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E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

61st session 

Agenda item 2 

MEPC 61/2/10

29 March 2010

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Application for Final Approval of the Special Pipe Hybrid Ballast Water Management 

System combined with PERACLEANÆ Ocean (SPO-SYSTEM) 

Submitted by Japan 

SUMMARY 

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

the application for Final Approval of the Special Pipe Hybrid Ballast 

Water Management System combined with PERACLEANÆ Ocean 

(SPO-SYSTEM) under 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: 7.1.2.5 

Action to be taken: Paragraph 4 

Related document: BWM/CONF/36; MEPC 53/24/Add.1, MEPC 53/2/12; MEPC 54/2/12; 

MEPC 57/2/5, MEPC 57/2/10 and BWM.2/Circ.13 

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 Convention shall be approved by the 

Organization. 

2 Japan herewith submits an application for Final Approval according to the 

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

Substances (G9)". This Procedure stipulates the required information (MEPC 57/21, annex 1, 

paragraph 4.2.1), which, according to section 6, should be evaluated by the Organization. 

In accordance with BWM.2/Circ.13, the document in the annex contains the non-confidential 

part of the manufacturer's application dossier, which includes the following: 

.1 summary of the application dossier of the Special Pipe Hybrid Ballast Water 

Management System combined with PERACLEANÆ Ocean (SPO-SYSTEM) 

according to Procedure (G9); 
MEPC 61/2/10 

Page 2 

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.2 list of references; and 

.3 statement of quality control of each test. 

The complete dossier will be made available to the experts of the GESAMP-BWWG with the 

understanding of confidential treatment. 

3 The receiving competent authority in Japan has verified the application dossier 

and believes it to satisfy the data requirements of Procedure (G9) adopted by 

resolution MEPC.169(57). 

Action requested of the Committee 

4 The Committee is invited to consider the proposal for approval and decide as 

appropriate. 

*** 
MEPC 61/2/10 

Annex, page 1 

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ANNEX 

NON-CONFIDENTAL INFORMATION ON THE SPECIAL PIPE HYBRID 

BALLAST WATER MANAGEMENT SYSTEM COMBINED 

WITH PERACLEANÆ OCEAN (SPO-SYSTEM) 

This annex has the following content: 

1 INTRODUCTION 

2 APPLICATION DATA SET 

3 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

4 MATERIAL SAFETY DATA SHEETS 

5 RISK CHARACTERIZATION 

6 RISK ASSESSMENT 

7 CONCLUSION 

8 REFERENCES 

LIST OF APPENDICES: 

APPENDIX 1 STATEMENT 

APPENDIX 2 QUALITY ASSURANCE STATEMENT 

APPENDIX 3 QUALITY ASSURANCE PROJECT PLAN (QAPP) FOR 

CORROSION TESTING OF SPO-SYSTEM 

APPENDIX 4 QUALITY MANAGEMENT PLAN (QMP) AND QUALITY 

ASSURANCE PROJECT PLAN (QAPP) FOR ANALYSIS OF 

BALLAST WATER TREATED BY SPO-SYSTEM 

1 INTRODUCTION 

1.1 Application process under Procedure (G9) for "Special Pipe Hybrid Ballast Water 

Management System Combined with PERACLEANÆ

 Ocean" (SPO-SYSTEM) 

"Special Pipe Hybrid Ballast Water Management System Combined with PERACLEANÆ Ocean" 

(hereafter referred as SPO-SYSTEM) represents one version of SP-Hybrid BWMS, which 

uses PERACLEAN Ocean as a Preparation and Peracetic acid (PAA) as well as Hydrogen 

peroxide (H2O2) as Active Substances. 

PERACLEANÆ Ocean to be used for SPO-SYSTEM as a Preparation was reviewed at 

the first meeting of the GESAMP-BWWG held from 23 to 27 January 2006 and was 

granted Basic Approval at MEPC 54 in March, 2006. The SEDNAÆ System which uses 

PERACLEANÆ Ocean for BWMS was reviewed at the fifth meeting of the GESAMP-BWWG 

from 14 to 18 January, 2008 and was granted Final Approval at MEPC 57 from March 31 

to April 4, 2008. 

The use of PERACLEANÆ Ocean for the SPO-SYSTEM was approved by Evonik Degussa 

who had applied for Basic Approval. 

The SPO-SYSTEM uses the same PERACLEANÆ Ocean as the Preparation, which had 

been granted Basic Approval and its injection concentration is lower than the Basic Approval. 
MEPC 61/2/10 

Annex, page 2 

I:\MEPC\61\2-10.doc 

Also its holding time is the same. Furthermore, the PAA concentration meter is installed so 

as to survey whether the PAA of the Active Substance goes under the detection limit at time 

of the ballast water discharge. 

1.2 Comments relevant to the PERACLEANÆ Ocean at the time of Basic Approval 

(MEPC 54/2/12, annex 5, section 9 "Conclusion and Recommendations") 

The following comments were made by the GESAMP-BWWG at time of the Basic Approval. 

This Final Approval application for the SPO-SYSTEM has been developed taking into 

consideration these comments as follows: 

.1 Upon application of PERACLEANÆ Ocean in ballast water, the PAA is 

degraded almost completely after less than 24 hours. Hydrogen peroxide, 

however, degrades more slowly with the degradation rate depending on the 

content of organic matter and particles in the ballast water. 

Applying the recommended dosing of 150 mg/L PERACLEANÆ Ocean, 

a typical concentration of hydrogen peroxide at 2 mg/L may be expected in 

the discharged ballast water. In cases where ballast water has a low 

content of organic matter and particles, and where the holding time is short 

(48 hours or less), concentrations of up to 15 mg/L of hydrogen peroxide 

may be expected. 

.2 Aquatic toxicity testing with treated ballast water shows that the acute 

toxicity encountered can be ascribed mainly to the content of hydrogen 

peroxide. It is further noted that even with the lowest concentration of 

hydrogen peroxide in the treated ballast water (2 mg/L), a dilution of the 

discharged ballast water of at least 200 times is required to reach 

environmental concentrations below the Predicted No-Effect-Concentration 

at 10 μg/L according to the EU Risk Assessment Report available. 

.3 Exposure modelling has been performed using the MAMPEC model. The 

assumptions on the scenarios as well as input parameters of the model are 

not presented in detail, which hinders the evaluation of the reliability of the 

model results. It appears from the dossier that resulting concentrations in 

the aquatic environment after discharge and dilution are at the maximum 

of 5-10 μg/L of hydrogen peroxide which is lower than or equal to the PNEC 

value established. Thus, the application and discharge of PERACLEANÆ

Ocean seem to cause no unacceptable harm to the environment. 

.4 A number of concerns in relation to safety of ships have been raised in 

section 5 due to the physico-chemical hazards of PERACLEANÆ Ocean. 

These concerns need to be addressed prior to initiation of full-scale testing 

on board ships. 

.5 Based on the submitted scientific information about the toxicological profile 

of PAA 15% preparation, we can anticipate major concerns towards acute 

adverse effects (corrosiveness, severe irritant for skin and eye, irritant for 

the respiratory tract). In this sense, we recommend as mandatory the 

application of RMM (risk management measures) for the protection of the 

exposed populations to the main routes of concern: dermal and inhalation. 

These control measures (PPE and RPE) must be put in place for use and 

handling of the preparation at the different stages of the process and with 

the different concentrations applied. 
MEPC 61/2/10 

Annex, page 3 

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.6 Additionally, it is recommended that dermal and inhalation sub-chronic 

effects in presented studies should be further investigated, taking into 

account realistic occupational exposure scenarios and covering 

non-accident situations. These data should be submitted before final 

approval. 

.7 There seems to be insufficient information on degradation of components of 

PERACLEANÆ Ocean during treatment of ballast water as it seems to 

depend on the content of organics and particles in ballast water. This 

should be further studied and reliable estimates or measurements of 

concentrations of the components at discharge should form the basis for 

the environmental risk assessment. 

.8 The selection of appropriate scenarios for discharge of treated ballast water 

needs consideration and justification. This would include proposals for 

numbers of ships in the harbour, the volume of treated ballast water, the 

frequency and duration of discharges, the dimensions of the harbour 

including water volume and flow. The Group notes that this is not 

necessarily an obligation of the individual applicant, but that this might be 

considered at a general level (refer to the report of first meeting of the 

GESAMP-BWWG contained in document MEPC 54/2/12). 

1.3 Composition of application for Final Approval 

This application addresses the comments made by the GESAMP-BWWG at the time of 

Basic Approval as outlined in the aforementioned paragraph 1.2. However, as this BWMS 

has not been installed on board a ship, data on the responses from shipboard tests are not 

included. This document has been developed by adding further safety information on 

handling PERACLEANÆ Ocean on the hypothesis of installation on board a ship and 

information about acute and chronic toxicity tests on three kinds of marine organisms by 

using two kinds of test water with a full-scale land-based test facility, degradation tests of 

Active Substances and corrosion tests. 

1.4 Application conditions of the system 

The following is the application condition of this BWMS: 

.1 the injection concentration of PERACLEANÆ Ocean is 80 mg/L; and 

.2 the holding time is at least 24 hours. 

1.5 Conclusion of Final Assessment Report 

This BWMS uses PERACLEANÆ Ocean with an injection concentration of 80 mg/L as a 

Preparation. This injection concentration is almost half of 150 mg/L used for the Basic Approval 

(see document MEPC 53/2/12). PAA as an Active Substance is added under surveillance by 

a PAA concentration meter so as not to exceed the detection limit when discharged. 

With reference to the use of PERACLEANÆ Ocean, the result of various tests implemented in 

a full-scale land-based test facility as well as the risk assessment on the environment, human 

beings and ships showed that the risks against them were within acceptable ranges. From 

this point of view, this BWMS deserves the Final Approval. 
MEPC 61/2/10 

Annex, page 4 

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2 APPLICATION DATA SET 

2.1 Identification of the Substance or Preparation (G9: 4.1) 

2.1.1 Preparations (G9: 4.2.2) 

The chemical Preparation used in this BWMS is a specific formulation, made by 

Evonik Degussa, known as PERACLEANÆ Ocean, and has been granted Basic Approval. 

In this BWMS, PERACLEANÆ Ocean is used at an injection concentration of 80 mg/L. The 

composition of PERACLEANÆ Ocean is shown in Table 2.1-1. 

Table 2.1-1: Composition of PERACLEANÆ Ocean 

Trade Name of Preparation PERACLEANÆ Ocean 

Composition of Preparation 

Component Chemical Name CAS Number Concentration (%) AS, RC or Other*

Peracetic acid 79-21-0 14 ñ < 17 AS 

Hydrogen peroxide 7722-84-1 13 ñ < 15 AS 

Acetic acid 64-19-7 24 ñ < 29 Other (stabilizer, solvent) 

Acidic (e.g., phosphoric acid) ― < 1 Other (stabilizer) 

Water 7732-18-5 < 39 ñ 49 Other (solvent) 

* Indicate whether the chemical is believed to be one of the following, giving justification for each proposal: 

AS = Active Substance; RC = Relevant Chemical; Other = Any other Chemical, e.g., solvent. 

2.1.2 Active Substances 

The Active Substances are, specifically, peracetic acid (hereinafter, referred to PAA) and 

hydrogen peroxide (hereinafter, referred to H2O2). 

PAA is produced by reacting H2O2 with acetic acid in an aqueous solution. In this process, 

PAA is not produced as a pure substance, but is produced in the form of an aqueous 

equibrium solution containing PAA, acetic acid, H2O2, and water: 

 CH3COOH + H2O2↔CH3CO(O2)H + H2O 

As shown in the above equation, an aqueous solution containing PAA has the same 

formulation of PERACLEANÆ Ocean, a Preparation used in this BWMS. Thus PAA and 

PERACLEANÆ Ocean are handled as the same substance on information of toxicity, etc., as 

described in section 2.2 this document and the followings. 

The amount of PAA in the equilibrium solution can range from 0.25 to 40%, depending on the 

targeted use. This equilibrium solution is a biocidal marketed product. PAA is a biocidal 

Active Substance with strong bactericidal, fungicidal, and virucidal activities. 

H2O2 is commonly viewed as an "environmentally friendly" or "green" chemical. This is 

particularly due to the physicochemical properties of this inorganic water-soluble substance. 

H2O2 is non-persistent, innocuous or even beneficial, can be broken down to produce 

oxygen, and does not accumulate. 
MEPC 61/2/10 

Annex, page 5 

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H2O2 is produced naturally by many living organisms, either within the organism itself or in 

the surrounding environment. For example, blue-green algae produce H2O2 under light 

irradiation at a rate of 1-50 μg/l per hour (Zepp et al., 1987). 

2.1.3 Relevant Chemicals (G9: 2.1.4) 

According to document MEPC 53/2/12, findings concerning the sterilization of river water by 

PAA suggest that there are no substances corresponding to the Relevant Chemicals. 

In regard to the application for the Final Approval of other systems using the same 

Preparation, however, the GESAMP-BWWG, indicates in document MEPC 57/2/10, annex 7, 

paragraph 7.1.4 that a small quantity of trihalomethanes are produced under a low organic 

load. Also in this BWMS, there was a possibility that by-products may be produced. Thus, 

the tests listed in section 5.2.2 in this application were conducted. 

As a result, small quantities of trihalomethanes, such as bromodichloromethane, 

dibromochloromethane, and bromoform were produced by ballast water treatment with this 

BWMS. Therefore, these three compounds are considered as Relevant Chemicals. The 

production of bromodichloromethane was confirmed only in some tests, and after 5 days, 

it reached below the detection limit. However, it is presumed that its decay results 

volatilization into the atmosphere. Due to its non-degradable properties, in this application, 

risk assessment was conducted on it as in other trihalomethanes. 

The following mechanism was considered regarding the production of trihalomethanes:

Figure 2.1-1: Reactions of Hydrogen Peroxide (H2O2), Peracetic Acid (PAA) 

and Bromide Ion in water 

Table 2.1-2 provides information on the Relevant Chemicals and the maximum detection 

concentrations, etc., found during the treatment by this BWMS. 

H H2O2 + 

HOBr 

Natural Organic 

Matter 

(NOM) Bromoform 

Bromodichloromethane 

Dibromochloromethane 

H2O2

H2O2 (HO2

-)

PAA Acetic acid 

Br - BrO - 
MEPC 61/2/10 

Annex, page 6 

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Table 2.1-2: List of ALL potential by-products in ballast water 

Chemical Name CAS Number Concentration (mg/L) 

in treated ballast water

(bio)degradation rate or 

half-life 

Bromoform 75-25-2 14.5 μg/L Non-degradable 

Bromodichloromethane 75-27-4 0.31 μg/L In the test, ND after 48 hours

Dibromochloromethane 124-48-1 1.75 μg/L Non-degradable 

2.1.4 Other Chemicals 

Preparation PERACLEANÆ Ocean contains acetic acid, acid and water as a stabilizer or 

solvent (see Table 2.1-1). This corresponds to Other Chemicals. 

However, acetic acid, its salts and acetate naturally occur in the environment and living 

organisms. Furthermore they are rapidly biodegraded. Due to their scientific characteristics, 

PERACLEANÆ Ocean preparations are not the object of risk assessment. In addition, this 

classification is also applicable to other systems using PERACLEANÆ Ocean, which was 

granted Final Approval. See below:

Acetic acid: Stabilizer, solvent 

Acid: Stabilizer 

Water: Solvent

2.2 Data on effects on aquatic plants, invertebrates and fish, and other biota, 

including sensitive and representative organisms (G9:4.2.1.1) 

2.2.1 Acute aquatic toxicity 

2.2.1.1 Acute aquatic toxicity of PERACLEANÆ Ocean and PAA

Available data on the acute toxicity of PERACLEANÆ Ocean on seawater and fresh water 

organisms was presented in the application for Basic Approval for PERACLEANÆ Ocean 

(MEPC 53/2/12) and the application for Final Approval (MEPC 57/2/5) for other system using 

the same Preparation. This data is summarized below: 

.1 The results of the toxicity tests for different fresh water species show 

differences in sensitivity ñ small organisms are more sensitive to 

PERACLEANÆ Ocean than large ones. The Active Substance, PAA, is well 

known for its bactericidal effect, and this ranking is not surprising. 

Comparing the results concerning daphnia, fish, and algae with recent 

findings (ECETOC-JACC 2001), the values correspond favourably. 

.2 The acute toxicity of PERACLEANÆ Ocean was investigated in two marine 

algae species, Macroystis pyrifera and Skeletonema costatum. The EC50

values (48 hours) in Macroystis pyrifera were 7.91 mg PERACLEANÆ

Ocean/L for germination and 10.9 mg PERACLEANÆ Ocean/L for germ 

tube length, corresponding to 1.19 and 1.64 mg PAA/L, respectively. The 

species Skeletonema costatum, exposed for 96 hours, was found less 

sensitive, with an EC50 value of > 16 mg PERACLEANÆ Ocean/L, 

corresponding to 2.4 mg PAA/L (MEPC 57/2/5). 
MEPC 61/2/10 

Annex, page 7 

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.3 In an additional acute toxicity test with PERACLEANÆ Ocean 

(test duration: 96 hours, water renewal after 48 hours), using the pacific 

herring (Clupea pallasi), no toxic effects were observed up to the highest 

test concentration of 16 mg PERACLEANÆ Ocean/L. Therefore, the 

LC50 became > 16 mg PERACLEANÆ Ocean/L, which corresponds 

to >2.4 mg PAA/L (MEPC 57/2/5). 

.4 Comparing available results obtained for the three trophic levels 

(not restricted to PERACLEANÆ Ocean), fish was found to be less sensitive 

(lowest acute LC50 is 0.91 mg PAA/L). For invertebrates, the lowest EC50

was obtained for Thamnocephalus platyurus, with 0.183 mg PAA/L. 

.5 Acute toxicity has relation to the size of test organisms.Embryonic stages of 

oysters and mussels were found to be most sensitive, with 48-hour EC50

values of 0.27 to 0.54 mg PAA/L. 

.6 Results of acute aquatic toxicity in the application for Final Approval 

(MEPC 57/2/5) for other system using the same Preparation are in the 

same range as those of previously presented data in the application for 

Basic Approval application of PERACLEANÆ Ocean (MEPC 53/2/12). 

2.2.1.2 Acute aquatic toxicity of H2O2

Data on H2O2 toxicity for seawater and fresh water organisms is presented in the application 

for Basic Approval (MEPC 53/2/12) and the application for Final Approval (MEPC 57/2/5) for 

other system using the same Preparation. 

The minimum acute toxicity value of H2O2 is 72-hour ECr50 at 1.38 mg/L for Alga, 

Skeletonema costatum. Therefore, 1.38 mg/L was used as acute aquatic toxicity data to be 

used for different risk assessments of H2O2 in this application. 

2.2.1.3 Acute aquatic toxicity of Relevant Chemicals 

The acute aquatic toxicity of Relevant Chemicals in this BWMS ñ bromoform, 

bromodichloromethane, and dibromochloromethane ñ is described below: 

.1 The minimum acute toxicity value for seawater species of bromoform 

is 12 mg/L for fish, Brevoorita tyrannus. Therefore, 12 mg/L was used as 

acute aquatic toxicity data to be used for different risk assessments of 

bromoform acute aquatic toxicity to aquatic environment in this application. 

.2 The minimum acute toxicity value of bromodichloromethane is 11.6 mg/L for 

fresh water alga, Psuedokirchneriella subcapitata. Therefore, 11.6 mg/L 

was used as bromodichloromethane acute aquatic toxicity data to be used 

for different risk assessments of the aquatic environment in this application. 

.3 The minimum acute toxicity value of dibromochloromethane is 9.6 mg/L for 

fresh water alga, Psuedokirchneriella subcapitata. Therefore, 9.6 mg/L was 

used as dibromochloromethane acute aquatic toxicity data to be used for 

different risk assessments of the aquatic environment in this application. 
MEPC 61/2/10 

Annex, page 8 

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2.2.1.4 Acute aquatic toxicity of the treated ballast water by SPO-SYSTEM

Using a full-scale land-based test facility of SPO-SYSTEM (treatment flow rate: 200 m3

/h), an 

acute aquatic toxicity test on treated ballast water was conducted from 1 to 13 October 2008. 

The simulated ballast water used for exposure in this test was obtained by treating test water 

under seawater and brackish water criteria prescribed in Guidelines (G8). The injection 

concentration of PERACLEANÆ Ocean was 150 mg/L, almost twice the concentration in the 

application. Test results are summarized below: 

.1 Seawater test 

The acute toxicity value based on the above seawater test results 

was 72-hour ECr50 at 13.2%, obtained when Skeletonema costatum (algae) 

was exposed to the test water (24-hour holding after treatment).The PAA 

concentration of 13.2% diluted water was lower than the lower detection 

limit (<0.5 mg/L), and the H2O2 concentration was 1.0 to 2.8 mg/L. These 

conformed to the results at the time of the Basic Approval, Final Approval 

for other system using the same Preparation, and the above mentioned 

acute aquatic toxicity value. 

.2 Brackish water test 

The acute toxicity value based on the above results of the brackish test was 

the 72-hour ECr50 at 10.7%, obtained when Skeletonema costatum (algae) 

was exposed to the test water (after 24-hour holding after treatment). The 

PAA concentration of the 10.7% diluted water was lower than the lower 

detection limit (<0.5 mg/L), and the H2O2 concentration was 1.7 to 2.6 mg/L. 

These results are the same level as that of seawater test. 

2.2.2 Chronic aquatic toxicity 

2.2.2.1 Chronic aquatic toxicity of PERACLEANÆ Ocean and PAA

Existing data on the chronic toxicity of PERACLEANÆ Ocean to seawater and fresh water 

organisms are presented in the application for Basic Approval (MEPC 53/2/12) and the 

application for Final Approval for other system using the same preparation (MEPC 57/2/5). 

This data is summarized below: 

.1 A fish early-life stage test with the fresh water fish, Danio rerio, was 

performed according to OECD 210. Neither the effects on hatching 

success nor behavioural and morphological changes were observed. The 

only effect seen was reduced survival in the two highest concentrations 

(15 and 150 μg/L PERACLEANÆ Ocean) in a time range of 5-12 days post 

hatching. No mortality change, depending on concentration, was observed. 

Furthermore, the overall NOEC is considered to be 2.25 μg PAA/L 

(MEPC 57/2/5). 

.2 Based on a specific study protocol (non-GLP) recommended by the 

Washington State Department of Ecology, a 16-day fish embryo 

development test using pacific herring (Culpea pallasi) gametes with 

PERACLEANÆ Ocean was performed. The NOEC (endpoint: percentage of 

hatched larvae) was 1.9 mg PERACLEANÆ Ocean/L (0.29 mg PAA/L) 

(MEPC 57/2/5). 
MEPC 61/2/10 

Annex, page 9 

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.3 The NOEC for Macroystis pyrifera (germination tube length) was 4 mg 

PERACLEANÆ Ocean/L (0.6 mg PAA/L). The species Skeletonema costatum 

was found less sensitive with a NOEC of 8 mg PERACLEANÆ Ocean/L 

(1.2 mg PAA/L) (MEPC 57/2/5). 

.4 The results for marine algae indicate that marine algae are less sensitive to 

PERACLEANÆ Ocean than fresh water species (MEPC 53/2/12). All 

referenced studies indicate a very steep dose response curve. However, 

fish larvae were much more sensitive than Daphnia magna (a long-term 

NOEC of 0.05 mg/L), leading to an overall NOEC of 2.25 μg PAA/L, based 

on the results of the fish test. 

.5 Using an assessment factor of 10, a PNEC of 0.225 μg/L can be derived 

corresponding to a PNEC of 1.5 μg PERACLEANÆ Ocean/L. 

2.2.2.2 Chronic aquatic toxicity of H2O2

Data on H2O2 chronic toxicity to seawater and fresh water organisms is presented in the 

application for Basic Approval (MEPC 53/2/12) and the application for Final Approval for other 

system using the same preparation (MEPC 57/2/5). The minimum chronic toxicity value of H2O2

is NOEC 0.1 mg/L for fresh water Alga, Chlorella vulgaris. Therefore, 0.1 mg/L was used as 

chronic aquatic toxicity data to be used for different risk assessments of H2O2 in this application.

2.2.2.3 Chronic aquatic toxicity of Relevant Chemicals 

The chronic aquatic toxicity of the Relevant Chemicals for this BWMS ñ bromoform, 

bromodichloromethane, dibromochloromethane ñ is described below: 

.1 The minimum chronic toxicity value of bromoform is MATC (Maximum 

Acceptable Toxicant Concentration) at 4.8 mg/L for fresh water fish, 

Cyprinodon variegates. Therefore, a NOEC (MATC) of 4.8 mg/L was used 

as the bromoform chronic aquatic toxicity data to be used for different risk 

assessments of aquatic environments in this application. 

.2 The minimum chronic toxicity value of bromodichloromethane is the 21-day 

NOEC at 0.78 mg/L for fresh water fish, Oryzias latipes. Therefore, a 

NOEC of 0.78 mg/L was used as the bromodichloromethane chronic 

aquatic toxicity data to be used for different risk assessments of aquatic 

environments in this application. 

.3 The minimum chronic toxicity value of dibromochloromethane is the 21-day 

NOEC at 0.063 mg/L for fresh water crustacean, Daphnia magna. 

Therefore, a NOEC of 0.063 mg/L was used as the dibromochloromethane 

chronic aquatic toxicity data to be used for different risk assessments of 

aquatic environments in this application. 

2.2.2.4 Chronic aquatic toxicity of treated ballast water by SPO-SYSTEM

Using Guidelines (G8) full-scale land-based test facility of SPO-SYSTEM (treatment flow 

rate: 200 m3

/h), a chronic aquatic toxicity test of treated ballast water was performed 

from 27 November to 24 December 2008. The ballast water used for exposure was obtained 

by treating test flow water under the seawater and brackish water criteria prescribed in 

Guidelines (G8). The injection concentration of PERACLEANÆ Ocean was 150 mg/L, nearly 

twice the application-use concentration. 
MEPC 61/2/10 

Annex, page 10 

I:\MEPC\61\2-10.doc 

Test results are summarized below. 

 .1 Seawater test 

The lowest no observed effect concentration based on seawater test was 

the 72-hour NOEC at <10% and 21-day NOEC at 10%, obtained when 

Skeletonema costatum (algae) and Hyale barbicornis (crustacean) were 

exposed to test water. The PAA concentration of 10% diluted water was 

lower than the detection lower limit (<0.5 mg/L), and the H2O2 concentration 

was 1.0 mg/L. These conform to the results at the application of Basic 

Approval and Final Approval for other system using the same Preparation. 

 .2 Brackish water test 

The no observed effect concentration based on brackish water test was 

the 72-hour NOEC at 3.2%, obtained when Skeletonema costatum (algae) 

was exposed to test water. The PAA concentration of the 3.2% diluted water 

was lower than the detection lower limit (<0.5mg/L), and the H2O2

concentration was 1.3 mg/L. This value is the same level as that of seawater. 

2.2.3 Endocrine disruption 

Information was unavailable for the endocrine disruption of Preparation PERACLEANÆ Ocean, 

Active Substances PAA and H2O2, and Relevant Chemicals bromoform, 

bromodichloromethane and dibromochloromethane. 

This is because they are not listed in the EUROPEAN COMMISSION DG ENV, "Towards the 

establishment of a priority list of substances for further evaluation of their role in endocrine 

disruption", 2000, and probably because the endocrine disruption of these compounds is not 

supposed in view of their structure. 

2.2.4 Sediment toxicity 

Information was unavailable concerning the toxicity effects of Preparation PERACLEANÆ

Ocean, Active Substances PAA and H2O2, and the Relevant Chemicals bromoform, 

bromodichloromethane, and dibromochloromethane on benthic habitants. On the basis of 

the GESAMP-BWWG Methodology (MEPC 57/2/10, annex 4, paragraph 3.2.4), bromoform 

shows a logPow of 2.4, bromodichloromethane shows a logPow of 2.10, and 

dibromochloromethane shows a logPow of 2.16. All the values are smaller than a logPow 

of 3, which causes sediment adsorption and accumulation. Thus, it is not supposed that 

these substances show bottom sediment toxicity (EU-RAR 2003). 

2.2.5 Bioavailability/biomagnification/bioconcentration 

PAA and H2O2 are highly water-soluble and readily degradable in the environment and 

organisms; thus, the possibility of biomagnification/bioconcentration is considered low. 

Concerning biomagnification/bioconcentration of bromoform, data is available on fresh water 

carp. Here, the BCF is 7.1ñ21 and 7.7ñ19, respectively, with a six-week exposure of 

bromoform at 0.1 mg/L and 0.01 mg/L. Accordingly, the possibility of biomagnification/ 

bioconcentration is believed to be low, and the fact that bromoform's logPow value is as 

small as 2.4 conforms well to the BCF. 
MEPC 61/2/10 

Annex, page 11 

I:\MEPC\61\2-10.doc 

Concerning biomagnifications/bioconcentration of bromodichloromethane, the BCF in fish is 7. 

Accordingly, the possibility of biomagnification/bioconcentration is believed to be low, and the 

fact that bromodichloromethane's logPow value is as small as 2.1 conforms well to the BCF. 

Concerning biomagnification/bioconcentration of dibromochloromethane, the BCF in fish is 9. 

Accordingly, the possibility of biomagnification/bioconcentration is believed to be low, and the 

fact that dibromochloromethane's logPow is as small as 2.16 conforms well to this BCF.

2.2.6 Food web/population effects 

Both PAA and H2O2 are highly water-soluble due to their log Pow values and undergo 

immediate in vivo degradation through such enzymes as catalase and peroxidase. 

Therefore, no bioaccumulation is assumed, and no effect is expected on humans through 

such food. 

The BCF of bromoform, bromodichloromethane and dibromochloromethane is <21, 7 and 9, 

respectively, indicating low bioaccumulation in living organisms (algae, invertebrates and fish) 

constituting the food web. For this reason, effects on the food web/population are unlikely.

2.3 Data on mammalian toxicity (G9: 4.2.1.2) 

2.3.1 Acute toxicity 

2.3.1.1 Data on mammalian acute toxicity of PERACLEANÆ Ocean and PAA 

In oral administration of PAA to rats, LD50 was 152 mg/kg bw (MEPC 53/2/12) 

and 36.7-98.9 mg/kg bw (ECETOC-JACC 2001). Main symptoms included decreased 

activity, diarrhea, increased secretion from nasal cavities and eyes, piloerection, gasping, 

excessive urination, ptoses, coloration of the nostrils and the back, salivation, and gasping 

sounds. These effects disappeared following the end of the 14-day observation 

(ECETOC-JACC 2001). In dermal administration to rabbits, LD50 was 229 mg/kg bw 

(MEPC 53/2/12) and 223.5ñ232.6 mg/kg bw (ECETOC-JACC 2001), with main symptoms 

including decreased activity, diarrhea, increased secretion from nasal cavities, piloerection, 

salivation, and lower gauge rotation. However, no pathological change was observed. Local 

effects included moderate to severe erythema, slight to severe edema, and crust formation 

(ECETOC-JACC 2001). In inhalation to rats, LD50 was 0.51ñ1.26 mg/L/4 h 

(aerosol), 0.08ñ0.19 mg/L/4 h (vapour) (MEPC 53/2/12), and > 0.24 mg/L/4h 

(ECETOC-JACC 2001). Main symptoms consisted of irregular breathing and wetted body 

hair. However, no change was confirmed in necropsy. The acute toxicity of PERACLEANÆ

Ocean and PAA was observed mainly in local inflammation of the application site. The 

toxicity varies depending on the composition and concentration of the solution exposed. 

2.3.1.2 Data on mammalian acute toxicity of H2O2

In oral administration of H2O2 to rats, LD50 was 874 mg/kg bw (male) and 801 mg/kg bw 

(female). Main symptoms included lethargy, rigidity, irregular breathing, hunched posture, 

and form change in the tongue, esophagus, and duodenum. In an experiment with dermal 

administration to rabbits, LD50 was -700 mg/kg bw, when a 90% solution was used. Main 

symptoms consisted of lacrimation, secretion from nasal cavities, erythema, edema, skin 

discoloration, eschar, shedding of epidermis, and reduced body weight. In inhalation to rats, 

LD50 was 1.69-2.36 mg/L/4 h, with main symptoms being agitation, calming, ataxia, shiver, 

paralyzed extremities, and increased respiration rate (EU-RAR 2003). The acute toxicity 

of H2O2 was seen mainly in local inflammation of the application site and in generalized 

symptoms caused by oxygen gas generated as the result of its decomposition. 
MEPC 61/2/10 

Annex, page 12 

I:\MEPC\61\2-10.doc 

2.3.1.3 Data on mammalian acute toxicity of Relevant Chemicals 

The acute toxicity of bromoform, bromodichloromethane and dibromochloromethane can be 

summarized as follows: 

.1 In oral administration of bromoform, LD50 was 933 mg/kg bw (mice) 

and 707 mg/kg bw (rats) (ATSDR 2005). Among bromine-derived THMs, 

acute lethal activity is lowest in bromoform. Toxicity symptoms caused by 

bromoform are said to be associated with impaired renal function 

(IPCS-EHC 2000). No quantitative information was available. Additionally, 

skin and eye irritation, headache, dizziness, forgetfulness, exanimation, 

twitch, and pneumonedema have been reported (U.S. NLM: HSDB 2003). 

.2 In accidental ingestion cases, central nervous depression is seen, such as 

lethargy and areflexia, and even a small dose can cause fatigue, headache, 

and dizziness (ACGIH 2001a). For oral administration to humans, a case 

has been reported in which a death was caused at 143 mg/kg of bromoform 

(U.S. NIOSH 2002). 

.3 In oral administration of bromodichloromethane, LD50 was 450 (male) 

to 900 (female) mg/kg bw (mice), and 916 (male) to 969 (female) mg/kg bw 

(rats) (MEPC 57/2/10, IPCS-EHC 2000). In an experiment involving oral 

administration of bromodichloromethane to rats, impaired hepatic and renal 

function, ataxia, calming, difficult breathing, and sensory paralysis has been 

observed (IPCS-EHC 2000). 

.4 In oral administration of dibromochloromethane, LD50 was 848 (female) 

to 1,186 (male) mg/kg bw (mice), and 800 (male) to 1200 (female) mg/kg 

bw (rats) (IPCS-EHC 2000, ATSDR 2005). In an experiment involving oral 

administration of dibromochloromethane to mice, ataxia, calming, and 

sensory paralysis were reported (IPCS-EHC 2000). 

2.3.2 Corrosion/irritation/sensitization 

2.3.2.1 Corrosion/irritation/sensitization of PERACLEANÆ Ocean and PAA 

PERACLEANÆ Ocean is extremely corrosive to the skin and eyes and can cause serious 

inflammation in the mucosa of the respiratory tract. The RD50 of aerosol generated from 

products having similar components was 21.5ñ24.1 mg/m3 (ECETOC-JACC 2001). 

Document MEPC 54/2/12 recommended the implementation of a skin infiltration test with PAA. 

Based on the findings of an experiment on PERACLEANÆ Ocean for toxicokinetics, repeated 

dose toxicity and corrosive properties, there was no need to obtain further data in response 

to the recommendations for risk assessment and appropriate risk control (MEPC 57/2/5). 

In a test with percutaneous administration to rabbits of PAA/H2O2/AcOH mixtures, 

a 17% PAA solution demonstrated corrosiveness, but a 0.35% PAA solution did not. 

In a four-hour test exposure to rabbit eyes involving a 0.15% PAA solution, slight irritation 

was noted. A 0.2% or more concentration showed an irritant property. A 5% solution caused 

irreversible impairment (ECETOC-JACC 2001). 

In a B ̧hler test on guinea pigs using varying compositions (5% and 12% PAA), no skin 

irritability was observed (ECETOC-JACC 2001). 
MEPC 61/2/10 

Annex, page 13 

I:\MEPC\61\2-10.doc 

2.3.2.2 Corrosion/irritation/sensitization of H2O2

In an eye irritation test involving rabbits using the Draize method, irreversible eye irritation 

was observed at a 10% H2O2 concentration, moderate irritation at 8%, and slight irritation 

at 5% (EU-RAR 2003). 

An exposure test on mice using 70% H2O2 aerosol demonstrated a 50% reduction in 

respiratory volume and irritation in the respiratory system at 696 mg/m3

, as the result of 

exposure to high-concentration aerosol (EU-RAR 2003). 

For sensitization, no test report is available for evaluation. However, given the fact that H2O2

has been used for several decades commercially and by individual consumers, it is 

extremely unlikely that H2O2 is a highly sensitizing substance (EU-RAR 2003). 

2.3.2.3 Corrosion/irritation/sensitization of Relevant Chemicals 

The effects on the skin and eyes of bromoform, bromodichloromethane, and 

dibromochloromethane can be summarized as follows: 

.1 According to a report, bromoform caused moderate irritation in a rabbit's 

skin after repeated contact (ACGIH, 2001a). Irritation in humans can cause 

reddening and can be absorbed through the skin (IPCS 2006). 

.2 In one report, the application of undiluted bromoform caused moderate eye 

irritation in rabbits, but the symptom disappeared in 1-2 days (ACGIH 2001). 

Eye irritation in humans is accompanied by reddening or pain 

(IPCS-EHC 2000). 

.3 Animal study data was not available concerning bromodichloromethane. 

Because bromoform, belonging to the same halogenated methane group as 

bromodichloromethane, can cause moderate irritation, bromodichloromethane 

is likely to demonstrate a similar level of irritation. 

.4 Animal study data was also not available concerning dibromochloromethane. 

Again, because bromoform, belonging to the same halogenated methane 

group as dibromochloromethane, causes moderate irritation, 

dibromochloromethane is likely to demonstrate a similar level of irritation. 

2.3.3 Repeated-dose toxicity 

2.3.3.1 Repeated-dose toxicity of PERACLEANÆ Ocean and PAA 

In a 90-day oral repeated-dose test on rats with 5% PAA, NOAEL = 5 mg/kg bw/day was 

obtained by local irritation. This dosage corresponds to 1.7 mg/kg bw/day for 15% PAA 

(ECETOC-JACC 2001). 

In an experiment dermal administering PAA/H2O2/HOAc = 40/14/27 to guinea pigs at a 

PAA concentration of 3.84 mg PAA/kg bw/day for 28 days and 90 days, slight skin irritation, 

reduced body weight gain, slight elevation of liver enzymes and LDH, slightly decrease in 

liver weights, increased leukocyte count, and relatively increased kidney and spleen weight 

were observed. However, no histopathological change was confirmed in the liver and 

kidneys (ECETOC-JACC 2001). 
MEPC 61/2/10 

Annex, page 14 

I:\MEPC\61\2-10.doc 

In an inhalation test of mice to PAA/H2O2/HOAc = 40/14/27 for 29 days, difficult breathing, 

eye irritation, reduced body weight gain, increased death rate, increased leukocyte and 

erythrocyte count, increased hemoglobin count and hematocrit value, and lung inflammation 

were noted. NOAEC = 281 mg PAA/m3

 (ECETOC-JACC 2001). 

Repeated-dose toxicity tests using a diluted PAA aqueous equilibrium solution can apply to 

PERACLEANÆ Ocean. Similarly, tested chemicals must be diluted prior to administration to 

test animals to levels suitable for repeated doses. 

Another repeated toxicity test is not required for PERACLEANÆ Ocean for the reasons stated 

below. 

No practicable tests have demonstrated overall the toxicity of an aqueous equilibrium 

solution of PAA. 

These facts are based on toxicokinetic data (see MEPC 53/2/12, annex 7, section 2.2.1) 

which confirm that PAA does not spread outside the initial application site. The effects of the 

application depend on the ability of the chemical to cause acute inflammation 

(i.e. concentrations) and its ability to release oxygen. The mechanism of action and the no 

observed effect concentration are not considered to vary depending on the specific 

difference or the length of test period. 

2.3.3.2 Repeated-dose toxicity of H2O2

In a 40- to 100-day test with gavage administration to rats, reduced body weight gain, 

increased spleen weight, decreased hematocrit and serum protein levels, lower erythrocyte 

count, and reduced hemoglobin concentration were observed. In this test, NOAEL 

was 20 mg/kg bw/day (EU-RAR 2003). 

In a 90-day test exposing rats to H2O2 in drinking water, a dose-related decrease in food intake 

and water consumption and mucosal hyperplasia were observed. NOAEL was 26-37 mg/kg 

bw/day (EU-RAR 2003). 

In a 28-day inhalation exposure study on rats, respiratory irritation, epidermal necrosis and 

inflammation in nasal cavities, mononuclear cell infiltration in the pharynx, and neutrophil 

infiltration and bleeding in perivascular regions of the lung were noted at 14.6 mg/m3

 or more. 

NOAEC was 2.9 mg/m3 (EU-RAR 2003). 

2.3.3.3 Repeated-dose toxicity of Relevant Chemicals 

The toxicity of bromoform caused by oral administration can be summarized as follows: 

.1 In a 14-day experiment with oral administration to ICR mice 

of 50-250 mg/kg/day of bromoform, the 250 mg/kg/day group demonstrated 

reduced fibrinogen content of the blood, heightened activity of aspartate 

aminotransferase (AST), decreased blood glucose levels and blood urea 

nitrogen (BUN) levels, and lower oral and cellular immune functions 

(reduced IgM antibody-forming cell count in the spleen and lower delayed 

allergic reaction) were noticed (ATSDR 2005). According to a screening 

test report, bromoform does not interfere with the transformation by the 

mitogen LPS (cell wall lipopolysaccharide) of spleen B cells obtained from 

C3H/He mice or the transformation by mitogen ConA (Concanavalin A) of 

spleen T cells obtained from BALB/C mice, and does not affect cellular 

immunity or humoral immunity (ATSDR 2005). 
MEPC 61/2/10 

Annex, page 15 

I:\MEPC\61\2-10.doc 

.2 In a 14-day experiment with oral administration to ICR mice of 72, 145, 

and 289 mg/kg/day of bromoform, hepatic focal inflammation, increased 

mitosis in hepatic cells, hyperplasia of kidney tubular epithelium, and 

glomus degeneration were observed in the 145 mg/kg/day or more group 

(ATSDR 2005). 

.3 In a 14-day experiment with oral gavage of 0, 50, 100, 200, 400, 

and 600 mg/kg/day of bromoform to B6C3F1 male mice, 

and 0, 100, 200, 400, 600, and 800 mg/kg/day to female mice, deaths were 

noted in the 600 mg/kg/day male group and the 800 mg/kg/day female 

group. Lethargy and ataxia were observed in the 600 mg/kg/day male 

group and the 600 mg/kg/day or more female group (NTP 1989). 

.4 In a 13-week (five days/nine weeks) oral gavage to B6C3F1 mice 

of 0, 25, 50, 100, 200, and 400 mg/kg/day of bromoform, hepatic cell 

vacuolation was noticed in the 200 mg/kg/day or more group, and reduced 

body weight gain was observed in the 400 mg/kg/day group 

(IPCS-EHC 2000). 

.5 In a test conducted after a 90-day oral gavage to ICR male mice 

of 10 mg/kg of bromoform, no effect of the dosage was confirmed. 

In the 100 and 400 mg/kg dose groups, in which many deaths occurred, 

a change was observed in part of their operant behaviour (ATSDR 2005). 

.6 In a 103-week experiment with oral gavage of 0, 50, and 100 mg/kg/day 

B6C3F1 of bromoform to male mice and 0, 100, and 200 mg/kg/day of 

bromoform to female mice, the 100 mg/kg/day or more female group 

demonstrated fatty degeneration of hepatic cells and the 200 mg/kg/day 

female group showed hyperplasia of the thyroid follicular epithelium 

(NTP 1989). 

.7 In a 14-day experiment with oral gavage to F344 rats of 0, 50, 100, 200, 

400, 600, and 800 mg/kg/day of bromoform, the 400 mg/kg/day or more 

group expressed reduced body weight gain and thyroid gland enlargement. 

In the cases involving death, lethargy and ataxia were noted (NTP, 1989). 

.8 In a one-month experiment giving bromoform-containing feed to Wistar rats 

after its microencapsulation to prevent vaporization (males: 0, 680, 2,040, 

and 6,120 ppm; females: 0, 720, 2,170, and 6,510 ppm), the 680 ppm or 

more male group displayed slight piloerection and decreased serum glucose. 

The 720 ppm or more group demonstrated decreased serum cholinesterase 

activity, lower creatinine levels, and decreased alkaline phosphatase activity 

in females. In the same group, reduced body weight gain and more 

frequent histopathological liver vacuolation were noted in both males and 

females. The 2,170 ppm or more group expressed lower serum glucose 

levels, declining urea nitrogen levels, and reduced lactate dehydrogenase 

activity. The same group also showed increased platelet counts in both 

males and females (2,040 ppm or more in males). The 6,120 ppm group 

expressed lower triglyceride levels and reduced cholinesterase activity in 

males. The group also showed increased leukocyte alkaline phosphatase

activity on both males and females (6,510 ppm in females). LOAEL was 

reported at 680 ppm (equivalent to 56.4 mg/kg/day) (ATSDR 2005). 
MEPC 61/2/10 

Annex, page 16 

I:\MEPC\61\2-10.doc 

.9 In a 13-week (five days/nine weeks) experiment with oral gavage 

administration to F344 rats of 0, 12, 25, 50, 100, and 200 mg/kg/day of 

bromoform, the 12 mg/kg/day or more male group demonstrated hepatic 

cell vacuolation, and the 100 mg/kg/day or more group showed lethargy. 

A significant difference was observed in the 50 mg/kg/day or more groups. 

NOAEL was 25 mg/kg/day (NTP 1989). 

.10 In a 90-day experiment on SD rats with drinking water containing 0, 5, 50, 500, 

and 2,500 ppm of bromoform and a subsequent, 90-day, non-administration 

observation period, the 2,500 ppm group demonstrated reduced food 

intake, reduced weight gain, lower lactase dehydrogenase activity 

(continuing also during the recovery period), and decreased lymphocyte 

count (during the recovery period). The 50 ppm or more dose group 

showed histopathological changes in the liver (vacuolation and fat 

infiltration) and in the thyroid (decreased follicular size and increased 

epithelium height). Effects on the liver and the thyroid were also seen with 

similar frequencies in the control group and the solvent control group. 

Thus, these effects were not considered to be attributable to the dosages 

except for the highest dosage group. The changes noted in the highest 

dosage group were slight and found to be recoverable (ATSDR 2005). 

.11 In a 103-week (five days/week) experiment with oral gavage to F344 rats 

of 0, 100, and 200 mg/kg/day of bromoform, the 100 mg/kg/day or more 

group expressed liver inflammation and hepatic cell fatty degeneration 

(NTP 1989). 

.12 In a two-year experiment on Wistar rats with feed containing 0, 400, 1,600, 

and 6,500 ppm of bromoform after its microencapsulation to prevent 

vaporization, the 1,600 ppm or more group demonstrated reduced body 

weight gain, lower triglyceride levels and reduced cholinesterase activity in 

serum, and pathological changes in the liver, including discoloration, 

roughening of the liver surface, hepatic cell fatty degeneration, 

microgranuloma, bile duct overgrowth, and biliary fibrosis. No hematological 

change was confirmed. 

.13 In this experiment, bromodichloromethane was also administered. 

A significant difference in the onset of biliary fibrosis was observed in the 

group given 6,500 ppm of bromodichloromethane. However, bromoform 

showed no significant difference (ATSDR 2005). In this application we 

estimate NOAEL at 400 ppm, but do not adopt it as the data available only 

exists in a summary. 

.14 The following information was obtained concerning the toxicity of 

bromoform administered by inhalation: 

.1 In a 10-day experiment exposing rats to 240 ppm (2,500 mg/m3

) of 

bromoform (total hours unknown) and in a two-month test 

with 24 ppm (250 mg/m3

) administered to rats for four hours/day, 

both cases expressed impaired prothrombin and glycogen 

synthesis in the liver and reduced glomerular rates in the kidneys. 

This information is from a summary in a report made years ago, 

and thus it is not reliable (U.S.EPA IRIS 2005). 
MEPC 61/2/10 

Annex, page 17 

I:\MEPC\61\2-10.doc 

.2 For the toxicity of bromoform caused by intravenous 

administration, the following information is available. 

.3 In a 10-day experiment with intravenous administration to guinea 

pigs of 100ñ200 mg/kg/day, the liver and kidneys showed a 

pathological change (U.S. NLM: HSDB 2003). 

The findings above suggest that bromoform targets repeated-dose toxicity 

at the liver and kidneys. 

.15 In 13-week and two-year studies conducted at NTP using mice and rats, 

effects on the liver were observed. These were also confirmed in the control 

group, and thus, it is impracticable to determine NOAEL accurately. 

Therefore, based on the effects on the liver (hepatic cell vacuolation) 

confirmed in a one-month test with oral administration (bromoform-containing 

feed) to Wistar rats, this application sets LOAEL by oral administration 

for 680 ppm (56.4 mg/kg/day). 

.16 ICSC has suggested that repeated inhalation of bromoform may adversely 

affect the central nervous system and the liver, causing tissue injury. 

.17 As for the repeated-dose toxicity of bromodichloromethane, in a 13-week 

(five day/week) experiment with oral gavage to rats and mice, dose-related 

effects were observed, including centrilobular hepatic degeneration in both 

male and female rats and renal necrosis in the 300 mg/kg bw/day group, 

renal degeneration and necrosis in male mice in the 100 mg/mg bw/day 

group, and centrilobular hepatic degeneration in female mice in 

the 200 mg/kg bw/day or more group. NOAEL was 150 mg/kg bw/day for 

rats and 50 mg/kg/day for mice (IPCS-EHC 2000). 

.18 As for the repeated-dose toxicity of dibromochloromethane, in a 13-week 

(five day/week) experiment with oral gavage to rats and mice, rats 

expressed serious injury or necrosis in the liver and kidneys, and 

vacuolation and degeneration of hepatic cells. Mice showed necrosis, 

vacuolation, or degeneration of hepatic cells, in addition to tubular 

degeneration and calcification. Based on these findings, NOAEL was set 

for 30 mg/kg/day (IPCS-EHC 2000). 

2.3.4 Chronic toxicity 

2.3.4.1 Chronic toxicity of PERACLEANÆ Ocean and PAA 

No relevant data was available in databases or various literatures. 

Document MEPC 54/2/12 recommends chronic inhalation studies on rats. PERACLEANÆ

Ocean is used in a closed or automated system on board. Access to the system by crew 

and passengers is restricted, and thus, the skin is rarely exposed to the Preparation (see 

section 3.2). For this reason, no further chronic inhalation study was considered necessary. 

This was confirmed in the process of registering PAA as a bactericide (MEPC 57/2/5). 

The nature of the toxicological effects (local inflammation and corrosion, and accompanying 

symptoms) is deducible from the findings of acute and subacute inhalation studies on PAA 

and subchronic pharynx studies. Currently available data are sufficient to allow effective risk 

assessment. 
MEPC 61/2/10 

Annex, page 18 

I:\MEPC\61\2-10.doc 

2.3.4.2 Chronic toxicity of H2O2

A number of reports are available for chronic toxicity of H2O2. However, some are poorly 

designed and others lack important information, and thus, they are not appropriate for 

evaluation. The data provided in section 2.3.3.2 is sufficient to allow deduction of effects of 

long-term administration. 

2.3.4.3 Chronic toxicity of Relevant Chemicals 

As for the chronic toxicity of bromoform, in a 103-week experiment with oral gavage of 

bromoform (solvent, corn oil) to mice (0, 100, 200 mg/kg bw/day) and rats (0, 50, 100 mg/kg 

bw/day), female and male rats demonstrated non-neoplastic regions in the liver as fatty 

degeneration and chronic renal infiltration (IPCS-EHC 2000). 

In a one-year experiment with drinking water containing bromoform given to F344 rats 

(0, 6.2, 29, 57 mg/kg bw/day) and to B6C3F1 mice (0, 8.3, 39, 73 mg/kg bw/day), effects 

were observed mainly on the kidneys (pathological changes in tubule and renal glomus). 

This suggests that bromoform affects different organs depending on the solvent or the dose 

method (IPCS-EHC 2000) used. 

As far as we are aware, there are no reports of studies conducted to determine chronic 

effects of bromoform on humans. Meanwhile, there is a report that trihalomethane in 

drinking water is associated with a higher incidence of bladder cancer, colon cancer, rectal 

cancer, and spleen cancer. U.S. NTP judged this report to be incomplete because the 

experiment did not exclude factors other than trihalomethane (NTP 1989).

As for the chronic toxicity of bromodichloromethane, in a one-year experiment on rats and 

mice with the administration of bromodichloromethane in drinking water, nephrotoxic effects 

were observed, such as glomerular injury (IPCS-EHC 2000). 

As for the chronic toxicity of dibromochloromethane, in a two-year (five day/week) 

experiment with oral gavage of dibromochloromethane to rats and mice; female/male rats in 

the 40 mg/kg/day or more group demonstrated fatty degeneration in the liver, males in 

the 40 mg/kg/day or more group and females in the 80 mg/kg/day group showed cytoplasmic 

degeneration in the liver; and males in the 40 mg/kg/day or more group expressed increased 

incidents of nephropathy. For mice, cytomegalic cells in the liver, hepatic necrosis, fatty 

degeneration and calcareous deposition in the liver were observed. Male mice also 

demonstrated nephropathy (IPCS-EHC 2000). 

2.3.5 Developmental and reproductive toxicity 

2.3.5.1 Developmental and reproductive toxicity of PERACLEANÆ Ocean and PAA 

The data of the developmental and reproductive toxicity are not reliable, because the testing 

method is inappropriate and because the endpoints set are irrelevant to the toxicity. 

For these reasons, it is impracticable to determine the existence of developmental and 

reproductive toxicity in PAA (ECETOC-JACC 2001). 

In a developmental toxicity test based on OECD 414 with administration of a 35% PAA 

solution in drinking water, no dose-related deformity was observed in foetal mice at the 

highest testing concentration of 700 mg PAA/L (MEPC 57/2/5). 
MEPC 61/2/10 

Annex, page 19 

I:\MEPC\61\2-10.doc 

2.3.5.2 Developmental and reproductive toxicity of H2O2 

For the developmental and reproductive toxicity of H2O2, there has been no reliable animal 

study report in evaluation. 

Any reliable standardized testing method (e.g., oral administration by drinking water) would 

not express any toxicity of H2O2 for the following reasons: 

.1 unlike oxygen and water, decomposition products of H2O2, there is much 

uncertainty about H2O2 reaching a foetus; and 

.2 the mother's local effects are considered to be limited to interfering with the 

nutritional balance and causing general toxicological effects. 

In a 90-day test administering H2O2 in drinking water to catalase-deficient mice, no adverse 

effects were found on the reproductive system. This suggests that H2O2 is not a reproductive 

toxicant (EU-RAR 2003). 

2.3.5.3 Developmental and reproductive toxicity of Relevant Chemicals 

As for developmental toxicity of bromoform, 0, 50, 100, and 200 mg/kg/day oral (gavage) 

administrations of bromoform were given to pregnant Sprague Dawley rats (15 rats per group) 

for 10 days from day 6 to day 15 of gestation. In this study, the outer shape, bony framework, 

and organs of the embryos were observed following the performance of a caesarean section at 

the end of the pregnancy. No effects of the administrations were observed concerning the 

weight of the mother rats, embryonic weight, and the pregnant state. Although the tendency of 

the increase in the incidence of skeletal mutation (mid-parietal bone, delayed sternal 

ossification, and 14 costae) in the embryos was observed, no increase in visceral abnormality 

was found. In addition, 50 mg/kg/day was reported as having no effect (ATSDR 2005). 

In a 10-day oral (gavage) study using 150, 200 mg/kg/day of bromoform on pregnant 

F344 rats from day 6 to day 15 of gestation, all embryonic death was found at the dosage 

where toxity develops in the mother rats (ATSDR 2005). 

As for reproductive toxicity of bromoform, test results showed no effect from bromoform on 

the fecundity of mice (fertility rate, survival rate of infants, weight and gender bias per pair) 

during the oral (gavage) administration of 50, 100, and 200 mg/kg/day of bromoform 

to 20 pairs of male and female Swiss CD-1 mice for 105 days. In an oral (gavage) study 

where 0, 50, 100, and 200 mg/kg/day of bromoform was given to 17 to 20 ICR mice per 

group, one week prior to mating, during continuous mating for 14 weeks and for three weeks 

following that (breeding continued until the mating and delivery of F2), in F1, an inhibitation of 

weight increase in males from the 200 mg/kg/day-treated group, a decrease in kidney weight 

in males and females, and an increase in liver weight were observed; however, there were 

no effects on reproductive potential (ATSDR 2005). 

No information regarding the developmental and reproductive toxicity of bromoform against 

humans was found. 

As for developmental toxicity of dibromochloromethane, in an oral (gavage) study of 

pregnant rats from day 6 to the day of gestation, no effect to the number of embryos and 

foetus body weight was observed. The incidence of anomalies did not increase 

(IARC 1999c; IPCS-EHC 2000). 
MEPC 61/2/10 

Annex, page 20 

I:\MEPC\61\2-10.doc 

In a 52-week study on BDCM in drinking water at doses of 22 and 39 mg/kg/day, 

no histrogical changes to the reproductive organs of male rats were observed; however, 

effects on sperm mobility were found (IARC 1999c; IPCS-EHC 2000). 

As for developmental toxicity of dibromochloromethane, in an oral (gavage) study in pregnant 

rats from day 6 to day 15 of gestation, the incidence of anomalies did not increase 

(IPCS-EHC 2000). 

In a two-generation reproductive study of administration to the drinking water of male and 

female mice, fertility and the gestational index decreased in the 4 mg/L-treated group for 

the F1 generation, while the gestation index decreased significantly in the F2 generation. 

In the 1, 4 mg/L-treated groups, the number of F1 and F2 litters and the postnatal four-day 

survival rate decreased significantly. Other effects were seen, including a decreased 

lactation index and reduced postnatal body weight. No dominant lethal or teratogenic effects 

were observed in the F1 or F2 generations (IPCS-EHC 2000). 

2.3.6 Carcinogenicity 

2.3.6.1 Carcinogenicity of PERACLEANÆ Ocean and PAA 

Following the application of 7,12-dimethylbenz[a]anthracene to the ICR Swiss mice, a 0.3, 1, 

and 3% PAA solution was applied two times/week for 66 weeks, and promoter activity was 

seen in a dose-dependent manner, but not at 0.3%. However, PAA cannot be classified as 

an initiator from this test (ECETOC-JACC 2001). 

In addition, the mutagenicity/genetoxicity test result was negative, and it can be said that there 

is no induced carcinogens causing gene mutation (see section 2.3.6.1 of this document). 

2.3.6.2 Carcinogenicity of H2O2

In a study of carcinogenicity in mice from administration by drinking water, the formation of 

dose-dependent tumours to the duodenum was seen, but no carcinogenicity was observed in 

the rats. In species of mice with hypersensitivity, it was concluded that H2O2 was 

carcinogenic to the duodenum, although it is at very low level. Tumours disappeared after 

the discontinuation of the administration (EU-RAR 2003). The carcinogenicity evaluation by 

the IARC was of Group 3, not classifiable as to its carcinogenicity to humans (IARC 1999a). 

2.3.6.3 Carcinogenicity of Relevant Chemicals 

An oral (gavage) study was performed in which a five days/week oral administration 

of 0, 50, and 100 mg/kg/day of bromoform was given to B6C3F1 male mice and 0, 100, 

and 200 mg/kg/day to female mice for 103 weeks. The study results showed that the 

incidence of tumours did not increase (NTP 1989). In an oral (gavage) study in which 0, 100, 

and 200 mg/kg/day was given for five days/week to F344 rats for 103 weeks, adenomatous 

polyposis of the large intestine and adenocarcinoma of the large intestine were observed in 

male and female rats from the 200 mg/kg/day treated group, and it was reported that the rate 

of tumour incidence in females is significant if polyposis and adenocarcinoma are included 

(NTP 1989). 

As for intraperitoneal administration, the study of an eight-week observation was performed 

following the 4, 48, and 100 mg/kg/day intraperitoneal administration 18, 23, or 24 times to 

male A/St mice, and a significant increase in the number of pulmonary adenoma incidence 

per rat was observed in the 48 mg/kg/day-treated group; however, no increase was observed 

in the 100 mg/kg/day treated group (ATSDR 2005). 
MEPC 61/2/10 

Annex, page 21 

I:\MEPC\61\2-10.doc 

As for the initiation, in the study where drinking water containing 500 ppm of phenobarbital 

was administered for 47 days, following three days after the oral (gavage) administration 

of 202 mg/kg of bromoform to the partially hepatectomized male SD rats or non-treated rats, 

it was reported that no nidus of a γ-glutamyl transpeptidase reaction developed in the kidney 

(ATSDR 2005). 

As for the carcinogenicity, as stated above, no increase in the incidence of tumours was 

observed in the mice in the oral study; however, a significant difference was found in the 

increase of tumour incidence in the large intestine of only the rats at the high dosage 

of 200 mg/kg/day. In addition, the IARC classified the bromoform to be Group 3 (a substance 

not classifiable as to its carcinogenicity to humans), due to there being no data regarding 

human carcinogenicity and the only evidence being limited to that obtained on animals. 

Meanwhile, the US EPA defined the slope factor of excess risk of carcinogenesis 

as 7.9×10-3 (mg/kg)-1, based on the study results of female rats (adenomatous polyposis of 

the large intestine and adenocarcinoma) using the linearized multistage model (LMS) as a 

carcinogenic substance with no threshold, and the carcinogenicity of bromoform was 

genotoxic (ATSDR 2005). 

The IARC classified bromodichloromethane in Group 2B -possibly carcinogenic to humans 

(IARC 1999c). 

The IARC classified dibromochloromethane in Group 3 ñ not classifiable as to its 

carcinogenicity to humans (IARC 1999d). 

2.3.7 Mutagenicity/genotoxicity 

2.3.7.1 Mutagenicity/genotoxicity of PERACLEANÆ Ocean and PAA 

There is no new information concerning PERACLEANÆ Ocean, PAA, and H2O2 (refer to 

documents MEPC 53/2/12 and MEPC 57/2/5). 

More recent studies of in vitro experiments in mammalian cell cultures, indicate that a 

PAA solution does not cause significant genotoxic potential and did not cause gene 

mutations and chromosomal aberrations in either the presence or absence of a metabolic 

activation system. Only in one chromosomal aberration assay in vitro a positive result was 

obtained at highly cytotoxic concentrations (0.3 μL/mL without S9). However, a recent in 

vitro chromosomal aberration assay did not show such an effect, even at cytotoxic 

concentrations, suggesting that the earlier findings may have been an artifact. PAA did not 

induce micronuclei in in vivo mouse micronucleus tests when administered by gavage up to 

the maximum tolerated dose levels and did not induce unscheduled DNA synthesis in two 

recent rats in vivo/ex vivo UDS assays when administered by gavage up to the maximum 

tolerated dose level. Therefore, it can be concluded that PERACLEANÆ Ocean and PAA are 

unlikely to have mutagenic potential or be genotoxic. 

2.3.7.2 Mutagenicity/genotoxicity of H2O2

H2O2 was mutagenic and genotoxic in variety of in vitro test systems: the Ames test, in vitro

chromosomal aberration, and in the UDS, SCE, and DNA repair tests. On the other hand, 

H2O2 was negative in in vivo test systems, including the DNA repair test of an intravenous 

injection of H2O2 in rat hepatocytes and the micronucleus study of H2O2 administered orally 

through drinking water and by intraperitoneal injection. On the basis of these results, 

H2O2 was shown not to be mutagenic in vivo (EU-RAR 2003).
MEPC 61/2/10 

Annex, page 22 

I:\MEPC\61\2-10.doc 

2.3.7.3 Mutagenicity/genotoxicity of Relevant Chemicals 

As for mutagenicity of bromoform, in the reverse mutation test (Ames test) performed in a 

hermetically sealed desiccator using Salmonella typhimurium, a positive reaction was 

indicated to TA100 and TA1535 without S9 activation (used to investigate the liver extract of 

rats and metabolic activities) (ATSDR 2005). On the other hand, the ordinary plate method 

indicated negative. This is due to the loss of bromoform by volatilizing (ATSDR 2005). 

In the reverse mutation test (Ames test), which NTP performed by the preincubation method 

using Salmonella typhimurium, TA 100 without S9 activation, TA97, and TA 98 with 

S9 activation, a false positive was indicated; however, TA1535 and TA1537 was negative 

regardless of whether it was with or without S9 activation (NTP 1989). 

A positive was indicated in the sex-linked recessive lethal mutation test mating after food 

containing 3,000 ppm of bromoform was fed to a male Drosophila melanogaster for 3 days. 

However, it was negative in the same test using intraperitoneal administration (NTP 1989). 

Meanwhile, a negative was indicated in the gene translocation study performed using oral 

administration (NTP 1989). 

The results were positive in the mutagenic test using mouse lymphoma regardless of 

whether it was with or without S9 activation (NTP 1989). 

As for genotoxicity, a study of Aspergillus nidulans treated with bromoform was performed 

and an increase in aneuploid expression with S9 activation was found (ATSDR 2005). The 

results of positive without S9 activation, negative with metabolic activation, and negative for 

both, were reported in chromosomal aberration tests using Chinese hamster ovarian cells 

(CHO) (NTP 1989). 

On the other hand, a positive result for both was reported in chromosomal aberration tests 

using Chinese hamster lung cells (CHL) (ATSDR 2005). A negative was shown in the 

chromosomal aberration test in which bromoform was administered once intraperitoneally to 

male B6C3F1 mice and a bone marrow smear sample created 24 hours later, but a positive 

tendency was seen in the micronucleus test (NTP 1989). In addition, negative results were 

obtained in the micronucleus test in which 0, 175, 350, 700, and 1,400 mg/kg of bromoform 

were administered once intraperitoneally to male ddY mice and a bone marrow smear sample 

created 24 hours later (ATSDR 2005). In order to confirm these, another micronucleus test 

was performed in which 0, 50, 250, and 1,000 mg/kg of bromoform were administered 

intraperitoneally once to ICR mice and a bone marrow smear sample created 24 and 48 hours 

later, and the results were negative (ATSDR 2005). In contrast, in the chromosomal 

aberration tests in which 0, 25.3, and 253 mg/kg of bromoform were administered 

intraperitoneally once to male and female Long-Evans rats and a bone marrow smear sample 

created 12 hours later, in the study in which over 25.3 mg/kg and 25.3 mg/kg was administered 

once each and in which a sample was created 6, 12, 18, and 24 hours later, a positive was 

shown in the lethal group; 6, 12, and 18 hours later respectively (ATSDR 2005). 

Tests for DNA damage were also performed, and bromoform showed a positive result in the 

SOS chromotest using Escherichia coli, PQ37 (ATSDR 2005). In addition, a positive result 

was indicated in the Rec-assay using Bacillus subtilis (ATSDR 2005). In the sister chromatid 

exchange (SCE) test using CHO cells, the results of positive without S9 activation, negative 

with metabolic activation, and negative with both were reported (NTP 1989). An SCE test in 

which 200-800 mg/kg of bromoform was administered once intraperitoneally to male B6C3F1 

mice and a bone marrow smear sample created 24 hours later was negative; however, 

a weak positive was observed from the sample created 36 hours later (NTP 1989). In the 

irregular DNA synthesis (SPS) test of S-phase liver cells in which 0, 200, and 600 mg/kg of 
MEPC 61/2/10 

Annex, page 23 

I:\MEPC\61\2-10.doc 

bromoform was administered once orally to male B6C3F1 mice and cells collected after 

killing 48 hours later, the 600 mg/kg-treated group indicated positive (ATSDR 2005). In the 

unscheduled DNA synthesis (UDS) test of liver cells in which 0, 324, and 1080 mg/kg of 

bromoform was administered once orally to male SD rats and cells collected after killing two 

and 14 hours later, the results were negative (ATSDR 2005). No binding was found in the 

experiment that investigated the binding of liver cells to DNA 16 to 18 hours later following a 

single oral administration of 14C-bromoform (2.7 mCi/mmol) to SD rats (ATSDR 2005). 

As above, in in vitro tests, opposing results of positive and negative were seen for 

genotoxicity in the DNA damage test and chromosomal aberration tests using CHL cells or 

CHO cells. In addition, a positive was shown in the DNA damage and mutagenic test using 

bacteria and in the chromosomal aberration tests using fungi and the gene mutation test 

using mouse lymphoma. Moreover, the results obtained from the SCE test and micronucleus 

test using mice in in vivo studies show that bromoform is genotoxic. 

In addition, no study information was found regarding the mutagenicity/genotoxicity of 

bromoform in humans. 

The results of in vitro studies for bromodichloromethane are both positive and negative ñ 

positive and negative in the Ames and chromosomal aberration tests using CHO cells, 

positive in a mutagenicity test using mouse lymphoma cells with metabolic activation, and 

negative in that without metabolic activation (IARC 1999c). 

The results of in vivo studies showed that sister chromatid exchange was induced in the 

mouse bone marrow in an oral study, while chromosomal aberration was induced in the rat 

bone marrow in an intraperitoneal study. However, no micronucleus was induced in the 

mouse bone marrow in an intraperitoneal study, unscheduled DNA synthesis was not 

induced in rat livers in an oral study, and DNA strand breakage was not induced in rat 

kidneys (IARC 1999c). 

The results of in vitro studies were both positive and negative in Ames tests; however, they 

were positive in a test considering the volatility of dibromochloromethane in a closed system. 

In other studies, positive results were observed in a mutation test using mouse lymphoma cells, 

a chromosomal aberration test using cells from Chinese hamster lungs (CHL), and a sister 

chromatid exchange test using human lymphoid cells. In addition, DNA strands were broken in 

human lymphoblastic leukemia cells, but not in rat primary-cultured hepatocytes (ATSDR 2005). 

The results of in vivo studies showed that sister chromatid exchange was induced in the mouse 

bone marrow in an oral study and chromosomal aberration was induced in the rat bone 

marrow in oral and intraperitoneal studies. Meanwhile, on the other hand; no micronucleus 

was induced in the mouse bone marrow in an intraperitoneal study, irregular DNA synthesis 

was not induced in rat liver in an oral study, and DNA strand breakage was not induced in rat 

liver, kidneys, and in the duodenum (ATSDR 2005). 

2.3.8 Toxicokinetics 

2.3.8.1 Toxicokinetics of PERACLEANÆ Ocean, PAA, and H2O2

Although transdermal and transmucosal absorption is possible for the components of 

PERACLEANÆ Ocean, PAA and H2O2, they have a small molecular weight, are a highly 

soluble and low fat soluble substance, and their absorption is limited by their rapid degradation 

on the entry sites. Systemic absorption is limited by their rapid enzymatic degradation in cells 

of mucous membranes in the skin or digestive organs and respiratory system. For example, 

contact with severely irritant concentrations of PAA can lead to absorption into the circulatory 
MEPC 61/2/10 

Annex, page 24 

I:\MEPC\61\2-10.doc 

system due to damaged skin and destruction of the barrier. PAA and H2O2 degrade 

extremely rapidly in blood, yielding oxygen and acetic acid or oxygen and water, respectively. 

The remaining acetic acid is a physiological substance absorbed into physiological metabolic 

pathways or excreted via urine. It is therefore unlikely that organs beyond the site of first 

contact will be affected (ECETOC-JACC 2001, EU-RAR 2003). 

2.3.8.2 Toxicokinetics of Relevant Chemicals 

Bromoform administered orally by gavage to rats is rapidly absorbed and distributed to the 

liver, brain, kidney, and adipose tissue. Unchanged bromoform accounted for 67% of the 

dose and CO2 for 4%, and both were excreted through breathing within 8 hours following the 

administration. Only 4% appeared in urine and 2% was retained in tissues. In contrast, 

in mice, unchanged bromoform accounted for 6% of the dose and CO2 for approximately 40%, 

and both were excreted through breathing within 8 hours following the administration. 

Five per cent of the dose was excreted in urine, and 8% was retained in tissues (IARC 1999a). 

Meanwhile, trihalomethanes including bromodichloromethane and dibromochloromethane 

are normally thought to be rapidly absorbed and excreted after being metabolized, mainly to CO2. 

2.4 Data in environmental fate and effect under aerobic and anaerobic conditions 

(G9: 4.2.1.3) 

2.4.1 Modes of degradation (biotic; abiotic) 

2.4.1.1 Modes of degradation of PERACLEANÆ Ocean, PAA and H2O2

These are investigated in detail in the application for Final Approval for another system that 

uses the same Preparation (MEPC 57/2/5); and contents of investigation are as follows: 

.1 PERACLEANÆ Ocean is readily biodegradable under conditions according to 

OECD guidelines. PAA showed rapid degradation, especially in salt water 

and in the presence of sediment and light. H2O2 degraded slower, but 

degradation increased significantly in the presence of sediment and salt water. 

.2 In fresh water, both components are more stable, especially under cold 

conditions, and H2O2 was detected over the longer period than that of PAA. 

Additionally, the presence of sediments facilitates degradation in fresh water. 

.3 Under realistic conditions, it can be assumed that sediment, which is 

usually present in ship ballast water tanks, enhances degradation. When 

the ballast water is discharged, photolytic degradation additionally occurs. 

Therefore, the actual environmental concentrations are most probably 

lower than those measured under laboratory conditions. 

2.4.1.2 Modes of degradation of Relevant Chemicals 

It can be presumed that bromoform is resistant to biodegradation under aerobic conditions. 

Meanwhile, the chemical bonds in bromoform are not subject to hydrolysis and do not 

hydrolyze in a water environment. 

Biodegradation of Bromodichloromethane only occurs under anaerobic conditions, and no 

biodegradation occurs under aerobic conditions. Its speed is relatively fast in that more 

than 50% biodegrade in half a month to one month (US NLM: HSDB). Hydrolysis does not 

occur. Biodegradation of Dibromochloromethane only occurs under anaerobic conditions 
MEPC 61/2/10 

Annex, page 25 

I:\MEPC\61\2-10.doc 

and no biodegradation occurs under aerobic conditions. Its rate is relatively fast in that more 

than 20% biodegrade in half a month to one month (US NLM: HSDB). Hydrolysis does not 

occur. 

2.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

2.4.2.1 Bioaccumulation, partition coefficient, octanol/water partition coefficient of 

PERACLEANÆ Ocean, PAA and H2O2

The organic carbon normalized distribution coefficient can be derived from the octanol-water 

partition coefficients of the Active Substances PAA and H2O2, using the following equations, 

according to the EU technical guidance document on risk assessment (EC 2003): 

.1 For organic acids, the following equation can be used: 

logKoc = 0.6 logKow + 0.32 

The log Koc of 0.164 (Koc = 1.45 L/kg) can be calculated for PAA, in which 

the log Kow is -0.26 at pH 7. 

.2 For H2O2, the following equation for non-hydrophobics can be used: 

Log Koc = 0.52 log Kow + 1.02 

The log Koc of 0.2 (Koc = 1.58 L/kg) can be calculated for H2O2 using the 

above equation (EU 2003). 

Both Koc values indicate a negligible absorption to organic matter, which would also indicate 

a very low absorption potential to soil and sediment. This is confirmed by the Mackay level 

equilibrium distribution (refer to MEPC 53/2/12). 

Therefore, the bioaccumulative potential of PERACLEANÆ Ocean is also presumed to be 

negligible. 

2.4.2.2 Bioaccumulation, Partition Coefficient, and Octanol/Water Partition Coefficient 

of Relevant Chemicals 

For bromoform, BCF is a maximum of 21 in the study on carp (NITE 2007), and it can be 

concluded that no bioaccumulation exists. In addition, the logPow value of bromoform is 

small; 2.4 dovetails with the results. 

The maximum logPow value of bromodichloromethane is equivalent to bromoform or lower 

than 2.1, and it can be concluded that no bioaccumulation exists. 

The BCF of dibromochloromethane is 9 and the logPow value is 2.24. Therefore, it can be 

concluded that this substance also is not bioaccumulative. 

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

(ballast water, marine and fresh water) 

PERACLEANÆ Ocean contains PAA and H2O2 as Active Substances, as stated in 

section 2.1.1 in this document. However, as stated in section 2.1.2, these Active Substances 

degrade into acetic acid and water or into oxygen in a short time. Therefore, persistence is 

not assumed in PERACLEANÆ Ocean, PAA, and H2O2. 
MEPC 61/2/10 

Annex, page 26 

I:\MEPC\61\2-10.doc 

In contrast, since the produced bromoform, if treated by this BWMS, did not degrade during 

the test period (5 days after treatment), its half-life was not defined and showed high 

persistence. However, it is guessed that persistence is not high because bromoform diffuses 

in the air for volatile. 

2.4.4 Reaction with organic matter 

Documents MEPC 53/2/12 and MEPC 57/2/5 state the following: 

.1 In addition to the presented studies of disinfectant by-products of PAA in 

water treatment, the study of effluents and surface water from municipal 

wastewater treatment plants has been published (Nurizzo et al., 2005). 

According to this, a slight amount of aldehydes was detected only under 

extremely high bromide content (0.9 mg/L) and a high content of oxidizable 

organic carbon (3.2-4.9 mg/L). No formation of halogenated by-products 

was observed under any condition. 

.2 Additional laboratory findings indicate that no brominated and chlorinated 

phenols will form during waste water disinfection with PAA. 

.3 However, PAA is used as an oxidizing reagent in chemical synthesis 

(ECETOC-JACC 2001). Additionally, H2O2 is also widely used as an 

oxidizing reagent and is renowned for oxidation of amine and aldehyde, 

forming reactions of organic peroxides and expoxides, and it reacts with a 

wide range of functional groups (EU-RAR 2003). 

.4 In addition, as indicated in section 2.1.3 in this document, PAA oxidizes 

chloride ion and bromide ion in seawater and produces hypochlorous acid 

and hypobromous acid; these react with natural organic matter and 

subsequently afford trihalomethanes, as already described. 

.5 Furthermore, an increase of AOX was observed as a result of the analysis 

of the ballast water before and after the treatment using the full-scale 

land-based test facility. However, it can be said that the reason for this is 

the addition of a high-concentration of organic matter, in order to fulfil water 

quality criteria of the Guidelines (G8) land-based test. 

.6 Three kinds of THMs are treated as the Relevant Chemicals produced by 

hypobromous acid, which is THMs precursor and an intermediate product 

reacting with organic matter (refer to section 2.1.3 in this document). The 

THMs do not react with organic matter, with the exception of a strong base 

or powerful oxidants, as they are structurally stable. 

2.4.5 Potential physical effects on wildlife and benthic habitats 

PERACLEANÆ Ocean and the Active Substances, PAA and H2O2, readily degrade in the 

environment and do not accumulate, as described in detail so far. Additionally, their diffusion 

in the air is minute, as they are not particularly volatile. Furthermore, as almost all organisms 

have the enzyme system to eliminate these peroxides, potential effects on the environmental 

and benthic organisms are low. 

The solubility of bromoform in water is 0.1 g/100 mL, and it is dissolved in water at the 

current discharge concentration of 14.5 μg/L (refer to section 5.2.2.4 in this document). 

Therefore it was concluded that potential physical effects are low. On the other hand, some 
MEPC 61/2/10 

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I:\MEPC\61\2-10.doc 

bromoform diffused during the vapour phase, due to its high volatility, but such diffused 

concentration is lower than the background concentration in the air. As such, it can be 

concluded that the potential physical effects are low. 

The solubility of bromodichloromethane in water is 4,500 mg/L, and it completely dissolved in 

water at the current discharge concentration of 0.31 μg/L. Therefore, it was concluded that 

potential effects on benthic organisms are low. On the other hand, as this compound is 

highly volatile, some diffusion in the vapour phase was expected according to the forecast of 

environmental distribution (18% distribution in the air) obtained by estimation from Mackay 

Level III model (EPI SUITE v3.2), but such concentration was lower than the background 

concentration in the air. As such, it can be concluded that its potential effects on 

environmental organisms are low. 

The solubility of dibromochloromethane in water is 2,700 mg/L, and it dissolved completely in 

water at the current discharge concentration of 1.75 μg/L. Therefore, it was concluded that 

potential effects on benthic organisms are low. On the other hand, as this compound is 

highly volatile, some diffusion during the vapour phase was expected, according to the 

forecast of environmental distribution (15% distribution in the air) obtained by estimation from 

Mackay Level III model (EPI SUITE v3.2), but such concentration was lower than 

background concentration in the air, and as such, it can be concluded that its potential 

effects on environmental organisms are low. 

2.4.6 Potential residues in seafood 

PERACLEANÆ Ocean, PAA and H2O2 do not accumulate in sea products due to their 

extremely high water solubility. 

Bromoform does not accumulate in sea products, as it has high solubility to water and a 

logPow of 2.4. 

Bromodichloromethane does not accumulate in sea products, as it has high solubility to 

water and a logPow of 2.10. 

Dibromochloromethane also does not accumulate in sea products, as it also has high 

solubility to water and a logPow of 2.16. 

2.4.7 Any known interactive in effects 

PAA is used as an oxidant in chemical synthesis (ECETOC-JACC. 2001). Additionally, H2O2

is widely used as an oxidant, is known for its oxidation of amine and aldehyde, forming a 

reaction of organic peroxides and expoxides, and reacts with a wide range of functional 

groups (EU-RAR 2003). 

In addition, as indicated in section 2.1.3 in this document, PAA oxidizes chloride ion and 

bromide ion in seawater and produces hypochlorous acid and hypobromous acid, and these 

react with natural organic matter and secondarily produce trihalomethanes. 

Bromoform is a relatively stable substance and is persistent under aerobic conditions. 

Meanwhile, biodegradation occurs due to methane bacteria and denitrifying bacteria under 

anaerobic conditions. 

Bromodichloromethane is a relatively stable compound and is persistent under aerobic 

conditions. Meanwhile, biodegradation occurs due to methane bacteria. 
MEPC 61/2/10 

Annex, page 28 

I:\MEPC\61\2-10.doc 

Dibromochloromethane is a relatively stable compound and is persintent under aerobic 

conditions; however, biodegradation occurs due to methane bacteria. 

2.5 Physical and chemical properties for the Active Substances and preparations 

and treated ballast water, if applicable (G9: 4.2.1.4) 

Physical and chemical properties of PAA, H2O2 and Relevant Chemical are shown in 

Tables 2.5-1 to 2.5-5. 

Table 2.5-1: Physical and chemical properties of Active Substance PAA 

Property Value 

Reference/Comments/ 

Justification for 

missing data 

Melting point (°C) 0 

Boiling point (°C) 105 

Flammability (flash point 

for liquids; °C) 40.5 

Density (20°C; kg/m3) 1200 

Vapour pressure (20°C; Pa) 2600 

Vapour density (air = 1) 2.6 

IPCS ICSC 1999 

Water solubility (temp; 

effect of pH; mg/l) Miscible US NLM HSDB 2002 

pH in solution 2.6 

Dissociation constant (pKa) 8.2 

Oxidation-reduction 

potential 1.81 eV 

IPCS ICSC 1999 

Corrosivity to material or 

equipment 

Corrosive to most metals, including 

aluminium 

US NLM HSDB 2002 

Reactivity to container 

material 

Not compatible with aluminium, 

carbon steel, some cross-linked 

polyethylene and metal alloys 

containing copper 

ECETOC-JACC 2001 

Auto-ignition temperature 

(°C) 200 

Explosive properties Above 40.5°C explosive vapour/air 

mixtures may be formed 

IPCS ICSC 1999 

Oxidizing properties Strong oxidizing agent ECETOC-JACC 2001 

Surface tension N/A 

Viscosity 3.280 cP at 25.6°C (78°F) US NLM HSDB 2002 

Thermal stability and 

identity of breakdown 

products 

Decomposition can be initiated by 

high temperature, liberating large 

volume of oxygen gas 

Other physical or chemical 

properties 

Vinegar-like odour 

Odour threshold: 50 ppb 

Henry's law constant: 0.22 Pa·m3

/mol 

ECETOC-JACC 2001 

N/A: Not available. 
MEPC 61/2/10 

Annex, page 29 

I:\MEPC\61\2-10.doc 

Table 2.5-2: Physical and chemical properties of Active Substance H2O2 

Property Value 

Reference/Comments/ 

Justification for 

missing data 

Melting point (°C) -0.43 

Boiling point (°C) 150-152 (decomposition) 

Flammability (flash point 

for liquids; °C) Not flammable 

Density (20°C; kg/m3) 1442.5 

Vapour pressure (20°C; Pa) 300 

EU-RAR 2003 

Vapour density (air = 1) 1 IPCS ICSC 2005 

Water solubility 

(temp; effect of pH; mg/l) Miscible EU-RAR 2003 

pH in solution 4.6 (35% w/w) US NLM HSDB 2009d 

11.62 EU-RAR 2003 Dissociation constant (pKa) 11.75 US NLM HSDB 2009d 

Oxidation-reduction 

potential 

As an oxidizing agent: 

1.763 V (at pH 0) 

As a reducing agent: 

-0.66 V (at pH 0) 

EU-RAR 2003 

Corrosivity to material or 

equipment 

Attacks many organic substances IPCS ICSC 2005 

Reactivity to container 

material 

Contact with most metals, 

reductants or organic matters cause 

violent decomposition with 

exception of passive material 

(e.g., stainless steel) 

EU-RAR 2003 

Auto-ignition temperature 

(°C) 

Not applicable EU-RAR 2003 

May decompose violently if traces 

of impurities are present; 

decomposed by many organic 

solvents 

IARC 1985 

Explosive properties 

Reacts violently with combustible 

and reducing material causing fire 

and explosion hazard 

EU-RAR 2003 

Strong oxidizer US NLM HSDB 2009d 

Powerful oxidizer Oxidizing properties UN classification: 5.1 

(≥ 8% aq. Solution) 

EU-RAR 2003 

Surface tension 80.4 dynes/cm 

Viscosity 1.245 cP 

US NLM HSDB 2009d 

Thermal stability and identity 

of breakdown products 

Self-decomposition by heat, to 

produce oxygen and water 

Henry's law constant; 

7.5 × 10-4 Pa·m3

/mol 

EU-RAR 2003 

Other physical or chemical 

properties Heat of decomposition; 

-28.3 × 105

 J/kg 

US NLM HSDB 2009d 
MEPC 61/2/10 

Annex, page 30 

I:\MEPC\61\2-10.doc 

Table 2.5-3: Physical and chemical properties of Relevant Chemicals Bromoform 

Property Value Reference/Comments/ 

Justification for missing data 

Melting point 8oC ATSDR 2005 

Boiling point 149-150oC ATSDR 2005 

Flammability No ATSDR 2005 

Density (20oC; kg/m3) 2899 ATSDR 2005 

Vapour pressure (20oC; Pa) 667 Pa 

(20oC NTP 2008b 

Vapour density (air=1) 8.7 NTP 2008b 

Water solubility 3190 mg/L 

(30oC) U.S. EPA 2005 

pH in solution N/A Not hydrolyzed 

Dissociation constant N/A No dissociable group 

Oxidationreduction potential N/A No ionization 

Corrosivity to material or 

equipment Yes ATSDR 2005 

Reactivity to container 

material Yes ATSDR 2005 

Auto ignition temperature 

(oC) N/A Considered non-flammable due to chemical structure 

Explosive Properties 

Not considered to 

be an explosion 

hazard 

MSDS (APPENDIX 2.3) 

Oxidizing properties N/A MSDS (APPENDIX 2.3) 

Surface tension 41.50mN/m 

(20oC) NTP 2008b 

Viscosity 1.8 cP NTP 2008b 

Thermal stability and 

breakdown product 

May form toxic 

fumes of 

bromides when 

heated to 

decomposition 

MSDS (APPENDIX 2.4) 

volatile Other physical and 

chemical properties Evaporation heat: 

46.05 kJ/mol 

ATSDR 2005 

N/A: Not Available. 
MEPC 61/2/10 

Annex, page 31 

I:\MEPC\61\2-10.doc 

Table 2.5-4: Physical and chemical properties of Relevant Chemical 

Bromodichloromethane 

Property Value Reference/Comments/Justification for 

missing data 

-57 IPCS/ICSC 2006 Melting point (°C) -57.1 IARC 1991 

90 IPCS/ICSC 2006 Boiling point (°C) 90.1 IARC 1991 

Flammability (flash point 

for liquids; °C) N/A Not supposed, due to a chemical structure like bromoform 

Density (20°C; kg/m3) 1.980 ATSDR 1989 

Vapour pressure (20°C; 

Pa) 6600 IPCS/ICSC 2006 

Vapour density (air = 1) 5.6 IPCS/ICSC 2006 

Water solubility (temp; 

effect of pH; mg/l) 

4500 (20oC; pH: 

N/A) 

IPCS/ICSC 2006 

pH in solution N/A Not supposed, due to structure 

Dissociation constant 

(pKa) N/A Not supposed, due to structure 

Oxidation-reduction 

potential N/A Hardly undergoes oxidation/reduction reaction in normal state, due to structure 

Corrosivity to material 

or equipment N/A May impair resin, like bromoform 

resi N/A May impair resin, like bromoform 

Auto-ignition temperature 

(°C) N/A Non-flammable 

Explosive properties N/A Explosive properties are not supposed, due 

to chemical structure 

Oxidizing properties N/A Oxidizing properties are not supposed due 

to chemical structure 

Surface tension N/A No data in different databases and literature 

Viscosity N/A No data in different databases and literature 

Thermal stability and 

identity of breakdown 

products 

On contact with 

hot surfaces or 

flames this 

substance 

decomposes 

forming toxic and 

corrosive gases, 

including 

hydrogen 

chloride and 

hydrogen 

bromide 

IPCS/ICSC 2006 

Other physical or chemical 

properties 

Reacts with 

strong bases, 

strong oxidants 

and magnesium 

IPCS/ICSC 2006 

N/A: Not Available. 
MEPC 61/2/10 

Annex, page 32 

I:\MEPC\61\2-10.doc 

Table 2.5-5: Physical and chemical properties of Relevant Chemicals 

Dibromochloromethane 

Property Value Reference/Comments/Justification for 

missing data 

Melting point (°C) -20 ATSDR 2005 

120 ATSDR 2005 

Boiling point (°C) 119-120 

(748 mmHg) IARC 1991 

Flammability (flash point for 

liquids; °C) N/A Non-flammable; ATSDR 2005 

Density (20°C; kg/m3) 2451 ATSDR 2005 

Vapour pressure 

(20°C; Pa) 10,133 ATSDR 2005 

Vapour density (air = 1) N/A Specific gravity believed to be higher than 

air, like other trihalomethanes 

Water solubility (temp; effect 

of pH; mg/l) 

2700 (20 oC; 

pH: N/A) ATSDR 2005 

pH in solution N/A Not supposed, due to structure 

Dissociation constant (pKa) N/A Not supposed, due to structure 

Oxidation-reduction potential N/A Hardly undergoes oxidation/reduction 

reaction in normal state, due to structure 

Corrosivity to material or 

equipment N/A May impair resin, like bromoform 

Reactivity to container material N/A May impair resin, like bromoform 

Auto-ignition temperature (°C) N/A Nonflammable 

Explosive properties N/A Explosive properties are not supposed, due 

to chemical structure 

Oxidizing properties N/A Oxidizing properties are not supposed due 

to chemical structure 

Surface tension N/A No data in different databases and literature 

Viscosity N/A No data in different databases and literature 

Thermal stability and identity 

of breakdown products N/A 

Like other trihalomethanes, degradation by 

heating to produce carbon monoxide, 

carbon dioxide, hydrogen chloride, and 

hydrogen bromide gas 

Other physical or chemical 

properties N/A 

Like other trihalomethanes, it is thought to 

react with strong bases, strong oxidizing 

agents, and metal magnesium 

 N/A: Not Available. 

2.6 Analytical methods at environmentally relevant concentration (G9: 4.2.1.5)

Table 2.6-1 shows the determination method for Active Substances, PAA and H2O2, and

analytical methods for Relevant Chemicals. Details are given in the toxicity test of aquatic 

organisms. 
MEPC 61/2/10 

Annex, page 33 

I:\MEPC\61\2-10.doc 

Table 2.6-1: Analytical methods at environmentally relevant concentration 

Active Substances and Relevant Chemical 

Substance Method Applicability Sensitivity 

Reference/Comments/ 

Justification for missing 

data 

PAA 

Photometric 

determination 

(ABTS method) 

In liquid 0.5 mg/L Pinkernel U et al., 1997 

H2O2

Redox titration 

method 

(Potassium 

permanganate) 

In liquid 0.5 mg/L JIS K1463, 2007 

Bromoform 

Bromodichloromethane 

Dibromochloromethane 

Purge and trap 

GC/MS method In liquid 0.0001 mg/L JIS K0125, 1995 

3 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

3.1 Outline of SPO-SYSTEM 

3.1.1 SPO-SYSTEM principle 

This BWMS is a ballast water management system combining chemical sterilization by 

Active Substance of PERACLEANÆ Ocean for Preparation for which Evonik Degussa was 

granted Basic Approval and physical sterilization by the Special Pipe. Figure 3.1-1 shows 

the principle of this BWMS. 

PERACLEANÆ Ocean is proportionally injected so that a set concentration is obtained 

depending on ballast water flow rate. PAA and H2O2 sterilize bacteria in ballast water and 

then are promptly decomposed in water. The Special Pipe sterilizes aquatic organisms by 

combination of shearing force generated upstream of the forward slit plate and impact force 

generated when cavitation formed at the forward slit plate hits the after slit plate and 

collapses. 
MEPC 61/2/10 

Annex, page 34 

I:\MEPC\61\2-10.doc 

Figure 3.1-1: SPO-SYSTEM principle 

3.1.2 SPO-SYSTEM flow 

Each component constituting this BWMS is installed in the engine room (pump room for a 

tanker), PO storage tank room and control room. Figure 3.1-2 shows a flow chart when this 

BWMS ballasting (a) and de-ballasting (b). 

Dosing of 80mg of PO

against 1L of seawater Ballast 

Tank 

Special

Pipe 

PO Injector Ballast

Pump

PERACLEAN® Ocean 

component 

Peracetic acid (CH3COOOH) 

Hydrogen peroxide (H2O2) 

Acetic acid (CH3COOH) 

Water (H2O) 

Principle of sterilizing 

of Special Pipe

Sterilizing effect by the shearing force 

at forward slit plate 

Sterilizing effect by Cavitation crash 

at after slit plate 

Fwd 

Slit 

Plate 

Aft 

Slit 

Plate 

Fwd 

Slit 

Plate 

Sea 

Water

Sea 

Chest 

PO 

STORAGE 

TANK 

※PO・・・PERACLEANÆ Ocean 
MEPC 61/2/10 

Annex, page 35 

I:\MEPC\61\2-10.doc 

Figure 3.1-2 (a): SPO-SYSTEM in ballasting 

Figure 3.1-2 (b): SPO-SYSTEM in de-ballasting 

1. Filter 4. Special Pipe 7. PO Storage Tank 10. Control Panel 

2. PO Injector 5. Back Wash Pump 8. PO Injection Pump 11. PAA Conc. Meter 

3. Ballast Pump 6. Press. Transmitter 9. PO Flow Meter 

1. Filter 4. Special Pipe 7. PO Storage Tank 10. Control Panel 

2. PO Injector 5. Back Wash Pump 8. PO Injection Pump 11. PAA Conc. Meter 

3. Ballast Pump 6. Press. Transmitter 9. PO Flow Meter 

Strainer 

(Yard) 

Strainer 

(Yard) 

Sea Chest 

Overboard 

Overboard 

ENGINE ROOM

PO STORAGE

TANK ROOM

CONTROL ROOM

Ballast 

Tank 

4

7 8 10 

1 3

9

5 2 6 6 11 

Strainer 

(Yard) 

Strainer 

(Yard) 

Sea Chest 

Overboard 

Overboard 

4

7 8 10 

1 2 3

9

6

ENGINE ROOM

PO STORAGE

TANK ROOM

CONTROL ROOM

Ballast 

Tank 

5 6 11 
MEPC 61/2/10 

Annex, page 36 

I:\MEPC\61\2-10.doc 

3.2 The manner of application (G9: 4.2.6 and 7) 

3.2.1 PERACLEANÆ Ocean 

3.2.1.1 The maximum dosage concentration 

PERACLEANÆ Ocean is injected to give its concentration 80 mg/L in ballast water. This 

PERACLEANÆ Ocean injection amount is automatically controlled for the flow rate of ballast 

water and the injection concentration is kept to be 80 mg/L even if the ballast water flow 

rate varies. An injection concentration of 80 mg/L is approximately half of that 

of 150 mg/L when Evonik Degussa was granted Basic Approval. 

In addition, various tests required for Procedure (G9) application of this BWMS were conducted 

with an injection concentration of 150 mg/L of PERACLEANÆ Ocean. This is because the 

influence level on the hulls, crews and the environment is evaluated more strictly than the 

influence caused by an actual use of the PERACLEANÆ Ocean injection concentration 

of 80 mg/L and this system is ensured in practical operation with greater allowance for safety. 

This means that a concentration of 150 mg/L is adopted for verification of influence on the 

environment and 80 mg/L is adopted for an actual operating system. 

3.2.1.2 Holding time 

The holding time in the ballast tank for ballast water treated by this BWMS should 

be 24 hours after which no PAA is detected even under any environmental condition. This 

holding time of 24 hours is the same as the holding time when Evonik Degussa was 

granted a Basic Approval. 

3.2.1.3 The maximum allowable discharge concentration 

The maximum allowable discharge concentration of Active Substance for this BWMS is 

specified as follows: 

.1 When the tank holding time is 24 hours as described above, it has been 

confirmed that the concentration of PAA falls below the detection limit 

(0.5 mg/L) under any environmental condition. Accordingly, little PAA (less 

than 0.5 mg/L) is contained in the ballast water discharged by operation of 

this BWMS. The concentration of PAA below the detection limit is the 

same as the condition when Evonik Degussa was granted Basic Approval. 

Therefore, it is provided that the maximum allowable discharge concentration 

of PAA is less than 0.5 mg/L. Furthermore, when ballast water is 

discharged, PAA contained in the ballast water is monitored by a PAA 

concentration meter and PAA is confirmed to be below the detection limit. 

.2 The concentration of H2O2 should be below 12 mg/L, which is contained in 

PERACLEANÆ Ocean with an injection concentration of 80 mg/L. The 

maximum allowable discharge concentration of 12 mg/L of H2O2 is 

approximately half of the 21 mg/L when Evonik Degussa was granted Basic 

Approval. 

.3 Then, the maximum allowable discharge concentrations of Relevant 

Chemicals should be the following concentrations obtained by adding 

a 95% confidence limit value to the concentrations (average value 

of 3 replicate determinations) immediately after treatment which recorded 

the highest concentration among time-dependent data measured in the 
MEPC 61/2/10 

Annex, page 37 

I:\MEPC\61\2-10.doc 

conducted test (section 5.2.2.7 of this document). In addition, the 

maximum allowable concentrations of these Relevant Chemicals were not 

set when Evonik Degussa was granted Basic Approval. This BWMS 

generates a little concentration of Relevant Chemicals, however, for these 

trihalomethanes, the maximum allowable concentration is also set and 

assessed against the environmental risk. See below: 

Bromoform: 14.5 μg/L 

Dibromochloromethane: 1.75 μg/L 

Bromodichloromethane: 0.31 μg/L 

4 MATERIAL SAFETY DATA SHEETS 

MSDS for PERACLEANÆ Ocean as the Preparation, PAA and H2O2 as Active Substances 

and Relevant Chemicals of this BWMS are contained in the confidential document. 

5 RISK CHARACTERIZATION 

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

5.1.1 Persistence (G9: 5.1.1.1) 

Persistence (P) 

Since the half-lives of PAA and H2O2, Active Substances of PERACLEANÆ Ocean are 

several minutes to several days in the environment, both compounds are readily degradable 

and not persistent in the environment. 

On the other hand, bromoform, bromodichloromethane and dibromochloromethane of 

Relevant Chemicals are not degradable and have the persistence. 

5.1.2 Bioaccumulation (G9: 5.1.1.2) 

Bioaccumulation (B) 

Due to the high water-solubility and low octanol-water partition coefficient (log Pow; < 0), 

there is no anxiety of bioaccumulation for PAA and H2O2, Active Substances of 

PERACLEANÆ Ocean. 

Meanwhile it is not supposed that there is any bioaccumulative potential for bromoform, 

bromodichloromethane, dibromochloromethane of Relevant Chemicals based on their BCH 

and log Pow values described in section 2.4.2 of this document. 

5.1.3 Toxicity test (G9: 5.1.2.3) 

Toxicity (T) 

Toxicity is judged by using a chronic toxicity value (NOEC < 0.01 mg/L) for aquatic organisms. 

As for Active Substances, PAA has the Toxicity because its NOEC is less than 0.01 mg/L. 

However, it is not listed as an endocrine disruptor, and carcinogenicity, mutagenicity or 

reprotoxicity is not found in in vitro mammalian tests. 

H2O2 does not have toxicity because its NOEC is 0.1 mg/L. 
MEPC 61/2/10 

Annex, page 38 

I:\MEPC\61\2-10.doc 

As for the Relevant Chemicals, bromoform does not have toxicity because the chronic 

toxicity value (NOEC) is 4.8 mg/L. 

Bromodichloromethane does not have toxicity because the chronic toxicity value (NOEC) 

is 0.78 mg/L. 

Dibromochloromethane does not have toxicity, because the chronic toxicity value (NOEC) 

is 0.063 mg/L. 

5.1.4 Does the Active Substance and/or preparation meet all three criteria for PBT? 

Active Substances of PERACLEANÆ Ocean and Relevant Chemicals of this BWMS do not 

meet the PBT criteria specified in the Methodology (MEPC 56/2/2, annex 4) and 

Procedure (G9) (MEPC 57/21, annex 1). Therefore these compounds do not meet PBT 

compounds. 

Table 5.1-1: PBT concerning Active Substances and Relevant Chemicals 

 Persistent (y/n) Bioacumulativ

e (y/n) Toxic (y/n)

Reference/Comments/ 

Justification for 

missing data

PBT criteria 

Half-life: 

> 60 days in marine 

water, or 

> 40 days in fresh 

water,* or 

> 180 days in marine 

sediments, or 

> 120 days in fresh 

water sediments

Experimentally 

determined BCF 

> 2,000, or if no 

experimentally 

BCF has been 

determined, 

log Pow;3

Toxicity 

Chronic 

NOEC < 

0.01 mg/L

PAA N N Y 

See sections 2.2.2.1, 

2.4.2 and 2.4.3 in this 

document 

H2O2 N N N 

See sections 2.2.2.2, 

2.4.2 and 2.4.3 in this 

document 

Bromoform Y N N 

See sections 2.2.2.3, 

2.4.2 and 2.4.3 in this 

document 

Bromodichloro 

methane Y N N 

See sections 2.2.2.3, 

2.4.2 and 2.4.3 in this 

document 

Dibromochloro 

methane Y N N 

See sections 2.2.2.3, 

2.4.2 and 2.4.3 in this 

document 

* For the purpose of marine environmental risk assessment half-life data in fresh water and fresh 

water sediment can be over ruled by data obtained under marine conditions. 

5.2 Evaluation of the treated ballast water (G9: 5.2) 

5.2.1 Basic Approval 

This BWMS uses a Preparation, PERACLEANÆ Ocean which was reviewed at the first meeting 

of GESAMP-BWWG held from 23 to 27 January 2006 and was granted Basic Approval at 

MEPC 54 from 20 to 24 March, 2006. Meanwhile, the injection concentration was 150 mg/L 

when the Basic Approval was granted. This BWMS is applying 80 mg/L of injection 
MEPC 61/2/10 

Annex, page 39 

I:\MEPC\61\2-10.doc 

concentration, which is almost half of that used for the Basic Approval. Active Substances 

were identified as PAA and H2O2 for the Basic Approval, and their risk was assessed. In this 

BWMS, PAA and H2O2 are also identified as Active Substances and their risks are assessed. 

The maximum allowable discharge concentration of H2O2 is 12 mg/L which is almost half 

of 21 mg/L for Basic Approval. On the other hand, there was no substance corresponding 

Relevant Chemicals according to the Basic Approval. However, since generation of a little 

amount of trihalomethanes is confirmed in this BWMS, they are identified as Relevant 

Chemicals and subjected to risk assessment. 

5.2.2 Final Approval 

5.2.2.1 Performed tests 

The following seven tests were performed for Final Approval using this BWMS: 

.1 confirmation test of by-products using the full-scale land-based test facility; 

.2 Active Substances degradation test using the full-scale land-based test 

facility (Part 1: Storage in Simulated ballast Tank); 

.3 Active Substances degradation test using the full-scale land-based test 

facility (Part 2: Storage in Temperature Controlled Container); 

.4 change with time test of by-products using the downscaled land-based test 

facility; 

.5 full-scale toxicity test (acute and chronic); 

.6 corrosion test using the full-scale land-based test facility; and 

.7 corrosion test with high-concentration PERACLEANÆ Ocean using the 

full-scale land-based test facility. 

5.2.2.2 Test facility 

The tests for the Final Approval were performed using the test facility of SPO-SYSTEM for 

Guidelines (G8) land-based test (treatment flow rate: 200 m3

/h). Only the downscaled 

land-based test facility of SPO-SYSTEM was used for "SPO-SYSTEM Change with Time Test 

of By-products". 

5.2.2.3 Test site 

Test site is the coastal facility in Imari city, Saga Prefecture in the Southwest Japan. 

The land-based test facility mainly consists of simulated ballast tanks (200 m3

) (a barge was 

moored at the public quay and divided into four sections), a ballast pump and this BWMS. 

5.2.2.4 Confirmation test of by-products using the full-scale land-based test facility 

This test was carried out to confirm the kind and the amount of by-products 

(Relevant Chemicals) which were produced by the treatment using this BWMS. 

With regard to trihalomethanes, 1.9 to 7.8 μg/L of bromoform, 0.2 to 0.9 μg/L of 

chlorodibromomethane and only in some test, 0.1 μg/L of bromodichloromethane were 
MEPC 61/2/10 

Annex, page 40 

I:\MEPC\61\2-10.doc 

detected. These concentrations were higher in brackish water than in seawater. 

Furthermore, 0.4 μg/L of chloroform was detected in both untreated and treated water only in 

one test. 

On the other hand, halogenated phenols were not detected in every test group. Although 

AOX was also detected only in treated water this value was the total amount of absorbable 

halogenated organic compounds and not determined as specific compounds. And it was 

detected more in the case of brackish water criteria than seawater criteria. 

Bromoform, chlorodibromomethane and a small amount of bromodichloromethane were 

produced in the water which is treated by this BWMS with 80 or 150 mg/L of PERACLEANÆ

Ocean. According to the test results, it was determined that these three compounds were 

subjected to risk assessment. 

5.2.2.5 Active Substances Degradation Test using the full-scale land-based test 

facility (Part 1: storage in simulated ballast tank) 

By using the full-scale land-based test facility of this BWMS, we have carried out treatment of 

seawater and brackish water under the condition specified in Guidelines for approval of 

ballast water management systems (G8), which confirmed the degradation of PAA and H2O2. 

The results of tests satisfying seawater criteria showed that concentration of PAA and H2O2

reached below the lower detection limit (0.5 mg/L) within 21 hours and 45 to 117 hours, 

respectively. It is presumed that the difference of water temperature at each test affected the 

degradation rate of H2O2. On the other hand, the results of tests satisfying seawater criteria 

showed that concentration of PAA and H2O2 reached below the lower detection limit 

within 21 to 24 hours and 51 to 69 hours, respectively. 

With these test results, we confirmed that the peracetic acid degraded within 24 hours, 

of which concentration reached below the lower detection limit in ballast water treatment by 

SPO-SYSTEM using 80 mg/L of PERACLEAN®

 Ocean. And it was also confirmed that the 

concentration of H2O2 reached below the lower detection limit within 5 days holding time 

(120 hours). Furthermore, 5.4 and 9.6 mg/L of H2O2 were calculated as the lower and upper 

limit of 95% confidence interval, which remained 24 hours after the treatment. 

5.2.2.6 Active Substances degradation test using the full-scale land-based test facility 

(Part 2: storage in temperature controlled container) 

The objective of this test is to investigate effects of the existence of particulate substance 

and the temperature on the degradation behaviour of PAA and H2O2 in the simulated ballast 

water which was prepared by means of carrying out a treatment fulfilling seawater and 

brackish water by using the full-scale land-based test facility of this BWMS. 

PAA degraded most quickly, which was stored at 20oC, and its concentration reached below 

the lower detection limit (0.5 mg/L) within 4 hours in seawater and 10 to 12 hours in brackish 

water. Along with the storage temperature decreased, the degradation rate slowed down. 

In case of storage at 5oC, it took 10 to 12 hours in seawater and 24 hours in brackish water. 

Furthermore the rate showed a tendency to slow down in brackish water rather than in 

seawater. On the other hand, there was no significant difference of degradation rate 

depending on the filtration. 

The degradation rate of H2O2 also slowed along with the decrease of the storage 

temperature and the slowest was observed in filtered brackish water and stored at 5oC, 

which took 380 hours not to be detected. 
MEPC 61/2/10 

Annex, page 41 

I:\MEPC\61\2-10.doc 

Above results concluded that the concentration of PAA reached below the lower detection 

limit (0.5 mg/L) within 24 hours in the simulated ballast water (brackish water) which was 

treated by this BWMS with 80 mg/L of PERACLEANÆ Ocean and was stored at 5oC, i.e. the 

temperature required longest time not to be detected. As for H2O2, the degradation rate 

slowed down in the same conditions, and it was confirmed to require 380 hours not to be 

detected (< 0.5 mg/L). 

From the foregoing and the test results described in section 5.2.2.5 of this document, it is 

evaluated that PAA concentration reached below the detection limit under cold condition, 

e.g., at 5oC, such temperature delays the degradation of PAA. Meanwhile the half-life of 

H2O2 was approximately 24 hours under the same condition; its degradation rate was fast. 

5.2.2.7 Change with time test of by-products using the downscaled land-based 

test facility 

This test was conducted to confirm the degradability of by-products (Relevant Chemicals) 

under the brackish water criteria specified in the Guidelines for approval of ballast water 

management systems (G8). 

The results revealed that 12 μg/L (upper limit: 14.5 μg/L) of bromoform was detected right 

after the treatment, which was the highest concentration among trihalomethanes, and 

furthermore, 1.5 μg/L (upper limit: 1.75 μg/L) of dibromochloromethane and 0.2 μg/L (upper 

limit: 0.31 μg/L) of bromodichloromethane were detected. No significant decay of by-products 

was observed within 5 days after the treatment. Consequently, it was confirmed that 

Relevant Chemicals did not degrade or degrade much slowly. This follows the existing data. 

5.2.2.8 Full-scale toxicity test (acute and chronic)

This test was performed to get hold of the acute and chronic toxicity of the ballast water 

discharge, which is treated by this BWMS, for algae, invertebrates and fish. 

5.2.2.8.1 Acute toxicity test 

.1 Seawater test 

See section 2.2.1.4(1) of this document. 

.2 Brackish water test 

See section 2.2.1.4(2) of in this document. 

5.2.2.8.2 Chronic toxicity test 

.1 Seawater test 

See section 2.2.2.4(1) of this document. 

.2 Brackish water test 

See section 2.2.2.4(2) of this document. 
MEPC 61/2/10 

Annex, page 42 

I:\MEPC\61\2-10.doc 

5.2.2.9 Corrosion test using the full-scale land-based test facility 

This test was conducted to evaluate the corrosive influence of the ballast water on ballast 

tank coatings and uncoated materials. The ballast water used was prepared by land-based 

test facility of this BWMS with 80 mg/L of the PERACLEANÆ Ocean injection rate as same as 

that of actual operation of this BWMS. 

The test results indicated that there is no or only allowable corrosive influence of treated 

water on the ballast tank coatings and uncoated materials. 

5.2.2.10 Corrosion test with high-concentration PERACLEANÆ Ocean using the 

full-scale land-based test facility 

This test was conducted to evaluate the corrosive influence of the ballast water on ballast 

tank coatings and uncoated materials over the period of 6 months. The ballast water used 

was prepared by land-based test facility of this BWMS with 150 mg/L of the PERACLEANÆ

Ocean injection rate almost as twice as that of actual operation of this BWMS. Thus severe 

condition was applied. 

The test results indicated that there is no or only allowable corrosive influence of treated 

water on the ballast tank coatings and uncoated materials in the same way of 80 mg/L. 

5.2.3 Determination of holding time 

Holding time of this BWMS is set at least 24 hours, within which PAA concentration reaches 

under the lower detection limit (0.5 mg/L) in all tests described in section 5.2.2 of this 

document. This holding time is the same as that has been granted Basic Approval. 

5.3 Risk characterization and analysis 

5.3.1 Reaction with organic matter (G9: 4.2.1.3) 

As for reaction with organic matter, it was confirmed with analysis of the ballast water before 

and after the treatment by using the full-scale land-based test facility. As the results, while 

an increase of AOX was observed, it could be said that the reason for this was the addition of 

a high-concentration of organic matter, in order to fulfill water quality criteria of Guidelines 

(G8) land-based test. 

In addition, generation of small amount of trihalomethanes was confirmed in various tests. 

It is supposed that their generation is due to the reaction of hypobromous acid, which is 

trihalomethanes precursor and an intermediate product, with organic matter. According to 

these results, trihalomethanes are considered as Relevant Chemicals and subjected to risk 

assessment in this application. As shown in section 5.3.8 of this document, their effects on 

the aquatic environment were at the negligible levels. 

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

PAA and H2O2, Active Substances of PERACLEANÆ Ocean, readily degrade in the 

environmental media. Abiotic degradation half-lives in seawater are in the range of several 

minutes for PAA, and up to 48 hours in fresh water at pH 4 to 7. For H2O2, half-lives of 

several hours up to 5 days were predicted under environmental conditions. The half-life will 

be more rapid in the presence of transitions metals, metal oxides and hydroxides, at 

Ph Values > 7. Heat and sunlight can induce photochemical decomposition. However, 

it should also be considered that H2O2 is also generated photochemically in water systems. 
MEPC 61/2/10 

Annex, page 43 

I:\MEPC\61\2-10.doc 

Both PAA and H2O2 are readily biodegradable with half-lives with sewage treatment plant 

inoculum of 2 to 3 minutes if the toxicity levels are not superseded. 

Degradation of PERACLEANÆ Ocean results only in the formation of oxygen and water as well 

as acetic acid that can be readily metabolised, yielding carbon dioxide and water. No persistent 

metabolites are formed. A half-life with the abiotic degradation of PAA is a few minutes. 

It was confirmed that the concentrations of PAA, an Active Substance reached below the 

detection limit (0.5 mg/L) within 24 hours under any conditions and the concentration of H2O2

became approximately half in the degradation tests conducted for the application for 

Final Approval (sections 5.2.2.5 and 5.2.2.6 in this document). However, there was hardly 

any degradation of the Relevant Chemicals including bromoform, bromodichloromethane and 

dibromochloromethane under the examined aerobic conditions (section 5.2.2.7 of this 

document). 

5.3.3 Prediction of discharge and environmental concentrations 

Predicted environmental concentrations (PEC) for H2O2 of Active Substance and bromoform, 

bromodichloromethane, and dibromochloromethane of Relevant Chemicals in the ballast 

water discharged from this BWMS were calculated by using MAMPEC model version 2.0 

targeting on Tokyo Bay. 

Table 5.3-1 shows the calculation results of PEC. 

Table 5.3-1: PEC calculation results in designated sea area 

using MAMPEC model, ver. 2.0 

5.3.4 Assessment of potential for bioaccumulation 

Due to the low octanol-water partition coefficients (log Kow = -0.26 for PAA and -1.5 for H2O2), 

PERACLEANÆ Ocean does not possess a bioaccumulative potential. Therefore, assessment 

of bioaccumulation is not necessary. 

On the other hand, as mentioned in section 2.4.2 of this document, log Kow values of 

Relevant Chemicals generated by this BWMS including bromoform, bromodichloromethane 

and dibromochloromethane are 2.4, 2.1 and 2.24, respectively, and all of them are lower 

than log Kow: 3, an index which induces the bioaccumulation. Consequently, it is assumed 

that there is no risk on bioaccumulation of the Relevant Chemicals discharged by this 

BWMS. 

PEC of H2O2 PEC of Relevant Chemicals (μg/ L) 

(μg/ L) Bromoform Dibromochloromethane Bromodichloromethane

Maximum 

concentration 

4.72E-01 1.47E-03 1.71E-04 2.87E-05 

95% 

concentration 

4.66E-01 1.35E-03 1.57E-04 2.65E-05 

Average 

concentration 

2.17E-01 8.54E-04 9.92E-05 1.65E-05 

Median 

concentration 

1.75E-01 8.44E-04 9.79E-05 1.61E-05 

Minimum 

concentration 

3.66E-02 1.84E-04 2.13E-05 3.53E-06 
MEPC 61/2/10 

Annex, page 44 

I:\MEPC\61\2-10.doc 

5.3.5 Effects assessment 

In this BWMS, the maximum discharge concentration of an Active Substance, H2O2 

is 12 mg/L, and those of Relevant Chemicals, bromoform, dibromochloromethane and 

bromodichloromethane are 0.0145 mg/L, 0.00175 mg/L and 0.00031 mg/L, respectively. 

As for H2O2, because the acute and chronic toxicity value is 1.38 mg/L and 0.1 mg/L, 

respectively, the ballast water discharge has an aquatic toxicity. However, due to its high 

degradation rate, and diffusion and dilution after the discharge, its concentration should 

become acceptable level. As for Relevant Chemicals, their concentrations in ballast water 

discharge are much less than the values that show the acute and chronic toxicity. 

Accordingly, there is no risk of toxicity. 

Taking in consideration of the physicochemical properties of these compounds, there is no 

bioaccumulative potential. Therefore the accumulative toxic effects are unlikely via food-web. 

5.3.6 Effects on aquatic organisms 

5.3.6.1 Estimated PNEC 

The PNEC of Active Substance and Relevant Chemicals discharged from the SPO-SYSTEM 

is estimated as follows: 

.1 H2O2: 0.01 mg/L of PNEC have been obtained in MEPC 57/2/10 already. 

.2 Bromoform: LC50 or EC50 have been obtained for 5 species of marine 

species and 4 species of fresh water species. Furthermore MATC and/or 

NOEC have been obtained for 2 fresh water species in total and the lowest 

concentration is 12 mg/L of 96h-LC50 for seawater and 4.8 mg/L of 

MATC for fresh water. By setting the assessment factors in this case 

to 1000 (long) and 100 (short), the results are 12 μg/L for PNECseawater

(long), 120 μg/L for PNECseawater (short), 4.8 μg/L for PNECfresh water (long) 

and 48 μg/L for PNECfresh water (short). 

.3 Bromodichloromethane: LC50 or EC50 have been obtained for 6 fresh water 

species, and NOEC have been obtained for 3 fresh water species in total 

and the lowest concentration is 11.6 mg/L of EC50 for algae and 0.78 mg/L 

of NOEC for fish. By setting the assessment factors in this case to 100 for 

seawater and 10 for fresh water, the results are 7.8 μg/L for PNECseawater

and 78 μg/L for PNECfresh water. 

.4 Dibromochloromethane: LC50 or EC50 have been obtained for 6 fresh water 

species, and NOEC have been obtained for 3 fresh water species in total 

and the lowest concentration is 9.6 mg/L of EC50 for algae and 0.063 mg/L 

of NOEC for crustacean. By setting the assessment factors in this case 

to 100 for seawater and 10 for fresh water, the results are 0.63 μg/L for 

PNECseawater and 6.3 μg/L for PNECfresh water.

5.3.6.2 PEC/PNEC ratio 

Based on the PEC obtained in section 5.3.3 of this document and the PNEC estimated in 

section 5.3.6.1 of this document, PEC/PNEC was calculated. The results are shown in 

Table 5.3-2. 

PEC/PNEC of H2O2 and Relevant Chemicals discharged from the SPO-SYSTEM were far 

lower than 1. 
MEPC 61/2/10 

Annex, page 45 

I:\MEPC\61\2-10.doc 

Accordingly, the toxicity of H2O2 was reflected in the toxicity test results (section 5.2.2.8 of 

this document), however, it was estimated that the dilution and degradation effects made its 

environmental risk acceptable. 

Table 5.3-2: PEC, PNEC and PEC/PNEC ratio 

Relevant Chemicals PEC (μg/L) PNEC (μg/L) PEC/PNEC 

H2O2 0.217 10 0.0217 

long short long short Bromoform 0.000854 12 120 7.12E-05 7.12E-06 

Dibromochloromethane 0.0000992 7.8 1.27E-05 

Bromodichloromethane 0.0000165 0.63 2.62E-05 

5.3.7 Effects on sediment 

As described in section 2.2.4 of this document, adsorption on sediment and persistence are 

not supposed for all of H2O2 and Relevant Chemicals discharged by this BWMS. Therefore, 

it is considered that there is no effect on sediment. 

5.3.8 Comparison of effect assessment with discharge toxicity 

The toxicity of H2O2 was reflected in the results of the toxicity tests. Nevertheless it was 

assumed that such risk was acceptable in the actual sea area because of the dilution and 

degradation after discharge of the ballast water. 

6 RISK ASSESSMENT 

6.1 Risk to safety of ship 

6.1.1 Increased corrosion 

As stated in sections 5.2.2.9 and 5.2.2.10 of this document, the results of the corrosion 

testing using the Guidelines (G8) full-scale land-based test facility indicate that the corrosive 

influence of the treated water prepared by this BWMS on the coating materials of the ballast 

tank and various materials is allowable. 

In consideration of the nature of PERACLEANÆ Ocean, it is unlikely that there is a fire 

hazard. Furthermore, although PERACLEANÆ Ocean possesses an explosive potential at 

high temperature (> 60oC), a storing method to maintain at 35oC or lower is adopted. If the 

temperature exceeds 35oC, the sufficient safety precautions are given. 

6.1.3 Storage and handling of the substances 

As for storage, filling, production and supply of PERACLEANÆ Ocean, full countermeasures 

are devised to remove any risks. 

6.1.4 Contact with, or inhalation of, process products 

As for contact inhalation, full countermeasures are devised to remove any risks. Moreover it 

is assessed that this BWMS is safe for ship as described in section 6.2 of this document 

(vide infra). 
MEPC 61/2/10 

Annex, page 46 

I:\MEPC\61\2-10.doc 

6.1.5 Noise 

It is not supposed that the operation of this BWMS generates noise. 

6.2 Risk to human health 

6.2.1 Health effects in humans (G9: 5.3.12) 

The health effect scenario in humans (except for shipboard personnel) is estimated by 

consideration of the seafood web and the ecosystem. As the ballast water discharge from 

this BWMS is unlikely to cause any impact on the environment, however, this route has a 

little risk. Relevant Chemicals are potentially dissipated from the ballast tank. When the 

Relevant Chemicals were measured, they were detected at low concentrations and were not 

at a level to affect human health. Therefore, volatile trihalomethanes have no risk to human 

health. 

Although residual PAA and H2O2 in the ballast water in the case of their slow degradation are 

unlikely to affect human health during inspection of the ballast tank, protective equipments 

should been worn during inspection to avoid any risk. 

Health effects in humans were summarized as follows, making reference to the method 

specified in document MEPC 57/2/10, annex 4, appendix 2. 

6.2.2 Human Exposure Scenario (HES) 

6.2.2.1 Exposure scenario-1: Exposure of shipboard personnel to Preparation when 

charged 

The highest inhalation exposure of PAA to workers is expected during pouring and filling by 

manual procedures. The application for Final Approval for another system using the same 

Preparation, in which 150 mg/L of the PERACLEANÆ Ocean is used (PAA = 22.5 mg/L, 

H2O2 = 21.5 mg/L), showed that exposure concentration to PAA was 0.0435 mg/m3

(MEPC 57/2/10). This value accounts for approximately 7.25% of 0.6 mg/m3

, a TLV of PAA 

proposed by the application for Final Approval of another system using PERACLEANÆ Ocean, 

therefore, it is concluded to be no risk of PAA to shipboard personnel (workers) (MEPC 57/2/10). 

A TLV-TWA of H2O2 by ACGIH is 1.4 mg/m3

. Consequently, H2O2 is considered to have little 

risk as well as PAA. 

On the other hand in this system, Preparation is stored in a PO storage tank at 35°C or lower 

temperature, which is isolated from an engine room and is injected into ballast water in filling 

using automatic control pump as required. Therefore, there is no risk that shipboard 

personnel are exposed to Preparation or its components in usual storage and injection. 

Active Substances, PAA, and H2O2 cause strong irritation to the skin, eyes, and respiratory 

systems at high concentrations; therefore, it is recommended that workers wear respirator, 

gloves and glasses, and protective clothing when they can be exposed to Active Substances. 

6.2.2.2 Exposure scenario-2: Exposure to vaporized Preparation in ballast tank 

after charge for shipboard personnel 

In this system, it is assumed that Preparation of 80 mg/L is added into ballast water and held 

for 1 to 2 days. Active Substances, PAA and H2O2, degrade in ballast water and Relevant 

Chemicals generate simultaneously. Considering that Active Substances quickly degrade in 
MEPC 61/2/10 

Annex, page 47 

I:\MEPC\61\2-10.doc 

water and they should be diluted in air phase in the ballast tank, exposure concentration of 

Active Substances under this scenario should be lower than the scenario-1 "filling and 

loading in manual operation". Consequently, no health risk of Active Substances is expected. 

However, Relevant Chemicals generated in ballast water are assumed to be volatilized into 

the air in a ship. Therefore, a model for distribution into the ship air from ballast water by 

volatilization was estimated using Mackey Level III of EPI SUITE V3.2. In the estimation by 

modelling, a release velocity into each environmental media (air/water/soil) is set at 0/1000/0 

and other setting values were used as default ones of the model. 

The model-estimated results of environmental distribution showed that 14-18% of Relevant 

Chemicals were distributed in the air. On the basis of the above estimation results, the 

concentrations of Relevant Chemicals in air phase in ballast tank is under the worst case, 

where the conditions of air ventilation rate of air phase in ballast tank of 0 is calculated. 

The content volumes of ballast water and air phase of ballast tank are assumed to be 15,000 

and 5,000 m3

, respectively, which are general values.

6.2.2.3 Exposure scenario-3: Exposure of general public after discharge of ballast 

water 

The exposure scenarios of general public after ballast water is discharge after treatment with 

this BWMS include: (1) exposure by vaporization from seawater, (2) indirect exposure 

through seafood via food chain, and (3) direct exposure to seawater of sea-bathers and 

fishermen. See below: 

.1 The risk to shipboard personnel that was assumed in a closed ballast tank 

is little, therefore, health risk in general environment can be ruled out. 

.2 The octanol-water partition coefficients of all Active Substances and 

Relevant Chemicals are less than 3, therefore, it is concluded that there is 

no concern about exposure via food chain. 

.3 Active Substances and Relevant Chemicals at concentrations in ballast 

water have no concern about irritation. The initial (maximum) concentration 

of Active Substance, PAA, in ballast water was 13.6 mg/L and in 

comparison with the NOAEL of PAA in animal study of 1.7 mg/kg/day, 

(although this exposure scenario is unrealistic) the concentration is 

correspondent to the volume of 7.5 L or more of seawater for humans 

(body weight: 60 kg). Furthermore, PAA and H2O2, Active Substances, 

relatively degrade rapidly and ballast water is diluted after discharge, 

therefore, it is concluded to have no risk for human health. In addition, 

Relevant Chemicals had no risk for human health to be concerned. 

6.2.3 Considered analysis 

Under normal conditions of using this BWMS, it is considered that Active Substances and 

Relevant Chemicals have no health risk to shipboard personnel and general public. 

6.3 Risk to the aquatic environment 

As summarized in section 5 of this document, there is little effect on the environment as a 

result of the ballast water discharge of this BWMS. 
MEPC 61/2/10 

Annex, page 48 

I:\MEPC\61\2-10.doc 

7 CONCLUSION 

This BWMS uses PERACLEANÆ Ocean with an injection concentration of 80 mg/L as a 

Preparation. This injection concentration is almost half of 150 mg/L used for the 

Basic Approval (see MEPC 53/2/12). PAA as an Active Substance is put under surveillance 

by a PAA concentration meter so as not to exceed the detection limit when discharged. 

With reference to the use of PERACLEANÆ Ocean, the result of various tests implemented in 

a full-scale land-based test facility as well as the risk assessment on the environment, human 

beings and ships showed that the risks against them were within acceptable ranges. From 

this point of view this BWMS deserves Final Approval.

8 REFERENCES 

ACGIH 2001. Documentation of the TLVs and BEIs. Bromoform. 

ATSDR 1989. Toxicological Profile for Bromodichloromethane. 

ATSDR 2005. Toxicological Profile for Bromoform and Dibromochloromethane. 

U.S. Department of health and human services. 

ECETOC-JACC 2001. Peracetic Acid (CAS No. 79-21-0) and its Equilibrium Solutions. 

JACC No.40. 

EU-RAR 2003. European Union Risk Assessment Report. Hydrogen peroxide. 

IARC 1991a. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Bromodichloromethane. 

IARC 1991b. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Dibromochloromethane. 

IARC 1999a. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Hydrogen peroxide. 

IARC 1999b. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Bromoform. 

IARC 1999c. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Bromodichloromethane. 

IARC 1999d. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to 

Human. Chlorodibromomethane. 

IPCS-EHC 2000. Environmental Health Criteria 216. Disinfectants and disinfectant 

by-products. 

IPCS-ICSC 1999. International Chemical Safety Cards #1031 Peracetic acid. 

IPCS-ICSC 2005a. International Chemical Safety Cards #0164 Hydrogen peroxide. 

IPCS-ICSC 2006. International Chemical Safety Cards #0393 Bromodichloromethane. 
MEPC 61/2/10 

Annex, page 49 

I:\MEPC\61\2-10.doc 

JIS K0125 1995. Testing methods for volatile organic compounds in industrial water and 

waste water. 

JIS K1463 2007. Hydrogen Peroxide. 

NITE 1986. Biodegradation and Bioconcentration of Existing Chemical Substances under 

the Chemical Substances Control Law. 

Nurizzo U, et al., 2005. By-products in surface and reclaimed water disinfected with various 

agents, Desalination, 176 (567-571) 

Pinkernell U, et al., 1997. Selective Photometric Determination of Peroxycarboxylic Acids in 

the Presence of Hydrogen Peroxide. Analyst, June 1997, Vol. 122 (567ñ571) 

US EPA ECOTOX 2007. Bromoform. 

US EPA ECOTOX 2009. Bromodichloromethane. 

US NLM HSDB 2002. Hazardous Substance Data Bank. Peracetic acid. 

US NLM HSDB 2009a. Hazardous Substance Data Bank. Bromoform. 

US NLM HSDB 2009b. Hazardous Substance Data Bank. Bromodichloromethane. 

US NLM HSDB 2009c. Hazardous Substance Data Bank. Dibromochloromethane. 

US NLM HSDB 2009d. Hazardous Substance Data Bank. Hydrogen Peroxide. 

US NTP 1989. TOXICOLOGY AND CARCINOGENESIS STUDIES OF TRI-BROMOMETHANE 

(BROMOFORM). 

USGS 2007. FINDING OF NO SIGNIFICANT IMPACT for Hydrogen Peroxide for Control of 

Mortality in Fresh water Finfish and Finfish Eggs Due to External Fungal and Bacterial 

Diseases. 

Zepp RG, et al., 1987. Algal-induced Decay and Formation of hydrogen Peroxide in Water: 

Its Possible Role in Oxidation of Anilines by Algae. Phytochemistry of Environment Aquatic 

Systems, 327 (215-224). 

LIST OF APPENDICES 

APPENDIX 1 STATEMENT 

APPENDIX 2 QUALITY ASSURANCE STATEMENT 

APPENDIX 3 QUALITY ASSURANCE PROJECT PLAN (QAPP) FOR 

CORROSION TESTING OF SPO-SYSTEM 

APPENDIX 4 QUALITY MANAGEMENT PLAN (QMP) AND QUALITY 

ASSURANCE PROJECT PLAN (QAPP) FOR ANALYSIS OF 

BALLAST WATER TREATED BY SPO-SYSTEM 

* * * 
MEPC 61/2/10 

Annex, page 50 

I:\MEPC\61\2-10.doc 

APPENDIX 1 

STATEMENT 

* * * 
MEPC 61/2/10 

Annex, page 51 

I:\MEPC\61\2-10.doc 

APPENDIX 2 

QUALITY ASSURANCE STATEMENT 
MEPC 61/2/10 

Annex, page 52 

I:\MEPC\61\2-10.doc 

* * * 
MEPC 61/2/10 

Annex, page 53 

I:\MEPC\61\2-10.doc 

APPENDIX 3 

QUALITY ASSURANCE PROJECT PLAN (QAPP) FOR CORROSION TESTING 

OF SPO-SYSTEM 

Extracted version 
MEPC 61/2/10 

Annex, page 54 

I:\MEPC\61\2-10.doc 
MEPC 61/2/10 

Annex, page 55 

I:\MEPC\61\2-10.doc 
MEPC 61/2/10 

Annex, page 56 

I:\MEPC\61\2-10.doc 

APPENDIX 4 

QUALITY MANAGEMENT PLAN (QMP) AND 

QUALITY ASSURANCE PROJECT PLAN (QAPP) 

FOR ANALYSIS OF BALLAST WATER TREATED BY SPO-SYSTEM 
MEPC 61/2/10 

Annex, page 57 

I:\MEPC\61\2-10.doc 
MEPC 61/2/10 

Annex, page 58 

I:\MEPC\61\2-10.doc 

_____________