I:\MEPC\61\2-6.doc 

# E

MARINE ENVIRONMENT PROTECTION

COMMITTEE

61st session Agenda item 2 MEPC 61/2/6

25 March 2010 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER

Application for Basic Approval of Kuraray Ballast Water Management System

Submitted by Japan

SUMMARY

Executive summary: This document contains an application for Basic Approval of Kuraray Ballast Water Management 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: 7.1.2.4

Action to be taken: Paragraph 4

Related documents: BWM/CONF/36; MEPC 53/24/Add.1; MEPC 57/21 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 the Convention shall be approved by the Organization.

2 Japan herewith submits an application for Basic 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 including:

.1 non-confidential information related to Kuraray Ballast Water Management System according to Procedure (G9);

.2 list of references; and

.3 quality control statement of each test.MEPC 61/2/6 Page 2

I:\MEPC\61\2-6.doc 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 61/2/6 Annex, page 1

I:\MEPC\61\2-6.doc ANNEX

NON-CONFIDENTAL INFORMATION ON KURARAY BALLAST WATER

MANAGEMENT SYSTEM

This annex has the following contents:

1 INTRODUCTION

2 APPLICATION DATA SET

3 USE OF THE ACTIVE SUBSTANCE

4 MATERIAL SAFETY DATA SHEETS

5 RISK CHARACTERIZATION

6 EVALUATION OF THE TREATED BALLAST WATER

7 RISK ASSESSMENT

8 CONCLUSION

9 REFERENCES

APPENDICES:

APPENDIX 1 STATEMENT
APPENDIX 2 QUALITY ASSURANCE STATEMENT

1 INTRODUCTION

1.1 Contents of the Basic Assessment Report

This final Basic Assessment Report is prepared in accordance with the "Methodology for information gathering and the conduct of wo rk of the GESAMP-BWWG" (BWM.2/Circ.13).

1.2 Application conditions of the system

The application for Basic Approval is to request permission for use of a ballast water management system (hereinafter referred to as "BWMS"). The conditions for Kuraray BWMS in this application are as follows:

.1 Ballast water to be processed: Filling ballast water.

.2 Number of times of ballast water treatments: Once.

.3 Active Substance to be used and concentration: Calcium hypochlorite at 2 mg/L as free active chlorine (FAC).

.4 Holding time: 0 h.

.5 Operation of neutralization treatment device: When the FAC concentration in the discharge ballast water exceeds 0.2 mg/L, it is neutralized prior to being discharged by adding sodium sulfite. And, when the FAC concentration is 0.2 mg/L or less, it is discharged without neutralization.MEPC 61/2/6 Annex, page 2

I:\MEPC\61\2-6.doc .6 Maximum allowable discharge concentrations of the Active Substance and Relevant Chemicals: Maximum allowable discharge concentration of FAC is 0.2 mg/L; calcium hypochlorite (the Active Substance of FAC) is lowered to 0.2 mg/L (as FAC) or less by the time of discharge. Maximum allowable discharge concentrations of Relevant Chemicals are estimated as the maximum detected concentration on the toxicity test as described below:

Bromoform: 0.101 mg/L

Dibromochloromethane: 0.002 mg/L

Dichloromethane: 0.062 mg/L

Monobromoacetic acid: 0.003 mg/L

Dibromoacetic acid: 0.04 mg/L

Tribromoacetic acid: 0.05 mg/L

Dibromochloroacetic acid: 0.03 mg/L

Monochloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, as chloramines)

Dichloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, as chloramines)

Trichloroamine: 0.2 mg/L (after neutralization: 0.02 mg/L, as chloramines)

Dibromoacetonitrile: 0.02 mg/L

1.3 Summary of the Basic Assessment Report

Since the BWMS discharges the FAC at 0.2 mg/L or less, the risk to sea environment is considered to be within tolerance. Furthermore, it is considered not to have any harmful effects on ships or the human body. Therefore, the BWMS is considered suitable for proceeding to further development and putting forward various tests and procedures used for the Final Approval.

2 APPLICATION DATA SET

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

2.1.1 Preparation (G9: 4.2.2)

The chemicals used in the BWMS are "Kuraray AS" of which calcium hypochlorite, as listed in Table 2.1-1, is the main component.MEPC 61/2/6 Annex, page 3

I:\MEPC\61\2-6.doc Table 2.1-1: Composition of Kuraray AS infused into a ballast line in the BWMS

* AS: Active Substance, RC: Relevant Chemicals, Other: Other Chemicals

2.1.2 Active Substances (AS)

The Active Substance used by the BWMS is calcium hypochlorite as described in section 2.1.1. The information on calcium hypochlorite is listed below. In addition, the concentration of calcium hypochlorite is represented by free active chlorine (FAC), which is the oxidizing power thereof except for the data set.

.1 Trade name: Not applicable.

.2 Chemical name: Calcium hypochlorite (calcium hypochlorite).

.3 CAS number: 7778-54-3.

.4 UN number and proper shipping name: 1748 (CALCIUMHYPOCHLORITE MIXTURE, DRY with more than 39% available chlorine).

.5 Molar mass: 142.98.

.6 Empirical formula: Ca(ClO) 2.

.7 Structural formula:

.8 Classification in accordance with the UN GHS system:

(Based on REGULATION (EC) No. 1272/2008)

Oxidising solids: Category 2, Acute toxicity: Category 4

Skin corrosion: Category 1B, Aquatic toxicity: Category acute 1 Composition of Kuraray AS

Component

Chemical Name CAS Number Empirical

formula Molar

Mass Concentration (%) AS, RC or

Other*

Calcium hypochlorite 7778-54-3 Ca(ClO) 2 142.98 ≥ 67 (as AvCl) AS

Calcium hydroxide 1305-62-0 Ca(OH) 2 74.09 ≤ 3
Polyphosphoric acid

sodium salt 68915-31-1 Na 5 P 3 O 10 367.86 ≤ 0.5

Sodium chloride 7647-14-5 NaCl 58.44 ≤ 12

Calcium chloride 10043-52-4 CaCl 2 110.98 ≤ 3 Calcium chlorate 10137-74-3 Ca(ClO 3 ) 2 206.98 ≤ 1

Calcium carbonate 471-34-1 CaCO 3 100.09 ≤ 3

Water - 18 to 24 Other (Additives in Preparation)MEPC 61/2/6 Annex, page 4

I:\MEPC\61\2-6.doc .9 Purity of the technical substance and identification of impurities (chemical name and CAS- number, etc.): See Table 2.1-1.

.10 Identity of any stabilizer or necessary additives: Not applicable.

2.1.3 Relevant Chemicals (RC) (G9: 2.1.4)

When seawater and brackish water is treated by Kuraray AS, as prepared for the BWMS, the composition analysis results (the measurement is performed in a 10% solution of the treated water) are as represented in Table 2.1-2 (appendix 2 of this Basic Assessment Report; measurement at the time of the aqueous toxicity test). As a result, in addition to calcium hypochlorite, which is the Active Substanc es, (1) Bromoform, (2) Dibromochloromethane, (3) Dichloromethane, (4) Monobromoacetic acid, (5) Dibromoacetic acid, (6) Tribromoacetic acid, (7) Dibromochloroacetic acid, (8) Chlo ramine (Monochloroamine, Dichloroamine, or Trichloroamine), and (9) Dibromoacetonitrile are detected. For this reason, these nine

substances are called the Relevant Chemicals in the BWMS. The substance information on the Relevant Chemicals is represented in Table 2.1-3.MEPC 61/2/6 Annex, page 5

I:\MEPC\61\2-6.doc Table 2.1-2: Composition analysis results in treated water diluted to 10%

Concentration in seawater (mg/L) Concentration in brackish water (mg/L)
Chemical Name Detection
limit (mg/L) Min.
concentration Max.
concentration Detection
limit (mg/L) Min.
concentration Max.
concentration

Sodium Bromate (as bromate ion)
Calcium Bromate (as bromate ion) 0.01 N.D. N.D. 0.01 N.D. N.D.

Calcium hypochlorite (as free active chlorine (FAC)) 0.01 <0.01 0.02 0.01 <0.01 0.02

Bromoform 0.0001 0.0017 0.0101 0.0001 0.0013 0.0020
Chloroform 0.0001 N.D. N.D. 0.0001 N.D. N.D.

Dibromochloromethane 0.0001 <0.0001 0.0002 0.0001 N.D. N.D.
Dichlorobromomethane 0.0001 N.D. N.D. 0.0001 N.D. N.D.
Dibromomethane 0.001 N.D. N.D. 0.001 N.D. N.D.
Dichloromethane 0.0001 <0.0001 0.0062 0.0001 <0.0001 0.0004 1,2-dibromo-3-chloro

propane 0.0001 N.D. N.D. 0.0001 N.D. N.D.

1,1,1-trichloroethane 0.0001 N.D. N.D. 0.0001 N.D. N.D.
Tetrachloroethane 0.0001 N.D. N.D. 0.0001 N.D. N.D. 1,2,3-trichloro propane 0.001 N.D. N.D. 0.001 N.D. N.D.
Monochloroacetic acid 0.005 N.D. N.D. 0.0005 N.D. N.D.
Dichloroacetic acid 0.002 N.D. N.D. 0.0001 N.D. N.D.
Trichloroacetic acid 0.001 N.D. N.D. 0.0001 N.D. N.D.
Monobromoacetic acid 0.001 N.D. N.D. 0.0001 <0.0001 0.0003
Dibromoacetic acid 0.001 0.001 0.004 0.0001 0.0013 0.0019
Tribromoacetic acid 0.001 0.003 0.004 0.0001 <0.0001 0.0050
Bromochloroacetic acid 0.001 N.D. N.D. 0.0001 N.D. N.D.
Bromodichloroacetic
acid 0.001 N.D. N.D. 0.0001 N.D. N.D.

Dibromochloroacetic
acid 0.001 <0.001 0.003 0.0001 <0.0001 0.0003

Monochloroamine (as chloramine)

Dibromoamine (as chloramine)

Trichloroamine (as chloramine) 0.01 <0.01 0.02 0.01 0.02 0.02

Dibromoacetonitrile 0.001 0.002 0.002 0.001 <0.001 0.001
Chloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D.

Dichloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D.
Trichloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D.
Bromochloroacetonitrile 0.001 N.D. N.D. 0.001 N.D. N.D.
2-chlorotoluene 0.001 N.D. N.D. 0.001 N.D. N.D.
4-chlorotoluene 0.001 N.D. N.D. 0.001 N.D. N.D. 2,4-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D. 2,6-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D. 2,4,6-dibromophenol 0.001 N.D. N.D. 0.001 N.D. N.D.

N.D.: Not detected.MEPC 61/2/6Annex, page 6I:\MEPC\61\2-6.docTable 2.1-3: Information on Relevant ChemicalsChemical (IUPAC) NameCASNumberMolar massEmpiricalformulaStructuralformulaClassification in accordance with the UNGHS system*Bromoform 75-25-2 252.73 CHBr3Acute Toxicity: Category 3Eye Ittitation: Category 2Skin irritation: Category 2Aquatic toxicity: Category Chronic 2Dibromochloromethane 124-48-1 208.28 CHBr2ClNot availableDichloromethane 75-09-2 84.93 CH2Cl2Carcinogenicity: Category 2Monobromoacetic acid 79-08-3 138.95 CH2BrCOOHAcute toxicity: Category 3Skin corrosion: Category 1AAquatic toxicity: Acute category 1Dibromoacetic acid 631-64-1 217.84 CHBr2COOHNot availableTribromoacetic acid 75-96-7 296.74 CBr3COOHNot availableDibromochloroaceticacid5278-95-5 252.29 CBr2ClCOOHNot availableMonochloroamine 10599-90-3 51.48 NH2Cl Not availableDichloroamine 3400-09-7 85.92 NHCl2Not availableTrichloroamine 10025-85-1 120.37 NCl3Not availableDibromoacetonitrile 3252-43-5 198.84 CHBr2CNNot available*Based on REGULATION (EC) No. 1272/2008.MEPC 61/2/6 Annex, page 7

I:\MEPC\61\2-6.doc 2.1.4 Other Chemicals (OC)

When the FAC in the discharged ballast water is 0.2 mg/L or more, the BWMS neutralizes the FAC by adding sodium sulfite (purity >97%), which is twice as much as the FAC concentration, prior to discharging it. However, when the FAC concentration is below 0.2 mg/L, the sodium sulfite is not applied.

In addition to sodium sulfite, additives in the preparation such as calcium chlorate, calcium hydroxide, calcium chloride, calcium carbonate and sodium polyphosphate are classified as Other Chemicals. Considering their content and properties, they are not used in the

environment risk assessment. All the data are described in the complete dossier.

2.2 Data on Effects on aquatic plants, invertebrates and fish, and other biota (including sensitive and representative organisms) (G9:4.2.1.1)

This section describes data on effects on aquatic plants, invertebrates, fish, and other biota (including sensitive and representative organism s) of calcium hypochlorite, which is the Active Substance and bromoform, dibromochloromethane, dichloromethane, monobromoacetic acid, dibromoacetic acid, trib romoacetic acid, dibromochloroacetic acid, chloramines, and dibromoacetonitrile which are the Relevant Chemicals.

2.2.1 Acute aquatic toxicity

2.2.1.1 Active Substance

Even though the data on the acute toxicity test performed by a standard test method using calcium hypochlorite for fish are not acquired, a number of reliable data in a special test condition are acquired and the minimum 96-h LC 50 is 23 μ g TRC/L. For crustacea, Ceriodaphnia dubia , 24-h LC 50 was 0.005 to 0.006 mg FRC/L (FRC = free available chlorine after a reaction). For algae, Thalassiosira pseudonana , 24-h LC 50 was equal to 75 μ g/L (20°C) (SIDS, 2004).

Therefore, in this Basic Assessment Report, it is assumed that the acute aquatic toxicity of calcium hypochlorite used for various risk assessments of the aqueous environment is 0.005 mg FRC/L.

2.2.1.2 Relevant Chemicals

2.2.1.2.1 Bromoform

The minimum value of LC 50 for fish, Cyprinodon variegates , is 7.1 mg/L. The minimum value

of LC 50 for crustacea, Americamysis bahia , is 24.4 mg/L. For algae, there is data on EC 50 Skeletonema costatum and the minimum value is 12.3 mg/L. Therefore, it is assumed that acute aquatic toxicity of bromoform used for various risk assessments of the aqueous environment is 7.1 mg/L (U.S. EPA: ECOTOX Database 2007).

2.2.1.2.2 Dibromochloromethane

96-h LC 50 for fish, oryzias latipes was 79 mg/L. 48-h EC 50 for crustacea, Daphnia magna was 27 mg/L. 96-h EC 50 growth inhibition for algae, Pseudokircheneriella subcapitata

, was 9.6 mg/L by speed calculation and 6.1 mg/L by area calculation (Ministry of the Environment in Japan, 1995).MEPC 61/2/6 Annex, page 8

I:\MEPC\61\2-6.doc From the above description, it is assumed that the acute toxicity of the bromoform used in various risk assessments of the aqueous environment is 9.6 mg/L, as speed calculation is dominatingly adopted in growth inhibition of algae.

2.2.1.2.3 Dichloromethane

The minimum value of LC 50 for fish, Fundulus heteroclitu , is 97.0 mg/L. The minimum value

of LC 50 for crustacea, Palaemonetes pugia

, is 108.5 mg/L. Even though there is the data

on EC 50 using algae, Pseudokircheneriella subcapitata and Bacillariophyceae, they both exceed 662 mg/L, which is not a definite value (EHC 164: IPCS, 1996). Therefore, it is assumed that the acute aquatic toxicity of the dichloromethane used in various risk assessments of the aqueous environment is 97.0 mg/L.

2.2.1.2.4 Monobromoacetic acid

Data on acute toxicity test for fish is not acquired. 24-h EC 50 that targets the swimming inhibition of crustacea, Daphnia magna

, was 65 mg/L. 72-h EC 50 that targets the growth inhibition of crustacea, Scenedesmus subspicatus

, wa s 1.4 mg/L (ECOTOX Database 2010a). Therefore, it is assumed that the acute aquatic toxicity of bromoacetic acid used in various risk assessments of the aqueous environment is 1.4 mg/L.

2.2.1.2.5 Dibromoacetic acid

96-h LC 50 using, fish, Pimephales promelas

, was 69 mg/L. Data on acute toxicity test for crustacea and algae is not acquired (ECOTOX Database, 2010a). Therefore, it is assumed that the acute aquatic toxicity of the dibromoacetic acid used in various risk assessments of the aqueous environment is 69 mg/L.

2.2.1.2.6 Tribromoacetic acid

Data on acute aquatic toxicity test of tribromoacetic acid for fish, crustacean and algae is not acquired.

2.2.1.2.7 Dibromochloroacetic acid

Data on acute toxicity test of dibromochloroacetic acid for fish, crustacean and algae is not acquired.

2.2.1.2.8 Chloramines

The minimum value of 96-h LC 50 for fish, Menidia menidia, was 0.040 mg/L and the minimum

value of LC 50 for crustacea, Daphnia magna , was 0.011 mg/L

. For algae, there is 10-d EC 50 data on Porphyra yezoensis and the minimum value was 0.014 mg/L. Further, 48-h EC 50 for Crassostrea virginica was 0.001 mg/L (CEPA, 2001). Therefore, it is assumed that the acute aquatic toxicity of the chloramine used in various risk assessments of the aqueous environment is 0.001 mg/L.

2.2.1.2.9 Dibromoacetonitrile

96-h LC 50 for algae, Pimephales promelas

, was 0.55 mg/L (ECOTOX Database, 2010e). Data on crustacea and algae is not acquired. Therefore, it is assumed that the acute aquatic toxicity of dibromoacetonitrile used in vari ous risk assessments of the aqueous environment is 0.55 mg/L.MEPC 61/2/6 Annex, page 9

I:\MEPC\61\2-6.doc 2.2.1.3 Treated ballast water (G9: 5.2.3)

The acute toxicity of the ballast water treated by using the prototype test of the BWMS has a value that the effect on algae ( Skeletonema costatum) in the brackish water condition under Guidelines (G8) for land-based testing is the most sensitive and ErC 50 was calculated to be 5.8% dilution. In brackish water test, growth inhibition on algae, Skeletonema costatum

, was observed in neutralization group with sodium sulfite addition. In the test, test water (treated water discharge: TWD) is prepared by dilution of the BWMS treated water (sodium sulfite injection concentration is 3 mg/L-FAC) to 10, 2, 0.4, 0.08 and 0.016%. Another test water (neutralization) is prepared by adding sodium sulfite to make 2 mg/L solution after diluting the treated water to 33v/v% with filtrated brackish water.

In algae test, FAC in all the test water is below 0.01 mg/L. Regarding concentration of Relevant Chemicals in 10%-TWD and neutralization group, bromoform, dichloromethane and

chloramines are detected but others are not detected. The maximum detected concentration of bromoform and dichloromethane during the algae test are 0.0013 mg/L and 0.0002 mg/L each. Acute toxic concentration of bromoform and dichloromethane are 7.1 mg/L and 97.0 mg/L each, as described before. The detected concentrations of the two chemicals are way below the acute toxicity level, while chloramines are detected as 0.2 mg/L in 10%-TWD group (less than 0.1 mg/L in neutralization group). The acute toxic concentration of chloramines is 0.001 mg/L as described before, and the detected concentration is 20 times as more. Therefore the effect on algae seems to be caused by the chloramines.

2.2.2 Chronic aquatic toxicity

2.2.2.1 Active Substance

In fish, the minimum value of 133-d NOEC (No Observed Effect Concentration) of Ictalurus punctatus was 0.005 mg TRC/L (SIDS, 2004).

As for other shellfish, 56-d of LC 50 of Dreissena polymorpha ( zebra mussel) was 0.08 mg/L

and 15-d. NOEC of Crassostrea virginica ( oyster) was 0.062 mg/L (SIDS, 2004).

From the above description, it is assumed that the chronic aquatic toxicity of calcium hypochlorite used in various risk assessments of the aqueous environment uses 0.005 mg/L TRC/L.

2.2.2.2 Relevant Chemicals

2.2.2.2.1 Bromoform

There is data on the chronic toxicity for fish, for example, Cyprinodon variegates and 28-d MATC (Maximum Acceptable Toxicant Concent ration) is 4.8 mg/L (Ward et al, 1981)

. 96-h NOEC of algae, for example, Pseudokircheneriella subcapitata is 10 mg/L (ECOTOX, 2007). There was no data on crustacea. Therefore, it is assumed that the chronic aquatic toxicity of the bromoform used in various risk assessments of the aqueous environment uses the NOEC (MATC) of 4.8 mg/L.

2.2.2.2.2 Dibromochloromethane

There was no data on fish. There is data on the chronic toxicity that targets the breeding toxicity of crustacea, Daphnia magna and 21-d NOEC was 0.063 mg/L. 72-h NOEC of algae, Pseudokircheneriella subcapitata was 4.5 mg/L (Ministry of the Environment in Japan (1995)) Therefore, it is assumed that the chronic aquat ic toxicity of the dibromochloromethane used in various risk assessments of the aqueous environment uses the NOEC of 0.063 mg/L.MEPC 61/2/6 Annex, page 10

I:\MEPC\61\2-6.doc 2.2.2.2.3 Dichloromethane

32-d NOEC that targets the growth including the initial life stage of fish, Pimephales promelas

, was 82.5 mg/L (IPCS: EHC, 1996). Data on toxicity test for the crustacea and algae is not acquired. Therefore, it is assumed that the chronic aquatic toxicity of the dichloromethane used in various risk assessments of the aqueous environment uses the NOEC of 82.5 mg/L.

2.2.2.2.4 Monobromoacetic acid

There is data on the chronic toxicity that targets the breeding toxicity of crustacea, for example, Daphnia magna, and 21-d NOEC was 1.6 mg/L (ECOTOX Database 2010a). There was no data on fish and algae. Therefore, it is assumed that the chronic aquatic toxicity of the monobromoacetic acid used in various risk assessments of the aqueous environment uses the NOEC of 1.6 mg/L.

2.2.2.2.5 Dibromoacetic acid

Data (NOEC or MATC) on chronic toxicity of the dibromoacetic acid for fish, crustacea and algae is not acquired.

2.2.2.2.6 Tribromoacetic acid

Data (NOEC or MATC) on chronic toxicity of the tribromoacetic acid for fish, crustacea and algae is not acquired.

2.2.2.2.7 Dibromochloroacetic acid

Data (NOEC or MATC) on chronic toxicity of t he dibromochloroacetic acid for fish, crustacea and algae is not acquired.

2.2.2.2.8 Chloramines

Data (NOEC or MATC) on the chronic toxicity of the chloramine is not acquired.

2.2.2.2.9 Dibromoacetonitril

Data (NOEC or MATC) on chronic toxicity of the dibromoacetonitrile is not acquired.

2.2.2.3 Treated ballast water (G9: 5.2.3)

The chronic toxicity of the ballast water treated by using the prototype test of the BWMS has a value that the effect on algae ( Skeletonema costatum) in the brackish water condition according to Guidelines (G8) for land-based testing is the most sensitive one and 72h-NOEC is calculated to be 0.4% dilution. In brackish water test, growth inhibition on algae,

Skeletonema costatum , was observed in neutralization group with sodium sulfite addition. In the test, test water (treated water discharge: TWD) is prepared by dilution of the BWMS treated water (sodium sulfite injection concentration is 3 mg/L-FAC) to 10, 2, 0.4, 0.08 and 0.016%. Another test water (neutralization) is prepared by adding sodium sulfite to make 2 mg/L solution after diluting the treated water to 33v/v% with filtrated brackish water. In algae test, FAC in all the test water is below 0.01 mg/L. Regarding concentration of Relevant Chemicals in 10%-TWD and neutralization group, bromoform, dichloromethane

and chloramines are detected but others are not detected. The maximum detected concentrations of bromoform and dichloromethane during the algae test are 0.0013 mg/LMEPC 61/2/6 Annex, page 11

I:\MEPC\61\2-6.doc and 0.0002 mg/L each. Chronic toxic concentration (NOEC) of bromoform and dichloromethane are 4.8 mg/L and 82.5 mg/L each, as described before. The detected concentrations of the two chemicals are way below the chronic toxicity level, while chloramines are detected 0.2 mg/L in 10%-TWD group (less than 0.1 mg/L in neutralization group). The chronic toxic concentration of chloramines is not reported, but the detected concentration is 20 times as more as the acute toxicity level. Therefore, the effect on algae seems to be caused by the chloramines.

2.2.3 Endocrine disruption

2.2.3.1 Active Substance

The report that calcium hypochlorite shows the endocrine disruption for the aquatic is not acquired.

2.2.3.2 Relevant Chemicals

The report that the Relevant Chemicals such as bromoform, dibromochloromethane, dichloromethane, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, chloramines, and dibromoacetonitrile show the endocrine disruption for the aquatic is not acquired.

2.2.4 Sediment toxicity

2.2.4.1 Active Substance

The report that calcium hypochlorite has the sediment toxicity is not acquired. Calcium hypochlorite is an inorganic compound and although the half-life is changed depending on the conditions in water, it is rapidly degraded within several hours in seawater. Therefore, since calcium hypochlorite is not absorbed and accumulated in the sediment, it does not have sediment toxicity.

2.2.4.2 Relevant Chemicals

There was no information on the toxicity effect of all the Relevant Chemicals on the benthic zone. In addition, when it is determined based on methodology of the GESAMP-BWWG (MEPC 57/2/10, annex 4, paragraph 3.2.4), logP ow of the Relevant Chemicals are 2.4 (bromoform), 2.16 (dibromochloromethane), 1.25 (dichloromethane), 0.41 (monobromoacetic acid), 0.7 (dibromoacetic acid), 1.71 (tribromoacetic acid), 1.62 (dibromochloroacetic acid), and 0.47 (dibromoacetonitrile), and all of them are smaller than logPow of 3. Therefore, it is

not considered that bromoform shows the sediment toxicity. For chloramines, they exist in water and are subjected to the hydrolysis due to the physicochemical property. Both of them are not considered to show the sediment toxicity.

2.2.5 Bioavailability/biomagnification/bioconcentration

2.2.5.1 Active Substance

The information on bioavailability/biomagnifications/bioconcentration of calcium hypochlorite is not acquired. Calcium hypochlorite is an inorganic compound and although the half-life is changed depending on by the conditions in water, it is rapidly degraded within several hours. Therefore, for calcium hypochlorite, it is considered that the bioavailability/biomagnifications/

bioconcentration is low.MEPC 61/2/6 Annex, page 12

I:\MEPC\61\2-6.doc 2.2.5.2 Relevant Chemicals

Data on the biomagnification/bioconcentration of the bromoform is acquired by a test for the fresh water fish, cyprinus carpio . In the test that cyprinus carpio was exposed to the bromoform of 0.1 mg/L and 0.01 mg/L, respectively, for 6 weeks, the BCF was 7.1 to 21 and 7.7 to 19 (NITE, 2007). Therefore, it is determined that the possibility of biomagnification/bioconcentration is low. Further, if the logPow of the bromoform has a small value of 2.4, it meets the BCF very well.

For other Relevant Chemicals, it is determined that the possibility of the biomagnification/bioconcentration is low. The logPow and BCF of each chemical is; logPow=2.16, BCF=9 (dibromochloromethane), BCF=2.0 to 5.4 and less than 6.4 to 40 (dichloromethane), logPow=0.41, BCF=3.16 (monobromoacetic acid), logPow=0.7, BCF=3.16 (dibromoacetic acid), logPow=1.71 BCF=3.16 (tribromoacetic acid), logPow=1.62, BCF=3.16 (dibromochloroacetic acid), high solubility and reactivity (chloramines) and logPow=0.47, BCF=3.16 (dibromoacetonitrile).

2.2.6 Food web/population effects

2.2.6.1 Active Substance

Since calcium hypochlorite has the low bioconcentration and is rapidly degraded in water, the possibility of the effect on the living things (algae, invertebrates and fish) configuring the food-web and the population is not considered.

2.2.6.2 Relevant Chemicals

BCF of the Relevant Chemicals such as bromoform, dibromochloromethane, monobromoacetic acid, dibromoacetic acid, trib romoacetic acid, dibromochloroacetic acid

and dibromoacetonitrile are 21 or less. BCF of dichloromethane is less than 40 and considering other data possibility of bioconcentration is as low as other Relevant Chemicals.

And the bioconcentration of chloramines is not considered due to the high aqueous solubility and reactivity. Therefore, since the bioaccumulation for all the living things (algae, invertebrates and fish) configuring the food-web is low, the possibility of the effect on the food-web/population is low for all the Relevant Chemicals.

2.3 Data on Mammalian Toxicity (G9: 4.2.1.2)

2.3.1 Acute toxicity

2.3.1.1 Active Substance

LD 50 by oral administration of calcium hypochlorite to rat is 790 mg/kg bw (SIDS, 2004). No inhalation acute toxicity data of calcium hypochlorite is available. Inhalation of chlorine gas for 30 minutes gives LC 01 to be 122 ppm for mouse and 420 ppm for rat (SIDS, 2004). For human, it is shown that NOAEL of acute toxicity is 0.5 ppm (1.5 mg/m 3 ) as chlorine concentration from several researches on volunteers (SIDS, 2004).

2.3.1.2 Relevant Chemicals

LD 50 by oral administration of bromoform is 1400 to 1550 mg/kg bw in mouse and is 1147 to 1388 mg/kg bw in rat (IPCS, 2005).MEPC 61/2/6 Annex, page 13

I:\MEPC\61\2-6.doc For acute lethal action, bromoform is the lo west among bromine derived THM. Quantitative information was not acquired. Further, skin and ocular irritation, headache, dizziness, memory loss, loss of consciousness, c onvulsion, and pulmonary edema have been reported (US NLM: HSDB, 2003).

As an example of accidental ingestion, cent ral nervous system may be damaged which may induce a coma, areflexia, etc., and a small amount of bromoform leads to malaise, headache, and dizziness (ACGIH, 2001). Further, a case where human dies after oral ingestion of 143 mg/kg has been reported (U.S. NIOSH, 2002).

LD 50 by oral administration of dibromochlor omethane is 800 to 1,200 mg/kg bw in mouse and is 848 to 1,186 mg/kg bw in rat (ATSDR, 2005).

As the main symptom in the experimental animal after one-time oral administration, the central nervous system was damaged, includi ng liver and kidney failure (ATSDR, 2005).

LD 50 by oral administration of dichloromet hane is 1710 to 2250 mg/kg bw in mouse and LC 50 in inhalation exposure has 49100 to 55870 mg/m 3 in mouse, has 52000 mg/m 3 in rat, and has 40200 mg/m 3 in marmot (ICPS: EHC, 1996).

LD 50 by oral administration of monobromoacetic acid is 177 mg/kg bw in male rat (IPCS: EHC, 2000). LD 50 by endermatic application is 100 mg/kg bw in rat and is 59.9 mg/kg bw in rabbit (U.S.NLM: ChemIDplus, 2010).

LD 50 by oral administration of dibromoacetic acid is 1,737 mg/kg bw in male rat (IPCS: EHC, 2000).

Data on acute toxicity of tribromoacetic acid and dibromochloroacetic acid is not acquired.

LC 50 in inhalation exposure of trichloramine was 112 ppm (1 hour) in rat (U.S. NLM: ChemIDplus, 2010).

LD 50 by oral administration of dibromoacetonitrile to rodent was 245 to 361 mg/kg bw (WHO, 2004).

2.3.2 Effects on skin and eye

2.3.2.1 Active Substance

Although calcium hypochlorite generally is known to have corrosivity for skin, data is not acquired (SIDS, 2004). Hereinafter, it is considered that calcium hypochlorite is associated

with the mechanism of ocular irritation.

The critical effect of calcium hypochlorite on eye is estimated by calcium positive ion and alkaline of non-reactive calcium hydroxide (at 1%FAC pH = 12.0) of non-reactivity. Hypochlorite ion has a case where pH is dominantly inclined to alkaline, while chlorine mainly exists at pH4 or less. The reason is that chlorine concentration in water is generally represented as FAC (chlorine that can be used freely) (Cl 2 + HClO + ClO
- ). These are caused by dissolved gas chlorine or dissolved hypochlorite.) (SIDS, 2004).

Sensory organ irritation property of chlorine was evaluated by quantitatively reducing respiration rate after exposure for a short time in mouse and rat. In mouse, sensory organ irritation reaction was represented by 0.7 ppm (2.1 mg/m 3 ). After exposure for 60 minutes, 50% reduction concentration (RD 50 ) of number of respiration was 3.5 ppm (10.5 mg/m 3 ).MEPC 61/2/6 Annex, page 14

I:\MEPC\61\2-6.doc RD 50 of mouse exposed for 10 minutes was 9.3 ppm (27.9 mg/m 3 ). In rat and mouse, histological change due to the irritation after the exposure to chlorine of 9 ppm (27 mg/m 3 ) for 1, 3, 5 days mainly occurred in a nasal aperture and occurred in necrosis of epidermis, cell ablation, corrosion, ulceration squamous metaplasia (SIDS, 2004).

In general, a large amount of toxicity that is shown in repetitive inhalation and endermatic exposure is of substantially irritation property (SIDS, 2004).

2.3.2.2 Relevant Chemicals

For skin irritation, when bromoform repeated contacts to skin of rabbit, there were reports that moderate irritation shows (ACGIH, 2001). Further, for irritation to human, there was a red flare symptom and there was a possibility that irritation is absorbed into body through the skin (IPCS, 2005).

For ocular irritation, when bromoform undiluted solution is applied to the eye of rabbit, although moderate irritation was observed, there were reports that the irritation is recovered after 1 to 2 days. In addition, for ocular irritation of human, red flare symptom or pain is involved (IPCS, 2005).

For skin irritation, when dichloromethane of 0.5 ml is applied to rabbit in a half-closed manner for 24 hours, severe red flare and edema leading to necrosis and acanthosis were observed in both damaged skin and normal skin. Further, when dichloromethane of 0.5 ml is applied to rabbit in a closed manner for four-hour patch, although moderate irritation was observed regardless of whether there were other chlorinated solvents, there was no skin corrosivity (IPCS: EHC, 1996).

For ocular irritation, thickening of cornea, conjunctiva that leads to enhancement of intraocular pressure, moderate to severe inflammation of palpebra, and enhancement of intraocular pressure were observed in a test that drops a liquid dichloromethane of 0.1 ml to rabbit (in eyes of the rabbit). All the symptoms were reversible. The exposure of concentration of 17700 mg/m 3 shows light thickening of cornea and enhancement of intraocular pressure (IPCS: EHC, 1996).

Irritation of liquid dichloromethane to skin and eye is intermediate (IPCS: EHC, 1996).

Skin is immersed in chloramine aqueous solution having the concentration of 1 to 1000 mg/L for 10 minutes/day and hyperplasia of skin did not occur (IPCS: ECH, 2000). The test report on sensitization is not acquired.

Report on irritation of dibromochloromethane, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid and dibromochloroacetic acid to skin and eye is not acquired.

2.3.3 Repeated-dose toxicity

2.3.3.1 Active Substance

In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant Chemicals with a concentration of 0, 0.025, 0.05, 0.1, or 0.2 to 0.4% (NaClO) (equivalent to 0, 7, 14, 28, or 55 to 118 mg/kg bw/day) was administrated to rat for 13 weeks, although weight increase was suppressed in the maximum dose group in both male and female, histopathological change due to administration was not observed. From this, it was concluded that in the male, 0.1% NaClO (equivalent to 22.5 mg chlorine/kg bw/day) was NOAEL and in the female, 0.2% NaClO (equivalent to 55.6 mg chlorine/kg bw/day) was NOAEL (SIDS, 2004).MEPC 61/2/6 Annex, page 15

I:\MEPC\61\2-6.doc In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant Chemicals with a concentration of 0, 25, 100, 175, or 250 mg chlorine/L (chlorine solution) (male: 0, 3.5, 12.6, 19.5, or 24.9 mg chlorine/kg bw/day, female: 0, 2.1, 7.5, 12.8, or 16.7 mg chlorine/kg bw/day) was administrated to male and female rats for 90 days, it was concluded that the toxicity effect was not observed even in any administrated group and the maximum dose group (250 mg/L in drinking water, 17 to 25 mg/kg bw/day) is NOAEL (SIDS, 2004).

In a test in which drinking water including calcium hypochlorite and hypochlorite Relevant Chemicals with concentration of 0, 12.5, 25, 50, 100, or 200 mg chlorine/L (chlorine solution) (male: 0, 2.7, 5.1, 10.3, 19.8, or 34.3 mg chlorine/kg bw/day, female: 0, 2.8, 5.8, 11.7, 21.2, or 39.2 mg chlorine/kg bw/day) was administrated to male and female mice for 90 days, since the reduction in water ingestion dose was observed but the toxicity effect (the suppression of weight increase, the depression in organ weight, the depression in blood oxygen concentration) was not observed, it was concluded that 50 mg chlorine/L (10 to 12 mg chlorine/kg bw/day) was NOAEL (SIDS, 2004).

2.3.3.2 Relevant Chemicals

For the repeated-dose toxicity of bromoform, NOAEL that targets vacuolization of liver cell in forcible oral administration test using rat for 13 weeks is 25 mg/kg bw/day (IPCS: EHC, 2000).

According to ICSC, it is indicated that the central nervous system and liver are affected by the repeated inhalation of bromoform and there was a possibility to damage tissue.

For dibromochloromethane, NOAEL is 125 mg /kg bw/day (amended in the exposure situations: 89 mg/kg bw/day) (ATSDR, 2005).

For dichloromethane, it was confirmed that vacuolization of liver cell occurs in a male group of 166 mg/kg bw/day or more (ATSDR, 2000; IPCS: EHC, 1996).

For dibromoacetic acid, vacuolization of the liver cell was observed in a male group of 500 mg/L or more (U.S. NTP, 2007).

For chloramines, NOAEL is 50 mg/L (WHO, 2004) and for dibromoacetonitrile, NOAEL is 200 mg/L (WHO, 2004).

No reports are found on repeated-dose toxicity for monobromoacetic acid, tribromoacetic

acid and dibromochloroacetic acid.

2.3.4 Chronic toxicity

2.3.4.1 Active Substance

NOAEL of calcium hypochlorite on chronic to xicity is 22.5 mg chlorine/kg bw/day (SIDS, 2004).

2.3.4.2 Relevant Chemicals

In a test in which bromoform (solvent, cone oil) with a concentration of 0, 100, or 200 mg/kg bw/day and bromoform to mouse at a concentration of 0, 50, or 100 mg/kg bw/day was forcibly oral-administrated to rat for 103 weeks, fatty degeneration and chronic hepatic infiltration as nonneoplastic of liver were observed in the rat of male and female. Fatty degeneration was observed in the female mouse (IPCS, 2005).MEPC 61/2/6 Annex, page 16

I:\MEPC\61\2-6.doc In a test in which water including bromoform to F344 rat at a concentration of 0, 6.2, 29, or 57 mg/kg bw/day and to B6C3F1 mouse at 0, 8.3, 39, or 73 mg/kg bw/day for one year, since the effect on kidney (lesion of renal tubular and renal glomerulus) was mainly observed, it is described that the organ affe cted by bromoform is changed by solvent or dose method used in the test (IPCS, 2005).

NOAEL of dibromochloromethane is 40 mg/k g bw/day (amended in the exposure situations: 29 mg/kg bw/day) (ATSDR, 2005).

NOAEL of dichloromethane is 6 mg/kg bw/day (ATSDR, 2000).

As a result of drinking water dose of dibromoacetic acid of 0, 50, 500, or 1,000 mg/L (male: equivalent to 0, 2, 20, or 40 mg/kg bw/day, female: equivalent to 0, 2, 25, or 45 mg/kg bw/day) to Fischer 344 rat of male and female for two years, nephropathy was observed in all exposure groups and alveolar epithelium hyperplasia was observed in female group of 500 mg/L or more (U.S.NTP, 2007).

NOAEL of chloramines is 100 mg/L (male: equivalent to 9.8 mg/kg bw/day and female: equivalent to 10.6 mg/kg bw/day) (WHO, 2004).

No reports are found on chronic toxicity for monobromoacetic acid, tribromoacetic acid and

dibromoacetonitrile.

2.3.5 Developmental and reproductive toxicity

2.3.5.1 Active Substance

In a test in which a chlorine solution with a concentration of 0, 1, 2, or 5 mg/kg bw/day (as HClO) (0, 0.7, 1.4, or 3.5 mg/kg bw/day (with effective chloride concentration)) was forcedly oral-administrated to male Long-Evance rat from 56 days ago to 10 days later of mating and orally administrated to female Long-Evance rat during mating, pregnancy, and breast-dietary duration (up to a 21st day after delivery) 14 days before mating, suppression of weight increase or hermatological change, toxic symptom, or the like was not observed in parent animals (male and female) of the administrated group. Further, in the male, a reproductive system including a sperm morphology defect was not changed and even in the female, administration was not influenced with respect to the length of pregnancy duration. And so forth, there was no dose-dependent effect on a reproductive rate, an embryo survival, the number of a litter of embryos, weight of children born, an eye-opening day, etc., and an estral cycle or a vaginal opening day were not related to the administration in F1 (SIDS,2004).

In a test in which oral administration (drinking) of a chlorine (HClO) solution to a female SD rat with concentrations of 0, 0.7, 6.6, or 66 mg/L (with the effective chloride concentration) (equivalent to 0, 0.05, 0.5, or 5 mg/kg bw/day (with the effective chloride concentration)) during the pregnancy 2.5 months before conception and Cesarean section on the 20th day after the pregnancy was performed, there was no effect caused by the administration on the number of absorption embryos and embryo survival and ther e was no significant difference in occurrence frequency of skeletal abnormality and mutation between a control group and an administrated group. An embryonic weight has a slightly small value in a high-dose group (SIDS, 2004).

2.3.5.2 Relevant Chemicals

Concerning the developmental toxicity, in a test in which bromoform of 0, 50, 100, or 200 mg/kg bw/day was forcedly oral-administrated to a Sprague-Dawley rat (15 rats/groups) for 10 days including 6th to 15th days after the pregnancy of a Sprague-Dawley rat (15 heads/group) andMEPC 61/2/6 Annex, page 17

I:\MEPC\61\2-6.doc the outer shape, skeleton, and viscera of an embryo are observed by performing Caesarean operation at the end of pregnancy, the effects of the administration on the weight of a mother animal, the embryonic weight, and a pregnancy state are not recognized. The incidence of embryonic skeletal mutation (interparietal bone, ossifying delay of sternum core, and rib bone 14) has a tendency to increase, but the increase of visceral abnormality is not recognized. Further, it is reported that there is no effect of 50 mg/kg bw/day (Ruddick et al. , 1983).

In a test in which bromoform 150, or 200 mg/kg bw/day is forcedly oral-administrated to the F344 rat for 10 days including 6th to 15th days after pregnancy of an F344 rat, all embryos died in a dose in which toxicity is developed in the mother animal (Narotsky et al. , 1992).

Concerning the reproductive toxicity, bromoform of 50, 100, or 200 mg/kg bw/day is forcedly oral-administrated to male and female pairs of 20 sets of Swiss CD-1 mice for 105 days and in a test result for reproductive rate of mouse (fertility rate per pair, em bryonic survival, weight, sexed imbalance, etc.), no effect of bromoform is observed (Ruddick et al. , 1983). In a test in which bromoform of 1, 50, 100, or 200 mg/kg bw/day is forcedly oral-administrated to ICR mice (17 to 20 mice/group) for one week before mating, during 14-week continuous mating, and for three weeks thereafter (breeding is continuous up to mating and delivery of F2), suppression of weight increase was observed in males, a decrease of kidney weight, and an increase of liver weight can be observed in males and female of the 200 mg/kg bw/day group in F1, but no effect on fertility was observed (Gulati et al. , 1989).

Concerning the developmental toxicity, in a test in which dibromochloromethane of 0, 50, 100, or 200 mg/kg bw/day was forcedly oral-administr ated to the rat during 6th to 15th days after the pregnancy, the weight increase of the mother animal was suppressed, but embryonic abnormality or mutation was not observed (WHO, 2005).

Concerning the reproductive toxicity, a second-generation reproductive toxicity test (equivalent to average ingestion dose of 0, 17, 171, or 685 mg/kg bw/day) in which drinking water containing dibromochloromethane with a concentration of 0, 0.1, 1.0, or 4.0 mg/mL was administrated to male and female ICR-Swiss mice was performed and a conception rate (the number of pregnant animals/the number of mating animals × 100) and a pregnancy rate (the number of stomachs where children born exist/the number of pregnant animals × 100) decreased in a high-dose group with respect to the F1 generation and the conception rate decreased in the high-dose group of the F2 generation. Between both the F1 and F2 generations, the number of a litter of embryo s, a survival rate, a feeding rate (the number of weaning babies/the number of surviving babies × 100), and the weight of a child born decreased in the high-dose group. No effect of dominant lethality or teratogenicity was observed in the F1 or F2 generation (WHO, 2005).

Concerning the developmental toxicity, in an i nhalation exposure test of dichloromethane of a concentration of 1,250 ppm (4,400 mg/m 3 ) to the SD rat or Swiss mouse on 6th to 15th days after the pregnancy, an increase of a CO-Hb value, an increase of liver weight was observed in mothers of the rat and the mouse, and an extensive increase of the pelvis of the kidney and ossifying delay of sternum in the embryo of the rat, and over sternum could be observed in the embryo of the mouse, but an increase of the number of developments of abnormality was not recognized. In an inhalation test of 4500 ppm (16,250 mg/m3) to LE rat for 21 days before pregnancy and for 17 days after pregnancy, abnormality of embryo was not observed. Furthermore, in the rat, even when a dose in which suppression of the weight of the mother animal is observed is forcedly oral-administrated during 6th to 15th days after the pregnancy, effect on the embryo was observed and abnormality was not appeared on mixed food dosage (IPCS: EHC, 1996).MEPC 61/2/6 Annex, page 18

I:\MEPC\61\2-6.doc Concerning the reproductive toxicity, after inhalati on exposure of dichloromethane of 0, 100, 500, or 1,500 ppm (0, 350, 1,770, or 5,300 mg/m 3 ) to male and female rats (F344 and F0) for 14 weeks (6 hours/day and 5 days/week), which were mated, dichloromethane was exposed even to babies born (F1) for 17 weeks and in a test which F2 is acquired by mating, fertility potential, the number of births per one mother animal, a rearing situation of the baby, and survival rate are examined and according to a result of performing a histopathological test, abnormality up to the maximum exposure concentration (1,500 ppm) to all of F0, F1 (parent), F1, and F2 (baby) was observed (IPCS: EHC, 1996).

In a test in which monobromoacetic acid of 0 and 100 mg/kg bw/day is forcedly oral-administrated to the male SD rat once and the male SD rat was killed in 2 or 14 days after the administration, no effect caused by t he administration was observed in a histological examination of a genital organ weight, the number of sperms, a sperm shape, a fatality rate, and a seminiferous tubule. Further, even in a test in which monobromoacetic acid of 0 and 25 mg/kg bw/day is forcedly oral-administrated to the male rat for 14 days, no effect on the genital organ was observed (WHO, 2004).

In a test in which dibromoacetic acid of 0, 10, 30, 90, or 270 mg/kg bw/day is forcedly oral-administrated to the male SD rat for 14 days, histopathological evidences of sperm discharge abnormality including a decrease of the number of sperms each with a head part, and an abnormal acrosomal development of a step-15 sperm cell and discharge delay of a step-19 sperm cell was observed in a 10 mg/kg bw/day-or more group. A decrease of the number of sperms each with a tail part, a deterioration of motility of the sperm, and an increase in occurrence frequency of an abnormal form of the sperm tail part was observed in a 90 mg/kg bw/day-or more group. A decrease in testicular weight and epididymis weight and an increase of head part abnormality of the sperm in a testis was observed in a 270 mg/kg bw/day group (WHO, 2004).

In a test in which dibromoacetic acid of 0, 2, 10, or 50 mg/kg bw/day is forcedly oral-administrated to the male SD rat for 79 days, the male SD rat lives together with an untreated female one to one on 30th to 37th days and 49th to 56th days among 79 days, and the male SD rat lives together with the untreated females one (male) to two (female) on 65th to 71st days, no change, caused by the adm inistration, of the administration can be the number of heads of propagable males, the number of a litter of embryos, an embryo weight, and the number of implantations was observed. In a group in which the male SD rat lives together with the untreated female one (male) to two (female), a mating frequency during a mating period decreased and the number of babies born of the female decreased with a concentration of 10 mg/kg bw/day or more. Further, at autopsy of the male's genital organism, degeneration of the seminiferous tubule in a 10 mg/kg bw/day or more groups was observed. From this result, NOAEL is 2 mg/kg bw/day (WHO, 2004).

In a test in which water containing dibromochloroacetic acid is orally administrated to the male and female SD rats with concentrations of 0, 500, or 1500 ppm (male and female's average ingestion dose of dibromochloroacetic acid: equivalent to 0, 51, 89, or 112 mg/kg bw/day), a decrease of a water ingestion dose was observed in the male and female of a 1000 ppm-or more group and suppression weight increase was observed in 150 ppm of a non-pregnant female rat of a 150 ppm group. A decrease in sperm speed and a decrease in the maximum value of amplitude of lateral head displacement (ALH) were observed in the male of a 1500 ppm group (BrdU untreated) of the male. Meanwhile, in the BrdU-treated rat, an LI (labelling index) increased in the liver of the male of and the liver and kidney of the female of the 1500 ppm group. However, a histological change of the corresponding organism in the group was not observed. Further, in the pregnant rat, the reproductive toxicity was not observed and increase of the abnormality or mutation was not also observed (U.S. NTP, 2000).MEPC 61/2/6 Annex, page 19

I:\MEPC\61\2-6.doc Data on the developmental toxicity of chloramines is not acquired. Concerning the reproductive toxicity, in a test in which monochloramine of 0, 2.5, 5.0, or 10 mg/kg bw/day is forcedly oral-administrated to the male and female Long-Evans rats during the pregnant period and breast-feeding period from 66 to 76 days before the mating, there was no effect on the breeding potential, survival rate, the number of a litter of embryos, the average weight of children born, and the eye-opening day, which is caused by administrating test chemicals. Monochloramine has no effect on the sperm shape, a sperm's motion capability, etc., of the male and genital organism weights and autopsy of the genital organism of the male and female were also normal. From the result, NOAEL is 10 mg/kg bw/day (WHO, 2004).

Concerning the developmental toxicity, in a test in which dibromoacetonitrile of 0, 50 mg/kg bw/day was forcedly oral-administrated to the female Long-Evans rats on 7th to 21st days after the pregnancy, suppression of weight increase of the mother animal was observed, embryonic absorption of dibromoacetonitrile increased, and the weight of the embryo had a low value in a 50 mg/kg group. From the result, LOAEL using mother animal toxicity and embryonic absorption increase rate as an i ndication is 50 mg/kg bw/day (WHO, 2004).

Concerning the reproductive toxicity, in a test in which dibromoacetonitrile is drinking-administrated to the male and female SD rats with concentrations 0, 0.015, 0.050, or 0.15 g/L (male: equivalent to 0, 1.4, 3.3, or 8.2 mg/kg bw/day and female: equivalent to 0, 1.9, 5.3, or 10.8 mg/kg bw/day) for 34 days and the pregnancy period for the male and from 6th day after the pregnancy to 1st day after delivery for the female, no effect on the weight of the mother animal, autopsy, and the number of embryos which absorbing dibromoacetonitrile, which was caused by adminis tration was observed. There was no effect on the weights, sex ratio, and survival rate of children born, and the number of a litter of embryos in the administrated group. A distance between the anus and the genitals on the 1st day after the delivery was normal. From the result, NOAEL is 8.2 mg/kg bw/day for male and 10.8 mg/kg bw/day for female (WHO, 2004).

Test report on developmental and reproductive toxicity of tribromoacetic acid is not acquired.

2.3.6 Carcinogenicity

2.3.6.1 Active Substance

The carcinogenicity of calcium hypochlorite is assessed by reporting a drinking administration test by hypochlorous acid (SIDS, 2004).

Concerning the oral administration, a drinking administration test in which hypochlorous acid with concentrations of 0, 7, 140 or 275 mg/L is administrated to male and female B6C3F1 mice and F344 rats is performed and in the result, the development rate of the tumour does not increase. However, in the female rat, there is no dosage dependence, but the development frequency of mononuclear cell leuk aemia increased in medium and high dose groups. However, there was no significant difference in a death case due to the leukaemia between the control group and the administrated group (SIDS, 2004; U.S. NTP, 1992).

Further, before publication of the test result by the NTP, the International Agency for Research on Cancer (IARC) classifies calcium hypochlorite as group 3 (not classifiable as to carcinogenicity to humans) (IARC, 199l).

2.3.6.2 Relevant Chemicals

Concerning the carcinogenicity of bromoform, although the development rate of the tumour for mouse does not increase in the oral administration test, a significant difference in the increase of the development rate of the large intestine tumour was recognized in only a highMEPC 61/2/6 Annex, page 20

I:\MEPC\61\2-6.doc dose of 200 mg/kg bw/day administrated to the rat. Further, since there is no data on human carcinogenicity and a limited evidence cannot be acquired from the animal, the IARC classifies bromoform as group 3 (not classifiabl e as to carcinogenicity to humans). Further, concerning the carcinogenicity of bromoform, the U.S. EPA uses a linearized multi-stage cancer model (LMS) as a non-threshold carcinogens substance with genetic toxicity and calculates a slope factor of 7.9 × 10 -3 (mg/kg) -1 of an excessive cancer risk caused by oral ingestion according to a test result of the female rat (adenomatous polyps and adenocarcinoma of the large intestine (U.S. EPA, IRIS 2005).

When dibromochloromethane of 0, 40 or 80 mg/kg bw/day was forcedly oral-administrated to male and female Fischer 344 rats for 2 years (5 days/week), the tumour of which the development rate significantly increases was not observed in any part (WHO, 2005).

When dibromochloromethane of 0, 50 or 100 mg/kg bw/day was forcedly oral-administrated to male and female B6C3F1 mice for 2 years (5 days/week), a significant increase of liver cell cancer in the 100 mg/kg bw/day group of the male was recognized and the development

rate of liver cell adenoma and the liver cell adenoma or cancer significantly increased even in the 100 mg/kg bw/day group of the female (WHO, 2005).

Further, the IARC classifies the dibromochloromethane as group 3 (not classifiable as to carcinogenicity to humans, the carcinogenicity for the human cannot be evaluated) (IARC, 1991a). U.S. EPA classifies it as C (possibility carcinogenicity to human) (U.S. EPA IRIS, 1992).

In a test in which dichloromethane of 0, 2000 or 4000 ppm was inhaled and exposed to male and female B6C3F1 mice for 102 weeks (6 hours/day and 5 day/week), shortening of the lifespan of both the male and female mice due to carcinogenesis of lung and liver was observed. In each exposure group including the control group, an increase of dose-dependent development of bronchoalveolar cancer was observed in both the male and female mice. Although the frequency of development of liver cell adenoma or liver cell cancer in the control group was high for the male mouse, the devel opment of liver cell adenoma or liver cell cancer increased in a dose-dependent manner for the female mouse. In the exposure group to dichloromethane, an increase in the total number of developed cancers per an entity with the developed cancer in both the lung and the liver was observed (U.S. NTP, 1986).

In a test in which dichloromethane with concentrations of 0, 1000, 2000 or 4000 ppm was inhaled and exposed to male and female F344/N rats B6C3F1 mice for 102 weeks (6 hours/day and 5 days/week), mammary gland tumour and fibroadenoma increase in the dose-dependent manner in both the male and female rats and subcutaneous fibroma around mammary gland and fibrosarcoma (for the only male rat) also increased. Tumour nodule of liver and the liver cell cancer slightly had a tendency to increase in the female rat, while the tendency was not present in the male rat. Further, in the male rats of all groups including the control group, the survival rate of the male rat was low at the time when the exposure period is terminated and a lot of deaths occurred within 16 weeks before the exposure period is terminated. In the test, it was considered that the reason why the death rate was high was that mononuclear leukaemia including the control group is developed at high rates (U.S. NTP, 1986).

In a test in which dichloromethane of concentrations of 0, 50, 200 or 500 ppm was exposed to whole bodies of male and female SD rats for 2 years (6 hours/day and 5 day/week), an increase of hepatocyte vacuolation was observed in the male and female in the 500 ppm group and an increase of multinuclear hepatocyte was observed in the female and positive mammary gland tumour is developed at a de velopment rate as high as a spontaneous development rate. Further, a malignant tum our was not observed (IPCS: EHC, 1996).MEPC 61/2/6 Annex, page 21

I:\MEPC\61\2-6.doc Further, U.S. EPA (1995) calculates an oral slope factor as 7.5 × 10 -3 (mg/kg) -1 , a unit risk in drinking as 2.1 × 10 -7 ( μ g/L) -1 , and a unit risk in the inhalation exposure as 4.7 × 10 -7 (μg/m3) -1
(U.S. EPA, IRIS 1995). Furthermore, IARC classifies dichloromethane as group 2B (IARC, 1999b), ACGIH does as A3 (unknown for human but confirmed carcinogenicity for animal) (ACGIH, 2009), Japan Society for Occupational Health does as Group 2 (probably carcinogenicity to human with not enough proof) (J. of Occupational Health, 2009), U.S. EPA does as B2 (enough proof for carcinogenicity to animal; not enough proof for epidemiological research) (U.S.EPA IRIS, 1993), and U.S.NTP does as R (expected to be carcinogenic to human) (U.S.NTP, 2002).

In a test in which a drink containing dibromoacetic acid of 0, 50, 500 or 1000 mg/L (male: equivalent to 0, 2, 20, or 40 mg/kg bw/day and female: equivalent to 0, 2, 25, or 45 mg/kg bw/day) was administrated to the male and female F344/N rats for 2 years, cystic degeneration of the liver increased in a full exposure male group. Further, mononuclear cell leukaemia was significantly increased in a male of the 50 and 500 mg/L male groups and a female of the 1000 mg/L female group (U.S. NTP, 2007).

In a test in which a drink containing dibromoacetic acid of 0, 50, 500 or 1000 mg/L (male: equivalent to 0, 4, 45, or 87 mg/kg bw/day and female: equivalent to 0, 4, 35, or 65 mg/kg bw/day) was administrated to the male and female B6C3F1 mice for 2 years, liver tumour was developed in male and female exposure groups and a significant increase

of the liver cell adenoma and the liver cell adenoma or cancer (binding form) was observed in the male of the full exposure group and the female of the 500 mg/L-or more group. Hepatoblastoma increased in the male of the 500 mg/L-or more groups and the liver cell cancer increased in the male of the 1000 mg/L group and the female of 500 mg/L groups. Although pneumocyte adenoma increased in both the male and the female, in particular, it significantly increased in the male of the 500 mg/L group (U.S. NTP, 2007).

Further, the international organizations do not assess the carcinogenicity of dibromoacetic

acid.

IARC classifies chloramines as group 3 (Not cl assifiable as to carcinogenicity to humans) (IARC, 2004). Further, U.S. EPA classifies monochloramine as D (Not classifiable as to carcinogenicity to humans) (U.S. EPA IRIS, 1993).

IARC assesses dibromoacetonitrile as group 3 (Not classifiable as to carcinogenicity to humans) (IARC, 1999).

The test report on carcinogenicity of monobromoac etic acid, dibromochloroacetic acid and tribromoacetic acid is not acquired. Further, international organizations do not assess the carcinogenicity of the three bromoacetic acids.

2.3.7 Mutagenicity/genotoxicity

2.3.7.1 Active Substance

When in vitro , chlorine/hypochlorous acid solution may have a certain kind of mutagenicity,

while in vivo , it is concluded that chlorine/hypochlorous acid solution does not have mutagenicity (SIDS, 2004).

2.3.7.2 Relevant Chemicals

For bromoform, in vitro test, in a DNA-damaging test using a CHL cell and a CHO cell and the chromosome aberration test, opposite positive and negative results of genetic toxicity was observed. Further, in the DNA-damaging using the bacteria, the mutagenic test, theMEPC 61/2/6 Annex, page 22

I:\MEPC\61\2-6.doc chromosome aberration test using fungus, and a genetic mutation test using a mouse lymphoma cell, the positive result was observed. Furthermore, in vivo test, the positive result was acquired in the SCE test using the mouse and the micronuclear test, such that bromoform is considered to be chemicals having the genetic toxicity (Anderson et al ., 1990; Fujie et al ., 1990, Hayashi et al ., 1988, LeCurieux et al ., 1995, Matsui et al ., 1989, Mirsalis

et al ., 1989, Myhr et al ., 1990; NTP, 1989; Pereira et al ., 1982, Rapson et al ., 1980; Simmon

et al ., 1977, Simmon and Tardiff, 1978, Stocker et al ., 1997, Zeiger, 1990).

For Dibromochloromethane, in an in vitro test system, there are both a report that genetic mutation was induced in salmonella typhimurium and a report that the genetic mutation was not induced and the genetic mutation was induced in the mouse lymphoma cell (L5178Y), while the genetic mutation was not induced in yeast. The sister chromatid exchange was induced in a human lymphoid cell of the human, a rat liver cell, and a rat erythroblastic leukaemic cell, chromosome aberration was induced in the mouse lymphoma cell (L5178Y) and the Chinese hamster lung cell, and DNA strand cleavage was induced in a human acute lymphoblastic leukaemia cell, but the DNA strand cleavage was not induced in primary hepatocytes of the rat (ATSDR, 2005).

In an in vivo test system, the system chromatid exchange was induced in oral-administrated

bone marrow of the mouse and the chromosome aberration was induced in oral-administrated or intraperitoneally administrated bone marrow of the marrow, but micronuclear was not induced in intraperitoneally administrated bone marrow of the mouse, unscheduled DNA synthesis was not induced in oral-administrat ed liver of the rat, and the DNA strand cleavage was not induced in the liver, kidney, and duodenum (ATSDR, 2005).

For dichloromethane, in the in vitro test system, the genetic mutation was induced in salmonella typhimurium regardless of the metabolic activation system. In the Chinese hamster lung cell (V79), the genetic mutation was not induced under non-existence of the metabolic activation system, but a slight increase of the frequency of the sister chromatid exchange was recognized. In the Chinese hamste r ovary cell (CHO), the sister chromatid exchange was not induced. Although cross- link formation between DNA and protein was induced in a liver cell of a mouse having a GSTT1 gene function, it was not induced in the lung cell of the mouse, the liver cell of t he hamster, and the lung cell of the hamster (IPCS: EHC, 1996).

In the in vivo test system, in the inhalation exposure test to the mouse, the sister chromatid exchange was induced in the lung cell and slight micronuclear induction in peripheral blood erythrocyte was recognized, but the sister chromatid exchange micronuclear and chromosome aberration were not induced in the bone-marrow cell in oral, intraperitoneal, or subcutaneous administration to the mouse. Further, in drosophila, sex-linked recessive lethal mutation is not induced (IPCS: EHC, 1996).

For monobromoacetic acid, in the in vitro test system, the positive was induced in an S9 additive system of the genetic mutation test using TA98 and TA100 of salmonella typhimurium and the DNA damaging was induced in the mouse leukaemia cell, but the negative was observed in SOS chromo test using Escherichia coli and a micronuclear test using red blood cells of newt (US NLM: HSDB, 2010; WHO, 2004).

For dibromoacetic acid, in the in vitro test system, the positive was observed in TA100 of the genetic mutation test using salmonella typhimurium and in TA98, the negative was observed. Further, in the SOS chromo test using Escherichia coli , the positive was observed, but in the micronuclear test using the red blood cells of newt, the negative was observed (WHO, 2004).MEPC 61/2/6 Annex, page 23

I:\MEPC\61\2-6.doc In the in vivo test system, in a test in which dibromoacetic acid was drinking-administrated to male and female mice for 3 months and peripheral blood erythrocyte was examined,

induction of micronuclear was observed in the male and it was not observed in the female (U.S. NTP, 2007).

For tribromoacetic acid, in the in vitro test system, in the genetic mutation test using salmonella typhimurium , the positive was observed, but even in the SOS chromo test using

Escherichia coli , the positive was observed (IPCS: EHC, 2000).

For monochloramine, in the in vitro test system, in the genetic mutation test using salmonella typhimurium , the slightly positive or negative was obs erved and in the genetic mutation test using the mouse lymphoma cell, the positive was observed as the S9 additive-free system (WHO, 2004).

In the in vivo test system, in the micronuclear test using the intraperitoneally administrated bone marrow cell of the mouse and the chromosome aberration test, the negative was

observed and even in the micronuclear test usi ng the oral-administrated marrow cell of the mouse, the negative was observed (WHO, 2004).

According to these results, monochloramine may show the mutagenicity in the in vitro system, but does not show the significant mutagenicity in the in vivo system (WHO, 2004).

For dibromoacetonitrile, in the in vitro test system, in the genetic mutation test using salmonella typhimurium , the negative was observed and in the SOS chromo test using

Escherichia coli , the DNA damaging shows an equivocal result (WHO, 2004).

In the in vivo test system, in both the micronuclear test in the oral administration to the mouse and the DNA binding test in the oral administration to the rat, the negative was observed (WHO, 2004).

Data on mutagenicity/genetic toxicity of dibromochloroacetic acid is not acquired.

2.3.8 Toxicokinetics

2.3.8.1 Active Substance

Data on toxicokintetics of calcium hypochlorite is not acquired.

2.3.8.2 Relevant Chemicals

In the test in which bromoform is forcedly oral-administrated to the rat, bromoform is rapidly absorbed and distributed to the liver, brain, kidney, and fatty tissue. Up to 8 hours after the administration, 67% and 4% of the administrated dose are discharged as unchanged bromoform and carbon dioxide, in the expired br eath, respectively. Only 4% is discharged through the urine and a remaining dose in the tissue is low as 2%. Meanwhile, in the mouse, up to 8 hours after the administration, appr oximately 6% and approximately 40% of the administrated dose are discharged as unchanged bromoform and carbon dioxide, in the expired breath, respectively. Further, 5% is discharged through the urine and a remaining dose in the tissue is 8% (IARC, 1999a).

In general, trihalomethane is rapidly absorbed and primarily metabolized into carbon dioxide, and thereafter, rapidly discharged. Among them, it is considered that bromoform has comparatively low toxicity and carcinogenicity by determination from the animal test. As one of the causes, it is considered that since bromoform is comparatively lipophilicity, biological availability is low (IPCS, 1996; NTP, 1989).MEPC 61/2/6 Annex, page 24

I:\MEPC\61\2-6.doc According to a result in which dibromochloromethane was forcedly oral-administrated to the rat with 100 mg/kg and the mouse with 150 mg/kg, the rat discharged 18% as carbon dioxide and 48% as unchanged dibromochloromethane and the mouse discharged 72% as carbon dioxide and 12% as unchanged dibromochloromethane in the expired breath. Radioactive activations which remain in principal organs of the rat and the mouse main were 1.4% and 5.0%, respectively, and both the rat and the mouse discharged less than 2% through the

urine. The half-life of the dibromochloromethane was 1.2 hours in the rat and 2.5 hours in the mouse (WHO, 2005).

Inhaled dichloromethane is rapidly absorbed in the lung or digestive tract and most of dichloromethane is discharged as unchanged dichloromethane in the expired breath. The rest other than unchanged dichloromethane is metabolized as carbon oxide, carbon dioxide, and inorganic chloride. In the case of high-concentration exposure, except for the metabolism, metabolism including glutathione transferase (GST) is made and dichloromethane including GST is metabolized to carbon dioxide through formaldehyde and formic acid. This route operates when oxidative metabolic route is saturated (IPCS: EHC, 1996).

When dibromoacetic acid is forcedly oral-administrated to the rat, it is estimated that blood

concentration reaches the maximum in 1 hour after the administration and dibromoacetic acid is rapidly absorbed. Although body distribution is unclear, protein binding or accumulation in blood cells by intracavernous administration is not recognized. It is anticipated that dibromoacetic acid is metaboliz ed as glyoxylic acid from the in vitro test result, etc., and furthermore, metabolized as glycolate, oxalate, glycine, and carbon dioxide and rapidly discharged. Further, dibromoacetic acid has placental permeability and is detected as high as plasma concentration of the mother animal even in embryonic blood plasma, but is not detected in breast milk (WHO, 2004).

Monochloramine oral-administrated to the rat is rapidly absorbed in the digestive tract. In the human, most of monochloramine ingested from dr ink reaches the stomach, but monochloramine loosened from the stomach does not enter a body circulation system. In 5 days after the administration, chloride ions are detected from whole blood, skin, testis, etc. Monochloramine is metabolized as chloride ions and primarily discharged to the urine (WHO, 2004).

Although data on the biological fate of dibromoacetonitrile is not acquired, after dichloroacetonitrile is orally administrated to the rat and the mouse, dichloroacetonitrile is absorbed in the digestive tract through verification in the feces.

It is known that halogenated acetonitrile is formed in vivo after chlorinating water is ingested,

such that dichloroacetonitrile and dibromoacetonitrile were detected from the stomach of the rat after sodium hypochlorite/potassium bromi de was orally administrated. It is probably considered that dichloroacetonitrile and dibromoacetonitrile are produced by reacting with organic compounds in the stomach (WHO, 2004).

Data on toxicokintetics of monobromoacetic acid , tribromoacetic acid and dibromochloroacetic acid is not acquired.

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 Active Substance

Calcium hypochlorite, which is the Active Substance, is dissociated into calcium and hypochlorite ions in water and the hypochlorite ion is rapidly degraded. The rate of degradation is influenced by temperature, pH, light and impurities (metal, salt).MEPC 61/2/6 Annex, page 25

I:\MEPC\61\2-6.doc Calcium hypochlorite solution is very sensitive to light, such that phase transition and degradation are caused by direct sunlight and thus chlorine and oxygen are produced. In atural waters, hypochlorite ions and chlorine molecules are unstable due to existence of inorganic and organic matter. The half-life of hypochlorite in the water is considered to be less than 2 hours by inorganic degradation and photolytic degradation (SIDS, 2004).

Since calcium hypochlorite is an inorganic substance, biodegradability cannot be measured. In water, a degradation by-product of calcium hypochlorite is calcium chloride in the presence of organic substances (SIDS, 2004).

2.4.1.2 Relevant Chemicals

It is estimated that when the conditions allow for long-term acclimation at low concentrations, bromoform can be biodegraded. Furthermore, it is estimated that even under anaerobic conditions, when the concentration of bromoform is low, bromoform is biodegraded. Furthermore, since bromoform does not have chem ical binding, which is easily hydrolyzed, bromoform is not hydrolyzed in a water environment (NITE, 2007, Tabak et al ., 1981, Bouwer and McCarty, 1983b).

In water, dibromochloromethane is comparativel y stable, the hydrolysis rate constant is

estimated to be 3.2 × 10 -11 /sec, and the hydrolysis half-life is reported to be 274 years (ATSDR, 2005).

Under aerobic conditions, the biodegradability is low (10 to 15%). However, there is a possibility that the degradation rate will slightly increase after the acclimation of the bacteria. Furthermore, under anaerobic conditions, dibromochloromethane is slowly degraded by methanogenic bacteria (ATSDR, 2005).

It is reported that dichloromethane is difficult to hydrolyze in natural environmental waters and the shortest hydrolysis half-life is 18 months. Since dichloromethane does not absorb light having a wavelength of 290 nm or greater, even though dichloromethane is exposed to sunlight for 1 year or more, dichloromethane is not photodegraded in surface waters (NEDO, 2005).

In an aerobic biodegradation test using a modified culture bottle for volatile substances according to the Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances, the degradation rate of dichloromethane by following biological oxygen demand (BOD) is 13% under test conditions substrate of 100 mg/L, activated sludge concentration of 30 mg/L, and time period of 4 weeks, by which dichloromethane was determined to be persistent. Furthermore, using a gas chromatograph (GC) for measurement, the degradation rate was only 1%. On the other hand, it is reported that under natural environmental conditions, the biodegradation rate increases. It is also reported that in the test using anaerobic bacteria, the degradation half-life was 11 days (NEDO, 2005). Dichloromethane was fully degraded in a sewage treatment plant (activated sludge process) for 6 hours to 7 days. Furthermore, it is reported that an elimination rate in the sewage treatment plant was 95% (volatilization: 2.6% and bioconversion: 92.4%) (NEDO, 2005).

From the above, it is considered that dichloromethane can be biodegraded under natural environmental conditions, anaerobic conditions and at sewage treatment plant, but not be biodegraded in practical environment.

Since monobromoacetic acid has no hydrolytic substituent, monobromoacetic acid is not considered hydrolyzed in the environment (US NLM: HSDB, 2010a).MEPC 61/2/6 Annex, page 26

I:\MEPC\61\2-6.doc In an OECD TG301D (closed bottle) test with monobromoacetic acid at a concentration of 2 mg/L using acclimated sludge, 82% of monobromoacetic acid was degraded. In another report using not-acclimated sludge, however, monobromoacetic acid was said to have no biodegradability (US NLM: HSDB, 2010a).

Since dibromoacetic acid has no hydrolytic substituent dependency, dibromoacetic acid is not considered hydrolyzed in the environment (US NLM: HSDB, 2010).

Although data of biodegradability is limitative, in a test using dibromoacetic acid of a concentration of 5 mM as a carbon source, halogenated compounds were produced at 30 ° C after 10 days (US NLM: HSDB, 2010).

Since tribromoacetic acid has no hydrolytic substituent, tribromoacetic acid is not considered hydrolyzed in the environment (US NLM: HSDB, 2010i).

In a test using tribromoacetic acid of a concentration of 0.1 w/v-% as the carbon source, halogenated compounds were produced at 30 ° C after 20 days, but growth of bacteria was not recognized (US NLM: HSDB, 2010).

Although information on degradability of dibromochl oroacetic acid was not acquired, it is considered that hydrolysis and biodegradation of dibromochloroacetic acid does not occur (or is very slow), as is also the case for halogenated acetic acid having a similar structure.

In water, chloramine compounds (mono, di, and trichloroamine) hydrolyze and vanish away very rapidly. When chloramines are hydrolyzed in water, the number of chlorines decreases and other chloramine forms are formed (CEPA, 2001).

In water, dibromoacetonitrile is hydrolyzed by a basic catalyst or chlorine, even though no data is available on biodegradation. It is reported that the half-life of the hydrolysis is 2 days at a pH of 8.7. In tap water, it is reported that the concentration of dibromoacetonitrile decreased to 20 to 50% during delivery of the water (US NLM: HSDB, 2010f).

2.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

2.4.2.1 Active Substance

Bioaccumulation of calcium hypochlorite can be disregarded due to its aqueous solubility and reactivity. Further, hypochlorite ions are found in living bacteria (SIDS, 2004).

In addition, since calcium hypochlorite is the inorganic matter, an octanol/water partition coefficient is not applied.

2.4.2.2 Relevant Chemicals

In a test for cyprinus carpio, BCF of bromoform is 21 at a maximum (NITE, 2007) and it is determined that bromoform does not have the bioaccumulation. Further, a value of logPow of bromoform is small as 2.4, which dovetails well with the result.

BCF of Dibromochloromethane is estimated to be 9 from the octanol/water partition coefficient (logPow = 2.16) and it is considered that the bioaccumulation is low (US NLM: HSDB, 2010).MEPC 61/2/6 Annex, page 27

I:\MEPC\61\2-6.doc In a 6-week bioconcentration test using cyprinus carpio of the Law Concerning the Examination and Regulation of Manufacture, etc. , of Chemical Substances, the concentration rates of dichloromethane in water concentrations of 0.25 mg/L and 0.025 mg/L are 2.0 to 5.4 and less than 6.4 to 40, respectively, and it is determined that dichloromethane has no or low bioconcentration (NEDO, 2005).

BCF of monobromoacetic acid is estimated to be 3.16 from the octanol/wa ter partition coefficient (logPow = 0.41) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010).

BCF of dibromoacetic acid is calculated to be 3.16 from the octanol/water partition coefficient (logPow = 0.70) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010e).

BCF of tribromoacetic acid is calculated to be 3.16 from the octanol/water partition coefficient (logPow = 1.71) and it is considered that bioaccumulation is low (US NLM: HSDB, 2010i).

BCF of dibromochloroacetic acid is calculated to be 3.16 from the octanol/water partition coefficient (logPow = 1.62) and it is considered that bioaccumulation is low (SRC, 2009).

Bioaccumulation of chloramines is not considered due to high aqueous solubility and reactivity of chloramines.

BCF of dibromoacetonitrile is estimated to be 3.16 from the octanol/water partition coefficient (logPow = 0.47) and it is considered that the bioaccumulation is low (US NLM: HSDB, 2010).

2.4.3 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh water)

When ballast water is treated in Kuraray AS as the Preparations, which uses calcium hypochlorite as a main component, 9 chemicals are produced as Relevant Chemicals (see section 2.1.3). Data including the identifications of persistence of the chemicals is organized

in Table 2.4-1.

In addition, calcium hypochlorite of the Active Substance does not correspond to the persistence (see section 2.4.1.1), either.

Table 2.4-1: Persistence and identification of principal degradation product

Method Result Reference/Comments/Justification for missing data

Bromoform N/A Persistent Section 2.4.1.2.1; not hydrolyzed. Under partial anaerobic conditions, it is further degraded, but it is difficult to be biodegraded under the aerobic environment.

Dibromochloromethane N/A Persistent ATSDR 2005, Section 2.4.1.2.2

Dichloromethane N/A Persistent NEDO 2005, Section 2.2.1.2.3

Monobromoacetic acid N/A Persistent US NLM: HS DB 2010a, Section 2.4.1.2.4

Dibromoacetic acid N/A Persistent US NLM: HS DB 2010e, Section 2.4.1.2.5

Tribromoacetic acid N/A Persistent US NLM: HS DB 2010i, Section 2.4.1.2.6

Dibromochloroacetic acid N/A Persistent Section 2.4.1.2.7

Chloramine N/A Easily degraded CEPA 2001, Section 2.4.1.2.8

Dibromoacetonitrile N/A Persistent Section 2.4.1.2.9

N/A: Not Available.MEPC 61/2/6 Annex, page 28

I:\MEPC\61\2-6.doc 2.4.4 Reaction with organic matter

2.4.4.1 Active Substance

Free available chlorine rapidly reacts with the inorganic matters and the organic matters in natural water and chlorinated/oxidized by-product such as chloramine or chloromethane is produced (SIDS, 2004).

Calcium hypochlorite reacts with dissolved organic matters in the water and produces various halogenated by-products. They incl ude trihalomethane type (THMs), halogenated acetic acid type (HAAs), halogenated acetonitrile type (HANs), chloral hydrate, chloropicrin, etc. (IPCS, EHC, 2000). Calcium hypochlorite reacts by three routes in the water; oxidation, reaction-addition and reaction-substitution reactions. Since chlorine ions are easily substituted with bromine ions in the water, inorganic matters in which chloride, bromide, or both chlorine and bromine are substituted are produced (IPCS, EHC, 2000).

2.4.4.2 Relevant Chemicals

Bromoform as a kind of THM is produced w hen hypobromous acid which is an intermediate product reacts with the organic substances in a THM precursor. Since bromoform itself is structurally stable, bromoform does not react with the organic matters.

Further, it is considered that since dibrom ochloromethane, dichloromethane, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, chloramine (monochloroamine, dichloroamine, or trichl oroamine), and dibromoacetonitrile have a stable chemical structure, they do not react with the organic matters.

2.4.5 Potential physical effects on wildlife and benthic habitats

2.4.5.1 Active Substance

Calcium hypochlorite is hydrolyzed and lost just after it is infused into the water. For this reason, it is determined that there is no physical effect on the wildlife or benthic habitats.

2.4.5.2 Relevant Chemicals

As the aqueous solubility of bromoform is 0.1 g/100 mL and at a maximum discharge concentration of 0.101 mg/L (sections 1.2 and 3.2.3), it is considered that bromoform is dissolved in the water. Accordingly, it is determined that the potential physical effect is low. Meanwhile, since bromoform has high volatility, some bromoform is diffused to vapour, but the diffusion concentration is lower than a background concentration in the atmosphere, so that it is determined that the potential and physical effects of bromoform are low.

It is considered that dibromochloromethane and dichloromethane are volatile and some parts of them are distributed from water into air, while halogenated acetic acids, chloramines and dibromoacetonitrile have low volatile pressure (less than 1 mmHg) and high water solubility (more than 1g/L) and mostly remain in water. Therefore, it is determined that there is no physical effect on the wildlife or benthic habitats.

2.4.5.3 Treated ballast water

In the ballast water treated by the system, the Relevant Chemicals might be produced, but they all have no potential effect on the wildlife or benthic habitats. Furthermore, in the BWMS, when FAC in the discharged ballast water is more than 0.2 mg/L, the ballast water isMEPC 61/2/6 Annex, page 29

I:\MEPC\61\2-6.doc neutralized in sodium sulfite and discharged. Therefore, it is determined that the ballast water discharged from the BWMS has no potential and physical effect on the wildlife or

benthic habitats.

2.4.6 Potential residues in seafood

2.4.6.1 Active Substance

As described in section 2.4.1.1, it is considered that calcium hypochlorite is rapidly degraded in the water and its half-life is several hours. Further, general consumers' ingestion of calcium hypochlorite through the food chain due to residual in see food is not considered due

the chemical structure.

2.4.6.2 Relevant Chemicals

It is determined that all Relevant Chemicals produced in the BWMS are not accumulated in the seafood according to solubility in the water and the octanol/water partition coefficient.

2.4.7 Known interactive in effects

2.4.7.1 Active Substance

Calcium hypochlorite is rapidly degraded in the water, but at the same time, THMs, HAAs, and HANs are produced by reaction with the organic matters.

2.4.7.2 Relevant Chemicals

Bromoform as a comparatively stable chemic al is persistent under the aerobic condition, while bromoform is bio-degraded in methane bacteria or denitrifying bacteria under the

anaerobic condition.

Other Relevant Chemicals are also the comparatively stable chemicals and some of them are bio-degraded under the naturalization condition.

2.5 Physical and chemical properties for the Active Substances and Preparations and treated ballast water, if applicable (G9: 4.2.1.4)

2.5.1 Melting point

Melting points of Active Substances and Relevant Chemicals are listed in complete dossier.

2.5.2 Boiling point

Boiling points of Active Substances and Relevant Chemicals are listed in complete dossier.

2.5.3 Flammability

Flammability of Active Substances and Relev ant Chemicals is listed in complete dossier.

2.5.4 Density (relative density)

Density (relative density) of Active Substances and Relevant Chemicals is listed in complete

dossier.MEPC 61/2/6 Annex, page 30

I:\MEPC\61\2-6.doc This is the system in which calcium hypochlorite used as the Active Substance infused to reach an FAC concentration of 2 mg/L in the ballast water as FAC. Further, calcium hypochlorite infused into the ballast water reacts in the water to produce the Relevant Chemicals and at the same time, to be rapidly degraded. For this reason, treatment of the ballast water by the BWMS does not change the density (relative density) of the treated

ballast water.

2.5.5 Vapour pressure, vapour density

Vapour pressure and vapour density of Active S ubstances and Relevant Chemicals is listed in complete dossier.

2.5.6 Water solubility/dissociation constant

Water solubility, dissociation constant of Active Substances and Relevant Chemicals is listed in complete dossier.

2.5.7 Oxidation/reduction potential

Oxidation/reduction potential of Active Subst ances and Relevant Chemicals is listed in complete dossier.

Although the oxidation/reduction potential of the treated ballast water is changed by existence of calcium hypochlorite, calciu m hypochlorite is degraded and reduced as time elapses, so that the concentration of the ballast water is restored to a concentration before

the treatment.

2.5.8 Corrosivity to the materials or equipment of normal ship construction

Corrosivity to the materials or equipment of normal ship construction of Active Substances and Relevant Chemicals is listed in complete dossier.

There is a possibility that calcium hypochlorite as the Active Substance and the Relevant Chemicals used in this system have corrosivity. It is considered that the treated ballast water has no effect on a shipís hull, taking into consideration of a residual concentration of calcium hypochlorite and concentrations of produced Relevant Chemicals. Furthermore, according to a result of a performed corrosion test, it is assessed that a corrosion effect on coating in the ballast tank is negligible.

2.5.9 Auto-ignition temperature

Auto-ignition temperature of Active Substances and Relevant Chemicals is listed in complete

dossier.

2.5.10 Explosive properties

Explosive properties of Active Substances and Relevant Chemicals are listed in complete

dossier.

2.5.11 Oxidizing properties

Oxidizing properties of Active Substances and Relevant Chemicals are listed in complete

dossier.MEPC 61/2/6 Annex, page 31

I:\MEPC\61\2-6.doc 2.5.12 Surface tension

Surface tension of Active Substances and Relevant Chemicals is listed in complete dossier.

2.5.13 Viscosity

Viscosity of Active Substances and Relevant Chemicals is listed in complete dossier.

2.5.14 Thermal stability and identity of relevant breakdown products

Thermal stability and identity of relevant breakdown products of Active Substances and Relevant Chemicals is listed in complete dossier.

2.5.15 Reactivity toward container material

There is a possibility that calcium hypochlorite used as the Active Substance basically have corrosivity. Accordingly, a material used in a chemical infusion unit adopts SUS316L, PVC, and PTFE by considering the corrosivity.

2.5.16 pH

A change of pH of the ballast water treated by the BWMS decreases and pH of the treated ballast water is restored as time elapses.

2.5.17 Salinity

In the BWMS, since calcium hypochlorite is infused into ballasting water, the salinity of the treated ballast water is not changed.

2.5.18 TOC, DOC, % particulate matter

Calcium hypochlorite used as the Active Substance reacts with the organic matters and serves to make them inorganic. Further, when calcium hypochlorite resides with the FAC concentration of 0.2 mg/L or more in passing water while it is discharged, calcium hypochlorite is neutralized with sodium su lfite and then discharged. Furthermore, this system performs filtration treatment. Accordi ngly, TOC, DOC, and particulate matters in the ballast water reduce at discharge.

2.5.19 Other known relevant physical or chemical hazards

Other known relevant physical or chemical hazards of Active Substances and Relevant Chemicals are listed in complete dossier.

A safety measure including removal through neutralization with sodium sulfite is performed even when the FAC concentration is 0.2 mg/L or more while the treated ballast water is discharged, so that there is no concern of physical or chemical hazards.

2.6 Analytical Methods at Environmentally Relevant Concentration (G9: 4.2.1.5)

Table 2.6-1 shows a measurement method of calcium hypochlorite used as the Active Substance and an analytic method of Relevant Chemicals.MEPC 61/2/6 Annex, page 32

I:\MEPC\61\2-6.doc Table 2.6-1: Analytical methods at environmentally relevant concentrations

of Active Substances and Relevant Chemicals

Chemical name Method A pplicability Sensitivity Reference/

Comments/

Justification for missing data

Calcium hypochlorite (FAC) DPD absorptionmetric

method In liquids 0.01 mg/L Water test method *

Bromoform PT-GC/MS method

or HS-GC/MS

method In liquids 0.0001 mg/L Water test method *

Dibromochloromethane PT-GC/MS method

or HS-GC/MS

method In liquids 0.0001 mg/L Water test method *

Dichloromethane PT-GC/MS method

or HS-GC/MS

method In liquids 0.0001 mg/L Water test method *

Monobromoacetic acid Solvent extraction ñ derivatization ñ gaschromatographicmass spectrometric

assay In liquids 0.0001 mg/L Notification No.261 of 2003 Ministry of Health, Labour and

Welfare

Dibromoacetic

acid Solvent extraction ñ derivatization ñ gaschromatographicmass spectrometric

assay In liquids 0.0001 mg/L Notification No.261 of 2003 Ministry of Health, Labour and

Welfare

Tribromoacetic

acid Solvent extraction ñ derivatization ñ gaschromatographicmass spectrometric

assay In liquids 0.0001 mg/L Notification No.261 of 2003 Ministry of Health, Labour and

Welfare

Dibromochloroacetic

acid Solvent extraction ñ derivatization ñ gaschromatographicmass spectrometric

assay In liquids 0.0001 mg/L Notification No.261 of 2003 Ministry of Health, Labour and

Welfare

Chloramine DPD absorptiometric

method In liquids 0.01 mgL Water test method *

Dibromoacetonitrile Gaschromatographicmass spectrometric

assay In liquids 0.001 mg/L Water test method *

* Water analysis manual published by Japan Water Works Association.

3 USE OF THE ACTIVE SUBSTANCE

3.1 Outline of Kuraray Ballast Water Management System

The BWMS consists of a combination of a filtration and a disinfection processes.MEPC 61/2/6 Annex, page 33

I:\MEPC\61\2-6.doc 3.1.1 Filtration process

The filtration process of the BWMS includes a filtration unit, which removes sediment particles. Following an automated program, the filtration unit regularly performs back-flushing by which long-term operation is possible free of filter clogging. By the back-flushing process, sediment, aqueous microorganisms, etc., that are caught on the filters

are returned to the sea area from which the ballast water was drawn.

3.1.2 Disinfection process

Following filtration, the water is treated by the disinfection process that infuses the Active

Substance. Active Substance used in the BWMS is KURARAY AS that contains calcium hypochlorite as the main component.

3.1.3 Disinfection component

Hypochloric acid is called free active chlorine (FAC) and has a strong disinfection effect. The BWMS treats seawater using an FAC concentration of 2 mg/L. FAC is often used as a disinfectant in the field of water treatment. FAC is added to drinking water or pools in many countries, therefore its safety has been confirmed.

Thus it is an advantage that the BWMS uses FAC to disinfect microorganisms in seawater. The seawater treated by the BWMS including the filtration process and the disinfection process satisfies the regulation D-2 of the BWM Convention.

3.2 The manner of application (G9: 4.2.6 and 7)

3.2.1 Maximum dosage concentration of KURARAY AS

Calcium hypochlorite is infused so that its concentration at the time of the infusion into the ballast water becomes 2 mg/L as FAC. The infusion dose of calcium hypochlorite is automatically controlled in proportion to the flow rate of the ballast water to maintain the FAC concentration at 2 mg/L.

3.2.2 Holding time

The holding time in the ballast tank after the treatment is not set. The reason is that when the FAC concentration in the discharged ballast water exceeds 0.2 mg/L, the FAC concentration is adjusted to 0.2 mg/L or less by the neutralization process prior to being discharged.

3.2.3 The maximum allowable discharge concentrations of the Relevant Chemicals

The concentration of the FAC and the Relevant Chemicals that are included in the treated water are measured in accordance with the toxicity test described in sections 6.2 and 6.3 of the basic assessment report. In the toxicity test, the treated water with calcium hypochlorite (added to a FAC concentration of 2 mg/L) is diluted to 10 v/v% Therefore, the maximum allowable discharge concentrations of the Relevant Chemicals (listed below) are at present ten times higher than the concentrations measured by the toxicity test (at 10 v/v%. In addition, as described above, calcium hypochlorite (the Active Substance) becomes 0.2 mg/L (as FAC) or less by the time of deballast, and the maximum allowable discharge concentration of FAC is 0.2 mg/L. See below:MEPC 61/2/6 Annex, page 34

I:\MEPC\61\2-6.doc Calcium hypochlorite (FAC): 0.2mg/L

Bromoform: 0.101 mg/L

Dibromochloromethane: 0.002 mg/L

Dichloromethane: 0.062 mg/L

Monobromoacetic acid: 0.003 mg/L

Dibromoacetic acid: 0.04 mg/L

Tribromoacetic acid: 0.05 mg/L

Dibromochloroacetic acid: 0.03 mg/L

Monochloroamine: 0.2 mg/L (as chloromines)

Dichloroamine: 0.2 mg/L (as chloromines)

Trichloroamine: 0.2 mg/L (as chloromines)

Dibromoacetonitrile: 0.02 mg/L

3.2.4 Handling, use, storage and transport of the chemicals

3.2.4.1 Calcium hypochlorite

3.2.4.1.1 Handling

At the time of handling, a worker wears goggle-type protective glasses, a dust respirator, and protective gloves made of rubber in addition to protective clothing such as long sleeves and long pants.

3.2.4.1.2 Storage and transport

Storage and transporting according to the recommendation of P & I International Group for transportation by ship (November 11, 1999, and November, 2000) are handled as follows:

.1 Avoid direct sunlight and maintain separation from residential areas. Transport in a drum and limit the packaging unit net weight to a maximum of 45 kg;

.2 If the external temperature exceeds 35 ° C, stored in a place where there are ventilation facilities; and

.3 Do not mix chlorinated isocyanuric acid (organic bleaching powder), reducing chemicals, flammable chemicals and acids.

3.2.4.1.3 Use

Calcium hypochlorite is stored as a powder and dissolved in seawater immediately before infusion. Thereafter, calcium hypochlorite is infused into the ballast pipe so that the FAC concentration becomes 2 mg/L.MEPC 61/2/6 Annex, page 35

I:\MEPC\61\2-6.doc 3.2.4.2 Sodium sulfite

3.2.4.2.1 Handling

At the time of handling, a worker wears goggle-type protective glasses, a dust respirator, and protective gloves made of rubber in addition to protective clothing such as long sleeves and long pants.

3.2.4.2.2 Storage and transport

A well-ventilated dry place shall be used for storage and direct sunlight must be avoided during transport and storage.

3.2.4.2.3 Use

Sodium sulfite is stored as a powder and is dissolved at the time of deballast. When the residual FAC concentration exceeds 0.2 mg/L at the time of deballast, the sodium sulfite is automatically infused into the deballast line.

3.2.5 Procedures and use of the system

At the time of filling ballast water, seawater is fed from the sea chest by operation of the ballast pumps to the filtration unit to remove sediments and larger planktons. Then in the chemical infusion unit Active Substance (calcium hypochlorite) is infused into the ballast line at a FAC conccentration of 2 mg/L.

At the time of deballasting, the residual FAC concentration is monitored by chlorine meters. When the residual FAC concentration is 0.2 mg/L or less, the discharge is performed as it is.

The residual FAC concentration is confirmed again just before being discharged.

When the residual FAC concentration is higher than 0.2 mg/L, the neutralization process is operated. In chemical infusion unit, sodium sulfite is infused into the deballast line. The FAC concentration is monitored again to be 0.2 mg/L or less just before being discharged.

3.2.6 Risk management measures in case of emergency

Generally, fire is one major problem considered on a ship. The risk is avoided by performing the following measures in case of fire.

When fire occurs in compartments in which calcium hypochlorite is stored, since there is a possibility of generating toxic gas such as chlorine, the protective equipment for fire extinction including self-contained respirator is prepared. The chemicals and the circumference thereof are water-sprinkled with a large amount of seawater and then cooled.

When fire occurs in compartments in which the sodium sulfite is stored, since there is a possibility of generating toxic gas such as sulfur oxide, etc., protective equipment including self-contained respirators are made available. The powder fire extinguisher is used for fire

extinction.

In the case of any circumference fire, the chemical is rapidly moved to a separate place.MEPC 61/2/6 Annex, page 36

I:\MEPC\61\2-6.doc 3.2.7 Other safety measures

Chemicals are stored appropriately. Opening and closing procedure of the valves of the filtration unit is conducted with safety measures to avoid malfunction.

When abnormalities in flow rate, pressure, etc., are detected, the alarm is issued immediately and the entire system automatic ally performs an emergency stop. Furthermore, when the emergency stop button of each device is pressed on the site, the entire system is shutdown.

Control of the BWMS is performed in the main control unit and various kinds of abnormal information are displayed on the main control unit. When an abnormality occurs, two kinds of signals, alarm and warning, can be generated. In the case of a warning, the yellow lamp of the main control unit is lighted and the abnormal conditions are displayed. In the case of the alarm, the red lamp of the main control unit is lighted and the abnormal conditions are displayed and the system immediately stops.

In the BWMS, when an alarm is issued, since the entire system stops immediately, which affects the ballast loading and unloading on the ship, adequate treatment is performed when a warning is issued.

3.2.8 Control of discharged water

When the residual FAC concentration in the discharged ballast exceeds 0.2 mg/L, it is automatically neutralized by the sodium sulf ite. When the residual FAC concentration is 0.2 mg/L or less, it is discharged as it is.

3.2.9 Control of the waste and recycling

In the filtration process, the sediment and the aqueous micro-organisms, and the like, which are generated by backflushing the filter, are discharged to the sea area where the ballast was originally drawn.

When signal that shows the lifespan of the filter is coming to the end is on, the ballast treatment is stopped and the filter exchange is immediately performed. The exchanged and used filter is incinerated on land or on a ship according to general waste treatment methods.

4 MATERIAL SAFETY DATA SHEETS

MSDS relating to each of Kuraray AS, which is an Active Substance and Kuraray NS, which is a neutralizer is shown in appendix 1 of the complete dossier.

5 RISK CHARACTERIZATION

5.1 Screening for Persistence, Bioaccumulation and Toxicity (G9: 5.1)

5.1.1 Persistence (G9: 5.1.1.1)

Since calcium hypochlorite, which is an Active Substance, has a very short half-life in water as described in section 2.4.1.1 of this Basic Assessment Report, it has no persistence.

Meanwhile, in the case of the Relevant Chemical s, as described in section 2.4.3 of this Basic Assessment Report, chloramines among nine c hemicals has no persistence, while eight substances including bromoform, dibromochlor omethane, dichloromethane, monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, and dibromoacetonitrile have persistence.MEPC 61/2/6 Annex, page 37

I:\MEPC\61\2-6.doc 5.1.2 Bioaccumulation (G9: 5.1.1.2)

Calcium hypochlorite, which is an Active Substance, does not cause the bioaccumulation due to high water solubility and reactivity as described in section 2.4.2.1 of this Basic Assessment Report.

Further, none of the nine Relevant Chemicals causes the bioaccumulation from their water-octanol partition coefficient and BCF.

5.1.3 Toxicity test (G9: 5.1.2.3)

The toxicity is determined using a chronic toxicity value of NOEC < 0.01 mg/L. Since calcium hypochlorite, which is an Active Substance, has the NOEC of 0.005 mg TRC/L, it has toxicity.

However, among the Relevant Chemicals, since bromoform, dibromochloromethane, dichloromethane, monobromoacetic acid have NOEC of more than 0.01 mg/L, they have no toxicity.

Meanwhile, no chronic toxicity test value can be found in respect to five chemicals including dibromoacetic acid, tribromoacetic acid, dibromochloroacetic acid, chloramines, and dibromoacetonitrile. As a result, these five chemicals are treated to have toxicity. (see section 2.2.2)

5.1.4 Do the KURARAY AS and Relevant Chemicals meet all three criteria for PBT?

From the above-mentioned result, the PBT of the Active Substances and Relevant

Chemicals is shown as Table 5.1-1. The Active Substances and the Relevant Chemicals of the BWMS do not correspond to the PBT substances.

Table 5.1-1: PBT of Active Substances and Relevant Chemicals

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n)

PBT criteria Half-life: > 60 days in marine water, or > 40 days in freshwater,* or > 180 days in

marine sediments, or > 120 days in

freshwater

sediments Experimentally

determined BCF > 2,000, or if no experimentally BCF has been determined, log Pow; 3 Chronic

NOEC < 0.01 mg/L Reference/

Comments/

Justification for missing

data

Calcium hypochlorite N N Y

Bromoform Y N N

Dibromochloromethane Y N N

Dichloromethane Y N N

Monobromoacetic acid Y N N

Dibromoacetic acid Y N Y

Tribromoacetic acid Y N Y

Dibromochloroacetic acid Y N Y

Chloramine N N Y

Dibromoacetonitrile Y N Y 5.1.1-5.1.3MEPC 61/2/6 Annex, page 38

I:\MEPC\61\2-6.doc 6 EVALUATION OF THE TREATED BALLAST WATER

6.1 Test of the treated ballast water for the Basic Approval

6.1.1 Outline of the tests

The performed tests are acute and chronic toxicity tests on aquatic organisms, a corrosion test, and a degradation test of FAC.

6.1.2 Test equipment

The test equipment consists of prototype land- based test equipment having a treatment flow rate of 960 L/h as shown in Figure 6.1-1.

Figure 6.1-1: Schematic diagram of small-scale set-up for Kuraray Ballast Water Management System

6.1.3 Quality control

Of the tests performed, the toxicity tests (acute and chronic toxicity tests) on aquatic organisms were conducted in accordance with "OECD Principles of Good Laboratory Practice (GLP)" (1997) under the quality control Institute of Environmental Ecology, IDEA Consultants, Inc., which has ISO/IEC 17025 (JIS Q 17025) accreditation.

The corrosion test was performed by the National Maritime Research Institute, based on ISO 9001 of Laboratory of Aquatic Science Consultant Co., Ltd. and QAPP conform to

ISO/IEC 17025.

The degradation test was performed by Kuraray Co., Ltd., independently.MEPC 61/2/6 Annex, page 39

I:\MEPC\61\2-6.doc 6.2 Acute toxicity test (G9: 5.2.2)

The test was performed in accordance with Guidelines (G8) for the seawater and brackish

water conditions.

The test consists of following three parts; a growth inhibition test on algae Skeletonema

costatum , an acute toxicity test on gammaridea Hyale barbicornis and an acute toxicity test

on fish Oryzias javanicus . These aquatic organisms are all marine species.

The results of acute toxicity test on ballast water were summarized in Table 6.2-1.

In accordance with Guidelines (G8) for land-based testing, the test under brackish water conditions showed the most sensitive effect on the algae, Skeletonema costatum , in which

ErC 50 was calculated as 5.8% dilution. FAC in the exposed water was less than 0.01 mg/L. In addition, under brackish water conditions, the growth inhibition on the algae, Skeletonema

costatum was observed in the neutralization group where test water was neutralized by adding 2.0 mg/L of sodium sulfite to 33% (v/v)-diluted TWD.

The growth inhibition is considered to be attributed to the chloramines (bonded chlorine). This effect, however, lasts very short as chlo ramines degrades quite rapidly. We will conduct necessary tests to confirm the chloramines effect and degradation for Final Approval.

No toxic effects on crustacea and fish were observed in 10% diluted-TWD and neutralized-TWD groups.

Table 6.2-1: LC 50 and ECr 50 and maximum concentration of Active Substance (FAC) upon exposure in toxicity test of ballast water treated by prototype test equipment

Test

water Max. concentration of FAC (mg/L) Fish: Oryzias javanicus (96h-LC 50 ) Crustacea: Hyale

barbicornis (96h-LC 50 ) Algae:

Skeletonema

costatum (72h-ErC 50 ) Algae

Skeletonema

costatum 0.01mg/L

Crustacea Hyale

barbicornis 0.01mg/L

Seawater

Fish Oryzias javanicus 0.02mg/L > 10% > 10% > 10%

Algae

Skeletonema

costatum <0.01mg/

L

Crustacea Hyale

barbicornis <0.01mg/

L Brackish

Water

Fish Oryzias javanicus 0.02mg/L > 10% > 10% 5.8%

* In the Table, acute toxicity values were expr essed as dilution rate of discharged ballast water. Maximum concentration of chloramines on algae test was 0.02 mg/L (10% dilution).MEPC 61/2/6 Annex, page 40

I:\MEPC\61\2-6.doc 6.3 Chronic toxicity test (G9: 5.2.1)

The test was performed in accordance with Guidelines (G8) for the seawater and brackish

water conditions.

The test consists of following three parts; a growth inhibition test on algae Skeletonema

costatum (same test performed in acute toxicity test), a chronic toxicity test on gammaridea Hyale barbicornis and a chronic toxicity test on fish Oryzias javanicus . These aquatic organisms are all marine species.

The results of chronic toxicity test on ballast water, which was treated by the prototype test equipment of the BWMS, were summarized in Table 6.3-1. The acute toxicity test on growth inhibition of algae stated in section 6.2 can also be a chronic toxicity test as life cycle of algae

is short time.

According to the results of the chronic toxicity test, it showed the most sensitive effect on the algae, Skeletonema costatum , and 72h-NOEC was calculated as 0.4% dilution. FAC in the exposed water was less than 0.01 mg/L. In additi on, under brackish water conditions, the growth inhibition on the algae, Skeletonema costatum was observed in the neutralization group, where test water was neutralized by adding 2.0 mg/L of sodium sulfite to 33% (v/v)-diluted TWD.

The growth inhibition is considered to be attributed to the chloramines (bonded chlorine) as stated in section 6.2. This effect, however, lasted very short as chloramines degraded quite rapidly. We will conduct necessary tests to confirm the chloramines effect and degradation for Final Approval.

No toxic effects on crustacea and fish were observed in 10% diluted-TWD and neutralized-TWD groups.

Table 6.3-1: NOEC and maximum concentration of Active Substance (FAC) upon exposure in toxicity test of ballast water treated by prototype test equipment

Test water Max. concentration of FAC in

No Observed Effect Test Water Case (mg/L) Fish: Oryzias javanicus (28day-NOEC) Crustacea: Hyale

barbicornis (21day-NOEC) Algae:

Skeletonema

costatum (72h-NOEC) Algae

Skeletonema

costatum <0.01mg/L

Crustacea Hyale barbicornis 0.02mg/L Seawater

Fish Oryzias javanicus 0.02mg/L 10% 10% 2%

Algae

Skeletonema

costatum <0.01mg/L

Crustacea Hyale barbicornis 0.02mg/L Brackish

water

Fish Oryzias javanicus 0.02mg/L 10% 10% 0.4%

* In Table, chronic toxicity (NOE C) was expressed as a ratio of discharged ballast water to test water. Maximum concentration of chloramines on algae test was 0.02 mg/L (10% dilution).MEPC 61/2/6 Annex, page 41

I:\MEPC\61\2-6.doc 6.4 Corrosion test

The influence of calcium hypochlorite (Kuraray AS) used in the ballast water management system that is under development by KURA RAY CO., LTD. on coating degradation under the environment of seawater and brackish water is investigated, and the results are used as the basic application data for Basic Approval. Here, the evaluation is carried out on the safer side by setting the concentration of the added calcium hypochlorite at a concentration (free active chlorine, FAC, concentration: 3 mg/L) higher than the charged concentration (FAC concentration: 2 mg/L) in the operation of Kuraray Ballast Water Management System.

It has been clarified that the influence of an Active Substance on ballast tank coating in the ballast water management system is limited even in the light of acceptance criteria of PSPC and that the influence thereof on the ballast tank protection performance and a service life is negligible.

6.5 Mode of Degradation

Degradation of FAC concentration in the system is determined. Calcium hypochlorite was infused into the system in the toxicity test to adjust the concentration of FAC to 2 mg/L and the FAC concentrations were measured for up to 120 hours by DPD method. Test water was adjusted in accordance with Guidelines (G8) for the seawater and brackish water conditions, and then passed through the filtration unit of the system. The water was stored in a dark room at four kinds of temperatures, 5, 10, 20 and 30°C.

The results under seawater and brackish water conditions are shown in Figures 6.5-1 and 6.5-2, respectively.

Degradation rate was generally higher in the brackish water and lower in the seawater. The degradation rate was higher at a higher temperature.

At 5°C under the seawater condition it had the lowest degradation rate. Even though a half-life, at which the concentration decreases from 2 mg/L upon infusion to 1 mg/L, was about 15 minutes, which is fast enough.

From the test results, it was suggested that the neutralization with sodium sulfite, which is operated when concentration of FAC is more than 0.2 mg/L, will be performed only in the case when deballasting is operated in a short period of time at a lower temperature.

0. 0 0. 2 0. 4 0. 6 0. 8 1. 0 1. 2 1. 4 1. 6 1. 8 2. 0

0 20 40 60 80 100 120

El

apsed ti m e hrFAC conc.mg/L 30 °C

20 °C

10 °C

5 °C

Figure 6.5-1: Time-dependent change of FAC concentration of treated ballast water

under seawater conditionsMEPC 61/2/6 Annex, page 42

I:\MEPC\61\2-6.doc 0. 0 0. 2 0. 4 0. 6 0. 8 1. 0 1. 2 1. 4 1. 6 1. 8 2. 0

0 20 40 60 80 100 120

Elapsed tim eFAC conc.mg 30 °C

20 °C

10 °C

5 °C

Figure 6.5-2: Time-dependent change of FAC concentration of treated ballast water

under brackish water conditions

6.6 Determination of holding time

In the system, the holding time of the ballast tank is not specified.

6.7 Risk characterization and analysis

6.7.1 Reaction with organic matter (G9: 4.2.1.3)

In order to examine the reaction between organic materials and calcium hypochlorite infused into the system, the concentrations of various chemicals were analysed using the toxicity test on aquatic organism. The results are shown in Table 2.1-2. Consequently, production of the following chemicals was confirmed, and they were considered relevant for risk assessment:

.1 bromoform,

.2 dibromochloromethane,

.3 dichloromethane,

.4 monobromoacetic acid,

.5 dibromoacetic acid,

.6 tribromoacetic acid,

.7 dibromochloroacetic acid,

.8 chloramines (monochloroamine, dichloroamine or trichloroamine), and

.9 dibromoacetonitrile.

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

Details about the decomposition of Active Substances and Relevant Chemicals in biotic and

abiotic environments are described in section 2.4.1.MEPC 61/2/6 Annex, page 43

I:\MEPC\61\2-6.doc In the BWMS, where the concentration of FAC is more than 0.2 mg/L upon deballasting, neutralization with sodium sulfite is to be performed to reduce the concentration to 0.2 mg/L or lower prior to discharge.

6.8 Prediction of Discharge and Environmental Concentrations

Prediction Environmental Concentration (PEC) of calcium hypochlorite and the Relevant Chemicals that were contained in ballast water discharged from the BWMS was calculated by using the MAMPEC model ver. 2.0 as applied to the Port of Tokyo.

Maximum discharge concentration of FAC is 0.2 mg/L. Maximum allowable discharge

concentration of Relevant Chemicals are described in section 3.2.3. Table 6.8-1 show

calculated PEC of each chemical.

Table 6.8-1(1): Calculation results of PEC using the MAMPEC model ver. 2.0 for the designated sea area

PEC of calcium hypochlorite (FAC: μg/ L)

Maximum concentration 0.020

95% concentration 0.0203 Average concentration 0.0129

Median concentration 0.0127

Minimum concentration 0.00278

Table 6.8-1(2): Calculation results of PEC using the MAMPEC model ver. 2.0 for the designated sea area

PEC of Relevant Chemicals (μg/L)

Bromoform Dibromochloromethane Dichloromethane

Maximum concentration 0.0114 0.000199 0.00512

95% concentration 0.0105 0.000182 0.00479 Average concentration 0.00668 0.000115 0.00290

Median concentration 0.00663 0.000114 0.00278

Minimum concentration 0.00145 0.0000247 0.000614

Table 6.8-1(3): Calculation results of PEC using the MAMPEC model ver. 2.0 for the designated sea area

PEC of Relevant Chemicals (μg/L)

Monobromoacetic

acid Dibromoacetic

acid Tribromoacetic

acid

Maximum concentration 0.000348 0.00468 0.00591

95% concentration 0.000322 0.00433 0.00546 Average concentration 0.000204 0.00275 0.00348

Median concentration 0.000204 0.00275 0.00349

Minimum concentration 0.0000443 0.000596 0.000753MEPC 61/2/6 Annex, page 44

I:\MEPC\61\2-6.doc Table 6.8-1(4): Calculation results of PEC using the MAMPEC model ver. 2.0 for the designated sea area

PEC of Relevant Chemicals (μg/L)

Dibromochloroacetic acid Chloramines(as Monochloroamine) Dibromoacetonitrile

Maximum concentration 0.00354 0.0214 0.00181

95% concentration 0.00328 0.0197 0.00168 Average concentration 0.00209 0.0125 0.00104

Median concentration 0.00209 0.0125 0.00101

Minimum concentration 0.000452 0.00269 0.000222

6.9 Assessment of potential for bioaccumulation

Referring to section 2.4.2, the log Pow values of FAC and the Relevant Chemicals discharged from the BWMS are considered to fall below the log Pow of 3, which indicates the chemicals are not prone to bioaccumulation. Therefore, there is no risk of bioaccumulation due to FAC and the Relevant Chemicals discharged from the BWMS.

6.10 Effects assessment

Maximum concentration of calcium hypochlorite as FAC estimated to be 0.2 mg/L when discharging ballast water without sodium sulfite neutralization. This value exceeds the acute toxicity 0.005 mg/L (LC 50 for 24 h) and chronic toxicity 0.005 mg TRC/L (NOEC for 133d).

Maximum concentration of chloramines also estimated to be 0.2 mg/L when discharging

ballast water without sodium sulfite neutralization. This value exceeds most of the acute toxicity such as 0.001 mg/L (EC 50 for 48 h) for clam. Therefore general assessment of effects of discharged ballast water in the system should be focused on calcium hypochlorite (FAC) and chloramines.

According to PEC values estimated in section 6.8, average concentration of calcium hypochlorite (FAC: 0.0129 μg/L) and chloramines (0.0125 μg/L) are higher than other

Relevant Chemicals.

When sodium sulfite neutralization is performed at discharge, on the other hand, maximum discharge concentration reduced to be 0.02 mg/L for the two chemicals. Therefore risk on discharged ballast water with neutralization expected to be allowable.

Both FAC and chloramines degrade rapidly. Chloramines degrade very rapidly after hydrolysis. Analysis at toxicity test was conducted soon after the treatment or neutralization. In actual operation of the BWMS on ship it is considered that FAC and chloramines are at quite low concentration. Therefore risk on discharged ballast water, in actual operation on ship or after neutralization conducted when FAC exceeds 0.2 mg/L, expected to be allowable.

For other Relevant Chemicals there is hardly any risk, because the maximum concentration of other Relevant Chemicals discharged from the BWMS do not exceed acute toxicity and chronic toxicity values. Moreover, with refe rence to section 6.9 when the properties of the discharged FAC and Relevant Chemicals are first considered, bioaccumulation is unlikely to occur, and any toxic effects resulting from accumulation through the food web are also unlikely to take place.MEPC 61/2/6 Annex, page 45

I:\MEPC\61\2-6.doc 6.11 Effects on aquatic organisms

6.11.1 Estimation of PNEC

The PNEC of the Active Substance and Relevant Chemicals discharged from the BWMS is determined as follows. With regard to tribromoacetic acid and dibromochloroacetic acid of the Relevant Chemicals, there are no data of toxicity test on aquatic organisms, and therefore, they are excluded for the determination of PNEC.

.1 Calcium hypochlorite (FAC)

PNEC short 0.5μg/L (Assessment Factor (AF) =10)

LC 50 and EC 50 are obtained from many marine and fresh water species (total 34) and the lowest is 0.005 mg/L (LC 50 ).

PNEC long 0.5μg/L (AF =10) NOEC is obtained from marine and fresh water species (4 each) and the lowest is 0.005 mg/L (NOEC).

.2 Bromoform:

PNEC short 710μg/L (AF =10)

LC 50 and EC 50 are obtained from 12 species and the lowest is 7.1 mg/L (LC 50 ).

PNEC long 96μg/L (AF =50) NOEC is obtained from 2 fresh water species and the lowest is 4.8 mg/L (NOEC).

.3 Dibromochloromethane:

PNEC short 96μg/L (AF =100)

LC 50 and EC 50 are obtained from 3 fresh water species and the lowest is 9.6 mg/L (EC 50 ).

PNEC long 0.63μg/L (AF =100) NOEC is obtained from 2 fresh water species and the lowest is 0.063 mg/L (NOEC).

.4 Dichloromethane:

PNEC short 9700μg/L (AF =10)

LC 50 and EC 50 are obtained from 6 fresh water species and 3 marine species and the lowest is 97.0 mg/L (LC 50 ).

PNEC long 82.5μg/L (AF =1000) NOEC is obtained from a fresh water fish and is 82.5 mg/L (NOEC).

.5 Monobromoacetic acid:

PNEC short 14μg/L (AF =100)

EC 50 is obtained from 2 species and the lowest is 1.4 mg/L (EC 50 ).

PNEC long 0.14μg/L (AF =10000) NOEC of 1.6 mg/L is obtained but from a non-sensitive species and EC 50 is applied as chronic index.MEPC 61/2/6 Annex, page 46

I:\MEPC\61\2-6.doc .6 Dibromoacetic acid:

PNEC short 69μg/L (AF =1000) PNEC long 6.9μg/L (AF =10000)

LC 50 is obtained from one species and is 69 mg/L (LC 50 ).

.7 Chloramines:

PNEC short 0.01μg/L (AF =100)

LC 50 and EC 50 are obtained from marine and fresh water species (3 each) and the lowest is 0.001 mg/L (EC 50 ) PNEC long: Not evaluated (rapidly degrade after hydrolysis).

.8 Dibromoacetonitrile:

PNEC short 0.55μg/L (AF =1000) PNEC long 0.055μg/L (AF =10000)

LC 50 is obtained from one fresh water species and is 0.55 mg/L (LC 50 ).

6.11.2 Ratio PEC/PNEC

On the basis of the PEC calculated in section 6.8.4 and the PNEC assumed in section 6.11.1, PEC/PNEC was calculated and the results are shown in Table 6.11-1.

PEC/PNEC of the Active Substance and Relev ant Chemicals, except for chloramines, discharged from the BWMS falls far below one. As stated in section 6.10, general assessment of effects of discharged ballast water in the system should be focused on calcium hypochlorite (FAC) and chloramines. For FAC, PEC/PNEC is no problem even at the maximum discharged concentration of 0.2 mg/L without neutralization.

For chloramines, however, the PEC/PNEC (short) ratio exceeds one. Chloramines have good resolvability and expected to degrade easily while stored in ballast tanks and after discharge. The result shows that there is a possibility to show some effect on surrounding marine environment when discharged soon after ballasting and without neutralization.

In this respect, PEC is calculated for chloramines in the case that sodium sulfite neutralization is performed. The discharged concentration is 0.02 mg/L, which is the maximum concentration detected. Average PEC is 0.00125 μ g/L and PNEC short

is 0.01 μ g/L. PEC/PNEC short is 0.125 falling short of one.

Thus with neutralization process, risk to the env ironment is considered allowable. In actual operation of the BWMS on ship, ballast water is not discharged soon after the treatment.

Taking into account the mode of degradation of chloramines, risk to the environment is also considered allowable. We will conduct necessary tests to confirm degradation of

chloramines and evaluate the risk to the environment for Final Approval.MEPC 61/2/6 Annex, page 47

I:\MEPC\61\2-6.doc Table 6.11-1: PEC, PNEC and PEC/PNEC ratio

PNEC (μg/L) PEC/PNEC Relevant Chemicals PEC (μg/L) long short long short
Calcium hypochlorite (FAC) 0.0129 0.5 0.5 0.0258 0.0258

Bromoform 0.00668 96 710 0.0000695 0.0000094

Dibromochloromethane 0.000115 0.63 96 0.0001825 0.0000011

Dichloromethane 0.0029 82.5 9700 0.0000351 0.0000002

Monobromoacetic acid 0.000204 0.14 14 0.0014571 0.0000145

Dibromoacetic acid 0.00275 6.9 69 0.0003985 0.0000398

Chloramines 0.0125 --- * 0.01 --- * 1.25

Dibromoacetonitrile 0.00104 0.055 0.55 0.018909 0.0018909

* PNEC long for chloramines is not evaluated because chloramines are very rapidly degraded by hydrolysis (see section 2.4.1.2).

6.12 Effects on sediment

As described in section 2.2.4, calcium hy pochlorite and the Relevant Chemicals discharged from the system are unlikely to cause adhesion or accumulation in the sediment. Therefore,

it is considered that there are no effects on sediment.

6.13 Comparison of general assessment of effects with discharge toxicity

Assessment of the treated ballast water summarized in section 6 shows there is a worry to

have effect on marine environment because of t he toxicity of chloramines when calcium hypochlorite (Active Substance) is infused in to ballast tanks and discharged in a short time without neutralization. However, in most cases there seems to be no problem considering that chloramines degrade rapidly while stored in ballast tanks in practical ship navigation.

The BWMS is the system that when ballast water is discharged in a short time after ballasting, the FAC concentration is monitored and sodium sulfite neutralization is conducted if necessary. Even if chloramines remained in the discharged water, the maximum concentration is confirmed to be 0.02 mg/L with neutralization and PEC/PNEC ratio is less

than 1 and risk is considered to be allowable.

The result of general assessment on effects is nearly identical to the test result that slight acute and chronic toxicity effects (ECr 50 is 5.8% dilution and NOEC is 0.4% on algae) have been observed in the toxicity tests of treated ballast water discharged from the system on aquatic organisms. The result is also nearly identical to the test results that growth inhibition is observed on algae at neutralization group (see appendix 2).

7 RISK ASSESSMENT

7.1 Risk to safety of ship

7.1.1 Increased corrosion

As described in section 6.4 "Corrosion test" of this Basic Assessment Report, the corrosion effect of ballast water treated by the system on coating in a ballast tank is not considered. Further, it is determined that the effect of corrosive force on such a level on other materials configuring ships is also within tolerance. Accordingly, it is considered not to have a

corrosion effect.MEPC 61/2/6 Annex, page 48

I:\MEPC\61\2-6.doc 7.1.2 Fire and explosion

In the BWMS, calcium hypochlorite is used as the Active Substance. Calcium hypochlorite does not cause self-combustion, but when it contacts other substances, it may generate heat. Accordingly, it is stored in a container that ensures complete isolation.

7.1.3 Storage and handling of the substances

The safety of the storage of calcium hypochlorite is ensured according to a recommendation (November, 1999 and November, 2000) of the P&I International Group for transportation by ship, as described in section 3.2.4.1.2 of this Basic Assessment Report. Further, in a well-ventilated dry place, calcium hypochlorite is stored while avoiding direct sunlight, thereby ensuring the safety.

7.1.4 Contact with, or inhalation of, process products

As described in section 2.3.2.1 of this Ba sic Assessment Report, calcium hypochlorite has irritation and when calcium hypochlorite is inhaled or contacts a skin, histological changes

may occur.

Furthermore, sodium sulfite as a neutralizer has almost no irritation. As a countermeasure thereof, as described in section 3.2.4 of this Basic Assessment Report, workers wear goggle-type protective glasses, a dust respirator, protective gloves made of rubber, and protective clothing such as long sleeves and long pants, thereby ensuring the safety in handling calcium hypochlorite. Even when handling sodium sulfite used as neutralizer, the workers wear goggle-type protective glasses, the dust respirator, the protective gloves made of rubber, and the protective clothing such as long sleeves and long pants.

7.1.5 Noise

In operating the system, noise is not generated.

7.2 Risk to human health

7.2.1 Health effects to humans (G9: 5.3.1.2)

An acute toxicity value of calcium hypoc hlorite which is an Active Substance

is LD 50 = 790 mg/L by oral administration to rats and NOAEL to humans as the chloride concentration of 0.5 ppm in inhalation exposure. Furthermore, in the case of high-concentration exposure, corrosivity or irritation to the skin and eyes may be generated. NOAEL of chronic toxicity of calcium hypochlorite by an animal test is 22.5 mg-chlorine/kg-bw/day. There is no report that calcium hypochlorite has carcinogeni city, mutagenicity, reproductive toxicity, or any effect on the endocrine system (see secti on 2.3 of this Basic Assessment Report).

Furthermore, the risk to the human health by other additives among preparations except calcium hypochlorite and sodium sulfite, which is the neutralizer, is not considered.

Bromoform which is a Relevant Chemical has an acute toxicity value of LD 50 = 1, 147-1,550 mg/kg by oral administration in the animal test and causes irritation to the eyes and skin. In chronic exposure, it is reported that NOAEL in the oral administration test to the rat for 13 weeks is 25 mg/kg. The IARC evaluates the carcinogenicity as group 3 (the carcinogenicity to humans cannot be evaluated). Further, from the results of the animal test, the effects on mutagenicity and the reproductive toxicity in a dosage in which toxicity exists in a mother animal are suspected, but the effect on the endocrine system is not reported (see section 2.3 of this Basic Assessment Report).MEPC 61/2/6 Annex, page 49

I:\MEPC\61\2-6.doc In the case of the hazardousness of dibromochlor omethane to the health, it is reported that the acute toxicity value by oral administration in the animal test is LD 50 = 800 mg/kg - 1200 mg/kg and the acute toxicity value in the oral admin istration test to a mouse for 13 weeks is NOAEL = 30 mg/kg. The reproductive toxicity is suspected in the high-concentration test, but the IARC evaluates the carcinogenicity as grou p 3 (the carcinogenicity to humans cannot be evaluated). It is reported that the mutagenicity shows both positive and negative results. There are no data showing effects on the endocrine system (see 2.3 of this Basic Assessment Report).

In the case of the acute effects of dichloromethane, it is reported that LD 50 by the oral administration in the animal test is 1,710 - 2,250 mg/kg and LC 50 by the inhalation exposure is approximately 50,000 mg/m 3 , so that the acute effects by dichloromethane shows irritation to the skin and eyes. The effects are shown for NOAEL = 6 mg/kg-bw/day in the oral administration test to rats for two y ears and in a capacity of 25 ppm (88.3 mg/m 3 ) or more in the inhalation toxicity test to the rat for 100 days. Although test data indicating the reproductive toxicity cannot be acquired, the IARC classifies the carcinogenicity as group 2B (there is a possibility that the carcinogenicity exists with respect to humans), so that the mutagenicity is suspected. There is no report that dichloromethane shows an effect on the endocrine system (see section 2.3).

Among monobromoacetic acid, dibromoacetic acid , tribromoacetic acid, dibromochloroacetic acid (which is halogenated acetic acid), monobromoacetic acid has the largest acute toxicity

value and LD 50 in the oral administration test to the rat was 177 mg/kg. Further, it represents the corrosivity/irritation. There are both positive and negative reports concerning reproductive toxicity and mutagenicity. An assessment result for the carcinogenicity by the international organization cannot be acquired, but for dibromoacetic acid, generation of a tumour is verified by animal tests. There are no data showing effects on the endocrine system (see section 2.3).

For chloramines, LC 50 in inhalation exposure test of trichloroamine to the rat is 112 ppm and NOAEL in the oral administration test of monochloroamine to the mouse for 90 days is 9.2 mg/kg-bw/day. There is no report that chloramines have carcinogenicity, mutagenicity, reproductive toxicity, and effects on the endocrine system (see section 2.3).

In the case of dibromoacetonitrile, it is reported that LD 50 by oral administration in animal tests is 245-361 mg/kg and the dibromoacetonitrile causes irritation to the skin, eyes, and respiration organisms due to the acute effects. NOAEL in the oral administration test to rats for 90 days is 11.3 mg/kg-bw/day. There is no data showing the reproductive toxicity, carcinogenicity, mutagenicity, and effects on the endocrine system (see section 2.3).

7.2.2 Human exposure scenario (HES)

In the BWMS, as a human exposure scenario (HES) of which health effects to the human are concerned, following a population, a unit operation, and an exposure route, an exposure frequency or duration with respect to the Active Substances and Relevant Chemicals are

considered.

7.2.2.1 Active Substances

(i) Temporary dermal and inhalation exposure to the worker in storage, transportation, and handling in manual operation.

(ii) Short-period inhalation exposure to the worker and the personnel by volatilization of residual Active Substances during a retention time in the ballast tank and temporary dermal exposure to the worker during a maintenance work, etc.MEPC 61/2/6 Annex, page 50

I:\MEPC\61\2-6.doc (iii) Dermal or oral exposure to the general public in surrounding waters after the ballast water is discharged.

7.2.2.2 Relevant Chemicals

(i) Short-period inhalation exposure to the worker and other personnel by volatilization of the Relevant Chemicals during the retention time in the ballast tank and temporary dermal and inhalation exposure to the worker during the maintenance work, etc.

(ii) Dermal or oral exposure to the general public in surrounding waters after the ballast water is discharged.

(iii) Chronic exposure to the general public through the food chain.

A margin of exposure (MOE) is calculated for the above short-period inhalation exposure and temporary dermal and inhalation exposure.

According to the result, MOEs of bromoform and dichloromethane are less than 100. However, since the hazardousness data is based on the chronic exposure and the exposure by the system is short-period and temporary, a simple comparison is difficult. Furthermore, the HES is based on the worst case and does not consider dilution by ventilation, so that it cannot be concluded that the health risk to the worker is directly generated by the MOE.

In the HES, on an inhalation route, which is a major exposure route, ACGIH is set to 5.2 mg/m 3
for bromoform and is 174 mg/m 3 for dichloromethane as a time weighted average (TWA) by an 8-hour weighted average. From comparison between the TWA and the estimated exposure concentration, the estimated exposure concentration (43.0 mg/m 3 ) is approximately 8.3 times more than the TWA for bromoform and the TWA is approximately five times more than the estimated exposure concentration (33.9 mg/m 3 ) for dichloromethane. From the above-mentioned results, even for dichloromethane, the concern of the health risk was low. For bromoform, the estimated exposure concentration is more than the TWA, but if the ventilation efficiency in the ballast tank is 10 times or more, the concentration becomes equal to or less than a concentration in which the health risk is concerned. Furthermore, since the TWA is an allowable concentration under a normal (chronic) exposure condition for a worker, a problem immediately does not occur with respect to temporary exposure in the system.

For dibromochloromethane and dibromoacetonitrile, since their MOEs are more than 100 as the worst cases, the health risk to the worker is not concerned.

Since the Relevant Chemicals include substa nces of which carcinogenicity, mutagenicity, and reproductive toxicity is doubted, ventilation should sufficiently be performed during the working in the ballast tank. At the same time, it is necessary to use the respiratory protective equipment, etc., and take measures to reduce the exposure concentration (ingestion dosage) to the workers as much as possible.

Further, in in-ship space except the ballast tank, a concern of the health risk decreases as the Relevant Chemicals are further diluted in comparison with in-tank space.

For dermal or oral exposure to the general public in surrounding waters after the ballast water is discharged, the exposure concentration in open general space is at a level which is not problematic in comparison with the ex posure concentration in the ballast tank.

For chronic exposure to the general public through the food chain, since logPow values of all the Relevant Chemicals are less than 3, the exposure to the general public through the food

web is not concerned.MEPC 61/2/6 Annex, page 51

I:\MEPC\61\2-6.doc 7.2.3 Assessment

From the above-mentioned results, in the BWMS, it can be concluded that a concern of the health risk to the personnel (worker) and the general public by the Active Substances, Relevant Chemicals, and sodium sulfite used as the neutralizer is low.

7.3 Risk to the aquatic environment

As described in section 6 of this Basic Assessment Report, the ballast water discharged from

the BWMS has almost no environmental effect.

8 CONCLUSION

An oxidizing substance, calcium hypochlorite, is used as the only Active Substance in this BWMS. In addition, although they are extrem ely small amounts, nine Relevant Chemicals are generated by the reaction between calcium hypochlorite and organisms. In this BWMS, calcium hypochlorite is stored in a fully safe method on board, and the safety of the ship and the personnel onboard are sufficiently ensured by wearing the protective equipment, etc., while the chemicals are handled. Furthermore, a risk effect to the general public and the environment around a discharge sea area is avoided through neut ralization with sodium sulfite when the FAC concentration is more than 0.2 mg/L prior to discharge. Since the concentration of FAC is 0.2 mg/L or less after the neutralization in addition to low concentrations of the Relevant Chemicals, it is assessed that there is almost no environmental effect. Accordingly, it is considered that the BWMS satisfies the requirements for Basic Approval.

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* * *MEPC 61/2/6 Annex, page 54

I:\MEPC\61\2-6.doc APPENDIX 1

STATEMENT

Example; Toxicity tests using three aquatic species for discharge water (high salinity, >32 psu)

* * *MEPC 61/2/6 Annex, page 55

I:\MEPC\61\2-6.doc APPENDIX 2

QUALITY ASSURANCE STATEMENTMEPC 61/2/6 Annex, page 56

I:\MEPC\61\2-6.doc ___________