For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies.

I:\MEPC\58\2.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 58th session Agenda item 2 MEPC 58/2 20 March 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Application for Final Approval of the Electro-Clean System (ECS)
Submitted by the Republic of Korea

SUMMARY
Executive summary: This document contains the non-conf idential information related to the application for Final Approval of the Electro-Clean System (ECS) in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9) adopted by resolution MEPC.126(53)
Strategic direction: 7.1
High-level action: 7.1.2
Planned output: 7.1.2.4

Action to be taken: Paragraph 7

Related documents: MEPC 53/24, MEPC 53/24/Add.1, MEPC 54/2/3, MEPC 57/2, MEPC 57/2/1 and BWM.2/Circ.12

Introduction

1 The ballast water management systems, which make use of Active Substances or Preparations containing one or more Active Subs tances, shall be approved by the Organization under regulation D-3.2 of the Ballast Water Management Convention.

2 The Procedure for approval of ballast wate r management systems that make use of Active Substances (G9) contains the information that should be included into a proposal for approval and provisions for risk characterizati on and analysis. According to section 6 of Procedure (G9), the Organization should evaluate the information provided in th e application.

3 According to BWM.2/Circ.12, a document on the proposal for approva l containing all the non-confidential data related to the respective ballast water mana gement systems that make use of Active Substance should be submitted to the Committee.MEPC 58/2 - 2 -

I:\MEPC\58\2.doc 4 The Republic of Korea has verified the applic ation dossier and believe s that it satisfies the data requirements of Procedure (G9) adopt ed by resolution MEPC 126(53). Therefore, the Republic of Korea submits the non-confiden tial data of the manuf acturer’s application dossier. The complete dossier has been submitte d to the Marine Environment Division of the Organization for review by the experts of the GESAMP-BWWG.

5 The applicant has submitted its Final Approval application dossier to MEPC 57 for review by the GESAMP-BWWG. The GESA MP-BWWG has reviewed the applicant’s application dossier and has made recommendati ons in its report of the fourth meeting. The applicant has conducted the appropriate test s and has equipped the system to ensure the safety of crew and ship in accordance w ith the recommendations of the GESAMP-BWWG (MEPC 57/2, annex 4).

6 This document contains the non-confiden tial information for Final Approval of Electro-Clean System (ECS) designed and manuf actured by Techcross Inc. The applicant’s responses and the measures taken to comply with the recommendations of the GESAMP-BWWG are provided in the Final Approval application dossi er and summarized in the introduction at the annex to this document.

Action requested of the Committee

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

***MEPC 58/2

I:\MEPC\58\2.doc ANNEX

NON-CONFIDENTIAL INFORMATION ON THE ELECTRO-CLEAN BALLAST WATER MANAGEMENT SYSTEM (THE REPUBLIC OF KOREA)

1 INTRODUCTION

The Electro-Clean System (ECS), designed and ma nufactured by Techcross Inc., is the ballast water management system that has been engineer ed for the disinfection of micro-organisms that would otherwise be indigenous to the aquatic ecosystem.
All of the information was pres ented to the IMO technical revi ews on ballast water management technologies during the de velopment phase. The availability of the electrochemi cal treatment of ballast water was first introduce d in document MEPC 53/2/31. The “Ballast Water Management System Electro-Clean” technology has been presented at MEPC 54, MEPC 55, MEPC 56, and BLG 11 for its developing and testing procedures. Th e system also has been presented at the Oceans ’06 Conference IEEE in Asia Pacific, Singapore, ICBWM 2006 in Singapor e, and 2006 Lloyd’s List Conferen ce on Ballast Water Management in London.
The applicant has provided the application do ssier for Final Approval, with appendices and references as follows:

– Application dossier: Application for Final Approval of Active Substances for ballast water manageme nt with Electro-Clean (Electrolytic-Disinfecti on) System submitted by the Republic of Korea

– Appendix 1 Recommendations of the GESAMP-BWWG and responses of the applicant that submitted th e dossier for Final Approval

– Appendix 2 Preliminary Report for The Type Approval Test Used by Electro-Clean Ballast Wa ter Manageme nt System

– Appendix 3 Analysis of Active substances and Relevant chemicals

– Appendix 4 Key data summary of acti ve substances, rele vant chemicals and other component

– Appendix 5 Installation and Operation Manual of Electro-Clean System (ECS)

– Appendix 6 MSDS of Active Substa nces, Relevant Chemicals and other component

– Appendix 7 Toxicity test report

– Appendix 8 Corrosivity test report

– Appendix 9 Data sheet of MAM-PEC and EUSES for risk assessment

– Appendix 10 Quality Assurance Project Plan (QAPP)

– Appendix 11 Estimated results for ECS treated water by EPI and TOPKAT

– ReferencesMEPC 58/2 ANNEX Page 2

I:\MEPC\58\2.doc The applicant’s responses to the recommenda tions of the GESAMP-BWWG mentioned in document MEPC 57/2, annex 4 (including the review on the first applicati on for Final Approval) are summarized as follows:

Responses to Recommendations of the GESAMP-BWWG, MEPC 57/ 2, annex 4

Summary 0.4 The discharge toxicity tests had b een conducted on samples drawn from the G8 land-based efficacy tests (in th e application dossier 6.2.1, Appendix 10).
Summary 0.5 Additional Land-based tests we re conducted in appr opriate conditions meeting salinity concentration and POC, DOC, TSS concentr ations of G8 standard (Appendix 2).
Summary 0.6 Active Substances are categorized into HOCl (OCl-), HOBr (OBr-), O3, H2O2 and OH-, which means that they can be genera ted at operating ECS. This report also contains analysis results of 32 by-produc ts, which can be generated at operating ECS (in the application do ssier 3.1.2, Appendix 3).

Summary 0.7 Human exposure scenarios are prepared on individual Active Substances, Relevant Chemicals and other co mponent. The human ex posure scenarios on cr ew onboard are made on treated water, and the human exposure scenarios on inhabita nts at discharging to marine environment are made on Activ e Substances, Relevant Chem icals and other component (in the application dossier 7.2, Appendix 9).

Summary 0.8 / 0.12 / 0.13 Online gas monitoring system is installed in order to improve safety to ship and crew. Safety level is improved against gas upon in stalling de-aeration sy stem. Moreover, the alarm system would work in case the gas concentration exceeds the limit level (in the application dossier 7.1, Appendix 5).

Summary 0.9 / 0.14 / – CONCLUS IONS AND RECOMMENDATIONS 9.4 The corrosivity tests, provided in the applic ation dossier, are conducted on coated/uncoated test samples and pipe samples. Additionally, the corrosivity test is also taken with test samples from the ballast tanks in test barge, which are used for more than two years (in the application dossier 7.1.1, Appendix 8).

Summary 0.10 / – CONCLUSIONS AND RECOMMENDATIONS 9.3 / 9.4.1 Neutralization is executed with sodium thiosulf ate at discharging with neutralizing system on ECS (in the application dossier 4.1.4, Appendix 5).

CONCLUSIONS AND RE COMMENDATIONS 9.4.2 As a neutralization system is installed in ECS system, discharged water has no TRO in treated water (in the applic ation dossier 4.1.4.1.3 Appendix 4).

CONCLUSIONS AND RECO MMENDATIONS 9.4.3 / 9.4.4 Adequate input data value is provided for PEC/PNEC calculation based on MAM-PEC (VER 1.6) model. Furthermore, the evaluati on also considered EUSES (VER. 2.1) model (in the application dossier 6.3.3.2, Appendix 9).MEPC 58/2 ANNEX

Page 3

I:\MEPC\58\2.doc CONCLUSIONS AND RE COMMENDATIONS 9.4.5 Freshwater (<3PSU) is tested by ECS and Acti ve Substances and Relevant Chemicals are analysed (in the applicati on dossier 2.6, Appendix 1).

CONCLUSIONS AND RE COMMENDATIONS 9.4.6 The documentation of the quality control/qua lity assurance programme is provided (Appendix 10).

This report contains information on indivi dual Active Substance wh ich composes Total Residual Oxidants (TRO). Ox idative Active Substances are generated during ballast water treatment by the ECS. The substances are co mposed of HOCl (OCl-), HOBr (OBr-), O3, H2O2 and OH- Radical (EPA, 1999) and these subs tances have been at tributed to remove micro-organisms. Such a system can be greatly beneficial as it can eradicate micro-organisms inhabiting inside organic matters in a very short period of time providing comparatively shor t substance half-life.

2 DATA-SET

2.1 Identification

The Active Substances, Relevant Chemicals and other component in discharged water through ECS are shown in Table below:

List of identified Active Substances, Relevant Chemicals and other component

Chemical name Control water (μg/L) Treated water (μg /L) before neutralization Treated water (μg /L) after neutralization LOD* (μg /L) LOQ* (μg /L)

HOCl (OCl - ) N.D. ≤ 653 N.D. 10 40

HOBr (OBr - ) N.D. ≤ 4873 N.D. 2 6

O 3 (H 2 O 2 ) N.D. ≤ 478 N.D. 20 60

2,3-dihydroxybenzoic acid N.D. N.D. N.D. 10 20 Active Substances

OH 2,5-dihydroxybenzoic acid N.D. N.D. N.D. 20 50

Trichloromethane 0.20 ≤ 0.12 ≤ 0.13 0.006 0.02

Dibromomethane N.D. ≤ 0.07 ≤ 0.06 0.006 0.02

Bromodichloromethane 0.02 ≤ 0.10 ≤ 0.12 0.008 0.03

Dibromochloromethane 0.02 ≤ 1.78 ≤ 1.97 0.006 0.02

Tribromomethane 0.10 ≤ 43.58 ≤ 49.65 0.005 0.02

1,2,3-Trichloropropane N.D. N.D. N.D. 0.006 0.02 Relevant Chemicals

2-Chlorotoluene N.D. N.D. N.D. 0.006 0.02MEPC 58/2 ANNEX Page 4

I:\MEPC\58\2.doc 4-Chlorotoluene N.D. N.D. N.D. 0.006 0.02

1,2-Dibromo-3-Chloropropane N.D. N.D. N.D. 0.009 0.03

1,3,5-Tribromobenzene N.D. N.D. N.D. 0.011 0.03

1,2,4-Tribromobenzene N.D. N.D. N.D. 0.011 0.03

Trichloroacetonitrile N.D. N.D. N.D. 0.004 0.01

Dichloroacetonitrile N.D. N.D. N.D. 0.003 0.01

Bromochloroacetonitrile N.D. N.D. N.D. 0.004 0.01

Dibromoacetonitrile 0.16 ≤ 21.11 ≤ 21.49 0.003 0.01

2,4-Dibromophenol 0.01 ≤ 0.02 ≤ 0.02 0.002 0.01

2,6-Dibromophenol 0.01 ≤ 0.02 ≤ 0.01 0.002 0.01

2,4,6-Tribromophenol 0.01 ≤ 0.25 ≤ 0.38 0.002 0.01

2-Chlorophenol N.D. N.D. N.D. 0.003 0.01

2,4-Dichlorophenol N.D. N.D. N.D. 0.002 0.01

2,4,6-Trichlorophenol N.D. N.D. N.D. 0.004 0.01

Pentachlorophenol N.D. N.D. N.D. 0.002 0.01

Monochloroacetic acid 0.19 ≤ 1.31 ≤ 1.26 0.005 0.02

Monobromoacetic acid N.D. ≤ 5.50 ≤ 4.99 0.006 0.02

Dichloroacetic acid 0.06 ≤ 0.61 ≤ 0.64 0.010 0.03

Trichloroacetic acid N.D. N.D. N.D. 0.011 0.03

Bromochloroacetic acid N.D. ≤ 1.33 ≤ 1.28 0.011 0.03

Dibromoacetic acid N.D. ≤ 17.21 ≤ 20.65 0.011 0.03

Bromodichloroacetic acid N.D. N.D. N.D. 0.010 0.03

Dibromochloroacetic acid N.D. ≤ 5.61 ≤ 7.00 0.009 0.03

Tribromoacetic acid N.D. ≤ 98.49 ≤ 114.25 0.011 0.03

Bromate ion N.D. ≤ 19.08 N.D. 0.11 0.37

Other component Sodium thiosulfate N.A. N.A. 24000 - -

*LOQ: Limit of Quantification (SD*10, n=7), *L OD: Limit of Detection (SD*3.14, n=7) = MDLMEPC 58/2 ANNEX

Page 5

I:\MEPC\58\2.doc 2.1.1 Active Substances

Substance name CAS No. UN No. Molecular

mass Structure AS/RC/ OC

Chlorine 7782-50-5 1017 70.90 AS

Calcium hypochlorite 7778-54-3 2880 142.98 AS Hypochl

orous acid/hyp ochlorite Sodium hypochlorite 7681-52-9 1791 74.44 AS

Hypobromous acid/hypobromite 7726-95-6 1744 159.82 AS

Hydrogen peroxide 7722-84-1 2015 34.01 AS

Ozone 10028-15-6 1956 48.00 AS

Ozone 10028-15-6 1956 48.00 AS Hydroxyl

radical Hydrogen peroxide 7722-84-1 2015 34.01 AS

2.1.2 Relevant Chemicals

2.1.2.1 HAAs

Substance name CAS No. UN No. Molecular

mass Structure AS/RC /OC

Monochloroacetic acid 79-11-8 3250 94.50 RC

Monobromoacetic acid 105-36-2 1603 167.01 RC

Dichloroacetic acid 79-43-6 1764 128.94 RC

Dibromoacetic acid 631-64-1 3261 217.86 RC

Dibromochloroacetic acid 5278-95-5 - - -

Tribromoacetic acid 10028-15-6 1956 48.00 RCMEPC 58/2 ANNEX Page 6

I:\MEPC\58\2.doc 2.1.2.2 THMs

Substance name CAS No. UN No. Molecular

mass Structure AS/ RC/ OC

Dibromochloromethane 124-48-1 2810 208.28 AS

Tribromomethane 75-25-2 2515 252.73 RC

2.1.2.3 HANs

Substance name CAS No. UN No. Molecular

mass Structure AS/ RC/ OC

Dibromoacetonitrile 3252-43-5 1935 198.86 RC

2.1.2.4 Phenols

Substance name CAS No. UN No. Molecular

mass Structure AS/ RC/ OC

2,4,6-Tribromophenol 118-79-6 2810 330.8 RC

2.1.2.5 Ion

Substance name CAS No. UN No. Molecular

mass Structure AS/RC/ OC

Bromate Potassium bromate 7758-01-2 1484 167.01 RCMEPC 58/2 ANNEX

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I:\MEPC\58\2.doc 2.1.3 Other component

2.2 Effects on aquatic organisms

2.2.1 Acute aquatic toxicity

2.2.1.1 Active Substances

2.2.1.1.1 Fish-aquatic toxicity

Several valid short-term toxicity data were ava ilable for each Active Substance in freshwater and seawater. The lowest toxicity endpo int was a 96hr-LC50 of 9.3μg/L for Oncorhynchus mykiss in ozone (US EPA, Ecotoxicology Database, 2008 fo r ozone). Hypochlorous acid was reported as toxic to fish from 96hr LC50 of 60μg/L in freshw ater and from 96hr LC50 of 32μg/L in seawater (OECD SIDS SIAM 18, 2004).

2.2.1.1.2 Crustacea -aquatic toxicity

Several short-term toxicity test results for aquatic crustacean were available. The most toxic Active Substance was assessed as hypochlorous acid, which has the 24hr-EC50 of 5μg FAC/L for Ceriodaphnia dubia (ECB, EU Risk Assessment Repor t for Sodium Hypochlorite).

2.2.1.1.3 Algae -aquatic toxicity

Aquatic toxicity studies for algae were availa ble for each Active Substance except for ozone. No data were available for aquatic algae toxicity study of ozone. Hypochlorous acid was evaluated as toxic substance from 24hr-LC 50 of 75μg/L (growth rate) for Thalassiosira pseudonana (ECB, EU Risk Assessment Repor t for Sodium Hypochlorite).

2.2.1.2 Relevant Chemicals

Most of the aquatic toxicity te sts were conducted in neutralized medium (pH 7-9.6). As the pH of the medium is always above the pKa, HAAs, TH Ms, HANs and Ion are fully dissociated and can be considered as dissolved salt of water.

2.2.1.2.1 Fish -aquatic toxicity

Short term toxicity data were available fo r monochloroacetic acid, dichloroacetic acid and dibromoacetic acid among HAAs. No data we re available for monobromoacetic acid, bromochloroacetic acid, dibromochloroacetic acid and tribromoacetic acid. Therefore, aquatic toxicity for these substances wa s assessed by toxicity for monochl oroacetic acid, dichloroacetic acid and dibromoacetic acid. Substance name CAS No. UN No. Molecular

mass Structure AS/RC/ OC

Sodium thiosulfate 7772-98-7 - 158.09 EmulsifierMEPC 58/2 ANNEX Page 8

I:\MEPC\58\2.doc It is considered that among several data of HAAs, the most valid data was derived from dibromoacetic acid from endpoints of 96hr-LC50 of 69mg/L for Pimephales promelas (US EPA, Ecotoxicology Database, 2008).

Valid THMs data for dibromochloromethane wa s available for 96hr-LC50 of 79mg/L using OECD TG 203 under GLP.

The lowest endpoint of dibromoacetoni trile was 96hr-LC50 of 0.55mg/L for Pimephales promelas (US EPA, Ecotoxicology Database, 2008).

Valid 2,4,6-tribromophenol data was available fo r 96hr-LC50 of 1.5mg/L using OECD TG 203 under GLP.

Acute toxicity to fish for potassium bromate was reported in several species. From the results, the lowest endpoint was 96hr-LC50 of 404mg/L for Morone saxatilis (Thomas H., 1997).

LC50 value for Sodium thiosulfate was only reported for Gambusia affinis . The 96hr-LC50 was ca. 24,000mg/L (ECB, IUCLID, 2000).

2.2.1.2.2 Crustacea -aquatic toxicity

Valid endpoint among several data of HAAs was monochloroacetic acid from 48hr-EC50 of 77mg/L for Daphnia magna (US EPA, Ecotoxicology Database, 2008).

Valid THMs data for dibromochloromethane wa s available for 48hr-EC50 of 27mg/L using OECD TG 202 under GLP.

No experimental aquatic crustacea toxici ty study for dibromoacetonitrile and other halo-acetonitrile were available. Theref ore, estimated data using ECOSAR was assessed. 48hr-LC50 of 3,897.8mg/L to Daphnia magna for dibromoacetonitrile was estimated.

For 2,4,6-tribromophenol, two GLP studies were ava ilable. From the lowest result, 48hr-EC50 of 0.26mg/L for Daphnia magna was assessed valid (ECB, IUCLID, 2000).

For potassium bromate, one freshwater study and one seawater study were available. The lowest endpoint was 48 hr-LC50 of 179mg/L to Daphnia magna (Thomas H., 1997).

2.2.1.2.3 Algae-aquatic toxicity

Valid endpoint among several data was monochl oroacetic acid from 72hr-ErC50 of 0.025mg/L for Scenedesmus subspicatus according to OECD TG 201 under GLP.

Form dibromochloromethane, 72hr-E b C50 of 6.1mg/L to Selenastrum caprocornutum was studied according to OECD TG 201 under GL P; therefore, this data was valid.

No experimental aquatic algae toxicity study for dibromoacetonitr ile and other halo-acetonitrile were available. Therefore, estimated data using ECOSAR was assessed. 96hr-EC50 of 2,231.3mg/L to green algae for dibromoacetonitrile was estimated.

For 2,4,6-tribromophenol, two GLP studies were available for Selenastrum cappricornutum

. The lowest value was 72hr-ECr50 of 0.4mg/L (ECB, IUCLID, 2000).MEPC 58/2 ANNEX

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I:\MEPC\58\2.doc For bromate ion, three seawater species were stud ied and test results were the same as 72hr-EC50 of 13.6mg/L (Thomas H., 1997).

2.2.2 Chronic aquatic toxicity

2.2.2.1 Active Substances

2.2.2.1.1 Fish -aquatic toxicity

For Active Substances, chronic fi sh toxicity studies were ava ilable only for hypochlorous acid. The lowest NOEC was 5μg/L during 133 days to Ictalurus punctatus (OECD SIDS SIAM 18, 2004).

2.2.2.1.2 Crustacea-aquatic toxicity

Several chronic toxicity studies were avai lable for hypochlorous acid and hydrogen peroxide. 15d-NOEC of 6.2μg TRO/L for molluscs was the lowest endpoint s among Active Substances (OECD SIDS, Risk Assessment Report, 18, 2004).

2.2.2.1.3 Algae-aquatic toxicity

There is only hypochlorous acid data for chronic algae aquatic toxicity. The lowest NOEC value for algae was 0.001mg/L during 21 days (E CB Risk Assessment Report for sodium hypochlorite, 2007).

2.2.2.2 Relevant Chemicals

2.2.2.2.1 Fish-aquatic toxicity

Fish chronic toxicity data were available for monochloroacetic acid, dibromochloromethane and sodium thiosulfate. The most valid NOEC was 3.2mg/L/21day to Oryzias latipes for dibromochloromethane according to OECD TG 201 under GLP.

2.2.2.2.2 Crustacea-aquatic toxicity

Chronic toxicity data for aquatic crustacea were available for monochloroacetic acid, monobromoacetic acid, dibromochloromethane a nd 2,4,6-tribromophenol. The lowest result was reported for Daphnia magna with NOEC of 0.1mg/L during 21days for 2,4,6-tribromophenol according to OECD TG 211.

2.2.2.2.3 Algae- aquatic toxicity

Chronic aquatic algae studies were no t available for Relevant Chemicals.MEPC 58/2 ANNEX Page 10

I:\MEPC\58\2.doc 2.2.3 Endocrine disruption effects

2.2.3.1 Active Substances

2.2.3.1.1 Hypochlorous acid/hypochlorite

Free chlorine is consumed upon contact with living tissu es making measurement of biodegradation impossible and unnecessary. Th e chloride ion is actively transported by freshwater and marine organisms, typically being concentrated in freshwater species and diluted in seawater forms including some hyperosmotic and isotonic groups su ch as chondrichthys (sharks, rays etc). Free chlorine is very toxic to biodegrading micro-organisms and it may interrupt the biodegradation of ot her materials at levels of great er than or equal to 0.01mg/L (ECB, IUCLID, 2000).

2.2.3.1.2 Hypobromous acid/hypobromite

There are no data available on the full-life-cycle test on fish or amphibian metamorphosis assay. In human or animal clinical e ffects, endocrine system was not affected because of any adverse effects for 0.2mg/L test (HSDB, 2008).

2.2.3.1.3 Hydrogen peroxide

There is only one test available on long-term effects on fish. It is an 8-month dietary carcinogenicity test that shows the ability of H 2 O 2 to enhance liver tumors on rainbow trout in a dose-dependent manner. In this test, however , unrealistically high concentrations of H 2 O 2 were used. Fish were also treated with a tumor-ini tialising agent and an an tioxidant simultaneously.

Therefore, this test is not regarded as valid (OECD SIDS, Risk Assessment Report, 2003).

2.2.3.1.4 Ozone

No information is available on e ndocrine disruption data for ozone.

2.2.3.1.5 Hydroxyl radical

Hydroxyl radical was evaluated by hydrogen peroxide and the re sult is the same as hydrogen peroxide.

2.2.3.2 Relevant Chemicals

There are no reliable data on the full-life cycle test on fish or amphibian metamorphosis assay. No instance has been reported for the endocri ne disruptive properties of HAAs, THMs, HANs, Phenols and Ion.

2.2.4 Bioaccumulation

2.2.4.1 Active Substances

Ozone exists as gas phase so that bi oaccumulation potential would be low.MEPC 58/2 ANNEX Page 11

I:\MEPC\58\2.doc Active Substances have low Log Pow and BCF values and it is expected th at Active Substances are not considered to be bioaccumulation on aquatic organisms.

2.2.4.2 Relevant Chemicals

For most of Relevant Chemicals, there is no food chain concentration potential. Due to low Log Pow and BCF values, it is unlikely that th ese will be accumulated through the food chain.

The octanol/water part ition coefficient (K ow ) (an index of the partitioning of a compound between octanol and water) range from - 7.18 to 4.02. Estimated BCF of 3.162-9.18, using a Log Kow, suggests that the potential for bioc oncentration in aquati c organisms is low.

2.2.5 Sediment toxicity and F ood web/population effects

2.2.5.1 Active Substances

Sediment toxicity testing is considered to be relevant only if log Kow >3. Active Substances have low Log Pow (ranges from -2.46 to 1.03) and BCF values so the substances are rapidly degraded in nature. Sediment toxicity and f ood web/population effects for Active Substances are not considered.

2.2.5.1.1 Hypochlorous acid/hypochlorite

Due to the calculated low Log Pow of hypochlor ous acid (Log Pow = -2.46), it is unlikely that it will be accumulated through the food chain.

2.2.5.1.2 Hypobromous acid/hypobromite

For food web, there is no potential concentration of food chain. In a test usin g soil, liquid bromine spill site, bromine concentration in soil continued to decrease (ECB, IUCLID, 2000 for bromine). There is no reliable data of BCF tes ting but hypobromous acid will easily react with other substances so the potential for sedime nt toxicity and food web/population effects would be low.

2.2.5.1.3 Hydrogen peroxide

H 2 O 2 is rapidly degraded in the environment (biotic and abiotic). Its half-life times are estimated to be < 1-5 days in surface water and sediment, one day in the air and from minutes to a few hours in soil.

Hydrogen peroxide does not bioaccumulate (log Kow < -1). Hydrogen peroxide adsorbs poorly to sediment particles and is rapidly degraded; thus, accumulation in the sediment is also not expected (OECD SIDS Initial Assessment Report for SIAM 9, 1999).

2.2.5.1.4 Ozone

A study was done to examine the solubility and st ability of ozone in sh rimp-meat extract (SME) and the bactericidal effect of ozone on shrimp-meat micro-organisms (Chen et al. , 1992, Hazard Text for ozone).MEPC 58/2 ANNEX Page 12

I:\MEPC\58\2.doc Ozone produced a decomposition rate of 2.7%/min in the SME from a saturated solution (1.4 mg O 3 /l) at 5 ~ 25oC. Nine bacterial strains we re tested and Salmonella typhimurium was found to be the most resistant to ozone (Hazard Text for ozone ). Ozone does not persist or concentrate in organisms; therefore, there is no concern of effect on any animal high up the food chain.

2.2.5.1.5 Hydroxyl radicals

Hydroxyl radical was evaluated by hydrogen peroxide and the re sult is the same as hydrogen peroxide.

2.2.5.2 Relevant Chemicals

2.2.5.2.1 Monochloroacetic acid

The Koc of monochloroacetic acid is estimated as 1.2, using a log Kow of 0.22 (Hansch et al .; Amer Chem Soc, 1995) and a regr ession-derived equation (Meykan et al .; Environ Toxicol Chem, 1999). According to a cl assification scheme (Franke et al .; Chemosphere, 1994), this estimated Koc value suggests that monochloroacetic acid is expected to have very high mobility in soil (HSDB, 2005).

Monochloroacetic acid was used as an anti-micr obiological additive in food and in tin coating for aqueous foodstuffs. However, in view of the low vapour pressure and high water solubility, monochloroacetic acid is expect ed to end up mainly in the water compartment (SIAM, 2004).

2.2.5.2.2 Monobromoacetic acid

The Koc of monobromoacetic acid is estimated as 1.201, usin g a log Kow of 0.41 with PCKOWIN v.1.66 (EPI). Monobromoacetic acid is not considered to be bioaccumulation (log Kow < 1).

It is speculated that monochloroacetic acid may be found in meat and other food products (US EPA, 2003b). This would result from the us e of chlorine in food production and processing, including the disinf ection of chicken; processi ng of seafoods, poultry and red meats; sanitizing of equipment and containers; and oxidizing and bl eaching in the flour industry (US EPA, 1994).

2.2.5.2.3 Dichloroacetic acid

The Koc of dichloroacetic acid is estimated as 1.895, using a log Kow of 0.92 with PCKOWIN v.1.66 (EPI). Dichloroacetic acid is not cons idered to be bioaccumulation (log Kow < 1). Dichloroacetic acid is adsorbed poorly to sediment particles and is rapidly degraded. Thus, accumulation in the sediment is also not expected.

It is speculated that dichloroacetic acid ma y be found in meat and other food products (US EPA, 2003b). This would result from the use of chlorine in food pr oduction and processing, including the disinf ection of chicken; processi ng of seafoods, poultry and red meats; sanitizing of equipment and containers; and oxidizing and bl eaching in the flour industry (US EPA, 1994).MEPC 58/2 ANNEX Page 13

I:\MEPC\58\2.doc 2.2.5.2.4 Bromochloroacetic acid

The Log Kow of bromochloroacetic acid is estimated as 0.61, using KOWWIN v.1.67. Bromochloroacetic acid does not bioaccumulate (log Kow < 3). Bromochloroacetic acid poorly adsorbs to sediment particles and is rapidly degraded, thus accumu lation in the sediment is also not expected.

2.2.5.2.5 Dibromoacetic acid

Dibromoacetic acid is rapidly degraded in the environment (biotic and abiotic). Its half-life times are estimated to be < 16.869days in air phase.

Dibromoacetic acid does not bioaccumulate (log Kow < 3). Dibromoacetic acid adsorbs poorly to sediment particles and is rapidly degraded, thus accumulation in the sediment is also not expected.

2.2.5.2.6 Dibromochloroacetic acid

No information of sediment toxicity for dibromoc hloroacetic acid is availa ble. However, the Koc of monochloroacetic acid and halo acetic acid family are estimated as 1.2 using a log Kow of 0.22 (HSDB, 2005). According to the classifi cation scheme, it may be suggested that dibromochloroacetic acid is expected to have high mobility in soil. There are no food web or population effects on dibromochloroacetic acid.

2.2.5.2.7 Tribromoacetic acid

The Log Pow value of tribromoacetic acid is 1.71 (EPI suit, EPA) and the Koc value of tribromoacetic acid is 0.437 (EPI su it, EPA). Therefore, the possibili ty of sediment toxicity is predicted to be very low.

2.2.5.2.8 Dibromochloromethane

Due to its Log Pow <3, dibromochloromethane is not considered to be sediment toxicity. Therefore, there is no toxicity because dibrom ochloromethane may be dissolved into water.

2.2.5.2.9 Tribromomethane

The Koc of tribromomethane is estimated as 35.04, using a log Kow of 2.4 with PCKOWIN v.1.66 (EPI). Tribromometh ane is not considered to be bioaccumulat ion (log Kow <3). Tribromomethane is poorly adsorbed to sedime nt particles and is ra pidly degraded, thus accumulation in the sediment is also not expected.

2.2.5.2.10 Dibromoacetonitrile

The log Kow for dibromoacetonitril e estimated from molecular structure is 0.47. Using this value of log Kow, it is estimated a BCF of 1.34, using a recommended regression equation. This indicates that dibromoacetonitrile will not bioc oncentrate in aquatic organisms and is not considered to be a sediment toxicity on dibromoacetonitrile due to Log Kow <3.MEPC 58/2 ANNEX Page 14

I:\MEPC\58\2.doc 2.2.5.2.11 2,4,6-Tribromophenol

The Koc of 2,4,6

- tribromophenol is estimated as 4200(SRC), using a log Kow of 4.13 (Hansch et al ., 1995) and a regression-derived equation (Lyman et al ., 1990). According to a classification scheme (Swann et al ., 1983), this estimated Koc value suggests that 2,4,6-tribromophenol is expected to have slight mobility in soil. An estimated pKa of 6.0 (SPARC, 2000), indicates that 2,4,6-tribromophe nol will primarily exist as an anion in the environment. Anions are not generally adsorbed to organic carbon and clay more strongly than their neutral counterparts.

2.2.5.2.12 Bromate ion

Potassium bromate is nearly bioaccumulated (log Kow <-7.18). Potassium bromate is adsorbed poorly to sediment particles and is rapidly degrad ed, thus accumulation in the sediment is also not expected. However, it is a chemical oxidizi ng agent found in drinking water as disinfection Relevant Chemical of surface water by ozonation.

2.2.5.2.13 Sodium thiosulfate

The Kow and BCF of sodium thiosulfate ar e estimated as -4.53 and 3.162, respectively (PC KOCWIN v.1.66, EPA, QSAR program). Sodium thiosulfate does not have endocrine disruption (Log Kow -4.53). Sodium thiosulfate ad sorbs poorly to aquatic organisms and rapidly degraded. Thus, food web/population effects are not expected. Also this s ubstance has inorganic chemical property; very low bi oaccumulation can be expected.

2.2.5.3 Treated ballast water

Sediment toxicity testing is considered relevant only if log Kow >3. No data were available for sediment toxicity in ballast water but Active S ubstances and most of other Relevant Chemicals have low Log Pow and BCF values, so the substa nces are rapidly degrad ed in environment. Therefore, sediment toxicity and food web/popul ation effects for ballast water would be low.

2.2.6 Determination of PNEC

2.2.6.1 Active Substances

The PNEC calculation results are summarized in the table below.

The PNEC calculation results ar e based on data-set endpoints.

Chemical name Information available Assessment Factor Endpoint PNEC

Hypochlorite Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Three long-term NOEC from fresh water (algae, crustaceans and fish) + one long-term NOEC from an additional marine taxonomic group (molluscs) 50 5ug/L 0.1ug/L

Hypobromite Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 1mg/L 0.0001 mg/LMEPC 58/2 ANNEX Page 15

I:\MEPC\58\2.doc Hydrogen peroxide Two L(E)C50 from fresh water (crustaceans and fish) + one long-term NOEC from fresh water (crustaceans) 1,000 0.1mg/L 0.0001 mg/L

Ozone One L(E)C50 from fresh water (fish) 10,000 9.3ug/L 0.0009 3ug/L

Hydroxyl radical Two L(E)C50 from fresh water (crustaceans and fish) + one long-term NOEC from fresh water (crustaceans) 1,000 30ug/L 0.03ug/ L

2.2.6.2 Relevant Chemicals

The PNEC calculation results are summarized in the table below.

The PNEC calculation results ar e based on data-set endpoints.

Chemical name Information available Assessment Factor Endpoint (mg/L) PNEC (mg/L)

Dibromochloromethane Three L(E)C50 from fresh water (algae, crustaceans and fish) + Two long-term NOEC from fresh water (crustaceans and fish) 500 1.5 0.003

Tribromomethane Three L(E)C50 from freshwater (algae, crustaceans and fish) + one L(E)C50 from sea water (algae) 10,000 18 0.0018

Dibromoacetonitrile Two L(E)C50 from freshwater (crustaceans and fish) + one L(E)C50 from sea water (crustaceans) 10,000 0.72 0.000072

2,4,6-Tribromophenol Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 1 0.0001

Monochloroacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 77 0.0077

Monobromoacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 34 0.0034

Dichloroacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 82 0.0082

Bromochloroacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 77 0.0077

Dibromoacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 65 0.0065

Tribromoacetic acid Three L(E)C50 from fresh water (algae, crustaceans and fish) 10,000 100 0.01

Sodium thiosulfate One L(E)C50 from fresh water (fish) + One long-term NOEC from fresh water (fish) 1000 600 0.6MEPC 58/2 ANNEX Page 16

I:\MEPC\58\2.doc 2.3 Mammalian toxicity

2.3.1 Acute toxicity

2.3.1.1 Active Substances

2.3.1.1.1 Oral LD50

A large number of studies on acute oral toxici ty of Active Substances have been performed. The results from these studies show th at acute oral toxicity is high and LD 50 values range from 75mg/kg (hydrogen peroxide, rat, 70% H 2 O 2 ) (OECD SIDS, Risk Assessment Report, 2003 for hydrogen peroxide) to 5,500mg/kg (bromi ne, guinea pig) (ECB, IUCLID, 2006).

Due to the gas property, ozone coul d not be evaluated for toxicity.

2.3.1.1.2 Dermal LD 50
A large number of studies on acute dermal toxicity of Active Substances have been performed. The results from these studies show that acute dermal toxicity is moderate and LD 50 values range from 700mg/kg (hydrogen peroxide, rabbit, 90% H 2 O 2 ) (OECD SIDS, Risk Assessment Report, 2003 for hydrogen peroxide) to 10,000mg/kg (hypochlorous acid, rabbit) (OECD SIDS, 2000).

Due to the gas property, ozone coul d not be evaluated for toxicity.

2.3.1.1.3 Inhalation LC 50
A large number of studies on acute inhala tion toxicity of Active Substances have been performed. The results from these studies show that acute inhala tion toxicity is high and LC 50 values range from 1.202mg/L (Hypoc hlorous acid, rat, 60 min) (ECB, EU Risk Assessment Report for Sodium Hypochl orite) to 250mg/L (mouse, 30 min) (OECD SIAM 16, 2003) to hypochlorous acid. But no inform ation is available on any potential systemic toxicity that can be caused by i nhalation route. Inhala tion toxicity is ava ilable for hypobromous acid, hydrogen peroxide and ozone.

2.3.1.2 Relevant Chemicals

2.3.1.2.1 Oral LD 50
(1) HAAs

A large number of studies on acute oral toxicity of HAAs have been performed. The results from these studies show that acute oral toxicity is high and LD 50 values range from 50mg/kg (monobromoacetic acid, rat) (R TECS, 2001) to 2,820mg/kg (dichloroacetic acid, rat) (RTECS, 2006).MEPC 58/2 ANNEX Page 17

I:\MEPC\58\2.doc (2) THMs

A large number of studies on acute oral toxicity of THMs have been performed. The results from these studies show that acute or al toxicity is moderate and LD 50 values range from 370mg/kg (dibromochloromethane, rat) (RTECS, 2005 ) to 1,388 mg/kg (tribromomethane, rat) (HSDB, 2005). And the results of QSAR analysis using TOPKAT v.6.1 to acute oral toxicity show that LD 50 values ranges from 308.9mg/kg (tri bromomethane, rat) to 914.5mg/kg (dibromochloromethane, rat).

(3) HANs

Two studies on acute oral toxi city of HANs (dibromoacetonitr ile) have been performed. The results from these studies show th at acute oral toxicity is high and LD 50 values range from 245 mg/kg (male) to 361 mg/kg (female) fo r rat (RTECS, 2004) and the results of QSAR analysis using TOPKAT v.6.1 to acut e oral toxicity show that LD 50 value is 425.8mg/kg.

(4) HPs

Three studies on acute oral t oxicity of HPs (2,4,6-tribromophe nol) have been performed. The results from these studies show th at acute oral toxicity is low and LD 50 values range from 1,486 mg/kg to 5,000mg/kg for rat (OEC D SIDS Initial Assessment Report, 2004; ECB, IUCLID, 2000) and the results of QSAR analysis using TOPKAT v.6.1 to acute oral toxicity show that LD 50 value is 1,100mg/kg.

(5) Ion

Three studies on acute oral toxicity of Ion (pota ssium bromate) have been performed. The results from these studies show that acute oral toxicity is high and LD 50 values range from 157mg/kg (rat) to 289mg/kg (mouse) and other LD 50 value is 714mg/kg for human (RTECS, 2007).

2.3.1.3 Other component

Three studies on acute oral toxicity of othe r component (sodium thiosulfate) have been performed. The results from these studies show that acute oral toxicity is low and LD 50 values range from 2,500mg/kg to 5,000mg/kg for rat and other LD 50 value is 3 gm/kg for dog (Registry of Toxic Effects of Chemical Substa nces, 2006 for disodium thiosulfate).

2.3.1.2.2 Dermal LD 50
(1) HAAs

A large number of studies on acute dermal toxici ty of HAAs have been performed. The results from these studies show that acute dermal toxicity is high and LD 50 values range from 59.9mg/kg (monobromoacetic acid, rabbit) (RTECS, 2001) to 510ul/kg (dichloroacetic acid, rabbit) (RTECS, 2006).MEPC 58/2 ANNEX Page 18

I:\MEPC\58\2.doc (2) HPs

Two studies on acute dermal toxicity of HP s (2,4,6-tribromophenol) ha ve been performed. The results from these study show that acute dermal toxicity is low and LD 50 values range from 2,000mg/kg (ECB, ICULID, 2000) for rat to 8,000mg/kg for rabbit (OECD SIDS Initial Assessment Report, 2004).

2.3.1.2.3 Inhalation LC50

(1) HAAs

Several studies on acute inhalation toxicity of HAAs have been performed. The results from these studies show that acute inha lation toxicity is very high and LC 50 values range from 0.18mg/L (monochloroacetic acid, ra t) (ECB, IUCLID, 2000) to 180mg/m 3 /4hr (dibromochloroacetic acid, rat) (ECB, Eu Risk Assessment Report, 2005). And the results of QSAR analysis using TOPKAT v.6.1 to acute oral toxicity show that LD 50 values range from 7.4g/m 3 /h (dichloroacetic acid, rat) to 10g/m 3 /h (monobromoacetic acid, dibromoacetic acid, tribromoacetic acid, rat).

(2) THMs

Two studies on acute inhalation toxicity of THMs have been performed. The results from these studies show that acute inhala tion toxicity is low and LC 50 values of tribromomethane range from 7mg/L/4h for dog (RTECS, 2006) to 12. 1mg/L/2hr for mouse (RTECS, 2006). And the results of QSAR analysis using TOPKAT v.6.1 to acute oral toxicity show that LD 50 values are above 10g/m 3 /h for rat to dibromochloromethane and tribromomethane.

(3) HANs

QSAR analysis using TOPKAT v.6.1 on acute inhalation toxicity of HANs (dibromoacetonitrile) has been performed. The result fr om this study shows that acute inhalation toxicity is moderate and LC 50 value is above 10g/m 3 /h for rat.

(4) HPs

One study on acute inhalation toxicity of HPs ha s been performed. The results from this study show that acute inhalati on toxicity is low and LC 50 values of 2,4,6-Tribromophenol range from 1,630mg/L/4h for rat.

2.3.2 Effects on skin and eye

2.3.2.1 Active Substances

2.3.2.1.1 Skin

Skin irritation values for Active Substances range from irritating to corro sive. Most of Active Substances are irritative to rodent, rabbit and hu man skin and corrosive on concentrated solution. Thus these substances have severe skin irritati on effects. Due to the gas property, Ozone could not be evaluated for toxicity.MEPC 58/2 ANNEX Page 19

I:\MEPC\58\2.doc 2.3.2.1.2 Eye

Eye irritation values for Active Substances range fr om irritating to corrosive. In draize test, most of Active Substances were irritative and corro sive to rabbit and hu man eyes. Thus, these substances have moderately to severe eye irrita tion effects. Due to the gas property, ozone could not be evaluated for toxicity.

2.3.2.2 Relevant Chemicals

2.3.2.2.1 Skin

Most of Relevant Chemicals have toxicity range from not irritating to corrosion. In a skin irritation study in Rabbit patch test for Monochloroacetic acid, value shows corrosion effects. The results from acute toxicity are shown toxic effects caused by Relevant Chemicals.

2.3.2.2.2 Eye

Most of Relevant Chemicals have toxicity range from moderately irritating to highly corrosive. In an eye irritation st udy in Rabbit FDA-Method for Monochl oroacetic acid, value shows highly corrosive effects. The results from acute toxicity show toxic effects caused by Relevant Chemicals.

2.3.3 Repeated-dose toxicity

2.3.3.1 Active Substances

According to GLP guideline test, there are no effects on repeat ed-dose toxicity (NOAEL<0.4 mg/kg, chlorine 99.7% purity) (OECD SI DS, 2006). Thus, these substances are not expected to be repeated-dose toxicity. Thus Active Substances are not considered to have repeated-dose toxicity effects.

2.3.3.2 Relevant Chemicals

In an oral study in Mice 103 weeks test for monochloroacetic acid, LOAEL was 50mg/kg bw (ECB, Eu Risk Assessment Report, 2005). The results from repeated toxicity show slightly toxic effects caused by Relevant Chemicals.

2.3.4 Chronic toxicity

2.3.4.1 Active Substances

According to GLP guideline test, there is no effect on chronic toxicity (NOAEL<0.4mg/kg, chlorine 99.7% purity) (OECD SIDS, 2006). Thus, these substances are not expected to be repeated-dose toxicity. Thus Active Substan ces are not considered to be a chronic toxicity effects.

2.3.4.2 Relevant Chemicals

Development toxicity shows slightly toxi c effects caused by Relevant Chemicals.MEPC 58/2 ANNEX Page 20

I:\MEPC\58\2.doc 2.3.5 Developmental and reproductive toxicity

2.3.5.1 Active Substances

According to OECD guideline test, there is no reproductive toxic eff ect (hypochlorous acid, Rat, 1.0, 2.0, and 5.0mg/kg) (ECB, EU Risk A ssessment Report for Sodium Hypochlorite). But ozone shows significant effects (0.44mg/L) (HSDB for ozone), minimal teratogenesis (1.97mg/L) (OECD SIDS, 2003 for hydrogen peroxi de) increased rates of fetal absorption (1.26mg/L, 8hr/day). Thus, some of Active Substances are not expe cted to be developmental and reproductive toxicity.

2.3.5.2 Relevant Chemicals

In an oral study in Rat 29 days test fo r Dibromoacetic acid, NOAEL was 50mg/L (4.4-11.6 mg/kg/day) (FPTC, 2006). The results from devel opment toxicity show slightly toxic effects caused by Relevant Chemicals.

2.3.6 Carcinogenicity

2.3.6.1 Active Substances

According to GLP guideline test, there is a negative effect (hypochlorous acid, mouse, 70, 140 or 275mg/L buffered water Frequency of treat ment) (ECB, Eu Risk Assessment Report for Sodium Hypochlorite). Due to th e gas property, Ozone could not be evaluated toxicity. Thus most of Active Substances are not expected to be carcinogenicity.

2.3.6.2 Relevant Chemicals

For most of Relevant Chemicals, there are slightly related results of carcinogenicity. In a study in rat (gavage to 0, 15 and 30mg/ kg/day for 103 weeks, monochlor oacetic acid) (ECB, EU Risk Assessment Report, 2005), result shows that the number of survival was decreased and acute inflammation of the nasal mucosa is produced. Th e results from carcinogenicity show slightly toxic effects caused by Relevant Chemicals.

2.3.7 Mutagenicity/genotoxicity

2.3.7.1 Active Substances

Some of in vitro and in vivo test show mutagenicity aberrations (positive, In vitro Cytogenic assay/Chromosomal, hydrogen per oxide) (OECD SIDS, Risk Assess ment Report, 2003) but most Active Substances have negati ve results on mutagenicity a ssay. Active Substances are not considered to be mutagenicity and genotoxicity.

2.3.7.2 Relevant Chemicals

For most of Relevant Chemicals, there are no t oxicity results of mutage nicity. In a study in Salmonella typhimurium (Ames test (plate incorporation) – in vitro study) for monochloroacetic acid (ECB, IUCLID, 2000), result was negative. The results from mutagenicity show no toxic effects caused by most of Relevant Chemicals.MEPC 58/2 ANNEX Page 21

I:\MEPC\58\2.doc 2.3.8 Toxicokinetics

2.3.8.1 Active Substances

Active Substances have low Log Pow (range from -2.46 to 1.03) and BCF values and it is expected that Active Substances are not consider ed to be bioaccumulation on aquatic organisms.

2.3.8.1.1 Hypochlorous acid/hypochlorite

This report evaluated chlorine , calcium hypochlorite and sodium hypochlorite because in water, chlorine, calcium hypochlorite and sodium hypoc hlorite are in a fast equilibrium with hypochlorous acid (HOCl), which again is in a fast equilibrium with hypochlorite ions (OCl - ).

Free chlorine is consumed upon contacting w ith living tissues, making measurement of biodegradation impossible and unnecessary. The ch loride ion is actively transported by most freshwater and marine organisms, typically being concentrated in freshwater species and diluted in saltwater forms including some hyperosmotic and isotonic groups su ch as chondrichthys (sharks, rays etc). Free chlorine is very toxic to biodegrading micro-orga nisms and may interfere with the biodegradation of other materials at leve ls of greater than or equal to 0.01mg/L (ECB, IUCLID, 2000 for chlorine).

2.3.8.1.2 Hypobromous acid

This report evaluated bromine because water a nd bromine are in a fast equilibrium with hypobromous acid (HOBr).

Bromine vapours enter the body thr ough skin and by respiratory system and digestive system. It has cumulative properties, being deposited in tissues as bromides (HSDB, 2008 for bromine).

The injurious effects of bromine generally s eem to be similar to those of chlorine.

Due to its oxidizing action, bromine liberates na scent oxygen free radicals from the water present in mucous membranes. Nascent oxygen is a pote nt oxidizer, capable of causing tissue damage. The extent of the damage is based on the dose of bromine and the availability of water to react with it. In addition, the formati on of bromic acids will result in secondary irritation during the reaction. Contact with the respiratory epithelium causes initial alveolar capillary congestion by focal and confluent patches of high-fibrinogen fluid. The fluid is interstitial at first but can fill the alveoli. Once this occurs, copious frothy, blood- tinged sputum is seen. A granulocyte response may occur several hours after inhalation. Hyaline membrane can be formed later resulting in clinical deterioration at a time when signs of improvement have occurred. Poor oxygen diffusion, hypoxia and hypercapnia result from developmen t of atelectasis, emphysema and membrane formation. Acute obstructive ventilatory impairme nt leads to severe, metabolic acidosis and death usually due to cardiac arrest seconda ry to the hypoxaemia (IPCS for bromine).

2.3.8.1.3 Hydrogen peroxide

Hydrogen peroxide is a normal meta bolite in the aerobic cell, but there is uncertainty about the true levels of the subs tance in biological media due to anal ytical difficulties. The steady state level appears to depend on the balance between its generation and degradation. Hydrogen peroxide passes readily across biol ogical membranes (permeability constant corresponds to that of water) and, because it slowly r eacts with organic substrates, it can diffuse at considerableMEPC 58/2 ANNEX Page 22

I:\MEPC\58\2.doc distances in the cell. There ar e two main hydrogen peroxide me tabolizing enzymes, catalase and glutathione peroxide s, which control H 2 O 2 concentration at different le vels and in different parts of the cell as well as in the blood. At low phys iological levels hydrogen peroxide is mainly decomposed by GSH peroxides whereas the contri bution of catalase increa ses with the increase of hydrogen peroxide concentration. Red blood cells remove hydrogen peroxide efficiently from the blood due to a very high catal ase activity whereas in the se rum catalase activity is low.

Both animal studies and human case reports indi cate that at high uptake rates hydrogen peroxide passes the absorption surface entering the adjacent tissues and blood vessels where it is degraded liberating oxygen bubbles. 1ml of 30% H 2 O 2 yields approximately 100ml of oxygen; thus mechanical pressure injury may be produced. Th e hazard of oxygen emboliz ation is pa rticularly high if the substance is admini stered into closed body cavities where the liberat ed oxygen (under pressure) cannot freely escape. In most cases the consequences of venous embolization are not catastrophic because the lung functions as an effective filter for microbubbles under normal conditions. However, in experiments with dogs, wh en the lungs were overloaded with a bolus injection of 30 ml of air, or when the animals were pretreated with a vasodilator (aminophylline) prior to venous infusion of microbubbles of air, embolization was detected in the femoral artery with Doppler monitoring. Regarding hydrogen peroxi de inhalation or skin contact at rates that would correspond to occupational exposures, there is no data on the systemic fate of the substance. In view of the high degradation cap acity for hydrogen peroxide in blood; however, it is unlikely that the endoge nous steady state level of th e substance is affected.

In biological systems, hydr ogen peroxide may also under go iron-catalyzed reactions (Fenton reaction, Haber-Weiss reaction) resul ting in the formation of hydroxyl radicals. The cellular toxicity of hydrogen peroxide app ears to largely depend on the generation of hydroxyl radicals. Genetically determined traits (acatalasaemia , glucose-6-phosphate dehydrogenase deficiency of the erythrocyt es) render humans more susceptible to peroxide toxicity.

Further scientific data are desi rable on the toxicokine tics of hydrogen peroxi de. After exploring the feasibility of such studies, industry has concluded that presently it seems impossible to measure the fate of exogenous hydrogen peroxide as any meas urement will interfere with physiological equilibria (OECD SIDS, Risk A ssessment Report, 2003 for hydrogen peroxide).

2.3.8.1.4 Ozone

There is no information on toxicokinetics.

2.3.8.1.5 Hydroxyl radical

Hydroxyl radical was evaluated by hydrogen per oxide and the result is the same as hydrogen peroxide.MEPC 58/2 ANNEX Page 23

I:\MEPC\58\2.doc 2.3.8.2 Relevant Chemicals

(1) HAAs

2.3.8.2.1 Monochloroacetic acid

The radiolabel was rapidly eliminated, mainly via urine. Other excretory routes were expired air and excreted faeces. After oral exposure in rats , 90% of the administered dose was recovered in urine within 24 hours; after ip in jection (100% absorption) 82-88% within 3 days ; and after sc exposure, 50% by 17 hours after administration. After oral exposure in mice, 34-61% was excreted in urine after 72 hours. In humans ( one case), after contamination of the skin with 14C-labelled MCAA, a half-life of a bout 15 hours has been found for excretion of radiolabel in urine, with qua ntitatively similar ex cretion via urine and breath (ATSDR, 2005).

2.3.8.2.2 Monobromoacetic acid

No studies of the absorption, distribution, meta bolism or excretion of monobromoacetic acid have been identified in the literature.

2.3.8.2.3 Dichloroacetic acid

NIOSH (NOES Survey 1981-1983) has statistically estimated that 1,592 workers (579 of these are female) are potentially exposed to dichloroacetic acid in the Un ited Sates. Possible routes of exposure include both inhalation and dermal cont act. The general population may be exposed to dichloroacetic acid via the ingestion of dri nking water containing dichloroacetic acid (HSDB, 2005).

2.3.8.2.4 Bromochloroacetic acid

No data of toxicokinetic on bromochloroacetic acid is available. Thus, the data of monochloroacetic acid may substitute bromochloroacetic acid.

2.3.8.2.5 Dibromoacetic acid

It was determined that halogenated acids (HAAs ) could be grouped according to the number and type of halogens: di-HAAs are nearly completely eliminated by metabolism and exhibit poor renal elimination and brominated tri-HAAs e xhibit both moderate renal and metabolic elimination, while TCAA is unique in that it is poorly metabolized, with only moderate urinary elimination, which accounts for its unusually long elimination half-life (FPTC, 2006).

2.3.8.2.6 Dibromochloroacetic acid

There is no information on toxicokinetics.

2.3.8.2.7 Tribromoacetic acid

No data of toxicokinetic on tr ibromoacetic acid is available.MEPC 58/2 ANNEX Page 24

I:\MEPC\58\2.doc (2) THMs

2.3.8.2.8 Dibromochloromethane

Both di- and tri-halogenated methane derivativ es have been found to produce increased blood levels of methemoglobin; the gr eatest increase caused by iodo-, followed by bromo- and chlorocompounds. CNS functional disturbances are re ported, including depression of rapid eyemovement sleep, as seen in carb on monoxide exposur es (HSDB, 2007).

2.3.8.2.9 Tribromomethane

The metabolism of bromoform, dibromochlorom ethane, and other trihalomethanes has been investigated by Anders and colleag ues. The first step in the metabolism of trihalomethanes is oxidation by the cytochrome P-450 mixed functi on oxidized system of liver. This has been demonstrated in vitro using isolated rat liver microsomes, and in vivo , where the rate of metabolism is increased by cytochrome P-4 50 inducers (phenobarbital) and decreased by cytochrome P-450 inhibitors (SKF-525A). The product of this reaction is presumed to be trihalomethanol, which then decomposes by lo ss of hydrogen and halid e ions to yield the dihalocarbonyl. Although this interm ediate has not been isolated, its formation has been inferred by the detection of 2-oxothiazolidin e-4-carboxylic acid (OZT) in an in vitro microsomal system metabolizing bromoform in the presence of cystei ne. The dihalocarbonyl molecule (an analogue of phosgene) is highly reactive, and may undergo a number of reactions, including: (a) direct reaction with cellular nucleophiles to yield cova lent adducts; (b) reacti on with two moles of glutathione (GSH) to yield carbon monoxide and oxidized glutathione (GSSG); and (c) hydrolysis to yield CO 2 . The amount of trihalomethane metabolized by each of these pathways has not been studied in detail, but it appears that conversion to CO 2 is the main route. However, this depends on the species, the trihalomethane being metabolized and metabolic conditions (cellular glutathione levels). Mink et al . (1986) found that mice oxidize d 72% of an oral dose of dibromochloromethane and 40% of an oral dose of bromoform to CO 2 . In contrast, rats oxidized only 18% of dibromochloromethane and 4% of bromoform to CO 2 . The fraction of the dose converted to carbon monoxide has not been quantif ied, but dramatically increased levels of carboxyhemoglobin have been repor ted following oral exposure of rats to bromoform (Anders et al ., 1978; Stevens and Anders, 1981). Mink et al . (1986) reported that about 10% of a dose of bromoform was present in blood in mice; th e form of the label was not investigated, but it may have been carboxyhemoglobin (ATSDR, 2005).

(3) HANs

2.3.8.2.10 Dibromoacetonitrile

Urinary thiocyanate accounted for 2.2 5–12.8% of a single gavage dose of bromochloroacetonitrile, dibromoacetonitrile, dich loroacetonitrile or trichloroacetonitrile during the 24-h period following dosing of male rats. Th is suggests that halogenated acetonitriles are metabolized via oxidative dehalogenation and de hydration to carbon dioxide and cyanide, which is then further metabolized to thiocyanate. The first step in this reaction is catalyzed by a mixed-function oxidase (such as a cytochro me P-450) and results in production of a halocyanomethanol. The identity of the isozyme th at carries out the indi vidual reactions has not been determined. It is proposed that the halocyanomethanols then dehydrate to form halocyanoformaldehydes or lose cyanide to fo rm haloformaldehydes, including phosgene. The cyanide carbon group is more readily excreted in the urine, whereas the halomethyl carbon groupMEPC 58/2 ANNEX Page 25

I:\MEPC\58\2.doc is excreted nearly equally in e nhaled air and in urine; excretion in faeces is low. Glutathione conjugation (mediated by glutathion e transferences or non-enzymatic) may also play a role in the metabolism of halogenated acetonitriles (WHO, 2004).

(4) HPs

2.3.8.2.11 2,4,6-Tribromophenol

2,4,6-Tribromophenol was rapidly absorbed from th e gastro-intestinal tract. The absorption, distribution, and elimination of this substance were examined in male or female Eolzman’s albino rats after a single oral administration at doses from 4.0 4 to 5.34mg/kg. This substance was rapidly absorbed in rats. The bulk of the radi oactivity (77 %) was readily excreted via urine and 2% to 14 % were eliminated in the feces , within 48 hours. The pharmacokinetics of this substance in rats appeared to follow a one comp artment open model system. The rate constant for elimination (Ke) was 0.3 and th e half-life in the blood was 2.03 hours. Based on the results of this study, this substance should neither be pe rsistent nor accumulative in mammalian systems (OECD SIDS, 2005).

(5) Ion

2.3.8.2.12 Potassium bromate

A number of 6,095 people were exposed (est): 67% from actual observed use of potassium bromate; 0% from observed use of a tradenam e product known to contai n potassium bromate; and 33% from observed use of a product in some type of general use which leads NIOSH to suspect that potassium bromate may be contained in that product (HSDB, 2002).

2.3.8.3 Sodium thiosulfate

Sodium thiosulfate is poorly ab sorbed form bowel and thiosulf ate ion distributes itself in extracellular fluid. Thiosulfate serves as subs trate for enzyme rhodanese, which mediates conversion of cyanide to much le ss toxic thiocyanate, which is excreted in urine (HSDB, 2008).

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

2.4.1 Modes of degradation (biotic; abiotic)

2.4.1.1 Active Substances

There are no data for hydrolysis. Active Subs tances have low Log Pow (range from -2.46 to 1.03) and BCF values.

Active Substances are rapidly degraded in na ture and they are not considered to be bioaccumulated on aquatic organisms.

2.4.1.1.1 Hypochlorous acid/hypochlorite

There are three species of chlorine in equilibriu m in water: gaseous chlo rine, HOCl (also a gas at room temperature and pressure), and ClO - . An example of the distribution among them as a function of pH is shown in figure below. For exampl e, at pH 7.5 half of th e chlorine is active as HOCl and half is available as ClO - . The pH of commercial solutio ns is above 11 and the onlyMEPC 58/2 ANNEX Page 26

I:\MEPC\58\2.doc species effectively present is ClO - (ECB, Risk Assessment Report For Sodium Hypochlorite, 2007).

Calculated variation in composition of a chlo rine solution with degree of acidity or alkalinity for 0.1 M Cl 2 in water at standard temperature and pressure

2.4.1.1.2 Hypobromous acid/hypobromite

Bromine will slowly be reduced to bromide by natural oxidizable materials (ECB, IUCLID, 2000 for bromine and Oil and Hazardous Material s/Technical Assistance Data System, 1985 for bromine).

In the presence of moisture and sunlight, bromine has a short life-time. It is transformed into hydrobromic acid and oxygen (ECB, IUCLID, 2000 for bromine).

Biological half-life was 10.5 days and in an av erage clearance of 0.68ml/min (HSDB, 2008 for bromine).

The biological half-life for brom ide through ingestion is 12 to 30 days; however, there are no data available on the inhalation of bromine (IPCS for bromine).

2.4.1.1.3 Hydrogen peroxide

Hydrogen peroxide is a very reactive substance in the presence of other substances, elements, radiation, materials or cells. Both biotic and abio tic degradation processes are important routes in the removal of hydrogen peroxide in the environment.

Biological degradation of hydrogen peroxide is an enzyme-mediated process. Abiotic degradation of H 2 O 2 is due to reaction with itself (dis proportionation), reaction with transition metals, organic compounds capable to react with H 2 O 2 , reaction with free radi cals, heat or light.MEPC 58/2 ANNEX Page 27

I:\MEPC\58\2.doc Hydrogen peroxide is normally a short-lived subs tance in the environment. Rapid degradation will occur due to many alternative and competit ive degradation pathways. However, like most substances, in special circumstances when degrad ation processes are inac tive, hydrogen peroxide can be an extremely persistent substance in the environmen t (OECD SIDS, Risk Assessment Report, 2003).

Abiotic degradation

Pure aqueous solutions of hydrogen peroxide are relatively stable. Stab ility increases with increasing concentration. Stability of pure hydr ogen peroxide in pure water is pH dependent. Decomposition is acid and alkali induced. St ability is at a maximum at pH 3.5-4.5 and decomposition rates are the hi ghest in alkaline solution.

Degradation in the aquatic environment takes place in the presence of a catalyst. Most transition metals, and especially Fe, Mn and Cu may have significant influence on degradation rates of hydrogen peroxide in natural wate r. Degradation rates in filtere d natural waters have been studied. Filtering natural wate r samples do in some extent allow differences between biodegradation and abiotic elimination processes.

In filtered (0.45μm) Greifensee water, hydrogen peroxide was 0.5μm initial concentration of degraded at rate of t1⁄2 = 25-100 hours. Grei fensee is a eutrophic lake in Switzerland (DOC 4-5mg/L, nitrate 1.5mg/L , Fe = 20μg/l, Mn = 10μg/l).

The half-life of H 2 O 2 in seawater samples from the Bay of Biscayne (filtered 0.2μm, initial concentration 3.4μg/l) was 60 hours. The half-life of H 2 O 2 in seawater samples from the Mediterranean shallow lagoon Etang de Tau (filtered 0.2μm) was 50-70 hours (k0.2= 0.013-0.010 h-1) (OECD SDIS, Risk Asse ssment Report, 2003 for hydrogen peroxide).

Direct photolysis is no t to be an important degradation process in the aquatic environment (OECD SIDS, Risk Assessment Report, 2003 for hydrogen peroxide).

Biodegradation

Hydrogen peroxide is biologically degradable. Aerobic bacteria produce catalase enzymes that convert H 2 O 2 to water and oxygen. Catalase is present in most aerobic bacteria and therefore biological degradation st arts readily when H 2 O 2 is in contact with microbial material (no remarkable lag-phase). There are no results available from standard test systems. Standard biodegradation tests are not dire ctly suitable for hydrogen peroxide because they are designed for organic substances.

It has been shown that the size of the microbial population in water has a crucial effect on the degradation rate. Therefore the ha lf-life is between minutes and hours in municipal wastewater (> 106 cells/ml) and only a few seconds in sludge (108-1010 cells/ml) . In natural water ( ≤ 103 cells/ml) the biodegradation half-life is from hours to a few days. Degradation kinetics is generally assumed to be of fi rst order with respect to H 2 O 2 at low concentrati ons and not of first order at higher concentrations (hundreds of mi crograms or more in surface water) leading to longer half-lives as initial concentrations increase (OECD SIDS, Risk Assessment Report, 2003 for hydrogen peroxide).MEPC 58/2 ANNEX Page 28

I:\MEPC\58\2.doc 2.4.1.1.4 Ozone

Modes of degradation (biotic and abiotic)

A laboratory study was conducted to determine the ra te constants for degrad ation of herbicides by ozone. The half-life for removal of 2,4-D at pH 7.5 and in the presence of bicarbonate ions was 39.5 minutes at a dissolved ozone concentra tion of 10 micromolar. The addition of a second herbicide did not affect the relative degradation ra te. Ozone has a half-life in ambient atmosphere of approximately 12 hours (Hazard text for ozone).

Abiotic degradation

Photochemical reacting with atmospheric polluta nts produces ozone. Moisture influences ozone deposition. Ozone's half-life in the ambient atmo sphere is approximately half a day. It causes toxic effects on several species of grass and clover, as well as on a variety of tree species (Hazard text, THOMES for ozone).

2.4.1.1.5 Hydroxyl radical

Hydroxyl radical was evaluated by hydrogen peroxi de and ozone. The result is the same as hydrogen peroxide and ozone on modes of degradation (biotic and abiotic).

2.4.1.2 Relevant Chemicals

2.4.1.2.1 Monochloroacetic acid

Seawater

or Fresh Water Test Duration Results Breakdown products Reference/ Comments/ Justification for

missing data

a) activated sludge a) 21 days a) 65% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 C/ Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc)

b) activated sludge b) 28 days b) 100% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 D/ Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc) Biodegradation

c) bacteria c) 2 days c) 100% (anaerobi c) ECB, IUCLID, 2000 / Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 29

I:\MEPC\58\2.doc 2.4.1.2.2 Monobromoacetic acid

Seawater

or Freshwater Results Breakdown products Reference/Comments/ Justification for missing data

Biodegradation Freshwater Mineralized in river water with 73% conversion to carbon dioxide in 8-10 days at 29oC. Carbon dioxide FPTC, 2006 / Reliability: 2g-Data from handbook or collection of data

2.4.1.2.3 Dichloroacetic acid

Seawater or Freshwater Test Duration Results Reference/Comments/ Justification for missing data

Biodegradation a) Seawater b) Freshwater 3 days incubation a) 8% degradation b) 14% degradation HSDB 2005 / Reliability: 2g-Data from handbook or collection of data

2.4.1.2.4 Bromochloroacetic acid

Seawater or Freshwater Test Duration Results Reference/Comments/ Justification for missing data

a) activated sludge a) 21 days a) 65% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 C/ Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc)

b) activated sludge b) 28 days b) 100% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 D/ Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc) Biodegradation

c) bacteria c) 2 days c) 100% (anaerobic) ECB, IUCLID, 2000/ Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 30

I:\MEPC\58\2.doc 2.4.1.2.5 Dibromoacetic acid

Test Duration Results Reference/Comments/ Justification for

missing data

Biodegradation Probability of Biodegradability = 1.000/ Due to probability of biodegradability is greater than 0.7, dibromoacetic acid may be capable to biodegradation. QSAR analysis using TOPKAT v.6.1 / Reliability: 2f-Accepted calculation method

1/2 – Life Air 16.869 days(concentration in oxidized at air) EPI suite, EPA/ Estimated by AopWin v.1.92 Reliability: 2g-Data from handbook or collection of data

2.4.1.2.6 Dibromochloroacetic acid

Seawater

or Freshwater Test Duration Results Reference/Comments/ Justification for

missing data

a) activated sludge a) 21 days a) 65% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 C/ Referred to data of monochloroacetic acid Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc)

b) activated sludge b) 28 days b) 100% (aerobic) ECB, IUCLID, 2000 / OECD Guide-line 301 D/ Referred to data of monochloroacetic acid Reliability: 1a-GLP guideline study (OECD, EC, EPA, FDA, etc.) Biodegradation

c) bacteria c) 2 days c) 100% (anaerobic) ECB, IUCLID, 2000 / Referred to data of monochloroacetic acid Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 31

I:\MEPC\58\2.doc 2.4.1.2.7 Tribromoacetic acid

Seawater

or Freshwater Results Breakdown products Reference/Comments/ Justification for missing data

Biodegradation a) Probability of Rapid Biodegradation : Biowin1 (Linear model)-0.3565 Biowin2 (Non-linear model)-0.0000 b) Expert Survey Biodegradaion Results : Biowin3 (Ultimate survey model)-2.7827 weeks Biowin4 (Primary survey model)- 3.7579 days EPI Suite, EPA / Estimated by BIOWIN v4.10 Reliability: 2g-Data from handbook or collection of data

2.4.1.2.8 Dibromochloromethane

Seawat

er or Fresh water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data

Biodegradation No data No data 28 days (25-39%) No data HSDB, 2006 / Statistic flask screening procedure/ Reliability: 2g-Data from handbook or collection of data

1/2 - Life Freshw
ater Biotic : volatilization 1/2-Life of river and lake are 2.6hr and 6 days, respectively. Abiotic : atmospheric 1/2-Life of about 280 days, 2.6 hr No data HSDB, 2006 / estimated volatilization half-lives for a model river/ Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 32

I:\MEPC\58\2.doc 2.4.1.2.9 Tribromomethnae

Seawater

or Freshwater Test Duration Results Breakdown products Reference/ Comments/ Justification for

missing data

Biodegradation Activate sludge for 7 days followed by three weekly subcultur
es at 25 °C In the 5 and 10mg/L cultures, tribromomethane had degraded by 11% and 4% respectively, at 7 days and by 48% and 35% respectively at 28 days. Tribromomethane was not biodegraded in aerobic batch cultures, but >99% of the initial tribromomethane was removed by treatment in a methanogenic (anaerobic conditions) biofilm column (2 day retention time in column). Under denitrifying conditions, a 60ug/l solution of tribromomethane degraded to 59, 37, 35, and 2ug/l after 2, 3, 4, and 6 weeks, respectively. No data available HSDB, 2005/ Reliability: 2g-Data from handbook or collection of data

Freshwater No data available Estimated to range from 1 to 581 hours No data available ATSDR, 2005/ Reliability: 2g-Data from handbook or collection of data

Freshwater No data available 1.7 years (at an aqueous concentration of 1X10 -17 mole/l hydroxyl radicals) No data available HSDB, 2005/ Reliability: 2g-Data from handbook or collection of data 1/2 - Life

No data available No data available 686 years (the rate constant of the hydrolysis: 3.2X10 -11 1/sec) (at abiotic status) No data available HSDB, 2005 / Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 33

I:\MEPC\58\2.doc 2.4.1.2.10 Dibromoacetonitrile

Test Duration Results Reference/Comments/ Justification for

missing data

Biodegradation (Biotic) Aquatic fate: 5% and 20% of dibromoacetonitrile are lost via hydrolysis in 10 days at pH 6 and 8, respectively (abiotic) The concern of dibromoacetonitrile in buffered water declined over the course of 10 days with 95%, 89%, and 81% remaining at pH 6, 7, and 8, respectively. HSDB, 2003 / Reliability: 2g-Data from handbook or collection of data

1/2 - Life Atmospheric fate: This reaction is estimated to be very slow; the resulti ng half-life of dibromoacetonitrile is 696 days HSDB, 2003 / Reliability: 2g-Data from handbook or collection of data

2.4.1.2.11 2,4,6-Tribromophenol

Seawater or Freshwater Test Duration Results Reference/Comments/ Justification for

missing data

Biodegradation Activated Sludge Concentration: 30mg/L Test Substance Concentration: 100mg/L 28 days 49 (±) % after 28 day(s) OECD SIDS Initial Assessment Report, 2004/ OECD TG 301 C/ Reliability: 2g-Data from handbook or collection of data

1/2 - Life Freshwater >32 days ( in air) HSDB, 2004/ Reliability: 2g-Data from handbook or collection of dataMEPC 58/2 ANNEX Page 34

I:\MEPC\58\2.doc 2.4.1.2.12 Potassium bromate

No information is available on modes of degradation data by potassium bromate.

2.4.1.3 Sodium thiosulfate

No information is available on modes of degrada tion by sodium thiosulfate. Due to the inorganic chemical property, very low bioaccumulation is expected.

2.4.2 Bioaccumulation, partition coefficient

2.4.2.1 Active Substances

Active Substances have low Log Pow (range from -2.43 to1.03) and Koc valu es (calculated using QSAR, KOWWIN) and it is exp ected Active Substances are not considered to be bioaccumulation on aquatic organisms.

2.4.2.2 Relevant Chemicals

There is no bioaccumulation, partition coefficient in the most of Relevant Chemicals. Due to low Log Pow and BCF values, it is unlikely that th ese will be accumulated through the aquatic organisms.

2.4.3 Main metabolites

2.4.3.1 Active Substances

Active Substances have low Log Pow (range from -2.43 to 1.03) and BCF values and it is expected Active Substances are not considered to be bioaccumulation on aquatic organisms and to be main metabolites.

2.4.3.2 Relevant Chemicals

For most of Relevant Chemicals, there is no food chain concentration potential. Due to low Log Pow and BCF values, it is unlikely that these will be accumulated through the aquatic organisms and metabolites.

2.4.4 Reaction with organic matter

2.4.4.1 Active Substances

2.4.4.1.1 Hypochlorous acid/hypochlorite

The stability of free chlo rine in natural water is very low b ecause it is a strong oxidizing agent and rapidly oxidizes inorganic compounds. It also oxidizes organic compounds, but more slowly than inorganic compounds (RTECS, Environment Impact and Health Effects 1: 37-63 (1978)).MEPC 58/2 ANNEX Page 35

I:\MEPC\58\2.doc 2 .4.4.1.2 Hypobromous acid/hypobromite

There is no data available on the reac tion with organic matter by bromine.

2.4.4.1.3 Hydrogen peroxide

Hydrogen peroxide may act as an oxidant, as a reductant or form addition compounds.

Hydrogen peroxide acts easily wi th various functiona l groups. Most aromatic and aliphatic amines as well as most aldehydes react with hydr ogen peroxide. Hydrogen peroxide reacts with many organic acids to form peracids (of which peracetic acid is the be st known and produced as an industrial chemical). Peracid formation in th e aquatic environment is an equilibrium reaction. Peracids react easily with ot her oxidizable substances.

Typical hydrogen peroxide addition compounds are organic and inorga nic peroxo compounds, epoxides. Epoxides are formed when hydrogen peroxi de (and peracids) reac ts with olefin double bonds.

On the other hand, as examples of non-reactive compounds, saturated alkanes, benzene, toluene and ethanol do not react with H 2 O 2 (at NTP) even in concentrated solutions. A catalyst is needed to achieve a reaction between these co mmon substances and hydrogen peroxide.

An important and powerful free radical reaction is the reaction of ferrous iron with hydrogen peroxide to produce Fenton’s reagent. Fenton’s reag ent produces hydroxyl radicals in the aquatic environment with the ability to oxidize a va riety of organic compounds. The potential for oxidation/degradation of compounds is much hi gher with Fenton’s reag ent than with hydrogen peroxide alone.

An illustrative test of the degradation potenti al of hydrogen peroxide and Fenton’s reagent on tertiary ethers was done by Yeh and Novak (1995). Their test solu tion system contained distilled water, methyl-tert-buthyl ether (MTBE) and et hyl-tert-buthyl ether (ETBE) (80-90mg/L each) and H 2 O 2 (100mg/L). No degradation of any of the chemicals was observed during 50 days. This indicates that H 2 O 2 is not capable to react with these tertia ry ethers at normal room temperatures.

A second set of experiments used solutions contai ning ferrous iron to produce Fenton’s reagent.

Oxidation of MTBE and ETBE in the presence of Fe (II) was very fast. The reaction was completed in a few minutes. Although the chem ical oxidation was rapid, the oxidation of MTBE and ETBE occurred only af ter the first dose of H 2 O 2 due to oxidation and precipitation of iron (III). Iron (II) was no longer present and capa ble of catalyzing the formation of Fenton’s reagent. Tert-butanol (TBA), acetone, and seve ral other unidentified reaction products were observed on gas chromatograms (OECD SI DS Risk Assessment Report, 2003).

2.4.4.1.4 Ozone

No information is available on reaction with organic matter.MEPC 58/2 ANNEX Page 36

I:\MEPC\58\2.doc 2.4.4.1.5 Hydroxyl radicals

Hydroxyl radical was evaluated by hydrogen peroxide and the re sult is the same as hydrogen peroxide.

2.4.4.2 Relevant Chemicals

For most of Relevant Chemicals, there is no accumulation through aquatic organisms. And there is no information which is avai lable on reaction with organic matter by Relevant Chemicals.

2.4.5 Potential physical effects on wildlife and benthic habitats

2.4.5.1 Active Substances

2.4.5.1.1 Hypochlorous acid/hypochlorite

The possible exposure routes of soils to HOCl are via contaminated sludges or via direct application of chlorinated water. As can be calculated with the model of Vandepitte and Schowanek, 1997, it becomes clear that HOCl concen trations available in domestic discharges are completely eliminated in the sewer system before entering the ac tivated sludge system. In addition, HOCl is a highly soluble molecule not likely to absorb onto activated sludges. Therefore, there is no evidence th at HOCl has the potential to c ontaminate activated sludges. And as a consequence, contamination of soils due to dumping of w ith HOCl polluted sludges can be excluded.

Contamination of soils due to direct applicatio n of chlorinated water will not be of permanent origin. The high content of organic matter in so il will allow a quick (order of seconds) reduction of HOCl (ECB, Risk Assessment Repor t For Sodium Hypochlorite, 2007).

2.4.5.1.2 Hypobromous acid/hypobromite

This chemical has disinfectant, which is cap able of killing active biota (Oil and Hazardous Materials/Technical Assistance Da ta System, 1985 for bromine).

Toxicity to aquatic plants was 0.02mg/L and a ll species were threatened, and may smother benthic life (Oil and Hazardous Materials/Technical Assistance Data System, 1985 for bromine).

Study of the effects of bromine releases from production activities showed serious effects upon vegetation in the locale of bromine manufacturing plants.

Coniferous trees suffered needle tip necrosis af ter 13 – 14 month and 1–2 month’s exposure times within a 3-mile radius of all bromine facilities sampled. At further distan ces of 3.5 – 12 miles, tip damage was sporadic, varying from tree to tree, and not evident on 1 – 2 month exposu re needles.

The foliage burn and death of trees within 0.5 – 1 mile were extreme. Conifers were decidedly more susceptible to the bromine emissions than broadleaf trees, shrubs, and grasses. Chlorophyll (a and b) levels were greatly reduced in the conifer trees surrounding the bromine plants. This was taken as a strong indicator of extrem e air pollution problems because chlorophyll does not reflect environmental problems until they become overwhelming (ECB, IUCLID, 2000 for bromine).MEPC 58/2 ANNEX Page 37

I:\MEPC\58\2.doc 2.4.5.1.3 Hydrogen peroxide

The toxicity of hydrogen peroxide to micro-organisms has been studi ed frequently, but nearly all tests have been performed in milk and so th ey cannot be used in the risk assessment.

Recently, an activated sludge respiration test has been conducted according to OECD Guideline 209 and, in compliance with GL P. In the test, nominal concentrations of 1, 3, 10, 30, 100, 300 and 1,000mg/L and non-adapt ed sludge were used. EC50 was 466mg/L.

In addition, there is one study on the effects of hydrogen per oxide on individu al bacterial population. It is an 18-hour cell multiplication inhibition test with Pseudomonas putida . In this study, an EC10 of 11mg/L was derived and th e study was done according to Bringmann and Kühn (there was no analytical monitoring or data on the test subs tance in the study).

There is also a study made by Baldry (1983) in which hydrogen peroxide was bacteriostatic above 0.15mmol/L (5.1mg/L) for Pseudomonas aeruginosa (pH 5) and Staphylococcus aureus (pH 6.5 and 8). However, H 2 O 2 was found to be a weak bactericide, as a solution containing 0.88mol/l (29.9g/L) did not give a to tal kill within 3.5 hours. The very same concentration was lethal to spores, so accord ing to this study, hydrogen peroxide is more effective as a sporicide than as a bactericide. This study, ho wever, cannot be us ed in the risk assessment since data are missing on dose -response (OECD SIDS, Risk Assessment Report, 2003).

2.4.5.1.4 Ozone

Ozone decomposes very rapidly in natural water. Therefore, there is no risk that ozone may make potential physical effects on w ildlife and benthic habitats.

2.4.5.1.5 Hydroxyl radicals

Hydroxyl radical was evaluated by hydrogen peroxide and the re sult is the same as hydrogen peroxide.

Hydrogen peroxide may react as an oxidant, as a reductant or form addition compounds. Hydrogen peroxide does r eact easily with va rious functional groups. Most aromatic and aliphatic amines as well as most aldehydes do react wi th hydrogen peroxide. Hydr ogen peroxide reacts with many organic acids to form peracids (of which peracetic acid is the best known and produced as an industrial chemical). Peracid formation in the aquatic environment is an equilibrium reaction. Peracids react eas ily with other oxidizable substances (OECD SIDS Risk Assessment Report, 2003).

2.4.5.2 Relevant Chemicals

Relevant Chemicals on Koc is estimated as 1.2-35.04, using a log Kow of -7.18-3.4 and a regression-derived equation, excep t potassium bromate. Accordi ng to a classification scheme, this estimated Koc value suggests that Relevant Chemicals are expected to have high mobility in environmental fate.MEPC 58/2 ANNEX Page 38

I:\MEPC\58\2.doc 2.4.5.3 Treated ballast water

No data were available for potential physical e ffects on wildlife and benthic habitats. Most of Active Substances and Relevant Chemicals have low Log Pow and BCF values, therefore, effects on wildlife and benthic habitats by treated ba llast water would be expectedly low.

2.4.6 Potential residuals in seafood

2.4.6.1 Active Substances

2.4.6.1.1 Hypochlorous acid/hypochlorite

No data on hypochlorite effects relevant to the food chain are available but no hypochlorite residue is thought to be present or to accumulate in the food chain. So an effect assessment is not applicable (ECB, Risk Assessment Re port For Sodium Hypochlorite, 2007).

2.4.6.1.2 Hypobromous acid/hypobromite

There are no data available on th e potential residu es in seafood.

2.4.6.1.3 Hydrogen peroxide

The estimated log Kow of about -1.5 indicates neg ligible potential of bioc oncentration in aquatic organisms (OECD SIDS, Risk Assessment Report, 2003).

2.4.6.1.4 Ozone

Ozone decomposes very rapidly in natural wate r. Therefore, no information is available on residues in seafood data by ozone.

2.4.6.1.5 Hydroxyl radicals

Hydroxyl radical was evaluated by hydrogen peroxide and the re sult is the same as hydrogen peroxide.

2.4.6.2 Relevant Chemicals

For most of Relevant Chemicals, there is no pot ential concentration of food chain. Due to low Log Pow and BCF values, it is unlikely that th ese will be accumulated through the food chain.

2.4.7 Any known interactive effects

There is no study of interactiv e effects on Active Substances.

2.5 Physical and chemical properties

2.5.1 Active SubstancesMEPC 58/2 ANNEX Page 39

I:\MEPC\58\2.doc 2.5.1.1 Hypochlorous acid/hypochlorite

Property Chlorine Calcium hypochlorite Sodium hypochlorite Melting point (°C) -101.5 a Decomposes at 175 b -20 ~ -30 c Boiling point (°C) -34.04 a Not applicable b 96 ~ 120 c
Flammability (flash point for liquids; °C) Not flammable in air d Slightly flammable g Non flammable solution g
Density (20°C; kg/m 3 ) 1.4085 kg/m 3 (liq) @6.864atm, 20°C f 2.35g/cm 3b 1.23g/cm 3 @25°C c
Vapour pressure (20°C; Pa) 6384hPa @20°C (measured) d Not applicable b 17.4~20 hPa @20°C c Vapour density (air = 1) 2.5 g N/A N/A

Water solubility (temp;

effect of pH; mg/L) Sol in water (25°C) with formation of aqueous Cl 2 (0.062moles/L), HOCl (0.030moles/L) and Cl - (0.030moles/L); total soly: 0.092moles/L. f Approximately 214g/L @20°C b 79.9 g/100gH 2 O a

pH in solution Not applicable Not applicable Not applicable Dissociation constant (pKa) N/A 7.53(HClO) h N/A Oxidation-reduction potential Strong oxidizer d Strong oxidizer h N/A

Corrosivity to material or equipment N/A N/A Contact with metals may evolve flammable hydrogen gas g

Reactivity to container material React explosively with

numerous common materials g N/A Contact with metals may evolve flammable hydrogen gas g Auto-ignition temperature (°C) Not flammable in air d N/A Non flammable solution g

Explosive properties Explosive under influence of a flame d Explosive under influence of a flame d Anhydrous sodium hypochlorite is very explosive c

Oxidizing properties Vigorous reaction in preliminary test d
Molecular chlorine is a strong oxidizer, e N/A Strong oxidizing agent usually stored and used in solution c

Surface tension 18.4g/s @20°C in contact with vapour g N/A N/A

Viscosity 41.2erg/cm 2 (-60°C) g N/A N/AMEPC 58/2 ANNEX Page 40

I:\MEPC\58\2.doc Thermal stability and identity of breakdown products Thermal expantion: 0.0028/K @0°C g N/A N/A

Other physical or chemical properties Critical temperature: 144 Critical pressure: 76.1 g Critical temperature: 144 Critical pressure: 77615 d N/A

Reference/Comments/ Justification for missing data a : CRC Handbook
b : OECD SIDS Initial Assessment Report For SIAM 18, 2004

c : ECB, Risk Assessment Report for Sodium hypochlorite, 2007
d : ECB, IUCLID, 2000

e : OECD SIDS Initial Assessment Report For SIAM 16, 2003
f : Merck Index

g : The chemical data base
h: OECD SIDS Initial Assessm ent Report For SIAM 18, 2004 Reliability: 2g: data from ha ndbook or collection of data (all references)
2.5.1.2 Hypobromous acid/hypobromite

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -7.2°C The Chemical Database* Boiling point (°C) -58.7°C The Chemical Database*
Flammability (flash point for liquids; °C) Non flammability IPCS CEC1999,* ICSC:0107 Density (20°C; kg/m 3 ) 3.119g/cm 3 ECB,IUCLID,2000* Vapour pressure (20°C; Pa) 190mmHg (25°C) The Chemical Database*

Vapour density (air = 1) 5.5 The Chemical Database* Water solubility (temp; effect of pH; mg/L) Insoluble The Chemical Database* pH in solution Not applicable Dissociation constant (pKa) N/A Oxidation-reduction potential N/A

Corrosivity to material or equipment Corrosiveness: Attacks some forms of plastic rubber and coatings ECB,IUCLID,2000*

Reactivity to container material See above IPCS CEC1999, * ICSC:0107 Auto-ignition temperature (°C) Flash point -19°C IPCS CEC1999, *ICSC:0107 Explosive properties Not explosive ECB, IUCLID, 2000*
Oxidizing properties Strong oxidant IPCS CEC1999, * ICSC:0107 Surface tension 40.9g/s 2 @ 25°C The Chemical Database* Viscosity 0.314sq mm/s The Chemical Database* Thermal stability and identity of breakdown products producing hydrogen bromide The Chemical Database*

Other physical or chemical properties Critical temp. 315 Critical pres. 102 A The Chemical Database*MEPC 58/2 ANNEX Page 41

I:\MEPC\58\2.doc 2.5.1.3 Hydrogen peroxide

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -0.40-0.43°C OECD SIDS Risk Assessment Report,2003 Boiling point (°C) 150-152°C (decomposition) OECD SIDS Risk Assessment Report,2003 Flammability (flash point for liquids; °C) Not combustible the substance may ignite combustible materials IPCS CEC2005, ICSC:0164

Density (20°C; kg/m3) 1.4425g/cm 3 (25°C) OECD SIDS Risk Assessment Report,2003 Vapour pressure (20°C; Pa) 3hPa (25°C) OECD SIDS Risk Assessment Report,2003 Vapour density (air = 1) 1.17 The Chemical Database Water solubility (temp; effect of pH; mg/L) miscible OECD SIDS Risk Assessment Report,2003 pH in solution N/A
Dissociation constant (pKa) 11.62(25°C) OECD SIDS Risk Assessment Report,2003 Oxidation-reduction poten tial Powerful oxidizer OECD SIDS Risk Assessment Report,2003 Corrosivity to material or equipment N/A

Reactivity to container material Explosion hazard particularly in the presence of metal IPCS CEC2005, ICSC:0164 Auto-ignition temperature (°C) N/A

Explosive properties Explosion hazard particularly in the presence of metal IPCS CEC2005, ICSC:0164

Oxidizing properties Powerful oxidizer OECD SIDS Risk Assessment Report,2003 Surface tension 80.4g/s 2 @ 20°C The Chemical Database Viscosity 0.01249 P(20°C) The Chemical Database Thermal stability and identity of breakdown products N/A

Other physical or ch emical properties Critical temp. 457 Critical pres. 207 A The Chemical DatabaseMEPC 58/2 ANNEX Page 42

I:\MEPC\58\2.doc 2.5.1.4 Ozone

Property Value Reference/Comments/ Justification for

missing data Melting point (°C) -192.2°C The Chemical Database
Boiling point (°C) -111.9°C The Chemical Database

Flammability (flash point for liquids; °C) Not combustible but enhances combustion of other substances IPCS CEC2004, ICSC:0068

Density (20°C; kg/m 3 ) 1.614g/cm 3 (liq.) 2.144g/L (gas) Merk index

Vapour pressure ( 20°C; Pa) 41257mmHg The Chemical Database
Vapour density (air = 1) 1.65 The Chemical Database
Water solubility (temp; effect of pH; mg/L) 10mg/L The Chemical Database pH in solution Not applicable Dissociation constant (pKa) N/A Oxidation-reduction potential N/A

Corrosivity to material or equipment Yes Attacks metals except gold and platinium IPCS CEC2004, ICSC:0068

Reactivity to container material See above IPCS CEC2004, ICSC:0068

Auto-ignition temperature (°C) Not combustible but enhances combustion of other substances IPCS CEC2004, ICSC:0068

Explosive properties Risk of fire and explosion when heated or on contact with combustible substances (alkene, ethers) IPCS CEC2004, ICSC:0068

Oxidizing properties Powerful oxidizing agent HSDB

Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products Decomposing and producing Oxygen IPCS CEC2004, ICSC:0068 Other physical or ch emical properties Critical temp. -12.1 Critical pres. 53.8a A The Chemical DatabaseMEPC 58/2 ANNEX Page 43

I:\MEPC\58\2.doc 2.5.1.5 Hydroxyl radical

Property Ozone Hydrogen peroxide Melting point (°C) -192.2 a -35 a Boiling point (°C) -111.9 a 108 a
Flammability (flash point for liquids; °C) Not combustible but enhances combustion of other substances b Not combustible the substance may ignite combustible materials b
Density (20°C; kg/m 3 ) 1.614g/cm 3 (liq.) 2.144g/l (gas) c 1.11g/cm 3 a
Vapour pressure ( 20°C; Pa) 41257mmHg a 25mmHg (30°C) a

Vapour density (air = 1) 1.65 a 1.17 a Water solubility (temp; effect of pH; mg/L) 10mg/L a Miscible a
pH in solution Not applicable N/A Dissociation constant (pKa) N/A 11.75 a Oxidation-reduction potentia l N/A Powerful oxidizer d
Corrosivity to material or equipment Yes Attacks metals except gold and platinium b N/A

Reactivity to container material See above b Explosion hazard particularly in the presence of metal b

Auto-ignition temperature (°C) Not combustible but enhances combustion of other substances b N/A

Explosive properties Risk of fire and explosion when heated or on contact with combustible substances (alkene, ethers) b Explosion hazard particularly in the presence of metal b
Oxidizing properties Powerful oxidizing agent d Powerful oxidizer e Surface tension N/A 80.4g/s 2 @ 20°C a Viscosity N/A 0.01249 P(20°C) a Thermal stability and identity of breakdown products Decomposing and producing Oxygen b N/A
Other physical or chemical properties Critical temperature: 12.1 Critical pressure: 53.8 a Critical temperature: 457 Critical pressure: 207 a

Reference/Comments/ Justification for missing data a : The chemical database
b : ICSC

c : Merck Index
d : HSDB

e : OECD SIDS Risk Assessment Report, 2003 Reliability: 2g: data from ha ndbook or collection of data (all references)MEPC 58/2 ANNEX Page 44

I:\MEPC\58\2.doc 2.5.2 Relevant Chemicals

2.5.2.1 Dibromochloromethane

Property Value Reference/Comments/ Justification for missing data

Melting point (°C) -20°C CRC Reliability: 2g-Data from handbook or collection of data

Boiling point (°C) 120°C CRC Reliability: 2g-Data from handbook or collection of data

Flammability (flash point for liquids; °C) 20°C The Chemical Database Reliability: 2g-Data from handbook or collection of data

Density (20°C; kg/m 3 ) 2.38 HSDB, 2006/ Reliability: 2g-Data from handbook or collection of data

Vapour pressure (20°C; Pa) 5.54mmHg at 25°C HSDB, 2006/ Reliability: 2g-Data from handbook or collection of data

Vapour density (air = 1) 7.1 The Chemical Database Reliability: 2g-Data from handbook or collection of data

Water solubility (temp; effect of pH; mg/L) 2.07×10 3 mg/L at 20°C HSDB, 2006/ Reliability: 2g-Data from handbook or collection of data pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment N/A
Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties N/A Oxidizing properties N/A Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/AMEPC 58/2 ANNEX Page 45

I:\MEPC\58\2.doc Other physical or chemical properties Enthalpy of formation at 25°C: -5.0 kcal/mole (gas); Gibbs free energy of formation at 25°C: -4. 50 kcal/mole (gas); entropy at 25°C: 78.31 cal/mole (gas) HSDB, 2006/ Reliability: 2g-Data from handbook or collection of data

2.5.2.2 Dibromoacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 49°C CRC Boiling point (°C) 242.94°C EPI Flammability (flash point for liquids; °C) 94°C The Chemical Data base Density (20°C; kg/m 3 )

Vapour pressure (20°C; Pa) 1.84 Pa (0.014mmHg at 25°C) The Chemical Data base

Vapour density (air = 1) Water solubility (temp; eff ect of pH; mg/L) Very solubl e The Chemical Data base pH in solution N/A Dissociation constant (pKa) 1.47 pKa The Chemical Data base Oxidation-reduction potential N/A Corrosivity to material or equipment Yes Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties Yes Oxidizing properties N/A Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.2.3 Tribromomethane

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 8.69°C CRC Boiling point (°C) 149.1°C CRC Flammability (flash point for liquids; °C) 83°C The chemical database
Density (20°C; kg/m 3 ) 2.8912g/cm 3 @ 20°C The chemical database
Vapour pressure (20°C; Pa) 720 Pa @ 25°C EPI Suit, EPA

Vapour density (air = 1) 8.7 HSDB, IARC 1991a, 1991bMEPC 58/2 ANNEX Page 46

I:\MEPC\58\2.doc

Water solubility (temp; effect of pH; mg/L) < 1mg/mL The chemical database pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment Yes HSDB 2005 Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties N/A Oxidizing properties N/A

Surface tension 41.53 dynes/cm @ 20°C HSDB 2005 Viscosity 1.73 cp @ 35°C The chemical database Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.2.4 Tribromoacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 132oC CRC Boiling point (°C) 245oC CRC Flammability (flash point for liquids; °C) N/A Density (20°C; kg/m 3 ) N/A
Vapour pressure (20°C; Pa) 0.000279mmHg at 25oC EPI Suit, EPA
Vapour density (air = 1)
Water solubility (temp; effect of pH; mg/L) 1,102 (25oC; mg/L) EPI Suit, EPA
pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment N/A Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties N/A Oxidizing properties N/A Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/AMEPC 58/2 ANNEX Page 47

I:\MEPC\58\2.doc 2.5.2.5 Dichloroacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -4°C Merck index Boiling point (°C) 193-194°C Merck index Flammability (flash point for liquids; °C) Yes (75°C) The chemical database
Density (20°C; kg/m 3 ) 1.563 (20°C; g/cm 3 ) The chemical database

Vapour pressure (20°C; Pa) 23.79 (25°C; Pa) HSDB 2005 / Daubert, T.E. et al . 1989 Vapour density (air = 1) 4.4 The chemical database Water solubility (temp; effect of pH ; mg/L) soluble The chemical database pH in solution N/A Dissociation constant (pKa) 1.26 The chemical database Oxidation-reduction potential N/A Corrosivity to material or equipment Yes Reactivity to container material N/A Auto-ignition temperature (°C) 194°C Explosive properties N/A Oxidizing properties N/A Surface tension N/A Viscosity 4.78 cp (35°C) Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.2.6 Monochloroacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 61.5-62.3°C IUCLID, 2000 Boiling point (°C) 189°C IUCLID, 2000 Flammability (flash point for liquids; °C) 126°C IUCLID, 2000
Density (20°C; kg/m 3 ) 1.4043 (20°C; kg/m 3 ) The Chemical Database
Vapour pressure (20°C; Pa) 99.67 (20°C; Pa) IUCLID, 2000

Vapour density (air = 1) 3.26 The Chemical Database
Water solubility (temp; effect of pH; mg/L) Very soluble(20°C; 4,210g/L) IUCLID, 2000 pH in solution N/A Dissociation constant (pKa) 2.87 (pKa) The Chemical Database Oxidation-reduction potential N/A Corrosivity to material or equipment Yes Reactivity to container material N/A Auto-ignition temperature (°C) 460°C IUCLID, 2000MEPC 58/2 ANNEX Page 48

I:\MEPC\58\2.doc Explosive properties N/A Oxidizing properties N/A Surface tension 35.17 g/s 2 at 100°C The Chemical Database Viscosity 2.23 cp (65°C) The Chemical Database Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.2.7 Monobromoacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 50 (oC) FPTC 2006 / Lide, 2003-2004 Boiling point (°C) 208 (oC) FPTC 2006 / Lide, 2003-2004 Flammability (flash point for liquids; °C) Yes (79oC) The chemical database / Combustible if heated
Density (20°C; kg/m 3 ) 1.93 (20oC; g/cm 3 ) FPTC 2006 / Lide, 2003-2004 Vapour pressure (20°C; Pa) 15.66 (25°C; Pa) EP Suit, EPA
Vapour density (air = 1) N/A
Water solubility (temp; effect of pH; mg/L) 1.75 (25oC), miscible FPTC 2006 / Nikolaou

e t al . 1999 pH in solution N/A Dissociation constant (pKa) 2.72 (pKa) The chemical database Oxidation-reduction potential N/A Corrosivity to material or equipment Yes The chemical database Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties N/A
Oxidizing properties Strong oxidizing The chemical database

Surface tension 40.3 (g/s 2 ; 55 oC) The chemical database

Viscosity 3.65 (cp ; 50 oC) The chemical database
Thermal stability and identity of breakdown products N/A
Other physical or ch emical properties N/AMEPC 58/2 ANNEX Page 49

I:\MEPC\58\2.doc 2.5.2.8 Dibromoacetonitrile

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 6.98°C EPI Suit, EPA
Boiling point (°C) 67-69°C @ 24 mmHg EPI Suit, EPA

Flammability (flash point for liquids; °C) Non flammability (37°C) The chemical database

Density (20°C; kg/m 3 ) 2.369 (20°C; kg/m 3 ) The chemical database
Vapour pressure (20°C; Pa) 2 mmHg The chemical database

Vapour density (air = 1) 6.86 The chemical database Water solubility (temp; effect of pH; mg/L ) Slightly soluble The chemical database pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment N/A Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties N/A Oxidizing properties N/A Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.2.9 2,4,6-Tribromophenol

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 93°C IUCLID, 2000 Boiling point (°C) 282-290°C IUCLID, 2000 Flammability (flash point for liquids; °C) Non flammable (102°C) IUCLID, 2000 / the chemical database Density (20°C; kg/m 3 ) 2.55 (20°C; kg/m 3 ) IUCLID, 2000
Vapour pressure (20°C; Pa) 0.0015 mmHg (25°C) The chemical database
Vapour density (air = 1) 11.4 The chemical database Water solubility (temp; effect of pH; mg/L) 50 (19°C; mg/L) IUCLID, 2000 / OECD Guide-line 105, GLP pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment N/A Reactivity to container material N/A Auto-ignition temperature (°C) >450°CMEPC 58/2 ANNEX Page 50

I:\MEPC\58\2.doc Explosive properties N/A Oxidizing properties N/A Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

2.5.3 Other components

2.5.3.1 Sodium thiosulfate

Property Value Reference/Comments/ Justification for

missing data Melting point (°C) 48 IUCLID,2000* Boiling point (°C) decomposition IUCLID,2000* Flammability (flash point for liquids; °C) Non flammable IUCLID,2000* Density (20°C; kg/m 3 ) ca. 1.74g/cm 3 (20°C) IUCLID,2000* Vapour pressure (20°C; Pa) Not applicable IUCLID,2000*

Vapour density (air = 1) N/A
Water solubility (temp; effect of pH; mg/L) 701g/L @20°C pH:ca. 6.5-9@100g/l and 25°C IUCLID,2000*

pH in solution N/A Dissociation constant (pKa) N/A Oxidation-reduction potential N/A Corrosivity to material or equipment N/A Reactivity to container material N/A Auto-ignition temperature (°C) N/A Explosive properties Not explosive IUCLID,2000*
Oxidizing properties No oxidizing properties IUCLID,2000*

Surface tension N/A Viscosity N/A Thermal stability and identity of breakdown products N/A
Other physical or chemi cal properties N/A

3 THE MANNER OF APPLICATION
3.1 System component

Electro-Clean system consists of Electro-Clean Module (ECM), rectifier, heat-exchanger, power distributor, control PC, neutra lizer and several sensors.

Electrolysis module is inst alled in the middle of the ballast pipe and disinfects micro-organisms in the ballast water. Rectifier receives AC power from MCC and supplies DC power to the electrolysis module while periodical ly changing the polarity of electrodes by the timer setting. When rectifier is operated, it generates heat, then heat-exchanger cools the rectifier. Power distributor supplies power to the ECS with 3-ph ase 440V input power and electricity is suppliedMEPC 58/2 ANNEX Page 51

I:\MEPC\58\2.doc to the control PC, rectifier and sensor units by the magnet. The cont roller unit on distributor switches on the magnet in an emergency to pr event problems that may occur in the system. Control PC is installed in ballast room or on di stributor panel and contro ls ECS. It collects all data-from sensor units and all ECS compon ents – through RTU and controls ECS with these data.

Neutralization system is installed in order to decrease TRO concentration by ECS before discharging the treated water in ba llast tanks. It is connected to inflow neutralizer automatically into ballast pipe. PLC would automatically cont rol the amount of neutra lizer according to TRO concentration. ECS has several se nsor units: conductivity sensor, pH sensor, temperature sensor, TRO sensor, gas sensor for H 2 and Cl 2 , and water leakage sensor. EC S is designed to be operated automatically, reflecting data from these sensor units.
3.2 Process of Electro-Clean System
3.2.1 The process of Electro-Clean System

The ballast water treatment proce ss of Electro-Clean System (ECS) consists of the steps shown in the figure below.

ECS working process
The ballast water is pumped into the piping of the ship through the sea chest by the pump. At this time, conductivity of this ballast water is sensed and this data is collected by control PC. Based on this data, control PC determines the curren t which is supplied to electrolysis module to generate TRO 10mg/L. This ballast water is disi nfected by the ECM and kept in the ballast tank until it is discharged. This disinfection process includes the part that supplies current to the electrodes in the ECM and the rectifier, power distributor and heat -exchanger, which are controlled by the online TR O sensor and control PC.

Water leakage detector is installed on ECM. If any water leakage is detected, the alarm system would be operated and then, the system would be automatically shut down.MEPC 58/2 ANNEX Page 52

I:\MEPC\58\2.doc 3.2.2 Gas detection and mitigation
During ECS operation, H 2 gas and Cl 2 gas are generated. The generate d gases are very small amount, even though, for more sa fety, gas de-aeration equipment are in stalled on ballast pi pe. Furthermore, on-line gas detector is installed and alarm syst em would work at exceed ing 3% and 0.8ppm of H 2 and Cl 2 , respectively. The ECS woul d be shut down at exce eding 4% and 1ppm of H 2 and Cl 2 , respectively. The disinfected ballas t water in the tank is discharged out of the ship by pumping.

3.2.3 Neutralizing system

At discharge, the treated water is neutralized by sodium thiosulfate an d TRO concentration of neutralized water is checked again using the online TRO sensor. Thus, neutralization system minimizes the toxic effect of TRO.

4 REMOVAL EFFICACY OF MICRO-ORGANISMS
4.1 Testing body and quality system

South Sea Institute of KORDI (Kor ean Oceanic Resear ch and Development Institute) is the testing organization that is accred ited by KOLAS (The Korea Labora tory Accreditati on Scheme) for ISO/IEC 17025 in field of aquatic organisms and all disinfection effi cacy tests are conducted by the quality system of ISO/IEC 17025. KOLAS is the governmen tal accreditation body in the Republic of Korea. KOLAS evaluates the technical competence of testing and calibration laboratories based on the general requirements of ISO/IEC 17025, general requirements for the competence of testing and calibration laboratories and specific t echnical requirements of each field.

South Sea Institute of KORDIMEPC 58/2 ANNEX Page 53

I:\MEPC\58\2.doc South Sea Institute of KORDI is the designated organization for land-based and shipboard testing for Type Approval of ballast water management systems in the Republic of Korea according to the Provisional Regulation of Type Approva l of ballast water management system.

The samples of ECS treated water and discha rged water with successful completion of land-based test was collected and delivered to toxicity test team and analysis team for Active Substances and by-products under th e strict supervision of KORDI.

4.2 Land-based test
4.2.1 Information of test barge

Four test ballast tanks were c onstructed on the barge, and ECS was installe d for the land-based test and corrosivity test. Each of four test tanks has 240m 3 of volume. All pipe s and valves in each test tank were installed and designed base d on regulation (G8), a nd four ballast pumps sized 500m 3 /h were installed. For sampling, four ta nks for treated water, which have 2m 3 in volume and four controlled water tanks with pipelines and valves were installed.

Electro-Clean Test Barge used fo r Type Approval Test by KORDI

4.2.2 Result of land-based test

The land-based tests were performed at two differe nt sites with more than 10PSU difference in salinity according to Guidelines (G8). The locati ons of the land-based tests were Ma-san port (saline concentration of 32~34PSU ) at South Sea of Korean peni nsular for seawater, and down stream of Sum-jin River (saline concentratio n of 16~21PSU) in Sout hern area of Korean peninsular for brackish water. The KORDI performe d all of the tests that took place and were all in line with regulation D-2 of the Convention. The tests in Ma-san for seawater commenced from 6th June 2007 to 21st January 2008 and a total of five repetitions we re performed. The tests in Sum-jin River for brackish water commence d from 1st August 2007 to 20th February 2008 and a total of six repetitions were performed.

The land-based test was performed successfully for a total of five times using seawater and six times using brackish water. The result of remova l efficacy of brackish water was satisfactory.MEPC 58/2 ANNEX Page 54

I:\MEPC\58\2.doc The analysis of control water in land-b ased test is shown in Tables below.
Water quality of seawater (Masan Bay)

Date Sample pH Temp. (°C) Salinity (PSU) DO (mg/L) TSS (mg/L) DOC (mg/L) POC (mg/L)
06-06-2007 Test water 8.0 19.8 33.4 6.9 48.8 1.6 3.3

20-06-2007 Test water 8.2 20.5 33.2 7.0 90.3 1.7 10.1

07-12-2007 Test water 8.1 9.5 32.7 9.3 40.4 1.6 2.9

17-12-2007 Test water 7.9 9.3 32.1 10.1 63.1 2.0 1.7

16-01-2008 Test water 8.1 6.9 32.9 10.2 58.5 1.8 1.1

Water quality of brackish water (Sumjin estuary)

Date Sample pH Temp. (°C) Salinity (PSU) DO (mg/L) TSS (mg/L) DOC (mg/L) POC (mg/L)

01-08-2007 Test water 7.9 27.0 19.3 6.5 52.9 5.4 6.2

22-08-2007 Test water 8.3 27.9 18.2 8.5 60.3 6.7 6.0

29-08-2007 Test water 7.9 26.5 18.6 7.8 60.3 6.5 5.5

10-09-2007 Test water 8.0 23.9 19.2 8.9 63.5 5.7 6.3

22-10-2007 Test water 8.0 21.6 20.1 19.1 57.9 6.1 5.8

20-02-2008 Test water 8.5 5.9 16.8 11.7 59.5 5.4 6.1

4.3 Shipboard test

4.3.1 Information of the testing vessel

The dimension of M/V Stx Yokohama are summarized in Table below.

M/V Stx Yokohama particulars

Name / Type M/V STX YOKOHAMA / Container ship
Gross Tonnage 8,306ton

Dimensions Length: 132.94m Breath: 20.50m Depth: 10.50m
Builder HANJIN Heavy Industries Co., Ltd.
Launching Date 30th May, 1998MEPC 58/2 ANNEX Page 55

I:\MEPC\58\2.doc 4.3.2 Result of shipboard test

Shipboard test was performed on M/V Stx Yokohama , based on regulation D-2. Test done on M/V Stx Yokohama was performed to prove the efficacy of sea water disinfection, and the test performed was to prove the effi cacy of sea water disinfection. A ll tests were performed at the Korea Marine Research Center, and satisfied regulation D-2.

Shipboard test on M/V Stx Yokohama have been performed every one week in different seas (Korea, China, and Japan) from February 3rd 2007 to July 30th 2007 (Total 24 weeks).

The operative conditions of ECS were fitted to generate 10mg/L of TRO. Continuous tests of Guidelines (G8) were successful and satisfied D-2 standard.

5 RISK CHARACTERIZATION

5.1 Screening for persistence, bi oaccumulation and toxicity

5.1.1 PBT criteria

Criteria for evaluating the long-term persistence, bioaccumulation and toxicity, th e so-called PBT criteria have been decided by several organizations and in several protocols and policies. The EU PBT criteria have decided the following criteria for persistence, bioaccumulation and toxicity.

Criteria for identification of PBT substances

Criterion PBT Criteria

P Half life>60 d in marine water or >40 d in freshwater or half life>180 d in marine sediment or >120 d in freshwater sediment B BCF >2,000 T Chronic NOEC <0.01mg/L or CMR or endocrine disrupting effects

5.1.2 PBT character of Active Substance and Relevant Chemicals

5.1.2.1 Active Substances

All Active Substances are not considered to be persistent, bioaccumulative and toxic. Active Substances have low log Kow and BCF values so that they are exp ected rapidly degraded. Thus, Active Substances are not co nsidered to be PBT substances.

5.1.2.2 Relevant Chemicals

All Relevant Chemicals are not considered to be persistent, bioaccumulative and toxic. Most of Relevant Chemicals have low log Kow and BCF values so that they are expected rapidly degraded. Thus, Relevant Chemicals are not considered to be PBT substances.

5.1.3 Summary of PBT evaluation

According to PBT evaluation, ECS treated ballast wa ter is not considered to be PBT substances.MEPC 58/2 ANNEX Page 56

I:\MEPC\58\2.doc 5.2 Toxicity evaluation of the treated ballast water

5.2.1 Test method and conditions

Toxicity tests of the treated ballast water fo r aquatic organisms were performed using EPA method. Acute and chronic toxicity tests classi fied by salinity conditions were conducted under three types of tropic levels. Samples from the land-based test conducted under Guidelines (G8) were used in the tests. Ballast water, used as sample, was collected immediately after treatment by ECS and stored for 72 hours separately, and was passed through the neut ralizing apparatus in the table below.

Characterization of toxicity test water and test protocol

Salinity Trophic level Sample Method Algae Chronic (0, 72hrs sample) EPA OPPTS 850.5400 Acute (0, 72hrs sample) EPA method 2007.0 Invertebrate Chronic (0, 72hrs sample) EPA OPPTS 850.1300 Acute (0, 72hrs sample) EPA method 2004.0 >32 PSU

Fish Chronic (0, 72hrs sample) EPA method 1006.0 Algae Chronic (0, 72hrs sample) EPA OPPTS 850.5400 Acute (0, 72hrs sample) EPA method 2007.0 Invertebrate Chronic (0, 72hrs sample) EPA method 1007.0 Acute (0, 72hrs sample) EPA method 2004.0 <21 PSU

Fish Chronic (0, 72hrs sample) EPA method 1006.0

Test species for aquatic toxicity

Brackish water Seawater Algae Nannochloris oculata Skeletonema costatum

Invertebrate Caridina multidentata Monocorophium acherucicum

Fish Poecillia latipinna Sebastes oblongusMEPC 58/2 ANNEX Page 57

I:\MEPC\58\2.doc 5.2.2 Results and conclusions

5.2.2.1 Acute toxicity

Toxicity test results for the treated ballast water were presented in Table below. In brackish water and seawater, no significant difference in morta lity was observed between treated group and the control.

Acute toxicity test with ECS treated brackish water

Trophic

level Species Endpoint Time after ECS operation Result

0hrs LC0: 100% ECS effluent
water Invertebrate Caridina multidentata 96 hrs, mortality 72hrs LC0: 100% ECS effluent
water

0hrs LC0: 100% ECS effluent
water Fish Poecillia latipinna 96 hrs, mortality 72hrs LC0: 100% ECS effluent
water

Acute toxicity test with ECS treated sea water

Trophic level Species Endpoint Time after ECS operation Result

0hrs LC0: 100% ECS effluent water Invertebrate Monocorophiu m acherucicum 96 hrs, mortality 72hrs LC0: 100% ECS effluent water

0hrs LC0: 100% ECS effluent water Fish Sebastes oblongus 96 hrs, mortality 72hrs LC0: 100% ECS effluent waterMEPC 58/2 ANNEX Page 58

I:\MEPC\58\2.doc 5.2.2.2 Chronic toxicity

Toxicity test results for the treated ballast water were presented in Table below. In brackish water and seawater, no significant difference in morta lity was observed between treated group and the control.

Chronic toxicity test with ECS treated brackish water

Trophic level Species Endpoint Time after ECS operation Result

0hrs EC0: 100% ECS effluent water Algae Nannochloris oculata 96hrs, growth
rate 72hrs EC0: 100% ECS effluent water

0hrs NOEC: 100% ECS effluent water Invertebrate Caridina multidentata 21 days, growth rate 72hrs NOEC: 100% ECS effluent water

0hrs NOEC: 100% ECS effluent water Fish Poecilia latipinna 21 days, growth rate 72hrs NOEC: 100% ECS effluent water

Chronic toxicity test with ECS treated sea water

Trophic level Species Endpoint Time after ECS operation Result

0hrs EC0: 100% ECS effluent
water Algae Skeletonema
costatum 96hrs, growth inhibition 72hrs EC0: 100% ECS effluent
water

0hrs NOEC: 100% ECS effluent water Invertebrate M onocorophium acherusicum 21 days, Growth rate 72hrs NOEC: 100% ECS effluent water

0hrs NOEC: 100% ECS effluent water Fish Sebastes oblongus 21 days, Growth rate 72hrs NOEC: 100% ECS effluent water

5.2.3 Determination holding time

ECS system is operated only duri ng ballasting and does not produce any oxidant to be required for holding. Therefore, consider ation of the holding time of th e treated ballast water is not necessary and all Active Substances were eliminated by Neutralization procedure.MEPC 58/2 ANNEX Page 59

I:\MEPC\58\2.doc 5.2.4 Conclusion of toxicity test of the treated ballast water

As a result, for every trophic le vel and tank storage time, acute/chr onic toxicity tests showed that the treated water had no effect even for undilu ted sample with the highest concentration.

In document MEPC 57/2/1, toxicity test for non-neut ralized water showed that there were lots of Active Substances in discharged water and that toxicity varied with the concentration of the discharged water. In this test, as a conseque nce of installing neutralizing apparatus, which automatically injects proper amount of sodium thiosulfate depending on TRO concentration, re-conducted toxicity tests showed Active Substances that had been toxic previously disappeared. Therefore, this toxicity test is conducted fo r detecting the effect of mutual reaction among disinfection Relevant Chemicals or various chemical compounds formed by the reaction between Active Substances and raw water no t by the residual Active Substances.

In conclusion, ECS-treated wate r shows no toxicity. This corres ponds to the data-set and risk assessment for aquatic toxicity with the concentr ation of disinfection Relevant Chemicals.

The PNEC is calculated using the assessm ent factors according to Procedure (G9).

Assessment factors to derive a PNEC for the marine aquatic compartment

Information available Assessment factor Freshwater assessment Lowest short-term L(E)C50 from fr esh water species representing three trophic levels 1000 Lowest chronic NOEC from three freshwater or saltwater species representing thr ee trophic levels 10

Saltwater assessment Lowest short-term L(E)C50 from marine species representing three trophic levels 1000 Lowest chronic NOEC from three freshwater or saltwater species representing thr ee trophic levels 100

Lowest chronic NOEC from three sa ltwater species representing three trophic level 100 Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels + at least two chronic NOECs from additional marine taxonomic groups 10

Short-term test results are available for fish a nd aquatic invertebrates in fresh and seawater. In the all test results, endpoints we re showed no effect in mortality in all species. In chronic term test results, fish and aquatic invertebrates were tested in fresh and seaw ater. Similar to acute toxicity test result, in the all te st results endpoints were showed no effect in mortality, therefore, the most sensitive species appears to be seawater invertebrate Monocorophium acherucicum with 21 days NOEC of 100%.

As short-term EC0 from freshwater and saltw ater species, representi ng three trophic levels (algae, invertebrate and fish) are available an assessment factor of 1,000 may be used. Applying this to the long-term NOEC for inve rtebrate gives a PNEC of 1,000mg/L.MEPC 58/2 ANNEX Page 60

I:\MEPC\58\2.doc 5.3 Risk assessment of treate d ballast water discharges
5.3.1 Treated ballast water release discharge information

The disinfected ballast water in the tank is discharged out of th e ship by pumping. At discharging TRO is eliminated with neutralization system which uses sodium thio sulfate as neutralizing agent, and TRO concentration of neutralized wa ter is checked using th e online TRO sensor.

5.3.2 Estimation of the PEC
The PEC of Relevant Chemicals and neutralizer in ballast water was estimated by MAM-PEC VER. 1.6 model. Active S ubstances were not detected in treated ballast water so that the PEC for Active Substance was not consid ered. According to document BLG 11/4/15 (23th February 2007), MAM-PEC VER. 1.6 model is described in such detail as the Port of Rotterdam (dimensions, dynamics and shipping patterns data). Emission load was calculated from Port Statistics 2005 of the Port of Rotterdam and the statis tics are showed in the following.

To running MAM-PEC VER. 1.6 m odel, input parameters of physico-chemical properties and emission load for each Relevant Chemicals and ne utralizer should be entered. Physico-chemical property data were referred from each Key Data Summary. The input parameters were the same as input parameters of EUSES 2.1 which was used for human and worker risk assessment. The emission load was calculated from ballast wate r concentration for each chemical and average amount of ballast water in the Port of Rotterdam.

5.3.2.1 The PEC calculation result

The PEC estimation results for Relevant Chemi cals and neutralizer by MAM-PEC are shown as follows. Average concentration was used in PEC/PNEC calculation.

Estimated total concentrations for Relevant Ch emicals and neutralizer in effluent water by MAM-PEC VER. 1.6 Model

Chemical name Maximum Concentratio n (ug/l) 95% Concentratio n (ug/l) Average Concentratio n (ug/l) Median Concentrati

on (ug/l) Minimum Concentra tion (ug/l)
Dibromochloromethane 6.64E-06 6.60E-06 2.12E-06 2.15E-07 3.12E-08

Tribromomethane 5.48E-05 5.38E-05 1.96E-05 4.39E-06 7.62E-07

Dibromoacetonitrile 3.59E-05 3.55E-05 1.22E-05 2.07E-06 3.35E-07 2,4,6-Tribromophenol 1.24E-06 1.23E-06 3.96E-07 4.09E-08 6.01E-09

Monochloroacetic acid 3.29E-06 3. 27E-06 1.07E-06 1.28E-07 1.99E-08

Monobromoacetic acid 1.32E-05 1.31E-05 4.28E-06 5.08E-07 7.87E-08

Dichloroacetic acid 2.24E-06 2.23E -06 7.14E-07 7.13E-08 1.01E-08

Bromochloroacetic acid 2.66E-06 2.63E-06 8.82E-07 1.27E-07 2.01E-08

Dibromoacetic acid 7.30E-05 7.26E-05 2.32E-05 2.30E-06 3.27E-07

Tribromoacetic acid 4.04E-04 4.02E-04 1.29E-04 1.27E-05 1.81E-06

Sodium thiosulfate 8.50E-02 8.45E-02 2.70E-02 2.68E-03 3.80E-04MEPC 58/2 ANNEX Page 61

I:\MEPC\58\2.doc 5.3.3 Assessment of potential for bioaccumulation

No data were available for BCF of ballast wate r but Active Substances and Relevant Chemicals have low Log Pow (<3) and BCF (<500). Theref ore, bioaccumulation through aquatic organisms for ballast water would be low.

5.3.4 Effects assessment

Among Active Substances, hydrogen peroxide does re act easily with various functional groups. But most of Active Substances and Relevant Ch emicals have low Log Pow and BCF values and it could be expected rapidly degraded in environment.
5.3.5 Effects on aquatic organisms

The PNEC is calculated using the assessment f actors according to the EU Technical Guidance Document on Risk Assessment. Active Substances were not detected in treated ballast water so that the PNEC for Active Substance was not considered.

PNEC was calculated in the data-s et endpoints and balla st water test endpoint s in tables below, respectively. In the data-set, endpoints were mainly available for acute toxicity endpoints in freshwater species. In the ballast water toxici ty test, 100% ballast water endpoints for each Relevant Chemical and neutralizer are the same as the measured concentration in treated water so that the PNEC for ballast water wa s calculated in the measured c oncentration in treated water.

The PNEC calculation results a ccording to data-set endpoints

Chemical name Information available Assessment Factor Endpoint (mg/L) PNEC (mg/L)

Dibromochloromethane Three L(E)C50 from freshwater (algae, crustaceans and fish ) + Two long-term NOEC from freshwater (crustaceans and fish) 500 1.5 0.003

Tribromomethane Three L(E)C50 from freshwater (algae, crustaceans and fish) + one L(E)C50 from seawater (algae) 10,000 18 0.0018

Dibromoacetonitrile Two L(E)C50 from freshwater (crustaceans and fish) + one L(E)C50 from seawater (crustaceans) 10,000 0.72 0.0000 72

2,4,6-Tribromophenol Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 1 0.0001

Monochloroacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 77 0.0077

Monobromoacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 34 0.0034

Dichloroacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 82 0.0082MEPC 58/2 ANNEX Page 62

I:\MEPC\58\2.doc Bromochloroacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 77 0.0077

Dibromoacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 65 0.0065

Tribromoacetic acid Three L(E)C50 from freshwater (algae, crustaceans and fish) 10,000 100 0.01

Sodium thiosulfate One L(E)C50 from freshwater (fish) + One long-term NOEC from freshwater (fish) 1000 600 0.6

The PNEC calculation results according to ballast wat er toxicity test endpoints

Chemical name Information available Assessment Factor Endpoint (mg/L) PNEC (mg/L)

Dibromochloromethane Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00197 0.0000 197

Tribromomethane Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.04965 0.0004 965

Dibromoacetonitrile Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.02149 0.0002 149

2,4,6-Tribromophenol Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00038 0.0000 038

Monochloroacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00126 0.0000 126

Monobromoacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00499 0.0000 499

Dichloroacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00064 0.0000 064

Bromochloroacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.00128 0.0000 128

Dibromoacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.02065 0.0002 065

Tribromoacetic acid Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 0.11425 0.0011 425

Sodium thiosulfate Three long-term NOECs from saltwater species (algae, crustaceans and fish) 100 24 0.24

5.3.6 Effects on sediment

Active Substances and Most Relevant Chemicals have low Log Pow and BCF values and it could be expected rapidly degraded in environmen t. Therefore, effects on sediment by Active Substances and Relevant Chemicals in ballast water would be low.MEPC 58/2 ANNEX Page 63

I:\MEPC\58\2.doc 5.3.7 Comparison of effect assessm ent with discharge toxicity

The Active Substance and Relevant Chemicals were measured in ECS-treated water. In the same concentration, aquatic toxi city tests were conducted. From the toxicity test results, no mortality was observed so that toxic effect to ECS-treat ed water for aquatic or ganism would be low.

6 RISK ASSESSMENT

6.1 Risk to safety of ship

Risk to the crew was assessed according to EA SE model in EUSES. From the EUSES results, ECS treated ballast water has low potential for the crew.

An extended corrosivity test was conducted on uncoated test samples as suggested by the GESAMP-BWWG in document MEPC 57/2. Th e corrosivity test was conducted by Mokpo National Maritime Universit y, the Republic of Korea.

As a result of electro-chemical experiment on uncoated sample s, ECS-treated water may not make significant effect on corrosion because it disinfects micro-organism with TRO 10mg/L.

Pipe material is also tested as sugge sted by the GESAMP-BWW G. All tested TRO concentrations do not affect corrosion of pipe based on Tafel analysis because it has similar corrosion potential in comparing electric current corrosivity.

Finally, the tanks in the test barge of Techcross Inc. have been used for more than two years. Therefore, it was able to observe corrosion of tanks in long-term perspective. The test barge is constructed by the same material with the actual vessels and it is operated in similar conditions. There is not any significant difference in corros ion between natural seaw ater and ECS-treated water, observing poles and ceiling of tanks. On the contrary, there is more corrosion detected in natural seawater than ECS-treated water in the as pect of ballast tank floor. The floor is the place where seawater remains for a long period so that it may be an important factor of corrosion. Consequently, ECS-treated water makes less eff ect on corrosion to test samples than natural seawater effects.

H 2 gas and Cl 2 gas are generated through electrolysis di sinfection process. The generated gases are very small amount, even though, for more safe ty, gas de-aeration equipment is installed on ballast pipe. Furthermore, on-line gas detector is installed and alarm system would work at exceeding 3% and 0.8 ppm of H 2 and Cl 2 , respectively. The ECS would be shut down at exceeding 4% and 1 ppm of H 2 and Cl 2 , respectively.

6.2 Risks to human health

Risk to human health for ECS ballast wa ter by-products was assessed by using EUSES. The effect assessment of Relevant Chemicals fo r carcinogenic and mutageni c was carried out in sections 2.3.6 “Carcinogenicity” and 2.3.7 “Mutagen icity”. Endocrine disr uptive properties were also carried out in se ction 2.2.3 “Endocrine disruption”. A Human Exposure Scenario (HES) was conducted according to EUSES Human Exposure Scenario.MEPC 58/2 ANNEX Page 64

I:\MEPC\58\2.doc In EUSES, risk assessment result is carri ed out by calculating “Margins Of Safety” (MOS)/Reference MOS. “MOS” means the ratio of the estimated no-effect or effect level parameter to the estimated exposur e level for human sub-populations.

If MOS/Ref MOS is above 1, the substance is of no immediate concern. If MOS/Ref MOS is below 1, the substance should be of concern.

Risk assessment results using EUSES showed th at ratio MOS/Reference MOS for ballast water by-products is > 1 to general populat ion in local and region al scale, therefore, ECS-treated ballast water has low risk poten tial for human health.

6.3 Risks to the aquatic environment

Risk to aquatic environment by Relevant Ch emicals was carried out by PEC/PNEC ratio. If PEC/PNEC ratio is less than or equal to 1, the substance is of no immediate concern. In PEC/PNEC ratio is greater th an 1, the substance should be of concern. Active Substances were not detected in treated ballast water so that ri sk assessment to aquatic environment for Active Substance was not considered. PNEC was determin ed in data-set endpoi nts and ballast water toxicity test endpoints so that PEC/PN EC was calculated in two endpoints.

If PEC/PNEC for by-products and neutralizer are < 1; therefore ECS-treated ballast water has low risk potential for aquatic environment.

Risk assessment results for aquatic envi ronment are summarized in table below.

PEC /PNEC ratio for aquatic environment in da ta-set endpoints and ballast water toxicity test endpoints

Chemical name Data-set endpoints Ballast water toxicity test endpoints

Dibromochloromethane 7.07E-07 0.0001076

Tribromomethane 1.09E-05 3.948E-05

Dibromoacetonitrile 2.22E-01 5.677E-05
2,4,6-Tribromophenol 3.96E-06 0.0001042

Monochloroacetic acid 1.39E-07 8.492E-05

Monobromoacetic acid 1.26E-06 8.577E-05

Dichloroacetic acid 8.71E-08 0.0001116

Bromochloroacetic acid 1.15E-07 6.891E-05

Dibromoacetic acid 3.57E-06 0.0001123

Tribromoacetic acid 1.29E-05 0.0001129

Sodium thiosulfate 0.000045 0.0001125MEPC 58/2 ANNEX Page 65

I:\MEPC\58\2.doc 7 ASSESSMENT REPORT

This report was written according to Procedure (G9).

Analysis on Active Substances and Relevant Chem icals test and toxicity test using discharge water at the land-based test as Type Appr oval test were conducted by Kong-Ju National University and Kyung Hee University, respectiv ely, in accordance with the quality system of KORDI.

7.1 Overview of data and endpoints

The data and endpoints for aqua tic environment and hu man health were collected by recommended database and reference according to the OECD Wo rk on Investigation of High Production Volume Chemicals. Reliability of Key Data Summary was followed by Klimisch et al . (1997).

Toxicity test has been conducte d by certified research laborat ory of Kyung Hee University in the Republic of Korea. The test water was co llected under the strict supervision of KORDI (Korea Ocean Research and Development Institute). During toxicity tests, the internationally recognized protocols such as EPA methods are applied. The test wate r is the same water used in the land-based tests for Type Approval and representative speci es were used. The test was conducted in compliance with Quality Assura nce Program of KORDI, certified by KOLAS.

KORDI certified by KOLAS measured TRO at land-based test and measurement of gas (H 2 and Cl 2 ). The chemical analysis of discharged water is conducted in accordance with EPA method and internationally recognized protocols with reliability. The testing body improves its reliability through strict QA/QC. All test pro cedures from sampling to pre-treatement are supervised by KORDI w ith KOLAS certification.

7.2 Risk assessment on ship, crew and en vironment during tests and development

Online gas monitoring system is installed in orde r to improve safety to ship and crew. Safety level is improved against gas upon installing de-aeration system . Moreover, the alarm system would work in case the gas concentration exceeds the limit level (in the application dossier 7.1, Appendix 5).

Risk to the crew was assessed according to EA SE model in EUSES 2.1. EASE was specifically developed by the UK Health and Safety Executi ve for the purpose of modelling inhalation and dermal workplace exposure across a wide range of circumstances. EASE is an analogue model, i.e. it is based on the measured data which are assigned to specific scenarios.

The applicant has instructed researcher, manage r and operator to wear helmets and protective gloves during installation, land-based test, and on- board test. Additionally, first-aid medicine is always prepared for emergency situ ation and accidents at test site.

7.3 Environmental exposure assessment
Toxicity to ECS-treated ballast water was tested to aquatic species in seawater according to EPA methods. The PEC of treated ballast water disc harges was performed using MAM-PEC model. Risk assessment of aquatic environment was conducted using PEC/PNEC ratio in data-set endpoints and ballast water toxicity test endpoints. Risk assessmen t of human health for general population and crew was performed us ing Ratio MOS/Ref-MOS by EUSES 2.1.MEPC 58/2 ANNEX Page 66

I:\MEPC\58\2.doc 7.4 Compliance with the Convention

It has been clarified from the result of land-based tests that Electro-Clean System (ECS) complies with the Convention. It meets the efficacy re quirements of the Convention as shown by the land-based test results. The land-based tests we re conducted five times with seawater and six times with brackish water. Based on the full-scale land-based tests, the removal efficacy of ECS satisfies the D-2 standard. The toxicity tests and risk assessments with its effluent water show that the ECS-treated water does not have harmful influence on human and aquatic environment at all.

7.5 Qualitative statement of the level of uncertainty

In case of gas measurement, the measurement results are lower in both on-barge test and shipboard test compared to the previous te st (MEPC 54/2/3). The potential influence of temperature on gas amount has been detected. All tests were c onducted under the strict quality assurance project plan of KORDI in order to minimize the uncertainties.

7.6 Risk management possibilities

The applicant provides safety inst ructions for unexpected emergenc y situations such as fire and disorder. Moreover, the alarm system and automa tic control program of ECS set off the alarm and automatically shut down the program if any risk to ship a nd crew is detected.MEPC 58/2 ANNEX Page 67

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