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

kindly asked to bring their copies to meetings and not to request additional copies.

I:\MEPC\59\2-16.DOC 

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

59th session 

Agenda item 2 

MEPC 59/2/16

 8 April 2009

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Report of the eighth meeting of the GESAMP-Ballast Water Working Group 

Note by the Secretariat 

SUMMARY

Executive summary: This document contains the report of the eighth meeting of 

the GESAMP-Ballast Water Working Group (GESAMP-BWWG) 

and includes the evaluation of proposals submitted for approval by 

Japan, Germany, the Republic of Korea and China. Following the 

decision of MEPC 58, only the main body of the GESAMP-BWWG’s 

reports is translated in all the three working languages with the 

annexes in English only. 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 3 

Related document: GESAMP-BWWG 8/6 (attached) 

Introduction

1 The eighth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) 

was held at IMO Headquarters from 16 to 21 February 2009 and its report is attached to this 

document as GESAMP-BWWG 8/6. 

2 The main purpose of this meeting was to review the proposals for approval of ballast water 

management systems that make use of Active Substances to treat ballast water prior to discharge 

into the marine environment. The findings of the Group are contained in annexes 4 to 8 of the 

attached report. 
GESAMP-BWWG 8/6 - 2 - 

I:\MEPC\59\2-16.DOC 

Action requested of the Committee

3 The Committee is invited to: 

 .1 agree that Final Approval is not given to the Special Pipe Hybrid Ballast Water 

Management System (combined with Ozone treatment) submitted by Japan in 

document MEPC 58/2/1 (see annex 4*

); 

 .2 agree that Final Approval is given to the RWO Ballast Water Management System 

(CleanBallast) submitted by Germany in document MEPC 59/2 (see annex 5); 

 .3 agree that Final Approval is given to the NK-O3 BlueBallast System (Ozone) 

submitted by the Republic of Korea in document MEPC 59/2/3 (see annex 6); 

 .4 agree that Basic Approval is given to the Blue Ocean Shield Ballast Water 

Management System submitted by China in document MEPC 59/2/2 

(see annex 7); 

.5 agree that Basic Approval is given to the HHI Ballast Water Management System 

(EcoBallast) submitted by the Republic of Korea in document MEPC 59/2/4 

(see annex 8); 

 .6 note the opinion of the GESAMP-BWWG that the application related to 

the HHI Ballast Water Management System (EcoBallast) also fulfilled the 

requirements of Procedure (G9) for Final Approval (see section 4.7 and annex 8); 

 .7 agree that ballast water management systems which employ UV light should 

also be reviewed in accordance with the requirements of Procedure (G9) 

(see paragraphs 4.2.2 and 4.2.3); 

 .8 urge Administrations to thoroughly evaluate the application dossiers and confirm 

that they are satisfactory and complete before submitting their proposals to the 

Organization in accordance with Procedure (G9) (see paragraphs 4.2.4 to 4.2.7); 

 .9 consider changing references to “Toxicity” in section 5 of Procedure (G9) to 

“Ecotoxicity” in order to remove any suggestion that mammalian toxicity studies 

need to be performed on treated ballast water (see annex 6, section 4.7); 

 .10 note the Group’s recommendations for corrosion testing contained in section 5.1 

of the report and invite Member and observers to submit their further 

contributions with a view to endorsing these recommendations and their inclusion 

in the Methodology at MEPC 60; and 

 .11 approve the report in general. 

*** 

 

*

 Paragraphs and annexes referred to in this section are those of document GESAMP-BWWG 8/6. 
I:\MEPC\59\2-16.DOC 

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

GESAMP-BALLAST WATER WORKING 

GROUP (GESAMP-BWWG) 

8th session 

Agenda item 6 

GESAMP-BWWG 8/6

 21 February 2009

 Original: ENGLISH

REPORT OF THE EIGHT MEETING OF THE GESAMP-BALLAST WATER 

WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

1 INTRODUCTION ....................................................................... 3 

2 ISSUES OF CONFIDENTIALITY ............................................ 3 

3 TERMS OF REFERENCE AND TIME FRAME ....................... 4 

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS ........................................................... 5 

5 ANY OTHER BUSINESS.................................................. 7 

6 CONSIDERATION AND ADOPTION OF THE REPORT .......... 10 
GESAMP-BWWG 8/6 - 2 - 

I:\MEPC\59\2-16.DOC 

ANNEXES 

ANNEX 1 List of members attending the eighth session of the GESAMP-BWWG 

ANNEX 2 Agenda for the eighth session of the GESAMP-BWWG 

ANNEX 3 Terms of reference and time frame for the GESAMP-BWWG 

ANNEX 4 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – Special Pipe Hybrid Ballast Water Management System 

(combined with Ozone treatment) also referred to as the SP-Hybrid BWMS Ozone 

version (Japan) 

ANNEX 5 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – RWO Ballast Water Management System, CleanBallast 

(Germany) 

ANNEX 6 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – NK-O3 BlueBallast System (Republic of Korea) 

ANNEX 7 Review of proposals for approval of ballast water management systems that make 

use of Active Substances –Blue Ocean Shield Ballast Water Management System 

(China) 

ANNEX 8 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – HHI BWMS, EcoBallast (Republic of Korea) 
 - 3 - GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

1 INTRODUCTION 

1.1 The eighth GESAMP-Ballast Water Working Group (GESAMP-BWWG) meeting was 

held at IMO Headquarters, London, from 16 to 21 February 2009, under the chairmanship 

of Mr. Jan Linders. A list of members attending this meeting is shown in annex 1 and the 

agenda, as adopted by the Group, is set out in annex 2. 

1.2 The meeting was opened by Mr. Miguel Palomares, Director of Marine Environment 

Division, who informed the Group that 12 proposals for approval had been submitted for 

consideration by MEPC 59 in accordance with the agreed deadline of 19 December 2008. 

Mr. Palomares expressed his appreciation for the effort made by the members of 

the GESAMP-BWWG to have an additional meeting (the ninth meeting) in March 2009, and to 

extend the eighth meeting over the weekend in an attempt to evaluate as many proposals as 

possible. He drew the attention of the Group to the importance of reviewing the various 

proposals in the chronological order of their submissions to ensure complete transparency and a 

fair treatment for all the proponent Member States. It should be noted, in this context, that the 

outcomes of GESAMP-BWWG (8) and (9) will both be reported to MEPC 59. 

1.3 Mr. Palomares noted that, in view of the rapidly increasing workload for the Group and 

the importance and need for timely review of the proposals for approval, IMO would take all the 

possible actions to increase the effectiveness and efficiency of the Group in the common effort to 

respond to the increased number of proposals for approval. In this respect, Mr. Palomares 

expressed his appreciation for the productive stocktaking meeting of the Group in January and 

pledged IMO’s support for further developing the new tools identified during the workshop, 

including the adapted MAMPEC computer model and the hazard classification of the most 

frequently occurring chemicals in ballast water treatments. He welcomed the collaboration 

with GESAMP WG 1 (the GESAMP-EHS Group) and encouraged further co-operation in 

the GESAMP family. 

1.4 Finally, Mr. Palomares expressed his appreciation for the effort made by the 

two IMO consultants, Mr. John Crayford and Dr. Andrew Craven, for their hard work in 

preparing this meeting and for reviewing a large amount of documentation in a relatively short 

period of time. 

1.5 Mr. Dandu Pughiuc, Head of the Marine Biosafety Section, Marine Environment 

Division, reported on the contractual arrangements and informed the Group on the logistics of the 

meeting. He also informed the Group that, at the request of Dr. Stephan Gollasch, arrangements 

had been made for him to be excused when the proposal for approval of the RWO Ballast Water 

Management System (Germany) is reviewed, due to his involvement in the development of this 

technology. Dr. Gollasch took no part in this evaluation and his contract was consequently 

reduced to ten working days. 

2 ISSUES OF CONFIDENTIALITY 

2.1 Two proposals for Basic Approval of ballast water management systems that make use 

of Active Substances had been submitted by China (MEPC 59/2/2) and the Republic of Korea 

(MEPC 59/2/4) and one proposal for Final Approval had been submitted by Japan 

(MEPC 59/2/1). In addition, the Republic of Korea (MEPC 59/2/3) and Germany (MEPC 59/2) 

had re-submitted their proposals for Final Approval. All five submissions contained confidential 

supporting data. 
GESAMP-BWWG 8/6 - 4 - 

I:\MEPC\59\2-16.DOC 

2.2 The confidential nature of the information was recognized by the Group and was treated as 

such in order to protect the commercial interests of the manufacturers concerned. In order to ensure 

that the report did not contain any confidential information, the Group noted that the Secretariat 

would liaise with the relevant Administrations prior to submitting the report to MEPC. 

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast 

water management systems that make use of Active Substances (G9)”, all information gathered, 

materials, notes and reports obtained or made out during the work of the GESAMP-BWWG, 

were, and will be, treated as confidential. In this respect, all the members of the Group and 

the Consultants signed the Statements of Acceptance related to confidentiality. 

2.4 The original copies of these Statements, duly signed and dated by all involved, were filed 

with the Technical Secretary of the Group and will be kept together with the submissions. 

2.5 The submissions (dossiers) were deposited in a safe place in the IMO Headquarters and 

made available to the Consultants, at their request, during the working hours. They were 

available for consultation by the members of the Group for the duration of the meeting in the 

meeting room and returned to the Organization’s designated room after the working hours. 

2.6 On completion of the work, the Chairman of the GESAMP-BWWG obtained from the 

other members all the documents, drafts and any other associated records and reports, which 

were transmitted to the Technical Secretary of the GESAMP-BWWG for retention in confidence. 

All electronic records and data held on personal computers/laptops were destroyed when they 

were no longer necessary for the work of the GESAMP-BWWG. 

3 TERMS OF REFERENCE AND TIME FRAME 

3.1 The Group agreed to continue to be guided by the Terms of Reference approved 

by MEPC as contained in annex 3 of this report. 

3.2 The Group used the table below to determine the timetable for activities related to its 

regular meetings and agreed to decide, on a case-by-case basis, on the timing of additional 

meetings as appropriate. 

TIMETABLE FOR ACTIVITIES RELATED TO GESAMP-BWWG MEETINGS 

Timeline Activity 

28 weeks before MEPC Deadline for submission of application dossiers and related 

documents to be reviewed by the GESAMP-BWWG 

(8 weeks) Preparation of the meeting, including circulation of any relevant 

information provided by other delegations 

20 weeks before MEPC GESAMP-BWWG Meeting 

(1 week) Editing and completion of the draft report of the meeting 

(3 weeks) Review and approval of the report by GESAMP 

(1 week) Administrations confirm that no confidential data are contained 

in the report 

(1 week) Produce the final report addressing the comments by GESAMP 

13 weeks before MEPC Submission of the report of the meeting of the GESAMP-BWWG 

in accordance with the 13 weeks’ deadline for MEPC 
 - 5 - GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

3.3 The Group reconfirmed that its next meeting will take place from 23 to 27 March 2009 

to review as many as possible the remaining proposals received before the deadline 

of 19 December 2008. The Group agreed that, due to the large number of proposals received 

before the above-mentioned deadline, any proposals for approval that could not be reviewed in 

the next meeting, would be reviewed at subsequent meetings of the Group after MEPC 59 and 

will be reported to MEPC 60. 

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS 

4.1 Organisation of work

4.1.1 The Group noted that MEPC 59 had received 12 submissions for either Basic Approval 

or Final Approval. 

4.1.2 In an attempt to deal with this heavy workload, the Group concentrated its efforts on 

reviewing applications at this meeting and so did not have any significant discussions on 

the Methodology which it had done in previous meetings. 

4.1.3 As a result and with an additional working day, the Group was able to review 

three submissions for Final Approval and two submissions for Basic Approval. 

4.2 General observations resulting from review of the submissions 

4.2.1 Having reviewed all of the submissions, the Group agreed that there are a number of 

points arising which it wished to bring to the attention of MEPC. These are addressed in the rest 

of this section. 

4.2.2 Whilst previously, there had been some suggestions that systems employing U.V. light to 

treat ballast water might not produce chemical disinfection by-products, it is now considered that 

this might not be the case as some effects were shown in one of the systems reviewed. 

The Group considered that such finding emphasized the need to carry out ecotoxicological tests 

on the treated ballast water. 

4.2.3 As a result, the Group requested MEPC to agree that systems employing U.V. light to 

treat ballast water should also be considered as candidates for review in accordance 

with Procedure (G9). 

4.2.4 The Group agreed that each applicant should make a clear reference to the Methodology 

version being followed in the preparation of their application. 

4.2.5 The Group noted that, during this meeting, it was necessary to request additional 

information or clarification from all the applicants, as the dossiers were incomplete or, more 

commonly, the information provided was unclear, so slowing down the evaluation process. 

4.2.6 In this context, the Group invited MEPC to note that time spent evaluating inadequate 

dossiers prevented it from evaluating those that were complete and likely to be recommended for 

approval. 
GESAMP-BWWG 8/6 - 6 - 

I:\MEPC\59\2-16.DOC 

4.2.7 As a result, the Group reiterated its request to MEPC to urge each Administration to 

check that all technical descriptions and specifications of the BWMS and, in particular, those 

related to the operating conditions are included with each application. Equally important, all data 

pertaining to the safety of the ship and crew, human health and environmental exposure and risk 

need to be submitted with each application. Every application has to be fully evaluated by 

the Group and, whether it is recommended for approval or not, it takes the same amount of time. 

An application that is not recommended for approval may, therefore, deny another potential 

applicant the chance of an early and possibly successful evaluation. 

4.3 Detailed review of the submissions

4.3.1 Details of the submissions reviewed by the Group can be seen in: 

Annex BWMS Administration 

4 Special Pipe Hybrid Ballast Water Management System 

(combined with Ozone treatment) also referred to as the 

SP-Hybrid BWMS Ozone version 

Japan 

5 RWO Ballast Water Management System 

(CleanBallast) 

Germany 

6 NK-O3 BlueBallast System (Ozone) Republic of Korea 

7 Blue Ocean Shield Ballast Water Management System China 

8 HHI Ballast Water Management System (EcoBallast) Republic of Korea 

4.3.2 With regard to the criteria associated with Procedure (G9), having reviewed all of the 

information associated with these submissions, the Group recommended that: 

 .1 Final Approval be not given for Special Pipe Hybrid Ballast Water Management 

System (combined with Ozone treatment) also referred to as the SP-Hybrid 

BWMS Ozone version; 

 .2 Final Approval be given to RWO Ballast Water Management System 

(CleanBallast); 

 .3 Final Approval be given to NK-O3 BlueBallast System (Ozone); 

 .4 Basic Approval be given to Blue Ocean Shield Ballast Water Management 

System; and 

.5 Basic Approval be given to HHI Ballast Water Management System (EcoBallast). 

4.4 Specific comments related to Special Pipe Hybrid Ballast Water Management 

System (combined with ozone treatment)

4.4.1 After consultation with the applicant, the Group noted that the ballast water 

management system requires a minimum salinity of 17 PSU. Consequently, the system cannot 

be used to treat freshwater or lower salinity brackish waters. 
 - 7 - GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

4.5 Specific comments related to CleanBallast

4.5.1 The Group noted, with appreciation, the submission of Germany (MEPC 59/2) with 

respect to the evaluation of corrosion effects for ballast water management systems 

utilizing Active Substances and was of the view that this provided a framework, with additions 

and revision, for future evaluations to assess corrosion effects. Specifically, the Group 

recommends that corrosion effects should be evaluated through long-term testing (>6 months) of 

relevant materials at the maximum treatment or exposure concentration with the test conditions 

and evaluations as further pointed out in section 5.1 below. 

4.5.2 As a consequence of reviewing this application, the Group made further observations 

related to corrosivity testing which are described under Any Other Business (Section 5). 

4.6 Specific comments related to Blue Ocean Shield Ballast Water Management System

4.6.1 In recommending that Basic Approval be given to Blue Ocean Shield Ballast Water 

Management System, the Group would like to point out that the documentation of this 

application was poorly presented and lacked some information. However, it was agreed that 

sufficient aspects of this system were presented to allow the Group to be satisfied that further 

large-scale testing could be carried out without significant risk to the crew, the ship and the 

environment. 

4.6.2 As a result, the applicant is advised to review the requirements of Procedure (G9) and 

ensure that all of these are met when making the application for Final Approval, taking note of 

the remarks in the evaluation (Annex 7). 

4.7 Specific comments related to HHI Ballast Water Management System (EcoBallast) 

4.7.1 The Group noted that the eco-toxicity testing had been performed as a full-scale 

land-based test in accordance with the requirements of Procedure (G9) for Final Approval. 

 

4.7.2 In evaluating the application for Basic Approval, the Group noted that the required tests 

had been performed correctly and that the results demonstrated that the system met the 

requirements of Procedure (G9) to allow it to be recommended for Final Approval. 

5 ANY OTHER BUSINESS 

5.1 Recommendations for corrosion testing 

5.1.1 Having reviewed the application for CleanBallast, the Group recommended that 

applicants should take account of the following points related to corrosivity testing: 

 .1 testing should include uncoated substrates and marine epoxy coated steel; 

Coatings should be in accordance with the IMO Performance standard for 

protective coatings for dedicated seawater ballast tanks in all types of ships and 

double-side skin spaces of bulk carriers (MSC.215(82)); 

 .2 substrates should include low carbon steel and other metals (e.g., stainless steel, 

Cu alloys and Ni alloys) and non-metals (e.g., gasket and seal materials) as may 

be found in a ships seawater piping, fittings and structures which will be exposed 

to the Active Substance, Relevant Chemicals or Disinfection By-products; 
GESAMP-BWWG 8/6 - 8 - 

I:\MEPC\59\2-16.DOC 

.3 in the case that passive materials are exposed to the Active Substances, 

Relevant Chemicals or Disinfection By-products, these should be examined for 

localized corrosion resistance by immersion with specimen configurations as 

defined in ASTM G78 Standard Guide for Crevice Corrosion Testing of 

Iron-Base and Nickel-Base Stainless Alloys in Seawater and Other 

Chloride-Containing Aqueous Environments. As an additional evaluation, short 

term laboratory tests should be conducted in accordance with 

ASTM G61 – 86(2003) e1 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements for Localized Corrosion 

Susceptibility of Iron-, Nickel-, or Cobalt-Based Alloys; 

 .4 testing of coated substrates should be conducted using ISO 2812-2:2007 Paints 

and varnishes – Determination of resistance to liquids – Part 2: Water immersion 

method as guidance; 

 .5 testing should be conducted with controls (untreated) and treated effluents under 

continuous exposure and also, if appropriate, intermittent exposure of the 

specimens at the maximum treatment concentration of the ballast water 

management system ASTM G31 – 72(2004) Standard Practice for Laboratory 

Immersion Corrosion Testing of Metals can be used as a guide for such testing. 

As a minimum, testing source waters should be conducted using full strength, 

once-through (not refreshed) natural seawater. If appropriate, testing should also 

include testing in fresh or brackish water; 

 .6 test duration should not be less than 6 months; 

 .7 subsequent evaluation of uncoated materials should include an evaluation of the 

corrosion rate, by weight loss, and the depth and density of localized corrosion 

(i.e. pitting or crevice attack). These evaluations may be made with the assistance 

of ISO 11463 Corrosion of Metals and Alloys – Evaluation of Pitting Corrosion 

and ASTM G 46 Guide for Examination and Evaluation of Pitting Corrosion; 

 .8 subsequent evaluation of coated materials and coating properties of both controls 

and samples exposed to treatment conditions should include: 

 .1 coatings adhesion according to ISO 4624 Paints and Varnishes 

– Pull-Off Test for Adhesion; 

 .2 degree of blistering according to ISO 4628-2 Paints and Varnishes – 

Evaluation of Degradation of Coatings – Designation of Quantity and Size 

of Defects, and of Intensity of Uniform Changes In Appearance 

– Part 2: Assessment of Degree of Blistering; 

 .3 degree of rusting according to ISO 4628-3 Paints And Varnishes – 

Evaluation of Degradation of Coatings – Designation Of Quantity And 

Size of Defects, and of Intensity of Uniform Changes in Appearance 

– Part 3: Assessment of Degree of Rusting; 

 .4 degree of cracking according to ISO 4628-4 Paints and Varnishes – 

Evaluation of Degradation of Coatings – Designation of Quantity And Size 

of Defects, and of Intensity of Uniform Changes in Appearance 

– Part 4: Assessment of Degree of Cracking; 
 - 9 - GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

 .5 degree of flaking according to ISO 4628-5 Paints And Varnishes – 

Evaluation of Degradation of Coatings – Designation of Quantity and Size 

of Defects, and of Intensity of Uniform Changes In Appearance 

– Part 5: Assessment of Degree of Flaking; and 

 .6 degree of delamination around a scribe according to ISO 4628-8 Paints 

and Varnishes – Evaluation of Degradation of Coatings – Designation of 

Quantity and Size Of Defects, and of Intensity of Uniform Changes in 

Appearance – Part 8: Assessment of Degree of Delamination and Corrosion 

Around a Scribe. 

5.2 Next Stocktaking Workshop

5.2.1 The Group agreed that it would be very useful to hold a second stocktaking workshop, in 

the autumn of 2009, in order to discuss general problems arising from the review of applications 

for approval. In addition, it was thought necessary to continue developing those aspects of 

the Methodology which would assist the applicants in preparing dossiers and the Group for 

reviewing applications. 

5.2.2 The Group agreed that the following issues should be included in the workshop: 

 .1 Comparison of TRO in different systems – In this context, the Group had become 

aware that TRO is expressed in different ways by applicants and that, to achieve 

some consistency whilst making the reporting meaningful, it would be necessary 

to discuss the issue in depth prior to making recommendations; 

 .2 Check list for BA and FA – The Group agreed that it would be useful to develop a 

checklist, for reference by applicants and Administrations when generating 

dossiers for the Group to review; 

 .3 Human Exposure Scenario – The Group recognized that the HES still required 

significant development before it can be used properly by the applicant and 

reviewed by the Group; 

 .4 Modelling of Predicted Environmental Concentrations – The Group recognized 

the need to finalize the input parameters that would be most usefully employed by 

the MAMPEC model for calculating environmental concentrations of disinfectant 

by-products; 

 .5 Testing of volatile chemical by-products – Recognizing that GESAMP–WG 1 has 

developed protocols for the ecotoxicological testing of volatile compounds, 

the Group agreed that it would be useful to discuss the relevance of this to the 

testing of treated ballast water; 

 .6 Consideration of systems producing DBP – The Group agreed that further 

consideration needs to be given to the disinfectant by-products generated by 

generic types of systems, e.g., U.V. light and electrolysis; and 

 .7 Development of a model application – Recognizing that most of the applications 

are not well presented, it was agreed that it would be useful to develop a model 

dossier for applicants to follow when submitting documentation of their systems 

for review by the Group. 
GESAMP-BWWG 8/6 - 10 - 

I:\MEPC\59\2-16.DOC 

6 CONSIDERATION AND ADOPTION OF THE REPORT 

6.1 A draft report of the eighth meeting of the GESAMP-BWWG was produced 

on 21 February 2009 and, after a paragraph-by-paragraph review, the Group agreed on the final 

text and requested the Secretariat to make the necessary editorial changes to ensure consistency 

with IMO documents’ format and style. 

6.2 The Chairman expressed his appreciation for the long hours and substantial efforts made 

by the members of the Group throughout the week and closed the meeting at 17 h 30. 

*** 
GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 1 

LIST OF MEMBERS WHO ATTENDED THE EIGHTH SESSION 

OF THE GESAMP-BWWG 

Mr. Jan Linders (Chairman) 

Senior Risk Assessor 

National Institute for Public Health and 

 Environment Expert Centre on Substances 

Anthonie van Leeuwenhoeklaan 9 

RIVM-SEC 

P. O. Box 1 

NL-3720 BA Bilthoven 

The Netherlands 

E-mail : jan.linders@rivm.nl 

Tel : +31 30 274 3164 

Fax : +31 30 274 4401 

Ms Teresa Borges 

Senior Technical Officer 

Avenida Rio de Janeiro, no 58, 3o dto 

1700-338 Lisbon 

Portugal 

E-mail : tborges@dgs.pt 

Tel : +351 2 1843 0599 

Mobile : +351 9 1779 8048 

Dr. Stephan Gollasch 

GoConsult 

Grosse Brunnenstr. 61 

22763 Hamburg 

Germany 

E-mail : sgollasch@aol.com 

Tel : +49 40 390 54 60 

Mobile : +49 177 590 54 60 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15-16 Toranomon 

Minato-ku 

Tokyo 105-0001 

Japan 

E-mail : s-hanayama@sof.or.jp 

Tel : +81 3 3502 1886 

Fax : +81 3 3502 2033 

Mobile : +44 791 213 2909 

Ms Annette Kronborg 

Director 

Adalia Toxicology Consultants 

Runslingan 3E 

SE-187 72 TÄBY 

Sweden 

E-mail : annette.kronborg@adalia.se 

Tel : +46 8 510 149 36 

Fax : +46 8 510 126 02 

Mobile : +46 70 483 11 23 

Mr. Edward Lemieux 

Section Head, Corrosion Engineering, Code 6136 

Center for Corrosion Science & Engineering 

Naval Research Laboratory 

Key West, Florida 

USA 

E-mail : edward.lemieux@nrl.navy.mil 

Tel : +1-305-293-4214 

Fax : +1-305-293-4213 

Mobile : +1-240-475-6918 
GESAMP-BWWG 8/6 

ANNEX 1 

Page 2 

I:\MEPC\59\2-16.DOC 

Dr. Kitae Rhie, 

Professor of Biology Department 

Kyung Hee University 

#1 Hoe-ki Dong 

Dong-dae-moon Ku 

Seoul 130-701 

Republic of Korea 

E-mail : rhiekt@khu.ac.kr 

Tel : +82 2 961-0720 

 : +82 2 961-0603 (Lab) 

Fax : +82 2 961 0244 

Mobile : +82 16 9343 3860 

Dr. Frank Stuer-Lauridsen 

LITEHAUZ ApS 

Diplomvej 381 

DK 2800 Lyngby 

Denmark 

E-mail : fsl@litehauz.dk 

Tel : +45 8870 8675 

Mobile : +45 2023 0202 

IMO-GESAMP CONSULTANTS 

Dr. Andrew Craven 

23 Wenlock Drive 

Escrick 

York YO19 6JB 

United Kingdom 

E-mail : andrew.craven7@btinternet.com 

Mobile : +44 (0) 7849 070 668 

Fax : +44 (0) 1904 728 428 (H) 

Mr. John Crayford 

2 Dunmow Hill 

Fleet 

Hampshire 

GU51 3AN 

United Kingdom 

E-mail (home) : j.crayford@ntlworld.com 

E-mail (work) : j.crayfor@imo.org 

Tel : +44 (0)1252 672245 
GESAMP-BWWG 8/6 

ANNEX 1 

Page 3 

I:\MEPC\59\2-16.DOC 

GESAMP 

Mr. Martin Soderberg 

GESAMP Officer 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment, London SE1 7SR 

United Kingdom 

E-mail : msoderbe@imo.org 

Tel : +44 (0)20 7463 4139 

Fax : +44 (0)20 7587 3210 

Mobile : 0755 269 9604 

IMO SECRETARIAT 

Mr. Miguel Palomares 

Director 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail : mpalomares@imo.org 

Tel : +44 (0)20 7587 3218 

Fax : +44 (0)20 7587 3210 

Mr. René Coenen 

IMO Technical Secretary to GESAMP 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail : rcoenen@imo.org 

Tel : +44 (0)20 7587 3239 

Fax : +44 (0)20 7587 3261 

Mr. Dandu Pughiuc 

IMO Technical Secretary to GESAMP-BWWG 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail : dpughiuc@imo.org 

Tel : +44 (0)20 7587 3247 (Direct) 

Fax : +44 (0)20 7587 3261 

Mr. Huang Tianbing 

Technical Officer, Marine Biosafety Section 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail : thuang@imo.org 

Tel : +44 (0)20 7463 4198 

Fax : +44 (0)20 7587 3261 

*** 

GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 2 

PROVISIONAL AGENDA FOR THE EIGHTH MEETING OF 

THE GESAMP-BALLAST WATER WORKING GROUP 

1 Introduction 

2 Issues of confidentiality 

3 Terms of reference and time frame 

4 Review of proposals for the approval of Active Substances 

 .1 Special Pipe Hybrid BWMS – combined with ozone treatment (Japan) 

 .2 CleanBallast (Germany) 

 .3 NK-O3 BlueBallast System (Ozone) (Republic of Korea) 

 .4 Blue Ocean Shield BWMS (China) 

 .5 HHI BWMS (EcoBallast) (Republic of Korea) 

5 Any other business 

6 Consideration and adoption of the report 

*** 

GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 3 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with the Procedure for approval of ballast water management systems that make 

use of Active Substances (G9) (adopted by resolution MEPC. 169(57)) for consideration 

by MEPC 59. 

2 For Basic Approval, the Group should review the comprehensive proposal submitted by 

the Member of the Organization along with any additional data submitted as well as other 

relevant information available to the Group and report to the Organization. 

 In particular, the Group should undertake: 

.1 scientific evaluation of the data-set in the proposal for approval 

(see paragraphs 4.2, 6.1, 8.1.2.3, 8.1.2.4 of Procedure (G9)); 

.2 scientific evaluation of the assessment report contained in the proposal for 

approval (see paragraph 4.3.1 of Procedure (G9)); 

.3 scientific evaluation of the risks to the ship and personnel to include consideration 

of the storage, handling and application of the active substance 

(see paragraph 6.3 of Procedure (G9)); 

.4 scientific evaluation of any further information submitted 

(see paragraph 8.1.2.6 of Procedure (G9)); 

.5 scientific review of the risk characterization and analysis contained in the proposal 

for approval (see paragraph 5.3 of Procedure (G9)); 

.6 scientific recommendations on whether the proposal has demonstrated a potential 

for unreasonable risk to the environment, human health, property or resources 

(see paragraph 8.1.2.8 of Procedure (G9)); and 

.7 preparation of a report addressing the above-mentioned aspects for consideration 

by MEPC (see paragraph 8.1.2.10 of Procedure (G9)). 

3 For Final Approval, the Group should review the discharge testing (field) data and 

confirm that the residual toxicity of the discharge conforms to the evaluation undertaken 

for Basic Approval and that the previous evaluation of the risks to the ship and personnel 

including consideration of the storage, handling and application of the active substance remains 

valid. The evaluation will be reported to the MEPC (see paragraph 8.2 of Procedure (G9)). 

4 The Group should keep confidential all data, the disclosure of which would undermine 

protection of the commercial interests of the applicant, including intellectual property. 

*** 

GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 4 

REVIEW OF PROPOSALS FOR THE APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

Special Pipe Hybrid Ballast Water Management System (combined with Ozone treatment) 

also referred to as the SP-Hybrid BWMS Ozone version 

Submitted for Final Approval by Japan as MEPC 59/2/1 

0 SUMMARY 

0.1 Having considered the responses of the applicant to the concerns expressed during the 

evaluation of the system for Basic Approval and the additional information provided, the Group 

agreed to recommend that the Special Pipe Hybrid Ballast Water Management System (combined 

with Ozone treatment) should not be given Final Approval. 

0.2 Reasons for not recommending that Final Approval be given: 

 .1 the level of maximum discharge concentration; 

 .1 the applicant submits that the maximum discharge concentration, after 

adjustment of background concentrations, of TRO is 0.69 mg/L as O3

(1.02 mg/L as Cl2) and the Group considered this an unacceptably 

high level of TRO for marine environmentally safety. The Group is of the 

position that even if 1.02 mg/L as Cl2 was partly caused by natural 

background levels (ca. 0.02 mg O3 /L), which could be measured only 

around the test facility, the authority or Administration of another port with 

lower TRO levels could not accept such ballast discharge as usual 

operation; 

 .2 the confirmation of the performance by Discharge Water Treatment Tank (DWTT) 

to ensure maximum discharge concentration; 

 .1 the Group noted that the treatment of the discharge is done through 

passage of the DWTT which is noted to alarm at a TRO of 0.15 mg/L 

(as O3) and an automatic shutdown at 0.2 mg/L (as O3). Despite this 

the Group was concerned that the applicant did not adequately show 

that DWTT, used to regulate TRO, was capable of removing high dosages 

of TRO; 

 .2 also the Group noted that the applicant should provide more information 

and evidence to ensure DWTT had sufficient absorption capacity for the 

recommended 2070 hours’ maintenance period; 

 .3 after further communication with the applicant, the Group concluded that 

this component of the system has not yet been developed or tested in an 

operational system; and 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 2 

I:\MEPC\59\2-16.DOC 

 .4 further, the requirement of the DWTT or other neutralizing system should 

be to lower the TRO sufficiently for the entire discharge, not just that 

portion which is deemed a result of the treatment system as these effects 

are likely inseparable; 

 .3 the Group noted that the testing conducted by the applicant was with natural waters 

having a background concentration of 0.21 to 1.21 mg/L TRO as O3. The Group 

considers such testing inappropriate and recommends that full-scale testing 

conducted for the purposes of submitting data for Basic or Final Approval be 

conducted in natural waters with TRO less than 0.02 mg/L as Cl2. Also, the Group 

noted that the analytical method for measurement of TRO, which the applicant 

applied during ecotoxicity testing and performance test of DWTT, only ensures the 

detection level of 0.15 mg/L as O3 (0.22 mg/L as Cl2). The Group was of the 

opinion that this detection level is too high to evaluate the concentration 

after DWTT. (See 5.5); and 

 .4 corrosivity – the Group noted that the applicant attempted to evaluate long-term 

performance based on the inspection of in-service shipboard tanks, piping and 

pumping systems, but the Group agreed that visual examination of such broad 

areas was insufficient, alone, without usage history or tank pre-condition, to 

characterize corrosion impact, as concluded previously in document MEPC 58/2/7 

GESAMP-BWWG 6/9, annex 7, paragraph 4.7.5. Though the Group encourages 

the inspection of shipboard systems subjected to the Active Substances to be 

certain that no obvious or extensive failures have occurred as a result of use with 

the treatment system, these should not be considered a sufficient replacement for 

long-term studies on both uniform and localized corrosion rates at the anticipated 

treatment concentration of Active Substances (See 5.4). 

0.3 In making this recommendation, the Group also expressed the following concerns: 

 .1 TRO measurements – With regards to the measurement of TRO, TRO 

measurements for all scales of testing and for each type of test (i.e. acute toxicity, 

chronic toxicity, lon- term DWTT performance, etc.) were made on discrete 

samples collected at the test facility and transported to the laboratory. These 

measurements were conducted the next day allowing significant time (>12 hours) 

for oxidant decay and so were likely underestimate the actual TRO in any given 

sample. Further concern was evident in the TRO measurements as a significant 

concentration of oxidant was measured in the raw seawater with up to 1.21 mg 

TRO /L (as O3). These are very high concentrations of oxidant in natural waters 

and likely compromises the validity of these tests (See 5.7); 

 .2 Functioning of the DWTT – The DWTT was tested for 230 hours at small scale 

with a flow rate of 20 m3

/h with no reduction in TRO removal and only some 

reduction in bromoform removal over the test period. Finally, the applicant 

suggested that the DWTT activated carbon should be refreshed at 2070 hours for 

ships up to 1400 m3

/h (See 5.9); 

 .1 The Group was concerned with the DWTT discharge treatment system 

since activated carbon removal of the Active Substances, Relevant 

Chemicals and disinfection by-products will be related to flow rate and 

total volume treated. The applicant only tested the system at <0.2% of the 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 3 

I:\MEPC\59\2-16.DOC 

suggested total volume capacity and anticipated flow rate for the 

recommended exchange cycle of the DWTT. Moreover, since the DWTT 

is arranged to automatically shutdown the discharge in the event of 

excessive TRO and since the DWTT cannot be refreshed during ship 

operations, this scenario could reasonably be expected to result in the 

inability to discharge pollutant free treated discharge water. With respect 

to the TRO of the discharge, the applicant notes that the system is designed 

to automatically shutdown if the TRO exceeds 0.2 mg/L, yet the 

discharges reported in Section 6.5 are as high as 0.46 mg/L (as O3). It is 

not clear whether the proposed TRO control deducts the background 

concentration to make its analysis or whether the TRO monitoring system 

was not employed during this or the other testing (See 5.5); 

 .3 Residual toxicity in treated ballast water – The Group noted that the various 

required tests were conducted at different scales. Specifically, the acute toxicity 

testing was conducted at a full-scale land-based test facility in accordance 

with Guidelines (G8) at 200 m3/h. The Group noted that whilst the TOC values 

were in accordance with Guidelines (G8), the DOC values were less than half the 

required value. The chronic toxicity tests were conducted at a small-scale test 

facility not in accordance with Guidelines (G8) at a flow rate of 20 m3

/h and only 

at one salinity (seawater). Finally, the long-term performance of the DWTT was 

conducted at 20 m3/h and was neither tested at full scale nor with the proposed 

integrated TRO sensor (See 5.6); and 

 .4 The Group recalled that in the dossier on the SP-Hybrid BWMS the substance 

ozone was defined as an Active Substance with a half life of about 5 s. Therefore, 

the Group did not consider that ozone was of any concern to the environment; 

 .1 In performing the calculations with the model MAMPEC, the applicant 

used TRO expressed as O3 as a Relevant Chemical and defined a worst 

case estimation of TRO as O3 of 4.5 d. This may lead to confusion with 

the concept of ozone being of no relevance to the environment. The Group 

advises the applicant to use a definition of TRO that expresses the 

concerns for the remaining residual oxydant more appropriately. 

0.4 Notwithstanding these remarks, the Group also made the following observations: 

 .1 The Group was satisfied that the risks to the crew from exposure to ozone and 

bromate could be mitigated by adequate engineering control measures and use 

of Personal Protective Equipment and Respiratory Protective Equipment 

(PPE/RPE). 

 .2 The Group also recognized that the Applicant made a good attempt to build up the 

various human exposure scenario (HES) concerning occupational (e.g., inspection 

of ballast water tank as well as tank cleaning) and general public exposure 

(swimming and eating fish from the area) to bromoform. 

 .3 The overall conclusion is: there is no reason for concern with regards to human 

exposure to this relevant chemical in the concentrations as generated by the 

system. However, some aspects in the HES ought to be further elaborated by the 

applicant (allocation of appropriate assessment factors). 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 4 

I:\MEPC\59\2-16.DOC 

 .4 After consultation with the applicant the Group noted that the BWMS requires a 

minimum salinity of 17 PSU for it to function and so its application should be 

limited accordingly. 

1 INTRODUCTION

1.1 It was recalled that the SP-Hybrid BWMS Ozone version had been recommended 

for Basic Approval at the second meeting of the Group as the Special Pipe Ballast Water 

Management System (combined with Ozone treatment). This was given Basic Approval 

by MEPC 55. 

1.2 The data used to evaluate the SP-Hybrid BWMS Ozone version were extracted from 

the Japanese submission to the fifty-ninth session of MEPC as document MEPC 59/2/1. 

2 COMPLETENESS OF THE DOSSIER

2.1 Whilst recognizing that there were some omissions from the submission, the Group 

agreed that such omissions were either justified or of minor significance. 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group noted that the system being considered for Final Approval was the same as 

that which had been given Basic Approval with the following exceptions: 

 .1 the name had been changed and the reference to ozone is important to 

differentiate it from another system being developed which uses different 

Active Substances to ozone; and 

 .2 the post-treatment DWTT is applied to all ballast water discharge so that there is 

no need to specify the storage time of treated ballast water in the tank to reduce 

the level of ozone present; and 

 .3 the applicant for Basic Approval was the Japan Association of Marine Safety 

whilst the applicant for Final Approval is Mitsui Engineering & Shipbuilding Co. 

However, in both cases, the applications were submitted to MEPC from 

the Japanese Government. 

3.1.2 Noting these exceptions, the Group recalled that the ballast water treatment and 

disinfecting system comprises of four main sections as follows: 

 .1 the first being a pre-treatment filtration unit; 

 .2 the second contains a mechanical treatment element and a chemical treatment 

element where ozone generated on board is injected into the ballast water; 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 5 

I:\MEPC\59\2-16.DOC 

 .3 the third is a gas/liquid separation unit where undissolved ozone is removed and 

then destroyed; and 

 .4 the fourth and final section is a post-treatment unit designed to control the 

concentration of oxidants remaining in the ballast water. 

A schematic representation of this system is shown below: 

Figure 1 – Configuration of SP-Hybrid BWMS Ozone version 

3.1.3 In addition, it was recalled that the applicant had indicated that the treatment system is 

fully automated with the controls intended to be integrated in the ships ballasting consol. 

The in-line main treatment unit allows the disinfection treatment to be applied during uptake of 

ballast water. 

3.1.4 It was further recalled that ozone will be generated ‘on demand’ and will be injected into 

the ballast water to a maximum level of 4 mg Ozone/litre ballast water. The system includes a 

ballast water discharge conditioning unit to treat oxidants remaining in the ballast water at 

discharge. 

3.1.5 It was also recalled that there is no need to store ozone on board ship and the previous 

submission identified the intended safety measures to be put in place that will reduce the risk of 

crew exposure to ozone. 

S.C.

Gas/Liquid 

Separation

Control Panel

Pre -Filter Gas/Liquid Separation Tank To ballast tank

O.B.

Waste Ozone

Destruction Unit

Special Pipe

(Slit plate )

Ballast Water Treatment 

Control Panel

Ballast Pump

Ballast Control Panel

Ozone Generator

Oxygen Generator

Discharge Water 

Treatment Tank

From 

ballast tank

InactivationUnit

Gas/Liquid Separation Unit

Flow Meter

Ozone Generator Module

Ozone Injector

Flow of Ozone

Electric Control Wire

Ballast Line

TRO Sensor

Post-TreatmentUnit

Flow of Ozone

(low concentration)

Flow of Oxygen

S.C.

Gas/Liquid 

Separation

Control Panel

Pre -Filter Gas/Liquid Separation Tank To ballast tank

O.B.

Waste Ozone

Destruction Unit

Special Pipe

(Slit plate )

Ballast Water Treatment 

Control Panel

Ballast Pump

Ballast Control Panel

Ozone Generator

Oxygen Generator

Discharge Water 

Treatment Tank

From 

ballast tank

InactivationUnit

Gas/Liquid Separation Unit

Flow Meter

Ozone Generator Module

Ozone Injector

Flow of Ozone

Electric Control Wire

Ballast Line

TRO Sensor

Post-TreatmentUnit

Flow of Ozone

(low concentration)

Flow of Oxygen
GESAMP-BWWG 8/6 

ANNEX 4 

Page 6 

I:\MEPC\59\2-16.DOC 

3.1.6 The Group noted that application for Final Approval of the SP-Hybrid BWMS Ozone 

version was made on the understanding that it was for use under the following conditions: 

.1 Ballast water required for treatment 

Sea and brackish water containing bromide ion. Fresh water containing no 

bromide ion is not included in this application. 

.2 Times of ballast water treatment 

It is treated only once on ballasting. 

.3 Concentration of Active Substance (Ozone) when in use 

Ozone as Active Substance is injected on ballasting in such manner to achieve the 

concentration of 3 mg/L in the ballasting water. 

.4 Holding time 

Holding time following ballast water treatment is not specified. Ballast water can 

be discharged immediately after treatment. 

.5 Use of DWTT 

At the time of ballast water discharge, the Relevant Chemicals should be removed 

by the DWTT. 

.6 The maximum allowable discharge concentration of Relevant Chemicals 

The concentration of relevant chemicals at the time of discharge following removal 

by the DWTT is less than 0.07 mg/L for Bromate ion, less than 0.19 mg/L 

for Bromoform and less than 0.2 mg/L for TRO (as O3). 

3.2 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.2.1 The Group recognized ozone as the Active Substance for this system which reacts with 

the components in seawater to produce the following Relevant Chemicals: 

 .1 bromate ions; 

 .2 bromoform; and 

 .3 Total Residual Oxidants (TRO) which is a term commonly used to describe all of 

the oxidants in the seawater resulting from treatment by the system concerned. In 

the case of ozone treatment, TRO is recognized as including ozone, bromate ion 

and hypobromous acid. 

3.2.2 The Group noted the following maximum concentrations of by-products reported in the 

ballast water treated by this system: 

 .1 bromate ions : 70 μg/L; 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 7 

I:\MEPC\59\2-16.DOC 

 .2 bromoform : 18 μg/L; 

 .3 TRO : 1180 μg/L (including background levels). 

 690 μg/L (after subtraction of background levels). 

3.2.3 Whilst noting that the maximum concentration of TRO generated by this system 

was 690 μg/L the Group also noted that the applicant argued that, for the purposes 

of Risk Assessment, 200 μg/L should be used as, following treatment with ozone (4/mg/L) and 

its almost simultaneous removal in the DWTT: 

 .1 45% of measurements were <150 μg/L (detection limit); 

 .2 6% of measurements were 140 μg/L to 200 μg/L; 

 .3 45% of measurements were 200 μg/L to 300 μg/L; and 

 .4 3% of measurements were 300 μg/L to 690 μg/L. 

3.2.4 In addition, the Group noted that the applicant argued further that the maximum 

concentration of ozone which will be actually used is 3 mg/L (c.f. the above figures were 

obtained following 4 mg/L treatment) and the above measurements were obtained without any 

detention time, the realistic operational values of TRO could be taken as 200 μg/L. 

3.2.5 Whilst recognizing the argumentation proposed by the applicant, in the absence of 

measurements generated from the treatment of ballast water at 3 mg/L, the Group considered that 

a TRO concentration of 0.69 mg/L as O3 should be used for the purposes of Risk Assessment. 

3.3 Data associated with each of the chemical by-products 

3.3.1 The data provided by the applicant and used by the Group in the Risk Assessment are 

shown for: 

 .1 ozone appendix 1 (as a surrogate for TRO) 

 .2 bromate appendix 2; 

 .3 bromoform appendix 3; and 

 .4 treated ballast water appendix 4 

4 CONSIDERATION OF CONCERNS EXPRESSED BY THE GROUP DURING 

ITS PREVIOUS REVIEW FOR BASIC APPROVAL 

4.1 The Group recalled that, as part of its evaluation of the system for Basic Approval, it had 

raised the following points: 

.1 due consideration should be given to the fact that the risk assessment currently 

performed has been based upon an incomplete data set and therefore the risk 

assessment should be considered as indicative only. A complete data set may 

result in a different conclusion;
GESAMP-BWWG 8/6 

ANNEX 4 

Page 8 

I:\MEPC\59\2-16.DOC 

.2 due consideration should be given to the fact that the information on the substance 

bromoform as a possible Relevant Chemical is considered insufficient for a risk 

assessment on this chemical on all topics, therefore, additional information should 

be provided on this substance; 

.3 the discharge from the “waste ozone destruction unit” should be suitably sited and 

included in the Ozone monitoring and alarm system; 

.4 it should be confirmed that the levels of THM and free Ozone in the ballast tanks 

remain acceptable. Additional safety precautions should be put in place until such 

confirmation is obtained; 

.5 it should be confirmed that the noise levels when the system is in operation remain 

within permitted levels for machinery spaces (MEPC 55/2/16, annex 5, 

paragraph 10.4.2.5); 

.6 it should be confirmed that the initial assessment that the corrosion effect will be 

limited is correct and that there is no additional corrosion effect on ballast piping, 

ballast tanks or degradation of protective coatings resulting from the use of the 

system; and 

.7 the apparent discrepancy between the measured chronic toxicity of the treated 

ballast water and the assessment of bromate should be investigated further. 

Awaiting the results of such investigations, the discharge of ballast water treated 

with Ozone during further development and testing should only take place under 

controlled conditions and into an environment where a sufficient dilution can be 

assured for avoiding unreasonable risks to the aquatic environment. 

4.2 The Group noted that, in response to these concerns, the application for Final Approval 

included the following: 

.1 acute toxicity tests of treated ballast water from the land-based test facility 

(See Table 4.3.23); 

.2 repetition of chronic toxicity test (See Table 4.3.23); 

.3 degradation test for generated Relevant Chemicals (See Table 4.3.21); 

.4 removal test for generated Relevant Chemicals (See Table 4.3.21); 

.5 long-term performance test of DWTT (See Table 4.3.3); 

.6 inspection for hull corrosion in full-scale shipboard system (See Table 4.3.14); 

.7 analysis for volatile Bromoform from ballast tank (See Table 4.3.14); and 

.8 noise measurement test in full-scale shipboard system (See Table 4.3.5). 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 9 

I:\MEPC\59\2-16.DOC 

4.3 A summary of the specific concerns made by the Group and the response of the applicant 

with references to the information provided in addition to the non-confidential submission 

to MEPC is shown in the table below: 

No Comments of 

GESAMP-BWWG 

Response in application for 

Final Approval 

Reference in 

Folder ‘Nonconfidential, 

confidential 

and 

appendices

.1 

The risk assessment should be 

considered based on a complete 

data set. 

Data set was improved and risk 

assessment was provided again. 2, 3, 4, 5, 6, 7 

.2 

Additional information should be 

provided on Bromoform as 

Relevant Chemical for a risk 

assessment. 

Information on Bromoform was added 

to the data set. Risk assessment was 

provided based on the concentration of 

Bromoform which was measured in the 

various tests. 

2, 3, 4, 5, 6, 7 

.3 

The discharge from the “waste 

Ozone destruction unit” should 

be suitably sited and monitored 

in the Ozone monitoring and 

alarm system. 

Concentration of Ozone discharged 

from the waste Ozone destruction unit 

was confirmed with both the land-based 

and shipboard systems and safety 

measures were established. 

3.2.5.6.3.6.1, 

3.2.7.1.5, 

7.1.4.2.5 

.4 

Confirm that the THM and free 

Ozone in the ballast tanks remain 

acceptable. 

Concentration of THM and Ozone in 

the ballast tanks was confirmed with 

shipboard system. The concentration 

was acceptable. 

3.2.5.6.3.5.1, 

7.1.4 

.5 

Confirm that the noise of the 

system remain within permitted 

levels for machinery space. 

Operation noise was measured with the 

shipboard system. The noise in the 

engine room remained within the 

permitted level. 

7.1.5, App 12 

.6 

Confirm the initial assessment 

that the corrosion effect will be 

limited, and that there is no 

additional corrosion effect from 

use of the system. 

It was confirmed that corrosion of the 

full-scale shipboard system after 

operation for a certain term was 

acceptable. There are no additional 

corrosion effects. 

7.1.1.1 

.7 

The apparent discrepancy 

between the measured chronic 

toxicity of the treated ballast 

water and the assessment of 

Bromate should be investigated 

further. The discharge of ballast 

water should only take place 

under controlled conditions. 

Concentration of Bromate ion was 

measured in the repetition of the 

chronic toxicity test. Treated ballast 

water is discharged with post treatment 

each time to avoid risks. 

2, 4, 5, 6, 7 

.8 

Quantitative data on 

Hypobromous acid ion or 

Hypobromous acid might have 

been useful. 

Hypobromous acid ion and 

Hypobromous acid generated by the 

reaction of seawater and Ozone is 

described in 2.1 Identification of 

Substance or Preparation. 

2.1, App 1-1 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 10 

I:\MEPC\59\2-16.DOC 

No Comments of 

GESAMP-BWWG 

Response in application for 

Final Approval 

Reference in 

Folder ‘Nonconfidential, 

confidential 

and 

appendices

.9 

Sampling and analysis for other 

chemicals such as Bromoform 

should be included in the further 

testing. Such data should be 

submitted in the application for 

Final Approval. 

Information on the other chemicals that 

may be formed was investigated by 

open literature recommended by 

GESAMP. (Amy D et al. 2001, Gunten 

v, et al. 1994, Fabbricino et al. 2005) 

Sampling and analysis of Bromoform, 

other THM’s and chlorophenols were 

included in various developments and 

tests. Bromoform was confirmed to be 

generated. A data set of Bromoform 

was added to the application of Final 

Approval. 

2, 6.2, 6.3 

.10 

It should be noted that the dashes 

indicate “data not required” 

which might not be strictly 

correct. If it is not applicable or 

Relevant then, perhaps this 

should be indicated and the 

reason given. 

The reason for non-applicability or nonrelevance was described. 2 

.11 

Justification for non-submission 

of oral and dermal toxicity data 

for Ozone and absence of 

inhalation and dermal toxicity 

data for Bromate should be 

presented. 

Reasons such as difference of main 

exposure route etc. were described. 2.3 

.12 

It is highly recommended that 

strict mitigation measures to 

avoid human inhalation and 

exposure to Ozone during the 

process should be applied. 

Excellent separation of Ozone from 

ballast water in Gas/Liquid Separation 

Tank and excellent removal of Ozone in 

Waste Ozone Destruction Unit were 

obtained. Further, Ozone Leak 

Monitors were installed. If a leakage 

should be detected, there is a visible 

and audible alarm and the system 

performs an emergency stop. Since 

there is possibility of contact with 

Residual Oxidant in ballast tanks, safety 

measures require the wearing of 

protective equipment. These were tested 

in the full-scale land-based system and 

in the full-scale shipboard system. 

3, 7.1, 7.2 

.13 The exposure to Bromate should 

be totally avoided. 

Possibility of exposure to Bromate is 

limited to internal inspections of the 

ballast tank. Exposure in internal 

inspections is completely avoided with 

protective clothing, mask, goggles, 

gloves, etc. 

7.2.2.2 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 11 

I:\MEPC\59\2-16.DOC 

No Comments of 

GESAMP-BWWG 

Response in application for 

Final Approval 

Reference in 

Folder ‘Nonconfidential, 

confidential 

and 

appendices

.14 

Bromoform and other 

brominated DBP: as highly 

reactive compounds capable of 

bioaccumulating, exposure to 

these in the long-term should be 

minimized. 

There is no probability of long term 

exposure to Bromoform, etc. However, 

these chemicals may remain in the 

ballast tank. During tank internal 

inspections, exposure is completely 

avoided by protective clothing, mask, 

goggles, gloves, etc. 

3.2.7.1.6, 

7.2.2.3.1 

.15 

The potential for cumulative 

toxicological effects of the 

mixture of chemicals generated 

by the system should be taken 

into account. 

Sampling and analysis of THM were 

performed in the course of various 

developments and tests including the 

land-based and shipboard system were 

performed. Analysis of chlorophenols 

was performed in the chronic toxicity 

test, to check for generation of 

compounds which may exert influence. 

2.1, 6.2, 6.3, 

6.4, 6.5, 6.6 

.16 

It is recommended that placards 

giving additional warnings of the 

hazards related to the inhalation 

of Ozone be provided on board 

to promote a general awareness. 

An Ozone Leak Monitor is placed at the 

required location and measures were 

taken so that if a leakage should be 

detected, there is a visible and audible 

alarm and the system performs an 

emergency stop. A caution plate is 

posted at the place where there is a 

possibility of inhalation of Ozone by 

shipboard personnel. 

3.2.5.4, 3.2.7, 

7.1.4 

.17 

The THM levels in the ballast 

tank should be regularly 

measured during the further 

prototype development and 

testing period. Precautionary 

measures to mitigate any risk to 

the crew from contact with THM 

are put in place until it can be 

demonstrated that the risk is 

negligible. 

Sampling and analysis of THM were 

performed in various developments and 

tests including the land-based and 

shipboard system. 

In the tank internal inspections where 

there is possibility to contact with 

THM by shipboard personnel, exposure 

is completely avoided by protective 

clothing, mask, goggles, gloves, etc. 

2.1, 

3.2.7.1.6, 

6.2, 6.3, 6.4, 

6.5, 

6.6, 7.2.2.3.1 

.18 

The reaction of Ozone with 

seawater should be analysed 

further. 

Sampling and analysis of treated ballast 

water were performed in various 

developments and tests including the 

land-based and shipboard system. 

Analysis of chlorophenols was also 

performed in the second chronic 

toxicity test to confirm generated 

quantity. Using additional information 

obtained from various documents, the 

reaction of Ozone and seawater was 

re-analysed. 

2.1, 6.2, 6.3, 

6.4, 6.5, 6.6, 

APPENDIX 1-

1 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 12 

I:\MEPC\59\2-16.DOC 

No Comments of 

GESAMP-BWWG 

Response in application for 

Final Approval 

Reference in 

Folder ‘Nonconfidential, 

confidential 

and 

appendices

.19 Specify the analysis method of 

Bromate. 

The analysis method for Bromate ion 

applied in various tests was specified. 

2.6, 6.2, 6.3, 

6.4, 6.5, 6.6, 

APPENDIX 

2,3,9 

.20 

It is recommended that toxicity 

data and degradation data found 

in analyses of the treated ballast 

water are related to TRO and not 

only to the concentration of 

Bromate ion. 

In various developments and tests 

including the land-based and shipboard 

system, THM such as Bromoform were 

analysed in addition to Bromate ion and 

TRO. In the second chronic toxicity 

test, chlorophenols were analysed. 

2.1, 6.2, 6.3, 

6.4, 6.5, 6,6, 

APPENDIX 

2,3,9 

.21 

The group noted that the dossier 

did not include any information 

about degradation rates in 

sediment and freshwater for 

Bromate ions or TRO. 

Information on the degradation rates of 

Bromoform as Relevant Chemical in 

addition to Bromate ion and TRO in the 

sediment and freshwater was added. 

2.4.1 

.22 

As the group accepts the minor 

role of Ozone after the treatment 

of the ballast water the risk 

assessment has been focused on 

Bromate ion. Therefore only for 

Bromate the PNEC has been 

derived. The acute toxicity data 

presented in the Table T8.1 is 

considered complete for Bromate 

but Table T8.2 does not show a 

complete data set for the chronic 

toxicity of Bromate. 

Bromate, Bromoform and TRO were 

measured in the toxicity tests of treated 

ballast water. A complete data set of 

each chemical was added. 

2.2.2, 

6.2 

6.3 

.23 

However, the group considered 

that there was a discrepancy 

between the toxicity data 

available on Bromate (see Tables 

T8.1 and T8.2), which result in a 

derived PNEC for Bromate of 

0.26μg/L, and the concentration 

of Bromate in treated ballast 

water at 0.16 mg/L, which 

causes no effect in the chronic 

toxicity tests with treated ballast 

water. 

In the second chronic toxicity test, 

Bromate ion, TRO, Bromoform and 

other THM were analysed and 

consistency with the toxicity data was 

verified and used for the final 

evaluation. 

2.2.2, 

6.3 
GESAMP-BWWG 8/6 

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No Comments of 

GESAMP-BWWG 

Response in application for 

Final Approval 

Reference in 

Folder ‘Nonconfidential, 

confidential 

and 

appendices

.24 

Under normal operating 

conditions it is expected that the 

discharge concentration of TRO 

will be about 0.16 mg/L as TRO. 

Since the derived PNEC for 

Bromate is 0.26μg/L, a dilution 

of more than 500 times would be 

required before long-term 

toxicity can be avoided. The 

Group was not aware of 

information that allows an 

evaluation of whether this can be 

obtained under realistic and 

representative conditions. 

TRO concentration of discharged 

ballast water and concentration of 

Relevant Chemicals were analysed and 

re-evaluated in various developments 

and tests including the full-scale 

land-based and shipboard systems. Post 

treatment is conducted with the 

Discharge Water Treatment Tank in all 

cases. Relevant Chemicals were 

re-evaluated under such conditions. 

These results and decomposition rate of 

Relevant chemicals were used for the 

re-evaluation. 

6.2, 6.3, 6.4, 

6.5, 6.6, 6.9, 

6.12, 7.2, 

APPENDIX 

2,3,9 
GESAMP-BWWG 8/6 

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5 OTHER CONCERNS ARISING DURING THE REVIEW 

5.1 The Group noted that the applicant submitted that the maximum discharge concentration, 

after adjustment of background concentrations, of TRO is 0.69 mg/L as O3 (1.02 mg/L as Cl2) 

and the Group considered this an unacceptably high level of TRO for environmentally safety. 

5.2 The Group noted that the treatment of the discharge is done through passage of 

the DWTT which was noted to alarm at a TRO of 0.15 mg/L (as O3) and an automatic shutdown 

at 0.2 mg/L as O3. Despite this the Group was concerned that the applicant did not adequately 

show that the Discharge Water Treatment Tank (DWTT), used to regulate TRO, was capable of 

removing high dosages of TRO or that the DWTT had sufficient absorption capacity for the 

recommended 2070 hours maintenance period. The Group recommended that the applicant 

either show that the DWTT or a neutralizing agent can reduce the TRO (due to treatment and 

background) to <0.2 mg/L as Cl2 as a minimum. 

5.3 The Group noted that the testing conducted by the applicant was with natural waters 

having a concentration of 0.21 to 1.21 mg TRO /L as O3. The Group considers such testing to be 

inappropriate and recommended that full scale testing conducted for the purposes of submitting 

data for Basic or Final Approval be conducted in natural waters with TRO less than 0.02 mg/L 

as Cl2. Furthermore, the requirement of the DWTT or other neutralizing system should be to 

lower the TRO sufficiently for the entire discharge, not just that portion which is deemed a result 

of the treatment system as these effects are likely inseparable. 

5.4 The Group noted that the applicant attempted to evaluate long term performance based on 

the inspection of in-service shipboard tanks, piping and pumping systems, but the Group agreed 

that visual examination of such broad areas was insufficient, without usage history or tank 

pre-condition, to characterize corrosion impact, as concluded previously in document 

MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, paragraph 4.7.5. 

5.5 The Group was concerned with the DWTT discharge treatment system since activated 

carbon removal of the AS, RC and disinfection by-products will be related to flow rate and 

total volume treated. The applicant only tested the system at <0.2% of the suggested total 

volume capacity and anticipated flow rate for the recommended exchange cycle of the DWTT. 

Moreover, since the DWTT is arranged to automatically shutdown the discharge in the event of 

excessive TRO and since the DWTT cannot be refreshed during ship operations, this scenario 

could reasonably be expected to result in the inability to discharge pollutant free treated 

discharge water. With respect to the TRO of the discharge, the applicant noted that the system is 

designed to automatically shutdown if the TRO exceeds 0.2 mg/L, yet the discharges reported 

in section 6.5 are as high as 0.46 mg/L both as O3. It is not clear whether the proposed TRO 

control deducts the background concentration to make its analysis or whether the TRO 

monitoring system was not employed during this or the other testing. 

5.6 The Group noted that the various required test were conducted at different scales. 

Specifically, the acute toxicity testing was conducted at a full scale land-based test facility in 

accordance with Guidelines (G8) at 200 m3/h. The Group noted that whilst the TOC values were 

in accordance with Guidelines (G8), the DOC values were less than half the required value. The 

chronic toxicity tests were conducted at a small scale test facility not in accordance 

with Guidelines (G8) at a flow rate of 20 m3

/h and only at one salinity (seawater). Finally the 

long term performance of the DWTT was conducted at 20 m3

/h and was never tested at full scale 

or with the proposed integrated TRO sensor. 
GESAMP-BWWG 8/6 

ANNEX 4 

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I:\MEPC\59\2-16.DOC 

5.7 The Group noted that TRO measurements for all scales of testing and for each type of test 

(i.e. acute toxicity, chronic toxicity, long term DWTT performance, etc.) were made on discrete 

samples collected at the test facility and transported to the lab. These measurements were 

conducted the next day allowing significant time (>12 hours) for oxidant decay, as such these 

measurements likely underestimate the actual TRO in any given sample. Further concern was 

evident in the TRO measurements as a significant concentration of oxidant was measured in the 

raw seawater with up to 1.21 mg TRO /L as O3. These are very high concentrations of oxidant in 

natural waters and likely compromise the validity of these tests. 

5.8 As a result, the Group concluded that due to the high background TRO of the raw intake 

waters and the potential underestimation of TRO measurements caused by delaying analysis until 

the day following sampling that all such tests should be repeated. 

5.9 The Group concluded that the testing of the DWTT was insufficient in treated volume 

capacity and flow rates relative to the proposed shipboard treatment volume and flow rate. 

Additionally, the Group expressed concern that the testing did not sufficiently evaluate the long 

term performance of the DWTT as the recommended exchange cycle is 2070 hours, but the 

system was only tested for 230 hours. The Group noted that no evaluations of the DWTT with 

the integrated TRO control system were presented and that discharge concentrations of TRO 

exceeded 0.2 mg/L (as O3). 

5.10 The Group recommended that the applicant repeat testing, as appropriate, of the 

complete, integrated ballast water management system be conducted in accordance 

with Guidelines (G8) and to insure that the tests are conducted at a test facility whose natural 

waters have a TRO <0.2 mg/L (as Cl2) and that all measurements of TRO should be completed 

immediately following sample acquisition, to the extent possible. 

5.11 The Group recommended that the applicant demonstrate, either by calculation or 

experimentation, the anticipated exchange frequency required relative to both treated volume and 

flow rates. Further, the applicant should demonstrate that the DWTT tested as part of 

the G8 testing (i.e. at 200 m3

/h) sufficiently reduces the Active Substances and Relevant 

Chemicals. 

6 HUMAN HEALTH ASSESSMENT

6.1 Based on the data provided by the applicant in its submissions for both Basic Approval 

and Final Approval, the Group agreed that the hazards to human health posed by this system 

could be described in association with the chemicals produced as shown below: 

 .1 Ozone 

.1.1 Ozone is toxic when inhaled and even at low doses can be harmful to the upper 

respiratory tract and lungs as well as being irritating to the eyes. 

 .1.2 Long term exposure to low doses can cause non-carcinogenic lesions in the nose 

and lungs. 

 .1.3 Exposure during pregnancy can affect foetal development. 
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I:\MEPC\59\2-16.DOC 

 .2 Bromate

 .2.1 Bromate is toxic when ingested. 

 .2.2 It is irritant to skin, eyes and respiratory system. 

 .2.3 It may be a human carcinogen. 

 .3 Bromoform 

 .3.1 Bromoform is toxic by inhalation and harmful if swallowed. 

 .3.2 It is irritating to the skin and eyes. 

 .3.3 It may also be a human carcinogen. 

7 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC 

7.1 Risks associated with exposure of the crew to the Active Substance (Ozone) 

7.1.1 The Group recognized that the ozone used by this system is generated on board and so 

there will not be any risks associated with the storage of chemicals. 

7.1.2 As a result, the Group agreed that the only risk to the crew from exposure to ozone would 

be from leakages in the pipe-work. 

7.1.3 However, the Group noted that the system is equipped with ozone leak monitors located 

at the ozone generator, near the ozone injector and near the waste ozone destruction unit. 

On detection of an ozone leak, visible and audible alarms are raised, the ozone generation is 

stopped and evacuation of the crew from the area is urged. 

7.1.4 In addition, the applicant indicated that portable ozone monitors are provided for use as 

appropriate. 

7.1.5 Whilst recognizing that ozone has a short half-life in seawater, the Group considered that 

exposure of the crew to ozone might occur when entering the ballast tank e.g., during inspection. 

Therefore, the Group recommended the use of PPE and RPE. 

7.1.6 The Group was satisfied that the risks to the crew from exposure to ozone could be 

mitigated by adequate engineering control measures and the use of PPE/RPE. 

7.2 Risks to the safety of the ship

7.2.1 The Group recalled that, previously, it had expressed concerns related to the potential 

corrosivity of ozone on the materials of construction. The Group noted that, in response to these 

concerns, the applicant had provided the following information: 

 .1 The applicant indicated that ozone is a strong oxidizer and therefore provisions for 

corrosion resistant materials of construction in the treatment system components is 

necessary. The applicant recommended the use of stainless steel for all system 

components and delivery systems. The type and grade of stainless steel is not 

identified; and 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 17 

I:\MEPC\59\2-16.DOC 

 .2 The applicant conducted a visual assessment of the corrosion condition of barge 

ballast tanks, system components and pumping systems subsequent to 8 months 

operation with the installed system. The applicant provided no details regarding 

the frequency or conditions of operation or pre-existing material conditions. The 

applicant notes the absence of corrosion in both the ballast tank, where the 

corrosion-control measures were judged not to be necessary at the application 

of Basic Approval, and in the equipment, where the corrosion-control measures 

were required due to contact with a high concentration of Ozone. 

7.2.2 The Group determined that this conclusion could not be accepted since it contradicts 

known and published data regarding increased localized corrosion of stainless steel and other 

passive metals in ozonated seawater. Furthermore, the Group noted that the applicant attempted 

to evaluate long term performance based on the inspection of in-service shipboard tanks, piping 

and pumping systems, but the Group agreed that visual examination of such broad areas was 

insufficient, alone, without usage history or tank pre-condition, to characterize corrosion impact, 

as concluded previously in document MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, 

paragraph 4.7.5. Though the Group encourages the inspection of shipboard systems subjected to 

the Active Substances to be certain that no obvious or extensive failures have occurred as a result 

of use with the treatment system, these should not be consider a sufficient replacement for long 

term studies on both uniform and localized corrosion rates at the anticipated treatment 

concentration of Active Substances. 

7.2.3 The Group recommended that long-term studies, as appropriate, be carried out or 

otherwise documented from literature to quantify, at the treatment and possible exposure 

concentrations, resultant ballast tank coatings degradation and the expected uniform and 

localized corrosion rates on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, 

stainless steel, etc.) and non-metallic materials (e.g., EPDM rubber) materials used for ballast 

tanks, fixtures and piping. 

7.3 Risks associated with exposure of the crew to Relevant Chemicals

7.3.1 The Group recognized the argumentation proposed by the applicant that the risk to the 

crew from bromate can occur when entering ballast water tanks e.g., during inspection. Bromate 

is classified as a probable human carcinogen (IARC, 1999; EPA, 2001) and IPCS (2000) has 

recommended a TDI of 1 μg/kg bw/d based on a NOAEL for the formation of renal tumours in 

rats at 1.3 mg/kg bw/d using an AF 1000. Therefore the Group recommended the use of personal 

protective equipment (PPE) and respiratory protective equipment (RPE). 

7.3.2 In considering the risks associated with potential acute inhalation exposure of the crew to 

bromoform during tank cleaning operations, the Group noted the following argumentation: 

 .1 Maximum concentration of bromoform in ballast water = 0.19 mg/L 

 .2 Assuming t1/2 for bromoform is 185 d and using the Mackay model level III, then 
GESAMP-BWWG 8/6 

ANNEX 4 

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I:\MEPC\59\2-16.DOC 

 .2.1 Proportion expected to partition into the atmosphere = 3.25% 

 .3 Assume the volume of ballast water taken on board = 15000 m3

 .3.1 Assume the headspace in the tank = 5000 m3 

 .4 Then the concentration of bromoform in the airspace of the ballast tank = 

3

3

3

0.0185 / 0.0185 /

5000

15000 0.19 / 0.0325 mg L g m

m

m

mg L

Volume of air

Volume of water Concentration in air × = × × = =

 .5 Assuming the concentration of bromoform is not diluted around the ship 

(not likely), then the crew would be exposed to 0.0185 g/m3

 .5.1 Assume: a crew member works for 5 h, once/month in the tank 

 a crew member weighs 60 kg 

 a crew member breaths 10 m3

 in 5 h 

 .6 The exposure to bromoform during this activity would be: 

mg kg kg

m mg m

Weight of Crew member

Volume of air breathed Concentration of bromoform in air 3.09 /

60

10 18.5 / 3 3

= × = ×

 .7 The Oral LD50 of rats is 1147 mg/kg 

 .8 The Margin of Safety is calculated as 1147/3.09 = 371 

7.3.3 According to the applicant the risks associated with acute exposure to bromoform were 

concluded to be of lower concern. However, the Group has the following considerations to 

make: 

 .1 generally speaking, the use of LD50 as a critical threshold value to derive an 

acute MOS is not the most appropriate one because this type of toxicity test 

addresses mortality as an endpoint and not acute adverse effects; 

 .2 considering the maximum concentration of bromoform in air space of the BWT 

of 0.0185 g/m3 (18.5 mg/m3

) as calculated by the applicant using Mackay 

level III model and comparing this value with the Japanese OEL of 10.3mg/m3, 

and taking into consideration that this will be a worst case scenario (no dilution 

was assumed), the Group considered that acute exposure to bromoform volatized 

in the BWT will not represent a risk to the crew; and 

 .3 the Group wanted also to highlight that as a general rule the different MOS have to be 

refined with the appropriated assessment factors (AF) in order to address uncertainties 

related to extrapolation from animal toxicity data to the exposed human population. 
GESAMP-BWWG 8/6 

ANNEX 4 

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I:\MEPC\59\2-16.DOC 

7.3.4 In addition, the Group noted the argumentation, proposed by the applicant, associated 

with the potential long-term exposure to bromoform as a result of tank washing. 

 .1 Take the No Observed Adverse Effect Level (NOAEL) as 25 mg/kg/d 

 .2 The Chronic Exposure associated with working in the tank for 5 h once a month 

would be: 

 3.09 mg/kg/30d = 0.103 mg/kg/d 

 .3 Therefore, the MOS is 25/0.103=243 and so the risks associated with chronic 

exposure of the crew in tank cleaning is regarded as minimal. 

7.3.5 According to the applicant the risk associated with long-term exposure to bromoform as a 

result of tank cleaning was concluded to be of lower concern. However, the Group had the 

following considerations to make: 

 .1 considering the maximum concentration of bromoform in air space of the BWT 

of 0.0185 g/m3 (18.5 mg/m3) as calculated by the applicant’s model and 

comparing this value with the Japanese OEL of 10.3mg/m3

, and taking into 

consideration that this will be a worst case scenario (no dilution was assumed), 

the Group considered that long-term exposure to bromoform volatized in 

the BWT from tank washing operations will not represent a risk to the crew; 

 .2 the Group noted that the relevant NOAEL (25 mg/kg bw/d) for MOS derivation 

was adequately chosen by the applicant; and 

 .3 however, the MOS for long-term exposure needs to be refined with the 

appropriate assessment factors (AF) in order to address uncertainties related to 

extrapolation from animal toxicity data to the exposed human population. 

7.3.6 With regard to the potential exposure of the crew to bromoform in their living spaces, 

the Group noted the following arguments proposed by the applicant: 

 .1 Assume the living space is about 1600 m3 ; 

 .2 assume the living space has a direct connection to the BWT (a totally unrealistic 

worst case scenario); 

 .3 then, the concentration of bromoform above the ballast water would be diluted by 

the living space to 75% of the ballast water tank head space, i.e.: 

 (5000 x 0.0185)/(5000+1600) = 0.014 g/m3 . 

 .4 Assume the living space is continuously ventilated at 78 m3

/min; 

 .5 therefore, the air is replaced every 20 min ( i.e. 1600 m3

/78 m3) and the 

bromoform concentration is diluted 72 times/day. 

 .6 Assume exposure of a 60 kg crew is 24 h/d; 
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 .7 then the crew member would breath 20 m3/d; 

 .8 then the crew member would be exposed to: 

 .9 0.014 g/m3 x 1/72 x 20 m3 x 1/60 kg = 0.064 mg/kg bw/d 

(390 times less than the NOAEL of 25 mg/kg/13 weeks); 

 .10 As a result, the risks to the crew from long-term exposure to bromoform would be 

minimal. 

7.3.7 The Group agreed with the assumptions used by the applicant to develop HES for the 

living space and refer to the considerations made in the previous paragraph regarding the use 

of AF for MOS derivation, until a more final HES will be developed by the Group. 

7.4 Risks to the general public from potential exposure to bromoform in the atmosphere 

7.4.1 The Group noted that, using similar calculations to those described above, the applicant 

argued that the concentration in the atmosphere of bromoform would be 0.367 μg/m3. The Group 

agreed that this would not lead to unacceptable risks. 

7.5 Risks to the general public from potential exposure to bromoform via seafood

7.5.1 Based on the properties of bromoform and the predicted levels in the environment, 

the Group agreed that the risks to the general public from ingestion of bromoform from seafood 

was minimal. 

7.6 Risks to the general public from potential exposure to bromoform whilst bathing in 

the sea

7.6.1 Having noted that the calculated PEC for bromoform would be 0.0113 μg/L (see below at 

paragraph 8.2.2) and the NOAEL has been reported as 25mg/kg/d, the Group agreed that the 

risks associated with exposure to bromoform by swimming in the sea would be minimal. 

7.6.2 The Group agreed with the arguments made by the applicant concerning the assessment 

of general public exposure via environment and the conclusions achieved. In cases where a 

combined exposure may occur (e.g., swimming in the water and eating fish from the area), 

the Group also suggested that the TDI approach could be integrated in the iterative process and 

the predicted daily uptake considering all uptake routes simultaneously taken into account 

(Guidelines for drinking-water quality, WHO, 2006). 
GESAMP-BWWG 8/6 

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8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

Chemical Persistence (P) 

(Yes/No) 

Bioaccumulation (B) 

(Yes/No) 

Toxicity (T) 

(Yes/No) 

Ozone No 

(1⁄2 life ~ 5 sec 

No 

(Log Pow <1) 

Yes 

(NOEC 0.002mg/L/90d) 

Bromate Yes 

(1⁄2 life > 40d) 

No 

(Log Pow -7.18) 

No 

(NOEC >0.13 mg/L/7d) 

Bromoform Yes 

(1⁄2 life 185 d) 

No 

(BCF 21) 

No 

(NOEC 10 mg/L/4d) 

8.2 Calculation of Predicted Environmental Concentrations (PEC)

8.2.1 The Group noted that the MAMPEC model ver. 2.0 had been used to calculate 

the Predicted Environmental Concentrations (PEC) of the Active Substance and Relevant 

Chemical associated with this system, using the Port of Tokyo as the model harbour. 

8.2.2 The resultant PECs are shown in the table below, together with the chosen toxicity data 

that define the lowest value and the applicable assessment factor. Finally, this leads to the 

presented PEC/PNEC-ratio. 

Chemical Conc. In BW 

(μg/L) 

PEC 

(μg/L) 

Toxicity 

(μg/L) 

Assessment 

Factor 

PNEC 

(μg/L) 

PEC/PNEC 

TRO (as O3) 690 0.0432 

Bromate 70 0.00517 30000 1000 30 0.000172 

Bromoform 190 0.0113 7100 1000 7.1 0.00159 

8.2.3 The Group recalled that in the review of the dossier on the SP-Hybrid BWMS the 

substance ozone was defined as an Active Substance with a half life of about 5 s. Therefore, 

the Group does not consider ozone as a substance of any concern to the environment. Therefore, 

no PEC/PNEC for ozone has been calculated. 

8.2.4 In performing the calculations with the model MAMPEC, the applicant used TRO 

expressed as O3 as a Relevant Chemical and defined a worst case estimation of half-life TRO 

as O3 of 4.5 days. This may lead to confusion with the concept of ozone being of no relevance to 

the environment. The Group advised the use of a definition of TRO that expresses the concerns 

for the remaining residual oxygen in a more appropriate way. 

8.2.5 As the Group defined a standard emission environment and a GESAMP-BWWG standard 

harbour during the stocktaking workshop in January 2009, the Group performed some additional 

calculations using the estimated PECs in the discharged ballast water of the applicant and the 

standard harbour and standard emission environment. It should be noted that the applicant was 

not able to perform these calculations because at the time of submission these standard conditions 

were not yet defined. Therefore, the calculations presented below only show a comparison with 

the results obtained by the applicant. The results are used to validate the results of the standard 

environment definition. 
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ANNEX 4 

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Results of risk assessment using the estimated load of the applicant and the standard 

environment as defined by the Group. 

Chemical Conc. In BW 

(μg/L) 

PEC 

(μg/L) 

Toxicity 

(μg/L) 

Assessment 

Factor 

PNEC 

(μg/L) 

PEC/PNEC 

TRO (as O3) 690 0.117 

Bromate 70 0.0311 30000 1000 30 0.00104 

Bromoform 190 0.0346 7100 1000 7.1 0.0048 

In the above table, the results are presented of the calculation using the emission load estimated 

by the Group based on the concentration established by the applicant in the standard 

environment. 

Results of risk assessment using the load based on the ballast water concentration of the 

applicant and the standard environment as defined by the Group 

Chemical Conc. In BW 

(μg/L) 

PEC 

(μg/L) 

Toxicity 

(μg/L) 

Assessment 

Factor 

PNEC 

(μg/L) 

PEC/PNEC 

TRO (as O3) 690 12.4 

Bromate 70 3.3 30000 1000 30 0.11 

Bromoform 190 3.67 7100 1000 7.1 0.52 

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risk to the safety of the ship 

9.1.1 The Group concluded that visual examination of exposed ship structures and systems was 

insufficient, alone and without usage history or tank pre-condition, to characterize corrosion 

impact, as concluded previously in document MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, 

paragraph 4.7.5. The Group further concluded that visual assessment of corrosion should not be 

considered a sufficient replacement for long term studies on both uniform and localized corrosion 

rates at the anticipated treatment concentration of Active Substances. 

9.1.2 The Group recommends that long-term studies, as appropriate, be carried out or otherwise 

documented from literature to quantify, at the treatment and possible exposure concentrations, 

resultant ballast tank coatings degradation and the expected uniform and localized corrosion rates 

on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc.) and 

non-metallic materials (e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping. 

9.2 Risk to crew and general public 

9.2.1 The Group considered that the HES would need to be allocated with the appropriate 

assessment factors (AF) in order to address the uncertainties deriving from the extrapolation of 

results from animal toxicity testing to human exposure. However, the Group is also in favour 

that for Final Approval and in order to address the risk to the crew from inhalation exposure to 

disinfectant by-products, the applicant could use the Occupational Exposure Level (OEL) in 

order to avoid the uncertainty related to route-to-route extrapolation from oral to inhalation. 
GESAMP-BWWG 8/6 

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9.2.2 In addition, the Group would like to suggest that in what concerns general public 

exposure (by swimming and eating fish from the area), the TDI approach could be integrated in 

the iterative process and the predicted daily uptake considering all uptake routes simultaneously 

taken into account (Guidelines for drinking-water quality, WHO, 2006). 

9.3 Risks to the environment

9.3.1 The Group agreed that due to the high level of TRO generated by this system and the lack of 

adequate performance of the DWWT, the potential risks to the environment were unacceptably high. 

9.3.2 In this context, the Group also expressed concern that the natural sea water used in the 

various tests also had such high levels of TRO as to make environmental testing very difficult 

and so recommended that more suitable seawater was used for future testing. 

9.4 Conclusions

9.4.1 Having reviewed all of the data, the Group agreed that it could not recommend this 

system for Final Approval at this stage and recommended that the applicant develop its 

neutralization as well as carrying out future tests under more suitable conditions. 

* * * 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 24 

I:\MEPC\59\2-16.DOC 

Appendix 1 

Basic Data on Ozone 

1 CHEMICAL IDENTIFICATION 

Chemical 

Name 

Molar 

mass 

Structural 

formula 

CAS 

Number 

Concentration in 

discharge ballast water, 

after treatment of the 

DWTT 

(Bio) 

degradation 

rate or halflife 

AS, 

RC or 

OC 

Ozone 48.00 10028-

15-6 N/A 5.8 Sec AS 

TRO 

(as O3) N/A N/A N/A 0.21 - 1.18mg/L 

(<0.15 - 0.69mg/L) 0.75-4.5 day RC 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity 

Species LC50

(mg/L) Reference/Comments 

Morone saxatilis, SW 0.08 (96-h 

LC50) 

ECOTOX data base 

(U.S. EPA, 2007a) 

Morone americana, 

SW 

0.2 (96-h 

LC50) 

ECOTOX data base 

(U.S. EPA, 2007a) 

Oncorhynchus 

mykiss, FW 

0.0093 (96-h 

LC50) 

ECOTOX data base 

(U.S. EPA, 2007a) 

Fish 

Ictalurus punctatus, 

FW 

0.03 (96-h 

LC50) 

ECOTOX data base 

(U.S. EPA, 2007a) 

Crustacea N/A N/A 

ECOTOX data base 

(U.S. EPA, 2007a) Other literature was not 

available for data. 

Molluscs Dreissena 

polymorpha, FW 

0.53 (5.8-h 

LC50) Harrington et al. (1997) 

Algae N/A N/A 

ECOTOX data base 

(U.S. EPA, 2007a). Other literature was not 

available for data. 

2.2 Chronic Aquatic Toxicity 

Species 

NOEC 

(mg/L) Reference/Comments 

Fish Oncorhynchus 

mykiss

0.002 

(90 day) Wedemeyer et al., 1979 

Crustacea N/A N/A ECOTOX data base (U.S. EPA, 2007a). 

Data were not available in other literature. 

Algae N/A N/A ECOTOX data base (U.S. EPA, 2007a). 

Data were not available in other literature 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 25 

I:\MEPC\59\2-16.DOC 

2.3 Information on Endocrine Disruption Not Available 

2.4 Sediment Toxicity Due to short half-life (~ 5.8 s), it is unlikely to adhere to or 

accumulated in sediment. 

2.5 Bioavailability/Biomagnification/Bioconcentration 

Chemical 

name logPow/BCF information 

Cause for 

concern 

(Yes/No) 

Reference/Comments/ 

Justification for missing data 

logPow N/A 

Ozone 

BCF N/A 

No 

Due to Ozone being an inorganic 

compound and having a short half 

life in the environment, there is no 

need for it to be considered. 

logPow N/A 

TRO BCF N/A No 

Due to the short half life of the 

TRO, there is no need for it to be 

considered. 

2.6 Food web/population effects

2.6.1 Due to it short half-life, it is anticipated that the potential for bioaccumulation in the food 

chain would be minimal. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

3.1.1 It was recognized that it is not possible to determine the oral and dermal toxicities of 

gases. However, the Group recognized that the inhalation LC50 of ozone is 0.012 mg/L/4h. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) decomposes very rapidly to form oxygen. 

4.2 Partition Coefficients 

Log Pow N/A 

BCF N/A 

4.3 Persistence and Identification of Main Metabolites 

4.3.1 With a short half-life (5.8 s), ozone is not regarded as persistent. 

4.4 Reaction with Organic Matter not considered required.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats not considered 

required.

4.6 Potential Residues in Seafood not considered required.
GESAMP-BWWG 8/6 

ANNEX 4 

Page 26 

I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property Value 

Reference/Comments/ 

Justification for missing data 

CAS number 10028-15-6 Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Molecule weight 48.0 ISCS 1993 

Liquid density 1358 g/L (at -112oC) Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Evaporation heat 15.2kJ/moL Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Melting point -193oC ISCS 1993 

Boiling point -112oC ISCS 1993 

Flammability 

Noncombustible but promotes 

burning of other substances. 

No inflammability to liquid. 

ISCS 1993 

Density (20oC) 2.144g/L(N.T.P) 

(at 0oC,101kPa) 

Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Vapour pressure (20oC) >1 atm ISCS 1993 

Vapour density (air=1) 1.6 (air=1) ISCS 1993 

Water solubility 0.1g/100mL (at 0oC) ISCS 1993 

pH in solution N/A Exits as a gas 

Dissociation constant N/A Not applicable since Ozone is a gas. 

Oxidation reduction 

potential 2.07V 

Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed, Section 2.Physical 

Properties P.39-P.40 June-2001 

Corrosivity to Material Yes 

Ozone reacts with inorganic 

compounds including metals and 

organic compounds. See section 2.1, 

APPENDIX 1-1 (confidential dossier). 

Reactivity to container 

material Yes 

Ozone reacts with inorganic 

compounds including metals and 

organic compounds. See section 2.1, 

APPENDIX 1-1. 

Auto ignition temperature 

(oC) 

Non-combustible but 

promotes burning of other 

substances. Various reactions 

may cause a fire or explosion. 

Ozone reacts with inorganic 

compounds including metals and 

organic compounds. See section 2.1, 

APPENDIX 1-1. 

Explosive Properties 

May cause a fire or explosion 

when heated or coming in 

contact with a combustible 

material (alkene, ether). 

ISCS 1993 

Oxidizing properties Yes ISCS 1993 

Surface tension 3.84×10-2N/mm 

(at -183oC) 

Refer to section 2.1 and APPENDIX 1-1 

Viscosity 1.57×10-3Pa.s(at -183oC) Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Thermal stability and 

breakdown product Oxygen Ullmann’s Encyclopedia of Industrial 

Chemistry 6th Ed,2001 

Other physical and chemical 

properties N/A Refer to section 2.1 and APPENDIX 1-1 

* * * 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 27 

I:\MEPC\59\2-16.DOC 

Appendix 2 

Data on Bromate 

1 CHEMICAL IDENTIFICATION 

Chemical 

Name 

Empirical 

Formula 

Molar 

mass 

Struc-tural 

formula CAS Number AS, RC or Other 

Bromate ion BrO3

-

 127.9 15541-45-4 RC 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity 

Species LC50 and EC50

(mg/L) 

Reference/Comments/ 

Justification for missing data 

Fish Oncorhynchus keta, SW 512 (96-h LC50) ECOTOX data base 

(U.S. EPA, 2007a) 

Crustacea Neomysis awatschensis, 

SW 176 (24-h LC50) ECOTOX data base (U.S. EPA, 2007a) 

Crassostrea gigas, SW 30 (96-h EC50) ECOTOX data base 

(U.S. EPA, 2007a) Molluscs 

Crassostrea gigas, SW 170 (24-h EC50) ECOTOX data base 

(U.S. EPA, 2007a) 

Algae N/A N/A 

ECOTOX data base 

(U.S. EPA, 2007a) 

Other literature was not available 

for data. 

2.2 Chronic Aquatic Toxicity 

Species NOEC 

(mg/L) 

Reference/Comments/Justification for 

missing data 

Fish N/A N/A 

ECOTOX data base U.S. EPA, 2007a). 

Data were not available in other 

literature. 

Crustacea N/A N/A 

ECOTOX data base (U.S. EPA, 2007a). 

Data were not available in other 

literature. 

Algae Skeletonema 

costatum, SW 

>0.125 

(7 days) Erickson and Freeman, 1978 

2.3 Information on Endocrine Disruption Not Available, but not considered required. 

2.4 Sediment Toxicity Not thought to be applicable due to its water solubility. 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 28 

I:\MEPC\59\2-16.DOC 

2.5 Bioavailability/Biomagnification/Bioconcentration

Chemical 

name logPow/BCF information 

Cause for 

concern 

(Yes/No) 

Reference/Comments/ 

Justification for missing data 

Bromate logPow -7.18 

ion BCF N/A No SRC, 2007 

2.6 Food web/population effects

2.6.1 The Log Pow of Bromate suggests that its bioaccumulation in the food chain would be 

minimal. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

Exposure Route Value Species Reference 

Oral LD50 280 mg/kg Rat GESAMP-BWWG 3/9, annex 6 

3.2 Corrosion/Irritation 

 Species Results Reference 

Skin Human Irritant RTECS & EEC Classification R36/37/38 

Eyes Human Irritant RTECS & EEC Classification R36/37/38 

Inhalation Not specified Irritant EEC Classification R36/37/38 

3.3 Sensitization 

3.3.1 Assumed not to be a sensitizer as EEC Classification does not include R43. 

3.4 Repeated Dose Toxicity

3.4.1 Exposure of rats to 30 mg/kg/d for 15 weeks produced significant increases in blood 

serum parameters indicative of live and kidney toxicity (GESAMP-BWWG 3/9, annex 6). 

3.4.2 NOAEL and LOAEL reported as 30 mg/kg/d. 

3.5 Development and Reproductive Toxicity 

3.5.1 Exposure of rats to 30 mg/kg/d for five and eight generations did not produce any 

observable developmental or reproductive toxicity. 

3.6 Carcinogenicity 

Species Method Results Reference 

Carcinogenicity Rat Possible human carcinogen IARC Gp 2B 

Mutagenicity Bacteria 

Hamster 

Ames Mutagenic 

Mutagenic 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 29 

I:\MEPC\59\2-16.DOC 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) bromate ions are converted into bromide 

ions by microbial degradation under anaerobic conditions. 

4.2 Partition Coefficients 

Log Pow -7.18 

BCF N/A 

4.3 Persistence and Identification of Main Metabolites 

4.3.1 With a half-life of > 40 d, bromate ions are considered to be persistent. 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property Value Reference/Comments 

CAS number 7758-01-2 WHO, 2005 

Molecule weight 167.01 WHO, 2005 

Liquid density N/A Not liquid but solid 

Evaporation heat Not considered to be a fire 

hazard MSDS(APPENDIX 7-1-2) 

Melting point 350o

C WHO, 2005 

Boiling point 370o

C(decomposes WHO, 2005 

Flammability Yes ICSC, 2003 

Density (20oC) 3.27g/m3 WHO, 2005 

Vapour pressure (20oC) N/A MSDS(APPENDIX 7-1-2) 

Vapour density(air=1) N/A MSDS(APPENDIX 7-1-2) 

Water solubility 

70g/L(20o

C) 

133g/L(40o

C) 

498g/L(100o

C) 

HydroChem Industrial 

Services,Inc. 

pH in solution Not Found MSDS(APPENDIX 7-1-2) 

Dissociation constant Not Found WHO, 2005 

Oxidation reduction potential 1.05V NTP 2008a 

Corrosivity to Material Yes NTP 2008a 

Reactivity to container 

material 

Yes MEPC 55/2 

Auto ignition temperature 

(

o

C) 

No MEPC 55/2 

Explosive Properties 

Risk of fire and explosion 

on contact with 

combustible, organic or 

other easily oxidizable 

materials. 

MEPC 55/2 

Oxidizing properties Oxidizer HydroChem Industrial 

Services,Inc. 

Surface tension Not Found Material Safety Data Sheet 

of Potassium Bromate 

Viscosity No ICSC, 2003 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 30 

I:\MEPC\59\2-16.DOC 

Thermal stability and 

breakdown product 

No HydroChem Industrial 

Services,Inc. 

Other 

physical and 

chemical 

properties 

contact with combustible materials may cause fire. 

Incompatible with combustible material, organics, 

reducing agents, aluminium, finely powdered metals. 

The substance decomposes on heating or on burning 

producing toxic and corrosive fumes including 

bromine, and oxygen, which increases fire hazard. The 

substance is a strong oxidant and reacts violently with 

combustible and reducing materials, metal powder, 

fats, carbon, sulphur, phosphorus, ammonium salts, 

and metal sulphides causing fire and explosion hazard 

http://physchem.

ox.ac.uk/MSDS/

PO/potassium_B

romate.html 

http://www.itcilo

.it/english/actrav/

telearn/osh/ic/77

58012.htm 

* * * 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 31 

I:\MEPC\59\2-16.DOC 

Appendix 3 

Data on Bromoform 

1 CHEMICAL IDENTIFICATION 

Chemical 

Name 

Empirical 

Formula 

Molar 

mass 

Structural 

formula CAS Number AS, RC or Other 

Bromoform CHBr3 252.7 75-25-2 RC 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity 

Species LC50(mg/L) or 

EC50(mg/L) 

Reference/Comments/ 

Justification for missing data 

Cyprinodon 

variegatus, SW 7.1 (96-h LC50) ECOTOX data base (U.S. EPA, 2007a) 

Brevoortia tyrannus, SW 12 (96-h LC50) ECOTOX data base (U.S. EPA, 

2007a) Fish 

Lepomis macrochirus, FW 29 (96-h LC50) ECOTOX data base (U.S. EPA, 

2007a) 

Americamysis bahia, SW 24.4 (96-h LC50) ECOTOX data base (U.S. EPA, 

2007a) 

Penaeus aztecus, SW 26 (96-h LC50) ECOTOX data base (U.S. EPA, 

2007a) 

Daphnia magna, FW 46 (48-h LC50) ECOTOX data base (U.S. EPA, 

2007a) 

Crustacea 

Daphnia pulex, FW 44 (96-h LC50) ECOTOX data base (U.S. EPA, 

2007a) 

Skeletonema 

costatum, SW 12.3 (96-h EC50) ECOTOX data base (U.S. EPA, 2007a) 

Pseudokirchneriella 

subcapitata, FW 42 (72-h EC50) ECOTOX data base (U.S. EPA, 2007a) Algae 

Pseudokirchneriella 

subcapitata, FW 40.1 (96-h EC50) ECOTOX data base (U.S. EPA, 

2007a) 

2.2 Chronic Aquatic Toxicity 

Species MATC (mg/L) or 

NOEC(mg/L) 

Reference/Comments/ 

Justification for missing data 

Fish Cyprinodon 

variegatus MATC; 4.8 (28 d) Ward et al., 1981 

Crustacea N/A N/A 

ECOTOX data base 

(U.S. EPA, 2007a). Data were 

not available in other literature. 

Algae Pseudokirchneriella 

subcapitata, FW NOEC;10 (96 h) ECOTOX data base (U.S. EPA, 2007a) 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 32 

I:\MEPC\59\2-16.DOC 

2.3 Information on Endocrine Disruption

Not Available, but not considered required. 

2.4 Sediment Toxicity 

As log Pow is <3 it is not expected to cause sediment toxicity. 

2.5 Bioavailability/Biomagnification/Bioconcentration

Chemical 

name logPow/BCF information 

Cause for 

concern 

(Yes/No) 

Reference/Comments/ 

Justification for missing data 

logPow 2.4 

Bromoform BCF 

0.1mg/L: 

7.1-21 

0.01 mg/L: 

7.7-19 

No NITE, 2007 

2.6 Food web/population effects

The BCF of bromoform suggests that its potential to bioaccumulate in the food chain would be 

minimal. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

Exposure Route Value Species Reference 

Oral LD50 707-1550 mg/kg 

933-2440 

Mouse 

Rat 

Dermal LD50 

Inhalation LC50 7000 μg/L/4h Dog 

3.2 Corrosion/Irritation 

Route Species Results Reference 

Skin Human Irritant GESAMP-BWWG 3/9, annex 6 

Eye Human Irritant GESAMP-BWWG 3/9, annex 6 

Inhalation Human Irritant GESAMP-BWWG 3/9, annex 6 

3.3 Sensitization 

Not thought to be a sensitizer. 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 33 

I:\MEPC\59\2-16.DOC 

3.4 Repeated Dose Toxicity 

3.4.1 A summary of the repeated toxicity data evaluated by the Group for bromoform is shown 

in the table below: 

Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure dose Missing 

Species Rats and Mouse 

NOAEL 25mg/kg/d (rat), 100mg/kg/d(Mouse) 

NOEL 

3.4.2 The Group noted a 13-week study, performed in rats, where a NOAEL of 25mg/kg bw/d 

could be derived on the basis of the absence of liver lesions whereas in the study in mice 

was 100mg/kg bw/d (NTP, 1989). 

3.4.3 A summary of the chronic toxicity data evaluated by the Group for bromoform is shown 

in the table below: 

Exposure Route Oral 

Exposure Duration 2 years 

Exposure dose 100 and 200 mg/kg/d 

Species Rat 

Method 

Results Small increase in tumours of the large intestine 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

EHC 216(2000) 

3.4.4 The Group noted that no neoplasic effects were associated with the exposure of mice to 

bromoform. However, adenocarcinomas of the colon or rectum were observed in 3/50 male rats 

dosed with 200mg/kg and 1/50 female rats dosed with 100mg/kg and 8/50 female rats dosed 

with 200mg/kg (c.f. 0/48 in female control rats). 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 34 

I:\MEPC\59\2-16.DOC 

3.5 Development and Reproductive Toxicity 

3.5.1 A summary of the development and reproductive toxicity data evaluated by the Group for 

bromoform is shown in the table below: 

Exposure Route Oral Oral 

Exposure Duration At days 6-15 of gestation 105 days 

Exposure dose 50, 100 and 200 mg/kg/d 

Species Rat Rats (male and female pairs) 

Method 

Results Evidence of foetotoxic response.

No foetal malformations 

observed 

No detectable effect on fertility, 

litters/pair, live pups/litter, 

proportion of pups born alive, 

sex or body weights 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

EHC 216 (2000) EHC 216 (2000) 

3.5.2 It was noted that Ruddick et al. (1983) had conducted a teratological investigation in 

Sprague-Dawley rats, where bromoform was administered by gavage at dose of 50, 100 

or 200mg/kg bw/d on gestation days 6-15. Evidence of foetotoxic response was observed, but 

there were no foetal malformations. This study was used to examine effects on fertility and 

reproduction in Swiss CD-1 female rats. There were no detectable effects of bromoform on 

reproduction function. Bromoform was found to induce resorption in F344 pregnant rats, at 

higher doses (150 and 200mg/kg bw/d). 

3.6 Carcinogenicity 

3.6.1 A summary of the carcinogenicity and mutagenicity data, evaluated by the Group for 

bromoform, is shown in the table below: 

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity Rats 5 days exposure/week 

for 2 years 

No evidence 

observed 

NTP, 1989a 

Mutagenicity Bacteria 

Not 

identified 

(Ames test) 

In vivo 

Mutagenic 

Inconclusive 

3.6.2 The Group noted that IARC had evaluated carcinogenicity of bromoform and concluded 

that there is inadequate evidence for its carcinogenicity in humans and limited evidence for its 

carcinogenicity in experimental animals. IARC classified bromoform in Group 3 

(not classifiable as to its carcinogenicity to humans). EPA (2005) classified bromoform as 

possible human carcinogen (Group 2B). 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 35 

I:\MEPC\59\2-16.DOC 

3.6.3 In addition, the Group noted that bromoform is largely positive in bacterial assays of 

mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies 

have given contradictory results. 

3.6.4 The Group noted that the applicant had not submitted any data related to mutagenicity. 

However, it was agreed that, with the development, reprotoxicity and carcinogenicity data, this 

additional information was not essential. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

4.2 Partition Coefficients 

Log Pow 2.4 

BCF 7.1 – 21 

4.3 Persistence and Identification of Main Metabolites 

With a half-life of 32 – 185 d, bromoform is regarded as persistent. 

4.4 Reaction with Organic Matter 

Not considered required.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Not considered required.

4.6 Potential Residues in Seafood 

Not considered required.
GESAMP-BWWG 8/6 

ANNEX 4 

Page 36 

I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Physical property Value 

Reference/Comments/ 

Justification for missing 

data 

CAS number 75-25-2 U.S. EPA 2005 

Molecule weight 252.77 U.S. EPA 2005 

Liquid density 2.899 g/mL (20o

C) U.S. EPA 2005 

Evaporation heat 46.05 kJ/mol ATSDR 2005 

Melting point 8o

C U.S. EPA 2005 

Boiling point 149-150o

C U.S. EPA 2005 

Flammability No ATSDR 2005 

Density (20oC) 2.899 g/mL ATSDR 2005 

Vapour pressure (20oC) 667 Pa NTP 2008b 

Vapour density (air=1) 8.7 NTP 2008b 

Water solubility 3190mg/L(30o

C) U.S. EPA 2005 

pH in solution N/A Not hydrolyzed 

Dissociation constant N/A No dissociable group 

Oxidationreduction potential 

N/A No ionization 

Corrosivity to 

Material 

Yes ATSDR 2005 

Reactivity to container 

material 

Yes ATSDR 2005 

Auto ignition temperature 

(

o

C) - N/A 

Explosive Properties Not considered to be an 

explosion hazard MSDS(APPENDIX 7-1-2) 

Oxidizing properties N/A MSDS(APPENDIX 7-1-2) 

Surface tension 41.50mN/m (20 oC) NTP 2008b 

Viscosity 1.8 cP NTP 2008b 

Thermal stability and 

breakdown product 

May form toxic fumes of 

bromides when heated to 

degradation 

MSDS(APPENDIX 7-1-2) 

Other physical and 

chemical properties 

Volatilize ATSDR 2005 

* * * 
GESAMP-BWWG 8/6 

ANNEX 4 

Page 37 

I:\MEPC\59\2-16.DOC 

Appendix 4 

Data on Treated Ballast Water 

1 CHEMICAL IDENTIFICATION Treated Ballast Water 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity 

2.2 Chronic Aquatic Toxicity 

Test water 

Max. concentration of 

Relevant Chemicals in No 

Observed Effect Test Water 

Case (mg/L) 

Fish:Oryzias 

javanicus 

(28d-NOEC)

Crustacea: 

Hyale 

barbicornis 

(21d-NOEC) 

Algae: 

Skeletonema 

costatum 

(78h-NOEC)

Bromate ion 0.03 

Bromoform: 0.0093

TRO (as O3) 0.96 Sea water Generated TRO by 

Ozone Treatment 

(mg/L as O3) 

0.69 

Before 

PT;10% 

After 

PT;100% 

Before 

PT;10% 

After 

PT;100% 

Before 

PT;10% 

After 

PT;100% 

2.3 Information on Endocrine Disruption 

Not Available, but not considered required. 

2.4 Sediment Toxicity

Not considered required.

2.5 Bioavailability/Biomagnification/Bioconcentration

Not considered required. 

*** 

Test 

water 

Max. concentration of 

Relevant Chemicals (mg/L)

Fish: 

Oryzias 

javanicus 

Crustacea: 

Hyale 

barbicornis 

(96h-LC50) 

Algae: 

Skeletonema 

costatum 

(72h-ECr50) 

Bromate ion 0.07 

Bromoform: 0.0023

TRO (as O3) 0.85 Sea water Generated TRO by 

Ozone Treatment 

(mg/L as O3)

<0.15 

>100% >100% >100% 

Bromate ion 0.04 

Bromoform: 0.015 

Brackish TRO (as O3) <1.18 

water Generated TRO by 

Ozone Treatment 

(mg/L as O3)

<0.15 

>100% 71% >100% 

GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 5 

REVIEW OF PROPOSALS FOR THE APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUSBSTANCES 

RWO Ballast Water Management System (CleanBallast) 

Submitted by Germany 

0 SUMMARY

0.1 Having reviewed all the information provided by the applicant, the Group agreed to 

recommend to the MEPC that Final Approval be given to the RWO Ballast Water Management 

System (CleanBallast), subject to the Administration verifying that all the following 

recommendations have been fully addressed prior to issuance of a Type Approval Certificate: 

 .1 the neutralization step should always be employed prior to discharge; the Group 

considered this step of great importance to ensure the safety of the marine 

environment, recognizing the importance of the neutralization process as an 

environmental risk mitigation measure. 

 .1 the maximum allowable dosage of Active Substances (TRO) should 

be 2.5 mg/L as Cl2 for the first treatment at intake and 1.5 mg/L as Cl2 for 

the second treatment at discharge, if required. These parameters should be 

monitored by TRO sensors adequately maintained, and also recorded during 

when the BWMS in use; and 

 .2 the maximum allowable discharge concentrations of Active Substances 

– the concentration of TRO after neutralization should be kept to a level not 

exceeding the range of 0.1-0.2 mg/L. During the Type Approval procedure 

by the Administration, the applicant should finalize the maximum allowable 

discharge concentrations of TRO in the range of 0.1-0.2 mg/L as Cl2 and 

validated by the Administration. This parameter should be monitored and 

recorded during discharge. 

0.2 In addition to the above recommendation, the Group made the following observations: 

 .1 it was noted that the applicant had used the model calculations using 

the MAMPEC-model and the model MIKE to generate estimations of the PECs 

for different Relevant Chemicals; 

 .2 it was also noted that the results used were only based on the MAMPEC results. 

Although the attempt of the applicant was appreciated the Group found some 

difficulties in reproducing the results of the applicant as the documentation did 

not include a listing of the input values used. The results obtained by the Group 

were too high by a factor of about 100 for the commercial harbour and a factor of 

about 50 for the OECD-EU commercial harbour. However, the Group did 

consider these results as indicative as a standard scenario has not been endorsed 

yet. It is recommended that applicants deliver all the input and output data used 

in the modelling; and 
GESAMP-BWWG 8/6 

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.3 the Group noted the thorough evaluation of corrosion of both uncoated and marine 

epoxy coated steel. The applicant concluded, from these tests, that CleanBallast 

was compatible with epoxy based ballast water tank coating systems as certified 

by Germanischer Lloyd (GL). However, the corrosion evaluation of uncoated 

steel was insufficient due to the low exposure dose through the majority of the 

exposure evaluation. This was not considered a reason influencing the 

FA recommendation. 

1 INTRODUCTION

1.1 The Group noted that the EctoSysTM system had been recommended to MEPC 

for Basic Approval at its second session in May 2006. 

1.2 It was also noted that Final Approval for the CleanBallast system, which employed 

the Basic Approved Ectosys technology, had not been recommended to MEPC due to a number 

of perceived shortcomings. 

1.3 The data used to evaluate the CleanBallast system for Final Approval were extracted from 

the German submission to the fifty-ninth session of MEPC as document MEPC 59/2. 

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the development of the CleanBallast system started in 2003 and that 

different treatment devices for mechanical separation and disinfection (including the advanced 

EctoSys® electrolysis) had been tested in parallel, achieving a direct comparison of their 

performance at the naturally changing inlet water quality. 

2.2 It was also noted that the EctoSys® electrolysis system had received Basic Approval 

of Active Substances at the MEPC 55 and that RWO GmbH had purchased the EctoSys®

technology from the former owner Permascand (Sweden) including all rights (BWM.2/Circ.11). 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group noted that the CleanBallast system comprised: 

 .1 a filtration process employing 50μm filters; followed by; 

 .2 electrochemical oxidation to produce disinfection at uptake and discharge using an 

algae monitor to measure the concentration of algae which relates to the current 

applied to the electrolysis cell; and, if required; and 

 .3 a neutralization system to lower the TRO concentration in high salinity seawater. 

3.1.2 The Group noted that electrochemical oxidation process employed a controlled current to 

ensure that the maximum dose of disinfectant produced is proportional to the ballast water uptake 

flow rate resulting in a maximum of 2 mg/L of Total Residual Oxidant (TRO). The current is 

regulated in proportion to the concentration of algae in the ballast water which is monitored using 

an algae monitor. 
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3.1.3 Furthermore, the Group noted that the system is capable of functioning in both saline 

(sea water) and fresh (river water). 

3.2 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC) 

3.2.1 The Group recognized the following chemical reactions that take place during 

electrolysis: 

.1 H2O → OH* + H+ + e- primary reaction in fresh water; 

.2 2 Cl- → Cl2 + 2 e- 

.3 Cl2 + H2O → HCl + HOCl 

.4 HOCl + Br- → HOBr + Cl3.2.2 The Group agreed with the applicant that the following chemicals should be regarded 

as Active Substances: 

 .1 Hydroxyl Radicals (OH*

) which have very short half-lives (10-9 s) and so analysis 

and toxicity testing were neither necessary nor appropriate; and 

 .2 Free Active Chlorine as hypochloric acid (HOCl) and hypochlorite ion (OCl-) 

which react to form hypobromite. 

3.2.3 Recognizing that the Active Substances produced by the electrolysis of seawater react 

with naturally occurring organic and inorganic compounds, the Group also agreed that the 

following chemicals should be regarded as Relevant Chemicals: 

 .1 Free Active Bromine as hypobromic acid (HOBr) and hypobromite ion (OBr-

) 

 .2 Dibromochloromethane (CHBr2Cl); 

 .3 Tribromomethane (Bromoform) (CHBr3); 

 .4 Dichloroacetic acid; 

 .5 Trichloroacetic acid; 

 .6 Dibromoacetic acid; 

 .7 1,2,3-trichloropropane; 

 .8 Bromate; and 

 .9 Hydrogen. 
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3.2.4 Other Chemicals (OC) recognized by the Group as by-products of the process were: 

 .1 Oxygen; 

 .2 Adsorbable Organic Halogens (AOX); and 

 .3 Extractable Organic Halogens (EOX). 

3.2.5 Key data for the Active Substances, as supplied by the applicant, can be found in the 

following appendices to this annex: 

 .1 sodium hypochlorite appendix 1; 

 .2 sodium bromate appendix 2; 

 .3 tribromomethane appendix 3; 

 .4 dibromochloromethane appendix 4; 

 .5 dibromoacetic acid appendix 5; and 

 .6 trichloropropane appendix 6. 

4 CONSIDERATION OF THOSE CONCERNS EXPRESSED ABOUT THE 

PREVIOUS SUBMISSION FOR FINAL APPROVAL 

4.1 The Group recalled that, in considering the previous submission for Final Approval of 

this system, a number of concerns had been raised. It was noted that these concerns had been 

addressed by the applicant in this submission and so the Group considered each one as reported 

in the rest of this section. 

4.2 The Group recalled that, previously, it had recommended that a number of the chemicals 

identified by the applicant, inter alia, hydroxyl radicals, chlorine gas and hydrogen gas should be 

regarded as Active Substances and that a number of Disinfectant By-Products (DBPs), which had 

also been identified, should be regarded as Relevant Chemicals. 
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4.2.1 It was noted that the applicant had, subsequently, identified and quantitatively analysed the 

whole-effluent samples of treated water of several qualities (e.g., fresh, brackish and full salinity) as 

shown below: 

FreshWater BrackishWater SeaWater 

Chemical Units DL BW Control BW Control BW Contro

l 

Trichloromethane μg/L 0.3 0.38 0.32 <0.50 <0.50 <0.50 <0.50 

Dichlorobromomethane μg/L 0.1 0.38 <0.1 <0.50 <0.50 <0.50 <0.50 

Dibromochloromethane μg/L 0.1 0.82 <0.1 6 <0.50 5.3 <0.50 

Tribromomethane μg/L 0.1 1.44 <0.1 147 1.05 135 <1.43 

THM μg/L 3.02 <155 <6 <141 <2.9 

Monochloroacetic acid μg/L 0.1 0.21 <0.1 <0.50 <0.50 <0.50 <0.50 

Dichloroacetic acid μg/L 0.1 0.87 0.14 <0.30 <0.30 <0.30 <0.30 

Trichloroacetic acid μg/L 0.05 0.5 0.08 <0.20 <0.20 <0.20 <0.20 

Monobromoacetic acid μg/L 0.1 0.15 <0.1 <0.20 <0.20 <0.20 <0.20 

Dibromoacetic acid μg/L 0.1 1.28 <0.1 22 <0.47 5.0 <0.22 

Bromochloroacetic acid μg/L 0.1 1.07 <0.1 <0.6 <0.10 <0.17 <0.10 

HAA μg/L 4.08 <8.8 <1.74 <6.4 <1.52 

Bromate μg/L 1 2.6 <1 26 <1.0 9.9 <1.0 

AOX (as Cl2) mg/L 0.02/0.0

1 

0.14 0.1 0.06 <0.010 0.05 <0.012 

EOX (as Cl2) mg/L 0.01 0.01 <0.010 0.03 <0.010 

TRO (mean) mg/L 0.22 0.12 0.4 0.06 1.10 0.08 

AOX = Adsorbable Organic Halogens: Includes chlorinated and brominated adsorbable 

organic compounds e.g., trihalomethanes. 

EOX = Extractable Organic Halogens: i.e. the sum of all the organically bound halogens 

which can be extracted from solids. 

TRO = Total Residual Oxidants (HOCl and OCl-) which react in sea water to form 

sodium hypobromite). 

Note : As both AOX and EOX comprise individual disinfectant by-products, which have 

been processed separately, they are not treated as Relevant Chemicals. 

4.2.2 The Group noted this additional information and was satisfied. 

4.3 The Group recalled that, as the previous application had indicated that the maximum TRO 

in seawater was 2 mg/L and as no levels had been reported for fresh water, the Group had agreed 

that 2 mg/L should be treated as both the Maximum Dosage and the Maximum Allowable 

Discharge Concentration in accordance with Procedure (G9). 

4.3.1 The Group noted that the applicant had indicated that, in fresh water, the 

only Active Substance generated is the hydroxyl radical which has an extremely short half-life 

and would not enter the aquatic environment with the discharged ballast water. As a result, the 

applicant had indicated that TRO could not be detected above the natural background level. 
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4.3.2 As a result, the Group accepted the applicant’s argument that Maximum Dosage and Maximum 

Allowable Discharge Concentration were not relevant for this system when used with fresh water. 

4.4 The Group recalled that, previously, the applicant had explained that high levels of 

disinfection by-products such as THM were due to the fact that the EctoSys® system was run 

differently in the land-based tests than it will be in normal operation on board ships. The Group 

had then considered that a full chemical characterization of water treated by that system run in 

normal mode should be provided together with toxicity tests with the same water 

4.4.1 The Group noted that the applicant had stated that in its previous submission 

for Final Approval, the CleanBallast system was operated taking a worst case approach, i.e., the 

maximum current was applied to the electrodes, consequently generating concentrations close to 

the maximum TRO limit of 2 mg/L in marine waters at all times. This had been done both at 

ballasting and at deballasting treatment in order to allow a worst case approach in the subsequent 

risk assessment. This procedure was applied regardless of the actual need for such a high 

maximum concentration to achieve the biological efficiency defined by Guidelines (G8). 

4.4.2 The Group also noted that the applicant had clarified this point by stressing 

that 2 mg TRO /L had originally been reported as the result of running the system at a high rate 

even though this was unnecessary. The applicant had then explained that the purpose of the 

algae monitor, used during treatment at discharge, was to determine the amount of current needed 

to effect disinfection. This part of the system ensures that such high levels of TRO are not 

produced during the discharge of treated ballast water (ref: email from applicant 15/12/08). 

4.4.3 However, the Group noted that in the current application, the CleanBallast system 

including the EctoSys® electrolysis had been run under normal operating conditions, causing 

the TRO concentration/current applied at deballasting treatment to be minimized whilst fulfilling 

the performance criteria specified under the Guidelines (G8). 

4.4.4 It was noted that the same full-scale land-based test water treated by the CleanBallast system 

was used to provide the chemical analysis and carry out toxicity studies. It was noted that, under these 

conditions, both the concentrations of disinfection by-products and toxicity values were lower than had 

previously been reported under a worst-case scenario. It was also noted that such values were lower 

than had been reported under the application for Basic Approval. 

4.4.5 The Group noted that the applicant included the option of a neutralization system, though 

the system is not described in the non-confidential dossier, the system manual or system 

description and that without it the system is capable of up to 2 mg TRO /L (as Cl2) discharge. 

4.4.6 Whilst the included algal monitor is intended to mitigate this, the possibility of treatment 

in large concentrations of algae, and thus high discharges of TRO are possible. In fact, since the 

discharge sensor limit is 2 mg/L as Cl2, it is assumed that this is the practical limit of TRO 

discharge. The Group also noted that, during a land-based treatment test, a malfunction of the 

online TRO control unit upon discharge resulted in a TRO >2 mg/L (as Cl2) despite 

the Algal Monitor. In addition, in all land-based tests in both brackish and seawater conditions 

without neutralization the resultant discharge TRO was 0.76-1.42 and ~0.4 mg/L (as Cl2), 

respectively. However, when neutralization was applied the TRO discharge was undetectable. 

The Group recommended that Final Approval of this system should be conditional on the 

inclusion of the neutralization step in all cases. 
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4.5 The Group recalled that, previously it had noted that no detailed information about the 

control system which could ensure that the maximum designed TRO-concentration is maintained 

had been included in the CleanBallast system. In this context, it had also been noted that an 

algae monitor sensor was to be included in the industrialized version of the system installed on 

board ships. As this sensor had been under development at the time of the previous application, 

the Group had expressed its concern that a proper control system had not been fully developed 

and so could not be fully evaluated. 

4.5.1 The Group noted that the applicant had indicated that the Maximum Dosage 

Concentration of 2 mg/L TRO in marine waters is ensured by restricting the current distributed 

from the rectifier to the electrodes depending on the flow rate and conductivity. Thus, it is not 

linked to the function or operation of the Algae Monitor. 

4.5.2 In addition, the recommendation of GESAMP-BWWG on maintaining the 

maximum TRO concentration had been considered and an additional TRO online sensor included 

in the CleanBallast system for monitoring and controlling the produced TRO concentration in 

marine waters. 

4.5.3 The applicant also indicated that the Algae Monitor is not used for the measurement of 

the chemical properties of the effluent such as TRO levels but is used to continuously analyse the 

direct effect of the treatment on phytoplankton and, by a feed-back loop to the disinfection unit 

operation system (EctoSys®), to minimize the use of Active Substances at concentrations below 

the Maximum Dosage of 2 mg/L TRO. The Algae Monitor is a mitigation measure for the 

second EctoSys® treatment, reducing disinfection at deballasting only to a level needed for 

achieving the G8 efficiency. 

4.5.4 The Group was satisfied with this explanation. 

4.6 The Group recalled that it had been satisfied with the risks associated with the generation 

of hydrogen as a by-product of this system but had expressed concern that the formation of 

oxygen in a full-scale test has not been investigated.

4.6.1 It was noted that the applicant had indicated that, besides the measurements of the 

dissolved oxygen concentration in water, an additional oxygen gas analyser had been installed in 

the de-aeration pipe in the testing for the Final Approval. A slight increase of the dissolved 

oxygen concentration had been measured in the effluent water of the CleanBallast system, which 

was in the range of the dissolved oxygen saturation concentration. In accordance with the still 

low dissolved oxygen concentration, the measured oxygen gas concentrations were in the normal 

range of 20% Vol. 

4.6.2 In addition, it was noted that both the hydrogen gas and the oxygen gas by-products are 

removed by the de-aerator through the chimney directly to the ambient air well above the main 

deck or through the deck with the pipe ending well above the height of a human. 

4.6.3 The Group was satisfied with this explanation. 
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4.7 The Group recalled that, previously, it had noted that the long-term corrosion testing, 

which had been advised in the Basic approval evaluation, had not commenced and so the level of 

potential risk of accelerated corrosion to the ballast water piping could not be assessed.

4.7.1 The Group noted that the applicant had indicated that corrosion studies had been started. 

The applicant also indicated that the result showed that the CleanBallast system did not have any 

negative influence on the tested coating systems, which are intended for the use in seawater 

ballast tanks on ships. As a result, a “Certificate on compatibility of the CleanBallast system 

with epoxy based ballast water tank coating systems” for use on board ships has been issued. 

4.7.2 However, the Group noted that the applicant reported that the corrosion rate of steel was 

increased in high concentrations of the oxidizer. Whilst the Group agrees with this evaluation, 

the Group noted that since the exposure concentration of approximately 0.5 mg/L for 80 of 

the 100 day exposure. The Group concluded that these data are insufficient to fully characterize 

the anticipated corrosion effects of the CleanBallast system on uncoated steel. It is expected that 

the corrosion rate of uncoated steel would be significantly higher if the TRO had been 

maintained >1 mg/L (as Cl2), as documented in literature. 

4.7.3 The Group was not satisfied that this concern had been adequately addressed and 

recommended that the exposure and subsequent corrosion rate analysis be repeated by the 

applicant at the worst case exposure dosage anticipated from the CleanBallast system through the 

entirety of the test. This evaluation should include uncoated steel and any other metals (i.e. 

brass, stainless steel, etc...) or non-metallic materials (i.e. EPDM rubber, fluoropolymers, etc.) 

within the shipboard piping, pumping or structure which may be exposed to 

the Active Substances or Relevant Chemicals. The Group noted that in the case that passive or 

oxide forming materials are exposed in service, evaluations of the localized corrosion resistance 

of these materials should also be conducted. 

4.8 The Group recalled that, previously, it had noted that chronic aquatic toxicity studies had 

not been carried out in a land-based installation as required by Procedure (G9), but in a lab-based 

installation. Whilst the applicant had indicated that it is the TRO concentration which is relevant 

in relation to the toxicity of the treated water and not the scale of the installation, the Group 

considered that both the level of TRO and organic matter which leads to the level of halogenated 

by-products (DBP) and so to the toxicity of the treated water. For this reason the Group had 

expressed the view that toxicity tests with water samples from the land-based efficacy tests as 

required by Guidelines (G8) and Procedure (G9) would ensure that adequate levels of TRO and 

organic matter are used in all tests and the chemical characterization of treated water. 

4.8.1 The Group noted that the applicant had indicated that acute and chronic aquatic toxicity 

studies with six different species on three trophic levels and five phyla had been carried out using 

water treated in the full-scale CleanBallast system during land-based type approval testing. The 

tests and equipment fulfilled the criteria under the G8 guideline, as required by the G9 procedure. 

Water quality also fulfilled the inlet criteria. The full-scale land-based CleanBallast unit was 

operated according to normal procedures, similar as on board a ship. The treatment efficiency 

fulfilled the D-2 standard criteria. 

4.8.2 Having considered these additional data the Group was satisfied that the appropriate tests 

had been carried out and concluded that no negative influence on the coating system had been 

identified. 
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4.9 The Group recalled that, previously, it had expressed the view that brominated DBPs 

(Disinfection By-Products) are toxicologically relevant compounds generated by the process. 

As the applicant had not provided information concerning the Human Exposure Scenario an 

adequate conclusion as to the outcome of the Human Risk Assessment could not be achieved. 

Therefore, the Group had recommended that human exposure, when handling ballast water 

treatment operations, should be restricted and RMM put in place.

4.9.1 The Group noted that the applicant had indicated that Human Exposure Scenarios (HES) 

of Active Substances and Relevant Chemicals, including brominated disinfection by-products, 

originating from treated ballast water had been evaluated according to guidelines given by 

the Group and elaborated from templates and principles used in the available TGD 

(Technical Guidance Document, issued by the EU Commission) as well as reflecting the 

recommendations given by the Group concerning HES. Occupational as well as exposures via 

the environment have been addressed and inhalation, dermal route and oral exposures have been 

evaluated. 

4.9.2 The Group noted that the applicant had stated that, during normal ballast water operations 

on board the ship such as ballasting, ballast water storage and ballast water discharge, there 

would be no dermal or oral exposure route of Active Substances or Relevant Chemicals to the 

crew, due to the EctoSys® cell being installed in the main ballast pipe. 

4.9.3 The applicant also indicated that, as the inhalation route had raised concern, since 

brominated and other disinfection by-products might enter into the gas phase, special attention 

had been given to this potential risk when developing the HES. The application stated that HES 

concludes that the predicted concentration in the air for inhalation is far below 

existing OEL-values and so no risk to the crew on the ships is expected. Also, as the predicted 

daily uptake considering all uptake routes simultaneously is far below existing TDI values, no 

risk to the public from the TRO, its degradation products or by-products is expected from the 

environment. 

4.9.4 In case of damage to any equipment carrying treated ballast water (e.g., the ballast water 

piping), the CleanBallast system is automatically shut-down although it was recognized that any 

leakage might lead to exposure. The applicant stated that the Maximum Dosage Concentration 

of 2 mg/L Active Substances will never be exceeded in any step of the process, thus the acute 

toxicity of treated water is evaluated to have no dermal effect on humans, should there be a direct 

exposure outside normal operation, i.e. leakage. The potential exposure dose, duration and 

frequency of such events were assessed as producing negligible risk. Having considered the 

additional information provided, the Group concurred with the views of the applicant. 

4.10 The Group recalled that, previously, based on information provided in the application 

for Basic Approval, a PEC/PNEC ratio of discharged ballast water in Rotterdam harbour could 

be calculated to 0.85. Based on this ratio the Group concluded that, under the conditions of the 

test, there would be low risk for the environment. For a final risk assessment to the environment 

the Group indicated that it needed a better explanation of the presence and performance of the 

algae monitor and information on the validity and applicability of the model used. For reference 

reasons, the Group had recommended that calculations with the MAMPEC-model use as many of 

the same parameter values as possible. 
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4.11 The Group recalled that such recommendations had been made in order that more 

confidence in the applied tools and methods could be given to support the assumptions of the 

applicant there seems no risk for the environment. 

4.11.1 The Group noted that the applicant had subsequently used MAMPEC (ver.2) in addition 

to previous custom-made simulations to assess conservative PECTRO values for large commercial 

harbours comparable to Rotterdam. Using (as far as possible) the same input parameters 

(i.e. standard commercial harbour EU OECD commercial harbour) as for previous evaluations, 

the PEC/PNEC ratios for TRO as derived by MAMPEC for discharge concentrations relevant for 

normal operation of the CleanBallast operated in natural waters were reported as <1. The risk 

characterization is further based on input parameters varying over the whole range from the 

unrealistically conservative default assumptions on e.g., discharge quantities to a more balanced 

assessment of the discharge into the receiving environment. 

4.11.2 In addition to calculating predicted steady-state concentrations, the Group noted that 

plume modelling had been adopted to examine the acute exposure of receiving waters 

to Active Substances and Relevant Chemicals. Properly defined real case harbours had been 

used in order to simplify future comparisons. Immediate exposure during discharge as well as 

dilution/diffusion over time had been considered. The results had been compared to the outcome 

of the acute toxicity studies, calculated NOEC of the most sensitive species and literature 

references. 

4.11.3 Having considered the additional data provided, the Group was satisfied with the results 

provided. 

5 HUMAN HEALTH ASSESSMENT

5.1 Occupational exposure of the crew 

5.1.1 The Group noted that the applicant had developed a human exposure assessment from 

which it concluded that occupational exposure to TRC and its degradation products may occur in 

the following two situations: 

 .1 sampling from the system. However, sampling is expected only to be carried out 

by RWO technicians and thus no exposure to the crew on the ship due to sampling 

is expected; and 

.2 on the loading of the ballast tanks with water, the excessive air of the ballast tanks 

arising as air is replaced with water in the ballast tanks will be exhausted on board 

and humans on board may inhale some of this air. 
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5.1.2 The Group noted that, initially, the concentration in air (Cair) was calculated assuming 

equilibrium between the substances found in water and air:

air Cwater RT

H C = ⋅

Where: 

 Cair is the concentration in air (mg/m3

) 

 H is the Henry’s law constant (Pa m3/mole) 

 R is the Gas constant (8.314 Pa m3

/(mole K) 

 T is the absolute temperature (K) 

 Cwater is the concentration in ballast water (μg/L)

5.1.3 The Group also noted that if the substance was not detected, the concentration in water 

was assumed to be equal to the detection limit. 

5.1.4 The predicted concentration in air were than compared with the OEL values assigned by 

various countries when it was found that the predicted concentrations in air were well below the 

various OEL values, with the exception of dibromomethane which was slightly above the Dutch OEL 

value. 

5.1.5 However, further modelling showed that the required dilution of at least two fold is 

obtained for all ship sizes considered and so it was concluded by the applicant that exposure of 

the crew to dibromomethane by inhalation did not present a significant risk. 

5.2 Exposure via the environment 

5.2.1 The Group agreed that human exposure to TRO in the treated ballast water could 

occur as: 

 .1 oral intake due to bioaccumulation of the substance in the food chain; or 

 .2 oral, inhalational or dermal exposure during bathing in areas close to the ballast 

water outlet. 

5.2.2 The Group agreed with the applicant that the concentration in fish and bivalves may be 

calculated from: 

PECfish BCF PECMAMPEC = ⋅
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Where: 

PECfish is the concentration in fish (mg/kg) 

PECMAMPEC is the concentration in the water column calculated by the MAMPEC model 

BCF is the bioconcentration factor. 

Assuming that people are only eating fish from the area (very conservative), the daily 

intake via eating fish and bivalves is then calculated as: 

Uoral,fish = Mfish × PECFish × BIOoral = Mfish × BCF × PECMAMPEC × BIOoral 

Where: 

 Uoral,fish is the amount chemical uptake by eating fish 

Mfish is the amount fish eaten per day per person. It is set to the default value given in the 

ECHA TGD of 115 g/d (reference). 

BIOoral is the bioavailability for oral intake (set to 1) 

5.2.3 The Group considered that the input values should be shown in the Uoral,fish formula in 

order to understand its contribution to the overall exposure values (Table 5.4. - Appendix K of 

the confidential dossier). However, the Group agreed with the applicant that dermal, oral and 

inhalation exposure to humans could occur during swimming and that the total uptake during this 

activity could be estimated as: 

Utot,swimming = Iskin,swimming per day,pot × BIOdermal + Iinhalation,swimming per day,pot × BIOinhal + 

Ioral,swimming × BIOoral 

Where: 

Utot,swimming is the total amount of chemical potential uptake during swimming 

BIOder is the bioavailability for dermal uptake (set to 1) 

 BIOinh is the bioavailability for inhalation (set to 1) 

BIOoral is the bioavailability for oral intake (set to 1) 

Iskin,swimming per day,pot is the potential dermal uptake of substance (mg/kg/d) 

Iinhalation,swimming per day,pot is the inhalatory intake of substance (mg/kg/d) 

Ioral,swimming oral intake (mg/kg/d) 
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The skin uptake is calculated from so-called Dermal A model from the TGD on Information 

Requirements and Chemical Safety Assessment, (ECHA, 2008)): 

Iskin,swimming per day,pot = AREAskin × nswim × THdermal × PECMAM-PEC/BW 

Where: 

 Iskin,swimming per day,pot is the amount of chemical uptake via the skin during swimming 

(mg.kg/d) 

THdermal is the thickness of product layer on skin (default 10-4 m) 

AREAskin is the area of the body exposed to the water (m2

) 

BW is the body weight (kg) 

nswim mean number of events per day (d-1) 

The THdermal in the above equation may be replaced by: 

THdermal = Kp·Tcontact

Where: 

Kp is the permeability coefficient (-) and can be estimated from 

log Kp (cm/h) = -2.72 + 0.71·log KOW – 0.0061·MW. (US EPA(2000): DERWIN v1.43 

model) 

The Group considered that the input values should be shown in the Utot,swimming formula in 

order to understand its contribution to the overall exposure values (Table 5.4. – 

Appendix K of the confidential dossier).

5.2.4 The Group noted that a comparative calculation showed that for all relevant substances, 

the default value of 10-4 m resulted in a higher dermal uptake than using the log Kp equation. The 

only exception was 1,2,3-trichloropropane, which resulted in slightly higher dermal uptake. 

5.2.5 However, for this substance, the dermal uptake is orders of magnitude lower than the 

uptake via inhalation and eating fish. So overall, it was concluded that using the dermal model 

for calculating skin uptake, the contribution to the total uptake is negligible. 

5.2.6 Similarly, the Group agreed with the applicant that the oral uptake due to swimming, 

could be calculated from (TGD, ECHA) as: 

Ioral,swimming = W·nswim × CW/BW 

Where: 

Ioral,swimming is the total potential uptake during swimming (mg/kg bw/d) 

W is the volume water swallowed per event (m3) 
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I:\MEPC\59\2-16.DOC 

5.2.7 The Group considered that the input values should be shown in the Ioral,swimming formula in 

order to understand its contribution to the overall exposure values (Table 5.4. -Appendix K of the 

confidential dossier). 

5.2.8 Having considered the applicant’s Human Exposure Assessment and table of results, 

shown in appendix 8, the Group agreed that there was an acceptable risk to the crew or general 

public as a result of by-products produced by this ballast water treatment system. 

5.2.9 In addition and in what concerns the occupational scenario of sampling from the system 

identifying the technicians as the target population, the Group considered that the appropriate risk 

mitigation measures have to be put in place in order to minimize the exposure of operating 

technicians e.g., use of PPE/PRE. 

6 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC 

6.1 Based on the data described in section 5 of this report, the Group agreed that the 

by-products of this system do not pose a significant risk to either the crew or the general public. 

7 ENVIRONMENTAL RISK ASSESSMENT 

7.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T)

7.1.1 The Group agreed that the following classifications could be made on the by-products of 

this system. 

By-product Persistence (P) 

(Yes or No) 

Bioaccumulation (B) 

(Yes or No) 

Toxicity (T) 

(Yes or No) 

Sodium hypochlorite No 

(Log Kow=-3.4) 

No 

(Chronic 

NOEC=0.04) 

Sodium bromate Yes No 

(Log Kow=-7.2) No 

Tribromomethane Yes1 No 

(BCF=14) No 

Dibromochloromethane Yes 

Dibromoacetic acid 

Trichloropropane 

Note: the applicant states 1⁄2-life <60days but data evaluated in previous applications 

show 1⁄2-life >60 days 

7.2 Estimations of Predicted No Effect Concentrations (PNEC) of Active Substances 

(AS) and Relevant Chemicals (RC) 

7.2.1 The Group recalled that its previous consideration for Final Approval had indicated that 

in order to estimate the PNECTRO-saltwater value, the corresponding value for TRC in sea water 

of 0.3 μg/L had been taken, including a safety factor of 10. This value had been derived from the 

dilution of the effluent, plus the degradation of TRO in natural water to result in a PEC. 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 15 

I:\MEPC\59\2-16.DOC 

7.2.2 It was noted that the LOEC of three marine organisms under long-term exposure 

conditions to the whole effluent had been 1% effluent v/v. Therefore, the PNEC for the whole 

effluent would be 0.14 μg/L according to the Basic Approval dossier. 

7.2.3 The Group noted the relevant eco-toxicity values for sodium hypochlorite provided by the 

applicant and used to derive the associated PNEC values, as shown below: 

Specie Endpoint Result Reference/Justification 

of missing data 

Fish Leiostomus xanthurus 96 h LC50 0.09 mg/L Bellanca & Bailey (1977)

Fish Oncorhynchus kisutch 96 h LC50 0.032 mg/L Thatcher (1978) 

Crustacea Crangon nigricauda 96 h LC50 0.134 mg/L Thatcher (1978) 

Algae Thalassiosira 

pseudonana 

24 h LC50 0.075 mg/L Gentile (1976) 

Mollusc Crassostrea virginica 48 h EC50 0.026 mg/L Robert & Gleeson (1978) 

Fish Menidia peninsulae 28 d NOEC 0.04 mg/L Goodman et al. (1983) 

Mollusc Crassostrea virginica 15 d NOEC 0.007 mg/L 

 (TRC) 

Liden et al. (1980) 

Note: Shaded area in the above table represents the applicants proposed acute toxicity values for 

sodium chlorite at three trophic levels. 

7.2.4 Using the NOEC of 40 μg/L and an Assessment Factor of 1000, the Group considered 

that the PNEC should be 0.04 μg/L. 
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ANNEX 5 

Page 16 

I:\MEPC\59\2-16.DOC 

7.2.5 The Group noted the following applicants proposals for the estimation of PNEC values 

shown in the table below (ref applicant dossier M1, App. A, table A1) for the disinfectant 

by-products potentially associated with the system. The Group agreed with these proposals. 

Substance name 

Shortterm 

conc. 

μg/L 

Longterm 

conc. 

μg/L 

No 

data -

Short

-term 

No 

data -

Long 

term 

Assessment factor 

(fresh 

water) 

Assessment factor 

(ma-rine 

water) 

PNEC 

(fresh 

water) 

μg/L 

PNEC 

(ma-rine 

water) 

μg/L 

Tribromomethane 7,100 3,394 3 3 50 50 68 68 

Dibromochloromethan

e 

2900 63 3 2 50 500 1.26 0.126 

Sodium bromate 13,600 3 1,000 10,000 14 1.4 

Dichloroacetic acid 23,000 1,485,0

00 3 1 1,000 10,000 23 2 

Dibromoacetic acid 62,000 3 1,000 10,000 62 6 

1,2,3-trichloropropane 4,136 5,000 3 1 100 1,000 50 5 

Dichlorobromomethan

e 6,400 800 3 3 10 100 640 64 

Monobromoacetic acid 200 1,600 3 1,000 10,000 0.2 0.02 

Bromochloroacetic 

acid 

Dichlorobromoacetic 

acid 

Dibromochloroacetic 

acid 

Tribromoacetic acid 279,00

0 3 1,000 10,000 279 27.9 

Bromoacetonitrile 326,00

0 3 1,000 10,000 326 32.6 

Dibromoacetonitrile 550 3 1,000 10,000 0.55 0.055 

Bromochloroacetonitri

le 

Bromophenol 3,300 3 1,000 10,000 3.3 0.33 

p-bromophenol 2,000 300 3 3 10 100 30 3 

m-bromophenol 1,242 3 1,000 10,000 1.242 0.1242 

o-bromophenol 900 3 1,000 10,000 0.9 0.09 

2,4-dibromophenol 2,780 3 1,000 10,000 2.78 0.278 

2,6-dibromophenol 3,150 3 1,000 10,000 3.15 0.315 

2,4,6-tribromophenol 220 100 3 2 50 500 2 0.2 

1,1-dibromoethane 150,00

0 3 1,000 10,000 150 15 

1,2-dibromoethane 142,80

8 3 1,000 10,000 142.808 14.2808 

1,2-dibromo-3-

chloropropane 19,000 1,600 3 2 50 500 32 3.2 

2-chlorotoluene 700 140 3 2 50 500 2.8 0.28 

4-chlorotoluene 9,000 3,400 3 1 100 1,000 34 3.4 

1,2,3-tribromobenzene 
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I:\MEPC\59\2-16.DOC 

7.3 Calculation of Predicted Environmental Concentrations (PEC) of Active Substances (AS) 

and Relevant Chemicals (RC) 

7.3.1 The Group noted that PEC values for Active Substances and Relevant Chemicals had 

been derived for two generic cases in MAMPEC ver. 2.0, namely the “Commercial harbour 

scenario” and the “OECD-EU Commercial harbour”. 

7.3.2 The Group also noted that because the “commercial harbour” scenario of MAMPEC, 

which is based on the Rotterdam harbour in the Netherlands, has a lower salinity than sea water 

i.e. MAMPEC assumes a salinity of 34 psu for Rotterdam harbour whilst the salinity range is 

actually in the range of 0.3-28.6 psu. It was also noted that, over 1.5 month observations period, 

salinities had been identified in the range of: 

.1 5-25 psu in the Hook of Holland; 

.2 0-18 psu at Botlek Harbour (16 km up the estuary of the Hook of Holland); and 

.3 0-10 psu at Lek Harbour (25 km up the estuary of the Hook of Holland). 

7.3.3 As a result, the applicant had proposed that the maximum discharge concentration 

of TRO should be: 

.1 <1200 μg/L in seawater; 

.2 <500 μg/L in brackish water; and 

.3 no higher than background levels in fresh water, 

rather than the 2000 μg/L reported in previous submissions. It was noted that these differences 

were due to differences in the PSU of the untreated ballast water. 

7.3.4 The Group also noted that a second modelling system (MIKE 3 + ECOLAB) had been 

employed to calculate the PEC values of those chemicals identified in the treated ballast water. 

7.3.5 In this context, the Group noted the following PEC levels of Active Substances 

and Relevant Chemicals generated by the MAMPEC model. 

Original table provided by applicant: 

Sea Water Concentration 

(μg/L) 

Fresh water Concentration 

(μg/L) 

Name 

Treated 

sea water 

at 

discharge

Commercial 

Harbour 

OECD-EU 

Commercial 

Harbour 

treated fresh 

water 

OECD-EU 

Commercial 

Harbour 

2000 0.23 0.222 0 --- 

1200 0.135 0.133 0 --- 

500 0.056 0.055 0 --- Sodium Hypochlorite 

200 0.023 0.022 0 --- 

2000 0.23 0.222 0 --- 

1200 0.135 0.133 0 --- 

500 0.056 0.055 0 --- Sodium Hypobromite 

200 0.023 0.022 0 --- 
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ANNEX 5 

Page 18 

I:\MEPC\59\2-16.DOC 

Sea Water Concentration 

(μg/L) 

Fresh water Concentration 

(μg/L) 

Name 

Treated 

sea water 

at 

discharge

Commercial 

Harbour 

OECD-EU 

Commercial 

Harbour 

treated fresh 

water 

OECD-EU 

Commercial 

Harbour 

Dibromochloromethane 8.2 0.05 0.030 1.1 0.0039 

Tribromomethane 190 1.25 0.708 3 0.0112 

Bromate 19 0.47 0.136 4.4 0.0314 

Dichloroacetic Acid 0.97 0.00 0.005 1.4 0.0085 

Trichloroacetic Acid 0.28 0.01 0.003 2 0.0141 

Dibromoacetic Acid 9.3 0.17 0.062 2.2 0.0145 

Bromochloroacetic Acid 0.43 0.01 0.003 1.6 0.0105 

1,2,3-Trichloropropane 1 0.01 0.005 0 0.0000 

7.3.6 It was further noted by the Group that the applicant did not use the results obtained with 

the plume modelling system (MIKE-ECOLAB) and focused on the MAMPEC results. 

The Group agreed with this approach. 

7.3.7 The Group appreciated the attempt of the applicant but found some difficulties in reproducing 

the results of the applicant as the documentation did not include a listing of the input values used. The 

results obtained by the Group were a factor of about 100 for the commercial harbour and a factor of 

about 50 for the OECD-EU commercial harbour higher. However, the Group did consider these results 

as indicative as not yet a standard scenario has been endorsed. It is recommended that the applicant 

delivers all the data obtained in the use of modelling. 

Table constructed by the Group: 

Toxicity AF PNEC 

(μg/l) 

PEC(μg/l )* PEC/PNEC 

Chemical by-Product μg/l (fw

) 

(sw) (fw

) 

(sw

) 

(fw) (sw) (fw) (sw) 

75 (ac) - ? - ? Sodium hypochlorite 40 (ch) - 1000 - 0.04 0.0 0.13

5 3.38 

 Sodium hypobromite 0.0 0.13

5 

2900 (ac) Dibromochloromethane 63 (ch) 50 500 1.3 0.13 0.003

9 0.05 0.0039/1.3=0.003 0.05/0.13=0.04

7100 (ac) 100

0 7.1 Bromoform 

3394 (ch) 50 50 68 68 

0.011

2 1.25 

0.0112/68=0.0002 1.25/68=0.02

Bromate 13600(ac) 100

0 

1000

0 

13.

6 1.36 0.031

4 0.47 

0.0314/13.6=0.002 

(Applicant val 

0.01)

0.47/1.36=0.35

23000 (ac) 100

0 

1000

0 23 2.3 0.0085/23=0.0004 0.005/2.3=0.002 Dichloroacetic acid 

1485000(ch) 

0.008

5 

0.00

5 

 Trichloroacetic acid 

0.014

1 0.01 

62000 100

0 

1000

0 62 6.2 0.0145/62=0.0002 0.17/6.2=0.027 Dibromoacetic acid 

 

0.014

5 0.17 

 

 Bromochloroacetic acid 

0.010

5 0.01 

4136 (ac) 0.01/1000=0.00

Trichloropropane 001

5000 (ch) 100 1000 50 5 

0.000

0 0.01 

 
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ANNEX 5 

Page 19 

I:\MEPC\59\2-16.DOC 

7.3.8 The Group also noted the following PEC/PNEC ratios of Active Substance and Relevant 

Chemicals calculated from various initial concentrations measured in treated ballast water, both 

fresh and marine. 

 PEC/PNEC PEC/PNEC 

Name 

Initial 

concentrations 

in discharged 

marine water, 

μg/l 

Commercial 

(Marine) 

Harbour 

 OECD-EU 

Commercial 

(marine) 

Harbour 

Initial 

concentrations 

in discharged 

fresh water, 

μg/l 

 OECD-EU 

Commercial 

(fresh water) 

Harbour 

2000 5.64 5.54 0 --- 

1200 3.39 3.32 0 --- 

500 1.41 1.39 0 --- Sodium Hypochlorite 

200 0.56 0.55 0 --- 

2000 5.64 5.54 0 --- 

1200 3.39 3.32 0 --- 

500 1.41 1.39 0 --- Sodium Hypobromite 

200 0.56 0.55 0 --- 

Dibromochloromethane 8.2 0.51 0.30 1.1 0.004 

Tribromomethane 190 0.02 0.01 3 0.000 

Bromate 19 0.34 0.10 4.4 0.010 

Dichloroacetic Acid 0.97 0.00 0.00 1.4 0.000 

Trichloroacetic Acid 0.28 0.29 0.14 2 0.071 

Dibromoacetic Acid 9.3 0.03 0.01 2.2 0.000 

Bromochloroacetic 

Acid 0.43 0.003 0.001 1.6 0.00027 

1,2,3-Trichloropropane 1 0.00 0.00 0 0.000 

7.3.9 The Group noted that some of the assessment factors used for deriving PNECs 

(50 and 500) are not foreseen in Procedure (G9). The applicant provided a clarification regarding 

their use of assessment factors from draft EU Risk Assessment Reports on chlorine and sodium 

hypochlorite. 

7.3.10 The Group noted that as a result of the use of assessment factors as foreseen 

in Procedure (G9) (100 and 1000) raises the PNECs a factor of two for five compounds, and one 

recalculated value leads to a PEC/PNEC near 1 (dibromochloromethane = 1.02) in the 

standard Commercial (Marine) Harbour and to a value of 0.6 in the OECD-EU Commercial 

(Marine) Harbour scenarios based on the PEC of Relevant Chemicals calculated by 

MAMPEC v.2.0. 

7.3.11 The Group is satisfied with the clarifications provided by Applicant and it is the opinion 

of the Group that the MAMPEC scenarios are sufficiently conservative and that the discharge of 

treated ballast water should not raise concern regarding dibromodichloromethane. 

7.3.12 Considering these findings the Group is of the opinion that the application of 

CleanBallast as a ballast water management system would not result in unacceptable risks for the 

aquatic organisms in the receiving environment. 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 20 

I:\MEPC\59\2-16.DOC 

8 CONCLUSIONS AND RECOMMENDATIONS 

8.1 Risk to the safety of the ship 

8.1.1 The Group noted the thorough evaluation of corrosion of both uncoated and marine epoxy 

coated steel. The applicant concluded from these tests that CleanBallast was compatible with 

epoxy based ballast water tank coating systems as certified by Germanischer Lloyd (GL). 

However, the corrosion evaluation of uncoated steel was insufficient due to the low exposure 

dose through the majority of the exposure evaluation. 

8.1.2 The Group recommended that the exposure and subsequent corrosion rate analysis be 

repeated by the applicant at the worst case exposure dosage anticipated from the CleanBallast 

system through the entirety of the test. This evaluation should include uncoated steel and any 

other metals (i.e. brass, stainless steel, etc...) or non-metallic materials (i.e. EPDM rubber, 

fluoropolymers, etc...) within the shipboard piping, pumping or structure which may be exposed 

to the Active Substances or Relevant Chemicals. The Group notes that in the case that passive or 

oxide forming materials are exposed in service, evaluations of the localized corrosion resistance 

of these materials should also be conducted. 

8.1.3 Despite the above-mentioned criticism the Group agreed that these deficiencies should 

not hamper a Final Approval recommendation 

8.2 Risks to crew and general public 

8.2.1 The Group recognized that the methodology used by the applicant to develop HES 

associated with CleanBallast ballast water management system adequately addressed the 

potential risks of human exposure deriving from this system. The applicant has identified the 

relevant human exposure assessments regarding occupational and general public by using 

an OEL to address inhalation risk in the workplace and TDI to address the risk resulting from 

combined exposures (swimming and eating fish from the area). The Group agreed that the risk 

was acceptable to the crew and general public. 

8.3 Risks to the environment 

8.3.1 Having reviewed all of the data, the Group agreed that the risks to the environment 

caused by this system would be acceptable. 

8.4 Conclusion

8.4.1 The Group agreed to recommend Final Approval be given to the German application 

CleanBallast Ballast Water Management System by MEPC. 

8.4.2 The Group concluded that based on the information presented no unacceptable effects be 

expected upon the application of the CleanBallast Ballast Water Management System. 

* * *
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ANNEX 5 

Page 21 

I:\MEPC\59\2-16.DOC 

Appendix 1 

Data for Sodium hypochlorite 

1 Acute Aquatic Toxicity Data 

Species LC50 (mg/L) Reference/Comments

Fish Leiostomus xanthurus 0.09 96h Bellanca & Bailey (1977) 

Crustacea Crangon nigricauda 0.134 96h Thatcher (1978) 

Algae Thalassiosira pseudonana 0.075 24h Gentile (1976) 

2 Chronic Aquatic Toxicity Data 

Species NOEC 

(mg/L) Reference/Comments 

Fish* Menidia peninsulae 0.04 (28d) Goodman et al. (1983) 

Crustacea Crassostrea virginica 0.11 (60d) Scott et al. (1979) 

Algae N/A N/A Supp. Info: MEPC 55/2/4 

* Used to generate PNEC for RA (ref: email from applicant 09/01/09). 

3 Information on Endocrine Disruption 

Endocrine disruption have been screened and assessed based on information provided in MSDS. 

Information on endocrine disruption considered not relevant for this substance due to its 

chemical structure and other chemical/physical properties, e.g., vapour pressure. 

4 Sediment Toxicity 

No toxicity data available for sediment organisms, but not considered required. 

5 Bioavailability/Biomagnification/Bioconcentration 

Non adequate – an oxidizing, disinfectant and inorganic substance BCF <100. 

6 MAMMALIAN TOXICITY 

6.1 Acute mammalian Toxicity 

No available data for the pure substance. Indicative values for commercial 5% solution 

(MEPC 55/2/4). 

Value Species Reference/Comments/ 

Oral LD50 (mg/kg) 13000 Rat MSDS 

Dermal LD50 (mg/kg) > 3000 Rat MSDS 
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ANNEX 5 

Page 22 

I:\MEPC\59\2-16.DOC 

6.2 Corrosion/Irritation 

No available data for the pure substance. Indicative values for commercial 5% solution. 

Inhalation of fumes or mists causes respiratory tract irritation and irritation of mucous 

membranes. 

6.3 Sensitization 

Chronic hand dermatitis related to sensitization to sodium hypochlorite reported 

(Habets et al. 2006) 

6.4 Repeated-Dose Toxicity

Exposure Route Drinking water 

Exposure Duration 12 months 

Exposure dose 1, 10, 100 mg/L 

Species Rat 

Method --- 

Results 

Decrease of blood gluthatione with 10 or 100mg/L, increase of 

osmotic fragility after 6 months. In animals exposed for 3 months, 

the 3H-thymidine incorporation into nuclei of rat kidney and testes 

in the 100mg/L group was increased 

Reference/Comments Abdel-Rahman, M.S. Et. al 1984 (MEPC 57/2 

6.5 Carcinogenicity 

No available data for the pure substance. Indicative values can be found for commercial solutions 

of different concentrations. Sodium hypochlorite is not considered to be a carcinogen by 

the US National Toxicology Program, the International Agency for Research of Cancer, or 

the Occupational Safety and Health Administration. 

7 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

7.1 Modes of degradation 

.1 Abiotic route: Reduction 

 .2 Photodegradation: Decompose to form chloride 

7.2 Partition Coefficients 

Log Kow -3.42 

log Koc 1.16 

7.3 Persistence and Identification of Main Metabolites 

Not persistent, due to the rapid degradation. 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 23 

I:\MEPC\59\2-16.DOC 

7.4 Reaction with Organic Matter 

Oxidating agent, not considered required. 

7.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Fully miscible to water and thus potentially affecting physical wildlife and benthic habitats. 

7.6 Potential Residues in Seafood 

Low risk for residues in sea food – see further HES evaluation. 

7.7 Any Known Interactive Effects 

No. 

8 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE

Property Value Reference/Comments/ 

Justification for missing data 

Melting point (°C) -25 IUCLID 

Boiling point (°C) 96-99 IUCLID 

Flammability (flash point for liquids; °C) Non-flammable IUCLID 

Density (20°C; kg/m3) 1.21-1.23 IUCLID 

Vapour pressure (20°C; Pa) 17.4-20hPa IUCLID 

Vapour density (air = 1) N/A 

Water solubility pH; mg/l) (temp; effect of 79.9g/100g 

H2O IUCLID 

pH in solution N/A Not applicable 

Dissociation constant (pKa) N/A Not applicable 

Oxidation-reduction potential N/A Not applicable 

Corrosivity to material or equipment corrosive Chemical data base 

Reactivity to container material corrosive Chemical data base 

Auto-ignition temperature(°C) Non flammable 

Explosive properties explosive 

Oxidizing properties E0: 1.7V Strong oxidizer, ECB RA 

(2997) 

Surface tension N/A Not applicable 

DynamicViscosity 2.6mPa.s IUCLID 

Thermal stability and identity of breakdown 

products N/A 

Other physical or chemical properties N/A 

* * * 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

Appendix 2 

Data for sodium bromate

1 EFFECTS OF AQUATIC ORGANISMS 

1.1 Acute Aquatic Toxicity 

Species LC50 (mg/L) Reference/Comments 

Fish (Various Marine) 427 to 512 (96h) Hutchinson et al. (1997) 

Crustacea Daphnia magna 179 (48h) Hutchinson et al. (1997) 

Algae N/A N/A N/A 

Turbellaria Polycelis nigra 2258 (48h) Hutchinson et al. (1997) 

In conclusion, a number of studies provide evidence for the acute toxicity of bromate to 

invertebrates and fish in the lowest region of 30 mg BrO3

-

/L (Hutchinson et al. (1997)). 

1.2 Chronic Aquatic Toxicity

Species LC50 or EC50 

(mg/L)

Reference/Comments

Fish (marine) 279 (10day LC50) Hutchinson et al. (1997) 

Crustacea N/A N/A N/A 

Algae* 4 marine phytoplankton >13.6 (multi-generation EC50 Hutchinson et al. (1997) *

 Data added from email of applicant (09/01/09) – used by applicant to generate PNEC for RA 

Applying the factor of 10 used to extrapolate from acute to potential chronic toxicity, the 

available data suggest that to protect aquatic organisms from long-term adverse effects, 

concentrations should not exceed approximately 3.0 mg BrO3

-

/L (Hutchinson et al. (1997)) 

1.3 Information on Endocrine Disruption 

Not listed as endocrine disruptor (e.g., European Union (EU) Prioritization List etc.). 

1.4 Sediment Toxicity 

Very low risk for sediment toxicity due to low Log Pow and Koc values respectively. Bromate 

does not volatilize and adsorbs only slightly to soil or sediment. 

1.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments/Justification for 

missing data 

-7.18 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 25 

I:\MEPC\59\2-16.DOC 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian Toxicity

Value Species Reference/Comments/ 

Justification for 

Oral LD50 (mg/kg) 140 Mouse MSDS 

2.2 Corrosion/Irritation 

May be harmful by inhalation, ingestion, or skin absorption. Causes eye and skin irritation. 

(MSDS). 

2.3 Sensitization 

Not known. 

2.4 Repeated-Dose Toxicity 

No data. 

2.5 Development and Reproductive Toxicity 

No data. 

2.6 Carcinogenicity 

“Possible human” carcinogen Group 2B carcinogen (WHO). 

3 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

3.1 Modes of degradation (biotic and abiotic) 

Not readily biodegradable, 1/2-Life: ∞ (DHI). 

3.2 Partition Coefficients

Results 

Log Pow -7.18 

Koc 2.7exp-8 

3.3 Persistence and Identification of Main Metabolites 

Persistent (half-life >60days). Degrades to bromide ions. 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 26 

I:\MEPC\59\2-16.DOC 

3.4 Reaction with Organic Matter 

Oxidation – ultimately leading to formation back to Bromide ion. 

3.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Solubility in water implies possible effects. 

3.6 Potential Residues in Seafood 

Very unlikely. 

3.7 Any Known Interactive Effects 

No. 

4 PHYSICAL AND CHEMICAL PROPERTIES 

Relevant Chemical: Bromate (Sodiumbromate)

Property Value Reference/Comments 

Melting point (°C) 314 DHI 

Boiling point (°C) 718 DHI 

Flammability (flash point for 

liquids; °C) Non-flammable 

Density (17°C; kg/m3) 3339 US EPA Toxreview(2001) 

Vapour pressure (20°C; Pa) 2.3 kPa (highest) MSDS 

Vapour density (air = 1) N/A 

Water solubility of pH; mg/L) 

(temp; effect 

275 g/L at 0°C 909 g/L 

at 100°C 

US EPA Toxreview 

(2001) 

pH in solution N/A 

Oxidation-reduction potential N/A 

Corrosivity to material or 

equipment No 

Reactivity to container 

material No 

Oxidizing properties strong oxidant - 

* * * 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 27 

I:\MEPC\59\2-16.DOC 

Appendix 3 

Data for tribromomethane 

1 Chemical Identification 

 Concentration in BW, 

Chemical Name CAS Number max (μg/l) AS, RC or Other 

Tribromomethane 75-25-2 190 RC 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data

Species LC50 (mg/L) Reference/Comments

Fish Cyprinodon variegates 18 (96h LC50) Boccafusco et al. (1981) 

Fish* Cyprinodon variegates 7.1 (96h LC50) US EPA Aquire 

Crustacea Penaeus aztecus 20 (4d LC50) Gibson et al. (1981) 

Algae Selenastrum capricornutum 40 (96h EC50) US EPA(1978) 

* Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA. 

2.2 Chronic Aquatic Toxicity Data 

Species LC50/NOEC/MATC 

(mg/L) Reference/Comments 

Fish Cyprinodon variegatus LC50:4.8-8.5/28d Ward et al. (1981) 

Fish Cyprinodon variegatus MATC 3.394/28d US EPA Aquire 

Crustacea Penaeus aztecus LC50: 0.03-0.29/28d Gibson et al. (1981) 

Algae Selenastrum capricornutum NOEC: 10/96h US EPA (1978) 

* Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA. 

MATC=Maximum Acceptable Toxic Concentration: For a given ecological effects test, the 

range (or geometric mean) between the No Observable Adverse Effect Level and the Lowest 

Observable Adverse Effects Level. 

2.3 Information on Endocrine Disruption 

2.3.1 Endocrine disruption have been screened and assessed based on information provided 

in Toxprofile/MSDS. 

2.3.2 Information on endocrine disruption considered not relevant for this substance due to its 

chemical structure and other chemical/physical properties, e.g., vapour pressure. 

2.4 Sediment Toxicity 

2.4.1 Very low risk for sediment toxicity due to low Log Pow and Koc values respectively. 

Bromoform will exhibit only a minor affinity for soil materials and will tend to be highly mobile 

(Roy and Griffin 1985). 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 28 

I:\MEPC\59\2-16.DOC 

2.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments 

BCF<100, 2.4 DHI, CITI (1992) 

(“DHI” = report “Theoretical evaluation of the fate and effect of disinfection by-products”). 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity

Value Species Reference/Comments/Justif 

ication for missing data 

Oral LD50 (mg/L) 1-day:1147 

(Fem 

Rat (SpragueDawley) Toxprofile (Chu et al.

(1982)) 

3.2 Corrosion/Irritation 

Skin Contact: Causes skin irritation. 

Skin Absorption: May be harmful if absorbed through the skin. 

Eye Contact: Causes eye irritation. 

Inhalation: Toxic if inhaled. Material may be irritating to mucous membranes and upper 

respiratory tract. 

Ingestion: Harmful if swallowed. (MSDS). 

3.3 Carcinogenicity 

3.3.1 Carcinogenic effects have been observed in animals exposed to bromoform. 

3.3.2 Chronic oral exposure to bromoform resulted in increases in the occurrence of intestinal 

tumors in female rats. The International US Agency for Research on Cancer (IARC) concluded 

that there were inadequate human data and limited animal data and assigned bromoform to 

weight of evidence category 3, not classifiable as to carcinogenicity in humans. EPA classified 

bromoform as a probable human carcinogen, group B2. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation 

Abiotic: Fotolysis 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 29 

I:\MEPC\59\2-16.DOC 

4.2 Partition Coefficients

Results Reference/Comments

Log Pow 2.4 Toxprofile 

Koc 35.04 Toxprofile, DHI 

(“DHI” = report “Theoretical evaluation of the fate and effect of disinfection byproducts”). 

4.3 Persistence 

Half-life <60 days --> non persistent 

4.4 Reaction with Organic Matter 

Low. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Slightly soluble and thus posing a small potential threat to benthic habitats. 

4.6 Potential Residues in Seafood 

Bromoform do not appear to concentrate in fish. (Toxprofile p.3). 

4.7 Any Known Interactive Effects 

No. 

5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments 

Melting point (°C) 8.0 Toxprofile (Lide 2000) 

Boiling point (°C) 149.1 Toxprofile (Lide 2000) 

Flammability (flash point for liquids; 

°C) Non-flammable Toxprofile (HSDB 2004a, 2004b)) 

Density (20°C; kg/m3) 2.899 Toxprofile (Lide 2000) 

Vapour pressure (20°C; mmHg) 5 Toxprofile (Mabey et al. 1982) 

Vapour density (air = 1) 8.7 Toxprofile (Mabey et al. 1982) 

Water solubility pH; mg/L) 3100 (25°C) Toxprofile (Horvath 1982) 

* * * 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 30 

I:\MEPC\59\2-16.DOC 

Appendix 4 

Data for Dibromochloromethane

1 EFFECTS ON AQUATIC ORGANISMS 

1.1 Acute Aquatic Toxicity Data

Species LC50 (mg/L) Reference/Comments 

Fish Cyprinus carpio 52/0.75h Trns. Am. Fish. Soc. 

Crustacea --- --- No data found 

Algae Tetrahymena 

pyriformis 

65/24h Sci. Total. Environm. 

Algae* ? NOEC 2.9/72h Japanese ministry of environment 

* Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA. 

1.2 Chronic Aquatic Toxicity Data

Species LC50(mg/L) or 

NOEC(mg/L) Reference/Comments 

Fish Cyprinus carpio LC50: 34/days Trns. Am. Fish. Soc. 

Crustacea Daphnia magna NOEC 0.0063/21 d Japanese ministry of 

environment 

Algae Tetrahymena 

pyriformis 

LC50: 65/24h Sci. Total. Environm. 

* Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA. 

1.3 Information on Endocrine Disruption 

Endocrine disruption have been screened and assessed based on information provided 

in Toxprofile/MSDS. Information on endocrine disruption considered not relevant for this 

substance due to its chemical structure and other chemical/physical properties. 

1.4 Sediment Toxicity 

1.4.1 Very low risk for sediment toxicity due to low Log Pow and Koc values, respectively. 

1.4.2 No toxicity data available for sediment organisms. 

1.5 Bioavailability/Biomagnification/Bioconcentration

BCF Reference/Comments 

<100 DHI, Sangster (1994) 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 31 

I:\MEPC\59\2-16.DOC 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian Toxicity

Value Species Reference 

Oral LD50 (mg/kg) 848-1186 Rat Chu I et al. (1980) 

2.2 Corrosion/Irritation/sensitization 

Causes eye irritation. Causes skin irritation. 

Harmful if swallowed. May cause irritation of the digestive tract. 

Inhalation of high concentrations may cause central nervous system effects (MSDS). 

2.3 Carcinogenicity 

2.3.1 Carcinogenic effects have been observed in animals exposed to dibromochloromethane. 

Dibromochloromethane induced liver tumors in male and female mice. 

2.3.2 The US Department of Health and Human Services (DHHS) has not categorized the 

human carcinogenic potential of dibromochloromethane. The International Agency for Research 

on Cancer (IARC) concluded that there were inadequate human data and limited animal data and 

assigned dibromochloromethane to weight of evidence category 3, not classifiable as to 

carcinogenicity in humans. EPA classified dibromochloromethane as a possible human 

carcinogen, group C 

3 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

3.1 Modes of degradation 

Photolysis. 1/2 life: 19d. 

Anaerobic:(groundwater, Bouwer et al. 1981) half-lives estimated to be between 21 and 42 days 

(Bouwer and McCarty 1984). 

3.2 Partition Coefficients

Results Reference/Comment 

Log Pow 2.16 Sangster (1994) 

Koc 83.17 Mabey et al. (1982) 
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ANNEX 5 

Page 32 

I:\MEPC\59\2-16.DOC 

3.3 Persistence 

Half-life <60 days --> non persistent. 

3.4 Reaction with Organic Matter 

Low 

3.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Slightly soluble and thus posing a small potential threat to benthic habitats. 

3.6 Potential Residues in Seafood 

Dibromochloromethane do not appear to concentrate in fish. (Toxprofile p.3) Low risk for 

residues in sea food. 

3.7 Any Known Interactive Effects 

No 

4 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE

Property Value Reference/Comments 

Melting point (°C) -20 Toxprofile, Lide (2000) 

Boiling point (°C) 120 Toxprofile, Lide (2000) 

Flammability (flash point for liquids; 

°C) Non-flammable Toxprofile 

Density (20°C; kg/m3) 2.899 Toxprofile, Lide (2000) 

Vapour pressure mmHg (20°C); 76 Toxprofile (Mabey et al.

1982) 

Vapour density (air = 1) N/A ---- 

Water solubility of pH; mg/L 

(temp; effect)

2700 mg/L 

(20°C) Toxprofile (Heikes 1987) 

* * * 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 33 

I:\MEPC\59\2-16.DOC 

Appendix 5 

Data for dibromoacetic acid 

1 CHEMICAL IDENTIFICATION

Chemical Name CAS Number Concentration in BW, max (μg/l) AS, RC or Other

Dibromoacetic acid (DBAA) 631-64-1 9.3 RC 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

.1 Very few data could be retrieved, thus PNEC assessment factor set to 10000. 

.2 Only fish in US ECOTOX. Danish EPA QSAR: LC50 (fish, crust) > 1000 mg/L 

.3 Danish EPA QSAR: LC50 Algae: 419 mg/L 

2.3 Information on Endocrine Disruption

Not identified as endocrine disruptor. Endocrine disruption properties unlikely due to e.g., 

molecular structure. 

2.4 Sediment Toxicity

Adsorbs poorly to to sediment particles and is relatively rapidly degraded, thus potential for 

sediment accumulation is considered very low. 

2.5 Bioavailability/Biomagnification/Bioconcentration

BCF Reference/Comments/Justification for missing data 

3.162 

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

 Value Species 

Reference/Comments/Justification for 

missing data 

Oral LD50 (mg/kg) 1737 Rat MSDS 

3.2 Corrosion/Irritation 

Skin/eye contact: causes burns.

Harmful if inhaled.

Harmful if swallowed. 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 34 

I:\MEPC\59\2-16.DOC 

3.3 Sensitization 

Not identified as sensitizer. 

3.4 Repeated-Dose Toxicity 

No data. 

3.5 Development and Reproductive Toxicity 

No data. 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Effects fertility in rats: pre-implantation mortality, litter size (MSDS). 

Not found to be carcinogenic/mutagenetic. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

Half-life: 29d (DHI), not bioaccumulative. 

4.2 Partition Coefficients

 Results Reference/Comments/Justification for missing data

Log Pow 0.7 

Koc 1.895 

4.3 Persistence 

Not persistent (half-life <60d). 

4.4 Reaction with Organic Matter

Oxidation. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Solubility in water implies possible effects. 

4.6 Potential Residues in Seafood
GESAMP-BWWG 8/6 

ANNEX 5 

Page 35 

I:\MEPC\59\2-16.DOC 

Evaluated in HES (DHI), assessing no risk of hazardous levels of residues in seafood. 

4.7 Any Known Interactive Effects 

No. 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property Value Reference/Comments 

Melting point (°C) 54 DHI 

Boiling point (°C) 243 DHI 

Flammability (flash point for liquids; °C) Non-flammable 

Density (20°C; kg/m3) N/A 

Vapour pressure (20°C; Pa) 3.1 

Vapour density (air = 1) N/A 

Water solubility (temp; effect of pH; mg/L) 22140 (20°C) DHI 

Oxidation-reduction potential E0: 2.926V DHI 

Corrosivity to material or equipment corrosive MSDS 

Reactivity to container material not expected 

Oxidizing properties oxidizing agent DHI 

“DHI” = report “Theoretical evaluation of the fate and effect of disinfection by-products” (2008). 

* * * 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 36 

I:\MEPC\59\2-16.DOC 

Appendix 6 

Data for 1,2,3-Trichloropropane 

1 EFFECTS ON AQUATIC ORGANISMS 

1.1 Acute Aquatic Toxicty Data 

Species LC50 (mg/L) Reference 

Fish Pimephales promelas 66.5 (96h) USGS 

Crustacea Daphnia magna 20 (48h EC50) MSDS 

Crustacea* Ceriodaphnia dubia 4.136 (2d immobilisation) US EPA 

Algae N/A N/A N/A 

* Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA. 

1.2 Chronic Aquatic Toxicity Data

Species NOEC 

(mg/L)

Reference/Comments/ 

Justification for missing data 

Fish N/A N/A Toxprofile = U.S. Public Health 

Service (1992) 

Crustacea N/A N/A Toxprofile = U.S. Public Health 

Service (1992) 

Crustacea* Daphnia magna 5 (21 d reproduction) IUCLID 

Algae N/A N/A Toxprofile = U.S. Public Health 

Service (1992) 

* Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA. 

1.3 Information on Endocrine Disruption 

Not identified as an endocrine disruptor. 

1.4 Sediment Toxicity 

Very low risk for sediment toxicity due to low Log Pow and Koc values, respectively 

(see section 4.2). 

1.5 Bioavailability/Biomagnification/Bioconcentration

Bioaccumulation Reference/Comments 

Log Pow 1.98 Toxprofile 

BCF 9 IUCLID 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 37 

I:\MEPC\59\2-16.DOC 

2 MAMMALIAN TOXICITY 

2.1 Acute mammalian Toxicity 

Value Species Reference/Comments 

Oral LD50 (mg/kg) 369 Mouse MSDS 

Inhalation LC50 (mg/m3) 3400 Mouse MSDS 

2.2 Corrosion/Irritation 

Skin, Rabbit, 0.5ml/24h: Mild irritation effect. 

Readily absorbed through skin. Harmful if absorbed through skin. 

2.3 Sensitization 

No data. 

2.4 Repeated-Dose Toxicity 

No data. 

2.5 Development and Reproductive Toxicity 

No studies were located regarding developmental/reproductive effects in humans after 

inhalation/dermal/oral exposure to 1,2,3-trichloropropane. Further information: Toxprofile 

chapter 2). 

2.6 Carcinogenicity 

Carcinogen (IARC Group 2A). 

3 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

3.1 Modes of degradation (biotic and abiotic) 

Degradation mainly in gas-phase, radical mediated fotolysis. 

Nothing definitive is known about the biodegradability of the compound (Toxprofile). 

3.2 Partition Coefficients

Results Reference/Comments

Log Pow 1.98 Toxprofile 

Koc 131.8 DHI 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 38 

I:\MEPC\59\2-16.DOC 

3.3 Persistence Persistent (half-life > 60days) 

3.4 Reaction with Organic Matter No data. 

3.5 Potential Physical Effects on Wildlife and Benthic Habitats 

Solubility in water implies possible effects. 

3.6 Potential Residues in Seafood 

Low risk: Available data indicates that 1,2,3-trichloropropane would not significantly 

bioconcentrate in plants, aquatic organisms, or animals (EPA 1988b; Lyman et al. 1982). 

3.7 Any Known Interactive Effects 

No. 

4 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE

Property Value Reference/Comments

Melting point (°C) -47 DHI 

Boiling point (°C) 162 DHI 

Flammability (flash point for liquids; 

°C) 82.2 Toxprofile (Hawley 1981) 

Density (20°C; kg/m3) 1389 Toxprofile 

Vapour pressure (25°C; mmHg) 3.1 Toxprofile 

Water solubility (temp; effect of pH; 

mg/L) 1750 (20°C) Toxprofile 

Corrosivity to material or equipment No 

Reactivity to container material No 

Auto-ignition temperature(°C) 304 Toxprofile (Hawley 1981) 

Explosive properties No data Toxprofile 

Oxidizing properties E0: 1.583 DHI 

* * * 
GESAMP-BWWG 8/6 

ANNEX 5 

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I:\MEPC\59\2-16.DOC 

Appendix 7 

Aquatic Toxicity of Treated Ballast Water

1 Introduction

The Group noted that the applicant had carried out aquatic toxicity testing using the land-based 

treated ballast water discharge. All toxicity data disclosed were obtained at land-based type 

approval test cycles meeting Performance Standard D-2 concerning biological efficiency. Tests 

were carried out with water from several consecutive cycles and the most conservative values are 

reported in the summary tables below. 

2 Acute Aquatic Toxicity Tests in Fresh water (0.4 psu) 

The acute aquatic acute toxicity results from treated fresh water ballast are shown in the table 

below: 

Species Endpoint Result Reference/Justification of 

missing data 

Fish Danio rerio LC50 n.r.* DIN 38415-T6 

Crustacea Daphnia magna EC50 n.r.* DIN 38412-L30 

Algae Scenedesmus sp. EC50 n.r.* DIN 38412-L33 

Other Vibrio fischeri 

(Microtox©) 

EC50 n.r.* ISO 11348-2 

* n.r. = not reached. 

3 Acute Aquatic Toxicity Tests in Brackish water (22 psu) 

The acute aquatic acute toxicity results from treated brackish water ballast are shown in the table 

below: 

Specie Endpoint Result 

(%) 

Reference/Justification of 

missing data 

Fish Scophthalmus maximus LC50, %* >100 OECD 203 

Crustacea Acartia tonsa LC50, %* >100 ISO 14669 

Algae Skeletonema costatum EC10, %* 

EC50, %* 

61 

>100 

ISO 10253 

(*percentage of treated ballast water diluted in control water.) 

4 Acute Aquatic Toxicity Tests in Sea water (32-35 psu) 

The acute aquatic acute toxicity results from treated sea water ballast are shown in the table below: 

Specie Endpoint Result 

(%) 

Reference/Justification of 

missing data 

Fish Scophthalmus maximus LC50 74 OECD 203 

Crustacea Acartia tonsa LC50 60.5 ISO 14669 

Algae Skeletonema costatum EC10 

EC50 

14 

19 

ISO 10253 

(*percentage of treated ballast water diluted in control water.) 
GESAMP-BWWG 8/6 

ANNEX 5 

Page 40 

I:\MEPC\59\2-16.DOC 

5 Chronic Aquatic Toxicity Tests in Brackish water (22 psu) 

The chronic aquatic toxicity results from treated brackish water are shown in the table below: 

Specie Endpoint Result

(%) 

Reference/Justification of 

missing data 

Fish Scophthalmus 

maximus

NOEC 56 OECD 215 

Crustacea Nitocra spinipes NOEC >32* Danish standard reproduction test 

Algae Skeletonema 

costatum

EC10 

EC50 

61 

> 100 

ISO 10253 

Other Brachionus 

plicatilis

EC50 

NOEC 

> 100 

> 100 

ISO/DC 20666 

Chronic rotifer test 

6 Chronic Aquatic Toxicity Tests in Brackish water (22 psu) 

The chronic aquatic toxicity results from treated brackish water are shown in the table below: 

Specie Endpoint Result

(%) 

Reference/Justification of 

missing data 

Fish Scopthalmus 

maximus

NOEC 56 OECD 215 

Crustacea Nitocra spinipes NOEC >32* Danish standard reproduction test 

Algae Skeletonema 

costatum

EC10 

EC50 

14 

19 

ISO 10253 

Bivalve Crassostrea gigas LC50 

NOEC 

62 

46 

ASTM E724 

Chronic oyster embryo test 

Rotifer Brachionus 

plicatilis 

EC50 

NOEC 

> 100 

56 

ISO/DC 20666 

Chronic rotifer test 

* * * 
I:\MEPC\59\2-16.DOC 

Appendix 8 

Calculated total uptake 

Total Daily Intake and Risk Quotients 

Substance 

TDI 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

RQ (-) RQ (-) RQ (-) 

Exposure 

(μg/kg 

bw/d) 

Expo

(μg

bw

Man Female Child Man Female Child Man Fem

Sodium hypochlorite 324 1.9·10-3 3 2.1·10-3 5.2·10-3 0.000 0.000 0.000 -- -Sodium hypobromite 518 1.9·10- 2.1·10-3 5.2·10-3 0.000 0.000 0.000 - Trichloromethane CHCl3 10 - - - - - - - Dichlorobromomethane CHBrCl2 2.10 - - - - - - - Dibromochloromethane CHBr2Cl 30 7.7·10-1 7.3·10-1 3.7 0.026 0.024 0.122 6.0·10-2 5.7·Tribromomethane CHBr3 25 1.4 1.4 6.6 0.057 0.054 0.264 1.3·10-2 1.2·Bromate 1.00 3.8·10-3 4.3·10-3 1.1·10-2 0.004 0.004 0.011 2.5·10-4 2.8·Sodium bromate (BrO3) 1.17 4.5·10-3 5.0·10-3 1.2·10-2 0.004 0.004 0.011 3.0·10-4 3.3·Calcium bromate (BrO3) 1.53 5.0·10-3 5.5·10-3 1.4·10-2 0.003 0.004 0.009 3.3·10-4 3.7·Potassium bromate (BrO3) 2.18 5.4·10-3 6.1·10-3 1.5·10-2 0.002 0.003 0.007 3.6·10-4 4.1·Monochloroacetic acid (MCAA) 3.50 - - - - - - - Dichloroacetic acid (DCAA) 4.1·10-5 4.6·10-5 1.1·10-4 0.000 0.000 0.000 6.9·10-5 7.7·Trichloroacetic acid (TCAA) 40 6.3·10-5 6.9·10-5 1.8·10-4 0.000 0.000 0.000 8.8·10-5 9.7·Monobromoacetic acid (MBAA) - - - - - - - Dibromoacetic acid (DBAA) 20 1.5·10-3 1.6·10-3 4.3·10-3 0.000 0.000 0.000 1.3·10-4 1.4·Bromochloroacetic acid (BCAA) 9.6·10-5 1.0·10-4 2.9·10-4 - - - 1.0·10-4 1.1·Dichlorobromoacetic acid (DCBAA) 1.8·10-4 1.9·10-4 6.3·10-4 - - - - Dibromochloroacetic acid (DBCAA) 1.4·10-4 1.6·10-4 4.5·10-4 - - - - Tribromoacetic acid (TBAA) - - - - - - - Bromoacetonitrile - - - - - - - Monobromoacetonitrile 3.50 - - - - - - - Dibromoacetonitrile 23 3.5·10-5 3.5·10-5 1.4·10-4 0.000 0.000 0.000 - Bromochloroacetonitrile 0.057 1.1·10-5 1.3·10-5 3.2·10-5 0.000 0.000 0.001 - Bromophenol - - - - - - - p-bromophenol - - - - - - - m-bromophenol - - - - - - - o-bromophenol - - - - - - - 
GESAMP-BWWG 8/6 

ANNEX 5 Page 42 I:\MEPC\59\2-16.DOC MED JVC jw Substance 

TDI 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

Exposure 

(μg/kg 

bw/d) 

RQ (-) RQ (-) RQ (-) 

Exposure 

(μg/kg 

bw/d) 

Expo

(μg

bw

2,4-dibromophenol - - - - - - - 2,6-dibromophenol - - - - - - - 2,4,6-tribromophenol -- -- -- -- -- -- -- -Dibromoethane 1.14·10-2 - - - - - - - 1,1-dibromoethane 1.14·10 1,2-dibromoethane 1.14·10-2 -- -- -- -- -- -- -- -1,2-dibromo-3-chloropropane - 2.86·10-2 - - - - - - - 1,2,3-trichloropropane 6.3·10-3 -6.0·10-3 - 2.9·10-2 - - - - 2-chlorotoluene - - - - - - - 4-chlorotoluene - - - - - - - 1,2,3-tribromobenzene - - - - - - - 

***
GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 6 

REVIEW OF PROPOSALS FOR THE APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUSBSTANCES 

NK-O3 BlueBallast System (Ozone) 

Submitted by the Republic of Korea 

0 SUMMARY

0.1 Having considered the submission by the Republic of Korea and the responses 

provided by the applicant to the concerns expressed during the previous evaluations of 

the NK-03 BlueBallast system (Ozone), the Group agreed to recommend that Final Approval 

should be given to this proposal. 

0.2 The Group noted that the proposed system applies on board ozone generation without any 

chemicals carried on board the ship. A maximum dosage of 2.5 mg O3/L (7.5 mg/L as TRO) is 

then injected into the incoming ballast water for treatment. The Group also noted that TRO is 

classified as Active Substances for this system. 

0.3 The applicant stated that dosage of ozone is monitored and controlled automatically with 

a TRO sensor in the ballast water line after injection of ozone controlling the flow of injected 

ozone gas. With optimized side injector, the injected ozone gas is efficiently converted to 

dissolved oxidants, mainly hypobromous and hypobromide ion. The Group noted that the 

maximum TRO measurement following 2.5 mg O3/L ozone treatment (7.5 mg/L as TRO) 

was 6.160 mg/L, in which the utilization of ozone gas was up to 80%. The applicant provided 

improved a control scheme of ozone gas injection, and the Group noted that the results of TRO 

measured with fresh, brackish and seawater indicated the adequate reliability of the control 

mechanism. 

0.4 During review at its seventh meeting, the Group noted that no report of the results of 

chemical analyses had been available in the dossier. However, in the revised dossier for this 

meeting the applicant had carried out chemical analysis on the full-scale land-based treated 

ballast water. The Group was satisfied with the information provided for TRO and Relevant 

Chemicals analysis which was accompanied with appropriate indications of the limits of 

quantification, quality assurance and quality control (QC) and quality assurance (QA). 

0.5 The Group also noted that the applicant provided the information of additional toxicity 

testing in the Whole Effluent Test (WET) using both seawater and brackish water with five 

species. The results of these tests showed that none of the samples showed any difference in toxicity 

between treated and untreated ballast water. However, the Group noted that some of these toxicity 

tests needed improved QC in accordance with internationally recognized guidelines. 

0.6 The Group was pleased that, according to results of their assessment for TRO degradation 

rate in short voyage, the applicant decided to introduce the neutralization process by sodium 

thiosulphate for reduction of residual TRO and some Relevant Chemicals. The Group recognized the 

importance of the neutralization process as an environmental risk mitigation measure. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 2 

I:\MEPC\59\2-16.DOC 

0.7 The Group noted the applicant had concluded, from fifteen cycles of treated and untreated 

ballast cycles of coated and uncoated steel that coating tests that there were no significant effects 

of fifteen 100 hour cycles of treated ballast water on the ballast tank coatings and that corrosion 

rates were reduced in the case of uncoated samples installed in the treatment tank relative to 

those in the control. 

0.8 The Group considered that the actual exposure time for the treatment dose was 

insufficient for long term corrosion rates and that these data are insufficient to characterize long 

term corrosion rates of steel subjected to the treatment system accurately. Furthermore, 

the Group noted that such a conclusion would strongly conflict with published literature which 

indicate increased corrosion rates for TRO >1.0 mg/L as Cl2 (2.2 mg/L as Br2). 

0.9 The Group considered that, with the various mitigation measures put in place by the 

applicant, the occupational exposure risks to the Active Substances generated by the system 

would be acceptable. 

0.10 However the Group also recognized that the risk of handling the neutralization unit by the 

crew, namely in mixing and loading operations should be further elaborated by the applicant 

when fully operating the BWTS. 

0.11 The Group appreciated the efforts of the applicant to apply the model MAMPEC to 

generate estimations of the Relevant Chemicals in the system, although the results were achieved 

with an old version of the model, version 1.02 instead of the latest version (2.1). 

0.12 The Group was therefore not able to reproduce the results presented by the applicant. 

Nevertheless, the results were considered acceptable as currently no recommended model and 

scenario has been adopted. 

0.13 In conclusion, having reviewed all the information provided by the applicant, the Group 

agreed to recommend to the MEPC that Final Approval be given to the NK-O3 BlueBallast 

System subject to the Administration verifying that all the recommendations have been fully 

addressed prior to issuance of a Type Approval Certificate: 

 .1 maximum allowable dosage of Active Substances at 2.5 mg/L O3 in control 

scheme of ozone gas flow, and TRO of 7.5 mg/L as Br2 is monitored by TRO 

sensors adequately maintained. Both these parameters should be monitored and 

recorded during uptake; and 

 .2 maximum allowable discharge concentrations of Active Substances at TRO 

of 0.2 mg/L as Cl2 has been used as a reference value. In the current situation the 

applicant has shown that a TRO value of 0.08 mg/L as Cl2 was achievable under 

normal operational conditions based on the Maximum Detection Limits (MDL). 

This parameter should be monitored and recorded during discharge. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 3 

I:\MEPC\59\2-16.DOC 

1 INTRODUCTION

1.1 It was noted that the NK-O3 BlueBallast System had, originally, been submitted to 

the Group at its second session for Basic Approval which was not recommended. However, it 

was recommended for Basic Approval during its third session. 

1.2 It was also noted that this system had not been recommended for Final Approval 

following consideration by the Group during its seventh session. 

2 COMPLETENESS OF THE DOSSIER

2.1 The Group agreed that all of the data necessary to carry out a full review of this 

application for Final Approval had been provided by the applicant. Furthermore, the presentation 

of these data had made it relatively easy for the Group to examine specific aspects as needed. 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group recalled that the NK-O3 BlueBallast System uses a shipboard oxygen 

generator which takes ambient air and strips away the nitrogen leaving an oxygen rich mixture. 

This is then passed through a high frequency electrical field to produce ozone which is injected 

into the incoming ballast water. 

3.1.2 The five integrated modules of the system were noted as: 

 .1 an oxygen generator; 

 .2 an ozone generator; 

 .3 an ozone injector; 

 .4 a monitoring and control system; and 

 .5 a neutralizer. 

3.1.3 The Group also noted that ancillary equipment associated with this system which 

includes: 

 .1 a Power Supply Unit (PSU) to provide overall power to the system; 

 .2 a compressor to feed air to the oxygen generator (in some cases this can be based 

on the ship’s existing air compressors); 

 .3 a Refrigerated Dryer (RD) to de-humidify air being fed to the oxygen generator; 

 .4 a Chiller for the Closed Loop Cooling System (CLCS), which keeps the Ozone 

Generator cool; and 

 .5 an Ozone Destruct System (ODS) to convert any unused Ozone back to oxygen 

before release to the atmosphere. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 4 

I:\MEPC\59\2-16.DOC 

3.1.4 A schematic representation of the system is shown below: 

Figure 1 – Scheme of the NK-O3 BlueBallast system. 

3.2 Ozone Dosage and Control 

3.2.1 The Group noted that the ozone dosage and control is integrated into the ballast water 

management system which will be controlled from the bridge and/or cargo control room. 

It comprises the following aspects: 

 .1 activation, priming and stabilization – establishes a stable oxygen supply pressure 

and flow to the ozone generator; 

 .2 start of ballast water uptake triggers the ballast water treatment system to 

commence ozonation; and 

 .3 measurement of TRO levels in the treated influent which causes the amount of 

ozonation to be reduced if the levels of TRO reach 7.0 mg/L. 

3.2.2 A maximum dosage of 2.5 mg O3/L is then injected into the incoming ballast water for 

treatment. The applicant indicated that the dosage of ozone is monitored and controlled 

automatically using a TRO sensor in the ballast water line after injection of ozone. With an 

optimized side injector, the injected ozone gas is efficiently converted to dissolved oxidants, 

mainly hypobromous and hypobromide ion. 

3.2.3 The Group noted that the theoretical TRO for natural seawater could be limited 

to <7.0 mg/L. However, it is possible to produce much higher TRO concentration in treating 

fresh water. Therefore, the Group recognized that the maximum dose concentration of TRO 

(as Br2) to be 7.5 mg/L. 

3.2.4 The applicant provided details of an improved and simplified control scheme for ozone 

gas injection, and the Group noted that the results of TRO levels measured in fresh, brackish and 

seawater indicated the adequate reliability of the control system. The Group also noted that 

the maximum TRO measurement of ballast water treated with 2.5 mg O3/L 

(theoretically TRO 7.5 mg/L as Br2) was 6.2 mg/L. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 5 

I:\MEPC\59\2-16.DOC 

3.3 Neutralization System

3.3.1 It was noted that, on discharge of the treated ballast water, the BWMS monitors the TRO 

levels and that discharge does not start until the sensors are operational and the neutralizer feed 

system is functional. 

3.3.2 If the TRO levels exceed 0.1 mg/L then neutralization is activated with the neutralizer 

dose being calculated from the concentration of TRO monitored just before the neutralizer 

injection point, to offset all TRO still remains. The other set of TRO sensors is located after 

injection to confirm that neutralization is completed. However, if additional sensors, located 

after the neutralizing stage, detect levels >0.1 mg/L, the system is shut down. 

3.3.3 The Group noted that the applicant had reported that the sensors had recorded levels of 

TRO down to 0.02 mg/L during their testing. However, the TRO sensor used for neutralization 

had a sensitivity limit, specified by the manufacturer, of 0.08 mg/L. 

3.3.4 The Group noted that the applicant had indicated the need to replenish reagents used by 

the sensors which is to be done as part of the maintenance schedule. It was also noted that the 

detectors are set up in pairs so that, should one of the pair fail, the other sensor would allow the 

system to continue to function properly. In such an event, the system would also indicate the 

need for maintenance. In the event that both systems should fail, the system shuts down. 

3.4 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC) 

3.4.1 The Group noted that the Active Sustances (ozone) was generated in situ in this system 

and so there were no hazards associated with the storage of this chemical. 

3.4.2 The Group recognized the following reactions anticipated as taking place in ballast water 

treated with ozone: 

O3 + Br- O2 + OBr- k = 160 ± 20 M-1s

-1

O2 + OBr-

 2O2 + Br- k = 330 ± 60 M-1s

-1

OBr- + H3O+ HOBr + H2O k = 2.09 109 M-1s

-1

HOBr + H2O OBr-

 + H3O+ pKa = 8.8 ~ 9.0 

2O3 +OBr- 2O2 + BrO3

-

 k = 100 ± 20 M-1s

-1

HOBr + NH3 NH2Br + H2O k = 7.5 107

 M-1s

-1 

where O3 and OBr- are considered the real actives and k is the reaction rate constant. 

In the figure 2 these main reactions of the chemistry of ozone are depicted. 

Figure 2 – Main reaction scheme for ozone. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 6 

I:\MEPC\59\2-16.DOC 

3.4.3 Recognizing these reactions, the Group agreed with the applicant that ozone produced 

oxidants can be measured as Total Residual Oxidants (TRO). The Group also agreed that the 

oxidation of bromide ions by chlorine (hypochlorous acid/hypochlorite ion (HOCl/OCl-

)) will 

result in the formation of oxidized bromide ion (bromine) which is the residual oxidant most 

likely to exist for any extended period of time in concentrations potentially harmful to marine 

organisms. Bromine rapidly forms hypobromous acid (HOBr) in equilibrium with hypobromite 

ion (OBr-). 

3.4.4 Furthermore, it was recognized that ozonation of hypobromite ion results in bromate ion 

which, in turn, reacts with naturally occurring organic matter to form haloacetic acids (HAA) and 

trihalomethanes (THM). 

3.4.5 The Group noted the following highest levels of Active Substances and Relevant 

Chemicals recorded, by the applicant, during tests for Basic Approval and Final Approval. 

Additional tests 08 Additional 

tests 08 

(Neutralization

) 

Chemical Basic 

Approva

l 

tests 07 

Final 

Approva

l 

tests 07 

0 days 2 days 5 days Before After 

μg/L 

Ozone 2,500 2,350 2,500 - - 2,500 - 

TRO 7,500 4,840 6,160 840 190 - 100 

Bromate ion <2.00 <2.00 <0.004

3 

<0.004

3 

<0.004

3 

<0.004

3 

<0.004

3 

Bromoform 255 28.40 24.3 145 152 25.4 19.0 

Bromochloroacetic 

acid 

- 11.90 <0.02 <0.02 <0.02 <0.02 <0.02 

Dibromoacetic acid - 8.05 7.43 11.6 14.1 4.41 1.35 

Monochloroacetic 

acid 

- <2.13 11.4 4.11 4.45 2.97 1.04 

Dichloroacetic acid - 0.85 <0.14 1.1 <0.14 <0.14 <0.14 

Trichloroacetic acid - 0.70 43 51.4 50.1 <0.04 <0.04 

Sodium thiosulphate - - - - - - 5,290 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 7 

I:\MEPC\59\2-16.DOC 

3.4.6 Additional information on the AS, RC and OC were provided by the applicant as shown 

below: 

Component Chemical Name AS,RC,OC CAS 

Number Concentration (bio)degradation rate or half-life 

Ozone (Triatomic Oxygen) AS 10028-15-6 2.50 mg/L 5 sec 

TRO hypobromous acid 

hypobromite ion AS 13517-11-8 7.50 mg/L 

Bromate ion RC 15541-45-4 0.0020 mg/L 12 hours 

Tribromomethane (TBM) RC 75-25-2 0.2550 mg/L 38 days 

Bromochloroacetic acid 

(BCA) RC 5589-96-8 0.0119 mg/L 15 days 

Dibromoacetic acid (DBA) RC 631-64-1 0.0141 mg/L 15 days 

Monochloroacetic acid 

(MCA) RC 79-11-8 0.0114 mg/L 3.36 days 

Dichloroacetic acid (DCA) RC 79-43-6 0.0011 mg/L 15 days 

Trichloroacetic acid (TCA) RC 76-03-9 0.0514 mg/L 38 days 

Sodium thiosulphate OC 7772-98-7 5.29 mg/L 

3.4.7 The Group noted the comprehensive set of data associated with each of the above 

chemicals and included in appendices 1-10 of this Annex. 

4 CONSIDERATION OF CONCERNS EXPRESSED BY THE GROUP DURING 

ITS PREVIOUS REVIEW FOR FINAL APPROVAL 

4.1 Overview 

4.1.1 It was noted that the applicant had provided the following specific responses to concerns 

expressed by the Group related to the previous application for Final Approval of this system. 

4.2 Ozone monitoring and control (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, 

paragraph 0.3) 

4.2.1 The Group recalled that it had expressed the view that it would be necessary to have an 

improved ozone injection control system in order to ensure the correct dosing. 

4.2.2 In response to this observation, the Group noted that the applicant had provided a more 

detailed description of the ozone dosage control system which uses TRO sensors. Further 

evaluation of the TRO sensors had been undertaken, the results of which were shown in annex 2 

of the supplementary information provided by the applicant. 

4.2.3 Having reviewed this information, the Group agreed that the monitoring and control 

system associated with the ozone injection should ensure that the correct dose is applied without 

any undue excess. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 8 

I:\MEPC\59\2-16.DOC 

4.2.4 It was also noted that, in order to ensure that there is no undue excess ozone injected into 

the ballast water which could lead to the production of chemical by-products, the applicant had 

also included a TRO neutralizer (thiosulphate) as part of the standard design of the system which, 

it was claimed, is effective at keeping TRO levels in treated ballast water discharge below 

the PNEC level of 0.1 mg/L. 

4.2.5 The Group was satisfied that this additional information removed their concerns about the 

monitoring and control of the ozone injection system. 

4.3 Results of Chemical Analyses (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, 

paragraph 0.4) 

4.3.1 The Group recalled that, previously, it had expressed concern about the lack of 

information related to the chemical analyses of the treated ballast water i.e. lack of data, how and 

where analysis had been performed and lack of adequate quality control reports. 

4.3.2 In response to this concern, the Group noted that the applicant had now provided all the 

necessary information (supplementary data, annex 1). The information provided showed that few 

or no residual chemicals were detected in samples from land-based and ship-board tests. 

4.3.3 Additional analyses of chemical residues in the treated ballast water were also carried out 

(supplementary data, annex 3) which showed small amounts of monochloracetic acid, 

dichloroacetic acid, trichloroacetic acid, dibromoacetic acid and tribromomethane. 

4.3.4 Having reviewed this information, the Group was satisfied that it no longer had any 

concerns regarding this issue. 

4.4 Degradation time of TRO vs holding time of NK-O3 treated ballast water 

(MEPC 58/2/8, GESAMP-BWWG 7/9, Annex 6, paragraph 0.5) 

4.4.1 The Group recalled that it had, previously, noted that, the land-based G8 test showed that 

most of the TRO had been degraded in the ballast water after forty-eight hours and so this time 

had been proposed as a holding time for treated ballast water. 

4.4.2 However, the Group recalled that it had not been satisfied with this proposal as no 

ecotoxicity tests had been carried out after this proposed holding time and no exact 

measurements of the remaining TRO had been presented. Furthermore the dossier had included 

information which indicated that TRO levels were well above detectable levels after 48 h. 

4.4.3 The Group noted that the applicant had, subsequently, carried out additional ecotoxicity 

testing and TRO analyses at 0, 2 and 5 d intervals after treatment, the results, of which, were 

shown in annexes 2 and 3 of the supplementary information provided. 

4.4.4 The Group noted that at time 0, the treated ballast water had some toxicity whilst 

at 2 d and 5 d there was none. However, it was also noted that the observed toxicity was less 

than that previously recorded from tests carried out on the test barge. The Group agreed with the 

applicant that this was probably due to the effects of mixing, exposure to sunlight and elapsed 

time. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 9 

I:\MEPC\59\2-16.DOC 

4.4.5 In addition, it was noted that TRO levels were above detection limits after 2 d but were 

below toxic levels. 

4.4.6 Having reviewed the additional information, the Group was satisfied that treated ballast 

water could be discharged immediately after treatment provided that neutralization was 

employed. 

4.5 Reported Degradation Rate of TRO (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, 

paragraph 0.6) 

4.5.1 The Group recalled that it had, previously, expressed concerns regarding the apparent 

discrepancies between the applicant’s reported half-life of TRO in water with a high organic 

content and that of other BWMS: 

 – one BWMS, using ozonation had reported a half-life for TRO of 15 h resulting in 

concentrations of TRO of 160 μg/L after 5 d; and 

 – the applicant had reported a half-life of 1-2 d in its application for Basic Approval 

leading to a concentration of TRO of 130 μg/L after 5 d. 

4.5.2 In response to this observation, the Group noted that the applicant had undertaken 

additional measurements of TRO degradation, the results, of which, were shown in annex 2 of 

the supplementary information. 

4.5.3 In addition, should there still be concerns, the Group noted that the applicant had included 

a TRO neutralizer as part of the NK-O3 system. 

4.5.4 Having reviewed the additional information, the Group was satisfied with it. 

4.6 Whole Effluent Toxicity (WET) testing and QA procedures (MEPC 58/2/8, 

GESAMP-BWWG 7/9, annex 6, paragraph 0.7)

4.6.1 The Group recalled that it had, previously, expressed concern, that the reports of the 

samples taken for ecotoxicity testing after 5 d holding time had inconsistencies in the reported 

dates of tests and samples received at the laboratory. As a result, the Group was uncertain about 

the QA procedures employed in this activity. 

4.6.2 In response to these concerns, the Group noted that the applicant shared such concerns 

which might have been due to the involvement of two separate test facilities, one for the on-barge 

testing and one carrying out the necessary analyses. It appeared that the error was an 

administrative one related to recording of dates because of a delay to the start of the on-barge 

testing which meant that the WET testing was done 4 d after treatment. 

4.6.3 However, it was noted that extra vigilance had been taken when further tests were 

carried out. 

4.6.4 The Group was satisfied with this explanation and accepted the reported results. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 10 

I:\MEPC\59\2-16.DOC 

4.7 Disapproval of using animals to carry out new toxicity testing on Whole Effluent 

Toxicity (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.9) 

4.7.1 The Group recalled that it had expressed disapproval of animal testing for the purpose of 

generating new data which is not required for WET testing. 

4.7.2 The Group noted that the University concerned was trying to comply with Procedure (G9) 

which was of the opinion that mammalian toxicity should be determined using standard test 

methods. 

4.7.3 Whilst the Group recognized that paragraph 5.2 of Procedure (G9) states that “Toxicity 

testing is necessary for treated ballast water discharge as covered in this section”, the Group 

considered that, in the context of section 5 of Procedure (G9), this refers to ecotoxicity testing of 

fish, crustacean and algae. 

4.7.4 Nevertheless, the Group recognized the potential ambiguity of section 5.2 

of Procedure (G9) which it requests MEPC to consider with a view to changing references to 

“Toxicity” in section 5 of Procedure (G9) to “Ecotoxicity”.

4.8 Duration of corrosion tests (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, 

paragraph 0.10) 

4.8.1 The Group recalled that, previously, it had recommended that corrosion tests longer than 

the reported 100 h used by the applicant should be carried out using both coated and uncoated 

samples in order to verify the corrosive effect to steel and that the effect of using this BWTS on 

epoxy coated ballast tanks remains acceptable. 

4.8.2 In response to this request, the Group noted that the corrosion tests were just over 100 h 

for each ballast test cycle and, with a total of 12 test cycles, this gave a total exposure time for 

each test coupon of 1200 h. However, the Group noted that whilst the tests had been extended 

the time of exposure at the intended treatment dose of 7 mg TRO /L (as Br2) was minimal and 

that these tests would be insufficient to predict the long term corrosion rate of uncoated steel. 

4.8.3 Nevertheless, the applicant indicated that additional tests had been undertaken which are 

still ongoing although an interim report had been provided (annex 4 of the supplementary 

application). 

4.8.4 The Group noted that the applicant concluded from the interim results that there were no 

significant effects of fifteen 100 hour cycles of treated ballast water on the ballast tank coatings 

and that corrosion rates were reduced in the case of uncoated samples installed in the treatment 

tank relative to those in the control. As indicated previously, the Group considered that the 

actual exposure time at the treatment dose was insufficient for long term corrosion rates. 

Furthermore, the Group noted that such a conclusion would conflict with published literature 

which indicates increased corrosion rates for TRO > 1 mg/L as Cl2 (2.2 mg/L as Br2). 

4.8.5 Having considered this information, the Group agreed that the applicant should repeat the 

evaluation of uncoated steel substrates, in addition to other exposed metals and non-metallics to 

quantify, the effects on ballast tank coatings and other materials of construction. Such effects 

should include degradation as well as uniform and localized corrosion rates on typical marine 

vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc...) and non-metallic materials 

(e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping. Additionally, such 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 11 

I:\MEPC\59\2-16.DOC 

testing should be conducted for both continuous and intermittent exposure at the treatment 

concentration. Hoewever, this was not considered a reason influencing the FA recommendation. 

5 WHOLE EFFLUENT TESTING (WET) RESULTS

5.1 The Group noted that WET testing had been carried out on a mobile barge fitted with 

the NK-O3 system and two simulated ballast tanks of 312.5 m3

. Tests were carried out at two 

different sites so that sea water and brackish water media could be used. 

5.2 It was noted that samples of treated ballast water were taken immediately after treatment 

and two days and five days later. Ozone and TRO levels were measured immediately on site 

whilst other tests were carried out in the laboratories. 

5.3 The Group noted that the treated ballast water did not show any signs of toxicity two days 

and five days after treatment. However, some toxicity was observed in the ballast water 

immediately after treatment, the results of which are shown in the following two tables. 

Toxicity of treated, high salinity, ballast water immediately after treatment 

 Species NOEC LOEC EC50 Notes 

Microalgae Phaeodactylum 

tricornutum 50% 75% 83% Growth rate, 

96 h 

Dunaliella tertiolecta 50% 75% 81% Growth rate, 

96 h 

Rotifer Brachionus plicatilis > 100% > 100% > 100% Survival, 

24 h 

Brachionus plicatilis 25% 50% > 100% Growth rate, 

96 h 

Fish Cyprinodon variegatus > 100% > 100% > 100% Survival, 

96 h 

Cyprinodon variegatus > 100% > 100% > 100% Growth weight, 

7 d 

Amphipod Monocorophium 

acherusicum > 100% > 100% > 100% Survival, 

10 d 

Toxicity of treated, medium salinity, ballast water immediately after treatment 

 Species NOEC LOEC EC50 Notes 

Microalgae Phaeodactylum 

tricornutum 50% 75% > 100% Growth rate, 

96 h 

Dunaliella tertiolecta 50% 75% > 100% Growth rate, 

96 h 

Rotifer Brachionus plicatilis > 100% > 100% > 100% Survival, 

24 h 

Brachionus plicatilis > 100% > 100% > 100% Growth rate, 

96 h 

Fish Cyprinodon variegatus > 100% > 100% > 100% Survival, 

96 h 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 12 

I:\MEPC\59\2-16.DOC 

Cyprinodon variegatus > 100% > 100% > 100% Growth weight, 

7 d 

Amphipod Monocorophium 

acherusicum > 100% > 100% > 100% Survival, 

10 d 

5.4 Based on this information, the Group agreed that, even immediately following treatment, 

the treated ballast water was only slightly toxic. However, the Group also concurred with the 

views of the applicant that ozone-produced oxidants may persist for one to two days at toxic 

concentrations in treated ballast water. 

5.5 The Group also agreed with the decision of the applicant to include the sodium 

thiosulphate neutralizer as a standard part of the system. 

6 HUMAN HEALTH ASSESSMENT

6.1 The Group recalled that, at its seventh session, it had reviewed the potential human health 

problems associated with this system during which the following observations were made: 

.1 relevant toxicological data had been submitted by the applicant for ozone, TRO 

and disinfection by-products (DBP) in the confidential version (3.4). 

Additionally, the Whole Effluent Toxicity (WET) had been tested in new in vivo

studies for the endpoints of acute toxicity and genotoxicity/mutagenicity. Though 

the Group recognized that some ambiguity may exist regarding the requirements 

of toxicity testing under paragraph 5.2 of Procedure (G9) which states that 

“Toxicity testing is necessary for treated ballast water discharge as covered in this 

section”, the Group considers that this refers to toxicity testing of fish, crustacean 

and algae and not the use of animals for mammalian toxicity testing therefore 

disapproving it; 

.2 it was noted that MSDSs for ozone, bromoform, bromochloroacetic acid, 

dibromoacetic acid had been provided and that risk concerning crew exposure to 

the chemicals generated by the system the human exposure assessment had been 

elaborated by the applicant; 

.3 it had been noted that safety systems had been foreseen by the applicant to prevent 

contact of ship personnel to ozone in the vicinity of the NK-O3 System; 

.4 concerns had previously been expressed about the possibility of free ozone gas 

being present in the ship’s ballast tanks when they are emptied and that personnel 

may be exposed when entering the tanks for inspection and maintenance purposes, 

and also about the possibility of gaseous ozone being emitted from the ballast tank 

air vents during ballasting. However, the applicant had explained that it is highly 

improbable that ballast tanks would ever be opened and entered within a short 

time after the NK-O3 System having been operated, which occurs during 

ballasting. Ballast tanks need to be emptied prior to entry, giving more than 

sufficient time for the breakdown of ozone. To address the perceived concern of 

the Group, safety procedures had been supplemented to recommend an 

exclusion zone of 1 meter, to be painted on the ship’s deck around each 

ballast tank air vent with clear notice for personnel to keep out of these zones 

during ballasting. This will be included in crew induction and safety training 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 13 

I:\MEPC\59\2-16.DOC 

in ships fitted with the NK-O3 System, as reflected in the updated Operation 

and Maintenance Manual and Safety Manual for ozone system; and 

.5 the applicant had proposed risk mitigation measures concerning bromoform, 

which could include periodic sampling of system effluent as part of port State 

control compliance procedures. 

6.2 The Group was satisfied that, with the various mitigation measures put in place by the 

applicant, the occupational risk resulting from exposure to the Active Substance generated by the 

system showed to be acceptable. 

6.3 However, the Group also identified a point to be considered by the applicant when fully 

operating the ballast water management system: 

 .1 as thiosulphate is an irritant, the risks associated with the handling of the 

neutralization unit by the crew during mixing and loading operations need to be 

brought to the attention of the crew. 

7 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL 

PUBLIC

7.1 Risks to the safety of the ship 

7.1.1 The Group recalled that, during its previous evaluation for Final Approval, it had noted 

the following safety precautions which had been put in place to prevent exposure of the ships 

crew to ozone: 

 .1 the use of materials and construction that is designed to prevent any possible 

leakage of ozone from the system; 

 .2 a gas separation unit together with a waste ozone destruction unit placed after the 

treatment unit, to destroy ozone produced during start up and testing of the ozone 

and convert it back to oxygen prior to release to the atmosphere; 

 .3 an ozone densitometer to detect any possible accidental leakage from the system; 

 .4 recommended inspection and maintenance procedures and clearly outlined safety 

procedures as contained in supporting operating manuals for personnel; 

 .5 an automatic alarm and shut-down system linked to the ozone densitometer. This is 

designed to trigger if ozone levels in the vicinity of the system exceed 0.2 mg/L 

(the recommended safe level is 0.1 mg/L); and 

 .6 other events that will shut down the system immediately, close all valves and 

stop, all pumps are high ambient oxygen concentration (25%), no 

Volumetric Oxygen Deficit (VOD) available, emergency stop push button pressed 

and fire alarm. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 14 

I:\MEPC\59\2-16.DOC 

7.1.2 It was also noted that an additional extended corrosivity test had been conducted on 

coated and uncoated test samples as previously suggested by the Group. Having reviewed the 

results of this test, the Group was satisfied that the risks to the safety of the ship would be 

minimal. 

8 RISKS TO THE ENVIRONMENT 

8.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

8.1.1 The Group noted the following information related to the disinfection by-products of the 

Ballast Water Management System as supplied by the applicant: 

Chemical Persistence 

(y/n) 

Bioaccumulation 

(y/n) 

Toxicity 

(y/n) 

Ozone No 

Half-life: 5 sec 

No 

Log Pow: -0.87 

No 

Chronic NOEC = n/a 

TRO 

No 

Biodegrades Fast 

No 

BCF: 3.162 

Log Pow: -0.78 

No 

Chronic NOEC = n/a 

Bromate ion No 

Half-life: Sea water: 12 hours 

No 

BCF: 3.162 

Log Pow: 0.63 

No 

NOEC = 32 mg/L/24h 

LC50 = 93 mg/L/10d 

Bromoform 

Yes 

185 days 

Half-life: Water: 38 

days(applicant’s data 

Soil: 75 days 

No 

BCF: 14.06 

Log Pow: 2.40 

No 

NOEC=2.9 mg/L/96h 

=4.8 mg/L/28d 

Bromochloroacetic acid No 

Half-life: Water: 15 days 

No 

BCF: 3.162 

Log Pow: 0.61 

No 

Chronic NOEC = n/a 

Dibromoacetic acid No 

Half-life: Water: 15 days 

No 

BCF: 3.162 

Log Pow: 0.70 

No 

LC50 = 69 mg/L/96h 

Monochloroacetic acid 

No 

Half-life: Water: 3.36 days 

No 

BCF: 3.162 

Log Pow: 0.22 

No 

LOEC = 25 mg/L/28d 

NOEC = 32 mg/L/21d

Dichloroacetic acid 

No 

Half-life: Water: 15 days 

No 

BCF: 3.162 

Log Pow: 0.92 

No 

LC50 = 23 mg/L/96h 

Trichloroacetic acid 

No 

(Applicant said Yes) 

Half-life: Water: 38 days 

Soil: 75 days 

No 

BCF: 3.162 

Log Pow: 1.33 

No 

LC50 = 0.3 mg/L/14d 

Sodium thiosulfate 

No 

Biowin1 (Linear Model 

Prediction):Biodegrades Fast 

Biowin2 (Non-Linear Model 

Prediction): Biodegrades Fast 

No 

BCF: 3.162 

Log Pow: -4.53 

No 

LETC = 520 mg/L/48h

8.1.2 Based on the data in the above table, the Group agreed that none of the chemical 

by-products, produced by this system, would be classified as PBT. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 15 

I:\MEPC\59\2-16.DOC 

8.2 Calculation of PEC/PNEC Ratios 

8.2.1 The Group agreed with the applicant’s proposals for the estimation of the Predicted No 

Effect Concentrations (PNECs) for the various chemicals associated with this system as shown in 

the table below: 

Chemical name Toxicity 

(mg/L) 

Information Assess. 

Factor 

PNEC 

(μg/l) 

Ozone 0.0081 Lowest short-term L(E)C50 from freshwater 

species representing three trophic levels 1,000 0.0081 

TRO 0.080 Lowest short-term L(E)C50 from marine 

species; representing three trophic levels 1,000 0.080 

Bromate ion 21.0 Lowest short-term L(E)C50 from marine 

species; representing three trophic levels 1,000 21.0 

Bromoform 4.60 Lowest short-term L(E)C50 from marine 

species; representing three trophic levels 1,000 4.60 

Bromochloroacetic 

acid 0.033 

Lowest short-term L(E)C50 from freshwater 

species representing three trophic 

levels(Refer to Monochloroacetic acid) 

1,000 0.033 

Dibromoacetic 

acid 62.0 One lowest short-term L(E)C50 from freshwater; 1,000 62.0 

Monochloroacetic 

acid 0.033 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 0.033 

Dichloroacetic 

acid 21.0 Lowest short-term L(E)C50 from marine species; representing three trophic levels 1,000 21.0 

Trichloroacetic 

acid 0.30 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 0.30 

Sodium thiosulfate 805 Lowest short-term L(E)C50 from freshwater 

species representing three trophic levels 1,000 805 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

8.2.2 The Group noted that the applicant had used two scenarios, associated with Busan Port, to 

calculate the Predicted Environmental Concentration of the various chemical by-products as 

shown below: 

Scenario 1 

Emission 

Conc. 

Emission PEC Assessment 

factor 

Endpoint PNEC PEC / 

PNEC 

Chemical 

(mg/L) (g/d) (μg/L) ( - ) (mg/L) (μg/L) ( - ) 

TRO (not neut) 7.5000 2,105,953 0.2560 1,000 0.0800 0.0800 3.2000 

TRO (neut) 0.1000 28,079 0.0034 1,000 0.0800 0.0800 0.0426 

Bromoform 0.2550 71,602 0.5540 1,000 4.6000 4.6000 0.1204 

BCAA 0.0119 3,341 0.0297 1,000 0.0330 0.0330 0.9000 

DBAA 0.0141 3,959 0.0352 1,000 62.0000 62.0000 0.0006 

MCAA 0.0114 3,201 0.0231 1,000 0.0330 0.0330 0.7000 

DCAA 0.0011 309 0.0027 1,000 21.0000 21.0000 0.0001 

TCAA 0.0514 14,433 0.1340 1,000 0.3000 0.3000 0.4467 

Sodium thiosulfate 5.2900 1,485,399 14.100 1,000 805.0000 805.0000 0.0175 

Scenario 2 

Emission 

Conc. 

Emission PEC Assessment 

factor 

Endpoint PNEC PEC / 

PNEC 

Chemical 

(mg/L) (g/d) (μg/L) ( - ) (mg/L) (μg/L) ( - ) 

TRO (not neut) 7.5000 700,493 0.0852 1,000 0.0800 0.0800 1.0644 

TRO (neut) 0.1000 9,340 0.0011 1,000 0.0800 0.0800 0.0142 

Bromoform 0.2550 23,817 0.1843 1,000 4.6000 4.6000 0.0401 

BCAA 0.0119 1,111 0.0099 1,000 0.0330 0.0330 0.2994 

DBAA 0.0141 1,317 0.0117 1,000 62.0000 62.0000 0.0002 

MCAA 0.0114 1,065 0.0077 1,000 0.0330 0.0330 0.2328 

DCAA 0.0011 103 0.0009 1,000 21.0000 21.0000 0.0000 

TCAA 0.0514 4,801 0.0446 1,000 0.3000 0.3000 0.1486 

Sodium thiosulfate 5.2900 494,081 4.6900 1,000 805.0000 805.0000 0.0058 

8.2.3 Based on these data, the Group agreed that the PEC/PNEC ratios for each of the chemical 

by-products are expected to be less than 1 assuming that neutralization of TRO is carried out 

during discharge. 

8.2.4 Although the Group appreciated the attempts of the applicant to perform these 

calculations, the Group was not able to reproduce the results achieved. It was not clear what the 

reason for this deviation is except that the version used by the applicant is MAMPEC 1.02, whilst 

the version available to the Group is MAMPEC 2.1. 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

8.2.5 Nevertheless, the Group accepted the results of the modelling in general as that no 

environmental risk is expected from the application of the NK-O3 system, also as there is 

currently not an accepted modelling approach available. The Group recommended that the 

applicant apply the more recent version of the model in any future applications. 

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risk to the safety of the ship 

9.1.1 The Group considered that the actual exposure time at the treatment dose was insufficient 

to characterize the long term corrosion rates of steel subjected to the treatment system accurately.

9.1.2 As a result, the Group agreed that the applicant should repeat the evaluation of uncoated 

steel substrates, in addition to other exposed metals and non-metallics to quantify, the effects on 

ballast tank coatings and other materials of construction.

9.1.3 Nevertheless, the Group did not consider that this shortcoming was sufficient for it to 

recommend that Final Approval should not be given. 

9.2 Risks to crew and the general public

9.2.1 The Group recognized that some ambiguity may exist regarding the requirements of 

toxicity testing under paragraph 5.2 of Procedure (G9) which states that “Toxicity testing is 

necessary for treated ballast water discharge as covered in this section” however the Group 

considers that this refers to toxicity testing of fish, crustacean and algae and not the use of 

animals for mammalian toxicity testing therefore disapproving it. 

9.2.2 The Group was satisfied that, with the various mitigation measures put in place by the 

applicant, the occupational exposure risk to the active substance generated by the system showed 

to be acceptable. However the Group also identified the following point to be further elaborated 

by the applicant when fully operating the ballast water management system: 

 .1 the risk of handling the neutralization unit by the crew namely in what mixing and 

loading operations are concerned as the neutralizer thio-sulfate has irritative 

properties; 

9.3 Risks to the environment 

9.3.1 Having reviewed all of the data, the Group agreed that the risks to the environment 

caused by this system would be acceptable. 

9.4 Conclusions 

9.4.1 Notwithstanding the comments made in sections 9.1 to 9.3, the Group was satisfied with 

the response of the applicant to the questions posed to them after the earlier evaluation of the 

system. 

9.4.2 Having considered all of the data submitted for Final Approval, the Group agreed to 

recommend to MEPC that Final Approval be given to this system. 

* * * 
GESAMP-BWWG 8/6 

ANNEX 6 

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I:\MEPC\59\2-16.DOC 

Appendix 1 

Data on Ozone 

1 CHEMICAL NAME: Ozone 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments/ 

Justification for 

missing data 

Morone Americana 

White perch 

0.20 (0.181 - 0.223) / 96h / 

Mortality 

Flow through / Salt water 

Richardson et al. (1983) 

Lepomis macrochirus 

Bluegill

0.06 (0.05 - 0.06) / 24h / 

Mortality 

Flow though / Fresh water 

Paller and Heidinger 

(1979) 

L. macrochirus 

Bluegill

0.02 / 24h / Mortality (NRZERO) 

Flow through / Fresh water 

Paller and Heidinger 

(1980) 

Alosa sapidissima 

American shad 

0.39 (0.28 - 0.58) / 3h / Mortality

Static / Fresh water 

Coler and Asbury 

(1980) 

Catostomus 

commersoni 

White sucker

1.43 (0.97 - 1.92) / 1.33h / 

Mortality 

Flow through / Fresh water 

Coler and Asbury 

(1980) 

Ictalurus punctatus 

Channel catfish

0.03 / 96h / Mortality 

Flow through / Fresh water 

Hammond and Bishop 

(1979) 

Morone saxatilis 

Striped bass 

0.06 (0.03 - 0.12) / 12h / 

Mortality 

Flow through / Fresh water 

Hall et al. (1981) 

M. saxatilis 

Striped bass

0.08 (0.05 - 0.11) / 96h / 

Mortality 

Flow through / Salt water 

Hall et al. (1981) 

Notropis hudsonius 

Spottail shiner 

1.22 (1.06 - 1.4) / 3h / Mortality 

Static / Fresh water 

Coler and Asbury 

(1980) 

Oncorhynchus mykiss 

Rainbow trout 

0.0093 (0.0081 - 0.0106) / 96h 

Mortality / Flow through / Fresh 

water 

Wedemeyer et al. (1979) 

Perca flavescens 

Yellow perch 

0.06 (0.05 - 0.07) / 0.017h / 

Mortality 

Flow through / Fresh water 

Coler and Asbury 

(1980) 

Fish 

Pimephales promelas 

Fathead minnow 

0.1 / 0.008h / Mortality 

Flow through / Fresh water 

Coler and Asbury 

(1980) 

Nannochloris sp. 

Green algae 

0.45 a / 24h / Biomass 

Static 

Algae Toner et al. (1975) 

Nannochloris sp. 

Green algae 

0.45 b / 72h / Biomass 

Static 

Toner et al. (1975) 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 19 

I:\MEPC\59\2-16.DOC 

 Species LC50

(mg/L) 

Reference/Comments/ 

Justification for 

missing data 

Monochrysis lutheri 

Dinoflagellate 

1.00 c / 48h / Biomass 

Static 

Toner et al. (1975) 

Skeletonema costatum 

Diatom

0.10 d / 24h / Biomass 

Static 

Toner et al. (1975) 

Dreissena 

polymorpha 

Zebra mussel 

0.35 - 0.42 / 1.83h / Mortality 

(LT50) 

Flow through / Fresh water 

Molluscs Harrington et al. (1997) 

D. polymorpha 

Zebra mussel

0.26 - 0.36 / 1.18h / Mortality 

(LT95) 

Flow through / Fresh water 

Harrington et al. (1997) 

Amphibians 

Pleurodeles sp. 

Newt

1.6 - 1.8 / 12d / Hematological 

parameters, Biochemistry 

Fresh water 

Jaylet et al. (1989) 

a: severe biomass decrease in 24 h after 10-15min. exposure. 

b: severe biomass decrease in ca. 72 hr after 5 min. exposure, then recovers. 

c: severe biomass decrease in ca. 48 h after 5 min. exposure. 

d: complete biomass depletion in 24 h after 5 min. exposure. 

LT: time to % mortality of organisms 

NR-ZERO: 0% mortality or 100% survival of organisms 

2.2 Chronic aquatic toxicity 

No data was found on the chronic aquatic toxicity of ozone because of its short half-life. 

2.3 Endocrine disruption 

No data was found on the endocrine disruption potential of ozone because of its short half-life. 

2.4 Sediment toxicity 

No data was found on sediment toxicity of ozone because of its short half-life. 

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments/Justification 

for missing data 

- 0.87 3.162 no US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 

Ozone decomposes very rapidly in both seawater and freshwater. Therefore there is no risk that 

ozone may concentrate in organisms. 
GESAMP-BWWG 8/6 

ANNEX 6 

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I:\MEPC\59\2-16.DOC 

2.6 Food web/population effects 

Ozone decomposes very rapidly in both seawater and freshwater. Therefore, there is no risk that 

ozone may cause food-web/population effects. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments/Justification 

for missing data 

Oral LD50 (mg/L) n/a 

Dermal LD50 (mg/L) n/a 

Inhalation LC50

(mg/L/4h) 

0.015 - 0.016 

0.012 - 0.014 

0.032 

Rat 

Mouse 

Hamster 

CCOHS(Canadian Center for 

Occupational Health and Safety) 

n/a: not applicable. 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Justification for missing data 

Skin human Not irritant CCOHS 

Eyes human Irritant (>0.04 mg/for several 

minutes) 

CCOHS 

3.3 Sensitization 

The standard skin sensitization tests are not possible for gases and so there were no laboratory 

data available for this property. There are no data to suggest that ozone might be a sensitizer and 

it is not classified as such by the EEC. 

3.4 Repeated-Dose Toxicity 

From the available information, it was not possible to address the dose-response effects in 

relation to repeated inhalation exposure (sub-chronic, 90 days) to ozone. However, it can be 

expected that similar effects on the lungs of humans and other mammals even at low 

concentration. In addition, the severity of the respiratory responses to ozone becomes reduced 

following repeated daily exposures. This functional adaptation to the effects of ozone may 

persist for several days after exposure stops. Decreases in respiratory function do not appear to 

be more pronounced in cigarette smokers or people with pre-existing lung disorders (CCOHS).
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I:\MEPC\59\2-16.DOC 

3.4.1 Chronic and Long-term Toxicity 

Exposure Route Inhalation 

Exposure Duration 105 - 130 weeks 

Exposure dose 0.01 - 0.02 mg/kg/d 

Species rats and mice 

Method 

Results Increased incidence of non-carcinogenic lesions of the nose and lungs. 

NOAEL 

NOEL 

Reference/Comments CCOHS 

Exposure Route Inhalation 

Exposure Duration 3 - 18 months 

Exposure dose 0.003 - 0.013 mg/kg/d 

Species monkeys 

Method 

Results Significant structural alterations to lungs. 

NOAEL 

NOEL 

Reference/Comments CCOHS 

3.5 Developmental and Reproductive Toxicity 

Exposure Route Inhalation 

Exposure Duration 4 days in middle or late pregnancy 

Exposure dose 0.02 or 0.03 mg/kg/d 

Species rats (offspring) 

Method 

Results Reduced growth rates after birth and delayed behavioural 

development. No maternal toxicity. 

NOAEL 

NOEL 

Reference/Comments CCOHS 

Exposure Route Inhalation 

Exposure Duration days 7 - 17 of pregnancy 

Exposure dose 0.008, 0.016 or 0.024 mg/kg/d 

Species mice (offspring) 

Method 

Results Decreased foetal body weight gain. 

Maternal toxicity. 

NOAEL 0.016 mg/kg/d 

NOEL 

Reference/Comments CCOHS 

Exposure Route Inhalation 

Exposure Duration 

Exposure dose 0.013, 0.025, 0.03 or 0.04 mg/kg/d 

Species rats 
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I:\MEPC\59\2-16.DOC 

Method 

Results Embryotoxicity (increased resorptions) 

No Maternal toxicity. 

NOAEL 0.025 mg/kg/d 

NOEL 

Reference/Comments CCOHS 

Exposure Route Inhalation 

Exposure Duration 6 days prior to mating to postnatal day 22 

Exposure dose 

Species mice 

Method 

Results Reduced body weight and slight effects in neurobehavioral development of 

the offspring. 

No Maternal toxicity. 

NOAEL 

NOEL 

Reference/Comments CCOHS 

3.6 Carcinogenicity 

Species Method Details Results Reference/Comments

Rats 0.0024, 0.01 and 

0.02 mg/kg/d 

105-130 weeks 

No evidence for carcinogenicity 

in male and female rats. 

NTP,1994 

Mice 0.0024, 0.01 and 

0.02 mg/kg/d 

105-130 weeks 

Inconclusive evidence(male) 

Some evidence (female) 

No evidence as tumor promoter 

NTP,1994 

3.7 Mutagenicity/Genotoxicity 

Species Method Details Results Reference/Comments/

lymphocytes of 

hamsters 

0.0048-0.0086 

mg/kg/d for 5 h 

Cytogenetic aberrations Victorin k. (1992) 

NTP (1994) 

lung macrophages 

of female rats 

0.0024-0.016 

mg/kg/d for 6 h 

Cytogenetic aberrations Victorin k. (1992) 

NTP (1994) 

bacteria, mammalian 

and human cells 

in vitro

 Evidence for mutagenicity Victorin k. (1992) 

NTP (1994) 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater or 

Fresh water

Test 

Duration

Results Breakdown 

products

Reference/Comments/

Justification for 

missing data

Hydrolysis (pH 5) Seawater ≤ 5 sec O2

Hydrolysis (pH 7) Seawater 

Fresh water

≤ 5 sec 

200 sec

O2

Hydrolysis (pH 9) Seawater 

Fresh water

≤ 5 sec 

20 sec

O2

Biodegradation n/a 

1/2 - Life Pure water 

Fresh water 

Seawater 

Air 

not 

recorded 

20 min 

10sec~2min 

≤ 5 sec 

1 h 

O2 

Baba S. et al. (2002) 

n/a: not available

4.2 Partition Coefficients 

 Method Results Reference/Comments/Justification 

for missing data 

Log POW Estimated -0.87 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67 

KOC Estimated 23.74 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data 

Persistence Estimated No US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BIOWINTM v.4.10 
GESAMP-BWWG 8/6 

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Page 24 

I:\MEPC\59\2-16.DOC 

4.4 Reaction with organic matter 

4.4.1 In theory ozone can oxidize organic pollutants to carbon dioxide and water. In practice 

this does not happen, as it would take too long. The oxidation reactions usually attack C-C 

double bonds or aromatic groups in humic molecules, and aliphatic side chains or fatty acids by 

hydrogen atom abstraction. It will also oxidize complexed metal ions. 

4.4.2 Care needs to be taken when using ozone for reversible oxidations, for example the 

removal of color from dye waste. If the treated waste comes into contact with a reducing 

environment the molecule may convert to its previous form. This is not important for irreversible 

reactions. 

4.5 Potential physical effects on wildlife and benthic habitats 

4.5.1 The extremely short half-life of ozone in seawater (five seconds) precludes the possibility 

of such impacts. 

4.6 Potential residues in seafood 

4.6.1 The extremely short half-life of ozone in seawater (five seconds) precludes the possibility 

of such impacts. 

4.7 Any known interactive effects 

Forms bromine and related compounds in seawater as addressed in this report. 
GESAMP-BWWG 8/6 

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Page 25 

I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) -193°C 

-192.5°C 

SRC PhysProp 

Database 

CHEMINFO 

Boiling point (°C) -111.9°C 

-111.9°C 

SRC PhysProp 

Database 

CHEMINFO 

Flammability (flash point for 

liquids; °C) 

Non-flammable (does not burn) CHEMINFO 

Density (20°C; kg/m3) 1.5 (-183°C) 

2.14 (0°C, 1013 mbar ) 

Vapour pressure (20°C; Pa) 5,460kPa 

Not applicable (gas) 

> 7,000kPa (estimated, 50°C) 

CHEMINFO 

Vapour density (air = 1) 1.7 

1.66 CHEMINFO

Water solubility (temp; effect 

of pH; mg/L 

3 

1,100 (0°C), 600 (20°C) CHEMINFO 

pH in solution 6~9 

Not applicable CHEMINFO 

Dissociation constant (pKa) Not available 

Oxidation- reduction potential 2.07 E0 (V) 

Corrosivity to material 

or equipment 

Corrosive 1) 

Reactivity to container 

material 

Ozone attacks rubber. It can be used 

with glass, stainless steel, aluminum, 

Teflon, Tygon, Hypalon, polyvinyl 

chloride and polyethylene. 

CHEMINFO 

Auto-ignition Temperature 

(°C) 

Not applicable CHEMINFO 

Explosive properties Explosive when heated or in contact 

with combustible material 2)

Oxidizing properties Powerful oxidizer 

Surface tension 48.4 dyne/cm 

Viscosity 1.55 cP (-183°C) 

Thermal stability and identity 

of 

breakdown products 

Thermal oxidative decomposition 

will 

produce oxygen 3)

Other physical or chemical 

Properties 

Colorless/blue gas, Characteristic 

odour (freshly mown hay) 

CHEMINFO 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Indigo Colorimetric Method

Applicability Water 

Sensitivity 0.01 mg/L 

Reference/Comments Standard Method 4500-O3

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

No No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

Appendix 2 

Data for Hypobromous acid/Hypobromite ion 

1 CHEMICAL NAME: TRO (Hypobromous acid/Hypobromite ion) 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments/

Justification for 

missing data 

Chlorella sorokiniana

Green algae 

0.2 - 0.6 / 20h / Mortality (N/R) 

Renewal / Fresh water 

Kott and Edlis (1969) 

C. sorokiniana

Green algae

0.2 - 0.6 / 20h / Mortality (N/R) 

Static / Fresh water 

Kott and Edlis (1969) 

C. sorokiniana

Green algae

1 / 18h / Population change, 

general (N/R) 

Static / Fresh water 

Kott and Edlis (1969) 

Cladophora sp. 

Green algae

1 - 5 / 0.5 - 24h / Chlorophyll, 

(N/R) / Static / Salt water 

Betzer and Kott (1969) 

Algae 

Cladophora sp. 

Green algae

20 - 100 / 24h / Cell changes 

(N/R) 

Static / Salt water 

Betzer and Kott (1969) 

N/R: Endpoint was not reported.

2.2 Chronic aquatic toxicity 

No information on the chronic aquatic toxicity of TRO was found in the literature.

2.3 Endocrine disruption 

No information on the endocrine disruption potential of TRO was found in the literature. Their 

short half-lives present an extremely low risk of such. 

2.4 Sediment toxicity 

No information on the sediment toxicity of TRO was found in the literature. Their short half-lives 

present an extremely low risk of such.

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments/Justification 

for missing data 

- 0.78 3.162 no US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 28 

I:\MEPC\59\2-16.DOC 

The octanol/water partition coefficient log value of hypobromous acid is -0.78 and is therefore 

considered not to pose a risk of concentration in organisms. 

2.6 Food web/population effects 

No information on the food web/population effects of TRO was found in the literature. Their 

short half-lives present an extremely low risk of such. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

No information on the acute mammalian toxicity of hypobromous acid/hypobromite ion was 

found in the literature. 

3.2 Corrosion/Irritation 

No information on the acute mammalian corrosion/irritation of hypobromous acid/hypobromite 

ion was found in the literature. 

3.3 Sensitization

No information on the acute mammalian sensitization of hypobromous acid/hypobromite ion was 

found in the literature. 

3.4 Repeated-Dose Toxicity 

No information on the acute mammalian repeated dose toxicity of hypobromous 

acid/hypobromite ion was found in the literature. 

3.4.1 Chronic and Long-term Toxicity 

No information on the chronic and long-term mammalian toxicity of hypobromous 

acid/hypobromite ion was found in the literature. 

3.5 Developmental and Reproductive Toxicity 

No information on the acute mammalian developmental and reproductive toxicity of 

hypobromous acid/hypobromite ion was found in the literature. 

3.6 Carcinogenicity

No information on the mammalian carcinogenicity of hypobromous acid/hypobromite ion was 

found in the literature. 

3.7 Mutagenicity/genotoxicity 

No information on the mammalian mutagenicity/genotoxicity of hypobromous acid/hypobromite 

ion was found in the literature. 
GESAMP-BWWG 8/6 

ANNEX 6 

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4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater 

or 

Fresh 

water

Test 

Duration

Results Breakdown 

products

Reference/Comments/

Justification for 

missing data

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation n/a 

1/2 – Life n/a 

n/a: not available

4.2 Partition Coefficients 

 Method Results Reference/Comments/ Justification 

for missing data 

Log POW Estimated -0.87 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67 

KOC Estimated 23.74 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/ Justification 

for missing data 

Persistence Estimated No US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BIOWINTM v.4.10 

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No potential effects indicated in the literature. 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property(with units and 

reference) 

Value Reference/Comments/ 

Justification 

for missing data 

Melting point (°C) 208.57 EPI Suite, v.3.20; 

MPBPWINTM v.1.42 

Boiling point (°C) 527.32 EPI Suite, v.3.20; 

MPBPWINTM v.1.42 

Flammability(flash point for 

liquids; °C) 

Not available 

Density (20°C; kg/m3) Not available 

Vapour pressure (20°C; Pa) 3.06x10-13 mmHg(25°C) EPI Suite, v.3.20; 

MPBPWINTM v.1.42 

Vapour density (air = 1) Not available 

Water solubility (temp; effect 

of 

pH; mg/L) 

1.0x106 EPI Suite, v.3.20; 

WSKOWWINTM v.1.41 

pH in solution Not available 

Dissociation constant (pKa) 8.8 Perrins et al. (2006) 

Oxidation- reduction potential Not available 

Corrosivity to material 

or equipment 

Not available 

Reactivity to container material Not available 

Auto-ignition Temperature 

(°C) 

Not available 

Explosive properties Not available 

Oxidizing properties Not available 

Surface tension Not available 

Viscosity Not available 

Thermal stability and identity 

of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Not available 

6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method DPD Colorimetric Method

Applicability Water 

Sensitivity 0.02 mg/L 

Reference/Comments Standard Method 4500-CL G 
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6.2 Material Safety Data Sheet provided: No. 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

No No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
GESAMP-BWWG 8/6 

ANNEX 6 

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Appendix 3 

Data on Bromate ion 

1 CHEMICAL NAME: Bromate ion 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments/

Justification for 

missing data 

Cymatogaster aggregate, 

Shiner perch 

880 / 72h / Mortality 

(LC100) 

Static / Salt water 

Crecelius E.A. (1979) 

Leiostomus xanthurus 

Spot 

399 (304 - 590) / 6d 

Salt water 

Richardson et al. 

(1981) 

Morone saxatilis 

Striped bass 

230 (200 - 271) / 6d 

Salt water 

Richardson et al.

(1981) 

M. saxatilis 

Striped bass

31 (21 - 40) / 96h / EC50

Salt water 

Richardson et al.

(1981) 

Oncorhynchus keta 

Chum salmon 

512 / 96h / Mortality 

Static / Salt water 

Crecelius E.A. (1979) 

Fish 

Cyprinus carpio 

Common carp 

397 / 40h / Mortality (NRLETH) 

Gavage / Fresh water 

Loeb and Kelly (1963) 

Neomysis awatschensis 

Opossum shrimp 

176 / 24h / Mortality 

Static / Salt water 

Crecelius E.A. (1979) 

Pandalus danae 

Coon stripe shrimp 

880 / 72h / Mortality 

(LC100) 

Static / Salt water 

Crecelius E.A. (1979) 

Daphnia magna 

Water flea

179 / 48h 

Fresh water 

Anderson B.G. (1946) 

Crustacea 

D. magna 

Water flea

210 / 48h / Immobile, 

Intoxication 

(LETC) / Fresh water 

Anderson B.G. (1946) 

Chilomonas paramecium 

Cryptomonad 

38 / Population growth rate 

(N/R) 

Fresh water 

Bringmann and Kuhn 

(1981) 

Glenodinium halli 

Dinoflagellate

16 / 7d / Population 

changes, 

general (N/R) / Salt water 

Erikson and Freeman 

(1978) 

Isochrysis galbana 

Haptophyte

8 - 16 / 7d / Population 

changes, 

general (N/R) / Salt water 

Erikson and Freeman 

(1978) 

Algae 

Skeletonema costatum 

Diatom

0.125 - 16 / 7d / Population 

changes, general (N/R) / Salt 

water 

Erikson and Freeman 

(1978) 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

 Species LC50

(mg/L) 

Reference/Comments/

Justification for 

missing data 

Thalassiosira 

pseudonana, Diatom

16 / 7d / Population 

changes, 

general (N/R) / Salt water 

Erikson and Freeman 

(1978) 

Crassostrea gigas 

Pacific oyster 

170 (105 - 303) / 24h / 

Abnormal, 

Development (EC50) 

Static / Salt water 

Brixham 

Environmental 

Laboratory (1995) 

C. gigas 

Pacific oyster

30 / 48h / Developmental 

changes, 

general (EC50) 

Static / Salt water 

Crecelius E.A. (1979) 

C. gigas 

Pacific oyster

56 / 24h / Abnormal, 

Development 

(LOEC) 

Static / Salt water 

Brixham 

Environmental 

Laboratory (1995) 

C. gigas 

Pacific oyster

32 / 24h / Abnormal, 

Development 

(NOEC) 

Static / Salt water 

Brixham 

Environmental 

Laboratory (1995) 

Macoma inquinata 

Bent-nosed clam 

880 / 72h / Mortality 

(LC100) 

Static / Salt water 

Crecelius E.A. (1979) 

Molluscs 

Protothaca staminea 

Littleneck clam 

880 / 72 h / Mortality 

(LC100) 

Static / Salt water 

Crecelius E.A. (1979) 

Worms Polycelis nigra 

Planarian 

2,258 / 48h / Mortality 

(LT50) 

Static / Fresh water 

Jones J.R.E. (1941) 

N/R: Endpoint was not reported 

NR-LETH: 100% mortality or 0% survival of organism 

LETC: Lethal threshold concentration

2.2 Chronic aquatic toxicity 

 Species LC50(mg/L) 

or NOEC 

(mg/L) 

Reference/Comments/

Justification for 

missing data 

Leiostomus xanthurus 

Spot 

279 (244 - 317) / 10d / Mortality 

Salt water 

Richardson et al.

(1981) 

Fish 

Morone saxatilis 

Striped bass 

93 / 10d / Mortality 

Salt water 

Richardson et al.

(1981) 

2.3 Endocrine disruption 

No information on the endocrine disruption potential of bromate ion was found in the literature.
GESAMP-BWWG 8/6 

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Page 34 

I:\MEPC\59\2-16.DOC 

2.4 Sediment toxicity 

No information on the chronic sediment toxicity of bromate ion was found in the literature. 

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments/Justification 

for missing data 

0.63 3.162 no US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 

The octanol/water partition coefficient log value of bromate ion is 0.63 and is therefore 

considered not to pose a risk of concentration in organisms. 

2.6 Food web/population effects 

The EPI Suite estimates that bromate ion is not expected to bioaccumulate in the food chain 

because it does not exceed the BCF criteria. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments/ 

Justification for missing data 

Oral LD50 (mg/kg) 280 - 495 rats, mice 

and hamsters 

Kurokawa et al. (1990) 

Oral LOAEL (6h) 385 rats Fujie et al. (1988) 

Dermal LD50 (mg/kg) n/aa

 

Inhalation LC50

(mg/L/4h) 

n/ab

 

n/aa: not available. Refer to chronic and long-term dermal toxicity data. 

n/ab

: not applicable. 

3.2 Corrosion/Irritation 

 Species Method Results 

(including scores 

where available) 

Reference/Comments/Justification 

for missing data 

Skin Not specified human Irritant MSDS 

Eyes Not specified human Irritant MSDS 

3.3 Sensitization 

EEC Classification for bromate ions did not include R43 (May cause sensitization by skin 

contact). 
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3.4 Repeated-Dose Toxicity 

Exposure Route Oral 

Exposure Duration 2 weeks 

Exposure Dose 0, 10.8, 54, 108, 270 or 540 mg/kg/d 

Species mice 

Method 

Results Based on changes in enzyme activities. 

NOAEL 108 

NOEL 

Reference/Comments Kawana et al. (1991) 

Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure Dose 0, 16, 32, 63, 140, 270, 540 or 1,080 mg/kg/d 

Species rats 

Method 

Results Died within 7 weeks (≥ 270 mg/kg/d). 

Significant inhibition of body weight gain (≥ 63 mg/kg/d). 

Significant increases of serum parameters (63 mg/kg/d). 

63 mg/kg/d (an adverse effect level). 

NOAEL 

NOEL 

Reference/Comments Kurokawa et al. (1990) 
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3.4.1 Chronic and Long-term Toxicity 

Exposure Route Dermal (shaven dorsal skin) 

Exposure Duration twice weekly for 51 weeks 

Exposure Dose 0.2 ml of a potassium bromate solution in acetone (40mg/ml) 

Species mice 

Method 

Results No skin tumours were seen in the test group or control group. 

NOAEL 

NOEL 

Reference/Comments Kurokawa et al. (1984) 

Exposure Route Oral 

Exposure Duration 15 months 

Exposure Dose 30 mg/kg/d 

Species rats 

Method 

Results Inhibition of body weight gain and renal effects. 

NOAEL 

LOAEL 30 

NOEL 

Reference/Comments Nakano et al. (1989) 

Exposure Route Oral 

Exposure Duration 100 weeks 

Exposure Dose 0, 1.1, 6.1, 12.9 or 28.7 mg/kg/d 

Species rats 

Method 

Results Based on kidney effects. 

NOAEL 1.1 

NOEL 

Reference/Comments DeAngelo et al. (1998) 

Exposure Route Oral 

Exposure Duration 100 weeks 

Exposure Dose 0, 6.9, 32.5 or 59.6 mg/kg/d 

Species mice 

Method 

Results No effects on survival, body weight, organ weights, serum chemistry or the 

incidence of non-neoplasic lesions were observed. 

NOAEL 59.6 

NOEL 

Reference/Comments DeAngelo et al. (1998) 
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3.5 Developmental and Reproductive Toxicity 

Exposure Route Oral 

Exposure Duration 35 days 

Exposure Dose 2.2, 7.7 or 22 mg/kg/ds 

Species rats 

Method 

Results Significant decrease (18%) in epididymal sperm density (treated males in 

the 250-ppm (22 mg/kg/d) dosed group). 

Female reproductive function was not adversely affected. 

There were no treatment related gross or microscopic changes in the kidney, 

liver, spleen, testis, or epididymis. 

No indication of the developmental endpoints or any effects were observed. 

NOAEL 7.7 

LOAEL 22 

NOEL 

Reference/Comments Wolf and Kaiser (1996) 

3.6 Carcinogenicity 

Species Method Details Results Reference/Comments/

Rats 0, 0.7, 1.3, 2.5, 5.6, 

12 or 33 mg/kg/d 

104 weeks 

(Drinking water) 

Significantly increased renal adenomas 

and carcinomas 

(≥ 5.6 mg/kg/d). 

Significantly increased dysplastic foci in 

the kidney 

(≥ 1.3 mg/kg/d). 

Increased incidence of follicular tumours 

of thyroid gland and of peritoneal 

mesotheliomas 

(33 mg/kg/d). 

Kurokawa et al.

(1986b) 

Rats 0 or 32.3 mg/kg/d 

104 weeks 

(Drinking water) 

Increased dysplastic foci and renal 

adenomas, adenocarcinomas, follicular 

adenomas and adenocarcinomas of the 

thyroid gland. 

Kurokawa et al. (1987) 

Mice 0, 6.9, 32.5 or 

59.6 mg/kg/d 

100 weeks 

(Drinking water) 

Increased renal adenomas and carcinomas 

(6.9 mg/kg/d). 

Not increased renal tumours 

(32.5 or 59.6 mg/kg/d). 

DeAngelo et al. (1998) 
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3.7 Mutagenicity/Genotoxicity 

Species Method 

Details

Results Reference/Comments/ 

Justification for 

missing data

Chinese 

hamster 

fibroblasts 

Chromosomal 

aberration 

assay 

Increase in the frequency of 

exchange-type aberrations. 

Ishidate et al. (1984) 

Mouse bone 

marrow 

cells 

Micronucleus 

test 

Increased micronuclei. Hayashi et al. (1988) 

V79 

Chinese 

hamster 

cells 

Cytotoxicity, 

micronucleus, 

chromosome 

aberration, 

HPRT gene 

mutation, and 

comet assays 

Cytotoxic, increased the frequency of 

cells with micronuclei, increased the 

number of chromosome aberrations, 

and increased DNA migration, 

increased levels of 8-

oxodeoxyguanosine, induced gene 

mutations at the HPRT locus. 

Speit et al. (1999) 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater or 

Fresh water

Test 

Duration

Results Breakdown 

products

Reference/Comments/

Justification for 

missing data

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation n/a 

1/2 - Life Sea water 12 hours GESAMP-BWWG 5/9, 

annex 5 (p22) 

n/a: not available

4.2 Partition Coefficients 

 Method Results Reference/Comments/ Justification 

for missing data 

Log POW Estimated 0.63 

-7.18 

(NaBrO3) 

US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, KOWWINTM v.1.67 

SRC PhysProp Database 

KOC Estimated 14.3 US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, PCKOCWINTM v.1.66 
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I:\MEPC\59\2-16.DOC 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data 

Persistence Estimated No US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BIOWINTM v.4.10 

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No potential effects indicated in the literature. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 40 

I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES 

Property(with units and 

reference) 

Value Reference/Comments/

Melting point (°C) 38 (bromate ion) 

381 (Sodium bromate) WHO (2005) 

Boiling point (°C) 1,390 MSDS-FisherScientific

Flammability Non-flammable (Not applicable) MSDS-SienceLab 

Density (20°C; kg/m3) 3,339 

3,340 

U.S. EPA(2001) 

NIOSH-ICSC 

Vapour pressure 

(20°C; Pa) 

5.6x10-16 (25°C) SRC PhysProp 

Database 

Vapour density (air = 1) 5.2 MSDS-FisherScientific

Water solubility 

(temp; effect of 

pH; mg/L) 

3.64x105 (20°C) NIOSH-ICSC 

pH in solution 5.0~9.0 MSDS-SigmaAldrich 

Dissociation constant 

(pKa) 

Not available MSDS-SienceLab 

Oxidation- reduction 

potential 

Not available 

Corrosivity to material or 

equipment 

Non corrosive 

(Neutral in aqueous solution) 

MSDS-SienceLab 

HSDB 

Reactivity to container 

material 

Avoid contact with strong reducers, 

finely powdered metals, alcohols, strong 

acids, ammonium compounds, 

combustible materials. 

MSDS-FlinnScientific 

Auto-ignition Temperature 

(°C) 

Not applicable MSDS-SienceLab 

Explosive properties Risk of fire and explosion on contact with 

combustible substances and reducing 

agents. 

NIOSH-ICSC 

Oxidizing properties Strong oxidizer MSDS-FlinnScientific 

Surface tension Not available MSDS-SigmaAldrich 

Viscosity Not available 

Not applicable 

MSDS-SigmaAldrich 

MSDS-FisherScientific

Thermal stability and 

identity of 

breakdown products 

Stable 

When heated to decomposition, emits 

toxic fumes of bromides. 

MSDS-SienceLab 

MSDS-FlinnScientific 

Other physical or chemical 

properties 

Colorless or White, odorless crystals or 

powder 

MSDS-FlinnScientific 

MSDS-FisherScientific
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Ion chromatographic Method 

Applicability Water 

Sensitivity 0.0043 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 300.0 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

No No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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Appendix 4 

Data on Tribromomethanes 

1 CHEMICAL NAME: Tribromomethane (Bromoform) 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments/ 

Justification for 

missing data 

Brevoortia tyrannus 

Atlantic menhaden 

12 (9 - 15) / 96h / Mortality 

Flow through / Salt water 

Anderson et al. (1979) 

Gibson et al. (1981) 

Cyprinodon 

variegatus 

Sheepshead minnow 

7.1 (4.6 - 11) / 96h / Mortality 

Flow through / Salt water 

Ward et al. (1981) 

C. variegatus 

Sheepshead minnow

2.9 (NOEC) / 96h / Mortality 

Static / Salt water 

Heitmuller et al. (1981) 

Cyprinus carpio 

Common carp 

52 (50 - 54) / 3-5d / Mortality 

Renewal / Fresh water 

Mattice et al. (1981) 

Fish 

Lepomis macrochirus 

Bluegill 

29 (24 - 36) / 96h / Mortality 

Static / Fresh water 

Buccafusco et al.

(1981) 

Daphnia magna 

Water flea 

46 (42 - 51) / 48h / Mortality 

Static / Fresh water 

LeBlanc, G.A. (1980) 

Daphnia pulex 

Water flea

44 / 96h / Mortality 

Renewal / Fresh water 

Trabalka et al. (1978) 

Americamysis bahia 

Opossum shrimp 

24.4 / 96h / Mortality 

Salt water 

U.S. EPA (1978) 

Crustacea 

Penaeus aztecus

Brown shrimp 

26 (20 - 30) / 96h / Mortality 

Flow through / Salt water 

Anderson et al. (1979) 

Selenastrum 

capricornutum, Green algae 

38.6 (26.1 - 53.8) / 96h / 

Chlorophyll (EC50) / Fresh water 

U.S. EPA (1978) 

S. capricornutum 

Green algae

10 / 96h / Chlorophyll / NOEC 

Fresh water 

U.S. EPA (1978) 

Skeletonema costatum 

Diatom 

12.3 / 96h / 

Photosynthesis(EC50)

Fresh water 

U.S. EPA (1978) 

Algae 

Protothaca staminea 

Littleneck clam 

7 / 28d / Mortality (LC0) 

Flow through / Salt water 

Gibson et al. (1981) 
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2.2 Chronic aquatic toxicity 

 Species NOEC/IC50 (mg/L) Reference/Comments/ 

Justification for 

missing data 

Cyprinodon 

variegatus 

Sheepshead minnow 

4.8 / 28d / Mortality (NOEC) 

Flow through / Salt water 

Fish Ward et al. (1981) 

C. variegatus 

Sheepshead minnow

8.5 / 28d / Mortality (LOEC) 

Flow through / Salt water 

Ward et al. (1981) 

Glenodinium halli 

Dinoflagellate 

> 32 / 7d / Population changes, 

general (IC50) / Salt water 

Erickson et al. (1978) 

Isochrysis galbana 

Haptophyte 

32 (8 - 32) / 7d / Population 

changes, general (IC50) / Salt water 

Erickson et al. (1978) 

Skeletonema costatum 

Diatom 

32 (2 - 32) / 7d / Population 

changes, general (IC50) / Salt water 

Erickson et al. (1978) 

Algae 

Thalassiosira 

pseudonana, Diatom 

32 (1 - 32) / 7d / Population 

changes, general (IC50) / Salt 

water 

Erickson et al. (1978) 

2.3 Endocrine disruption 

No information on the endocrine disruption potential of bromoform was found in the literature. 

2.4 Sediment toxicity 

Tribromomethane is relatively stable in the air, but reactions with other chemicals in the air cause 

them to break down slowly (about 50% in 1 or 2 months). Tribromomethane in water or soil may 

also be broken down by bacteria, but the speed of this process is not known. 

According to CITI (1992) and Sangster (1994), the value of Log Pow is 2.4, which is smaller 

than the indicated value of bioaccumulation which is 3. And Koc value from EPI Suit V 3.20 

is 35.04 and it is smaller than 500l/kg. Therefore, it is considered to have low possibility of 

sediment toxicity. 

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments/Justification 

for missing data 

2.40 14.06 no US EPA (2005) 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 

The bioaccumulative potential of an organic chemical reflects the tendency of a chemical to be 

taken up and retained by an aquatic organism, both from water and through food, which then 

results in higher concentration of that chemical in an organism than in its environment. Log Pow 

is a common term to classify chemicals as bioaccumulative. 
GESAMP-BWWG 8/6 

ANNEX 6 

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The value of Log Pow is 2.4 and this value is smaller than 3 which is used as a rough indication 

for bioaccumulation and the BCF-value using the method of regression-based extrapolation 

was 14.06 which is smaller than the value of 2000. The substance is considered to be not 

bioaccumulative. 

2.6 Food web/population effects 

The PBT Profiler estimates that tribromomethane (bromoform) is not expected to bioaccumulate 

in the food chain because it does not exceed the BCF criteria. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments/ 

Justification for missing data 

Oral LD50 (mg/kg) 933 - 1,388 

707 - 1,550 

rats 

mice 

EPA, EHC 216 (2000) 

Dermal LD50 

(mg/kg) 

2,000 rabbits Torkelson (1994) 

Inhalation LC50

(mg/L/4h) 

4,500 mg/m3

(LCLO) 

≥ 7,000 ppm 

1,070 - 1,260 ppm 

rats 

dogs 

rabbits 

ACGIH (1991) 

ACGIH (1991) 

Dykan (1964) 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Justification for missing data 

Skin human Irritant (Redness). 

Prolonged or repeated contact 

causes defatting and cracking of 

the skin. 

International Chemical Safety 

Cards (WHO/IPCS/ILO) 

MSDS 

Eyes human Irritant (Redness, Pain). 

Contact with eyes causes 

irritation and may be painful. 

International Chemical Safety 

Cards (WHO/IPCS/ILO) 

MSDS 

3.3 Sensitization 

EEC Classification for bromoform did not include R43 (May cause sensitization by skin contact). 
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3.4 Repeated-Dose Toxicity 

Exposure Route Oral 

Exposure Duration 90 days 

Exposure Dose 0, 0.65, 6.1, 57 or 218 mg/kg/d (male) 

0, 0.64, 6.9, 55 or 283 mg/kg/d (female) 

Species rats 

Method 

Results Decreased lymphocyte counts. 

Decrease in LDH in both males and females at the high dose. 

Increased hepatic lesions (increased cytoplasmic volume and vacuolation 

due to fatty infiltration). 

Increased thyroid lesion (decreased follicular size and colloid density and 

occasional focal collapse of follicles). 

NOAEL 57 (male), 55 (female) 

LOAEL 218 (male), 283 (female) 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

Chu et al. (1982b) 

Exposure Route Oral 

Exposure Duration 13 weeks (5days per week) 

Exposure Dose 0, 25, 50, 100 or 200 mg/kg/d (rats) 

0, 25, 50, 100, 200 or 400 mg/kg/d (mice) 

Species rats and mice 

Method 

Results The only significant finding, hepatic vacuolation, was observed in male rats 

(≥ 50 mg/kg/d) and male mice (≥ 200 mg/kg/d). 

NOAEL 25 (rats), 100 (mice) 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

NTP (1989a) 

3.4.1 Chronic and long-term toxicity 

Exposure Route Oral (diet) 

Exposure Duration 24 months 

Exposure dose 0, 22, 90 or 364 mg/kg/d (male) 

0, 38, 152 or 619 mg/kg/d (females) 

Species rats 

Method 

Results Enzyme changes and altered liver appearance at necropsy. 

NOAEL 22 (male), 38 (female) 

LOAEL 90 (male), 152 (female) 

NOEL 

Reference/Comments/ 

Justification for 

missing data

Tobe et al. (1982) 
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Exposure Route Oral 

Exposure Duration 103 weeks (5 days per week) 

Exposure dose 0, 100 or 200 mg/kg/d 

Species rats 

Method 

Results Decreased body weight, lethargy, mild hepatotoxicity. 

NOAEL 

LOAEL 100 

NOEL 

Reference/Comments/ 

Justification for 

missing data

NTP 1989a 

Exposure Route Oral 

Exposure Duration 103 weeks (5 days per week) 

Exposure dose 0, 50 or 100 mg/kg (male) 

0, 100 or 200 mg/kg (female) 

Species mice 

Method 

Results No observed effects on body weight or hepatotoxicity (male). 

Decreased body weight, minimal to mild fatty changes in liver 

(female). 

NOAEL 100 (male) 

NOEL 100 (female) 

Reference/Comments/ 

Justification for 

missing data

NTP 1989a 

3.5 Developmental and Reproductive Toxicity 

Exposure Route Oral (gavage) 

Exposure Duration At days 6-15 of gestation 

Exposure dose 0, 50, 100 or 200 mg/kg/d 

Species rats 

Method 

Results Evidence of a fetotoxic response. 

No fetal malformations observed. 

NOAEL 50 (developmental), 200 (maternal) 

LOAEL 100 (developmental) 

NOEL 

Reference/Comments/ 

Justification for 

missing data

Ruddick et al. (1983) 
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I:\MEPC\59\2-16.DOC 

Exposure Route Oral (gavage) 

Exposure Duration 105 days 

Exposure dose 0, 50, 100 or 200 mg/kg/d 

Species mice 

Method Continuous breeding reproductive toxicity protocol. 

Results No detectable effect on fertility, litters/pair, live pups/litter, 

proportion of live births, sex of live pups, or pup body weight. 

NOAEL 100 (developmental / maternal) 

LOAEL 200 (developmental / maternal) 

NOEL 

Reference/Comments/ 

Justification for 

missing data

NTP (1989b) 

3.6 Carcinogenicity 

Species Method Details Results Reference/Comments

Rats 0, 100 or 200 

mg/kg/d. 

103 weeks 

(5 days per week) 

(via gavage in oil) 

Increased adenomatous polyps or 

adenocarcinomas. 

Some evidence for carcinogenic activity 

(male) and clear evidence (female). 

NTP (1989a) 

Mice 0, 50 or 100 mg/kg/d 

(male). 

0, 100 or 200 mg/kg/d 

(female). 

103 weeks (5 days per 

week) (via gavage in oil) 

No statistically significant increases in 

the incidence of any neoplastic lesion 

in any dose group compared to 

controls. 

NTP (1989a) 

3.7 Mutagenicity/Genotoxicity 

Species Method Details Results 

(with/without 

activation)d

Reference/Comments

In Vitro Studies 

Salmonella typhimurium 

TA100a

, TA1535 

Gene mutation nt/+ Simmon and Tardiff (1978) 

TA1535, TA1537b, 

TA100 

TA97, TA98 

Gene mutation -/- 

-/±C

±C

 /- 

NTP (1989A) 

TA100b Gene mutation -/+ Ishidate et al. (1989a) 

TA98 

TA100, TA1538a

Gene mutation +/+ 

-/- 

Zeiger (1990) 

S. typhimurium Ara Gene mutation -/+c

 Roldan-Arjona and 

Pueyo (1993) 

RSJ100 Gene mutation nt/+ DeMarini et al. (1997) 

Mouse lymphoma cellsb Gene mutation +/+ NTP (1989a) 

Chinese hamster 

fibroblastsb

Chromosome 

aberration 

+/- Ishidate et al. (1982) 

Chinese hamster 

fibroblastsb

Chromosome 

aberration 

-/± NTP (1989a) 
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I:\MEPC\59\2-16.DOC 

Species Method Details Results 

(with/without 

activation)d

Reference/Comments

Human lymphocytes DNA damage nt/+ Landi et al. (1999a) 

Human lung epithelial 

cells 

DNA damage nt/+ Landi et al. (2003) 

Toadfish leukocytesa Sister chromatid 

exchange 

nt/- Maddock and Kelly (1980) 

Human lymphocytesb Sister chromatid 

exchange 

nt/+ Morimoto and Koizumi 

(1983) 

Chinese hamster ovary 

cellsb

Sister chromatid 

exchange 

-/± NTP (1989a) 

Rat liver GGT-foci assay Initiation - Herren-Freund and Pereira 

(1986) 

CCRF-CEM human 

lymphoblastic leukemia 

cells 

DNA strand breaks nt/+ Geter et al. (2004a) 

F344/N primary rat 

hepatocytes 

DNA strand breaks nt/- Geter et al. (2004a) 

In Vivo Studies 

Mouse bone marrow 

cells 

Micronuclei - Ishidate et al. (1982) 

Mouse bone marrow 

cells 

Micronuclei - Hayashi et al. (1988) 

Mouse bone marrow 

cells 

Micronuclei - Stocker et al. (1997) 

Mouse bone marrow 

cells 

Chromosome 

aberrations 

- NTP (1989a) 

Rat bone marrow 

cells (oral) 

Rat bone marrow 

cells (ip) 

Chromosome 

aberrations 

+ 

+ 

Fujie et al. (1990) 

Rat renal cells DNA strand breaks - Potter et al. (1996) 

Rat liver, kidney or 

duodenum epithelial 

cells 

DNA strand breaks - Geter et al. (2004a) 

Mouse bone marrow 

cells 

Sister chromatid 

exchange 

+ Morimoto and Koizumi 

(1983) 

Mouse bone marrow 

cells (ip) 

Sister chromatid 

exchange 

+ NTP (1989a) 

Drosophila Sex-linked recessive 

lethal mutations 

 NTP (1989a) 

nt: Not tested. 

a: Assay was conducted in a closed system. 

b: Authors did not specify whether or not the assay was conducted in a closed system. 

c: Equivocal results obtained. 

d: With/without activation applies to in vitro assays only. 
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4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater 

or Fresh 

Water

Test 

Duration

Results Breakdown 

products

Reference/Comments/

Justification for 

missing data

Hydrolysis 

(pH 5) 

 n/a 

Hydrolysis 

(pH 7) 

 n/a 

Hydrolysis 

(pH 9) 

 n/a 

Ultimate 

Biodegradation

Survey

2.728 

(Weeks 

to Months )

PBT Profiler 

(Estimated)

Biodegradation 

Aerobic: limited biodegradation 

Anaerobic: readily biodegrade

1/2 - Life Water 

Soil 

Sediment 

Air

estimated 38 days 

75 days 

340 days 

380 days

PBT Profiler

Photolysis Air: 1~2 months 

Water: not asignificant degradation pathway

n/a: not available

4.2 Partition Coefficients 

 Method Results Reference/Comments/ Justification 

for missing data 

Log POW 2.40 U.S. EPA (2005) 

KOC 

Column, 

Keweenaw 7 soil; 

0.85% OC 

Estimated

114.8 

126 

35.04

ATSDR (2005) 

U.S. EPA (1996) 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, PCKOCWINTM v.1.66
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4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/ Justification 

for missing data 

Persistence Estimated Yes PBT Profiler 

The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

Bromoform is expected to be found predominantly in soil. It is also expected to be found in water 

but not in sediment. 

The PBT Profiler has estimated that Bromoform is expected to be found predominantly in soil 

and its persistence estimate is based on its transformation in this medium. Its half-life in 

soil, 75 days, exceeds the EPA criteria of ≥ 2 months (and ≤ 6 months). Therefore, Bromoform is 

estimated to be persistent in the environment. 

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No potential effects indicated in the literature. 
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5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

 PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments/ 

Justification 

for missing data

Melting point (°C) 6~7 

8.0 

8.0~8.5 

U.S. EPA(2005) 

ATSDR(2005) 

CHEMINFO 

Boiling point (°C) 149~150 

149.1 

149.5 

U.S. EPA(2005) 

ATSDR(2005) 

CHEMINFO 

Flammability(flash point for 

liquids; °C) 

Non-flammable (No data) ATSDR(2005) 

Density (20°C; kg/m3) 2.887x103

2.899x103

U.S. EPA(2005) 

ATSDR(2005) 

Vapour pressure (20°C; Pa) 700 (20°C) 

747 (25°C) 

NIOSH-ICSC 

U.S. EPA(2005) 

Vapour density (air = 1) 8.7 

8.72

ATSDR(2005) 

CHEMINFO

Water solubility (temp; effect 

of 

pH; mg/L) 

1.0x103 (20°C) 

3.1x103

 (25°C) 

3.19x103 (30°C) 

NIOSH-ICSC 

ATSDR(2005) 

U.S. EPA(2005) 

pH in solution Not available 

Dissociation constant (pKa) Not available 

Oxidation- reduction potential Not available 

Corrosivity to material or 

equipment 

Will attack some forms of plastics, 

rubber, and coatings 1)

ATSDR(2005) 

Reactivity to container 

material 

Not available 

Auto-ignition Temperature (°C) No data ATSDR(2005) 

Explosive properties Reactive Metal Powders can react 

explosively. Nitromethane or Cyclic 

Polyethylene Oxides/Potassium 

Hydroxide mixtures can explode. 

CHEMINFO 

Oxidizing properties Normally stabilized to prevent 

oxidation. 

CHEMINFO 

Surface tension 41.53 dynes/cm 

46.18 (15°C) 

ATSDR(2005) 

Viscosity 2.15 cP (15°C) 

0.74 centistokes(15°C, Estimated) 

2.217 cP (10°C) 

CHEMINFO 

Thermal stability and identity of 

breakdown products 

Stable under normal conditions. 

Gradually decomposes on standing, 

acquiring a yellow colour.2) 

CHEMINFO 

Other physical or chemical 

properties 

Colorless to yellow liquid with a 

sweet, suffocating, chloroform-like 

odor3)

CHEMINFO 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Liquid-Liquid Extraction Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.63 μg/L 

Reference/Comments/Justification 

for missing data 

Standard Method 8260B 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

Yes No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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Appendix 5 

Data on Bromochloroacetic acid 

1 CHEMICAL NAME: Bromochloroacetic acid 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Information on the acute aquatic toxicity of bromochloroacetic acid was not found in the 

literature. 

2.2 Chronic aquatic toxicity 

No information on the chronic aquatic toxicity of bromochloroacetic acid was found in the 

literature.

2.3 Endocrine disruption 

No information on the endocrine disruption potential of bromochloroacetic acid was found in the 

literature.

2.4 Sediment toxicity 

No information on the sediment toxicity of bromochloroacetic acid was found in the literature.

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments/Justification 

for missing data 

1.08 3.162 no WHO (2004) 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 

The octanol/water partition coefficient log value of bromochloroacetic acid is 1.08 and is 

therefore considered not to pose a risk of concentration in organisms. 

2.6 Food web/population effects 

The PBT Profiler estimates that bromochloroacetic acid is not expected to bioaccumulate in the 

food chain because it does not exceed the BCF criteria. 

3 MAMMALIAN TOXICITY

3.1 Acute toxicity 

No information on the acute toxicity of bromochloroacetic acid was found in the literature. 
GESAMP-BWWG 8/6 

ANNEX 6 

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Much more health effects data are available on dichloroacetate and dibromoacetate than on 

bromochloroacetate. Results of toxicity studies on dichloroacetate and dibromoacetate are 

informative of the potential health effects of bromochloroacetate because of qualitative 

similarities in the metabolism of the chlorinated/brominated dihaloacetates (NTP, 2008). 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Justification for missing data 

Skin human Causes burn. MSDS 

Eyes human Destructive to tissue of 

mucous membrane. 

MSDS 

3.3 Sensitization 

No information on mammalian sensitization of bromochloroacetic acid was found in the 

literature.

3.4 Repeated-dose toxicity 

Exposure Route Oral 

Exposure Duration 2 weeks 

Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L 

(0, 9, 18, 35, 75 or 140 mg/kg/d to male) 

(0, 8, 17, 35, 70 or 130 mg/kg/d to female) 

Species rats 

Method 

Results Increased right kidney weights (the highest dosed male group). 

No exposure-related gross or histopathologic lesions were observed. 

NOAEL 

NOEL 

Reference/Comments NTP (2008) 

Exposure Route Oral 

Exposure Duration 2 weeks 

Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L 

(0, 10, 20, 40, 80 or 170 mg/kg/d to male) 

(0, 9, 17, 40, 75 or 155 mg/kg/d to female) 

Species mice 

Method 

Results Increased mean body weights (250 mg/L-dose male group). 

No exposure-related gross or histopathologic lesions were observed. 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

NTP (2008) 
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Exposure Route Oral 

Exposure Duration 3 months 

Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L 

(0, 5, 10, 20, 40 or 75 mg/kg/d to male) 

(0, 5, 10, 20, 40 or 85 mg/kg/d to female) 

Species rats 

Method 

Results Increased liver weights (≥ 500mg/L). 

Increased kidney weights (1,000 mg/L dosed male group). 

Increased incidences of cytoplasmic vacuolization (1,000mg/L). 

NOAEL 

NOEL 

Reference/Comments NTP (2008) 

Exposure Route Oral 

Exposure Duration 3 months 

Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L 

(0, 8, 16, 32, 65 or 125 mg/kg/d to male) 

(0, 8, 17, 35, 70 or 140 mg/kg/d to female) 

Species mice 

Results Decreased body weight gain (≥ 250 mg/L dosed female group). 

Increased liver weights (the highest dosed male group and all exposed 

female groups). 

Periportal cytoplasmic vacuolization (all male groups and females exposed 

to 500 and 1,000 mg/L). 

Increased incidences of hematopoietic cell proliferation (62.5, 125 and 

250 mg/L males and 125 and 1,000 mg/L females). 

NOAEL 

NOEL 

Reference/Comments/ NTP (2008) 

3.5 Developmental and reproductive toxicity 

Exposure Route Oral 

Exposure Duration 14 days 

Exposure Dose 0, 24, 72 or 216 mg/kg/d 

Species rats 

Method 

Results Decreased epididymal sperm counts, the number of motile sperm. 

Increased epididymal sperm with misshapen heads or tail defects, the 

number of atypical residual bodies in seminiferous tubules, the number of 

Step 19 spermatids retained in Stage X and XI of the spermatogenic cycle. 

NOAEL 

LOAEL 24 

NOEL 

Reference/Comments Klinefelter et al. (2002) 
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Exposure Route Oral 

Exposure Duration 14 days (juvenile mice : postnatal day 8 to day 21) 

Exposure Dose 0, 8, 24, 72 or 216 mg/kg/d 

Species juvenile and adult mice 

Method 

Results Effects on fertility: disruption of spermatid differentiation. 

Reduced mean number of litters per male, the percentage of litters per 

female bred and the total number of fetuses per male (at two highest 

exposure groups). 

Spermatids with abnormal head morphology and atypical residual bodies. 

No affect relative testis, epididymal or seminal vesicle weights. 

NOAEL 72 

LOAEL 24 

NOEL 

Reference/Comments Tully et al. (2005) 

Exposure Route Oral 

Exposure Duration 14 days 

Exposure Dose 0, 8, 24, 72 mg/kg/d 

Species rats 

Method 

Results Reduced the fertility of cauda epididymal sperm 

 (evaluated by in utero insemination). 

ED50 = 2.7 

NOAEL 8 

NOEL 

Reference/Comments Klinefelter et al. (2002) 

kaydos et al. (2004) 

Exposure Route Oral 

Exposure Duration during cohabitation and separated after mating. 

gestation day 6 to onset of birth (pregnant rats) 

Exposure Dose 0, 60, 200 or 600 ppm (mg/L) 

(0, 5, 15 or 39 mg/kg/d to male) 

(0, 6, 19 or 50 mg/kg/d to female) 

Species rats 

Method 

Results Reduced implants per litter and live fetuses per litter (at 600 ppm). 

NOAEL 19 

LOAEL 50 

NOEL 

Reference/Comments NTP (1998) 
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3.6 Carcinogenicity 

Species Method Details Results Reference/Comments/ 

Justification for 

missing data

Rats 0, 250, 500 or 

1,000 mg/L. 

2 years. 

Malignant mesothelioma. 

Adenoma in Large intestine. 

Fibroadenoma in mammary gland. 

Clear evidence of carcinogenic activity. 

NTP (2008) 

Mice 0, 250, 500 or 

1,000 mg/L. 

2 years. 

Hepatocellular adenoma, 

 hepatocellular carcinoma, 

 hepatocellular adenoma or 

 carcinoma and hepatoplastoma 

 in Liver. 

Clear evidence of carcinogenic activity. 

NTP (2008) 

3.7 Mutagenicity/genotoxicity 

Species Method Details Results Reference/Comments

Salmonella typhimurium 

TA100 

Gene mutation Positive, 

with or without S9 

NTP (2008) 

S. typhimurium TA98 Gene mutation Negative, 

with or without S9 

NTP (2008) 

Escherichia coli strain WP2 

uvrA/pKM101

Gene mutation Negative, 

with or without S9 

NTP (2008) 

Mouse peripheral blood Chromosomal damage Negative NTP (2008) 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater 

or Fresh 

Water

Test 

Duration

Results Breakdown 

products

Reference/Comments/

Justification for 

missing data

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation Ultimate 

Biodegradati

on Survey

3.036 

Weeks

PBT Profiler 

(Estimated)

1/2 - Life Water 

Soil 

Sediment 

Air

estimated 15 days 

30 days 

140 days 

24 days

PBT Profiler

n/a: not available
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4.2 Partition Coefficients 

 Method Results Reference/Comments/Justification 

for missing data 

Log POW 1.080 WHO (2004) 

KOC Estimated 1.895 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data 

Persistence Estimated No PBT Profiler 

The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

Bromochloroacetic acid is expected to be found predominantly in soil. It is also expected to be 

found in water, but not in sediment. 

The PBT Profiler has estimated that Bromochloroacetic acid is expected to be found 

predominantly in soil and its persistence estimate is based on its transformation in this medium. 

Its half-life in soil, 30 days, does not exceed the EPA criteria. Therefore, Bromochloroacetic acid 

is estimated not to be persistent in the environment.

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No potential effects indicated in the literature. 
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5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments/ 

Justification 

for missing data

Melting point (°C) 27.5~31.5 

36 

WHO (2004) 

PBT Profiler 

Boiling point (°C) 210~215 

215 

U.S EPA (2005) 

SRC PhysProp 

Database 

Flammability (flash point for 

liquids;) 

Not available 

Density (20°C; kg/m3) 1,980 WHO (2004) 

Vapour pressure (20°C; Pa) 11 (25°C) 

18 (25°C) 

PBT Profiler 

SRC PhysProp 

Database 

Vapour density (air = 1) Not available

Water solubility 

(temp; effect of 

pH; mg/L) 

4.40x104 (25°C) 

2.46x105 (25°C) 

PBT Profiler 

SRC PhysProp 

Database 

pH in solution Not available 

Dissociation constant (pKa) 1.30 NTP (2008) 

Oxidation- reduction potential Not available 

Corrosivity to material or 

equipment 

Not available 

Reactivity to container 

material 

Not available 

Auto-ignition Temperature 

(°C) 

Not available 

Explosive properties Not available 

Oxidizing properties Not available 

Surface tension Not available 

Viscosity Not available 

Thermal stability and identity 

of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Hygroscopic crystal WHO (2004) 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.02 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 552.2 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

No No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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Appendix 6 

Data on Dibromoacetic acid 

1 CHEMICAL NAME: Dibromoacetic acid 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments 

Pimephales promelas 

Fathead minnow 

160 (138 - 1,380) / 24h / 

Mortality 

Static / Fresh water 

Mayes et al. (1985) 

P. promelas 

Fathead minnow

107 (99 - 119) / 48h / Mortality 

Static / Fresh water 

Mayes et al. (1985) 

P. promelas 

Fathead minnow

81 (73 - 91) / 72h / Mortality 

Static / Fresh water 

Mayes et al. (1985) 

Fish 

P. promelas 

Fathead minnow

69 (62 - 75) / 96h / Mortality 

Static / Fresh water 

Mayes et al. (1985) 

2.2 Chronic aquatic toxicity 

No information on the chronic toxicity of dibromoacetic acid was found in the literature.

2.3 Endocrine disruption 

No information on the endocrine disruption potential of dibromoacetic acid was found in the 

literature.

2.4 Sediment toxicity 

No information on the sediment toxicity of dibromoacetic acid was found in the literature.

2.5 Bioavailability/biomagnification/bioconcentration 

Log Pow BCF Cause for 

concern (yes/no) 

Reference/Comments 

1.22 3.162 no WHO (2004) 

PBT Profiler 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, KOWWINTM v.1.67, BCFWINTM

v.2.17 

The octanol/water partition coefficient log value of dibromoacetic acid is 0.70 and is therefore 

considered not to pose a risk of concentration in organisms.
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2.6 Food web/population effects 

The PBT Profiler estimates that dibromoacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments/ 

Justification for missing data 

Oral LD50 (mg/kg) 1,737 

(1,411-1,952) 

rats Linder et al. (1994a) 

Dermal LD50 (mg/kg) n/a 

Inhalation LC50 (mg/L/4h) n/a 

n/a: not available. 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Justification for missing data 

Skin human Causes burns. MSDS 

Eyes human Causes burns. MSDS 

3.3 Sensitization 

No information on mammalian sensitization of dibromoacetic acid was found in the literature. 

3.4 Repeated-Dose Toxicity 

Exposure Route Oral 

Exposure Duration 12 weeks 

Exposure Dose 0, 300, 1000 or 2000 mg/L 

Species mice 

Method 

Results Decreased water consumption and body weight 

(the highest dose group). 

Increased liver weight (≥ 1000 mg/L) and the total liver 

glycogen content (the highest dose group). 

Decreased serum glucose and serum insulin concentrations 

(≥ 1000 mg/L). 

NOAEL 

NOEL 

Reference/Comments Kato-Weinstein et al. (2001) 
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Exposure Route Oral 

Exposure Duration 13 weeks 

Exposure Dose 0, 125, 250, 500, 1000 or 2000 mg/L 

Species rats and mice 

Method 

Results Decreased mean body weights and water consumption due to poor 

palatability (the highest dose group). 

Increased liver weight in mice (≥ 1000 mg/L), in rats (≥ 125 mg/L). 

Increased cytoplasmic vacuolation in hepatocytes (all dose group of mice) 

and vacuolization (the highest dose group of rats). 

Cytoplasmic alteration in the pituitary glands (high-dose male rats). 

NOAEL 500 (mice), 1000 (rats) 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

NTP (1999b) 

Exposure Route Oral 

Exposure Duration 6 months 

Exposure Dose 0, 20, 72 or 161 mg/kg/d 

Species rats 

Method 

Results Decreased body weights gain (high-dose group). 

Neuromuscular toxicity (limb weakness, mild changes in gait and hypotonia) 

was revealed (mid- and high-dose). 

Depressed sensorimotor responses. 

Decreased activity and chest clasping (the highest dose). 

Degeneration of spinal cord nerve fibers (mid- and high-dose). 

Increased neuronal vacuolization of the spinal cord. 

NOAEL 

NOEL 20 

Reference/Comments Moser et al. (2004) 

Exposure Route Oral 

Exposure Duration 42 days 

Exposure Dose 250 mg/kg/d 

Species rats 

Method 

Results Abnormal posturing, light tremor, atypical movement of limbs and difficulty 

in moving hind limbs. 

NOAEL 

NOEL 

Reference/Comments Linder et al. (1995) 
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I:\MEPC\59\2-16.DOC 

Exposure Route Oral 

Exposure Duration 28 days 

Exposure Dose 0, 14-20, 33-39, 68-73, 132-150 or 236-285 mg/kg/d 

Species mice 

Method 

Results Decreased body weight gain and thymus weights (the highest dose group). 

Increased liver weights (all dose groups) and kidney weights 

(4 highest dose groups). 

Increased the number of spleen macrophages (3 highest dose groups), 

indicative of immunotoxicity, and there was a significant dose-dependent 

reduction in spleen IgM antibody-forming cell responses to sheep 

erythrocytes, representing a decrease in humoral immunity. 

NOAEL 250 mg/L (33 - 39 mg/kg/d) 

LOAEL 500 mg/L (68 - 73 mg/kg/d) 

NOEL 

Reference/Comments NTP (1999a) 

3.5 Developmental and Reproductive Toxicity 

Exposure Route Oral (single gavage) 

Exposure Duration 0 or 1,250 mg/kg 

Exposure dose Single 

Species rats (male) 

Method 

Results Adverse effects on sperm count, morphology and motility. 

NOAEL 

LOAEL 

NOEL 

Reference/Comments Linder et al. (1994a) 

Exposure Route Oral 

Exposure Duration 14 days 

Exposure dose 0, 10, 30, 90 or 270 mg/kg/d 

Species rats (male) 

Method 

Results Reduced testis and epididymis weights and testicular sperm head counts. 

Decreased cauda sperm count and sperm motility and increased frequency 

of abnormal cauda sperm morphology. 

Decreased caput sperm count and histopathological evidence of altered 

spermiation, including delayed release of Step 19 spermatids and atypical 

acrosomal development of Step 15 spermatids (≥ 10 mg/kg/d). 

LOAEL 10 (equivocal) 

NOEL 

Reference/Comments Linder et al. (1994b) 
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Exposure Route Oral 

Exposure Duration the first protocol: 42 days / the second protocol: 79 days 

Exposure dose the first protocol: 0 or 250 mg/kg/d 

the second protocol: 0, 2, 10 or 50 mg/kg/d 

Species Rats 

Method 

Results Decreased mating and fertility. 

Histological evidence for changes in seminiferous tubule staging of altered 

spermatid development. 

NOAEL 2 (corresponding) 

LOAEL 10 (equivocal) 

NOEL 

Reference/Comments Linder et al. (1995); Linder et al. (1997) 

Exposure Route Oral 

Exposure Duration Gestation day 15 to parturition 

Exposure dose 0, 0.97, 5.05 or 54.2 mg/kg/d 

Species rabbits 

Method 

Results Reduced sperm fertility 

NOAEL 

LOAEL 0.97 

NOEL 

Reference/Comments Veeramachaneni et al. (2000) 

Exposure Route Oral (single dose) 

Exposure Duration single 

Exposure dose 0, 600 or 1,200 mg/kg/d 

Species 

Method 

Results No changes in sperm motility, sperm morphology or cell membrane 

permeability. 

Mild changes in testes histopathology (the presence of basophilic bodies). 

NOAEL 

LOAEL 600 

NOEL 

Reference/Comments Vetter et al. (1998) 

Exposure Route Oral 

Exposure Duration days 1 to 8 of gestation 

Exposure dose 0, 62.5, 125 or 250 mg/kg/d 

Species rats (female) 

Results No treatment-related changes in body weight, reproductive organ weights, 

number of implantation sites, number of resorptions, number of corpora 

lutea, preimplantation losses or serum levels of progesterone and 

luteinizing hormone. The only effect was a 170% increase in serum 17βestradiol (250 mg/kg/d). 

NOAEL 125 

NOEL 

Reference/Comments Cummings and hedge (1998) 
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Exposure Route Oral 

Exposure Duration beginning 14 days prior to cohabitation and continuing through gestation 

and lactation (63-70 days of treatment) 

Exposure dose 0, 125, 250, 500 or 1,000 ppm (mg/L) 

Species rats 

Method 

Results Slight reduction in mating performance (1,000 mg/L group). 

NOAEL 66 (male), 60 (female), 

NOEL 

Reference/Comments Christian et al. (2001) 

3.6 Carcinogenicity 

Species Method Details Results Reference/Comments/ 

Rats 0, 50, 500 or 

1,000 mg/L. 

2 years. 

Malignant mesothelioma and 

 mononuclear cell leukemia. 

Some evidence of carcinogenic 

 activity. 

NTP (2007) 

Mice 0, 50, 500 or 

1,000 mg/L. 

2 years. 

Hepatocellular adenoma or 

 carcinoma, hepatocellular 

 carcinoma and heptoblastoma 

 in Liver. 

Alveolar/bronchiolar adenoma or 

 carcinoma in Lung. 

Clear evidence of carcinogenic 

 activity. 

NTP (2007) 

3.7 Mutagenicity/Genotoxicity 

Species Method Details Results 

(with/without 

activation)

Reference/Comments 

In Vitro Studies 

Salmonella typhimurium Gene mutation + NTP (2000c) 

S. typhimurium 

TA100 

Gene mutation +/+ Giller et al. (1997) 

S. typhimurium 

TA98, TA100 

Gene mutation +/+ Saito et al. (1995) 

Micronuclei in Pleurodeles 

waltl larvae (newt) 

erythrocytes 

Clastogenicity nt/- Giller et al. (1997) 

Escherichia coli strain PQ37 

 SOS chromotest 

DNA damage +/+ Giller et al. (1997) 

In Vivo Studies 

Mouse liver cell DNA damage + Austin et al. (1996) 

Mouse liver cell DNA damage + Parrish et al. (1996) 

nt: not tested. 
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4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater 

or Fresh 

water

Test 

Duration

Results Breakdown 

products

Reference/ 

Comments 

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation n/a 

1/2 - Life Water 

Soil 

Sediment 

Air

estimated 15 days 

30 days 

140 days 

16.869 

days

PBT Profiler 

EPI Suite v.3.20, 

AOPWINTM

v.1.92

n/a: not available

4.2 Partition Coefficients 

 Method Results Reference/Comments 

Log POW 1.220 WHO (2004) 

KOC Estimated 1.895 US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments 

Persistence Estimated No PBT Profiler 

The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

dibromoacetic acid is expected to be found predominantly in soil. It is also expected to be found 

in water, but not in sediment. 

The PBT Profiler has estimated that dibromoacetic acid is expected to be found predominantly in 

soil and its persistence estimate is based on its transformation in this medium. Its half-life in 

soil, 30 days, does not exceed the EPA criteria. Therefore, dibromoacetic acid is estimated not to 

be persistent in the environment.

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 68 

I:\MEPC\59\2-16.DOC 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No potential effects indicated in the literature. 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) 49 

54 

Health Canada.(2006) 

PBT Profiler 

Boiling point (°C) 195 

233 

Health Canada (2006) 

SRC PhysProp Database 

Flammability (flash point for 

liquids; °C) 

Not available 

Density (20°C; kg/m3) Not available 

Vapour pressure (20°C; Pa) 3 (25°C) PBT Profiler 

Vapour density (air = 1) Not available 

Water solubility (temp; effect of 

pH; mg/L) 

2.11x106 (25°C) 

2.20x104 (25°C) 

Health Canada (2006) 

PBT Profiler 

pH in solution Not available 

Dissociation constant (pKa) 1.48 (25°C) NTP:ChemIDplus/HSDB 

Oxidation- reduction potential Not available 

Corrosivity to material or 

equipment 

Not available 

Reactivity to container material Not available 

Auto-ignition Temperature (°C) Not available 

Explosive properties Not available 

Oxidizing properties Not available 

Surface tension Not available 

Viscosity Not available 

Thermal stability and identity of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Hygroscopic crystal WHO(2004) 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.02 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 552.2 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Reference/Comments/Justification 

for missing data 

No No No PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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I:\MEPC\59\2-16.DOC 

Appendix 7 

Data on Monochloroacetic acid 

1 CHEMICAL NAME: Monochloroacetic acid 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments 

Brachydanio rerio 

Zebra fish 

370 / 96h / Mortality 

Static / Fresh water 

CIT (1998) 

Poecilia reticulata 

Guppy 

369 / 96h / Mortality 

Static / Fresh water 

Akzo Nobel (1985) 

Leuciscus idus 

melanotus, Golden 

orfe 

100 / 96h / Mortality (LC0) 

Static / Fresh water 

Hoechst (1979) 

Fish 

L. idus melanotus, 

Golden orfe

500 / 96h / Mortality (LC100) 

Static / Fresh water 

Hoechst (1979) 

Crustacea Daphnia magna 

Water flea 

77 / 48h / Immobile, Intoxication

EC50 / Static / Fresh water 

Kϋhn et al. (1989) 

Scenedesmus 

subspicatus, Green algae 

0.033 / 72h / Population 

changes, 

general (EC50)

Static / Fresh water 

Algae Hoechst (1992) 

S. subspicatus 

Green algae

0.0058 / 72h / Biomass (NOEC) 

Static / Fresh water 

Hoechst (1992) 

Brachionus 

calyciflorus 

Rotifer 

68.9 (12 - 94) / 48h / Progeny 

counts/numbers, Reproduction 

(EC50) 

Static / Fresh water 

Inverteb- Radix (1998) 

rates 

B. calyciflorus 

Rotifer

40 / 48h / Progeny 

counts/numbers, 

Reproduction (NOEC) 

Static / Fresh water 

Radix (1998) 
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ANNEX 6 

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2.2 Chronic Aquatic Toxicity Data 

 Species NOEC 

(mg/L) 

Reference/Comments/ 

Brachydanio rerio 

Zebra fish 

320 / 12d / NOEC 

(embryo/larval) Fresh water 

Akzo Nobel (1985) 

B. rerio 

Zebra fish

560 / 12d / LOEC 

(embryo/larval) Fresh water 

Akzo Nobel (1985) 

Fish 

B. rerio 

Zebra fish

25 / 28d / LOEC (early life stage)

Fresh water 

CIT (1998) 

Crustacea Daphnia magna 

Water flea

32 / 21d / Reproduction, general 

NOEC / Renewal / Fresh water 

Kϋhn et al. (1989) 

2.3 Information on Endocrine Disruption 

No information on the endocrine disruption potential of monochloroacetic acid was found in the 

literature.

2.4 Sediment Toxicity 

No information on the chronic sediment toxicity of monochloroacetic acid was found in the 

literature.

2.5 Bioavailability/Biomagnification/Bioconcentration 

 Results Cause for 

concern 

(yes/no) 

Reference/Comments/Justification 

for missing data 

Log Pow 0.22 no EU Risk Assessment Report (2005) 

BCF 3.162 no US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BCFWINTM v.2.17 

The octanol/water partition coefficient log value of monochloroacetic acid is 0.22 and is 

therefore considered not to pose a risk of concentration in organisms. 

2.6 Food Web/Population Effects

The PBT Profiler estimates that monochloroacetic acid is not expected to bioaccumulate in the 

food chain because it does not exceed the BCF criteria. 
GESAMP-BWWG 8/6 

ANNEX 6 

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3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments 

Oral LD50 (mg/kg) 55 (40.4-74.8) 

76.2 a

 (70.7-82.2) 

260 (214-316) 

165 a

79.8 a

 (71.8-88.6) 

90 a

rats 

mice 

guinea pigs 

rabbits 

Maksimov and Dubinina (1974) 

Woodard et al. (1941) 

Berardi (1986) 

Morrison (1946) 

Woodard et al. (1941) 

Woodard et al. (1941) 

Dermal LD50 (mg/kg) 305 (242-384) 

250 a

178 b

490 (428-562) 

rats 

rabbits 

mice 

Hoechst (1979) 

Hoechst (1979) 

Hercules (1969) 

Berardi (1986) 

Inhalation LC50 

(mg/L/4h) 

180 c

 (146-221) 

mg/m3 

rats Maksimov and Dubinina (1974) 

a: based on SMCA 

b: solid MCAA under occlusive patch 

c: MCAA aerosol 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments 

Skin rabbits FDA 

similar to FDA 

OECD 404 

Induced corrosion and mortality 

Severe erythema and oedema 

No sings of irritation a

Hoechst (1979g) 

Pasquet and Mazuret 

(1975) 

Hoechst (1988b) 

Eyes rabbits FDA 

similar to FDA 

OECD 404 

Eyelids and mucous membranes 

discoloured and corroded. 

Extremely irritant 

Moderately irritant a

Hoechst (1979g) 

Pasquet and Mazuret 

(1975) 

Hoechst (1988b) 

a: based on SMCA 

3.3 Sensitization 

An open epicutaneous test in rabbits did not indicate any skin sensitizing effects of MCAA 

(induction: 10 drops of 5% MCAA soln/d to 6 cm2

 skin, challenge: 1 drop of 0.1-50% soln on 

day 30) (Maksimov and Dubinina, 1974). 

None of the Dunkin-Hartley guinea pigs sensitized to ethyl monochloroacetate in a maximization 

assay, cross-reacted with MCAA in a subsequent challenge (Braun and van der Walle, 1987). 
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3.4 Repeated-dose Toxicity 

Exposure Route oral 

Exposure Duration 13 weeks (5 days per week) 

Exposure Dose 0, 25, 50, 100, 150 or 200 mg/kg/d 

Species mice 

Method 

Results Increased mortality (at the highest group, mostly in male). 

Increased absolute and relative liver weights (at the highest group, female) 

Decreased mean body weight gain (at the highest group, female). 

Decreased cholinesterase levels (at the two highest group, female). 

NOAEL 100 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

NTP (1992) 

Bryant et al. (1992) 

Exposure Route oral 

Exposure Duration 0, 30, 60, 90, 120 or 150 mg/kg/d 

Exposure Dose 13 weeks (5 days per week) 

Species rats 

Method 

Results Almost all animals died ( ≥ 90 mg/kg/d). 

Decreased relative heart weights (60 mg/kg/d). 

No microscopic evidence of kidney or liver damage. 

NOAEL 30 

Reference/Comments NTP (1992) 

Bryant et al. (1992) 

Exposure Route inhalation 

Exposure Duration exact duration not clearly stated, but probably 4 months 

Exposure Dose 5.8 and 20.8 mg/m3

Species rats and guinea pigs 

Method 

Results Produced only some early functional changes (5.8 mg/m3

). 

Initial body-weight loss in both species. (20.8 mg/m3

) 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for 

missing data 

Maksimov and Dubinina (1974) 

3.5 Development and Reproductive Toxicity 

Exposure Route oral 

Exposure Duration gestation days 1 to 22 

Exposure dose 0 or 1.57 g/L (0 or 193 mg/kg/d) 

Species rats 

Method 
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Results A significant decrease in body weight gain was observed in exposed dams 

relative to controls. 

No adverse reproductive, developmental or teratogenic effects were 

reported 

NOAEL 193 (developmental) 

LOAEL 193 (maternal) 

Reference/Comments/ 

Justification for 

missing data

Johnson et al. (1998) 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

 Species Method Details Results Reference/Comments

Rats 0, 15 or 30 mg/kg/d 

2 years 

No evidence NTP (1992) 

Rats 0, 3.5, 26.1 or 

59.9 mg/kg/d 

2 years 

No evidence DeAngelo et al. (1997) 

Carcinogenicity 

Mice 0, 50 or 100 mg/kg/d 

2 years 

No evidence NTP (1992) 

3.7 Mutagenicity/Reprotoxicity 

Species Method Details Results Reference/Comments

In Vitro Assays 

bacterial gene mutation assays 

Salmonella typhimurium 

strain TA98, TA100, 

TA1535, TA1537 

Histidine reversion no mutagenic 

activity 

Mortelmans et al. (1986) 

NTP (1992) 

JETOC (1996) 

Escherichia coli WP2 

uvrA 

Tryptophan reversion no mutagenic 

activity 

JETOC (1996) 

mammalian gene mutation assays 

Mouse L5178Y/TK+/-

lymphoma cells 

Trifluorothymidineresistant mutation positive McGregor et al. (1987) 

NTP (1992) 

Amacher and Turner (1982) 

chromosomal aberration assays 

Chinese hamster ovary 

 (CHO) cells 

Cytogenetic analysis no clastogenic 

activity 

Galloway et al. (1987) 

NTP (1992) 

Chinese hamster lung 

fibroblast (CHL) cells 

Cytogenetic analysis no clastogenic 

activity 

Sawada et al. (1987) 

bacterial primary DNA damage assays 

Bacillus subtilis strains 

 168M, Hcr-9, FB-13 

 and MC-1 

DNA repair no genotoxic 

activity 

Elmore et al. (1976) 

Escherichia coli strains 

 WP2 and WP100 uvrA-

 recADNA repair no genotoxic 

activity 

Mamber et al. (1983, 1984) 

Salmonella typhimurium 

strain TA1535/pSK1002 

umu test no genotoxic 

activity 

Nakamura et al. (1987) 

Ono et al. (1991) 

Escherichia coli strains 

 PQ37 

SOS chromotest no genotoxic 

activity 

Giller et al. (1997) 
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Species Method Details Results Reference/Comments

Escherichia coli strains 

 K12 λ lysogen 

(GY5027) uvrBenvAProphage-induction 

 test (inductest) 

no genotoxic 

activity 

Mamber et al. (1984) 

mammalian cell primary DNA damage assays 

Chinese hamster ovary 

 (CHO) cells 

Sister chromatid 

 exchange 

- / + 

(with/without) 

Galloway et al. (1987) 

NTP (1992) 

Chinese hamster lung 

fibroblast (CHL) cells 

Sister chromatid 

 exchange 

no genotoxic 

activity 

Sawada et al. (1987) 

F344 rat hepatocytes DNA strand breaks genotoxic 

activity 

Chang et al. (1992) 

B6C3F1 mouse 

 hepatocytes 

DNA strand breaks genotoxic 

activity 

Chang et al. (1992) 

human lymphoblastic 

 CCRF-CEM cells 

DNA strand breaks no genotoxic 

activity 

Chang et al. (1992) 

In Vivo Assays 

Pleurodeles waltl larvae chromosomal aberration 

 in blood 

(micronucleus assay) 

no clastogenic 

activity 

Giller et al. (1997) 

male B6C3F1 mice Primary DNA damage 

(DNA strand breaks) 

no genotoxic 

activity 

Chang et al. (1992) 

male B6C3F1 mice Primary DNA damage 

(DNA strand breaks) 

no genotoxic 

activity 

Chang et al. (1992) 

male F344 rat Primary DNA damage 

(DNA strand breaks) 

no genotoxic 

activity 

Chang et al. (1992) 

Drosophila melanogaster 

canton-S wild-type male 

Sex-linked recessive 

 lethal mutation 

no mutagenic 

activity 

/ slight and 

equivocal 

increase 

Foureman et al. (1994) 

NTP (1992) 
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4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Sea 

water or 

Fresh 

water

Test 

Duration

Results Break-down 

products

Reference/ 

Comments

Hydrolysis at pH 

5 

 n/a 

Hydrolysis at pH 

7 

 n/a 

Hydrolysis at pH 

9 

 n/a 

Water 2 days 20% SRC 

Water 8 days 73.5% SRC 

Water 10 days 72.6% SRC 

Water 5.5 days 90% SRC 

Water 5 days 80% SRC 

Water 6 days 90% SRC 

Biodegradation

Water 5 days 80% SRC 

1/2 - Life Water 

Soil 

Sediment 

Air 

Neutral 

soil 

Acid soil 

estimated 

experimenta

l 

15 days 

30 days 

140 days 

20 days 

66 hour 

(15°C) 

33 days 

(7°C) 

 PBT-Profiler 

ECB, EU Risk 

Assessment Report 

(2005) 

n/a: not available. 

4.2 Partition Coefficients 

 Method Results Reference/Comments/Justification 

for missing data 

Log POW 0.22 EU Risk Assessment Report (2005) 

KOC Calculated using 

the 

QSAR 

Estimated 

4.0 

1.201 

EU Risk Assessment Report (2005) 

US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data 

Persistence Estimated No PBT Profiler 
GESAMP-BWWG 8/6 

ANNEX 6 

Page 77 

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The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

monochloroacetic acid is expected to be found predominantly in soil. It is also expected to be 

found in water, but not in sediment. 

The PBT Profiler has estimated that monochloroacetic acid is expected to be found 

predominantly in soil and its persistence estimate is based on its transformation in this medium. 

Its half-life in soil, 30 days, does not exceed the EPA criteria. Therefore, monochloroacetic acid 

is estimated not to be persistent in the environment.

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

The PBT Profiler estimates that monochloroacetic acid is not expected to bioaccumulate in the 

food chain because it does not exceed the BCF criteria. 

4.7 Any known interactive effects – No known effects indicated in the literature.

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) Commercial form: 61-65 

α-form: 62-63 

β-form: 55-56 

γ-form: 50-51 

δ-form: 43.8 

ECB IUCLID (2000) 

Boiling point (°C) 189 EU Risk Assessment Report 

(2005) 

Flammability(flash point for 

liquids; °C) 

126°C (melt) EU Risk Assessment Report 

(2005) 

Density (20°C; kg/m3) 1.58x103 EU Risk Assessment Report 

(2005) 

Vapour pressure (20°C; Pa) < 100 (20°C) 

8.7 (25°C) 

1,100 (80°C) 

EU Risk Assessment 

Report(2005) 

Vapour density (air = 1) 3.26 NIOSH-ICSC 

Water solubility (temp; effect 

of 

pH; mg/L) 

4.21x106 (20°C) EU Risk Assessment Report 

(2005) 

pH in solution 3.2 (100ml/L) EU Risk Assessment Report 

(2005) 
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Dissociation constant (pKa) 2.85 (25°C) EU Risk Assessment Report 

(2005) 

Oxidation- reduction potential 

Corrosivity to material or 

equipment 

Non-corrosive in presence of 

glass. 

Corrosive to metal 

MDSD-ScienceLab 

Reactivity to container 

material 

 

Auto-ignition Temperature 

(°C) 

470 NIOSH-ICSC 

Explosive properties Not explosive EU Risk Assessment Report 

(2005) 

Oxidizing properties Not oxidizing EU Risk Assessment Report 

(2005) 

Surface tension 35.2mN/m (100°C) EU Risk Assessment Report 

(2005) 

Viscosity 2.16 mPa·s, dynamic (70°C) Ullmann (1986) 

Thermal stability and identity 

of 

breakdown products 

Stable under ordinary 

conditions of 

use and storage 

MSDS-J.T.Baker 

Other physical or chemical 

properties 

Colorless crystals, Pungent MSDS-ScienceLab 

6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.14 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 552.2 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification 

for missing data 

no no no PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
GESAMP-BWWG 8/6 

ANNEX 6 

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I:\MEPC\59\2-16.DOC 

Appendix 8 

Data on Dichloroacetic acid 

1 CHEMICAL NAME: Dichloroacetic acid 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species L(E)C50

(mg/L) 

Reference/Comments/ 

Fish Cyprinus carpio 

Common carp 

82 - 123 / 96h / Mortality (N/R) 

Gavage / Fresh water 

Loeb et al. (1963) 

Daphnia magna 

Water flea 

106 / 24h / Equilibrium, 

Behavior 

(EC50) / Static / Fresh water 

Crustacea Trenel et al. (1982) 

Nitocra spinipes 

Harpacticoid copepod 

23 (21 - 25) / 96h / Mortality 

Static / Salt water 

Linden et al. (1979) 

Algae Scenedesmus 

subspicatus 

Green algae 

1,485 / 7d / Proliferation (EC03)

Static / Fresh water 

Trenel et al. (1982) 

Xenopus laevis 

African clawed frog 

4,060 (3,900 - 5,600) / 96h 

Mortality / Renewal / Fresh 

water 

Fort et al. (1993) 

X. laevis 

African clawed frog

3,560 (2,400 - 4,680) / 96h 

Teratogenic measurements 

(EC50)

Renewal / Fresh water 

Fort et al. (1993) 

Amphibians 

X. laevis 

African clawed frog

4,680 / 96h / Growth, general 

(LOEC) / Renewal / Fresh water 

Fort et al. (1993) 

Insects Aeschna umbrosa 

Dragonfly 

0.013 / 8h / Oxygen 

consumption 

(N/R) / Flow through / Fresh 

water 

Dominguez et al.

(1988) 

N/R: Endpoint was not reported. 

2.2 Chronic Aquatic Toxicity Data 

No information on the chronic aquatic toxicity of dichloroacetic acid was found in the literature.

2.3 Information on Endocrine Disruption 

No information on the endocrine disruption potential of dichloroacetic acid was found in the 

literature. 

2.4 Sediment Toxicity 

No information on the chronic sediment toxicity of dichloroacetic acid was found in the 

literature. 
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I:\MEPC\59\2-16.DOC 

2.5 Bioavailability/Biomagnification/Bioconcentration 

 Results Cause for 

concern 

(yes/no) 

Reference/Comments/ 

Log Pow 0.92 no WHO (2005) 

BCF 3.162 no PBT Profiler 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BCFWINTM v.2.17 

The octanol/water partition coefficient log value of dichloroacetic acid is 0.92 and is therefore 

considered not to pose a risk of concentration in organisms. 

2.6 Food Web/Population Effects

The PBT Profiler estimates that dichloroacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments 

Oral LD50 (mg/kg) 2,820 

4,480 

5,520 

rats (male) 

rats 

mice 

Smyth et al. (1951) 

Woodard et al. (1941) 

Woodard et al. (1941) 

Dermal LD50 (mg/kg) 795 

510 

rats (male) 

Rabbits 

Smyth et al. (1951) 

MSDS (Science Lab) 

Inhalation LC50

(mg/L/4h) 

n/a 

n/a: not available. 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Skin human Extremely hazardous in case of skin 

 contact (corrosive, irritant) 

Very hazardous in case of skin 

 contact (permeator) 

MSDS-ScienceLab 

Eyes human Extremely hazardous in case of eye 

 contact (irritant) 

MSDS-ScienceLab 

3.3 Sensitization 

EEC Classification for dichloroacetic acid does not include R43 (May cause sensitization by skin 

contact). 
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I:\MEPC\59\2-16.DOC 

3.4 Repeated-dose Toxicity 

Exposure Route oral 

Exposure Duration 3 months 

Exposure dose 0, 125, 500 or 2,000 mg/kg/d (sodium dichloroacetate) 

Species rats 

Method 

Results Decreased body weight. Increased liver, kidney and adrenals weight. 

Brain lesions. 

NOAEL 

LOAEL 125 

NOEL 

Reference/Comments Katz et al. (1978; 1981) 

Exposure Route oral (by capsule) 

Exposure Duration 13 weeks 

Exposure dose 0, 50, 75 or 100 mg/kg/d 

Species beagle dogs 

Method 

Results Decreased body weight, mean blood glucose, lactate and pyruvate levels. 

Brain lesions. 

NOAEL 

LOAEL 50 

NOEL 

Reference/Comments Katz et al. (1978; 1981) 

Exposure Route oral (by capsule) 

Exposure Duration 90 days 

Exposure dose 0, 12.5, 39.5 or 72 mg/kg/d 

Species beagle dogs 

Method 

Results Dyspnoea, partial paralysis of the hind limbs, and decreased erythrocyte 

count and haemoglobin levels. 

Decreased body weight gain. 

Organ lesions. 

NOAEL 

LOAEL 12.5 

NOEL 

Reference/Comments Cicmanec et al. (1991) 

3.5 Development and Reproductive Toxicity 

Exposure Route oral 

Exposure Duration gestation days 6 to 15. 

Exposure dose 0, 14, 140 or 400 mg/kg/d (first study) 

0, 900, 1400, 1900 or 2400 mg/kg/d (second study) 

Species rats 

Method 

Results First study 

Reduced maternal body weight gain (≥ 140 mg/kg/d). 

Increased dose-related liver weights of dams (at all dose levels). 

Decreased dose-related fetal growth and increased the total soft 

 tissue malformations (≥ 140 mg/kg/d). 
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Second study 

Occurred dose-related mortality in treated dams 

 (≥ 1,400 mg/kg/d). 

Increased post-implantation losses and reduced the number of live 

 fetuses per litter (≥ 900 mg/kg/d). 

NOAEL 14 (maternal and developmental) 

NOEL 

Reference/Comments Smith et al. (1992) 

Exposure Route oral 

Exposure Duration gestation days 6 to 15. 

Exposure dose from 1,900 to 3,500 mg/kg/d 

Species rats 

Method 

Results Reduced fetal body weight in the offspring of dams. 

 (1,900 mg/kg; gestation days 6-8) 

Fetal cardiac malformations in the offspring of pregnant dams. 

 (1,900 mg/kg; gestation days 9-11 and 12-15) 

 (2,400 mg/kg; gestation days 10 or 12) 

 (3,500 mg/kg; gestation day 12) 

NOAEL 

NOEL 

Reference/Comments Epstein et al. (1992) 

Exposure Route oral 

Exposure Duration 14 days 

Exposure dose 0, 18, 54, 160, 480 or 1,440 mg/kg/d 

Species rats (male) 

Results Decreased epididymis weights (≥ 480 mg/kg/d). 

Increased the percentage of abnormal cauda sperm and decreased the 

percentage of motile sperm (≥ 160 mg/kg/d). 

Increased spermatotoxicity (≥ 54 mg/kg/d). 

NOAEL 18 

NOEL 

Reference/Comments Linder et al. (1997) 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

Exposure Route oral 

Exposure Duration 60 and 75 weeks 

Exposure dose 0, 0.05, 0.5, 3.5 or 5.0 g/L 

(0, 7.6, 77, 410 or 486 mg/kg/d for 60 weeks) 

(0, 7.6 or 77 mg/kg/d for 75 weeks) 

Species mice (male) 

Method 

Results Decreased body weight. 

Increased relative liver weight. 

Significant positive dose-related trend in age-adjusted prevalence of 

liver tumours. 

Exhibited threshold of at least 500 mg/L (77 mg/kg/d) for tumour 

 response in mice. 

NOAEL 7.6 
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NOEL 

Reference/Comments DeAngelo et al. (1991) 

Exposure Route oral 

Exposure Duration 104 weeks 

Exposure dose 500 mg/L (410 mg/kg/d) 

Species mice (male) 

Method 

Results No significant treatment-related effects on drinking water 

 consumption, relative body weight gain or relative absolute spleen, 

 kidney or testes weight. 

Significant increase in the incidence of hepatocellular carcinomas 

 and hepatocellular adenomas (and/or combined). 

NOAEL 

NOEL 

Reference/Comments Daniel et al. (1992) 

Exposure Route oral 

Exposure Duration 90 - 100 weeks 

Exposure dose 0, 0.05, 0.5, 1, 2 or 3.5 g/L 

(0, 8, 84, 168, 315 or 429 mg/kg/d) 

Species mice (male) 

Method 

Results Significantly decreased mean body weights (≥ 315 mg/kg/d). 

Increased dose-dependent liver weight (≥ 84 mg/kg/d). 

Produced a dose-related increase in the incidence of hepatocellular 

carcinoma (not associated with either liver peroxisome or 

 hepatocyte proliferation). 

NOAEL 

NOEL 

Reference/Comments/ DeAngelo et al. (1999) 

Exposure Route oral 

Exposure Duration 100 weeks 

Exposure dose 0, 0.05, 0.5 or 1.6 g/L 

(0, 3.6, 40.2 or 139.1 mg/kg/d) 

Species rats (male) 

Method 

Results No significant differences in water consumption or survival. 

Reduced body weights and relative liver and kidney weights 

 (at the highest group). 

Increased prevalences of hepatocellular adenoma and hepatocellular 

 carcinoma (and/or combined). 

Induced hepatocyte peroxisome proliferation. 

NOAEL 

NOEL 3.6 

Reference/Comments DeAngelo et al. (1996) 

IARC and IRIS classified it in Group 2B (possibly carcinogenic to humans). 

ACGIH classified it as confirmed animal carcinogen with unknown relevance to humans. 
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3.7 Mutagenicity/Reprotoxicity 

Species Method Details Results Reference/Comments

In Vitro Assays 

bacterial gene mutation assays

Salmonella typhimurium 

strain TS 24, TA98, 

TA100, TA1535, 

TA1537, TA1538 

TA1950, TA2322 

Histidine reversion negative Waskell L. (1978) 

Fox et al. 1996) 

Herbert et al. (1980) 

S. typhimurium strain 

 TA98 

Histidine reversion positive 

(equivocal) 

Herbert et al. (1980) 

S. typhimurium strain 

 TA100

Histidine reversion positive DeMarini et al. (1994) 

Giller et al. (1997) 

S. typhimurium strain 

 TA1538

Histidine reversion positive a

(equivocal) 

Herbert et al. (1980) 

Escherichia coli 

 WP2uvrA 

Tryptophan 

 reversion 

negative Fox et al. (1996) 

mammalian gene mutatin assays 

Mouse L5178Y/TK+/-

lymphoma cells 

Thymidine-resistant 

mutation 

negative 

positive b

negative c

Fox et al. (1996) 

Harrington-Brock et al.

 (1998) 

bacterial primary DNA damage assays 

Escherichia coli WP2 Prophage-induction 

 test (inductest) 

positive DeMarini et al. (1994) 

Salmonella typhimurium 

strain TA1535

umu test negative 

/ 

positive 

Ono et al. (1991) 

Escherichia coli PQ37 SOS chromotest positive 

/ 

negative 

Giller et al. (1997) 

mammalian cell primary DNA damage assays 

B6C3F1 mouse 

 hepatocytes

DNA strand breaks positive d Chang et al. (1992) 

F344 rat hepatocytes DNA strand breaks negative Chang et al. (1992) 

human lymphoblastic 

 CCRF-CEM cells

DNA strand breaks negative Chang et al. (1992) 

Chinese hamster ovary 

 cells 

Chromosome 

aberration 

negative Fox et al. (1996) 

In Vivo Assays 

mice Micronuclei assay positive 

negative 

negative 

Fuscoe et al. (1996) 

Fox et al. (1996) 

Mouse leukocytes DNA strand breaks negative Fuscoe et al. (1996) 

Mouse hepatocytes DNA strand breaks positive 

positive 

negative 

Nelson and Bull. (1988) 

Nelson et al. (1989) 

Chang et al. (1992) 

Mouse splenocytes DNA strand breaks negative Chang et al. (1992) 

Mouse epithelial cells DNA strand breaks negative Chang et al. (1992) 

Fischer rat hepatocytes DNA strand breaks negative Chang et al. (1992) 

Sprague-Dawley rat 

 hepatocytes 

DNA strand breaks positive Nelson and Bull. (1988) 
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(a) The results in TA1538 were positive but did not “exhibit an unequivocal dose-response relationship” 

(Herbert et al., 1980). 

(b) Mutations/chromosome aberrations. 

(c) Micronuclei induction. 

(d) Small increase in strand breakage (7%) seen after 4-hour exposure, but not at 1 hour; response 

deemed negligible.

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Seawater 

or Fresh 

water

Test 

Duration

Results Breakdown 

products

Reference/Comments

Hydrolysis 

(pH 5) 

 n/a 

Hydrolysis 

(pH 7) 

 n/a 

Hydrolysis 

(pH 9) 

 n/a 

Sea water 3 days 8% HSDB (2005) 

Fresh water 3 days 14% HSDB (2005) 

Biodegradation 

Activated 

sludge 

14 days 97% HSDB (2005) 

1/2 - Life Water 

Soil 

Sediment 

Air 

estimated 

experimental 

15 days 

30 days 

140 days 

22 days 

22 days 

 PBT-Profiler 

HSDB (2005) 

n/a: not available. 
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4.2 Partition Coefficients 

 Method Results Reference/Comments 

Log POW 0.92 WHO (2005) 

KOC Estimated 

Estimated 

75 

1.895 

Science Research Council (SRC) 

US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments 

Persistence Estimated No PBT Profiler 

The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

dichloroacetic acid is expected to be found predominantly in soil. It is also expected to be found 

in water, but not in sediment.

The PBT Profiler has estimated that dichloroacetic acid is expected to be found predominantly in 

soil and its persistence estimate is based on its transformation in this medium. Its half-life in 

soil, 30 days, does not exceed the EPA criteria. Therefore, dichloroacetic acid is estimated not to 

be persistent in the environment.

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

The PBT Profiler estimates that dichloroacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria. 

4.7 Any known interactive effects 

No known effects indicated in the literature.
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5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) 10 

13.5 

MSDS-ScienceLab 

Lide DR. (1995-1996) 

Boiling point (°C) 193-194 Budavari et al. (1989) 

Flammability(flash point for 

liquids; °C) 

May be combustible at high 

temperature. 

Flash point: 110°C 

MSDS-ScienceLab 

Density (20°C; kg/m3) 1.563x103 Budavari et al. (1989) 

Vapour pressure (20°C; Pa) 19 NIOSH-ICSC 

Vapour density (air = 1) 4.4 NIOSH-ICSC

Water solubility (temp; effect 

of 

pH; mg/L) 

8.63x104

Miscible 

WHO (2005) 

Nikolaou et al. (1999) 

pH in solution Not available MSDS-ScienceLab 

Dissociation constant (pKa) 1.26 Maruthamuthu and Huie 

(1995) 

Oxidation- reduction potential Not available 

Corrosivity to material or 

equipment 

Highly corrosive liquid that gives 

off 

acidic vapors. 

Gerhartz W. (1985) 

Reactivity to container 

material 

 

Auto-ignition Temperature 

(°C) 

Not available MSDS-ScienceLab 

Explosive properties Not available MSDS-ScienceLab 

Oxidizing properties Not available 

Surface tension Not available 

Viscosity Not available 

Thermal stability and identity 

of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Colorless to slightly yellow liquid 

with a pungent odor 

Ashford RD. (1994) 

Budavari S. (1989) 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.14 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 552.2 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification 

for missing data 

no no no PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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Appendix 9 

Data on Trichloroacetic acid 

1 CHEMICAL NAME: Trichloroacetic acid 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50/EC50 

(mg/L) 

Reference/Comments/ 

Cyprinus carpio 

Common carp

88 - 336 / 66h / Mortality 

Gavage / Fresh water 

Loeb and Kelly (1963) 

Leuciscus idus 

melanotus, Carp 

10,000 / 48h / Mortality 

Fresh water 

Juhnke et al. (1978) 

Pimephales promelas 

Fathead minnow 

2,000 / 96h / Mortality 

Static / Fresh water 

Dennis et al. (1979) 

Poecilia reticulata 

Guppy 

9,160 / 48h / Mortality Jirasek et al. (1980) 

Salmonidae 

Trout family 

1,050 / 96h / Mortality 

Fresh water 

Knapek et al. (1974) 

Tinca tinca 

Tench 

3,420 / 96h / Mortality 

Fresh water 

Knapek et al. (1974) 

Fish 

Ictalurus punctatus a

Channel catfish 

2,000 / 1h, 2h, 4h, 8h, 24h, 48h, 

72h, 96h / Mortality 

Static / Fresh water 

Clemens and Sneed 

 (1959) 

Daphnia magna 

Water flea

137 / 1h / Enzyme activity 

(EC50) 

Static / Fresh water 

Janssen et al. (1993) 

D. magna 

Water flea

164 / 24h / Immobile, 

Intoxication 

(EC50) / Static / Fresh water 

Janssen et al. (1993) 

D. magna 

Water flea

146 / 48h / Immobile, 

Intoxication 

(EC50) / Static / Fresh water 

Janssen et al. (1993) 

Nitocra spinipes 

Harpacticoid copepod 

4,800 (4,400 - 5,200) / 96h 

Mortality / Static / Salt water 

Linden et al. (1979) 

Streptocephalus 

proboscideus, Fairy shrimp 

1.2 (1.0 - 1.3) / 24h / Mortality 

Static / Fresh water 

Centeno et al. (1993) 

S. proboscideus 

Fairy shrimp

1.5 (1.3 - 1.6) / 24h / Mortality 

Static / Fresh water 

Centeno et al. (1993) 

Crustacea 

Thamnocephalus 

platyurus, Fairy 

shrimp 

16.9 / 24h / Mortality 

Static / Fresh water 

Centeno et al. (1995) 

Algae a Chlorococcales 

Green algae order 

1,000 / 24h / Assimilation 

efficiency 

(EC10) / Static / Fresh water 

Krebs F. (1991) 
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 Species LC50/EC50 

(mg/L) 

Reference/Comments/ 

Pseudokirchneriella 

subcapitata, Green 

algae

10 / 96h / Population growth rate 

(LOEC) / Static / Fresh water 

Garten C.T.Jr. (1990) 

P. subcapitata 

Green algae

1 / 96h / Population growth rate 

(NOEC) / Static / Fresh water 

Garten C.T.Jr. (1990) 

Chlorella 

pyrenoidosa 

Green algae 

500 / 72h / Chlorophyll (NOEC) 

Static / Fresh water 

Huang and Gloyna 

(1968) 

C. vulgaris 

Green algae

100 / 96h / Population growth 

rate 

(NOEC) / Static / Fresh water 

Garten C.T.Jr. (1990) 

Invertebrates 

Uronema parduczi 

Cilicate 

435 / 20h / Population growth 

rate 

(N/R) / Fresh water 

Bringmann and Kuhn 

 (1980) 

Xenopus laevis 

African clawed frog 

4,430 (3,800 - 5,120) / 96h 

Mortality / Renewal / Fresh 

water 

Fort et al. (1993) 

X. laevis 

African clawed frog 

1,740 (1,550 - 1,950) / 96h 

Teratogenic measurements 

(EC50) 

Renewal / Fresh water 

Fort et al. (1993) 

Amphibians 

X. laevis 

African clawed frog

5,000 / 96h / Growth, general 

(LOEC) / Renewal / Fresh water 

Fort et al. (1993) 

Insects Aedes aegypti 

Yellow fever 

mosquito 

5,500 / 96h / Mortality 

Fresh water 

Knapek and Lakota 

 (1974) 

a: Toxicity studies for trichloroacetic acid, sodium salt. 

N/R: Endpoint not reported 

2.2 Chronic Aquatic Toxicity Data 

 Species NOEC (mg/L) Reference/Comments 

Fish a Cyprinus carpio 

Common carp 

7 / 63d / Growth, general (N/R) 

Fresh water 

Schulz D. (1970a, b) 

Anabaena variabilis 

Blue-green algae 

8 / 14d / Population growth rate 

Static / Fresh water 

Bednarz T. (1981) 

Chlorella 

pyrenoidosa 

Green algae 

0.3 / 14d / Population growth 

rate 

Static / Fresh water 

Bednarz T. (1981) 

Chlorococcum sp. 

Green algae

1.2 / 14d / Population growth 

rate 

Static / Fresh water 

Bednarz T. (1981) 

Dictyosphaerium 

pulchellum, Green 

algae 

7 / 14d / Population growth rate 

Static / Fresh water 

Bednarz T. (1981) 

Algae a

Scenedesmus acutus 

Green algae 

8.8 / 14d / Population growth 

rate 

Static / Fresh water 

Bednarz T. (1981) 
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 Species NOEC (mg/L) Reference/Comments 

Spirulina platensis 

Blue-green algae 

5 / 14d / Population growth rate 

Static / Fresh water 

Bednarz T. (1981) 

Stichococcus sp. 

Green algae 

100 / 14d / Population growth 

rate 

Static / Fresh water 

Bednarz T. (1981) 

Aquatic 

plants 

Lemna perpusilla 

Duckweed 

1,000 / 7d / Mortality (N/R) 

Fresh water 

Nishiuchi Y. (1974) 

a: Toxicity studies for trichloroacetic acid, sodium salt. 

N/R: Endpoint not reported. 

2.3 Information on Endocrine Disruption 

No information on the endocrine disruption potential of trichloroacetic acid was found in the literature.

2.4 Sediment Toxicity 

No information on the chronic sediment toxicity of trichloroacetic acid was found in the literature.

2.5 Bioavailability/Biomagnification/Bioconcentration 

 Results Cause for 

concern 

(yes/no) 

Reference/Comments 

Log Pow 1.33 no WHO (2004) 

BCF 0.4-1.0 and 

<1.7 

3.162 

no Hansch et al. (1995), NITE; CHRIP (2007) 

US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BCFWINTM v.2.17 

The octanol/water partition coefficient log value of trichloroacetic acid is 1.33 and is therefore 

considered not to pose a risk of concentration in organisms. 

2.6 Food Web/Population Effects

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria. 
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3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments 

Oral LD50 (mg/kg) 3,320 

4,970 

rats 

mice 

Woodard et al. (1941) 

Dermal LD50 (mg/kg) > 2,000 rats Tomlin (1994) 

Hoechst AG. (1974) 

Inhalation LC50

(mg/L/4h) 

n/a 

n/a: not available. 

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments/ 

Justification for 

missing data 

Skin human Very hazardous in case of skin 

 contact (irritant). 

Hazardous in case of skin contact 

 (corrosive). 

Slightly hazardous in case of skin 

 contact (permeator). 

MSDS-ScienceLab 

Eyes human Hazardous in case of eye contact 

 (corrosive). 

MSDS-ScienceLab 

3.3 Sensitization 

Species Method Results Reference/Comments/ 

Justification for 

missing data 

Guinea pigs Maximization test Not sensitizing ECB IUCLID (2000) 

mice Ear swelling test Not sensitizing ECB IUCLID (2000) 

3.4 Repeated-dose Toxicity 

Exposure Route oral 

Exposure Duration 0, 0.1, 0.5 or 2.0 g/L 

(0, 25, 125 or 500 mg/kg/d) 

Exposure dose 3 or 10 weeks 

Species mice (male) 

Method 

Results Increased liver weight (in the two highest dose groups). 

NOAEL 25 

NOEL 

Reference/Comments Parrish et al. (1996) 
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Exposure Route oral 

Exposure Duration 90 days 

Exposure dose 0, 0.05, 0.5 or 5.0 g/L 

(0, 4.1, 36.5 or 355 mg/kg/d) 

Species rats (male) 

Method 

Results Decreased absolute spleen weight and increased relative liver and kidney 

weights (at the two highest dose groups). 

Focal hepatocellular enlargement, intracellular hepatic swelling, hepatic 

glycogen accumulation and increased hepatiperoxisomal β-oxidation 

activity (at the highest dose group). 

NOAEL 36.5 

NOEL 

Reference/Comments Mather et al. (1990) 

Exposure Route oral 

Exposure Duration 10 weeks 

Exposure dose 0 or 0.025 g/L 

(0 or 3.8 mg/kg/d) 

Species rats 

Method 

Results Decreased body weight and kidney glutathione levels. 

Changed serum markers of lipid and carbohydrate metabolism. 

Mild liver and kidney histopathology. 

NOAEL 

LOAEL 3.8 

NOEL 

Reference/Comments Acharya et al. (1995; 1997) 

3.5 Development and Reproductive Toxicity 

Exposure Route oral 

Exposure Duration gestation days 6 to 15 

Exposure dose 0, 330, 800, 1200 or 1800 mg/kg/d 

Species rats 

Method 

Results Decreased maternal body weight gain, increased maternal spleen and 

kidney weights and increased resorptions. 

Reduced fetal weight and length. 

Increased in the incidence of soft tissue malformations, primarily involving 

the cardiocascular and renal systems. 

Skeletal malformations (orbit and hydronephrosis). 

NOAEL 

LOAEL 330 (maternal and developmental) 

NOEL 

Reference/Comments Smith et al. (1989) 
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Exposure Route oral 

Exposure Duration gestation days 1 to 22 

Exposure dose 0 or 2.73 g/L 

(0 or 290 mg/kg/d) 

Species rats 

Method 

Results Decreased maternal body weight gain. 

Increased resorption and cardiac soft tissue malformations. 

NOAEL 

LOAEL 290 (maternal, reproductive and developmental) 

NOEL 

Reference/Comments Johnson et al. (1998) 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

Exposure Route oral 

Exposure Duration 104 weeks 

Exposure dose 0, 500 or 4500 mg/L 

(0, 71 or 583 mg/kg/d) 

Species mice (female) 

Method 

Results Significantly increased in the incidence of combined liver tumour 

 (adenomas + carcinomas) in the high-dose group. 

NOAEL 

LOAEL 71 

NOEL 

Reference/Comments US EPA (1991) 

Exposure Route oral 

Exposure Duration 2 years 

Exposure dose 0, 50, 500 or 5000 mg/L 

(0, 3.6, 32.5 or 364 mg/kg/d) 

Species rats (male) 

Method 

Results Significantly decreased body weights and absolute liver weights 

 (in the high-dose group). 

Increased serum levels of ALT and palmitoyl CoA activity 

(in the high-dose group). 

NOAEL 32.5 

NOEL 

Reference/Comments DeAngelo and Daniel. (1992) 

DeAngelo et al. (1997) 

IARC classified it in Group 3 (no classifiable as to carcinogenicity to humans), IRIS classified it 

in Group C (possibly carcinogenic to humans) and ACGIH classified it as confirmed animal 

carcinogen with unknown relevance to humans. 
GESAMP-BWWG 8/6 

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Page 95 

I:\MEPC\59\2-16.DOC 

3.7 Mutagenicity/Reprotoxicity 

Species Method Details Results Reference/Comments/

In Vitro Studies 

Salmonella typhimurium 

strain TA98, TA100, 

TA1535, TA1538 

Histidine reversion negative Bignami et al. (1977) 

Salmonella typhimurium 

strain TA100 

Histidine reversion negative Rapson et al. (1980) 

Sato et al. (1985) 

DeMarini et al. (1994) 

Salmonella typhimurium 

strain TA98, TA100

Histidine reversion negative Waskell (1978) 

Mouse L5178Y/TK+/-

 lymphoma cells 

Thymidine-resistant 

 mutation 

positive 

(weekly) 

Harrington-Brock. (1985) 

Escherichia coli Prophage-induction 

 test (inductest) 

negative DeMarini et al. (1994) 

Salmonella typhimurium 

strain TA1535 pSK1002 

umu test positive Ono et al. (1991) 

In Vivo Studies 

Mouse bone marrow 

 cells 

Chromosomal 

 aberration 

positive Bhunya and Behera. (1987) 

Swiss mice Micronucleus test positive Bhunya and Behera. (1987) 

Swiss mice Sperm head 

 abnormality 

positive Bhunya and Behera. (1987) 

male B6C3F1 mouse 

 hepatocytes 

DNA strand breaks positive Nelson et al. (1989) 

Nelson and Bull. (1988) 

Sprague-Dawley rats 

 hepatocytes 

DNA strand breaks positive Nelson et al. (1989) 

Nelson and Bull. (1988) 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC 

CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Sea water 

or Fresh 

water

Test 

Duration

Results Breakdown 

products

Reference/ 

Comments

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation Activated 

sludge 

4 weeks 7 % NITE; CHRIP (2007)

1/2 - Life Water 

Soil 

Sediment 

Air 

estimated 

estimated 

experimental 

estimated 

estimated 

experimental 

38 days 

75 days 

119.6 

days 

340 days 

31 days 

31 days 

 PBT-Profiler 

PBT-Profiler 

HSDB (2007) 

PBT-Profiler 

PBT-Profiler 

HSDB (2007) 

n/a: not available 
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4.2 Partition Coefficients 

 Method Results Reference/Comments 

Log POW 1.33 Hansch et al. (1995) 

US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, KOWWINTM v.1.67 

KOC Estimated 

Estimated 

130 

2.738 

Science Research Council (SRC) 

US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments 

Persistence Estimated Yes PBT Profiler 

The PBT Profiler uses three environmental compartments (water, soil, and sediment) to 

determine the persistence of a chemical in the environment. If released to the environment, 

trichloroacetic acid is expected to be found predominantly in soil. It is also expected to be found 

in water, but not in sediment. 

The PBT Profiler has estimated that trichloroacetic acid is expected to be found predominantly in 

soil and its persistence estimate is based on its transformation in this medium. Its half-life in 

soil, 75 days, exceeds the EPA criteria of ≥ 2 months (and ≥ 6 months). Therefore, Acetic acid, 

trichloro- is estimated to be persistent in the environment.

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria. 

4.7 Any known interactive effects 

No known effects indicated in the literature.
GESAMP-BWWG 8/6 

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Page 97 

I:\MEPC\59\2-16.DOC 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) 57-58 

57.5 

56 

Budavari et al. (1996) 

Lide DR. (2005-2006) 

OECD SIDS 

Boiling point (°C) 196-197 

195.5 

197 

Budavari et al. (1996) 

Lide DR. (2005-2006) 

OECD SIDS 

Flammability(flash point for 

liquids; °C) 

Non flammable 

Flash point: not applicable 

MSDS-ScienceLab 

Density (20°C; kg/m3) 1.58x103 (20°C) 

1.62x103 (25°C) 

ECB IUCLID (2000) 

Budavari et al. (1996) 

Vapour pressure (20°C; Pa) 8 (6.0x10-2 mmHg at 25°C) 

120 (1.2hPa at 50°C) 

Perry and Green (1984) 

ECB IUCLID (2000) 

Vapour density (air = 1) 5.6 NIOSH-ICSC

Water solubility (temp; effect 

of 

pH; mg/L) 

1.3x106 (20°C) 

9.0x105

 (pH <1, 20°C) 

5.4x104 (25°C) 

ECB IUCLID (2000) 

Yalkowsky et al. (2003) 

pH in solution 1.2 in 0.1M solution O’Nell MJ. (2001) 

Dissociation constant (pKa) 0.51 

0.512-0.7 

0.7 

Serjeant and Dempsey 

 (1979) 

WHO (2004) 

OECD SIDS 

Oxidation- reduction potential Not available OECD SIDS 

Corrosivity to material or 

equipment 

Corrosive to iron, zinc and 

aluminum. 

Worthing and Walker 

 (1987) 

Reactivity to container 

material 

Not available 

Auto-ignition Temperature 

(°C) 

Not applicable MSDS-ScienceLab 

Explosive properties Not available ECB IUCLID (2000) 

Oxidizing properties Not available ECB IUCLID (2000) 

Surface tension 27.8 dynes/cm (80.2°C) ECB IUCLID (2000) 

Viscosity Not available 

Thermal stability and identity 

of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Colorless to white, crystalline 

solid. 

White deliquescent crystals. 

NIOSH-ICSC 

Morris and Bost. (2005) 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method Gas Chromatographic Method 

Applicability Water 

Sensitivity 0.04 μg/L 

Reference/Comments/Justification 

for missing data 

EPA Method 552.2 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments 

Yes no no PBT Profiler 

See table 2, section 2.1.4 in annex 5 

* * * 
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Appendix 10 

Data on Sodium thiosulphate 

1 CHEMICAL NAME: Sodium thiosulphate 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

 Species LC50

(mg/L) 

Reference/Comments 

Gambusia affinis 

Western mosquitofish 

24,000 / 96h / Mortality 

Static / Fresh water 

Fish Wallen et al. (1957) 

Pimephales promelas 

Fathead minnow 

10,000 / > 96h / Mortality (LT50) 

Static / Fresh water 

Terhaar et al. (1972) 

Daphnia magna 

Water flea 

805 / 4.2d / Mortality 

Static / Fresh water 

Dowden and Bennett 

 (1965) 

Crustacea 

D. magna 

Water flea

520 / 48h / Immobile, 

Intoxication 

(LETC) / Fresh water 

Anderson B.G (1946) 

Ankistrodesmus 

falcatus, Green algae 

64 / 1.2h / Photosynthesis (N/R) 

Static / Fresh water 

Wodzinski et al. (1978) 

Chlamydomonas 

reinhardtii, Green 

algae 

64 / 1.2h / Photosynthesis (N/R) 

Static / Fresh water 

Wodzinski et al. (1978) 

Lyngbya sp. 

Blue-green algae 

64 / 1.2h / Photosynthesis (N/R) 

Static / Fresh water 

Wodzinski et al. (1978) 

Algae 

Spirulina 

labyrinthiformis, Blue-green algae 

22 / 1 - 1.5h / Photosynthesis 

(N/R) 

Static / Fresh water 

Castenholz R.W(1977) 

Spirostomum 

ambiguum 

Protozoa 

1,710 / 24h / Mortality 

Static / Fresh water 

Nalecz-Jawecki and 

 Sawicki (1998) 

Invertebrates 

S. ambiguum 

Protozoa

1,700 / 24h / Deformation (EC50) 

Static / Fresh water 

Nalecz-Jawecki and 

 Sawicki (1998) 

N/R: Endpoint not reported. 

LETC: Lethal threshold concentration. 

2.2 Chronic Aquatic Toxicity Data 

No information on the chronic aquatic toxicity of sodium thiosulphate was found in the literature. 

2.3 Information on Endocrine Disruption 

No information on the endocrine disruption potential of sodium thiosulphate was found in the 

literature. 
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2.4 Sediment Toxicity 

No information on the chronic sediment toxicity of sodium thiosulphate was found in the 

literature.

2.5 Bioavailability/Biomagnification/Bioconcentration 

 Results Cause for 

concern 

(yes/no) 

Reference/Comments 

Log Pow -4.53 no WHO (2004) 

BCF 3.162 no US EPA Estimation Program Interface 

(EPI) Suite 

v.3.20, BCFWINTM v.2.17 

The octanol/water partition coefficient log value of sodium thiosulphate is -4.53 and is therefore 

considered not to pose a risk of concentration in organisms. 

2.6 Food Web/Population Effects

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food 

chain because it does not exceed the BCF criteria. 

3 MAMMALIAN TOXICITY 

3.1 Acute Mammalian Toxicity 

 Value Species Reference/Comments 

Oral LD50 (mg/kg) >5,050 rats PMEP 

Dermal LD50 (mg/L) n/a 

Intraperitoneal LD50 

(mg/kg) 

5,200 mice MSDS-Oxford 

University 

Inhalation LC50

(mg/L/4h) 

n/a 

n/a: not available

PMEP: Pesticide Management Education Program

3.2 Corrosion/Irritation 

 Species Method Results Reference/Comments 

Skin human Slightly hazardous in case of skin 

contact (irritant, permeator) 

MSDS-ScienceLab 

Eyes human Hazardous in case of eye contact 

(irritant) 

MSDS-ScienceLab 

3.3 Sensitization 

EEC Classification for sodium thiosulphate does not include R43 (May cause sensitization by 

skin contact). 
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I:\MEPC\59\2-16.DOC 

3.4 Repeated-dose Toxicity 

No information on the repeated-dose toxicity of sodium thiosulphate was found in the literature. 

3.5 Development and Reproductive Toxicity 

Exposure Route oral 

Exposure Duration gestation days 6 to 15 

Exposure dose 0, 5.5, 25.5, 118 or 550 mg/kg/d 

Species mice 

Method 

Results No indication of any effect on maternal or fetal survival. 

No incidence of visceral or skeletal abnormalities. 

The male/female ratio at the lowest and highest dose level are lower than 

other ratios. 

NOAEL 

NOEL 

Reference/Comments/ PMEP; Pesticide Management Education Program 

Exposure Route oral 

Exposure Duration gestation days 6 to 15 

Exposure dose 0, 4, 19, 86 or 400 mg/kg/d 

Species rats 

Method 

Results No indication of any effect on maternal or fetal survival. 

No incidence of visceral or skeletal abnormalities. 

NOAEL 

NOEL 

Reference/Comments PMEP; Pesticide Management Education Program 

Exposure Route oral 

Exposure Duration gestation days 6 to 15 

Exposure dose 0, 4, 19, 86 or 400 mg/kg/d 

Species hamsters 

Method 

Results No indication of any effect on maternal or fetal survival. 

No incidence of visceral or skeletal abnormalities. 

Unusual male/female ratio. 

NOAEL 

NOEL 

Reference/Comments PMEP; Pesticide Management Education Program 

Exposure Route oral 

Exposure Duration gestation days 6 to 18 

Exposure dose highest dose level of 580 mg/kg/d 

Species rabbits 

Results No indication of any effect on maternal or fetal survival at the highest dose 

level (580 mg/kg/d). No incidence of visceral or skeletal abnormalities at 

the highest dose level (580 mg/kg/d). 

No incidence of any effect on the male/female ratio of the fetuses. 

Reference/Comments PMEP; Pesticide Management Education Program 
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3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

No information on the carcinogenicity of sodium thiosulphate was found in the literature.

3.7 Mutagenicity/Reprotoxicity 

Species Method Details Results 

(with/without 

activation)

Reference/Comments

In Vitro Studies 

Salmonella typhimurium 

 strain TA98, TA100 

 TA1535, TA1537 

 TA1538 

Ames test negative Prival et al. (1991) 

Escherichia coli WP2 negative Prival et al. (1991) 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

 Sea water or 

Fresh water

Test 

Duration

Results Break-down 

products

Reference/ 

Comments

Hydrolysis (pH 5) n/a 

Hydrolysis (pH 7) n/a 

Hydrolysis (pH 9) n/a 

Biodegradation n/a 

1/2 - Life n/a 

n/a: not available 

4.2 Partition Coefficients 

 Method Results Reference/Comments 

Log POW Estimated -4.53 US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, KOWWINTM v.1.67 

KOC Estimated 6.124 US EPA Estimation Program Interface (EPI) 

Suite 

v.3.20, PCKOCWINTM v.1.66 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments 

Persistence Estimated n/a PBT Profiler 

n/a: not available. 

4.4 Reaction with organic matter 

No such reactions indicated in the literature. 
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I:\MEPC\59\2-16.DOC 

4.5 Potential physical effects on wildlife and benthic habitats 

No potential effects indicated in the literature. 

4.6 Potential residues in seafood 

No potential residues indicated in the literature. 

4.7 Any known interactive effects 

No known effects indicated in the literature.

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER, IF APPLICABLE 

Property(with units and 

reference) 

Value Reference/Comments

Melting point (°C) 48 ECB IUCLID (2000) 

Boiling point (°C) Decomposes 

300°C (decomposes below b.p.) 

ECB IUCLID (2000) 

NIOSH-ICSC 

Flammability(flash point for 

liquids; °C) 

Non flammable 

Flash point: Not applicable 

MSDS-ScienceLab 

Density (20°C; kg/m3) 9.1x102

1.74x103

ECB IUCLID (2000) 

Vapour pressure (20°C; Pa) Not applicable MSDS-ScienceLab 

Vapour density (air = 1) Not available MSDS-ScienceLab

Water solubility (temp; effect 

of 

pH; mg/L) 

2.09x105 (20°C) 

7.01x105 (20°C) 

1.0x105 (pH 6.5-9 at 25°C) 

NIOSH-ICSC 

ECB IUCLID (2000) 

pH in solution 7 in 1% solution MSDS-ScienceLab 

Dissociation constant (pKa) Not available 

Oxidation- reduction potential Not available 

Corrosivity to material or 

equipment 

Non corrosive in presence of glass. MSDS-ScienceLab 

Reactivity to container 

material 

Not available 

Auto-ignition Temperature 

(°C) 

Not applicable MSDS-ScienceLab 

Explosive properties Not explosive ECB IUCLID (2000) 

Oxidizing properties No oxidizing properties ECB IUCLID (2000) 

Surface tension Not available ECB IUCLID (2000) 

Viscosity Not available 

Thermal stability and identity 

of 

breakdown products 

Not available 

Other physical or chemical 

properties 

Powder. 

Colorless monoclinic crystals. 

The Merck Index. (1976) 

Weast RC. (1976) 
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6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments 

No no no PBT Profiler 

See table 2, section 2.1.4 in annex 5 

*** 
GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 7 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES 

Blue Ocean Shield - A Ballast Water Management System Consisting of Sedimentation by 

Hydrocyclone, Filtration and Low Pressure UV Disinfection 

Submitted for Basic Approval by China 

0 SUMMARY 

0.1 Having considered all of the data submitted for Basic Approval, the Group recommended 

that Blue Ocean Shield be given Basic Approval. 

0.2 The Group noted that the Blue Ocean Shield Ballast Water Management System uses a 

combination of sdimentation by hydrocyclone, filtration and low pressure UV disinfection to 

treat the ballast water. 

0.3 The Group was satisfied that, as the system does not involve the storage or generation of 

chemicals to treat ballast water, there were no associated storage safety problems. 

0.4 The Group noted that the UV technology in the Blue Ocean Shield System makes use of 

electromagnetic radiation (photons) in order to treat ballast water. As such, the Group considered 

that it was neither necessary nor feasible to provide the physical characteristics or toxicological 

profiles of such photons. 

0.5 However, it was recognized that the radiation (photons) might react with naturally 

occurring organic molecules in seawater to form by-products with safety and environmental 

concerns. Half-lives of the photons are expected to be in the order of micro- to milliseconds. 

0.6 Based on results from chemical analyses of treated ballast water, the Group concurred 

with the views of the applicant that it was not necessary to provide toxicological and 

ecotoxicological data on these by-products and that an evaluation of the possible effects of 

treated ballast water should suffice to provide a recommendation regarding Basic Approval. 

0.7 The Group recognized that the only potential for human health risk was related to 

exposure to UV irradiation from the treatment unit and therefore the Group recommended that 

appropriate risk mitigation measures be put in place. 

0.8 The Group noted that the applicant had provided some acute aquatic ecotoxicity data for 

the treated ballast water which demonstrated a lack of toxicity. Whilst the Group identified some 

shortcomings associated with these ecotoxicity studies, the data were considered acceptable 

for Basic Approval. As the applicant had not provided any chronic aquatic ecotoxicity testing on 

the UV-treated ballast water, the Group emphasized that this should be provided in the dossier 

for Final Approval. 
GESAMP-BWWG 8/6 

ANNEX 7 

Page 2 

I:\MEPC\59\2-16.DOC 

0.9 The Group noted that Procedure (G9) requires that “Proposed procedures for the use and 

technical equipment introduced needs to be taken into account”. However, it was also noted that 

no confirmation that the equipment is suitable for use on board a ship had been provided for 

evaluation by the Group. As a result, the Group proposed that such procedures should be 

properly documented so that they can be taken into account if the system is to be reviewed for 

Final Approval in the future. 

0.10 The Group noted that a significant proportion of the data, references and information 

provided in the confidential dossier was in Chinese, and that the Group does not possess facilities 

to assess such material. The Group was informed by the Chinese Administration that all the 

information provided in Chinese was also available in English. 

0.11 The Group emphasized that if the applicant wishes to present data, references or 

information to be taken into account when the system is to be reviewed for Final Approval in the 

future, then all such documentation should be provided in English (or if original documents are 

in Chinese, then the Group must be provided with accompanying English translations). 

0.12 The Group noted that, in the Basic Approval dossier received, not all items were properly 

addressed. If, according to the opinion of the applicant, items from the dossier should be waived 

on scientific grounds, the applicant should clearly indicate the reasoning for waiving these items. 

The Group considered it necessary that all the items should be addressed by a proper explanation. 

0.13 The Group reserved the right to comment in full on the entirety of any future dossier to be 

submitted for Final Approval. The Group feels able to recommend Basic Approval based on the 

dossier available, only by relying on the existing knowledge and expertise of members of 

the Group, together with information available from the public literature. However, it was 

agreed that sufficient aspects of this system were presented to allow the Group to be satisfied that 

further large scale testing could be carried out without significant risk to the crew, the ship and 

the environment. 

0.14 The applicant is advised to review the requirements of Procedure (G9) and ensure that all 

of these are fully met when making an application for Final Approval. 

0.15 Having reviewed all the information in the non-confidential submission and the 

information received from the applicant during its meeting, the Group recommended 

that Blue Ocean Shield be given Basic Approval with the following considerations if the system 

is to be reviewed for Final Approval in the future: 

.1 all the topics in this Summary (section 0) have to be carefully addressed by the 

applicant; 

.2 all the topics under section 2 (Completeness of the Dossier as mentioned below) 

have to be addressed by the applicant; and 
GESAMP-BWWG 8/6 

ANNEX 7 

Page 3 

I:\MEPC\59\2-16.DOC 

.3 The Group considered that the Level of Quantification (LOQ) for the by-products 

in treated ballast water were too high. This may lead to understatement of the 

potential levels in the treated ballast water. It was noted by the Group that the 

dossier did not include information about other relevant halogenated chemical 

by-products that may be produced according to open available literature. 

The LOQ of the analytical methods used for the potential by-products measured 

should be at a level that confirms that the potential amount of by-products 

produced by the system is sufficiently low and meets the international standards 

on these substances. It is common to determine these contaminants in natural 

waters at levels of 0.01 or 0.05 μg/L. The Group therefore recommended that this 

uncertainty should be clarified by additional analyses during the full scale testing 

on land and/or on board ships by the applicant and that these data are submitted in 

the application for Final Approval. 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by China in 

document MEPC 59/2/2, which was supplemented by additional confidential information 

provided by the applicant. 

2 COMPLETENESS OF DOSSIER

2.1 The Group had the following concerns which it considered should be addressed prior to 

application for Final Approval: 

 .1 a more detailed description of the system needs to be provided to include 

inter alia: 

 .1 system layout - the Group agreed that the information already provided 

was acceptable for Basic Approval; and 

.2 details of the protection devices and failsafe controls incorporated – 

the Group agreed that the information provided was acceptable 

for Basic Approval. The Group noted that the dossier’s system 

description, operational manual and control methodology was insufficient 

to assess or insure safe operation of the system. 

 .2 following application of the BWMS at both ballasting and deballasting, the Group 

wanted to know the concentration of potential by-products at the point of 

discharge of the treated ballast water; 

 .3 the quantification of THM and HAA for natural seawater maybe completely 

different from those obtained from fresh water or brackish water – the applicant 

indicated that tests had been carried out only in natural seawater; 

 .4 lack of chronic aquatic ecotoxicity testing on the UV-treated ballast water – the 

Group emphasizes that chronic testing should be provided in the dossier for Final 

Approval; 
GESAMP-BWWG 8/6 

ANNEX 7 

Page 4 

I:\MEPC\59\2-16.DOC 

 .5 the mutagenicity testing as referred to by the applicant (in email correspondence 

during the GESAMP-BWWG meeting) was not part of the confidential dossier; 

the Group wanted to highlight that all information and test data used in the human 

health risk assessment should be included in the future submission 

forFinalApproval; and 

.6 the Group agreed that the statement saying that corrosion was not anticipated 

should have been supported with evidence. 

2.2 The Group also considered that the Level of Quantification (LOQ) associated with the 

chemical analysis of the potential by-products measured in treated ballast water was too high and 

that much lower detection limits are achievable. Some concern was expressed that some of the 

chemicals analysed for might still be produced at levels lower than the detection limits used by 

the applicant. 

2.3 The Group noted that the applicant did not provide information concerning the processes 

and unit operations in which crew exposure may occur and therefore the Group recommends that 

for Final Approval this information should be included in the submission. 

2.4 Whilst no other physico-chemical properties, fate and behaviour in the environment and 

mammalian toxicity data had been provided, the Group agreed that this was not necessary, from 

the aquatic toxicity perspective, due to the low level of possible by-products being produced by 

the system. 

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the Blue Ocean Shield Ballast Water Management System 

3.1.1 The Group noted that the applicant had supplied the following information on the basic 

operation of the system. China Ocean Shipping (Group) Company (COSCO) has joined forces 

with Tsinghua University to develop a modular ballast water management system 

(Blue Ocean Shield) that operates in-line during the uptake and discharge of ballast water. Prior 

to UV treatment, a filter system specifically designed for ballast water applications will 

significantly reduce the sediment load of the ballast water, as well as remove some 

micro-organisms. The filtration system is installed on the discharge side of the ballast water 

pumps and is fully automatic in terms of its operation in cleaning. This does not, however, affect 

the treatment process and the flushing water is returned to the sea. The UV unit employs 

low-pressure, high output ultra violet (LPUV) lamps to destroy living micro-organisms present in 

the ballast water. 

3.1.2 Ballast water is treated at intake and once again at discharge. The treatment on intake 

ensures that a minimal amount of viable organisms enters the ballast water tanks and reduces 

sediment built-up in the tanks, which is a potential area for the survival of organisms. The water 

is treated again at discharge by the UV system only, to ensure that the potential re-growth of 

organisms in the ballast water tanks is decreased as much as possible. 
GESAMP-BWWG 8/6 

ANNEX 7 

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I:\MEPC\59\2-16.DOC 

3.2 Overview 

3.2.1 The ballast water management system 

3.2.1.1 The Group noted that this ballast water management system consists of four modular 

functions: 

.1 Hydrocyclone: removes most of larger or heavier particles. 

The Group noted that the hydrocyclone is a device used to separate particles in a liquid 

suspension based on the density and size of the particles. Hydrocyclones have a 

cylindrical section at the top, where liquid enters the unit, and a conical base. The 

particular Blue Ocean Shield hydrocyclone units have three exits: a small one on the 

bottom (weighty particles, underflow), a smaller exit at the top (lighter particles, 

overflow) and a larger exit in the middle (middle flow). In the treatment process, 

centrifugal force moves larger, weighty particles to the bottom exit and light particles to 

the top. 

 Parameters of hydrocyclone unit: 

 Flow rate: 250 m3

/hr 

 Working pressure: 0.8 bar 

 Maximum working pressure: 10 bar 

 Material: SS 316L 

.2 Filter:

The Group noted that the filter is a device used to separate solid particles by size. 

In the Blue Ocean Shield system, multiple element tubular filter units with accessorial 

filtration are used. The ship’s high-pressure gas can be automatically used by filters on 

cleaning function, which had more than two filter units installed at the same time in order 

to meet with uninterrupted water supply. Filter impurities from the ship arise through the 

discharge pipe into the water at the original port. 

 Parameters of filter unit: 

 Flow rate: 250 m3

/hr 

 Filtration degree: 50 micron 

 Working pressure: 2.0 bar 

 Maximum working pressure: 10 bar 

 Automatic cleaning 
GESAMP-BWWG 8/6 

ANNEX 7 

Page 6 

I:\MEPC\59\2-16.DOC 

Material 

- Filter housing: SS 316L 

 - Filter screen: seawater-fast material 

.3 UV disinfection: 

The Group noted that no substances are added to the process and it removes most 

micro-organisms and algae smaller than 50 μm (according to applicant). 

 Flow rate: 250 m3

/hr 

Low pressure UV lamps 

Material: SS 316L 

Maximum dose: 300 mJ/cm2 

Automatic washing wiper for quartz sleeves 

.4 Control and auxiliary equipment: including sampling points. 

The control system and transformer control the system and supply all components with 

power. The auxiliary equipment controls the flow and measures different alarm levels. 

3.2.1.2 A simplified diagram of the Blue Ocean Shield BWMS is given in Figure 1. 

Figure 1. Simplified diagram of the Blue Ocean Shield BWMS. 
GESAMP-BWWG 8/6 

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I:\MEPC\59\2-16.DOC 

3.2.1.3 The Group noted that the Applicant stated the Blue Ocean Shield system may be run in 

different configurations depending on the level of treatment required and the particular properties 

of the ballast water. For example: 

 .1 Hydrocyclone / Filter / UV; or 

 .2 Filter / UV 

3.2.1.4 According to the applicant, the Blue Ocean Shield can be viewed as flexible and 

modular, and can be applied in different configurations for different end user requirements. 

3.2.1.5 The Group decided this application for Basic Approval will focus on the UV treatment 

unit, as this is the only component involving the use of Active Substance. 

3.2.2 Description of pilot scale test system used for Basic Approval 

3.2.2.1 The Group noted that in order to confirm and justify this system, the applicant has 

developed a pilot scale system and systematic experiments were performed using “treated water” 

and raw seawater, as described below. 

3.2.2.2 The Group noted that the UV unit employs low-pressure, high-output ultra violet 

(LPUV) lamps to destroy living micro-organisms present in the liquid being treated. During 

deballasting, the ballast water is treated again by the UV unit to destroy any organisms which 

may have re-grown in the tanks during the voyage. The BWMS used for the pilot test consisted 

of a UV unit and a monitoring and control panel. The maximum flow rate designed for the pilot 

system is 2 m3

/h. The UV doses used for acute toxicity were 100 mJ/cm2 and 300 mJ/cm2. For 

other tests, the UV dose range was from 37 to 1990 mJ/cm2. 

3.2.2.3 The stated test strategy of the applicant was as follows: 

 .1 basic characteristics testing: to investigate any change in the seawater before and 

after treatment, the basic characteristics (i.e., ions, TOC, UV absorbance scanning, 

and SUVA) of seawater are compared with the “treated water”; 

.2 by-products formation testing: to investigate the possibility of the formation of 

harmful halogenated organics and inorganic compounds; and 

.3 toxicity testing: to investigate the acute aquatic ecotoxicity of sea water before and 

after UV system treatment. 

3.2.2.4 The seawater (DOC=8.1mg/L; SS=7.0 mg/L) transported to the laboratory was treated 

twice by the model Blue Ocean Shield ballast water treatment system. The control sample was 

not treated by the water treatment system. Part of control sample and treated water was used for 

the test immediately. 

3.2.2.5 According to the applicant, the results of biological efficacy testing of the BWMS 

showed that the system met the standard in regulation D-2 of the Convention in all test cycles. 
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3.3 Chemical processes involved (provided by the applicant)

3.3.1 The Group noted that according to the applicant, in the Blue Ocean Shield Ballast Water 

Management System, the UV system produces a “photon” as the only Active Substance, which is 

responsible for inactivating all harmful aquatic micro-organisms and pathogens present in the 

ballast water. 

3.3.2 For the Blue Ocean Shield system, “ballast water discharge” is the treated ballast water 

that has passed the UV unit twice, during ballasting and deballasting, respectively. 

3.3.3 The Blue Ocean Shield Ballast Water Management System does not intentionally add 

any Preparation besides UV light. 

3.3.4 According to the applicant, the Blue Ocean Shield Ballast Water Management System 

does not produce any Relevant Chemicals. 

3.3.5 As a result of the above points, the Group accepted that chemicals are neither required to 

be stored on board nor generated on demand. 

3.4 Active Substance (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.4.1 Active Substance 

3.4.1.1 In this LPUV-based system, the Group accepted that photons are the 

only Active Substance available to kill and inactivate micro-organisms. The definition of 

“photon” is a particle of electromagnetic radiation that travels at the speed of light, used to 

explain phenomena that require light to behave as particles rather than as waves. Accordingly, as 

the photons are only available upon turning on the LPUV lamp, there must be no residual 

photons in both the “ballast water” and “ballast water discharge”. 

3.4.1.2 Therefore the Group accepted that the photon has no chance of exposing aquatic plants, 

invertebrates, fish, and other biota, including sensitive and representative micro-organisms. 

Therefore, all tests for effects on such biota, are not applicable due to the non-residual 

characteristics of the photon. 

3.4.1.3 Likewise, since the photons generated in the LPUV reactor are never exposing 

mammals, all tests for effects on mammals are not applicable. 

3.4.1.4 The Applicant has produced a table of the physical and chemical properties of photons, 

but all parameters are labelled as not applicable. This has not been reproduced here as it provides 

no additional information. 

3.4.2 Relevant Chemicals 

3.4.2.1 Based on the analytical data provided by the Applicant and general information 

about UV treatment, the Group concurred with the views of the Applicant that the 

Blue Ocean Shield BWMS does not produce any “relevant chemical”. 
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3.4.3 Other Chemicals

3.4.3.1 It was recognized by the Group that the UV process may react with naturally occurring 

organic molecules in ballast water to form by-products with safety and environmental concerns. 

It was agreed that, it was neither necessary nor practical to provide their physical characteristics 

or toxicological profiles.

3.4.3.2 It was noted that the applicant had identified certain chemical by-products as being 

possible resultant products of the treatment system and had analysed the treated ballast water for 

Concentrations of potential chemical by-products in UV-treated natural seawater samples 

(provided by applicant)

Parameter/UV dose mJ/cm2 0 60 97 156 252 406 1234 1990 LOD*

chlorite mg/L 0.4 0.4 0.35 0.24 0.3 0.43 0.42 0.41 0.01 

chlorate mg/L 3.19 3.67 2.76 2.68 2.79 3.16 2.7 2.87 0.01 

Formaldehyde mg/L ND ND ND ND ND ND ND ND 0.01 

Aldehyde mg/L 2.85 4.38 3.5 2.28 2.72 1.88 1.62 2.01 0.01 

CHCl3 μg/l ND ND 2 2 2 3 5 6 1 

CHBr2Cl μg/l ND ND ND ND ND ND ND ND 1 

CHBrCl2 μg/l ND ND ND ND ND ND ND ND 1 

CHBr3 μg/l ND ND ND ND ND ND ND ND 1 

TTHMs μg/l ND ND 2 2 2 3 5 6 1 

MCAA μg/l ND ND ND ND ND ND ND ND 2 

DCAA μg/l 2 2 2 2 2 2 2 8 2 

MBAA μg/l 2 2 ND ND ND ND ND 4 2 

TCAA μg/l 2 2 ND ND ND ND ND 4 2 

BCAA μg/l 8 8 8 10 10 8 12 12 2 

BDCAA μg/l 2 2 2 ND ND ND ND 4 2 

DBAA μg/l ND ND ND ND ND ND ND ND 2 

CDBAA μg/l ND ND ND ND ND ND ND ND 2 

* ND means not detected 

* LOD: Limit of Detection (SD*3.14, n=7) = MDL (method detection limit) 

3.4.3.3 The Group considered that the Levels of Quantification (LOQ) for the haloacetic acids 

and trihalomethanes were too high and that this may lead to an underestimation of the levels in 

the treated ballast water. This uncertainty should be clarified in additional analyses during the 

full scale testing on land and/or on board ships by the applicant. 

3.4.3.4 The results of the chemical tests for the model Blue Ocean Shield Ballast Water 

Management System showed no significant concentration changes before or after UV irradiation 

when the doses were under 300mJ/cm2

. 
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3.4.4 Conclusions

3.4.4.1 Based on these results, the Group concurred with the views of the applicant that it was 

not necessary to provide toxicological and ecotoxicological data on these by-products and that an 

evaluation of the effects of treated ballast water should suffice to provide a recommendation 

regarding Basic Approval. 

3.4.4.2 The Group agreed that it was not necessary to evaluate the properties of 

any Active Substance or Relevant Chemical associated with this system. Instead, a brief 

evaluation was carried out on the data generated by the applicant from testing the treated ballast 

water, the results of which are shown in the appendix to this annex. 

4 HUMAN HEALTH ASSESSMENT

4.1 The Group identified that the only potential for human health risk was related to exposure 

to UV irradiation from the treatment unit and therefore recommended that appropriate risk 

mitigation measures be put in place. 

4.2 Although the concentrations of the mentioned chemical by-products were considered to 

be below LOQ, the Group considered that the LOQ was considerably too high for the 

quantification of these particular compounds and that the sensitivity of the analytical methods 

could be improved so as to give satisfactory and conclusive measurements to be able to evaluate 

human toxicological effects produced by the system. 

4.3 Pilot testing results indicated that UV did not have a significant impact on most chemicals 

(table in paragraph 3.3.4.2). The Group noted that for chloroform CHCl3 and THM (CHCl3 is a 

component of THM), there was little increase after UV (from undetectable to 3 μg/L when 

the UV dose is 406 mJ/cm2). However, this value is well below the EPA drinking water 

regulation safety value of 80 μg/L (USEPA, 2003) and WHO drinking water regulation which 

suggests 300 μg/L (WHO, 2006). 

4.4 The Group also noted that the applicant did not provide information concerning the 

processes and unit operations in which crew exposure may. Therefore, the Group recommended 

that the applicant should supply the above information for Final Approval according to 

paragraph 7.2.3. of the Methodology, appendix 2 (G9). 

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 The Group was satisfied that, as the system does not involve the storage or generation of 

chemicals to treat ballast water, there were no associated storage safety problems or risks. 

5.2 The Group noted that the submission identified a potential risk to the ship and its crew 

present in the BWMS related to overheating in the treatment unit from the UV lamps. The 

submission confirmed that these identified risks had been addressed by system safety measures 

that ensure there is automatic shut down, in a no flow situation, in order to prevent overheating.
GESAMP-BWWG 8/6 

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5.3 The submission recognizes that, concerning ship and personnel safety, the G9 procedures 

require that “Proposed procedures for the use and technical equipment introduced needs to be 

taken into account”. However no confirmation that the equipment is suitable for use on board a 

ship had been provided for evaluation by the Group. 

5.4 The Group noted that the UV lamps require a warm-up time before the system is ready 

for use. Full operating and maintenance procedures require to be evaluated to provide all 

necessary considerations for operators and crew safety. 

5.5 The Group noted that the electric power requirement of the system will not be an 

insignificant additional ship service demand. It requires to be confirmed that the equipment 

meets all regulatory standards for equipment to be installed on board a ship, both with regard to 

construction and prevention of electric shock to personnel. 

6 ENVIRONMENTAL RISK ASSESSMENT 

6.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

6.1.1 The Group recognized that it was not possible to evaluate the persistence, 

bioaccumulation and toxicity of any chemicals either within, or produced by, the system, as it 

does not use any Active Substances or produce any Relevant Chemicals. Assessment of the 

PBT-criteria was, therefore, considered to be not applicable. 

6.2 Derivation of the Predicted No Effect Concentration (PNEC) 

6.2.1 The Group confirmed that the acute aquatic ecotoxicity data provided do not indicate a 

potential risk to the environment and agreed that the derivation of a PNEC is not possible as the 

nature of the system does not involve the use of chemicals that make the derivation of a PNEC 

either possible or necessary. The Group noted that no effects had been observed during ecotoxicity 

tests, using a 100% concentration of UV-treated ballast water (see appendix to this annex). 

6.2.2 The Group considered that there should be an improvement in Quality Assurance 

and Quality Controls for any ecotoxicity tests provided for Final Approval, particularly with 

regard to the following issues: 

.1 preparation of water samples and living organisms needs to be described 

according to the procedures for quality control; 

.2 the dilutions of treated ballast water for acute toxicity tests were a serial sequence 

by the order of 1/2, and the results of the effect at each concentration need to be 

analysed according to proper statistical analysis; 

.3 according to the acute toxicity test protocol, the LCx is supposed to be presented 

instead of NOEC; 

.4 the number of algal cells for acute toxicity test at 96 hours after inoculation is 

supposed to reach to 1.1 x 106

 cells/mL according to the OECD method which 

was used for this test. The number of algal cells, at given time, were supposed to 

be analysed with proper statistical methods to provide the level of effect with 

significant level; and 

.5 Procedure (G9) requires the chronic ecotoxicity data for treated ballast water. 
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6.3 Calculation of the Predicted Environmental Concentration (PEC) 

6.3.1 The Group agreed that there would be no point in calculating the PEC of the treated 

ballast water as it was recognized that a 100% concentration of treated ballast water discharge 

would be acceptable under any situation. 

6.4 Calculation of the PEC/PNEC ratios 

6.4.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group 

agreed that it was not necessary to do so as the PEC/PNEC ratio could be regarded as less than 

one for all practical purposes. 

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

8.1.1 Subject to the concerns expressed above in this Annex, the Group agreed that this system 

was not likely to cause any concern with regards to the safety of the ship. Certain conditions and 

requirements have been set above for any future assessment of an application for Final Approval. 

7.2 Risks to the crew and the general public

7.2.1 The Group recognized that the levels of potentially hazardous chemicals (by-products) 

produced by this system were generally lower than the detection limits of the methods used to 

analyse for them. However, the Group considered that there might still be some human health 

concerns and so agreed that human exposure on board should be avoided until it can be 

demonstrated that the levels of such chemicals, if produced, are below the threshold limits for 

any toxicological concerns. Requirements have been set above for assessment of an application 

for Final Approval. 

7.2.2 The Group also noted that the applicant did not provide information concerning the 

processes and unit operations in which crew exposure may occur. Therefore, the Group 

recommended that the applicant should supply the above information for Final Approval 

according to paragraph 7.2.3 of the Methodology, appendix 2 (G9). 

7.3 Risks to the environment

7.3.1 Having reviewed all of the information submitted with this application, the Group agreed 

that this system will not cause any harm to the environment when carrying out the further work 

which is necessary to apply for Final Approval. 

7.4 Recommendations

7.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to 

recommend to MEPC that Basic Approval is given to this system. 
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7.4.2 However, the Group wished to inform MEPC that the following aspects, inter alia, should 

be given due consideration if the system has to be reviewed for Final Approval in the future: 

.1 All the topics addressed under section 0 (Summary) and section 2 

(Completeness of the Dossier) have to be addressed by the Applicant carefully. 

.2 The Group considered that the Level of Quantification (LOQ) for the haloacetic 

acids and trihalomethanes were too high. This may lead to underestimation of the 

potential levels in the treated ballast water. This uncertainty should be clarified in 

additional analyses during the full scale testing on land and/or on board ships by 

the applicant. 

* * * 
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Appendix 

Properties of Treated Ballast Water 

1 PHYSICOCHEMICAL PROPERTIES

The Group recognized that it was both unnecessary and irrelevant to report the physical 

properties of treated ballast water. 

2 MAMMALIAN TOXICITY

The Group noted that the applicant had indicated that, as there were no measurable chemical 

by-products, there was no need to provide any data with regards to mammalian toxicity. 

The Group agrees with this view. 

3 ENVIRONMENTAL EFFECTS 

The Group noted that some acute aquatic ecotoxicity tests had been carried out by the Applicant 

using treated ballast water. 

3.1 Acute Aquatic Ecotoxicity Data

The following text and Table 2 below summarize the Group’s evaluation of the acute aquatic 

ecotoxicity of 100% treated ballast water (supplied by Applicant). 

Premnas biaculeatus, Artemia salina and Skeletonema costatum were chosen as the challenge 

organisms for acute toxicity testing. The results show that no acute toxicity was observed in 

the 100% treated ballast water. 

Premnas biaculeatus, distributed widely in the Indian Ocean and the Pacific Ocean, is the 

preferred species for toxicity testing to assess possible risks for the environment since it is a 

sensitive indicator species and the bodyweight of Premnas biaculeatus is <3.0 g, which meets the 

requirement of USEPA test guideline. 

Artemia salina belongs to Arthropoda-Crustacea-Branchiopoda-Anostraca, and is distributed 

widely in high salt water areas all over the world. Artemia salina feeds primarily on zooplankton 

and phytoplankton and is also consumed by many other aquatic organisms, such as fish. 

Therefore, Artemia salina plays an important role in the food chain of high salt water areas, as 

well as belonging to the second trophic level animal, a requirement of Procedure (G9). 

Species of algae recommended by USEPA as test organisms for the algae acute toxicity test are 

the freshwater green alga, S.capricornutum (or R. subcapitata), the marine diatom, S. costatum, 

the freshwater diatom, N. pelliculosa, and the blue-green alga or cyanobacterium. In the ballast 

water acute toxicity test, S. costatum was selected for the test system, meeting the requirement 

of Procedure (G9) and USEPA test guidelines. 
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Table 2: The acute toxicity testing of the UV-treated ballast water 

Results Trophic 

level Species Method Endpoint 100 

mJ/cm2

300 

mJ/cm2

Reference 

Fish Premnas 

biaculeatus OECD 202 NOEC/96h 100% 100% (PSEC 2008 report 

E083420068) 

Invertebrates Artemia 

salina OECD 203 NOEC/96h 100% 100% (PSEC 2008 report 

E083490078) 

Algae Skeletonem

a costatum OECD 201 IrC50/96h 100% 100% (PSEC 2008 report 

E085480018) 

3.2 Information on Endocrine Disruption 

3.2.1 The Group noted that the endocrine disruption potential of treated ballast water had not 

been tested for specifically but the applicant reported that no potential endocrine disrupting 

chemicals had been identified in the treated water. 

3.2.2 Based on this information, the Group agreed that the treated ballast water was unlikely to 

have any endocrine disrupting effects. 

3.3 Sediment Toxicity 

The Group noted that the applicant had indicated that, based on the chemical analysis and 

toxicity tests of the treated ballast water, there would not be any sediment toxicity associated 

with the treated ballast water. The Group agrees with this view. 

3.4 Bioavailability/Biomagnification/Bioconcentration 

The Group noted that the applicant had indicated that, based on the chemical analysis of the 

treated ballast water, there was no indication of any chemical by-products that might be 

bioaccumulative. The Group agrees with this view. 

3.5 Food Web/Population Effects 

The Group noted that the applicant had indicated that, as the full strength treated ballast water did 

not have any measurable effect on any of the test species, it would be unlikely for the diluted 

ballast water to have any negative effects on ecological communities at environmentally relevant 

concentrations. The Group agrees with this view. 

3.6 Environmental Fate and Behaviour

The Group recognized that there is no chemical Active Substance or any Relevant Chemical 

produced by the system and so there was no need to consider their environmental fate any 

further. The Group agrees with this view. 

*** 

GESAMP-BWWG 8/6 

I:\MEPC\59\2-16.DOC 

ANNEX 8 

REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES 

HHI EcoBallast – A Ballast Water Management System Consisting of Filtration and 

Disinfection by Medium-Pressure Helix UV Reactor 

Submitted for Basic Approval by the Republic of Korea 

0 SUMMARY 

0.1 Having reviewed all the information received from the applicant, the Group decided 

to recommend that Basic Approval be given to the HHI EcoBallast Ballast Water 

Management System proposed by the Republic of Korea. 

0.2 The Group noted that the HHI EcoBallast Ballast Water Management System uses a 

combination of Filtration and Medium Pressure UV Disinfection to treat the ballast water. 

0.3 The Group was satisfied that, as the system does not involve the storage or 

generation of chemicals to treat ballast water, there were no associated storage safety 

problems. 

0.4 The Group noted that the Medium Pressure UV technology in the HHI EcoBallast 

System makes use of electromagnetic radiation (photons) in order to treat ballast water. 

As such, the Group considered that it was neither necessary nor practical to provide the 

physical characteristics or toxicological profiles of such photons. 

 

0.5 However, it was recognized that the radiation (photons) might react with naturally 

occurring organic molecules in seawater to form by-products with safety and 

environmental concerns. Half lives of the photons are expected to be in the order of 

micro- to milli-seconds. 

0.6 Based on results from the chemical analyses of treated ballast water, the Group 

concurred with the views of the applicant that it was not necessary to provide toxicological 

and ecotoxicological data on these by-products and that the evaluation of the possible 

effects of treated ballast water provided in the submitted dossier was sufficient. 

0.7 The Group noted that the acute and chronic aquatic ecotoxicity testing had been 

performed as a full-scale land-based test in accordance with the requirements 

of Procedure (G9) for Final Approval (MEPC 53/24/Add.1, appendix). 

0.8 The Group noted that the potential hazards for human health related to overheating 

of UV lamps and exposure to UV irradiation resulting from operating this system were 

sufficiently addressed by the applicant by engineering control measures put in place and 

training of operators. Therefore, the Group concluded that the risks to the crew from 

exposure were sufficiently mitigated by the measures put in place. 
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0.9 In addition, the Group noted that all the disinfection by-products measured in the 

discharged ballast water were under LOD with exception of AOX (Adsorbable Organic 

Halogens) (0.29mg/L at day 5). The Group considered that these chemicals are short-lived 

and would not pose a toxicological concern towards the general public swimming and 

eating fish from the area. 

0.10 Having reviewed all the information in the non-confidential submission and the 

information received from the applicant during the GESAMP-BWWG meeting, the Group 

decided to recommend that Basic Approval be given to the BWMS submitted by 

the Republic of Korea. 

0.11 Moreover, the Group was satisfied that the required tests had been performed 

correctly and that the results demonstrated that the system met the requirements 

of Procedure (G9) to allow it to be recommended for Final Approval. The Group is of the 

opinion that this application fulfilled the requirements for Final Approval in accordance 

with Procedure (G9). 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by 

the Republic of Korea in document MEPC 59/2/4, which was supplemented by additional 

confidential information provided by the applicant. 

2 COMPLETENESS OF DOSSIER

2.1 The Group did not have any concerns which it considered should be addressed 

for Final Approval as the application contained all the information required to allow it to be 

reviewed. 

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the HHI EcoBallast Ballast Water Management System 

The Group noted that the Applicant had supplied the following information on the basic 

operation of the system. The ballast water is treated at intake (ballasting) and again at 

discharge (de-ballasting). The treatment during intake ensures that a minimal amount of 

viable organisms enters into the ballast water tanks and reduces sediment build-up in the 

ballast water tanks, which is a potential area for survival and growth of organisms. 

The water is treated again during discharge to ensure that any potential re-growth of 

organisms in the ballast water tanks is prevented. The working principle is disinfection or 

destruction of organisms through UV radiation without addition of chemical compounds. 
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3.2 Overview 

3.2.1 The ballast water management system 

3.2.1.1 The Group noted that this ballast water management system consists of three 

separate functions: filtration; disinfection of marine organisms through UV radiation; and 

controls and auxiliary functions. Accordingly, the system is composed of the following 

three main units: 

 .1 a filtration unit; 

 .2 a UV reactor, and 

 .3 a control and cleaning unit. 

3.2.1.2 The EcoBallast system is illustrated schematically above and includes the 

following components: 

.1 The filtration unit – is composed of a 50 μm filter with automatic back 

flushing. The filter removes larger particles and organisms from the water. 

This filtration reduces the sediment load of the ballast water and hence 

reduces sediment build-up in the ballast water tanks. The filter is fully automatic 

in terms of its operation and cleaning without affecting the filtration process, and 

backwashing water is returned into the sea in situ. The filter unit operates only 

during ballasting; during de-ballasting, the filter unit is by-passed; 

.2 The UV Reactor – which treats the ballast water with UV radiation both 

during ballasting and again during de-ballasting to destroy any organism 

which might have re-grown or survived in the ballast water tanks during the 

voyage. 
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The Helix type UV reactor of the EcoBallast system has been specially 

designed for ballast water application to reduce space and to maximize 

its efficiency and it employs a high-intensity, medium-pressure 

ultra-violet lamp. The helix UV reactor overcomes the limitation of 

previous UV systems for application to ballast water treatment because 

the helical lamp structure decreases the probability that water volume 

segments, including micro-organisms, pass the UV chamber without 

being exposed to sufficiently high UV doses. Sectors with relatively 

high velocity and low irradiation flow have been eliminated as far as 

possible. The helix lamp arrangement (patent pending) overcomes the 

need for additional chemical treatment due to a revolutionary lamp 

arrangement leading to an extremely uniform dose distribution at ideal 

hydraulic conditions. The applied UV dose is ideal and even organisms 

with very high resistance to UV light can be inactivated definitively. 

.3 The control and cleaning system – controls the EcoBallast BWMS and 

supplies power to all items, and the water flow meter and alarms are installed 

at different levels 

3.2.1.3 The Group accepted that this system represents a chemical-free disinfection 

procedure as no chemical compounds are added to the process. 

3.2.1.4 The Group decided this application for Basic Approval focussed on the Helix-type UV 

reactor unit, as it is the only component involving the use of Active Substance. 

3.2.2 Description of pilot scale test system used for Basic Approval 

3.2.2.1 The Group noted that, in order to confirm and justify this system, the applicant had 

developed a pilot scale system and experiments were performed in accordance with the IMO 

requirements. The treated ballast water was used for the toxicity tests, corrosivity tests and 

chemical water analysis. Chemical analysis samples were collected in triplicate at 

beginning, middle, and end of ballasting and de-ballasting. The corrosivity of UV treated 

seawater was assessed directly after treatment at the time of ballasting, whilst the acute and 

chronic aquatic ecotoxicity was measured after five days storage at the time of de-ballasting. 
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3.2.2.2 The flow diagram of the test facility is shown above. It had three 280 m3

 ballast 

tanks and a 250 m3/h ballast pump. All materials for the test facility such as pipes, valves, 

steel and paints were the same as used in ships. The test facilities were run under the 

following conditions: 

 Flow rate 210 ± 10 m3/h; 

 Treatments Two treatments, during ballasting and during de-ballasting; 

 Power consumption 39 ± 1 kW for UV unit 

 Less than 1 kW for Filter Unit 

 Treated volume more than 200 m3

 Salinity 34 PSU (Seawater), 21 PSU (Brackish water) 

 Note: For test operation, UV transmittance of water was in range between 88 and 95%. 

In this operation, the UV dose was in range between 190 and 350 mWs/cm2. 

3.2.2.3 The Group noted that, according to the applicant the full scale (200 m3

/h) 

performance test was done according to the IMO Guidelines (G8). Test results showed that 

the EcoBallast system meets the Ballast Water Performance Standard contained in 

regulation D-2 of the IMO Ballast Water Management Convention. 

3.3 Chemical processes involved (provided by the applicant) 

3.3.1 The Group noted that according to the applicant, in the HHI EcoBallast BWMS, the 

UV process produces a photon as the only Active Substance, which is responsible for 

inactivating all harmful aquatic micro-organisms and pathogens present in the ballast water. 

3.3.2 For the HHI EcoBallast system, ballast water discharge is the treated ballast water 

that has passed the UV unit twice, during ballasting and deballasting, respectively. 

3.3.3 The HHI EcoBallast BWMS does not intentionally add any Preparation besides UV 

light. 

3.3.4 According to the Applicant, the HHI EcoBallast BWMS can produce Relevant 

Chemicals. The UV radiation of EcoBallast can be absorbed by certain molecules, such as 

nitrate and dissolved organic matter (DOM) in the seawater and cause photo-chemical 

reactions to produce reactive oxygen species such as hydroxyl radical (OH•). Therefore 

hydroxyl radical (OH•) is defined by the Applicant as Relevant Chemicals. 

3.3.5 As a result of the above points, the Group accepted that chemicals are neither 

required to be stored on board nor generated on demand. 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 6 

I:\MEPC\59\2-16.DOC 

3.4 Active Substance (AS), Relevant Chemicals (RC) and Other Chemicals (OC) 

3.4.1 Active Substance 

3.4.1.1 In this MPUV-based system, the Group accepts that photons are the 

only Active Substance available to kill and inactivate micro-organisms. The definition of 

photon is a particle of electromagnetic radiation that travels at the speed of light, used to 

explain phenomena that require light to behave as particles rather than as waves. 

Accordingly, as the photons are only available upon turning on the MPUV lamp, there must 

be no residual photons in both the ballast water and ballast water discharge. Half-lives of 

the photons are expected to be in the order of micro- to milliseconds. 

3.4.1.2 Therefore the Group accepted that the photon has no chance of exposing aquatic 

plants, invertebrates, fish, and other biota, including sensitive and representative 

micro-organisms. Therefore, all tests for effects on such biota, are “not applicable” due to 

the non-residual characteristics of the photon. 

3.4.1.3 Likewise, since the photons generated in the MPUV reactor are never exposing 

mammals, all tests for effects on mammals are not applicable. 

3.4.2 Relevant Chemicals 

3.4.2.1 The Group noted that the hydroxyl radical (OH•) is defined by the Applicant as 

a Relevant Chemical in this BWMS. The Group concurred with the applicant that the 

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

nanoseconds. Under these circumstances where the hydroxyl radical (OH•) can react 

non-selectively with organic compounds to give possible reaction products, the Group 

proposed that it was neither necessary nor practical to provide the physical characteristics or 

toxicological profiles of the hydroxyl radical. 

3.4.3 Other Chemicals

3.4.3.1 It was recognized that the UV process may react with naturally occurring organic 

molecules in ballast water to form by-products with safety and environmental concerns. 

It was agreed that, it was neither necessary nor practical to provide their physical 

characteristics or toxicological profiles.

3.4.3.2 It was noted that the applicant had identified certain chemical by-products as being 

possible resultant products of the treatment system and had analysed the treated ballast 

water for them, as part of the application for Basic Approval, with the following results: 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 7 

I:\MEPC\59\2-16.DOC 

Concentrations of potential chemical by-products in control and UV-treated 

brackish water 21 PSU samples (provided by applicant) 

Time (day 0) Time (day 1) Time (day 5) 

Chemical compounds Unit MDL 

Control Treated Control Treated Control Treated 

AOX mg/L 0.01 0.45 0.39 0.76 0.36 0.68 0.29 

EOX mg/L 0.01 ND ND ND ND ND ND 

Bromate μg/L 0.46 ND ND ND ND ND ND 

Trichloromethane μg/L 0.001 ND ND ND ND ND ND 

Dibromochloromethane μg/L 0.001 ND ND ND ND ND ND 

Bromoform μg/L 0.001 0.003 0.002 0.003 ND 0.004 ND 

Dibromomethane μg/L 0.001 ND ND ND ND ND ND 

Dichlorobromomethane μg/L 0.001 ND ND ND ND ND ND 

1,2,3-Trichloropropane μg/L 0.001 ND ND ND ND ND ND 

1,2-Dibromo-3-chloropropane μg/L 0.001 ND ND ND ND ND ND 

2-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

3-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

4-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3-Dichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,4-Dichlorophenol+ 

3,5-Dichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,5-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,6-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

3,4-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,5-Trichlorophenol 

+2,4,5-Trichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,3,6-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,4,6-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

3,4,5-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4,5-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,5,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

PCP μg/L 0.03 ND ND ND ND ND ND 

2-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 

4-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 

1,2,4-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND 

1,3,5-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND 

Chloral hydrate μg/L 0.02 ND ND ND ND ND ND 

Dibromoacetonitrile μg/L 0.01 ND ND ND ND ND ND 

Dichloroacetonitrile μg/L 0.01 ND ND ND ND ND ND 

Trichloroacetonitrile μg/L 0.02 ND ND ND ND ND ND 

Monochloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Dichloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Trichloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Bromochloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Bromoacetic acid μg/L 0.01 ND ND ND ND ND ND 

Dibromoacetic acid μg/L 0.01 ND ND ND ND ND ND 

Density g/cm3 0.00001 1.0238 1.0237 1.0237 1.0237 1.0237 1.0237 

TRO mg/L 0.02 ND ND ND ND ND ND 

DOC mg/L 0.005 11.40 26.30 

POC mg/L 0.005 7.95 8.15 

TSS mg/L 77.10 79.53 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 8 

I:\MEPC\59\2-16.DOC 

Time (day 0) Time (day 1) Time (day 5) 

Salinity PSU 20.81 

 MDL = Method detection limit ND = Not detected 

Concentrations of potential chemical by-products in control and UV-treated 

seawater 34 PSU samples (provided by applicant) 

Time (day 0) Time (day 1) Time (day 5) Chemical compounds Unit MDL 

Control Treated Control Treated Control Treated 

AOX mg/L 0.01 0.51 0.51 0.45 0.48 0.24 0.29 

EOX mg/L 0.01 ND ND ND ND ND ND 

Bromate μg /L 0.46 ND ND ND ND ND ND 

Trichloromethane μg/L 0.001 ND ND ND ND ND ND 

Dibromochloromethane μg/L 0.001 ND ND ND ND ND 0.001 

Bromoform μg/L 0.001 0.015 0.008 0.016 0.008 0.010 0.004 

Dibromomethane μg/L 0.001 ND ND ND ND ND ND 

Dichlorobromomethane μg/L 0.001 ND ND ND ND ND ND 

1,2,3-Trichloropropane μg/L 0.001 ND ND ND ND ND ND 

1,2-Dibromo-3-chloropropane μg/L 0.001 ND ND ND ND ND ND 

2-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

3-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

4-Chlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3-Dichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,4-Dichlorophenol+ 

3,5-Dichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,5-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,6-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

3,4-Dichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,5-Trichlorophenol 

+2,4,5-Trichlorophenol μg/L 0.02 ND ND ND ND ND ND 

2,3,6-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,4,6-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

3,4,5-Trichlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4,5-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,4,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

2,3,5,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 

PCP μg/L 0.03 ND ND ND ND ND ND 

2-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 

4-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 

1,2,4-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND 

1,3,5-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND 

Chloral hydrate μg/L 0.02 ND ND ND ND ND ND 

Dibromoacetonitrile μg/L 0.01 ND ND ND ND ND ND 

Dichloroacetonitrile μg/L 0.01 ND ND ND ND ND ND 

Trichloroacetonitrile μg/L 0.02 ND ND ND ND ND ND 

Monochloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Dichloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Trichloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Bromochloroacetic acid μg/L 0.01 ND ND ND ND ND ND 

Bromoacetic acid μg/L 0.01 ND ND ND ND ND ND 

Dibromoacetic acid μg/L 0.01 ND ND ND ND ND ND 

Density g/cm3 0.00001 1.0139 1.0138 1.0138 1.0138 1.0139 1.0137 

TRO mg/L 0.02 ND ND ND ND ND ND 

DOC mg/L 0.005 4.62 4.55 

POC mg/L 0.005 2.12 2.20 

TSS mg/L 32.50 31.83 

Salinity PSU 33.95 

MDL = Method detection limit ND = Not detected 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 9 

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3.4.4 Conclusions 

3.4.4.1 Based on these results, the Group concurred with the views of the applicant that it 

was not necessary to provide toxicological and ecotoxicological data on these by-products 

and that an evaluation of the effects of treated ballast water should suffice to provide a 

recommendation regarding Basic Approval. 

3.4.4.2 The Group agreed that it was not necessary to evaluate the properties of 

any Active Substance or Relevant Chemical associated with this system. Instead, a brief 

evaluation was carried out on the data generated by the applicant from testing the treated 

ballast water, the results of which are shown in the Appendix to this Annex. 

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the potential hazards for human health related to overheating 

of UV lamps and exposure to UV irradiation resulting from operating this system were 

sufficiently addressed by the applicant by engineering control measures put in place and 

training of operators. Therefore the Group concluded that the risk of crew exposure was 

sufficiently mitigated by the measures put in place. 

4.2 In addition the Group noted that all the disinfection by-products measured in the 

discharged ballast water were under LOD with exception of AOX (Adsorbable Organic 

Halogens) (0.29mg/L at day 5). The Group considered that these chemicals are short-lived 

and would not pose a toxicological concern towards the general public swimming and 

eating fish from the area. The Group identified that the only potential for human health risk 

was related to exposure to UV irradiation from the treatment unit and therefore recommends 

that appropriate risk mitigation measures be put in place. 

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC 

5.1 The Group was satisfied that, as the system does not involve the storage or 

generation of chemicals to treat ballast water, there were no associated storage safety 

problems or risks. 

5.2 The Group noted that the submission identified the only potential risk to the ship 

and its crew present in the BWMS was related to UV irradiation and overheating in the 

treatment unit from the UV lamps. The submission confirmed that these identified risks 

had been addressed by system safety measures that ensure that there is no risk of personnel 

exposure to UV-irradiation and that automatic shut down occurs, in a no-flow situation, in 

order to prevent overheating.

5.3 The Group noted that the corrosivity of UV-treated seawater had been tested with the 

discharged ballast water from the EcoBallast BWMS during about six months. The test 

results showed no significant changes of the corrosivity of the discharged seawater 

compared to raw seawater. The Group concluded the results indicated that UV-treated 

seawater, the effluent of EcoBallast, has negligible effect on coating performance of ship’s 

ballast tank, when compared with natural seawater and coating performance will meet 

the IMO PSPC requirement. 
GESAMP-BWWG 8/6 

ANNEX 8 

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I:\MEPC\59\2-16.DOC 

5.4 The Group noted that the applicant had provided information 

(during the GESAMP-BWWG meeting) about normal maintenance procedures to keep the 

surface of the quartz sleeve in the UV lamps clean. This procedure includes frequent 

cleaning (every 15 hours of operation) using cleaning solution of of low concentration of 

biodegradable organic acid. The Group recommends that detailed information for safe use 

of the cleaning procedure on-board should be supplied during Type Approval and evaluated 

by the Administration in accordance with Procedure (G8).

6 ENVIRONMENTAL RISK ASSESSMENT 

6.1 Assessment of Persistence (p), Bioaccumulation (B) and Toxicity (T) 

6.1 The Group recognized that it was not possible to evaluate the persistence, 

bioaccumulation and toxicity of any chemicals within or produced by the system, as it does 

not use a chemical active substance or produce any relevant chemical for assessment. 

Assessment of the PBT-criteria is therefore considered not applicable. 

6.2 Derivation of the Predicted No Effect Concentration (PNEC) 

6.2.1 The Group noted that the applicant had provided some acute and chronic aquatic 

ecotoxicity data for the 100% treated ballast water that demonstrated a complete lack of 

toxicity in all studies except the chronic tests on Pacific Oyster ELS and Sea Urchin ELS 

with NOEC values of 12.5% and 6.25% respectively, and LC25 values of 49% and 18.5% 

respectively (both LC50 values were > 100%). 

6.2.2 The Group noted that the slight effects seen in the two chronic ecotoxicity tests had 

not been sufficiently described by the applicant in the non-confidential dossier. In response 

to a request for further information, the Group was informed that slight chronic toxicity 

effects had been observed in echinoderm and mollusc. However, the LC50 values of the 

chronic toxicity effect to echinoderm and mollusc were greater than 100% of 

the UV-treated ballast water and there should be no need for holding time in order to 

prevent adverse effects to the environment upon discharge of the ballast water. The Group 

concurred with this view. 

6.2.3 The Group agreed that the derivation of a PNEC is not possible as the nature of the 

system does not involve the use of chemicals that make the derivation of a PNEC either 

possible or necessary. The Group noted that full results of the ecotoxicity tests are provided 

in the Appendix to this annex. 

6.3 Calculation of the Predicted Environmental Concentration (PEC) 

6.3.1 The Group agreed that there would be no point in calculating the PEC of the treated 

ballast water, in view of the absence of any PNEC values. 

6.4 Calculation of the PEC/PNEC ratios 

6.4.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group 

agreed that it was not necessary to do so in the present assessment. 
GESAMP-BWWG 8/6 

ANNEX 8 

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7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

7.1.1 Based on the points expressed above in this Annex, the Group agreed that this 

system was not likely to cause any concern with regards to the safety of the ship. 

7.2 Risk to the crew and the general public

7.2.1 The Group agreed that the potential hazards for human health related to overheating 

of UV lamps and exposure to UV irradiation resulting from operating this system were 

sufficiently addressed by the applicant by engineering control measures put in place and 

training of operators. Therefore the Group concluded that the risk of crew exposure was 

sufficiently mitigated by the measures put in place. 

7.2.2 In addition the Group noted that all the disinfection by-products measured in the 

discharged ballast water were under LOD with exception of AOX (Adsorbable Organic 

Halogens) (0.29mg/L at day 5). The Group considered that these chemicals are short-lived 

and would not pose a toxicological concern towards the general public swimming and 

eating fish from the area. The Group agreed that the only potential for human health risk 

was related to exposure to UV irradiation from the treatment unit and therefore recommends 

that appropriate risk mitigation measures be put in place. 

7.3 Risks to the environment

7.3.1 Based on the acute and chronic aquatic ecotoxicity tests carried out on the treated 

ballast water, the Group agreed that this system was not likely to cause any concern with 

regards to the environment. 

7.4 Recommendations

7.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to 

recommend that Basic Approval be given to this system. 

7.4.2 Moreover, the Group was satisfied that the required tests had been performed 

correctly and that the results demonstrated that the system met the requirements of 

Procedure (G9) to allow it to be recommended for Final Approval. The Group was of the 

opinion that this application fulfils the requirements for consideration for Final Approval. 

* * * 
GESAMP-BWWG 8/6 

ANNEX 8 

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Appendix 

Properties of Treated Ballast Water 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unnecessary and irrelevant to report the 

physical properties of treated ballast water. 

2 MAMMALIAN TOXICITY

The Group noted that the applicant had indicated that, as there were no measurable 

chemical by-products, there was no need to provide any data with regards to mammalian 

toxicity. The Group agrees with this view. 

3 ENVIRONMENTAL EFFECTS 

The Group noted that some acute and chronic aquatic ecotoxicity tests had been carried out 

by the Applicant using 100% treated ballast water, both seawater (34 psu) and brackish 

water (21 psu). Results of the tests and conclusions of the Group are presented below. 

3.1 Acute Aquatic Ecotoxicity Data

3.1.1 The following text below summarizes the Group’s evaluation of the acute aquatic 

ecotoxicity of 100% treated ballast water, the detailed results of which are presented below 

in Tables 3 and 4 (supplied by Applicant). All acute tests showed no significant effects and 

all results were > 100% ballast water concentration. 

 .1 Algae: For the study to assess the effects of the UV-treated ballast water on 

the diatom, Skeletonema costatum, during 72 hours, NOEC and LOEC 

values based on the cell densities at the end of the experiment were 

calculated for both 34 psu and 21 psu treated ballast water. 

 .2 Crustacean: For the study to assess the effects of the UV-treated ballast 

water on the copepod, Tigriopus japonicus, during 48 hours, EC50, and LC50 

values based on mobilization and survival data at the end of the experiment 

were calculated for both 34 psu and 21 psu UV-treated ballast water. 

 .3 Fish: For the study to assess the effects of the UV-treated ballast water on 

flounder, Paralichthys olivaceus, during 96 hours, and LC50 values based on 

survival data at the end of the experiment were calculated for both 34 psu 

and 21 psu treated ballast water. 

 .4 Echinoderms: For the study to assess the effects of the UV-treated ballast 

water on sea urchin, Anthocidaris crassispina, during 48 hours, EC50, 

and LC50 values based on mobilization and survival data at the end of the 

experiment were calculated for 34 psu treated ballast water. 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 13 

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.5 Mollusc: For the study to assess the effects of the UV-treated ballast water 

on pacific oyster, Crassostrea gigas, during 48 hours, EC50, and LC50 values 

based on mobilization and survival data at the end of the experiment were 

calculated for 34 psu treated ballast water.

Table 3: Acute aquatic toxicity of UV-treated 34 psu ballast water 

LC50 and/or EC 50 Species End point Conc.(%)

Guideline Reference

Algae Skeletonema costatum EC50 72 h > 100 OECD 201

Crustacean Tigriopus japonicus EC50 48 h

LC50 48 h

> 100

> 100 OECD 202

Fish Paralichthys olivaceus LC50 96 h > 100 OECD 203

Echinoderm Anthocidaris crassispina EC50 48 h

LC50 48 h

> 100

> 100 OECD 202

Mollusc Crassostrea gigas EC50 48 h

LC50 48 h

> 100

> 100 OECD 202

Table 4: Acute aquatic toxicity of UV-treated 21 psu ballast water 

LC50 and/or EC 50 Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum EC50 72 h > 100 OECD 201

Crustacean Tigriopus japonicus EC50 48 h

LC50 48 h

> 100

> 100 OECD 202

Fish Paralichthys olivaceus LC50 96 h > 100 OECD 203

3.2 Chronic Aquatic Ecotoxicity Data 

3.2.1 The following text below summarizes the Group’s evaluation of the chronic aquatic 

ecotoxicity of 100% treated ballast water, the detailed results of which are presented below 

in Tables 5 and 6 (supplied by Applicant). The algae and fish chronic studies showed no 

significant effects and these results were equivalent to 100% ballast water concentration. 

However the two chronic studies on mollusc (Pacific Oyster ELS) and echinoderm 

(Sea Urchin ELS) showed some significant effects with NOEC values of 12.5% and 6.25%, 

respectively, (both LC50 values were > 100%). 

 .1 Algae: For the study to assess the effects of the UV treated ballast water on 

the diatom, Skeletonema costatum, during 96 hours, NOEC and LOEC values 

based on cell densities at the end of the experiment were calculated for both 

34 psu and 21 psu treated ballast water. 

 .2 Fish: For the study to assess the effects of the UV treated ballast water on 

olive flounder, Paralichthys olivaceus, during seven or eight days, NOEC 

and LOEC values based on number of living organisms at the end of the 

experiment were calculated for 34 psu and 21 psu treated ballast water. 
GESAMP-BWWG 8/6 

ANNEX 8 

Page 14 

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 .3 Echinoderms: For the study to assess the effects of the UV treated ballast 

water on the sea urchin, Anthocidaris crassispina, during 14 days, NOEC 

and LOEC values based on the living organisms at the end of the experiment 

were calculated for 34 psu treated ballast water. 

 .4 Mollusc: For the study to assess the effects of the UV treated ballast water on 

pacific oyster, Crassostrea gigas, during 10 days, NOEC and LOEC values 

based on the living organisms at the end of the experiment were calculated 

for 34 psu treated ballast water. 

Table 5: Chronic aquatic toxicity of UV-treated 34 psu ballast water 

LC50, LOEC, and/or 

Species NOEC

End point Conc.(%)

Guideline Reference

Algae Skeletonema costatum NOEC 96 h 100 OECD 201

Fish Paralichthys olivaceus NOEC 8 d 100 OECD 212

Echinoderm Anthocidaris crassispina

NOEC 14 d

LOEC 14 d

LC50 14 d

6.25

12.50

> 100

OECD 210

Mollusc Crassostrea gigas

NOEC 10 d

LOEC 10 d

LC50 10 d

12.50

25.00

> 100

OECD 210

Table 6: Chronic aquatic toxicity of UV-treated 21 psu ballast water 

NOEC

Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum NOEC 96 h 100 OECD 201

Fish Paralichthys 

olivaceus NOEC7 d 100 OECD 212

3.2.2 The Group noted the variability observed in the data sets on the two tests showing 

low levels of chronic toxicity, in particular with respect to the mollusc test. 

3.2.3 The Group was satisfied with the response from the applicant regarding a revised 

text in the MEPC 59/2/4: 

 .1 Page 22 in MEPC 59/2/4 

 .1 From: “No chronic toxicity was observed; see report in Appendix III. 

Section 3.2” 
GESAMP-BWWG 8/6 

ANNEX 8 

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 .2 To: “No chronic toxicity was observed in algae and fish, however, 

slight chronic toxicity was observed in echinoderm and mollusc; see 

report in Appendix III. Section 3.2” 

 .2 Page 30 and page 31 in document MEPC 59/2/4 

 .1 From: “5.2 Toxicity testing of the treated ballast water Acute and 

chronic ecotoxicity tests with “EcoBallast” treated seawater and 

brackish water covering multiple test species (a fish, an invertebrate 

and a plant) indicated no acute or chronic toxicity to any test 

organisms at any effluent concentrations as tested. Even the full 

strength effluent (100%) did not show any deleterious effects on any 

of the test species. Consequently, the effluent can be expected to be 

non-toxic to aquatic organisms as well as to the marine environment 

in general (Appendix III). The actual NOEC of “EcoBallast” treated 

seawater and brackish water was not measurable; the statistically 

determined NOEC was 100%. (Appendix III). Since the free 

radicals have a very short lifetime and no significant toxic effects to 

aquatic organisms have been observed, and the NOEC has been 

shown to be 100%, there should be no need for holding time in order 

to observe further adverse effects upon discharge.” 

 .2 To: “5.2 Toxicity testing of the treated ballast water Acute and 

chronic ecotoxicity tests with “EcoBallast” treated seawater and 

brackish water covering multiple test species (a fish, an invertebrate 

and a plant) indicated no significant acute or chronic toxicity to test 

organisms. Only slight chronic toxicity effect was observed in 

echinoderm and mollusc. However, LC50 values of the chronic 

toxicity effect to echinoderm and mollusc were greater than 100%. 

Even the full strength effluent (100%) did not show deleterious 

effects on the test species. Since the free radicals have a very short 

lifetime and no significant acute and chronic toxic effects to aquatic 

organisms have been observed, there should be no need for holding 

time in order to observe further adverse effects upon discharge.” 

3.2.4 The Group concluded that these results may reflect low residual toxicity in 

discharged water, but they are considered to have minor potential for environmental impact 

and did not require any further action. 

3.3 Information on Endocrine Disruption 

3.3.1 The Group noted that the endocrine disruption potential of treated ballast water had 

not been tested for specifically but the applicant reported that no potential endocrine 

disrupting chemicals had been identified in the treated water. 

3.3.2 Based on this information, the Group agreed that the treated ballast water was 

unlikely to have any endocrine disrupting effects. 
GESAMP-BWWG 8/6 

ANNEX 8 

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3.4 Sediment Toxicity 

3.4.1 The Group noted that the applicant had indicated that, based on the chemical 

analysis and toxicity tests of the treated ballast water, there would not be any sediment 

toxicity associated with the treated ballast water. The Group agrees with this view. 

3.5 Bioavailability/Biomagnification/Bioconcentration 

3.5.1 The Group noted that the applicant had indicated that, based on the chemical 

analysis of the treated ballast water, there was no indication of any chemical by-products 

that might be bioaccumulative. The Group agrees with this view. 

3.6 Food Web/Population Effects 

3.6.1 The Group noted that the applicant had indicated that, taking into account the 100% 

treated ballast water had been used to measure any effects on the test species, it would be 

unlikely for the diluted ballast water to have any significant negative effects on ecological 

communities at environmentally relevant concentrations. The Group agrees with this view. 

3.7 Environmental Fate and Behaviour

3.7.1 The Group recognized that there is no chemical Active Substance or any 

assessable Relevant Chemical produced by the system and so there was no need to consider 

their environmental fate any further. 

___________