FineBallast MF" BWMS in removing/inactivating target 

organisms during ballasting after five days of storage (B); 

- acute and chronic environmental toxicity after 5 days of storage from the time 

of ballasting (B); 

- the corrosivity of treated seawater after 5 days of storage from the time of 

ballasting (B); 

- any by-product formation after "FineBallast MF" BWMS treatment at day 0 

after ballasting (B), and at day 5 after ballasting (B), and; 

- acute and chronic toxicity of the detoxified cleaning solution (C) to use as a 

worst-case scenario after 5 days of storage. 

Water samples (A, B, C) collected and stored for 5 days after beginning sampling (Day 0) 

were used for the toxicity tests for all test species (seawater or brackish), but with fish 

species, additional water samples (A, B, C) were collected at Day 2 and used for water 

renewal. The test facility made an additional run for Day 2 sampling. 

Five-day stored samples at room temperature (20o

C) were used for the chemical analysis 

and toxicological tests according to the requirements listed in Guidelines (G8) (MEPC 58/23). 

The storage aims to simulate the condition for deballasted water at a certain period 

(at least 5 days) after stored in ballast tanks. 
MEPC 61/2/3 

Annex, page 7 

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Table 1.1: Sample information for the "FineBallast MF" BWMS 

Sample for Sampling 

Location 

On-site 

measurements Off-site measurement 

Corrosivity A B C - Corrosivity 

Toxicity Day 5 after 

ballasting A B C 

Brachionus plicatilis (Rotifer) 

Skeletonema costatum (Algae) 

Monocorophium acherusicum

(Amphipod) 

Ruditapes philippinarum

(Bivalve) 

Cyprinodon variegates (Fish) 

Chemical 

Analysis 

Day 5 after 

ballasting A B C 

- DO 

- pH 

- H2O2

- Salinity 

- TRO 

- Temperature 

- TSS 

- POC 

- DOC 

Free chlorine 

Thiosulfate 

Bromate 

Bromoform 

Chloroform 

Dibromochloromethane 

Dichlorobromomethane 

Monobromoacetic acid 

Dibromoacetic acid 

Tribromoacetic acid 

Monochloroacetic acid 

Dichloroacetic acid 

Trichloroacetic acid 

Bromochloroacetic acid 

Dibromoacetonitrile 

1,2,3- Trichloropropane 

Temperature, salinity, pH and dissolved oxygen concentration were measured for the 

samples used for acute and chronic toxicity tests using seawater and acute toxicity tests 

using brackish water before and during the tests. The result of on-site measurement is 

shown in Table 1.2. 

The same samples, collected and stored for 5 days under the same conditions before 

testing, were used for each chemical and toxicological test protocol for a given test time and 

treatment. 
MEPC 61/2/3 

Annex, page 8 

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Table 1.2: The result of water quality on samples for all analyses at consecutive times 

Purpose of 

Analysis 

Sample 

ID 

Sampling 

Date 

Storage 

after 

treatment 

(d) 

pH Temperature 

(°C) 

Salinity 

(psu) 

Dissolved 

Oxygen 

(mg/L) 

A 2009.09.07 5 8.2 24.2 33.4 7.6 

B 2009.09.07 5 8.4 24.7 33.7 7.5 

Chemical analysis 

during acute 

seawater toxicity 

test C 2009.09.08 5 7.7 26.1 34.3 7.4 

A 2009.09.07 5 8.2 24.2 33.4 7.6 

#1 B 2009.09.07 5 8.4 24.7 33.7 7.5 

C 2009.09.08 5 7.7 26.1 34.3 7.4 

A 2009.09.17 5 8.1 25.7 33.1 7.5 

#2 B 2009.09.17 5 8.2 26.2 33.4 7.8 

C 2009.09.18 5 7.8 26.9 33.2 7.4 

A 2009.09.27 5 7.9 25.5 33.2 7.4 

#3 B 2009.09.27 5 8.1 25.4 33.4 7.6 

C 2009.09.28 5 7.8 25.7 33.5 6.9 

A 2009.10.07 5 8.2 25.4 34.0 7.6 

B 2009.10.07 5 8.1 25.3 34.3 7.4 

Chemical 

analysis 

during Fish 

Chronic 

Toxicity test 

#4 

C 2009.10.08 5 7.7 25.5 34.5 6.7 

A 2009.10.07 5 8.2 25.4 21.0 7.6 

B 2009.10.07 5 8.1 25.3 21.2 7.4 

Chemical analysis 

during acute 

brackish water 

toxicity test C 2009.10.08 5 7.7 25.5 21.1 6.7 

1.5 Quality control and assurance (G9: 4.2.4) 

Quality Control and Assurance (QA/QC) is of primary importance. The essential goal is to 

deliver reliable analytic results of defined quality. All testing processes in analytical 

laboratories contain a rigorous quality control/quality assurance program consisting of a 

Quality Management Plan (QMP) and a Quality Assurance Project Plan (QAPP). 

All analyses were carried out in accordance with standard methods, and toxicity testing was 

performed under supervision of the KORDI (Korea Ocean Research & Development 

Institute), Korea Testing & Research Institute (KTR) and NeoEnBiz. The KORDI laboratory is 

accredited by KOLAS (The Korea Laboratory Accreditation Scheme) for phytoplankton and 

micro-organism analyses. The KORDI study director is accredited by IOC-UNESCO for 

identification of harmful microalgae (appendix I). The KTR laboratory is accredited by KOLAS 

for chemical analysis of environmental samples (appendix II). All the ecotoxicological tasting 

was carried out by NeoEnBiz Institute according to GLP. The data on quality assurance (QA) 

are provided for each test report (appendix III). Although the NeoEnBiz Institute is not 

accredited specifically for toxicological testing and the accreditation is not required for toxicity 

testing, the NeoEnBiz has specialized ecotoxicology laboratories and personnel with solid 

experience in many toxicological researches mostly funded by the Korean government 

(e.g., Ministry of Land, Transport and Maritime Affairs). It also has conducted toxicity testing 

for the approval of previous ballast water management systems including GloEn-PatrolTM 

of Panasia Co. (MEPC 59/2/7). 
MEPC 61/2/3 

Annex, page 9 

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2 DEFINITIONS 

2.1 Terms and definitions 

2.1.1 "FineBallast MF" BWMS is the commercial name of the ballast water management 

system developed and used by the Mitsui Engineering & Shipbuilding Co., Ltd. The system is 

comprised of a microfiltration module with a pre-treatment component (pre-filtration for large 

particles over 100-200 micrometres, CIP, and a control unit (see paragraph 1.2). "FineBallast MF" 

BWMS treats ballast water at ballasting. During ballasting, the seawater is treated by filtration 

only. Particles and marine organisms retained by the membrane filter are discharged back 

into the sea through washing of the membrane filter. For maintenance of the membrane filter 

however, the oxidizing agent, H2O2 is used for cleaning. 

2.1.2 "Treated Water" refers to water treated by the "FineBallast MF" BWMS. 

2.1.3 "Ballast Water Discharge" refers to ballast water discharged overboard after the 

treatment by the "FineBallast MF" BWMS. 

2.1.4 "Active Substance" in the "FineBallast MF" BWMS, is defined as H2O2

(hydrogen peroxide), which is used for the membrane module cleaning, and the small 

amount of H2O2 can remain in treated water. 

2.1.5 "Preparation" as defined in Procedure (G9) is not used by the "FineBallast MF" 

BWMS. 

2.1.6 "Relevant Chemicals" – The oxidizing effect of H2O2 can cause oxidation reactions 

to produce reactive oxygen species such as hydroxyl radicals (OH•). The hydroxyl radical 

can react with various chlorinated and brominated chemicals in natural seawater to produce 

a variety of chloro- and bromo-compounds. Here the oxidation by-products of OH• are 

defined as Relevant Chemicals. 

2.2 Active Substances 

H2O2 is clear colourless liquid normally handled in an aqueous solution. H2O2 in itself 

(at NTP) is stable. Pure aqueous solutions in clean inert containers are relatively stable. 

Maximum stability is at pH 3.5~4.5. Commercial solutions must be stabilized with additives to 

prevent possible violent decomposition due to catalytic impurities or elevated temperatures 

and pressure. 

H2O2 is not flammable. There is a dangerous fire hazard from the chemical reaction of H2O2

with flammable materials, however. H2O2 is a powerful oxidizer, particularly in its 

concentrated state, and reacts violently with combustible and reducing materials causing a 

fire and explosion hazard. 

H2O2 can behave both as an oxidizing and as a reducing agent. 

as an oxidizing agent: H2O2 + 2H+

 + 2e- ==> 2H2O Eo = + 1.763 V at pH 0 

HO2

-

 + H2O + 2e- ==> 3OH- Eo = + 0.878 V at pH 14 

as a reducing agent: H2O2 ==> O2 + 2H+

 + 2e- Eo = - 0.66 V at pH 0 

HO2

-

 + OH- ==> O2 + H2O + 2e- Eo = + 0.08 V at pH 14 
MEPC 61/2/3 

Annex, page 10 

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H2O2 is widely used as an oxidizing and reducing agent. In these redox reactions H2O2 is 

normally degraded. In addition-reactions, the H2O2 molecule as a whole is attached to 

another molecule to form perhydrates (analogous to hydrates e.g., Na2CO3•1.5H2O2, 

(NH2)2CO•H2O2). In substitution-reactions, the peroxide group is transferred to another 

molecule and hydrogen atoms are substituted (e.g., peroxo compounds). H2O2 also forms 

stable salts with certain cations (e.g., K2O2). 

H2O2 has been used as an algaecide and bactericide, at concentrations in the millimolar 

range (e.g., 0.2~1.5 mmol/L against filamentous cyanobacteria; Barroin and Feuilade, 1986). 

H2O2 is a powerful oxidant capable of damaging nucleic acids, proteins and pigments. 

Although this damage may be incurred by a direct reaction between biomolecules and the 

H2O2, many of these effects are mediated by the Fenton reaction, whereby more reactive 

oxidants are generated, in particular the hydroxyl radical (OH•): 

H2O2 + Fe2+ ==> OH• + OH-

 + Fe3+

The extreme reactivity of the hydroxyl radical (OH•) is indicated by its short half-life, typically 

nanoseconds. Hydroxyl radicals (OH•) attack nucleic acids, proteins and membranes and a 

consequently few parts of the cell are immune to their effects; even catalyses and 

peroxidases are attacked and degraded by this highly reactive oxygen species. 

2.3 Relevant Chemicals 

The reaction of hydroxyl radicals (OH•) with naturally occurring chlorine and bromine ions in 

seawater during micro filter cleaning using approximately 1.5% of H2O2 solution can possibly 

produce the various residual oxidative by-products as listed in Table 2.1. As cleaning solution 

is catalysed by manganese dioxide before transferring into the ballast tank for more 

than 6 hours, the remaining H2O2 and its oxidative by-products decrease below a certain 

level (for H2O2, less than 1 mg/L) in the ballast tank. 

The manganese concentration in seawater is reported with 0.4~10μg/L (US EPA, 1984). 

Dissolved manganese of 0.198 mg/L was detected in the maximum in the detoxified cleaning 

solution in the bench-scale test. After it moves to the ballast tank, the detoxified cleaning 

solution is diluted to at least 70 times or more. Therefore, it is expected that dissolved 

manganese that remains in the detoxified cleaning solution decreases below the 

environmental influence concentration (see appendix IX). 

Concentrations of potential Relevant Chemicals were measured in the detoxified cleaning 

solution as well as in the treated water after a 5-day storage period. The detoxified cleaning 

solution is diluted at least 70 times after transferring to the ballast tank. The concentration of 

remaining Relevant Chemicals in the cleaning solution is therefore expected to be decreased 

considerably. 

A variety of chemicals can be produced by the reaction of oxidizing chemicals such as H2O2

with seawater in the CIP unit. However, only a limited number of chemicals are known to be 

potentially harmful to human and ecosystem so far. Potential harmful Relevant Chemicals, 

which can be produced by the reaction of oxidative chemicals with seawater, are listed in 

Table 2.1, following document MEPC 59/2/13. Such chemicals should be checked in treated 

ballast water when oxidative chemicals are used in any capacity that contacts seawater. 

Chemicals listed in Table 2.1 were analysed in samples of treated water and detoxified 

cleaning solution as well as untreated water to evaluate the risk posed by the by-products 

remained in effluents from the tested BWMS. The measurement of the detoxified cleaning 
MEPC 61/2/3 

Annex, page 11 

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solution samples was included to assess the environmental safety under the worst-case 

condition. 

 Table 2.1: Overview of Potential Relevant Chemicals in Ballast Water using 

Oxidative Chemicals as Active Substances 

Ingredient (IUPAC 

Name) 

Identification Numbers 

(CAS) Chemical Formula Molecular Weight (g/mole) 

Total Residual Oxidant - - - 

Free chlorine - - - 

Sodium thiosulfate 7772-98-7 Na2S2O3 158.11 

Sodium bromate 7789-38-0 NaBrO3 150.9 

Bromoform 75-25-2 CHBr3 252.73 

Chloroform 67-66-3 CHCl3 119.38 

Dibromochloromethane 124-48-1 CHBr2Cl 208.28 

Dichlorobromomethane 75-27-4 CHBrCl2 163.83 

Monobromoacetic acid 79-08-3 C2H3BrO2 138.95 

Dibromoacetic acid 631-64-1 C2H2Br2O2 217.84 

Tribromoacetic acid 75-96-7 C2H1Br3O2 296.74 

Monochloroacetic acid 79-11-8 C2H3ClO2 94.5 

Dichloroacetic acid 79-43-6 C2H2Cl2O2 128.94 

Trichloroacetic acid 76-03-9 C2H1Cl3O2 163.36 

Bromochloroacetic acid 5589-96-8 C2H2BrClO2 173.39 

Dibromoacetonitrile 3252-43-5 C2HBr2N 198.84 

1,2,3- Trichloropropane 96-18-4 C3H5Cl3 147.43 

3 DATA ON THE EFFICACY OF ORGANISM REMOVAL FROM NATURAL SEAWATER 

The efficacy of ballast water management systems which produce Active Substances was 

evaluated by Administration in accordance with the Guidelines for approval of ballast water 

management systems (G8). The Guidelines (G8) include general requirements concerning 

design and construction, technical procedures for evaluation and the procedure for issuance 

of the Type Approval Certificate of ballast water management system. The Guidelines (G8) 

are unique compared to the requirements for type approval of traditional marine equipment 

as type approval of ballast water management systems requires both land-based and 

shipboard test. 
MEPC 61/2/3 

Annex, page 12 

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3.1 Preparation for the test 

3.1.1 Cleaning tanks and pipes 

The water tanks for test were cleaned by fresh seawater pumped from the sea to remove dirt 

and residues left over in the tanks. And also each tank was pressure-washed down with 

fresh water after each test. 

3.1.2 Test water 

Test water was prepared in a 10 m3

 tank using high salinity seawater at the Jangmok Bay or 

brackish water, which is made with addition of groundwater to seawater of Jangmok Bay 

depending on the required salinity (> 32 PSU or 3-32 PSU, respectively, with a minimum 

difference of 10 PSU). The 10 m3

 of test water was used for both testing and control. 

The combination of indigenous organisms and cultured surrogate species (> 50μm : Artemia 

salina) 10 μm - 50 μm: Amphidinium carterae, Scrippsiella trochoidea and/or Tetraselemis

spp. was added to fulfill the biological water quality criteria. One or more cultured species 

were used at a time depending on the abundance of harvested indigenous organisms and 

culture conditions. Also, soluble glucose, seaweed powder and prepared mud were added to 

adjust the initial concentrations of dissolved organic carbon (DOC), particulate organic 

carbon (POC) and total suspended solids (TSS) to meet chemical water quality criteria. 

3.2 Test methods 

All nets for the concentration of organisms in the test site should be strictly separated into 

three sets (each set uses two types of nets; 7 μm mesh and 45 μm mesh in diagonal 

dimension) to avoid cross-contamination. 

3.2.1 Temperature and salinity 

Temperature and salinity were measured using an YSI 6600 multiparameter water quality 

sonde. 

3.2.2 pH 

The pH meter used was a model 1230, manufactured by Orion Research Inc. 

3.2.3 Dissolved oxygen 

DO was measured using an YSI 6600 multiparameter water quality sonde. 

3.2.4 Determination of dissolved organic carbon (UNESCO, 1994) 

"UNESCO, 1994" process was applied for dissolved organic carbon (DOC) analysis. 

3.2.5 Determination of dissolved particulate organic carbon (UNESCO, 1994) 

"UNESCO, 1994" process was applied for dissolved particle organic carbon (DOC) analysis. 

3.2.6 Determination of total suspended solids (APHA, 1995) 

"APHA, 1995" process was applied for total suspended solids analysis. 
MEPC 61/2/3 

Annex, page 13 

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3.2.7 Viability test of organisms 

Organisms ≥ 10~50 μm 

The disinfection efficacy of the "FineBallast MF" BWMS on 10~50 μm sized organisms 

(mainly phytoplankton) was assessed by three kinds of measurements using light 

microscope, epifluorescence microscope and fluorometer (Turner Designs 10-AU). 

Organisms > 50 μm 

Survivorship of the organisms larger than 50 μm (mainly zooplankton) was determined based 

on the appendage's movement under a stereomicroscope (APHA-804C, 1985). 

DAPI count for heterotrophic bacteria 

For setting up the condition of influent water, 50 mL seawater was fixed with neutralized 

formalin (final conc. 2%~4%). One millilitre in well-fixed seawater is stained with 0.2 mL DAPI 

(6-diamidino-2-phenylindole) working solution. After 5 minutes, at least 10 fields were 

counted under UV filter set of fluorescent microscopy at (× 1,000). 

Indicator microbes 

The microbes analysis applied for this test is as follows: 

Escherichia coli (E. coli) 

Vibrio cholerae (serotypes O1 and O139) 

Enterococci 

Finally, the test mentioned above was additionally conducted with disinfected distilled water 

in order to confirm whether there was any contamination as a control or not. Water quality of 

each test is summarized in Table 3.1. 

 Table 3.1: A brief summary of water qualities at the test waters for land-based test 

(The parenthesis is standard deviation) 

Test-1 (Seawater) Test-2 (brackish water) 

Salinity (PSU) 32.3 (±0.01) 21.4 (±0.01) 

DOC (mg/L) 2.8 (±1.6) 5.4 (±0.4) 

POC (mg/L) 1.1 (±0.0) 5.9 (±0.6) 

TSS (mg/L) 27.3 (±8.4) 63.3 (±1.5) 

3.3 Test results 

3.3.1 Test-1 (Seawater) 

The organism concentrations of test water for the land-based test sampling were set 

following Guidelines (G8). The water quality of the location is summarized in Table 3.2. 

The range of the organism concentration for the group bigger than 50 μm in size was 

from 177,480 to 194,880 inds/m3

, while that of the group between 10 μm and 50 μm in size 
MEPC 61/2/3 

Annex, page 14 

I:\MEPC\61\2-3.doc 

was from 1,845 to 2,150 inds/mL, in test water (Table 3.3). The range of heterotrophic 

bacterial population density was from 1.9 to 2.8 ×106

 inds/mL in test water (Table 3.3). 

However, after "FineBallast MF" BWMS treatment, the number of living organisms for all 

groups in treated water met the D-2 standard. 

Table 3.2: Water quality of Test-1 

Date Sample pH Temp. 

(°C) 

Salinity

(PSU) 

DO 

(mg/L) 

TSS 

(mg/L) 

DOC 

(mg/L) 

POC 

(mg/L) 

2009.09.16 Test 

water 8.0 25.4 32.3 6.5 27.3 2.8 1.1 

2009.09.21 Untreated 7.9 20.4 32.2 6.6 21.1 1.8 0.7 

2009.09.21 Treated 8.0 20.3 32.1 7.3 13.2 1.6 0.3 

Table 3.3: Biological efficacy of "FineBallast MF" BWMS from land-based test (Test-1) 

Date Sample Sampling 

at 

50μm< 

(inds/m3) 

10~50μm 

(inds/mL) 

Heterotro. 

Bacteria 

(inds/mL) 

E. coli 

(cfu/100mL)

Vibrio 

cholerae 

(cfu/100mL) 

Entero 

coccus

(cfu/100mL)

20% 180,960 1,898 2.8E+06 9,683 ND 328 

50% 177,480 1,845 1.9E+06 6,217 ND 165 

2009.

09.16 Test water 

80% 194,880 2,150 2.4E+06 3,033 ND 195 

20% 4,361 28 - ND ND 10 

50% 9,135 25 - ND ND 1 

2009.

09.21 Untreated 

80% 42,723 1,560 - ND ND 7 

20% ND ND - ND ND 8 

50% ND ND - ND ND 4 

2009.

09.21 Treated 

80% ND ND - ND ND 16 

*ND: not detected. 

3.3.2 Test-2 (Brackish water) 

The organism concentrations of test water for the land-based test sampling were set as the 

guideline of Guidelines (G8). The water quality of the location is summarized in Table 3.4. 

The range of the organism concentration for the group bigger than 50μm in size was 

from 123,200 inds/m3

 to 132,825 inds/m3, while that of the group between 10 μm and 50 μm 

in size was from 1,627 inds/mL to 1,878 inds/mL in test water (Table 3.5). The range of 

heterotrophic bacterial population density was from 2.3 to 2.9 ×106

 inds/mL in test water 

(Table 3.5). However, after "FineBallast MF" BWMS treatment, the number of living 

organisms for all groups in treated water met the D-2 regulation. 
MEPC 61/2/3 

Annex, page 15 

I:\MEPC\61\2-3.doc 

Table 3.4: Water quality of Test-2 

Date Sample pH Temp. 

(°C) 

Salinity 

(PSU) 

DO 

(mg/L) 

TSS 

(mg/L) 

DOC 

(mg/L) 

POC 

(mg/L) 

2009.10.07 Test 

water 7.6 20.9 21.4 6.5 63.3 5.4 5.9 

2009.10.12 Untreated 7.5 16.3 21.2 4.8 42.9 2.8 1.3 

2009.10.12 Treated 7.8 16.3 20.9 7.0 6.6 1.9 0.8 

Table 3.5: Biological efficacy of "FineBallast MF" BWMS from land-based test (Test-2) 

Date Sample Sampling 

at 

50μm< 

(inds,/m3) 

10~50 

μm 

(inds/mL)

Heterotro. 

Bacteria 

(inds/mL) 

E. coli 

(cfu/100mL)

Vibrio 

cholerae 

(cfu/100mL) 

Entero 

coccus

(cfu/100mL)

20% 132,825 1,878 2.8E+06 ND ND 18 

50% 130,900 1,627 2.3E+06 83 ND 14 

2009.

10.07 

Test 

water 

80% 123,200 1,760 2.9E+06 33 ND 43 

20% 1,740 15 - 300 ND ND 

50% 4,172 26 - 333 ND 40 

2009.

10.12 Untreated 

80% 4,869 3,430 - 2,567 ND 3,333 

20% ND 1 - ND ND ND 

50% ND 3 - ND ND ND 

2009.

10.12 Treated 

80% ND ND - ND ND ND 

*ND: not detected. 

4 DATA REGARDING EFFECTS ON AQUATIC PLANTS, INVERTEBRATES, FISH 

AND OTHER BIOTA, INCLUDING SENSITIVE AND SIGNIFICANT ORGANISMS 

(G9: 4.2.1.1) 

This section is intended to evaluate the effects of preparations and their components on 

organisms and the environment when released with treated ballast water or accidentally 

during the process. 

The effects of the untreated (A) and treated water (B) as well as detoxified cleaning 

solution (C) on various marine organisms were compared in acute tests using seawater and 

brackish water and also in chronic tests using seawater. Undiluted cleaning solution (C), 

which initially contained 1.0%~1.5% of H2O2 and were consequently catalysed by MnO2, was 

included as the worst-case scenario. 
MEPC 61/2/3 

Annex, page 16 

I:\MEPC\61\2-3.doc 

4.1 Acute aquatic toxicity 

No significantly higher acute toxicity was observed in the samples of treated ballast water (B) 

and detoxified cleaning solution (C) compared to the samples of untreated waters (A) using 

both seawater (34 psu) and brackish water (21 psu). Data were summarized in Tables 4.1 

and 4.2, and the raw data was reported in appendix III. For sampling, see section 1.4. 

The sample C was included to evaluate the remaining toxicity in the cleaning solution after 

the detoxification process. Since the cleaning solution is the only water which contacts with 

H2O2, and also it is diluted more than 70 times with treated water before deballasting, the 

results of sample C can be considered as worst-case condition. 

Bacteria: In assessing the toxicity of treated ballast water and cleaning solution on the 

bacteria Vibrio fischeri, using the "FineBallast MF" BWMS, through the 30 minutes' period, 

NOEC and EC50 values based on luminescence inhibition at the end of the experiment were 

100% and >100% for both seawater and brackish water. 

Algae: In assessing the toxicity of treated ballast water and cleaning solution using the 

"FineBallast MF" BWMS on the marine diatom, Skeletonema costatum, through the 72 hours' 

period, NOEC values based on growth inhibition at the end of the experiment were 50% for 

untreated and treated seawater samples or 100% for all other samples. EC50 for all samples 

were >100% for both seawater and brackish water. 

Rotifer: In studying the toxicity of treated ballast water and cleaning solution using the 

"FineBallast MF" BWMS on the marine rotifer, Brachionus plicatils, over a 24 hours' period, 

NOEC and LC50 values based on mortality data at the end of the experiment were 100% 

and >100% only for seawater. 

Amphipod: In assessing the toxicity of treated ballast water and cleaning solution using the 

"FineBallast MF" BWMS on the marine amphipod, Monocorophium acherusicum, over 

a 96-hour period, NOEC and LC50 values based on mortality data at the end of the 

experiment were 100% and >100% for both seawater and brackish water. 

Bivalve: In assessing the toxicity of treated ballast water and cleaning solution using 

the "FineBallast MF" BWMS on the marine bivalve, Ruditapes philippinarum, over 

a 96-hour period, NOEC and LC50 values based on mortality data at the end of the 

experiment were 100% and >100% only for seawater. 

Fish: In assessing the toxicity of treated ballast water and cleaning solution using the 

"FineBallast MF" BWMS on the marine fish, Cyprinodon variegatus, over a 96-hour period, 

NOEC and LC50 values based on mortality data at the end of the experiment were 100% 

and >100% for both seawater and brackish water. 
MEPC 61/2/3 

Annex, page 17 

I:\MEPC\61\2-3.doc 

Table 4.1: The result of acute toxicity tests using various marine organisms 

exposed to untreated (A), treated ballast water (B) and detoxified 

cleaning solution (C) using seawater (34 psu) 

Taxon Species Test 

Protocol Endpoint 

Sampl

e 

ID*

Results 

(NOEC, %) 

Results (LC50

or EC50, %) 

A 100 >100 

Bacteria Vibrio fischeri B 100 >100 ISO 

11348-1 

Luminescence 

inhibition 

(30 min) C 100 >100 

A 50 >100 

Algae B 50 >100 Skeletonema 

costatum 

ASTM 

E1218-97a 

Growth 

inhibition 

(72 hrs) C 100 >100 

A 100 >100 

Rotifer B 100 >100 Brachionus 

plicatilis 

ASTM 

E1440-91 

Mortality 

(24 hrs) C 100 >100 

A 100 >100 

Amphipod Monocorophium B 100 >100 

acherusicum EPA 1994 Mortality 

(96 hrs) C 100 >100 

A 100 >100 

Bivalve B 100 >100 Ruditapes 

philippinarum 

ASTM 

E2122-02 

Mortality 

(96 hrs) C 100 >100 

A 100 >100 

Fish B 100 >100 Cyprinodon 

variegatus 

USEPA 

821/R02/ 

014 

Mortality 

(96 hrs) C 100 >100 

Table 4.2: The result of acute toxicity tests using various marine organisms 

exposed to untreated (A), treated ballast water (B) and detoxified cleaning 

solution (C) using brackish water (21 psu) 

Taxon Species Test Protocol Endpoint Sample

ID*

Results 

(NOEC, %) 

Results 

(LC50 or EC50, %)

A 100 >100 

Bacteria Vibrio fischeri ISO 11348-1 B 100 >100 

Luminescence 

inhibition 

(30 min) C 100 >100 

A 100 >100 

Algae B 100 >100 Skeletonema 

costatum 

ASTM 

E1218-97a 

Growth 

inhibition 

 (72 hrs) C 100 >100 

A 100 >100 

Amphipod B 100 >100 Monocorophium 

acherusicum EPA 1994 Mortality 

(96 hrs) 

C 100 >100 

A 100 >100 

B 100 >100 Fish Cyprinodon 

variegatus 

USEPA 

821/R02/ 

014 

Mortality 

(96 hrs) C 100 >100 
MEPC 61/2/3 

Annex, page 18 

I:\MEPC\61\2-3.doc 

4.2 Chronic aquatic toxicity 

No significantly higher acute toxicity was observed in the samples of treated ballast water (B) 

and detoxified cleaning solution (C) compared to the samples of untreated waters (A) using 

seawater (34 psu). Data were summarized in Table 4.3 and the raw data reported in 

appendix III. For sampling, see section 1.4. 

Algae: In assessing the chronic toxicity of treated ballast water and cleaning solution using 

the "FineBallast MF" BWMS on the marine diatom, Skeletonema costatum, over a 96-hour 

period, NOEC and EC50 values based on growth inhibition at the end of the experiment 

were 100% and >100% for seawater, respectively. 

Rotifer: In assessing the chronic toxicity of treated ballast water and cleaning solution using 

the "FineBallast MF" BWMS on the marine rotifer, Brachionus plicatils, during 96 hours, 

NOEC and EC50 values based on the growth of population at the end of the experiment 

were 100% and >100% for seawater, respectively. 

Fish: For the study to assess the chronic toxicity of treated ballast water and cleaning 

solution using the "FineBallast MF" BWMS on the marine fish, Cyprinodon variegatus, 

during 30 days, NOEC and LC50 values based on mortality data at the end of the experiment 

were 100% and >100% for seawater, respectively. 

Table 4.3: The result of chronic toxicity tests using various marine organisms 

exposed to untreated (A), treated ballast water (B) and detoxified cleaning 

solution (C) using seawater (34 psu) 

Taxon Species Test 

Protocol Endpoint Sample ID*

Results 

(NOEC, %) 

Results (LC50

or EC50, %) 

A 100 >100 

Algae B 100 >100 Skeletonema 

costatum 

ASTM 

E1218-97a 

Growth 

inhibition 

(96 hrs) C 100 >100 

A 100 >100 

Rotifer B 100 >100 Brachionus 

plicatilis 

ASTM 

E1440-91 

Population 

growth 

(96 hrs) C 100 >100 

A 100 >100 

Fish B 100 >100 Cyprinodon 

variegatus 

USEPA 

821/R02/014 

Mortality 

(30 days) C 100 >100 

4.3 Endocrine disruption 

There is no evidence of H2O2 and its oxidative Relevant Chemicals having any significant 

endocrine disrupting effect on organisms as low as the detected concentration levels in water 

samples treated by this system (see Tables 6.1, 6.2 and 6.3), nor at higher levels. 

4.4 Sediment toxicity 

There were only negligible amounts of residual chemicals with no significant toxicity resulting 

from the treatment as shown in Tables 4.1, 4.2 and 4.3, and appendices II and III. 

Additionally, H2O2 and most Relevant Chemicals are highly soluble and highly polar 

substances; no remarkable adsorption for sediment particles is expected. Residual 
MEPC 61/2/3 

Annex, page 19 

I:\MEPC\61\2-3.doc 

chemicals from the "FineBallast MF" BWMS treatment will not reach benthic environments to 

cause any adverse effects on benthic organisms due to both the low level of residual 

chemicals and also the low reactivity of the chemicals to sediment particles. 

4.5 Bioavailability/biomagnification/bioconcentration 

There were no experimental results for the Active Substance or possible Relevant Chemicals 

defined here to be bioconcentrated and/or biomagnified in aquatic organisms. Since H2O2

and most oxidative chemicals are well known to quickly degrade chemically and be 

biologically metabolized, such chemicals are not easily bioconcentrated and/or biomagnified. 

From the results of the chemical analyses and toxicity tests for the "FineBallast MF" BWMS 

treated seawater and the worst-case samples compared to those of untreated water, it is not 

possible that biologically significant amounts of toxic chemicals are bioavailable for 

bioconcentration in aquatic organisms or further biomagnification through the marine food 

chain. 

4.6 Food web/population effects 

There were no available results for the Active Substance or possible Relevant Chemicals 

defined here to be transferred through food web, indirectly adversely affecting the upper 

trophic level of marine biota. Residual chemicals and toxicity were negligible and 

biomagnification was not feasible for residual chemicals from the treatment. 

It is therefore not possible that significant adverse effects occur indirectly in the transfer of 

chemicals through the marine food web. In addition, we cannot expect that discharged 

ballast water would adversely affect the higher level of the ecosystem including populations 

and communities in either brackish or full seawater environments. 

5 DATA ON MAMMALIAN TOXICITY (G9:4.2.1.2) 

The "FineBallast MF" BWMS does not adopt or use any Active Substances intended to be 

directly exposed to mammalian or non-mammalian organisms. The only chemical used in the 

system is H2O2 (1.5% or less in seawater), which is only used for cleaning filter modules and 

is subsequently catalysed by manganese dioxide. The final concentrations of H2O2 and total 

residual oxidants in the detoxified cleaning solution were never greater than 1.0 mg/L 

(see appendix II) and no aquatic toxicity was observed even from the detoxified cleaning 

solution, which can be a worst-case sample for the BWMS treated seawater. 

The only possible exposure to H2O2 fumes is to the personnel operating the system during 

necessary procedures, and likewise exposure to liquid H2O2 is possible in cases of 

carelessness or accident. There is only little possibility, however, of anyone being exposed to 

Relevant Chemical, oxidizing by-products of the reactive of H2O2 with organic matters in 

seawater. 

5.1 Acute toxicity 

5.1.1 General 

H2O2 is corrosive to the skin, eyes, and mucous membranes at high concentrations (>10%); 

and at lower concentrations may cause irritation. Other effects occur from inhalation or 

ingestion and may include gas embolism, gastric irritation, gastric distension and emesis, 

accumulation of fluid in the lungs, unconsciousness, and respiratory arrest. Symptoms 

become more severe as the concentration of H2O2 increases (SCCP, 2007). 
MEPC 61/2/3 

Annex, page 20 

I:\MEPC\61\2-3.doc 

The systemic effects of H2O2 result from its interaction with catalase in the tissues liberating 

oxygen and water as it decomposes. One millilitre of 3% H2O2 liberates 10 mL of oxygen. 

When the amount of oxygen evolved exceeds maximum blood solubility, venous embolism 

occurs. Intravascular oxygen embolism may also occur. Ingestion of dilute solutions 

(3%~10%) produces mild gastrointestinal irritation, gastric distension and emesis, and on 

rare occasions, gastrointestinal erosion or embolism. Ingestion of 10%~20% solution 

produces similar symptoms, but exposed tissues may also be burned. Ingestion of 20%~40% 

produces the symptoms described for lower volumes, but may also induce rapid loss of 

consciousness followed by respiratory arrest. 

5.1.2 Oral Exposure 

If ingested, solutions of H2O2 up to concentrations of 9% are generally non-toxic; however, 

even a 3% solution is mildly irritating to mucosal tissue and may cause vomiting and 

diarrhea. Ingestion of industrial-strength solutions (approximately 10%) causes systemic 

toxicity and has been associated with fatalities. 

Ingestion of household solutions (3%) usually causes mild mucosal irritation and vomiting. 

Gastric distension due to liberation of oxygen in the stomach may occur, but hollow-organ 

rupture is uncommon when dilute solutions are ingested. Ingestion of concentrated solutions 

(approximately 10%) can cause extreme irritation, inflammation, and burns of the alimentary 

tract, and hollow-organ distension and rupture is a significant danger. H2O2 enemas have 

caused colonic rupture, intestinal gangrene with gas bubbles, and acute ulcerative colitis. 

5.1.3 Respiratory exposure 

Vapours, mists, or aerosols of H2O2 can cause upper airway irritation, inflammation of the 

nose, hoarseness, shortness of breath, and a sensation of burning or tightness in the chest. 

Exposure to high concentrations can result in severe mucosal congestion of the trachea and 

bronchi and delayed accumulation of fluid in the lungs. 

5.2 Effects on eyes and skin 

H2O2 is poorly absorbed through intact skin. It is widely used as a disinfectant medicine for 

injured skin. When used for disinfectant purposes (at 3% to 5%), it is mildly irritating to the 

skin and mucous membranes. At a concentration of 10%, which is found in some 

hair-bleaching solutions, it is strongly irritating and may be corrosive. 

Prolonged exposure to concentrated vapour or dilute solutions can cause irritation and 

temporary bleaching of skin and hair. Contact with concentrated solutions can cause severe 

skin burns with blisters. 

Exposure to concentrated vapour, mist, or aerosol can cause stinging pain and tearing. 

Solutions of 5% or greater can cause injury to the eye surface if splashed in the eye 

(sometimes with delayed effects). 

5.3 Repeated-dose toxicity

There is a sufficient database of animal studies available to characterize the repeated dose 

toxicity of H2O2 via the oral route. Decreased body weight gain was a typical finding in 

gavages studies on rats employing a dose range of 50 mg/kg~500 mg/kg BW/day. Regarding 

other parameters examined, a decreased erythrocyte count, haematocrit, plasma protein 

concentration, and plasma catalase were not uncommon observations. When administered 

in drinking water, 0.5% H2O2 consistently decreased body weight gain (as well as intake of 
MEPC 61/2/3 

Annex, page 21 

I:\MEPC\61\2-3.doc 

water) in rats and mice, and further studies at lower dose levels showed the same effect 

even at 1,500 ppm in rats and at 3,000 ppm in mice (SCCP, 2007). The latter, a 

well-conducted 90-day study with a catalase deficient strain of mice, indicated that the 

NOAEL of H2O2 in drinking water was 100 ppm implying a daily dose of 26 mg/kg BW for 

males and 37 mg/kg BW for females. LOAEL was 300 ppm based on dose related reductions 

in food and water consumption among females, and on the observation of duodenal mucosal 

hyperplasia in one male. Hyperplasia was a consistent finding at higher levels of 1,000 ppm 

and 3,000 ppm both in males and females, and was completely reversible in the recovery 

period. At the top dose (3,000 ppm) total plasma protein and globulin concentrations were 

reduced. 

Repeated exposure H2O2 inhalation toxicity is not well elucidated. Some studies showed that 

local effects in the skin, airways, and lungs might occur at about 10 mg/m3

. A recent 28-day 

range finding inhalation toxicity study in rats (SCCP, 2007) showed respiratory tract irritation 

and concentration-related necrosis and inflammation of the epithelium in the anterior regions 

of the nasal cavity at 14.6 mg/m3

 and 33 mg/m3 but not at 2.9 mg/m3 (the apparent NOAEL). 

5.4 Chronic toxicity 

Because H2O2 is rapidly decomposed in the body, it is unlikely to cause chronic toxicity. 

However, repeated exposures to H2O2 vapour may cause chronic irritation of the respiratory 

tract and partial or complete lung collapse. Repeated contact with vapour or solution may 

result in the bleaching of skin and hair. 

5.5 Developmental and reproductive toxicity 

H2O2 is not included in Reproductive and Developmental Toxicants, a 1991 report published 

by the U.S. General Accounting Office (GAO) that lists 30 chemicals of concern because of 

widely acknowledged reproductive and developmental consequences. No reports were 

located on the developmental or reproductive effects of H2O2 in humans. 

5.6 Carcinogenicity 

The International Agency for Research on Cancer (IARC) has determined that H2O2 is not 

classifiable as to carcinogenicity in humans (IARC, 1999). 

5.7 Mutagenicity/genotoxicity 

H2O2 played a role as a mutagen and genotoxicant in a variety of in vitro test systems. 

However, regarding the in vivo genotoxicity of H2O2, studies employing modern 

methodologies resulted in a negative outcome. The available studies are not in support of a 

significant genotoxicity/mutagenicity for H2O2 under in vivo conditions as H2O2 is degraded so 

quickly when introduced into a body regardless of exposure route (oral, dermal and 

respiratory). According to the principles followed in the EU, H2O2 is not classified as a 

mutagen. 

5.8 Toxicokinetics 

Biological membranes are highly permeable to H2O2; the permeability constants 

of 0.2 cm/min for peroxisomal membranes and 0.04 cm/min for erythrocyte plasma 

membranes may be compared with those for water in a variety of membranes, ranging 

from 0.02 to 0.42 cm/min (Branco et al. 2004). Thus, H2O2 is expected to be readily taken up 

by cells constituting absorption surfaces, but at the same time, it is effectively metabolized 

and it is uncertain to what extent the unchanged substance may enter blood circulation. 
MEPC 61/2/3 

Annex, page 22 

I:\MEPC\61\2-3.doc 

Moreover, in the blood, red blood cells have an immense metabolic capacity to 

degrade H2O2. 

Animal studies show that administration of high concentrations of H2O2 through various 

routes, resulting in high rates of absorption, leads to oxygen bubble formation in blood 

vessels. This indirectly indicates that H2O2 has been absorbed systemically but then rapidly 

degraded by metabolizing enzymes in the circulating blood. 

There are two main H2O2 metabolizing enzymes, catalase and glutathione peroxidase, which 

control H2O2 concentration at different levels and in different parts of the cell. In the blood, 

red blood cells efficiently remove intracellular and extracellular H2O2. 

In aerobic cellular metabolism complete reduction of a molecule of oxygen to water requires 

four electrons, and in a sequential univalent process the superoxide anion radical (O2

-

), H2O2

and the hydroxyl radical (OH•) intermediates are formed (Fridovich 1978; 1983). In the 

presence of reduced metal ions (Fe2+; Cu+

) hydroxyl radicals may originate from H2O2

through the Fenton reaction. The chemical reactions involved in the generation of reactive 

oxygen species are shown below. 

Molecular oxygen is reduced to water by four one-electron reduction steps: 

O2 + e → O2

–

• (superoxide anion) 

O2

–

• + e + 2H+ → H2O2 (hydrogen peroxide) 

H2O2 + e + H+

 → OH• + H2O (hydroxyl radical) 

OH• + e + H+

 → H2O (water) 

H2O2 is a normal metabolite in the aerobic cell, but there is uncertainty about its true levels in 

biological media due to analytical difficulties. The steady state level appears to depend on 

the balance between its generation and degradation. H2O2 passes readily across biological 

membranes (permeability constant corresponds to that of water) and, because it slowly 

reacts with organic substrates, it can diffuse at considerable distances in the cell. There are 

two main H2O2 metabolizing enzymes, catalase and glutathione peroxidase, which control 

H2O2 concentration at different levels and in different parts of the cell as well as in the blood. 

At low physiological levels H2O2 is mainly decomposed by GSH peroxidase whereas the 

contribution of catalase increases with an increase in H2O2 concentration. Red blood cells 

remove H2O2 efficiently from the blood due to very high catalase activity whereas in the 

serum, catalase activity is low. 

The systemic absorption of H2O2 is limited by its rapid enzymatic degradation in mucous 

membrane cells lining the gastrointestinal and respiratory tract and to a certain extent also in 

skin. Tissue damage, for example, on contact with severely irritant concentrations of H2O2, 

can lead to absorption into circulation. In the blood, H2O2 is very rapidly degraded yielding 

Oxygen and Water. The rapid degradation limits systemic availability of H2O2. It is therefore 

unlikely that organs beyond the site of first contact will be affected. 

6 DATA ON ENVIRONMENTAL FATE AND EFFECTS UNDER AEROBIC AND 

ANAEROBIC CONDITIONS (G9: 4.2.1.3) 

6.1 Modes of degradation (biotic; abiotic) 

All chemical compounds formed by treatment using "FineBallast MF" BWMS are expected to 

follow natural decomposition processes by natural biotic or abiotic pathways. 
MEPC 61/2/3 

Annex, page 23 

I:\MEPC\61\2-3.doc 

H2O2 is a quite reActive Substance in the presence of other substances, elements, radiation, 

materials or cells. Both biotic and abiotic degradation processes are important routes in the 

removal of H2O2 in the environment. 

Biological degradation of H2O2 is an enzyme-mediated process. Abiotic degradation of H2O2

is due to reaction with itself (disproportionation), reaction with transition metals, organic 

compounds capable of reacting with H2O2, reaction with free radicals, heat or light. 

H2O2 is normally a short-lived substance in the environment. Rapid degradation occurs due 

to many alternative and competitive degradation pathways. However, like most substances, 

in special circumstances when degradation processes are inactive, H2O2 can be an 

extremely persistent substance in the environment. 

The reliable degradation rate of chloroform in water under aerobic condition was not 

available. However, under anaerobic condition, chloroform is known to be readily 

biodegraded in water and sediment. 

6.1.1 Biotic degradation 

H2O2 is biologically degradable. Aerobic bacteria produce catalase enzymes that convert 

H2O2 to water and oxygen. Catalase is present in most aerobic bacteria and therefore 

biological degradation readily starts when H2O2 is in contact with microbial material 

(no remarkable lag-phase). 

Therefore, the half-life is between minutes and hours in municipal wastewater (> 106

cells/mL) and only a few seconds in sludge (108

-1010 cells/mL). In natural waters (≤ 103

cells/mL) the biodegradation half-life is from hours to a few days. Degradation kinetics is 

generally assumed to be of the first order with respect to H2O2 at low concentrations and not 

of the first order at higher concentrations (hundreds of micrograms or more in surface water) 

leading to longer half-lives as initial concentrations increase (Spain et al., 1989; Moffett and 

Zafirioiu, 1990; Wong and Zhang, 2008). 

The degradation rate of chloroform in surface water is assumed to be 0 day-1 due to the lack 

of reliable data and that in sediment to be 0.046 day-1, which means that the half-life in 

sediments is 15 days (EU, 2007). 

6.1.2 Abiotic degradation 

H2O2 decomposes into water and oxygen at rates which depend on contact with catalytic 

materials (metals, activated carbon, enzymes) and other factors (heat, sunlight) (Moffett and 

Zafiriou, 1990; Goor et al. 2005). 

H2O2 ==> H2O + 1/2O2, H = -98.30 kJ/mol 

This reaction is highly exothermic and takes place in the presence of small amounts of 

catalyst even in aqueous solution. In the absence of catalyst, it occurs only in the gas phase 

at high temperature (Goor et al., 2005). 

Many materials and substances have a catalytic action on the degradation of H2O2. Most 

transition metals and heavy metals can induce H2O2 decomposition. The range of 

decomposition rates is large because of varying catalytic efficiency. With the exception of 

fluorine, the halogens also catalyse the decomposition of H2O2 by a cyclic oxidation-reduction 

mechanism (Wong and Zhang, 2008). 
MEPC 61/2/3 

Annex, page 24 

I:\MEPC\61\2-3.doc 

In spite of the lack of information, chloroform may not be degraded substantially by any 

abiotic process. 

6.2 Bioaccumulation, partition coefficient, octanol/water coefficient 

H2O2 is such a reactive and short-lived polar substance that no significant bioaccumulation is 

expected. There are no experimental results on bioaccumulation and octanol/water 

coefficient available. The estimated log POW (octanol/water coefficient) based on structure 

analyses of about -1.5 indicates negligible potential of bioaccumulation in aquatic organisms. 

Therefore, the estimated BCF (bioconcentration factor) for fish is ranged 1.4~3.3, which 

means that the concentration in fish is only 1.4~3.3 times higher than in water (EU, 2003). 

Chloroform is not readily bioaccumulated in aquatic environments. There are some 

experimental data on bioaccumulation of chloroform in fresh water fish. The BCF of 

chloroform for fish species ranged from 1.4~13 during 1 or 42 days of exposure period with 

flow-through exposure system (EC, 2007). 

6.3 Persistence and identification of the main metabolites in the relevant media 

(ballast water, marine and fresh waters) 

H2O2 is a very reActive Substance in the presence of other substances, elements, radiation, 

materials or cells. Both biotic and abiotic degradation processes are important routes in the 

removal of H2O2 from the environment. 

Besides H2O2 is not readily volatilized, chloroform can be fast volatilized into the air 

compartment. So the volatilization will be the most important route for its removal from the 

aquatic environment. 

6.4 Reaction with organic matter 

To identify products of concern to the environment from the reaction of radicals with organic 

matter, some chloro- and bromo-compounds were analysed in three types of test water 

(untreated-, treated- and detoxified cleaning solution) (Tables 6.1, 6.2 and 6.3). 

There was no significant detection of any potential Relevant Chemical. Only one chemical, 

thiosulfate, was detected in one sample of treated seawater prepared for the chronic toxicity 

test by the BWMS (Table 6.3), however, it was not detected in other 3 samples for the 

chronic test, and also not detected in all samples for the acute seawater and brackish water 

tests. 

No other chemical was detected in all the treated water samples for both acute and chronic 

tests. 

Chloroform was detected in one untreated water sample (0.19 ppb) and two cleaning solution 

samples (0.09 and 0.20 ppb). In other samples, chloroform concentration was all 

below 0.01 ppb. 

Bromform and 1,2,3- Trichloropropane was detected as 0.03 and 0.42 ppb only in one 

sample of untreated seawater prepared for acute and chronic toxicity test, respectively. They 

were not detected in other untreated water or all samples of treated and cleaning solution. 

These two chemicals detected only from untreated water samples were not related to the 

BWMS treatment. They were probably produced naturally, but removed during the filtering 

and/or cleaning process of the BWMS. 
MEPC 61/2/3 

Annex, page 25 

I:\MEPC\61\2-3.doc 

As described above, only two Relevant Chemicals were detected in one treated seawater 

and two cleaning solution samples. Also the detected concentrations were similar to natural 

levels, so they would not cause any considerable risk to aquatic organisms or human. There 

are enough evidences that any of relevant harmful by-products will not be produced and 

remained in water for at least 5 days after the treatment by "FineBallst MF" BWMS from the 

chemical and toxicological results. 

Detailed methods and results are described in appendix II. 

Table 6.1: The concentration of H2O2 and potential Relevant Chemicals in 

untreated (A), treated by "FineBallast MF" BWMS (B) and detoxified 

cleaning solution samples (C) prepared together with samples for 

acute toxicity tests using seawater (34 psu) 

Chemical Unit Untreated water (A)

[Sample ID: A-A] 

Treated water (B)

[Sample ID: A-B]

Detoxified Cleaning 

solution (C) 

[Sample ID: A-C] 

Total Residual Oxidant mg/L <0.1 <0.1 <0.1 

Free chlorine mg/L <0.03 <0.03 <0.03 

Thiosulfate mg/L <0.02 <0.02 <0.02 

Bromate μg/L <0.39 <0.39 <0.39 

Bromoform μg/L 0.03 <0.03 <0.03 

Chloroform μg/L <0.01 <0.01 0.09 

Dibromochloromethane μg/L <0.02 <0.02 <0.02 

Dichlorobromomethane μg/L <0.02 <0.02 <0.02 

Monobromoacetic acid μg/L <0.103 <0.103 <0.103 

Dibromoacetic acid μg/L <0.049 <0.049 <0.049 

Tribromoacetic acid μg/L <0.322 <0.322 <0.322 

Monochloroacetic acid μg/L <0.160 <0.160 <0.160 

Dichloroacetic acid μg/L <0.130 <0.130 <0.130 

Trichloroacetic acid μg/L <0.039 <0.039 <0.039 

Bromochloroacetic acid μg/L <0.089 <0.089 <0.089 

Dibronoacetonitrile μg/L <0.001 <0.001 <0.001 

1,2,3- Trichloropropane μg/L <0.05 <0.05 <0.05 
MEPC 61/2/3 

Annex, page 26 

I:\MEPC\61\2-3.doc 

Table 6.2: The concentration of H2O2 and potential Relevant Chemicals in 

untreated (A), treated by "FineBallast MF" BWMS (B) and detoxified 

cleaning solution samples (C) prepared together with samples for 

acute toxicity tests using brackish water (21 psu) 

Chemical Unit Untreated water (A) 

[Sample ID: E-A] 

Treated water (B) 

[Sample ID: E-B] 

Detoxified Cleaning 

solution (C) 

[Sample ID: E-C] 

Total Residual Oxidant mg/L <0.1 <0.1 <0.1 

Free chlorine mg/L <0.03 <0.03 <0.03 

Thiosulfate mg/L <0.2 <0.2 <0.2 

Bromate μg/L <0.39 <0.39 <0.39 

Bromoform μg/L <0.03 <0.03 <0.03 

Chloroform μg/L <0.01 <0.01 <0.01 

Dibromochloromethane μg/L <0.02 <0.02 <0.02 

Dichlorobromomethane μg/L <0.02 <0.02 <0.02 

Monobromoacetic acid μg/L <0.103 <0.103 <0.103 

Dibromoacetic acid μg/L <0.049 <0.049 <0.049 

Tribromoacetic acid μg/L <0.332 <0.332 <0.332 

Monochloroacetic acid μg/L <0.160 <0.160 <0.160 

Dichloroacetic acid μg/L <0.130 <0.130 <0.130 

Trichloroacetic acid μg/L <0.039 <0.039 <0.039 

Bromochloroacetic acid μg/L <0.089 <0.089 <0.089 

Dibronoacetonitrile μg/L <0.001 <0.001 <0.001 

1,2,3- Trichloropropane μg/L <0.05 <0.05 <0.05 

Table 6.3: The concentration of H2O2 and potential Relevant Chemicals in untreated 

(A), treated by "FineBallast MF" BWMS (B) and detoxified cleaning solution 

samples (C) prepared together with samples for chronic toxicity tests 

using seawater (34 psu) 

Sample 

Type Untreated water (A) Treated water (B) Detoxified Cleaning solution (C) 

Chemical Time #1 #2 #3 #4 #1 #2 #3 #4 #1 #2 #3 #4 

Sample ID C1-A C2-A C3-A C4-A C1-B C2-B C3-B C4-B C1-C C2-C C3-C C4-C

Total Residual Oxidant mg/L <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

Free chlorine mg/L <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03

Thiosulfate mg/L <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 1.8 <0.2 <0.2 <0.2 <0.2 

Bromate μg/L <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39 <0.39

Bromoform μg/L <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03 <0.03

Chloroform μg/L <0.01 0.19 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.20 <0.01 <0.01 <0.01

Dibromochloromethane μg/L <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02

Dichlorobromomethane μg/L <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02

Monobromoacetic acid μg/L <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103 <0.103

Dibromoacetic acid μg/L <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049 <0.049

Tribromoacetic acid μg/L <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332 <0.332

Monochloroacetic acid μg/L <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160 <0.160

Dichloroacetic acid μg/L <0.130 <0.130 <0.130 <0.130 0.13 <0.130 <0.130 <0.130 <0.130 <0.130 <0.130 <0.130

Trichloroacetic acid μg/L <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039 <0.039

Bromochloroacetic acid μg/L <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089 <0.089

Dibronoacetonitrile μg/L <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001

1,2,3- Trichloropropane μg/L <0.05 <0.05 <0.05 0.42 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05
MEPC 61/2/3 

Annex, page 27 

I:\MEPC\61\2-3.doc 

6.5 Potential physical effects on wildlife and benthic habitats 

There is no logical possibility that the treatment could physically affect wildlife or benthic 

habitats. The treatment does not seem to affect the physical properties of the seawater and 

surrounding environment during operation. The chemical and toxicity data showed that there 

was no significant residual toxic effect from treatment of aquatic organisms including 

two benthic species (bivalves and amphipods), which serve as an important dietary source 

for wildlife. 

6.6 Potential residue in seafood 

H2O2 and its potential Relevant Chemicals are not readily bioaccumulated in aquatic 

organisms and not biomagnified through the marine food chain. So no potential residue in 

seafood from the treatment seems to occur. 

6.7 Known interactive effects 

There is no evidence of known or expected interactive effects. 

7 PHYSICAL AND CHEMICAL PROPERTIES OF THE PREPARATIONS, ACTIVE 

SUBSTANCE, AND TREATED BALLAST WATER, IF APPLICABLE (G9: 4.2.1.4) 

7.1 Physical and chemical properties of the Active Substance 

The "Fine Ballast MF" BWMS uses only one Active Substance, H2O2 for clearing its filter 

module. Most H2O2 is catalysed before ballasting so only a limited amount of H2O2 Relevant 

Chemicals can remain. 

H2O2 is clear colourless liquid, normally handled in an aqueous solution. H2O2 is not 

flammable. There is a dangerous fire hazard from the chemical reaction of H2O2 with 

flammable materials. However, H2O2 is a powerful oxidizer, particularly in its concentrated 

state, and reacts violently with combustible and reducing materials causing fires and 

explosion hazards. 

The identification and physico-chemical properties of the Active Substance are summarized 

below (see Tables 7.1 and 7.2). 

CAS-No: 7722-84-1 

EINECS-No: 231-765-0 

IUPAC name: hydrogen peroxide 

Synonyms: dihydrogen dioxide, hydrogen dioxide 

Molecular weight: 34.02 g/mol 

Molecular formula: H2O2

Structural formula: H - O - O - H 
MEPC 61/2/3 

Annex, page 28 

I:\MEPC\61\2-3.doc 

Table 7.1: Physical and chemical properties of pure H2O2 (EC, 2003) 

Property Value 

Melting point -0.4 or -0.43°C 

Boiling point 150-152°C decomposition 

Density 1.4425 g/cm3 (25°C) 

Viscosity 1.249 (20°C) 

Vapour pressure 3 hPa (25°C) 

Water solubility miscible in all proportions 

pKa 11.62 (25°C) 

Henry's law 

constant 7.5·10-4 Pa m3

/mol (20°C) measured 

The physico-chemical properties may change depending on the purity of the H2O2. 

 Table 7.2: Physical and chemical properties of H2O2-water mixture 

 solution (EC, 2003) 

H2O2 % 35% w/w 50% w/w 70% w/w 90% w/w 

Melting point -33°C -52°C -40°C -11°C

Boiling point 108°C 114°C 125°C 141°C

Density(25°C) 1.1282 1.1914 1.2839 1.3867 

Vapour pressure 

(partial) 

0.05 kPa 

(30°C) 

0.11 kPa 

(30°C) 

0.17 kPa 

(30°C) 

0.29 kPa 

(30°C) 

Vapour pressure 

(total) - 24 hPa 

(30°C) 

14.7 hPa 

(30°C) 

6.7 hPa 

(30°C) 

Saturated vapour 

concentration at 25 

°C (mg/m3

) 

- 787 1,685 3,049 

Surface tension at 

20°C (mN/m) 74.6 75.7 77.3 79.2 

Viscosity (1·10-

3

kg/ms) 1.11 1.17 1.24 1.26 

The partial vapour pressure of H2O2-water mixture considerably decreases with the decrease 

of H2O2 concentration in solution from 3 hPa (100%) to 0.48 hPa (35%), therefore, the 

saturated vapour concentration also decreases with the decrease of H2O2 concentration 

(Tables 7.1 and 7.2). 

Partial vapour pressure is very important to estimate the air concentration of chemicals 

(e.g., H2O2), which can be vaporized in water matrix. Figure 7.1 shows that partial pressure 

increases with the increase of H2O2 concentration and temperature. There is no data 

for 1.5% H2O2 solution (representative concentration in CIP unit during cleaning process) at 

room temperature (~20o

C), but the partial vapour pressure of the cleaning solution will be 

certainly lower than 10 Pa, which is that of 5% H2O2 solution at 50o

C (arrow in Figure 7.1). 
MEPC 61/2/3 

Annex, page 29 

I:\MEPC\61\2-3.doc 

Figure 7.1: Variation of Partial Vapour Pressure (Pa) of H2O2-water mixture depending 

on the concentration of H2O2 and temperature (o

C). (cited from internet 

site http://www.h2o2.com/intro/properties/physical.html#13) 

7.2 Corrosivity 

A corrosivity test was performed with treated ballast water from the "FineBallast" system 

over 30 days. The test results showed no significant changes in the corrosivity of treated 

ballast water compared to natural seawater (see Table 7.3 and appendix IV). 

 Table 7.3: The result of the corrosivity test with ballast water treated 

 by the "FineBallast MF" BWMS 

Test Item Sample Rating Number 

(mean ± S.D) Methods 

A 10 ± 0 

Rating of unscribed areas B 10 ± 0 

C 10 ± 0 

A 9 ± 1.7 

Rating of failure at scribe B 9 ± 1.7 

C 10 ± 0 

ASTM D 1645-08 

8 ANALYTICAL METHODS AT ENVIRONMENTALLY RELEVANT CONCENTRATIONS 

(G9: 4.2.1.5) 

All analyses were done according to standard methods with toxicity testing performed under 

supervision of KORDI. The testing laboratory, KTR is accredited by KOLAS for chemical 

analysis of environmental samples including DOC and POC analysis (appendix II). Although 

the NeoEnBiz Co. LTD Institute laboratory is not specifically accredited for toxicological 

testing, the personnel of this institute have solid experience in toxicological research, and all 

tests were performed according to good laboratory practice. Data on quality assurance are 

provided in each test report (appendix III). 

5% H2O2

100% H2O2
MEPC 61/2/3 

Annex, page 30 

I:\MEPC\61\2-3.doc 

An extraction of the Quality Assurance Project Plan (QAPP) for all testing is attached in 

appendix I. 

The Quality Management Plan (QMP) addresses the quality control management structure 

and policies of the Test Organization (including subcontractors and outside laboratories). 

The QAPP is a project specific technical document reflecting the specifics of the system to 

be tested, the test facility, and other conditions affecting the actual design and 

implementation of the required experiments. 

All analyses of Active Substance and Relevant Chemicals including by-products were 

conducted in accordance with standard operation procedures and the KTR quality manual 

(see Table 8.1). Quality assurance and control was performed based on a separated study 

plan as outlined in QAPP. 

Table 8.1: List of analytical methods for active and Relevant Chemicals 

Chemical CAS No. Molecular 

Formula Analytical Method 

Total Residual Oxidant - - US EPA 303.3; 1978 

Free chlorine - - ISO 7393-1; 1985 (E) 

Thiosulfate - S2O3

ISO 10636; 1994 

(modified) 

Bromate 15541-45-4 BrO3 ISO 15061; 2001 

Bromoform 75-25-2 CHBr3 US EPA 524.2; 1995 

Chloroform 67-66-3 CHCl3 US EPA 524.2; 1995 

Dibromochloromethane 124-48-1 CHBr2Cl US EPA 524.2; 1995 

Dichlorobromomethane 75-27-4 CHBrCl2 US EPA 524.2; 1995 

Monobromoacetic acid 79-08-3 C2H3BrO2 US EPA 552.2; 1995 

Dibromoacetic acid 631-64-1 C2H2Br2O2 US EPA 552.2; 1995 

Tribromoacetic acid 75-96-7 C2H1Br3O2 US EPA 552.2; 1995 

Monochloroacetic acid 79-11-8 C2H3ClO2 US EPA 552.2; 1995 

Dichloroacetic acid 79-43-6 C2H2Cl2O2 US EPA 552.2; 1995 

Trichloroacetic acid 76-03-9 C2H1Cl3O2 US EPA 552.2; 1995 

Bromochloroacetic acid 5589-96-8 C2H2BrClO2 US EPA 552.2; 1995 

Dibronoacetonitrile 3252-43-5 C2HBr2N US EPA 551.1; 1995 

1,2,3- Trichloropropane 96-18-4 C3H5Cl3 US EPA 524.2; 1995 

9 RISK CHARACTERIZATION 

9.1 Screening for persistency, bioaccumulation and toxicity 

The assessments on intrinsic properties of the Active Substance (H2O2) and detected 

Relevant Chemicals (chloroform), such as persistency, bioaccumulation and toxicity were 

conducted below. 

Persistency: The half-life of H2O2 (100%) in seawater samples varied from 50 to 70 hours. 

The half life of chloroform in seawater was not available, but in fresh water, those varied 

from 1.5~10 days. The standard criterion of persistency described in Procedure (G9) is 
MEPC 61/2/3 

Annex, page 31 

I:\MEPC\61\2-3.doc 

half-life >60 days. Both chemicals are removed relatively quickly and tend not to be 

persistent in aquatic environments. 

Bioaccumulation: The highest BCF of H2O2 (100%) and chloroform for fish is 3.3 and 13, 

respectively. The estimated log POW of H2O2 is -1.5 and that of chloroform is 2.0. The criterion 

for bioaccumulation is BCF > 2000 or log POW > 3.0. Both chemicals are not bioaccumulated 

or bioconcentrated because both have low Pow and also H2O2 is fastly degraded and 

chloroform is fastly volatilized into the air from the surface water. 

Toxicity: Not many NOEC results of H2O2 on marine organisms are available from the 

literature, but the lowest NOEC for fresh water organisms was 0.1 mg/L, which is not in the 

range of the toxicity criterion for NOEC (<0.01 mg/L). The lowest NOEC for chloroform on 

fresh water organisms was 1.4 mg/L, which is even higher than that of H2O2. 

PBT screening of the Active Substance and Relevant Chemicals detected in the 

"FineBallast MF" BWMS treated water showed that they are not included among the PBT 

chemicals. 

The chemical and ecotoxicological results also support that there is no significant remaining 

toxic effect in treated water and even in worst-case water after 5 days of storage. 

9.2 Toxicity testing of the treated ballast water 

Acute and chronic ecotoxicity tests with "FineBallast MF" BWMS treated seawater and 

brackish water covering multiple test species (a bacteria, an algae, several invertebrates, 

and a fish) indicated no acute or chronic toxicity to any test organisms at any effluent 

concentrations as compared to control and the untreated water. Even full strength effluent 

(100%) did not reveal any significant deleterious effects on any of the test species in both 

acute and chronic tests. Consequently, the effluent is expected to be non-toxic to aquatic 

organisms as well as to the marine environment in general (appendix III). 

The actual NOEC for "FineBallast MF" BWMS treated seawater and brackish water was not 

measurable; the statistically determined NOEC was 100% (see appendix III). 

The cleaning solution is the only water containing Active Substances as high as 1.5% during 

the cleaning phase before detoxification by catalyses. To evaluate the worst-case scenario, 

the detoxified cleaning solution samples (C) were also included in all chemical and toxicity 

tests. 

Though TRO and free chlorine were detected in the detoxified cleaning solution that adds 

H2O2 of 10% concentration that is the concentration 6.7~10 times (1.0~1.5%H2O2) when 

operating usually, each concentration has decreased with the time passage. TRO value 

became 0.1 mg/L and free chlorine value became 0.05 mg/L two days later. And, other any 

Relevant Chemicals were not detected. Therefore, the residual chemicals and toxicities were 

negligible even in the cleaning solution after 5 days of storage (see appendix VIII). 

As free radicals due to H2O2 have a relative short lifetime and after 5 days of degradation, 

no significant toxic effects are expected for aquatic organisms. There should be no need for 

holding time in order to observe further adverse effects upon discharge. 
MEPC 61/2/3 

Annex, page 32 

I:\MEPC\61\2-3.doc 

9.3 Risk analysis for aquatic organisms 

Test results revealed no measurable levels of potentially toxic substances and no significant 

acute or chronic effects of the full strength effluent and also diluted samples on aquatic 

organisms. No apparent environmental risks could therefore be identified. 

Acute and chronic toxicity tests on "FineBallast MF" BWMS treated seawater and brackish 

water showed no effect on any of the test organisms (appendix III). 

The H2O2 concentrations were below 0.1 mg/L and chloroform were below 0.2 mg/L in all 

treated water samples for deballasting into the environment and also in detoxified cleaning 

solution, which are ~10 and 1000 times lower than the toxic levels among the reported 

values for marine organisms, respectively (see appendix VI for ecotoxicity data from the 

literature). 

In spite of the lack of reliable toxicity results, toxic concentration level of thiosulfate ranged 

tens of thousands ppm in water. The detected concentration of thiosulfate ion in a treated 

water sample (1.8 mg/L) was much below the reported toxic level and may be included 

in the range of naturally occurring level in seawater (0.12~2.4 mg/L; CigleneEki and 

C'osoviC, 1997). Thiosulfate can be produced biologically by sulfate reducing bacteria in 

seawater, however, it is not clear why it was detected only in one sample and not in others. 

Most of the toxicity data showed that the remaining levels of Active Substance and potential 

Relevant Chemicals are not considered toxic to most aquatic organisms. 

Two benthic species (amphipods and bivalves) exposed to the treated water also showed 

negligible toxic effects. Due to the rapid degration rate in sediment as well as low Pow and Kd

of both H2O2 and chloroform, a risk for aquatic organisms exposed to sediment is considered 

to be negligible. 

Due to the low bioaccumulative potency and low persistency in water of both H2O2 and 

chloroform, secondary poisioning and biomagnification through food chain could not occur in 

the aquatic ecosystems. 

In conclusion, it should be noted that the analyses performed and presented in this document 

are preliminary and will be complemented with further tests, both with regard to toxicity as 

well as the chemical properties of the treated water, if necessary. The test results found no 

measurable levels of potentially toxic substances and no acute and chronic effects of the full 

strength effluent and also diluted effluents on aquatic organisms. Therefore, no apparent 

environmental risk could be identified. Furthermore, no carcinogenic, mutagenic or endocrine 

disruptive substances were found in the samples treated by the BWMS. 

10 RISK ASSESSMENT 

10.1 Risk to ship safety 

10.1.1 Corrosion 

Influential factors on corrosion in seawater are salt content, solute gases such as oxygen, 

carbon dioxide, and pH level. Of the several factors, the solute oxygen content is of primary 

importance as a component influencing the corrosion behaviour of most metal in seawater. 

The water treated by "FineBallast MF" BWMS contained negligible amount of H2O2 due to 

the high efficient catalysing procedure, therefore, it seems to have any significant reactive 
MEPC 61/2/3 

Annex, page 33 

I:\MEPC\61\2-3.doc 

oxygen. There was no pH change in the treated ballast water as compared to untreated 

water (influent). 

The results of the 30-day preliminary corrosion test conducted on the "FineBallast MF" 

BWMS showed no significant difference in inscribed areas and failure at the scribe between 

untreated (A) and treated seawater (B). The results indicate that there is no detectable 

difference in oxidizing potency due to reactive oxygen between the untreated water and 

treated water. 

Only a small difference (~9%) was detected for the cleaning solution (C) compared to 

untreated (A) and normally treated water (B) probably due to a greater number of oxidants in 

the worst-case samples (see appendix IV). 

The conditions for the corrosion test here were very severe because the test duration was 

not long enough; test solutions in each treatment were changed every day with 5-day aged 

water after sampling. In realistic conditions, the surface of the ballast tank will not likely be 

exposed to changed water every day. In any event, we should not expect additional 

corrosivity from the "FineBallast MF" BWMS treated seawater for at least a month. Further 

experiments adopting a longer test period and realistic exposure conditions should be 

conducted related to corrosivity in future research. 

10.1.2 Personnel safety 

A risk assessment (RA) study of a "FineBallast MF" BWMS installed on land was conducted. 

The objective of the study was to identify and summarize all known hazardous events that 

could occur during normal operation and maintenance phases (see appendix VII for details). 

An RA workshop was carried out by attendees with a lot of experience in mechanical and 

process design, fabrication and installation, etc., in MES. The scope of the RA study is as 

follows: Membrane module, CIP unit and Human safety. 

Table 10.1: Potential hazard list for each module to workers operating the BWMS 

Hazard 

No. Hazard System  (or Sub-system) Mode 

1 Membrane module falling Human safety maintenance 

2 Membrane module comes out due to 

fouling Membrane module Operation 

3 Cleaning solution floods the CIP tank CIP unit Cleaning 

4 CIP tank or chemical line leakage CIP unit Cleaning 

5 CIP tank solution levels too low CIP unit Cleaning 

6 Oxygen released on decomposition 

which may intensify fires CIP unit Storage 

10.1.3 Exposure values 

According to ACGIH guidelines, the exposure limit for H2O2 is 1 ppm. For the Basic Approval 

test under Procedure (G9), it is difficult to simulate the actual environment on ship, thus we 

check strict conditions about this matter. During CIP unit working, the seawater containing 

H2O2 feeds from the "Feed Tank" (see Figure 1.3) and returns to this tank from membrane 
MEPC 61/2/3 

Annex, page 34 

I:\MEPC\61\2-3.doc 

units. The inside air of the "Feed Tank" is checked during seawater circulation where H2O2

mist is expected to exist. From the two analyses, the values are 2.7 ppm and 3.1 ppm. These 

values exceed the ACGIH guidelines, however, the tank hatch is closed for normal operations, and 

has a very low risk of leakage. For the Guidelines (G8) test, we would simulate the actual 

environment on ship as closely as we can, and check exposure values again. 

10.1.4 Human health risk assessment 

Direct contact during this operation is minimized by recommended handling procedures that 

include appropriate personal protective equipment, gloves, goggles and, if needed, 

respiratory protection. No additional risk to workers or ship personnel is considered to arise 

from the "FineBallast MF" BWMS. 

Furthermore, there is no concern for mutagenicity or carcinogenicity, already argued above 

(sections 5.6 and 5.7). 

After all, the product can be handled safely in this method of ballast water management. 

The 8-hour averaged air concentration of H2O2 in the BWMS work place should be 

maintained at below 1 ppm under regulation (Table 10.2). The measured H2O2 concentration 

in the air of feed tank is below 3.1 ppm and therefore the H2O2 concentration in air of the 

BWMS working place should be much lower. 

To estimate the air concentration using evaporation model, we used the exposure model 

program. The variable volume of the work place (50~1,000 m3

) and the ventilation rate 

(0~3/hr) was used for the estimation (see appendix V for details). The reasonable 

conservative values of most the physico-chemical parameters were used for the estimation, 

the air concentration results are all below 1 ppm, however. 

Therefore, we concluded that there is only negligible risk even for the workers 

staying 8 hours everyday in the place for BWMS operation. 

Table 10.2: Standards or guidelines on human health from various agencies 

for H2O2 in air 

Regulatory body* H2O2 Description 

OSHA 1 ppm 

AGCIH 1 ppm 

Permissible exposure limit (PEL), averaged over an 

8 hours work shift; TWA (time weighed average) 

NIOSH 75 ppm Immediately dangerous to life or health (IDLH) 

AIHA 50 ppm 

Emergency response planning guidelines (ERPG-2), 

maximum airborne concentration below which it is 

believed that nearly all individuals could be exposed 

for up to 1 hour without experiencing or developing 

irreversible or other serious health effects or 

symptoms which could impair an individual's ability 

to take protective action 

*OSHA: Occupational Safety and Health Administration, USA 

AGCIH: American Conference of Industrial Hygienists, USA 

 NIOSH: The National Institute for Occupational Safety and Health Administration, USA 

 AIHA: American Industrial Hygiene Association, USA 
MEPC 61/2/3 

Annex, page 35 

I:\MEPC\61\2-3.doc 

10.2 Risk to environment 

The chemical analyses (appendix II) and the toxicity tests (appendix III) have led to the 

conclusion that there is negligible risk to the aquatic environment. Neither potential 

hazardous substances nor significant acute and chronic toxicity in the treated water samples 

as well as cleaning solution were significantly observed for the BWMS evaluated in this 

report. 

Under realistic emission scenarios, discharged water will be diluted at minimum, dozens of 

times or more, so any residual toxicity would seem to be insignificant both during and after 

deballasting from the ship if realistic conditions are relevant to the test conditions in this 

report. 

To evaluate the possible environmental effect due to the discharge of ballast water treated by 

the "FineBallast MF" BWMS, the model estimation of probable environmental concentrations 

(PECs) of the Active Substance (H2O2) and Relevant Chemical (chloroform) was conducted 

using the similar parameters with Tokyo harbour condition. Then, the PECs of both 

chemicals were compared to the predicted no effect concentrations (PNECs) reported 

previously. 

10.2.1 Prediction of discharge and environmental concentrations (G9: 5.3.8) 

10.2.1.1 Introduction 

The Marine Anti-foulant model (MAMPEC) was used in this dossier to predict environmental 

concentrations of H2O2 considered as most part of TRO in the port water after discharge. 

MAMPEC was originally programmed to calculate environmental concentrations of 

anti-fouling biocides released from ship coatings. In a modified way it can be used to 

calculate concentrations that are released constantly into the water by other processes like 

for example ballast water treatment. The applicability of the model to any chemical substance 

made it a useful tool for environmental impact studies. 

10.2.1.2 H2O2 

As a worst case scenario, the following calculations are therefore all based on H2O2. PECs of 

H2O2 were calculated based on a degradation factor (half-life) determined during MAMPEC 

simulation. 

10.2.1.3 Parameterization of the model 

To determine the environmental concentration of the released compound in the harbour 

water and the sediment, several parameters are necessary. These parameters define the 

harbour and its characteristics, the compound that is being released in the designated sea 

area. This section provides detailed parameterization of the model. 

10.2.1.4 Half-life 

For modelling of various environmental scenarios a wide range of the half-life was used, from 

an hour to days. Within MAMPEC it was not possible to include the decay of the compound 

of interest during emptying the ballast water tank. In this case, therefore, a worst-case 

scenario was assumed that the water released from the ballast tanks has the same 

concentration at the start and at the end of discharge. 
MEPC 61/2/3 

Annex, page 36 

I:\MEPC\61\2-3.doc 

10.2.1.5 H2O2 concentrations in the ballast water and amount of ballast water released 

The following discharge H2O2 concentration was used in calculations: 

- 0.1 mg/L - a concentration observed in detoxified cleaning solution (when 10% 

H2O2 was used; see appendix VIII) 2 days or 5 days after treatment. 

Further it was assumed that all ships are equipped with the "FineBallast MF" BWMS with the 

water characterized by the same holding time (H2O2 level). 

It was assumed that there were 15 ships could be anchored in the Port of Tokyo and the total 

area is 1,504,718m2

. The total amount of ballasting and deballasting water in the designated 

sea area was set to be 1,378,117m3

 a year (based on 2001 statistical data). Simply 

assuming the amount of deballasting to be 1/2 the total amount of ballasting and 

deballasting, 689,059m3

/year or 1,888m3/day or 78.7m3/hour of ballast water will be 

discharged. These numbers for the Port of Tokyo were used in the publicly available dossiers 

of other ballast water management system developers and it would be reasonable to 

maintain the same scenarios in the current calculations. 

The following model inputs result from the assumptions above: 

Concentration of 

chemical 

(mg/L) 

Ballast water released per day 

(m3) 

Chemical released per day 

(g) 

0.1 of H2O2 1,888 188.8 

0.0002 of chloroform 1,888 0.3776 

10.2.1.6 Background concentration 

The background concentration of H2O2 was assumed to be 0 to determine exactly the 

amount introduced by the "FineBallast MF" BWMS. 

10.2.1.7 Results of modelling for H2O2 

The half-life is a critical variable to estimate the PEC of H2O2, however, it can be affected by 

many factors in the natural environments. The PECs of H2O2 were estimated 

under conditions described above using MAMPEC when the half-life of H2O2 varied 

from 0.94 to 960 hours, of which range covers the previously reported half-life of H2O2

(~60 hours) in water. 

The PEC of H2O2 increased with the increased of half-life. With the longest half-life, the 

maximum PEC of H2O2 was estimated as 0.012 μg/L. 

Predicted environmental concentrations of H2O2 (PEC H2O2) vary significantly depending on 

which value of the H2O2 half-life was selected as a model parameter. For a half-life less than 

an hour and discharge concentration of 0.1 mg/L, a range of PEC values was 

between 1.0E-07 and 5.5E-04 μg/L. For a half-life greater than 20 days and discharge 

concentration of 0.1 mg/L, a range of PEC values was between 1.5E-03 and 1.2E-02 μg/L. 
MEPC 61/2/3 

Annex, page 37 

I:\MEPC\61\2-3.doc 

10.2.1.8 Results of modelling for chloroform

Similar with the PEC estimation for H2O2 described above, the PECs of chloroform were 

estimated when the half-life of chloroform varied from 100 days to 900 days. The half-life of 

chloroform in seawater was not reported previously, so we adopted the conservative range 

for the PEC estimation. Maximum PEC of chloroform was only 0.000018 μg/L even with the 

conservative condition. 

10.2.2 Effects on aquatic organisms 

Predicted No-Effect Concentration (PNEC) for H2O2 is shown in Table 10.3. 

Table 10.3: Predicted No-Effect Concentration (PNEC) for H2O2 

Chemical PNEC (μg/L) Factor Applied Comment(s) 

H2O2 10 N/A EU RAR (2003) 

TRO 0.04 N/A Conservative value (PNEC of HClO in 

EU RAR (2007)) 

Chloroform 48-146 N/A EU RAR (2007) 

10.2.3 Risk to the aquatic environment 

The potential risk to the aquatic environment is based on a series of PEC/PNEC ratios for 

Active Substance, H2O2 (measured as TRO) and a Relevant Chemical, chloroform using 

a worst case scenario. 

Given below are the PEC/PNEC ratios for the average, minimum, and maximum 

concentrations of H2O2 in the Port of Tokyo using the dilutions predicted by the MAMPEC 

model for various H2O2 decay half-lives. PEC/PNEC ratios were always below 1 when 

the H2O2 concentration in the discharged water was 0.1 mg/L (>2 days after treatment). 

PEC/PNEC ratios were always below 1 when we used the PNEC value for H2O2 (10 μg/L) 

even under the worst-case conditions. 

Table 10.4: H2O2 PEC/PNEC ratios for discharged ballast water in the Port of Tokyo 

as PNEC 0.04 and 10 μg/L 

PEC/PNEC as PNEC 0.04 ug/L 

H2O2 in Discharge- 0.1 mg L-1 

PEC/PNEC as PNEC 10 ug/L 

H2O2 in Discharge- 1.3 mg L-1 

Half-life, h 

average minimum maximum average minimum maximum

0.9375 2.24E-03 2.50E-06 1.38E-02 8.97E-06 1.00E-08 5.50E-05 

1.875 4.48E-03 4.13E-05 2.22E-02 1.79E-05 1.65E-07 8.89E-05 

3.75 8.90E-03 3.35E-04 3.48E-02 3.56E-05 1.34E-06 1.39E-04 

7.5 1.74E-02 1.55E-03 5.28E-02 6.96E-05 6.18E-06 2.11E-04 

15 3.25E-02 4.68E-03 7.85E-02 1.30E-04 1.87E-05 3.14E-04 

30 5.63E-02 1.03E-02 1.15E-01 2.25E-04 4.10E-05 4.59E-04 

60 8.70E-02 1.77E-02 1.61E-01 3.48E-04 7.06E-05 6.44E-04 

120 1.19E-01 2.53E-02 2.09E-01 4.75E-04 1.01E-04 8.37E-04 

240 1.45E-01 3.10E-02 2.50E-01 5.79E-04 1.24E-04 9.98E-04 

480 1.62E-01 3.50E-02 2.78E-01 6.49E-04 1.40E-04 1.11E-03 

960 1.73E-01 3.75E-02 2.95E-01 6.91E-04 1.50E-04 1.18E-03 
MEPC 61/2/3 

Annex, page 38 

I:\MEPC\61\2-3.doc 

The PEC/PNEC results for chloroform were also estimated using the same method with 

those for H2O2. Results showed that PEC/PNEC ratios were far below 1 even under 

worst-case conditions. Therefore, the risks to aquatic organisms due to chloroform in the 

discharged water will be negligible. 

Table 10.5: Chloroform PEC/PNEC ratios for discharged ballast water in the Port 

of Toyko as PNEC 48 μg/L 

PEC/PNEC 

Chloroform in Discharge- 0.2 μg/L 

Half-life, days 

average minimum maximum 

100 2.06E-07 4.38E-08 3.60E-07 

450 2.08E-07 4.46E-08 3.67E-07 

900 2.08E-07 4.46E-08 3.67E-07 

Overall, the chemical analyses (appendix II) and the toxicity tests (appendix III) have led to 

the conclusion that there is negligible risk to the aquatic environment. Neither potential 

hazardous substances nor significant acute and chronic toxicity in the worst-case samples 

and treated water samples were significantly observed for the BWMS evaluated in this 

report. 

Under realistic emission scenarios, discharged water will be diluted at minimum, dozens of 

times or more, so any residual toxicity would seem to be insignificant both during and after 

deballasting from the ship if realistic conditions are relevant to the test conditions in this 

report. 

11 REFERENCES 

American Public Health Association (APHA), 1985. Standard Method for Examination of 

Water and Wastewater. American Water Association and Water Environment Federation 

16th Edition Washington D.C., 742-748 pp. 

American Public Health Association (APHA), 1995. Standard Method for Examination of 

Water and Wastewater. American Water Association and Water Environment Federation 

20th Edition Washington D.C. 1325 pp. 

Barroin, G. and Feuillade, M. (1986). Hydrogen Peroxide as a potential algicide for 

Oscillatoria rubescens D.C. Water Research, 20, 619-623. 

Branco MR, Marinho HS, Cyrne L and Antunes F. (2004) Decrease of H2O2 Plasma 

Membrane Permeability during Adaptation to H2O2 in Saccharomyces cerevisiae. 

The Journal of Biological Chemistry, 279: 6501-6506. 

Ciglenecki I and Cosovic B (1997). Electrochemical Determination of Thiosulfate in Seawater 

in the Presence of Elemental Sulfur and Sulfide. Electroanalysis 9, 775-780. 

EC (European Commission), Summary Risk Assessment Report. Hydrogen Peroxide. 2003. 

EC (European Commision), 2003. European Union Risk Assessment Report Vol. 38 – 

Hydrogen peroxide. 
MEPC 61/2/3 

Annex, page 39 

I:\MEPC\61\2-3.doc 

EC (European Commision), 2007. European Union Risk Assessment Report (Draft) – 

Chloroform. 

EC (European Commision), 2007. European Union Risk Assessment Report (Final) – 

Chlorine. 

Fridovich I (1978). The biology of oxygen radicals. Science 201, 875-880. 

Fridovich I (1983). Superoxide radical: an endogenous toxicant. Ann. Rev. Pharmacol. 

Toxicol. 23, 239-257. 

Garvey, M., B. Moriceau, and U. Passow1, 2007. Applicability of the FDA assay to determine 

the viability of marine phytoplankton under different environmental conditions. Marine

Ecology Progress Series, 352, 17-26. 

Goor G et al. (2005). Hydrogen Peroxide In: Ullmann's Encyclopedia of Industrial Chemistry, 

5th completely revised edition, Vol. A 13. Elvers B, Hawkins S, Ravenscroft M and Schulz G 

(eds), VCH, Weinheim, 443-466. 

IARC (1999). Monograph on the Evaluation of Carcinogenic Risk Chemicals to Humans. 

Volume 71. Re-evaluation of some organic chemicals, hydrazine and hydrogen peroxide. 

Jochem, F., 1999. Dark survival strategies in marine phytoplankton assessed by cytometric 

measurement of metabolic activity with fluorescin diacetate. Mar Biol, 135, 721–728. 

Moffett J and Zafiriou OC (1990) An investigation of hydrogen peroxide chemistry in surface 

waters of Vineyard Sound with H2

18O2 and 18O2. Limnology & Oceanography. 35: 1221-1229. 

Pouneva, I., 1997. Evaluation of algal culture viability and physiological state by fluorescent 

microscopic methods. Bulg. J. Plant Physiol., 23(1-2): 67-76. 

SCCP (Scientific Committee on Consumer Products), Opinion on hydrogen peroxide, in its 

free form or when released, in oral hygiene products and tooth whitening products, 

18 December 2007. 

Sharp, J.H., 1974. Improved analysis for "particulate" organic carbon and nitrogen from 

seawater. Limnol. Oceanogr. 19, 984-989. 

Spain JC, Milligan JD, Downey DC and Slaughter JK (1989). Excessive bacterial 

decomposition of H2O2 during enhanced biodegradation. Groundwater 27, 163-167. 

UNESCO, 1994. Protocols for Joint Global Carbon Flux Study (JGOFS) Core Measurement. 

Manuals and Guides, 29: 101-118 pp. 

US EPA (1984) Health assessment document for manganese. Final draft. Cincinnati, OH, 

US Environmental Protection Agency, Office of Research and Development (EPA-600/8).

* * * 
MEPC 61/2/3 

Annex, page 40 

I:\MEPC\61\2-3.doc 

APPENDIX I 

EXTRACTION OF QAPP 

Quality Assurance Project Plan (QAPP) 

For 

FineBallast MF System Testing 

For 

Type Approval 

By 

KORDI 

Republic of Korea 

In accordance with the 

Guidelines for approval of ballast water management systems (G8) 

Project Name: FineBallast MF – Ballast Water Management System 

* * * 
MEPC 61/2/3 

Annex, page 41 

I:\MEPC\61\2-3.doc 

APPENDIX II 

CHEMICAL ANALYSIS TEST REPORTS 

Quality Assurance Project Plan 

(QAPP) 

FineBallast MF Ballast Water Management System 

Korea Testing & Research Institute 

Chemical Analysis Data for Active Substance and Relevant Chemicals 

The Active Substance (H2O2) was not detected in water either untreated or treated by 

FineBallast MFTM at all tested salinities (21 psu or 34 psu). Consistently, TRO chemicals, 

which include H2O2, were not detected in any samples either. 

Only three Relevant Chemicals, chloroform, thiosulfate and 1,2,3- Trichloropropane were 

detected in a limited number of samples. 

A potential Relevant Chemical, 1,2,3- Trichloropropane, was detected in only one untreated 

water sample, and cannot, therefore, be a by-product of BWMS treatment. 

Thiosulfate was detected in one treated sample prepared for the chronic fish toxicity test, of 

which the concentration was 1.8 mg/L. 

Chloroform was detected in two detoxified cleaning solution samples (0.09 ug/L and 0.20 ug/L) 

and one untreated water sample (0.19 ug/L). 

The chemical analysis methods conducted for Basic Approval of BWMS was described and 

the raw results shown below. 

* * * 
MEPC 61/2/3 

Annex, page 42 

I:\MEPC\61\2-3.doc 

APPENDIX III 

AQUATIC ORGANISMS TEST REPORTS 

Quality Assurance Project Plan 

(QAPP) 

FineBallast MF Ballast Water Management System 

NeoEnBiz Co.

Aquatic Organisms Toxicity Test Report 

No significant acute or chronic toxicity was observed in treated water compared to untreated 

water (natural). 

* * * 
MEPC 61/2/3 

Annex, page 43 

I:\MEPC\61\2-3.doc 

APPENDIX IV 

CORROSIVITY TEST REPORTS 

FineBallast MF Ballast Water Management System 

Korea Testing & Research Institute 

Summary of Corrosivity Test Results 

Corrosivity tests were conducted to assess the effects of effluent from the "FineBallast MF" 

system on water ballast tank protective coatings. For the test, an epoxy coating system, 

which is the most widely used in ship's ballast tank coating, was applied to a Simulated Wave 

Ballast Tank (SWBT) according to IMO document MSC 82/WP.3. 

In conclusion, the test results clearly indicated that treated seawater, the "FineBallast MF" 

system effluent, had a negligible effect on ship ballast tank coating performance, when 

compared with natural seawater and coating performance meets the IMO PSPC 

requirements regardless of seawater conditions. 

* * * 
MEPC 61/2/3 

Annex, page 44 

I:\MEPC\61\2-3.doc 

APPENDIX V 

ESTIMATION OF AIR CONCENTRATION OF HYDROGEN PEROXIDE IN THE WORK 

PLACE (MAXIMUM REASONABLE APPROACH) 

To assess the health risks for workers operating the "FineBallast MF" system, air 

concentrations in the work place were estimated. Reasonable worst-case conditions were 

assumed for the conservative estimate. The ConsExpo (Ver. 4.1; RIVM) program was used, 

and as mode of release, the evaporation model was selected. The conditions for estimating 

air concentration in the work place are shown in Table AV.1 below. 

We assumed that workers work 8 hours every day in the work place. The product amount 

is 5,000 kg (L) and concentration of H2O2 is 1.5%. The volume of the space varies 

from 50 m3 to 1,000 m3

, which covers the reasonable volume range of the BWMS operating 

room in ships (the usual volume is 770 m3). The average ventilation rate is not known, so 

variable ventilation rates from 0 to 3 hr-1 were used for the calculation. Partial vapour 

pressure for room temperature (~20o

C) and 1.5% H2O2in water solution conditions were not 

known, so that of the more severe conditions (5% of H2O2 in water at 50o

C ) were used. 

The mass transfer rate was not known for H2O2, so one of the default approximating models 

(Langmuir's method) in the program was selected as it gives a higher value than other 

methods. 
MEPC 61/2/3 

Annex, page 45 

I:\MEPC\61\2-3.doc 

Table AV.1: Conditions for estimating maximum air concentration of H2O2 in 

working place 

Parameter Value 

Exposure duration 8 hr/day 

Product Amount 5,000 kg 

Weight Fraction Compound 0.015 (1.5%) 

Room Volume (Variable) 50~1,000 m3

Ventilation Rate (Variable) 0~3 /hr 

Release Area 100 cm2

Temperature 20oC 

Molecular Wt. 34 

Partial Vapour Pressure 

10 Pascal (5% of H2O2 in water at 50o

C) 

(from Fig.7.1) 

Mass Transfer Rate 

6,720 m/min 

(Approximation using Langmuir's method) 

Molecular Wt. of Matrix 18 

Exposure Frequency Everyday 

Log Pow -1.57 

Inhalation Rate 34.7 m3/day (default) 

Body Weight 65 kg (default) 

The results were shown below in Table AV.2. Although the estimation was conducted using 

the very severe conditions or higher parameters (reasonable worst-case conditions), the 

estimated air concentrations are always below 1 ppm. If we use the more realistic condition 

(e.g., the realistic partial vapour pressure would be <1 Pa), the estimated concentration will 

decrease considerably. 
MEPC 61/2/3 

Annex, page 46 

I:\MEPC\61\2-3.doc 

Table AV.2: Estimated H2O2 air concentration in working place (see Table AV.1 

 for conditions) 

(a) Ventilation Rate: 0~3 times/hr with Room Volume: 770 m3 

Ventilation 

Rate 

(1/hr) 

Air 

Concentration

(mg/m3) 

Air 

Concentration

(ppm) 

0 1.09 0.78 

0.25 1.04 0.75 

0.5 0.99 0.71 

1 0.91 0.65 

2 0.78 0.56 

3 0.69 0.49 

(b) Room Volume: 50~1500 m3

 with Ventilation Rate: 1 /hr 

Room 

Volume 

Air 

Concentration

(mg/m3) 

Air 

Concentration

(ppm) 

50 1.10 0.79 

250 1.04 0.75 

500 0.97 0.70 

770 0.91 0.65 

1500 0.86 0.62 

* * * 
MEPC 61/2/3 

Annex, page 47 

I:\MEPC\61\2-3.doc 

APPENDIX VI 

REFERENCE ECOTOXICITY DATA ON H2O2 AND CHLOROFORM 

FROM THE LITERATURE 

Here are shown the reference results of ecological toxicity for the Active Substance (H2O2) 

and the only detected Relevant Chemical (chloroform). There are not many reliable sources 

of toxicity data for marine organisms. We therefore collected the results from research using 

either marine or fresh water species. The lowest effect concentration of H2O2 for marine 

species was 850 μg/L and that for fresh water species was 100 μg/L (see Tables AVI.1 

and 2). Algae species were relatively sensitive compared to invertebrate and fish species. 

Table AVI.1: Acute Toxicity of H2O2 towards aquatic organisms 

Taxon Species name Common 

name 

Toxicity 

endpoint 

Conc. 

(μg/L) Reference 

Algae Nitzschia 

closterium 

Diatom 

(marine) EC50 (48 h) 850 Florence and 

Stauber, 1986. 

Algae Sceietonema 

costatum 

Diatom 

(marine) EC50 (72 h) 1,380 

Knight et al. 1995 

[recited from EC 

(2003)] 

Rotifer Brachionus 

plicatilis 

Rotifer 

(marine) EC50 (72 h) 2,400 Smit et al., 2008. 

Amphipod Corophium 

volutator 

Scud 

(marine) EC50 (10 d) 611,000 Smit et al., 2008. 

Cladocera Daphnia pulex Water flea 

(fresh water) EC50 (48 h) 2,400 

Shurtleff, 1989 

[recited from EC 

(2003)] 

Fish Pimephales 

promelas 

Fathead 

minnow 

(fresh water) 

LC50 (96 h) 16,400 

Shurtleff (1989) 

[recited from EC 

(2003)] 

Table AVI.2: Chronic Toxicity of H2O2 towards aquatic organisms 

Taxon Species name Common 

name 

Toxicity 

endpoint

Conc. 

(μg/L) Reference 

Algae Anabaena 

flosaquae 

Cyanobacteria 

(fresh water) 

LOEC 

(32 days) 100 

Kavanagh (1992) 

[recited from EC 

(2003)] 

The lowest effect concentration of chloroform for marine species was 385 μg/L and that for 

fresh water species was 1463 μg/L (see Tables AVI.3 and 4). 
MEPC 61/2/3 

Annex, page 48 

I:\MEPC\61\2-3.doc 

Table AVI.3: Acute Toxicity of chloroform towards aquatic organisms 

Taxon Species name Common 

name 

Toxicity 

endpoint 

Conc. 

(μg/L) Reference 

EC50 477,000 

Algae Skeletonema 

costatum 

Diatom 

(marine) NOEC 216,000 

Cowgill et al., 1989. 

Bivalve 

(Molluscs) 

Crassostrea 

virginica 

Oyster 

(marine) 

LC50 

(48 h) 

385 

Stewart et al. 1979 

[recited from EC 

(2007)] 

Fish Lepomis 

macrochirus 

Fish 

(marine) 

LC50 

(96 h) 

18,000 

Anderson and 

Lustry, 1980 

[recited from EC 

(2007)] 

Rotifer Brachionus 

calyciflorus 

Rotifer 

(fresh 

water) 

LC50 2,000 Snell et al., 1991. 

Table AVI.4: Chronic Toxicity of chloroform towards aquatic organism 

Taxon Species name Common 

name 

Toxicity 

endpoint 

Conc.

(μg/L) Reference 

Algae Chlamydomonas 

reinhardii 

Algae 

(fresh water) EC10 (72 h) 3,610 

Brack and Rottler, 

1994 [recited from 

EC (2007)] 

Invertebrates Daphnia magna Water Flea 

(fresh water) 

NOEC (21 

days) 6,300 

Kuhn et al. 1989 

[recited from EC 

(2007)] 

Fish Oryzias latipes Fish (fresh 

water) 

NOEC (6/9 

months) 1,463 

Toussaint et al.

2001 [recited from 

EC (2007)] 

* * * 
MEPC 61/2/3 

Annex, page 49 

I:\MEPC\61\2-3.doc 

APPENDIX VII 

RISK ASSESSMENT (RA) FOR THE BWMS 

The dangerous operation of six items shown in Table 10.1 was forecast, and listed in risk 

assessment (RA) that described in section 10. Here, a detailed content and the 

countermeasure of each dangerous operation are described. 

* * * 
MEPC 61/2/3 

Annex, page 50 

I:\MEPC\61\2-3.doc 

APPENDIX VIII 

EXPERIMENT USING 10% H2O2 AS CLEANING SOLUTION FOR THE BWMS 

The normal concentration of H2O2 in cleaning solution during CIP mode is in the range 

of 1%~1.5%. To simulate more severe conditions, 10% H2O2 seawater was used as cleaning 

solution and the chemicals remaining in the cleaning solution during the 5-day storage period 

were measured. 

Five samples were measured for TRO and other chemicals listed in Table. 1 Sample F1-A 

was the untreated seawater containing 10% H2O2 and sample F1-B was the same seawater 

with 10% H2O2, but used as cleaning solution for the BWMS. Both F1-A and F1-B were 

stored for 1 day before analysis. Samples F1-C, F2-C and F5-C were the seawater samples 

which were used as cleaning solution, but catalysed by MnO2 and stored for 1, 2 and 5 days, 

respectively. 

Only TRO and free chlorine were detected in all samples. TRO concentrations were 

about 100 mg/L in samples A and B, which were almost 1000 times lower than the initial 

nominal concentration level (10% or 100,000 mg/L) of H2O2. The TRO might decrease 

during 1-d storage due to the fast degradation of H2O2. TRO concentrations in the catalysed 

seawater samples were about 100 times lower than the unanalysed samples, which indicate 

efficient catalysing performance for MnO2 in the BWMS. 

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MEPC 61/2/3 

Annex, page 51 

I:\MEPC\61\2-3.doc 

APPENDIX IX 

MANGANESE ANALYSIS FOR THE BWMS 

FINEBALLAST MF BALLAST WATER MANAGEMENT SYSTEM 

Summary of Manganese analysis result 

To evaluate the environmental impact of Dissolved Manganese that remained in detoxified 

cleaning water of "FineBallast MF" BWMS, the Manganese analysis was done. 

In conclusion, the Dissolved Manganese concentration was detected from the test 

result in the detoxified cleaning water and (0.097 mg/L~0.198 mg/L) was detected as for 

about 10 to 20 times in natural seawater. However, the detoxified cleaning water is expected 

to become Dissolved Manganese concentration equal with natural seawater from the dilution 

in the ballast tank to at least 70 times or more. Fish growth inhibitions are assumed to 

be 0.028 mg/L of the Ministry of the Environment's Predicted No Effect Concentration (PNEC) 

to the aquatic life, and the diluted detoxified cleaning water does not exceed this value ("Volume 6 

of the chemical of the environmental risk evaluation", First Volume (2008)). 

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