I:\MEPC\57\2-10.doc 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.

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

57th session 

Agenda item 2 

MEPC 57/2/10

25 January 2008

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

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

(GESAMP-BWWG) 

Note by the Secretariat 

SUMMARY

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

GESAMP Ballast Water Working Group (GESAMP-BWWG) and 

includes the evaluation of proposals submitted for approval by 

South Africa, the Republic of Korea, Germany and Norway 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 4 

Related document: GESAMP-BWWG 5/9 (attached) 

Introduction

1 The fifth meeting of the GESAMP-BWWG was held at IMO’s temporary headquarters 

from 14 to 18 January 2008 and its report is attached to this document as GESAMP-BWWG 5/9. 

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

ballast water management systems (BWMS) that use Active Substances to treat ballast water prior 

to discharge into the marine environment. The reviews of those proposals evaluated by the Group 

are shown in annexes 5 to 8 of the attached report. The present report should be considered in 

conjunction with the fourth report of the GESAMP-BWWG (document MEPC 57/2). 

3 Over the two meetings held between MEPC 56 and MEPC 57and covering seven 

proposals, the GESAMP-BWWG recommended that Basic Approval could be granted to 

four proposals taking into account the accompanying remarks contained in the reports. 

The Group was only able to recommend Final Approval to one out of the three proposals 

submitted for consideration prior to MEPC 57. It should be noted that the Group’s decision not 

to recommend Final Approval to two proposals was in both cases based on a wide range of 

considerations. These Applicants are advised to take all of the recommendations made by the 

Group, and contained in its reports, into account prior to re-submission. 
MEPC 57/2/10 - 2 - 

I:\MEPC\57\2-10.doc 

4 The GESAMP-BWWG noted that during its third, fourth and fifth meetings, it was 

necessary to request additional information from nearly all applicants, as the dossiers were 

incomplete or, more commonly, the information provided was unclear, so slowing down the 

evaluation process. Administrations have the responsibility to ensure that Application dossiers 

are complete. They should 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. Through MEPC, the GESAMP-BWWG would like to impress upon submitting 

Administrations the need for a rigorous check of BWMSs application dossiers prior 

to submission. 

5 The GESAMP-BWWG continued to work on its Methodology for information 

gathering and conduct of work (the Methodology) and some improvements are proposed to 

sections 7.2 and 10. The latest version of the Methodology is provided in annex 4 of the 

attached report. 

Action requested of the Committee

6 The Committee is invited to: 

 .1 agree with the changes and additions included in sections 7.2 and 10 of the 

Methodology and to endorse the updated version of this Methodology as 

contained in annex 4 of the attached report; 

 .2 agree that Basic Approval should be granted to the Resource Ballast Technologies 

System as reported by South Africa in document MEPC 56/2/3 (see annex 5 of the 

current report); 

 .3 agree that Basic Approval should be granted to the GloEn-PatrolTM Ballast Water 

Management System as reported by the Republic of Korea in document 

MEPC 57/2/4 (see annex 6 of the current report); 

 .4 agree that Final Approval should be granted to the SEDNA® using PERACLEAN®

OCEAN Ballast Water Management System as reported by Germany in document 

MEPC 57/2/5 (see annex 7 of the current report); 

 .5 agree that Basic Approval should be granted to the OceanSaver® Ballast Water 

Management System (OS BWMS) as reported by Norway in document 

MEPC 57/2/6 (see annex 8 of the current report); 

 .6 reiterate the need for a careful completeness check of the application dossiers by 

the Administrations submitting proposals for approval to IMO bearing in mind 

that according to Procedure (G9) only satisfactory applications should be 

forwarded to the Organization; and 

 .7 approve the report in general. 

*** 
I:\MEPC\57\2-10.doc 

GESAMP-BWWG 

5th session 

Agenda item 9 

GESAMP-BWWG 5/9

 25 January2008

 Original: ENGLISH

REPORT OF THE FIFTH MEETING OF 

THE GESAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

1 INTRODUCTION ....................................................................... 2 

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

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

4 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR 

INFORMATION GATHERING AND THE CONDUCT OF 

WORK OF GESAMP-BWWG ........................................... 

 

5 

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST 

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

6 DATE FOR THE NEXT MEETING .................................... 6 

7 CONSIDERATION AND ADOPTION OF THE REPORT .......... 6 

ANNEXES

Annex 1 List of members who attended the fifth session of the GESAMP-Ballast Water 

Working Group 

Annex 2 Agenda for the fifth session of the GESAMP-Ballast Water Working Group 

Annex 3 Terms of reference for the Technical Group 

Annex 4 Methodology for information gathering and the conduct of work of 

GESAMP-BWWG – (Updated 18 January 2008) 

Annex 5 Review of Proposal for Basic Approval of Active Substance – ‘Resource 

Ballast Technologies System’, submitted by South Africa 

Annex 6 Review of Proposal for Basic Approval of Active Substance 

– ‘GloEn-PatrolTM Ballast Water Management System’, submitted by the 

Republic of Korea 

Annex 7 Review of Proposal for Final Approval of the Ballast Water Management System 

– ‘SEDNA® using PERACLEAN® OCEAN’, submitted by Germany 

Annex 8 Review of Proposal for Basic Approval of Active Substance – ‘OceanSaver® 

Ballast Water Management System’, submitted by Norway 
GESAMP-BWWG 5/9 - 2 - 

I:\MEPC\57\2-10.doc 

1 INTRODUCTION 

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

at IMO Headquarters, London, from 14 to 18 January 2008, under the chairmanship of 

Dr. Tim Bowmer. This extraordinary meeting was held in addition to the fourth regular meeting 

in November 2007. 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 expressed his appreciation for the effort made by the members of the 

GESAMP-BWWG to have this additional meeting before MEPC 57. He informed the Group on 

the volume of work for this session and encouraged the participants to do their utmost to try to 

evaluate, if possible, all the submissions which had been submitted before the deadline for the 

regular meeting (i.e., 7 September 2007). 

1.3 Mr. Palomares noted that in view of the rapidly increasing working load for the Group 

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

approach GESAMP, with the view to expanding the number of members of the 

GESAMP-BWWG. In this respect, Mr. Palomares invited the members of the Group to propose 

additional members that could be invited to participate the future sessions of the 

GESAMP-BWWG. 

 

1.4 Mr. Palomares informed the Group that Dr. Brigitte Behrends, who served as 

IMO consultant for the last two meetings of the GESAMP-BWWG, would not be available to 

continue to assist the Group and expressed his appreciation for her effort both during the 

preparatory phase and during the meeting, wishing her every success in her future career. 

1.5 Finally, Mr. Palomares expressed his sincere appreciation for the contribution of 

Dr. Tim Bowmer, who had chaired the Group for the last three meetings, and who will not be 

able to continue as chairman due to his new responsibilities as the Vice-Chairman of GESAMP. 

1.6 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 Mr. Egil Dragsund, arrangements 

had been made for him to be excused when the proposal for approval of the ‘OceanSaver® Ballast 

Water Management System’ (Norway) was reviewed, due to his involvement in the development 

of this technology. Mr. Dragsund took no part in this evaluation and his contract was 

consequently reduced to nine working days. 
 - 3 - GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

2 ISSUES OF CONFIDENTIALITY

2.1 Four proposals for approval of ballast water management systems submitted by the 

South Africa (Basic Approval), the Republic of Korea (Basic Approval), Germany 

(Final Approval) and Norway (Basic Approval) were reviewed at this meeting. 

2.2 The Secretariat reminded the Group that the non-confidential parts of the submissions had 

been circulated as MEPC documents (MEPC 56/2/3 for South Africa; MEPC 57/2/4 for the 

Republic of Korea; MEPC 57/2/5 for Germany; and MEPC 57/2/6 for Norway) and emphasized 

that members of the Group were requested to keep the data contained in the application dossiers 

confidential to protect the commercial interests of the manufacturers. 

2.3 Notwithstanding the above, the Group recalled the agreement of MEPC 55 that all 

information related to safety and environmental protection, including physical properties, 

environmental fate and toxicity, should be treated as non-confidential. The Group noted that the 

Organization, prior to submission of the Group’s evaluation report to the MEPC, would consult 

with the respective Administrations/applicants to ensure that the report does not contain any 

confidential information. In cases where the evaluation report is found to contain confidential 

information, the Organization would amend it accordingly, having taken the views of the 

respective manufacturer into account. 

2.4 In the case of requests to IMO from a third party for more information regarding an 

application, the Group was of the view that it might be appropriate for the Organization to 

provide the name and address of the national Administration that had submitted the original 

application for approval, which could then respond, as it feels appropriate. 

2.5 Mr. Pughiuc reported on the conclusion of the Statement of Acceptance of Access to 

Confidential Information and reminded the Group members of the need to hand over any 

documents, drafts, or any other associated records and reports, for retention in confidence at the 

end of the meeting or when they are no longer necessary for the work of the Group. He also 

pointed out to the inventory lists prepared by the IMO Consultant for each submission and 

confirmed that all the folders received from the Member States concerned are made available 

to the Group. 
GESAMP-BWWG 5/9 - 4 - 

I:\MEPC\57\2-10.doc 

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 56, as contained in annex 3 of this report. 

3.2 The Group agreed to use the table below to determine the timetable for activities related 

to its regular meetings and, on a case-by-case basis, to decide 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 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 

(1 week) Administrations confirm that no confidential data are 

contained in the report 

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

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

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

in accordance with the 13-week deadline for MEPC 
 - 5 - GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

4 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR INFORMATION 

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

4.1 Following the discussions regarding the further development of the Methodology 

conducted during its fourth meeting, the Group produced an updated version of its Methodology 

including additional guidance on Human Exposure Scenario (see paragraphs from 7.2.3 to 7.2.7) 

and on the procedure for Final Approval (see paragraphs 10.1 and 10.2). Further guidance 

regarding the Human Exposure Assessment has been incorporated as appendix 2 of the 

Methodology, which also contains in its section 6 a questionnaire on occupational exposure. 

4.2 With regard to Final Approval, the Group noted that according to Procedure (G9) the 

discharge testing should be performed as part of land-based type-approval process using the treated 

ballast water discharge. According to Guidelines (G8) each test cycle during the land-based testing 

should take place over a period of at least 5 days. The Group noted further that for ballast water 

management systems that treat the water at the intake, a 5 day lag-time between treatment and 

discharge as recommended by Guidelines (G8) to cover the possible re-growth of organisms is too 

long to allow representative sampling of water for ecotoxicity testing, as toxic chemicals will be 

degraded during the 5 days’ storage period. Consequently, the Group proposed that in the future 

“whole effluent” ecotoxicity testing and related analytical chemistry of exposure conditions should 

be conducted immediately after treatment and after a 24 or 48 hours interval to provide meaningful 

information regarding the possible impact on the receiving environment. Paragraph 10.2.4 of the 

Methodology was modified to reflect this change. 

4.3 The Group also discussed the structure and format of the Methodology, which differs 

from the reporting format used in the GESAMP-BWWG reports. This latter arrangement of the 

chapters has been adopted by the Group to improve the efficiency of the evaluation process. 

Although re-organizing the various sections of the Methodology according to the current 

reporting format is a laborious and time-consuming process, the Group agreed that it would save 

time in the long run and invited the Secretariat to explore the possibility of contracting the 

Consultant to review the format and structure of the Methodology and harmonize it with the 

reporting format used in GESAMP-BWWG reports. Such a review would also ensure that all the 

provisions contained in Procedure (G9) are adequately reflected in the Methodology and would 

assist in the effort to formalize the Methodology possibly as a technical circular. 

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS 

5.1 A detailed review of the submissions can be seen in: 

 Annex 5 Review of Proposal for Basic Approval of Active Substance – ‘Resource 

Ballast Technologies System’, submitted by South Africa 

 Annex 6 Review of Proposal for Basic Approval of Active Substance 

– ‘GloEn-PatrolTM Ballast Water Management System’, submitted by the 

Republic of Korea 

 Annex 7 Review of Proposal for Final Approval of the Ballast Water Management 

System – ‘SEDNA® using PERACLEAN® OCEAN’, submitted by 

Germany 

Annex 8 Review of Proposal for Basic Approval of Active Substance – 

‘OceanSaver® Ballast Water Management System’, submitted by Norway 
GESAMP-BWWG 5/9 - 6 - 

I:\MEPC\57\2-10.doc 

5.2 Whilst it is recommended that the summary, results and discussion of each of the reviews 

are considered in detail, the Group recommended that: 

 .1 Basic Approval be granted to the Resource Ballast Technologies System, 

submitted by South Africa; 

 .2 Basic Approval be granted to the GloEn-PatrolTM Ballast Water Management 

System, submitted by the Republic of Korea; 

 .3 Final Approval be granted to the SEDNA® using PERACLEAN® OCEAN Ballast 

Water Management System, submitted by Germany; and 

 .4 Basic Approval be granted to the OceanSaver® Ballast Water Management System, 

submitted by Norway. 

6 DATE FOR THE NEXT MEETING

6.1 The Group noted the information contained in BWM.2/Circ.12 regarding the date 

for its sixth meeting tentatively scheduled for 19 to 23 May 2008, subject to submission of 

relevant documents and application dossiers by Member States. The Group will review the 

application dossiers received before 21 March 2008 and will further develop its “Methodology 

for information gathering and the conduct of work” as necessary. The report of the Group will be 

approved by GESAMP itself and submitted to MEPC 58 (6-10 October 2008) for its 

consideration. 

7 CONSIDERATION AND ADOPTION OF THE REPORT

7.1 A draft report of the fifth meeting of the GESAMP-BWWG was produced 

on 18 January 2008, and, after a paragraph-by-paragraph review, the Group agreed on the 

final text and requested the Secretariat to make the necessary changes to ensure consistency with 

IMO documents format and style. 

7.2 In his closing remarks, the Chairman referred to the constantly increasing volume 

of work and commended the Group for considering all the seven proposals submitted 

for MEPC 57. He emphasized the usefulness of the planning meeting held on 

Sunday, 13 January 2008, with the IMO Consultant and the Secretariat, and believed that further 

optimization of the work of the Group would be needed to cope with the future workload. 

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

by the members of the Group throughout the week, valued the work done by the IMO consultant 

both in preparation and during the meeting week and closed the meeting at 17.00 hrs. 

*** 
GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 1 

LIST OF MEMBERS WHO ATTENDED THE FIFTH SESSION 

OF THE GESAMP-BALLAST WATER WORKING GROUP 

Dr. C.T. Bowmer (Chairman) 

TNO Chemistry 

Utrechtseweg 48 

Post Box 360 

3700 AJ Zeist 

The Netherlands 

E-mail: 

Tel: 

Fax: 

Mobile: 

tim.bowmer@tno.nl

+31 30 694 4645 

+31 30 694 4099 

+31 6 5318-1352 

Ms. Teresa Borges 

Senior Technical Officer 

Praça Pasteur 

No. 9 - 1◦

 esq. 

1000-238 Lisboa 

Portugal 

E-mail: 

Tel: 

Mobile: 

tborges@dgs.pt

+351 2 1843 0599 

+351 9 1779 8048 

Mr. Egil Dragsund 

Principal Marine Biologist 

Environmental and Technical Solutions 

Det Norske Veritas AS 

Veritasveien 1 

NO- 1322 Høvik 

Norway 

E-mail: 

Tel: 

Fax: 

Mobile: 

egil.dragsund@dnv.com

+47 6757 8894 

+47 6757 9911 

+47 9702 6956 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15 Toranomon 

Minatoku-ku 

Tokyo 105-0001 

Japan 

E-mail: 

Tel: 

Fax: 

s-hanayama@sof.or.jp 

+81 3 3502 1886 

+81 3 3502 2033 

Ms. Annette Kronborg 

Director 

Adalia Toxicology Consultants 

Runslingan 3E 

SE-187 72 TÄBY 

Sweden 

E-mail: 

Tel: 

Fax: 

Mobile: 

annette.kronborg@adalia.se

+46 8 510 149 36 

+46 8 510 126 02 

+46 70 483 11 23 
GESAMP-BWWG 5/9 

ANNEX 1 

Page 2 

I:\MEPC\57\2-10.doc 

Mr. Jan Linders 

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: 

Tel: 

Fax: 

jan.linders@rivm.nl 

+31 30 274 3164 

+31 30 274 4401 

IMO-GESAMP CONSULTANT 

 

Dr. Brigitte Behrends 

Marine Environment Chemist 

Marena Ltd. 

St. Annenstr. 27 

Jever 

D-26441 

Germany 

E-mail: 

Tel: 

Mobile: 

brigitte.behrends@marenaltd.com 

+49 (0) 4461 984 098 

+49 (0) 16 2244 3484 

GESAMP 

 

Mr. Fredrik Haag 

GESAMP Officer 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

fhaag@imo.org 

+44 (0)20 7463 4139 (Direct) 

+44 (0)20 7587 3210 

IMO SECRETARIAT 

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: 

Tel: 

Fax: 

dpughiuc@imo.org 

+44 (0)20 7587 3247 (Direct) 

+44 (0)20 7587 3261 

Mr. René Coenen 

IMO Technical Secretary to GESAMP 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

rcoenen@imo.org

+44 (0)20 7587 3239 

+44 (0)20 7587 3261 
GESAMP-BWWG 5/9 

ANNEX 1 

Page 3 

I:\MEPC\57\2-10.doc 

Mr. Huang Tianbing 

Technical Officer, Marine Biosafety Section 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

thuang@imo.org

+44 (0)20 7463 4198 (Direct) 

+44 (0)20 7587 3261 

*** 

GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 2 

AGENDA FOR THE FIFTH SESSION 

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 approval of Active Substances 

5 Further development of the Methodology for information gathering and conduct of work 

6 Future work programme 

7 Consideration and adoption of the report

*** 

GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 3 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with G9∗ for consideration by MEPC 57. 

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 G9); 

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

approval (see paragraph 4.3.1 of 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 G9); 

.4 Scientific evaluation of any further information submitted 

(see paragraph 8.1.2.6 of G9); 

.5 Scientific review of the risk characterization and analysis contained in the 

proposal for approval (see paragraph 5.3 of 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 G9); and 

.7 Preparation of a Report addressing the above-mentioned aspects for consideration 

by MEPC (see paragraph 8.1.2.10 of 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 MEPC (see paragraph 8.2 of 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. 

*** 

 

∗ G9 stands equivalent for MEPC 53/2/1, annex, as amended: Procedure for approval of ballast water 

management systems that make use of Active Substances (G9). 

GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 4 

METHODOLOGY FOR INFORMATION GATHERING AND THE 

CONDUCT OF WORK OF GESAMP-BWWG 

(Updated 18 January 2008) 

Page

1 INTRODUCTION................................................................................................... 4

 1.1 Terms and Definitions.............................................................................. 4

 1.2 Abbreviations used in the text................................................................. 5

 

2 GENERAL............................................................................................................... 6

 2.1 Legal provision......................................................................................... 6

 2.2 Principles of acceptability of BWMS that make use of Active 

Substances..................................................................................................... 7

 2.3 Submission of an application for Basic Approval................................. 7

 2.4 Confidentiality and data protection........................................................ 8

 2.5 Test Methods............................................................................................. 9

 2.6 Alternatives to testing and non-submission of data................................. 9

 2.7 Procedures and timelines......................................................................... 9

 

3.0 APPLICATION DATA SET.................................................................................. 10

 3.1 Identification of the Substance or Preparation (G9: 4.1).................... 10

 3.1.1 Preparations.................................................................................. 10

 3.1.2 Active Substances............................................................................ 11

 3.1.3 Relevant Chemicals (G9: 2.1.4).................................................. 11

 3.1.4 Other Chemicals........................................................................... 11

 3.2 Data on effects on aquatic plants, invertebrates and fish, and 

other biota, including sensitive and representative organisms 

(G9: 4.2.1.1).............................................................................................. 12

 3.2.1 Acute aquatic toxicity................................................................... 12

 3.2.2 Chronic aquatic toxicity............................................................... 12

 3.2.3 Endocrine disruption................................................................... 13

 3.2.4 Sediment toxicity.......................................................................... 13

 3.2.5 Bioavailability/biomagnification/bioconcentration................... 13

 3.2.6 Food web/population effects........................................................ 14

 3.3.0 Data on mammalian toxicity (G9: 4.2.1.2)............................................ 14

 3.3.1 Acute toxicity................................................................................ 15

 3.3.2 Effects on skin and eye................................................................. 15

 3.3.3 Repeated-dose toxicity................................................................. 15

 3.3.4 Chronic toxicity............................................................................ 16

 3.3.5 Developmental and reproductive toxicity.................................. 16

 3.3.6 Carcinogenicity............................................................................. 16

 3.3.7 Mutagenicity/genotoxicity........................................................... 17

 3.3.8 Toxicokinetics............................................................................... 17

 3.4.0 Data on environmental fate and effect under aerobic and 

anaerobic conditions (G9: 4.2.1.3)......................................................... 17

 3.4.1 Modes of degradation (biotic; abiotic)....................................... 18

 3.4.2 Bioaccumulation, partition coefficient, octanol/water partition 

coefficient.......................................................................................... 18

 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 2 

I:\MEPC\57\2-10.doc 

Page

 3.4.3 Persistence and identification of the main metabolites in the 

relevant media (ballast water, marine and fresh waters)......... 19

 3.4.4 Reaction with organic matter...................................................... 19

 3.4.5 Potential physical effects on wildlife and benthic habitats....... 20

 3.4.6 Potential residues in seafood....................................................... 20

 3.4.7 Any known interactive effects..................................................... 20

 3.5 Physical and chemical properties for the Active Substances and 

preparations and treated ballast water, if applicable (G9: 4.2.1.4).... 21

 3.5.1 Melting point................................................................................. 21

 3.5.2 Boiling point.................................................................................. 21

 3.5.3 Flammability (flash point)........................................................... 21

 3.5.4 Density (relative density)............................................................. 21

 3.5.5 Vapour pressure, vapour density................................................ 21

 3.5.6 Water solubility/dissociation constant........................................ 22

 3.5.7 Oxidation/reduction potential..................................................... 22

 3.5.8 Corrosivity to the materials or equipment of normal ship 

construction................................................................................... 22

 3.5.9 Auto-ignition temperature........................................................... 22

 3.5.10 Explosive properties..................................................................... 22

 3.5.11 Oxidizing properties..................................................................... 23

 3.5.12 Surface tension.............................................................................. 23

 3.5.13 Viscosity......................................................................................... 23

 3.5.14 Thermal stability and identity of relevant breakdown 

products......................................................................................... 23

 3.5.15 Reactivity towards container material....................................... 23

 3.5.16 pH................................................................................................... 23

 3.5.17 Salinity........................................................................................... 24

 3.5.18 TOC, DOC, % particulate matter.............................................. 24

 3.5.19 Other known relevant physical or chemical hazards................ 24

 3.6 Analytical methods at environmentally relevant concentration 

(G9: 4.2.1.5)......................................................................................................... 24

 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION................... 24

 4.1 The manner of application...................................................................... 24

 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)........................................... 25

 

6 RISK CHARACTERIZATION............................................................................. 26

 6.1 Screening for persistence, bioaccumulation and toxicity 

(G9: 5.1).................................................................................................... 26

 6.1.1 Persistence (G9: 5.1.1.1).............................................................. 26

 6.1.2 Bioaccumulation (G9: 5.1.1.2).................................................... 26

 6.1.3 Toxicity tests (G9: 5.1.2.3).......................................................... 26

 6.1.4 Does the Active Substance and/or preparation meet all 

three criteria for PBT?................................................................ 26
GESAMP-BWWG 5/9 

ANNEX 4 

Page 3 

I:\MEPC\57\2-10.doc 

Page

 6.2 Evaluation of the treated ballast water (G9: 5.2)................................. 27

 6.2.1 Basic Approval.............................................................................. 27

 6.2.2 Final Approval.............................................................................. 27

 6.2.3 Determination of holding time.................................................... 27

 6.3 Risk characterization and analysis......................................................... 27

 6.3.1 Reaction with organic matter 

(see G9: 4.2.1.3; this report 2.4.4).............................................. 27

 6.3.2 Characterization of degradation route and rate (G9: 5.3.5)... 27

 6.3.3 Prediction of discharge and environmental concentrations..... 28

 6.3.4 Assessment of potential for bioaccumulation............................ 28

 6.3.5 Effects assessment........................................................................ 28

 6.3.6 Effects on aquatic organisms....................................................... 29

 6.3.7 Effects on sediment....................................................................... 30

 6.3.8 Comparison of effect assessment with discharge toxicity......... 30

 

7 RISK ASSESSMENT.............................................................................................. 30

 7.1 Risk to safety of ship................................................................................ 30

 7.2 Risks to human health.............................................................................. 31

 7.3 Risks to the aquatic environment........................................................... 32

 

8 ASSESSMENT REPORT (G9: 4.3)...................................................................... 32

 

9 MODIFICATION TO THE APPLICATION...................................................... 33

 

10 FINAL APPROVAL............................................................................................... 33

 

APPENDIX 1 – KEY DATA SUMMARY FORM FOR GESAMP- BWWG 

TECHNICAL EVALUATION OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE 

SUBSTANCES TO COMPLY WITH THE CONVENTION....... 35

APPENDIX 2 – HUMAN EXPOSURE ASSESSMENT................................... 41
GESAMP-BWWG 5/9 

ANNEX 4 

Page 4 

I:\MEPC\57\2-10.doc 

1 INTRODUCTION

This document contains methodology for information gathering and the conduct of work by the 

GESAMP-BWWG when undertaking technical evaluations in accordance with resolution 

MEPC.126(53) on the Procedure for the approval of ballast water management systems that 

make use of Active Substances (G9). 

1.1 Terms and Definitions 

For the purpose of this document, these definitions are intended to supplement those in 

the Ballast Water Convention to facilitate a consistent evaluation of submissions: 

.1 Ballast Water Convention means the International Convention for the Control 

and Management of Ships’ Ballast Water and Sediments, 2004. 

.2 Ballast Water Management means mechanical, physical, chemical and 

biological processes – either singularly or in combination – to remove, render 

harmless, or avoid the uptake or discharge of Harmful Aquatic Organisms and 

Pathogens within Ballast Water and Sediments. 

.3 Preparation means any commercial formulation containing one or more Active 

Substances including any additives. This term also includes any Active 

Substances generated on board for purposes of Ballast Water Management and 

any relevant chemicals formed in the Ballast Water Management System that 

make use of Active Substances to comply with the Convention. 

.4 Active Substances means a substance or organism, including a virus or a fungus 

that has a general or specific action on or against Harmful Aquatic Organisms and 

Pathogens. 

.5 Other components of a preparation means any other substances in a preparation, 

other than the Active Substance(s) or substances, other than Relevant Chemicals, 

produced during the treatment of ballast water. 

.6 Relevant Chemicals means transformation or reaction products that are produced 

during and after employment of the Ballast Water Management System in the 

Ballast Water or in the receiving environment and that may be of concern to the 

ship’s safety, aquatic environment and/or human health. 

.7 Basic Approval means the approval of the use of Active Substances, according to 

their proposed manner of application, for prototype or type approval testing. 

The Basic Approval should confirm that the available information does not 

indicate possible unacceptable adverse effects or a potential for unreasonable risk 

of such a testing to environment, human health, property or resources. In 

recommending a Basic Approval, potential risks during full-scale deployment on 

commercial ships should be considered when possible. 

.8 Final Approval means the approval of a Ballast Water Management System 

using an Active Substance or Preparation to comply with the Convention and 

includes a review of the Type Approval tests in accordance with Guidelines for 

Approval of Ballast Water Management Systems. The Final Approval should 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 5 

I:\MEPC\57\2-10.doc 

confirm that previous evaluations of risks to ship, crew and the environment 

including storage, handling and application of Active Substances or Preparations 

remain valid and the concerns have been addressed, as well as that the residual 

toxicity of the discharge conforms to the evaluation undertaken for Basic 

Approval. The risk evaluation at Final Approval should take qualitatively into 

account cumulative effects that may occur due to the nature of shipping and port 

operations. It should consider the uncertainties involved in the application for 

approval, and as appropriate, provide advice on how these uncertainties can be 

dealt with. 

.9 GESAMP Ballast Water Working Group means the Technical Group that 

reports through GESAMP to MEPC. When considering the comprehensive 

proposal, the Group should take account of any other relevant data as well as other 

relevant information submitted to it. Experts working for GESAMP-BWWG act 

independently in their individual capacity. 

 GESAMP is the IMO/FAO/UNESCO-IOC/WMO/WHO/IAEA/UN/UNEP Joint 

Group of Experts on the Scientific Aspects of Marine Environmental Protection, 

an advisory and multi-disciplinary body consisting of specialized experts 

nominated by the sponsoring agencies. Experts working for GESAMP act 

independently in their individual capacity. 

1.2 Abbreviation used in the text 

ABBREVIATIONS 

< less than 

< less than or equal to 

> greater than 

> greater than or equal to 

μg microgram 

 

b.p. boiling point 

Bw body weight 

BWMS Ballast Water Management System 

 

°C degree Celsius (Centigrade) 

CAS Chemical Abstract Service 

Cc cubic centimetre 

 

D day(s) 

 

EC50 effect concentration, 50% (median effective concentration) 

 

G gram 

GHS Globally Harmonized System 

G9 Procedure for approval of Ballast Water Management 

Systems that make use of Active Substances (G9) 

Resolution MEPC.126(53) adopted 22 July 2005 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 6 

I:\MEPC\57\2-10.doc 

H hour 

 

IARC International Agency for Research on Cancer 

IC50 inhibition concentration, 50% 

ISO International Organization for Standardization 

IUPAC International Union of Pure and Applied Chemistry 

 

Kg kilogram 

Koc organic carbon-water partition coefficient 

 

L litre 

LC50 lethal concentration, 50% 

LD50 lethal dose, 50% 

LOAEL lowest observed adverse effect level 

LDLO lowest lethal dose 

LOEL lowest observed effect level 

Log P logarithm of the octanol/water partition coefficient 

 

MEPC Marine Environment Protection Committee 

m.p. melting point 

Mg milligram 

Ml millilitre 

 

Ng nanogram 

NOAEL no-observed-adverse-effect level 

NOEL no-observed-effect level 

 

OECD Organization for Economic Co-operation and Development 

Organization the International Maritime Organization 

 

Pow octanol-water partition coefficient 

 

TLV threshold limit value 

US EPA United States Environmental Protection Agency 

 

WHO World Health Organization 

 

wt weight 

 

2 GENERAL 

2.1 Legal provision 

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

Ballast Water and Sediments, 2004, stipulates that Ballast Water Management Systems (BWMS) 

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

by the Organization. During its fifty-third session, the Marine Environment Protection 

Committee (MEPC) adopted the Procedure for approval of Ballast Water Management Systems 

that make use of Active Substances (G9) through resolution MEPC.126(53). 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 7 

I:\MEPC\57\2-10.doc 

2.2 Principles of acceptability of BWMS that make use of Active Substances

A Ballast Water Management System that makes use of Active Substances accomplishes its 

intended purpose through action on Harmful Aquatic Organisms and Pathogens in ships’ ballast 

water and sediments. However, if the ballast water is still toxic at the time of discharge into the 

environment, the organisms in the receiving water may suffer unacceptable harm. Both the 

Active Substance itself or Preparation, as well as the treated ballast water, should be subjected to 

toxicity testing in order to determine if an Active Substance or Preparation can be used and under 

which conditions the potential for harming the receiving environment or human health is 

acceptably low. Ballast Water Management Systems that make use of Active Substances and 

Preparations must be safe in terms of the ship, its equipment and the personnel to comply with 

the Convention. 

2.3 Submission of an application for Basic Approval

2.3.1 The manufacturer of the Ballast Water Management System should evaluate the Active 

Substance(s) or Preparation(s) and the potential discharge of treated ballast water in accordance 

with the approval criteria specified below (G9: 8.1.2.1). Upon completion, the manufacturer 

should prepare an Application Dossier for the Ballast Water Management System that makes use 

of Active Substances and submit it to the Maritime Administration of a Member of the 

Organization (G9: 8.1.2.2). 

2.3.2 The Administration should evaluate the Application Dossier and confirm that it is 

satisfactory and complete before submitting it to IMO. 

2.3.3 Applications for Basic Approval of the Ballast Water Treatment System, associated 

with Active Substances, to be evaluated by the GESAMP Ballast Water Working Group should 

be addressed to: The Director, Marine Environment Division, International Maritime 

Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom. 

2.3.4 Application contents: 

.1 a complete Application Dossier including all documents identified in this 

paragraph (one paper version), including full study reports and full copies of 

literature. The complete Application Dossier should contain a contents list 

indicating the location of the information in the application. The order in which 

the information is presented, including overall structure such as how information 

is presented for the Active Substance, preparation, ballast water, risk assessment, 

assessment report, should follow this format, including its numbering, which is 

based on G9; 

.2 a non-confidential summary document (as provided to MEPC) to provide an 

overview of the application (electronic version); 

.3 a summary of the key data should be provided in a tabular format 

(electronic version); 

.4 the assessment report (electronic version); and 

.5 dossiers already used for registration of chemicals can be used to satisfy the data 

provisions of the G9 procedure (G9: 4.2.5). 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 8 

I:\MEPC\57\2-10.doc 

2.4 Confidentiality and data protection

The confidential information of the submitted documents should clearly be identified. Once an 

approval procedure is completed and the System using the Active Substance is approved, the 

following data should not be regarded as confidential: 

 .1 the name and address of the Administration; 

.2 the names and addresses of the Administrations of the Active Substance and/or the 

preparation (if different); 

.3 the names and amount of the Active Substance(s) in the preparations and the name 

of the preparation; 

.4 the names of Other Components of Preparations, in particular those that are 

regarded as dangerous according to the UN GHS or relevant IMO regulations and 

contribute to the hazard documentation of the preparation; 

.5 the names of Relevant Chemicals that may be formed during or after application 

of the BWMS and that may be of concern for the receiving environment or human 

health; 

.5.1 the names of Other Chemicals that may be formed during or after the 

application of the BWMS with a technical justification for why they 

should not be treated as Relevant Chemicals 

.6 physical and chemical data concerning the Active Substance, the preparation and 

its components and Relevant Chemicals; 

.7 a summary of the results of the tests conducted pursuant to Section 4.2 of the 

Procedure to establish the effects of the substance(s) or preparation(s) on humans 

and the environment; 

.8 a summary of the results of the tests conducted on the treated ballast water 

pursuant to Section 5.2 of the Procedure G9; 

.9 recommended methods and precautions against dangers resulting from handling, 

storage, transport and fire; 

.10 any means of rendering the Active Substance or preparation harmless; 

.11 Safety Data Sheets; 

.12 methods of chemical analysis; 

 .13 methods of disposal of the product and of its packaging; 

.14 procedures to be followed and measures to be taken in the case of spillage or leakage; 

.15 First Aid and medical advice to be given in the case of injury to persons; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 9 

I:\MEPC\57\2-10.doc 

.16 all results of the PBT assessment and the risk characterization pursuant to 

sections 5.1 and 5.3 of Procedure G9; and 

 .17 the uncertainty analysis specified in chapter 6.4.3 of Procedure G9. 

2.5 Test Methods

2.5.1 Tests should be carried out under internationally recognized guidelines (preferably OECD 

or equivalent) (G9: 4.2.3), and according to an internationally recognized quality assurance 

system (G9: 4.2.4) (e.g., GLP). Information may be derived from existing data where an 

acceptable justification is provided. Full copies of sources of data (e.g., literature papers) should 

be provided. 

2.5.2 Care should be taken to provide full supporting references and copies of the appropriate 

test laboratory reports in support of each application. If submissions are lacking relevant 

information, it may not be possible for the Group to conduct a thorough risk assessment. 

2.5.3 Many substances have acquired large databases for many of the hazards concerned and a 

weight of evidence approach has become necessary to ensure that the rating reflects the body of 

data rather than simply using the most conservative value. This, however, means the submission 

of all available end-point data for Active Substances and Relevant Chemicals is necessary to 

enable a thorough review. 

2.5.4 The Administration should supply a list of test substances (for example, trade names) 

specified in study reports and literature data and an explanation of how the tested substances 

relates to the current application. 

2.6 Alternatives to testing and non-submission of data

2.6.1 Alternative methods to testing on live organisms, e.g., in vitro testing methods, QSAR, 

extrapolation by analogy to known chemicals, or grouping of similar substances, may be used 

whenever justified. Sufficient documentation or references to documentation on the validity of 

the method should be provided, as well as documentation that the substance or preparation lies 

within the applicability domain of the method. 

2.6.2 Information that is not necessary, owing to the nature of the substance or of its proposed 

uses and taking into account all proposed risk management measures, need not be supplied. 

The same applies where it is not scientifically necessary or technically possible to supply the 

information. In such cases, a justification should be submitted, which would help the Group’s 

evaluation of the Application Dossier. 

2.7 Procedures and timelines 

2.7.1 Procedures for the evaluation of the dossier are given in the Appendix to G9. If, in the 

course of the review by the Ballast Water Working Group, it becomes evident that additional data 

are found to be necessary in order to finalize the evaluation, the Group may request that such data 

are submitted. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 10 

I:\MEPC\57\2-10.doc 

2.7.2 The Administration will be informed, in writing, of the decision of the Organization. 

The Administration may appeal against any decision made by the Organization. 

The Organization will consider the appeal and respond in writing to the Member of the 

Organization. 

2.7.3 It may be useful for a technical representative of the applicant to be available to the 

BWWG for an hour or so to answer questions regarding the system. 

3.0 APPLICATION DATA SET 

3.0.1 The dossier should contain the information specified in G9. In cases where information 

requested in accordance with Procedure G9 has not been submitted and no justification for 

non-submission is provided, the Group may not be able to judge the reasons for not submitting 

the information that may influence its evaluation and development of recommendations. 

3.0.2 For Active Substances and/or Preparations including any of its components as 

appropriate, data on properties should be included. For Relevant Chemicals, data should be 

provided as well. 

3.0.3 Fate and effect testing should be performed in the laboratory with Active Substances and 

Preparations (G9: 5.3.1). However, the Group notes that normally assessment of fate (including 

degradation, bioaccumulation) is not feasible for preparations, but only for individual substances. 

Therefore, degradation and fate testing of Preparations may not be appropriate. 

3.0.4 For treated ballast water, the Administration should provide both acute and chronic toxicity 

data (G9: 5.2.2). The discharge toxicity tests should include chronic test methods performed as 

part of the land-based type approval process with test species (fish, invertebrate, algae) that address 

the sensitive life stage (G9: 5.2.4). The results should include acute LC50 values and chronic 

NOECs (G9: 5.2.5). Therefore, 100% concentrations of samples of ballast water discharge 

should be tested (G9: 5.2.6), if appropriate. 

3.0.5 Any reference to specific test methods in the following is indicative with the purpose of 

providing guidance to an Administration on possible methods that may be considered. Any other 

internationally recognized test method may also be used as well. 

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

3.1.1 Preparations: For each Preparation, the application should include the following 

information (G9: 4.2.2): 

 .1 the Trade name; 

 .2 compositional information of the Preparation including: 

 .1 the chemical (IUPAC) name of each component; 

 .2 the concentration of each component (liquids in g/l; solids in %w/w; gases 

in %v/v); 

 .3 the CAS number of each component; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 11 

I:\MEPC\57\2-10.doc 

 .4 the UN number and proper shipping name of each component (where 

relevant); and 

 .5 an indication of whether the component is an Active Substance (AS) or a 

stabilizer or inhibitor or solvent, etc. 

3.1.2 Active Substance: For each Active Substance, the applicant should provide the 

following information: 

 .1 the Trade name (where relevant); 

 .2 the chemical (IUPAC) name; 

 .3 the CAS number; 

 .4 the UN number and proper shipping name (where relevant); 

 .5 the Molar mass; 

 .6 the empirical formula; 

 .7 the structural formula; 

 .8 the classification in accordance with the UN GHS system; 

 .9 the purity of the technical material and identification of impurities (chemical name 

and CAS-numbers, etc.); and 

 .10 the identity of any stabilizers or necessary additives. 

3.1.3 Relevant Chemicals (G9: 2.1.4): Where the process might produce by-products when 

reacting with ballast water, the applicant should provide the following information for those 

products deemed to be Relevant Chemicals: 

 .1 the Chemical (IUPAC) name; 

 .2 the CAS number; 

 .3 the Molar mass; 

 .4 the empirical formula; 

.5 the structural formula; and 

 .6 the classification in accordance with the GHS system. 

3.1.4 Other Chemicals: Where the process might produce by-products not deemed to be 

Relevant Chemicals by the applicant, a justification for such a conclusion should be provided. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 12 

I:\MEPC\57\2-10.doc 

3.2 Data on effects on aquatic plants, invertebrates and fish, and other biota, including 

sensitive and representative organisms (G9: 4.2.1.1) 

3.2.0 For every Active Substance or Preparation including any of its components, data should 

be presented and discussed either on the basis of toxicological tests or existing toxicological 

knowledge for each end point listed. 

3.2.1 Acute aquatic toxicity 

3.2.1.1 Short-term L(E)Cx from freshwater or saltwater representatives of 

three taxonomic groups (algae, crustaceans and fish) representing three trophic levels 

(e.g., OECD guidelines 201 (Algae, Growth Inhibition Test), 202 (Daphnia sp. Acute 

Immobilization Test), 203 (Fish, Acute Toxicity Test), Mysid shrimp acute toxicity test 

(USEPA 850.1035) should be accepted. To reduce further any remaining uncertainty, 

Administrations should, preferably, also submit data for two additional marine taxonomic groups 

(e.g., echinoderms, molluscs). 

3.2.1.2 In the case of whole effluent testing, EPA or equivalent, short-term methods for 

estimating the acute toxicity of substances and discharge provide acceptable alternatives. 

3.2.1.3 Such acute aquatic toxicity data should be provided for: 

.1 Preparations including any of its components; 

.2 Active Substances; 

.3 Relevant Chemicals; and 

.4 Treated ballast water (G9: 5.2.3). 

3.2.2 Chronic aquatic toxicity 

3.2.2.1 Long-term NOECs or ECx from three freshwater or saltwater species (normally algae 

and/or crustaceans and/or fish) representing three trophic levels (e.g., Fish: OECD 210, 215, 

or 212; Daphnia: OECD 211). To reduce further any remaining uncertainty, Administrations 

should preferably also submit two long-term NOECs from additional marine taxonomic groups 

(e.g., echinoderms, molluscs). 

3.2.2.2 In case of whole effluent testing, EPA short-term methods for estimating the chronic 

toxicity of substances and discharge provide acceptable alternatives, since the identification of the 

sensitive sub-lethal endpoints and vulnerable life-stages is the ultimate aim of the long-term testing. 

3.2.2.3 Such chronic aquatic toxicity data should be provided for: 

.1 Preparations including any of its components; 

.2 Active Substances; 

.3 Relevant Chemicals; and 

.4 Treated ballast water (fish, invertebrate, plant) (G9: 5.2.3). 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 13 

I:\MEPC\57\2-10.doc 

3.2.3 Endocrine disruption

3.2.3.1 Regarding the risks connected to endocrine disruption, non-standardized in vivo as 

well as in vitro tests may be conducted as long as no internationally standardized tests are 

available (e.g., full-life-cycle test on fish or amphibian metamorphosis assay). When substantial 

evidence on such effects is available, this should be taken into account on a case-by-case basis 

and in the effect assessment for each compartment of relevance. If there is no indication for 

endocrine disruption – e.g., due to the structure of the substance or results of other available 

studies – these tests may be waived. 

3.2.3.2 Such information on endocrine disruption should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.2.4 Sediment toxicity

3.2.4.1 Substances that are potentially capable of depositing on or adsorbing to sediments to a 

significant extent should be assessed for toxicity to sediment-dwelling organisms. Testing is 

considered relevant only if log Kow > 3 or if there is similar adsorption behaviour and should 

include a maximum of three long-term tests with species representing different living and feeding 

conditions (e.g., Chironomus spec. (OECD 218), Lumbriculus variegates) including a minimum 

of two tests with marine species. 

3.2.4.2 For substances that are persistent in marine waters or may accumulate in sediments, a 

specific marine sediment assessment is necessary. 

3.2.4.3 Such information on sediment toxicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

.4 Treated ballast water. 

3.2.5 Bioavailability/biomagnification/bioconcentration

3.2.5.1 If log Pow >3, testing of the bioaccumulation potential should be considered taking 

into account the following points: 

 .1 One bioconcentration factor (BCF) determined in a bioconcentration study 

(at two dosing levels) with fish (e.g., OECD 305) or bivalves. The BCF should be 

based on uptake/elimination kinetics (k1/k2). The half-life for elimination should 

be reported. Fat content in marine fish typically ranges between 0.5 and 15% of 

the whole body weight. BCF should be normalized to 6% fat; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 14 

I:\MEPC\57\2-10.doc 

 .2 The biomagnification and persistence in the food web should be discussed based 

on the results from aquatic toxicity testing, mammalian toxicity evaluation and 

bioaccumulation and biodegradation data; and 

 .3 There are no data provisions on bio-availability since it is considered that the 

bio-availability in the toxicity test systems is equivalent to the conditions under 

assessment. If the bioavailability of the Active Substance or Relevant Chemical in 

the discharge or the receiving environment is to be assessed, consequently, the 

bio-availability in the toxicity testing is to be reconsidered. 

3.2.5.2 Such information on bioavailability/biomagnification/bioconcentration should be 

provided for: 

 .1 Active Substances; 

 .2 Any components of a preparation; and 

 .3 Relevant Chemicals. 

3.2.6 Food web/population effects

3.2.6.1 The biomagnification and persistence in the food web should be discussed based on 

the results from aquatic toxicity testing, mammalian toxicity evaluation and bioaccumulation and 

biodegradation data. 

3.2.6.2 An assessment of secondary poisoning is redundant if for the substance of concern 

absence of bioaccumulation potential can be demonstrated (BCF <500 L/kg wet weight for the 

whole organism at 6% fat). If not, testing should include: 

 .1 one long-term NOECs based on reproduction studies with a bird species; and 

.2 two NOECs from long-term studies with two mammalian species (from section 2.3 

below). 

3.2.6.3 Such information related to the food web/population effects should be provided for: 

 .1 Active substances; and 

.2 Relevant Chemicals. 

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2) 

3.3.0.1 Information that is deemed to be unnecessary need not be supplied. However, in such 

cases a scientific justification should be submitted in order to explain why the data have not been 

provided. In general, testing with vertebrate animals should be avoided if other type of 

information is available that allows an assessment of hazards and risks to humans. 

Such alternative information may be obtained by validated in vitro methods, Quantitative 

Structure Activity Relationships (QSAR), and grouping or read-across with similar substances. 

If available, human experience or epidemiological evidence should be presented and discussed. 

3.3.0.2 In general, information should be provided on the Active Substance and the 

Preparation including any of its components, as appropriate. Information on Relevant Chemicals 

formed during or after application of the BWMS should be provided as well. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 15 

I:\MEPC\57\2-10.doc 

3.3.1 Acute toxicity 

3.3.1.1 The acute toxicity should be known for at least two routes of exposure, one of which 

should be the oral route. Active Substances or Preparations that are gases should be tested 

by inhalation. 

3.3.1.2 The submission of dermal and/or inhalation studies instead of or in addition to oral 

studies may be requested depending on the physico-chemical properties of the substance, the 

proposed or potential application of the substance/products. 

3.3.1.3 Such information on acute toxicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.2 Effects on skin and eye 

3.3.2.1 The tests should provide information on the degree and nature of skin, eye and 

associated mucous membrane irritation, especially with regard to the reversibility of responses. 

The tests should provide sufficient information to assess the potential to cause skin sensitization 

reactions. Animal testing should, whenever possible, be minimized. Tests should be performed 

with the Active Substance(s) or Preparation(s). 

3.3.2.2 Testing of Active Substances or Preparation should include a study on acute dermal 

irritation/corrosion and a study on acute eye irritation/corrosion. The recommended tests are 

OECD guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye 

Irritation/Corrosion). These tests need not be carried out on a strong acid or base (pH below 2 or 

above 11.5). Where the Active Substance or Preparation has shown to have potentially corrosive 

properties, or is a severe skin irritant, an eye irritation test should not be carried out. Results 

from in vitro test methods, which are close to validation by recognized organizations, may be 

submitted. 

3.3.2.3 The recommended test for Skin Sensitization is OECD guideline 406. While the 

guinea-pig Maximization test is considered to be the preferred adjuvant technique in certain 

cases, there may be good reasons for choosing the Buehler test or the Local Lymph Node 

Assay (LLNA). However, scientific justification should be given when either of the two latter 

mentioned is used. The test is not needed if the Active Substance or Preparation is already 

classified in an internationally recognized system or otherwise known as a sensitizer. 

3.3.2.4 Such information related to the effects on skin and eyes should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.3 Repeated-dose toxicity 

3.3.3.1 A 90-day sub-chronic toxicity study in two species, one rodent and another 

mammalian species, using the oral route unless another one is more appropriate. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 16 

I:\MEPC\57\2-10.doc 

3.3.3.2 Such information on repeated dose toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

3.3.4 Chronic toxicity 

3.3.4.1 There is a need for a chronic toxicity study of a minimum duration of 12 months 

in two species – one rodent and another mammalian species – unless a full justification 

demonstrates that this test is not necessary. 

3.3.4.2 Any chronic study can be combined with a carcinogenicity study. 

3.3.4.3 Such information on chronic toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.5 Developmental and reproductive toxicity 

3.3.5.1 Testing should include: 

.1 a two-generation reproduction and fertility study (OECD guideline 416 – 

Two-Generation Reproduction Toxicity Study); and 

.2 a prenatal developmental toxicity (teratogenicity) study in two species 

(OECD guideline 414 – Prenatal Developmental Toxicity Study). 

3.3.5.2 However, these key data can be modified (either reduced or accelerated or extended) 

and influenced by factors such as structural relationships with a known reproductive toxicant, the 

results of other toxicity studies (including toxicokinetics), concerns for endocrine disruption and 

anticipated use, and human exposure patterns. 

Such information on developmental and reproductive toxicity should be provided for: 

 .1 Preparation including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.6 Carcinogenicity 

3.3.6.1 Carcinogenicity studies should be performed with one rodent and one other 

mammalian species. The carcinogenicity testing of an Active Substance or preparation may not 

be needed where justification demonstrates that these tests are not necessary. Carcinogenicity 

studies may be combined with the chronic toxicity studies. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 17 

I:\MEPC\57\2-10.doc 

3.3.6.2 Such information on carcinogenicity should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.7 Mutagenicity/genotoxicity 

3.3.7.1 Genotoxicity data should be available for Active Substances or preparations from at 

least three tests: a bacterial gene mutation test, an in vitro mammalian cell cytogenicity study and 

an in vitro mammalian cell gene mutation assay. In case of positive or equivocal results, further 

in vivo mutagenicity testing with bone marrow assay for chromosomal damage or a micronucleus 

test is necessary. If this test is negative it should be evaluated whether mutagenicity or evidence 

of DNA damage can be demonstrated in tissue other than bone marrow. 

3.3.7.2 Such information on mutagenicity and genotoxicity should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.3.8 Toxicokinetics 

3.3.8.1 Basic data on the toxicokinetics of Active Substances and other components of a 

preparation as well as Relevant Chemicals should be included. Information on absorption, 

distribution, metabolism and elimination (e.g., OECD 417) should be presented, if available, to 

allow better understanding of toxic effects and a reduction of animal testing. The potential for 

dermal absorption should be evaluated preferably in vitro or by physico-chemical data to reduce 

the need for any specific dermal toxicity testing. 

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

(G9: 4.2.1.3) 

3.4.0.1 The route of abiotic and biotic degradation of the Active Substances, components of a 

preparation and Relevant Chemicals under aerobic and anaerobic conditions should be assessed, 

resulting in the identification of relevant metabolites in the relevant media (ballast water, marine 

and fresh waters) (G9: 5.3.4). 

3.4.0.2 The partition coefficients solids-water partition coefficient (Kd) and/or organic carbon 

normalized distribution coefficient (Koc) of the Active Substances, components of a preparation 

and Relevant Chemicals should be determined (G9: 5.3.6). 

3.4.0.3 The data submitted in accordance with this paragraph should clarify, in addition to the 

degradation of the substance, other relevant routes of dispersion in and from water, such as 

volatilization, adsorption, sedimentation and transformation into bound residues. Accordingly, 

the exposure of organisms living in water and the sediment should be established. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 18 

I:\MEPC\57\2-10.doc 

3.4.1 Modes of degradation (biotic; abiotic) 

3.4.1.1 Testing should include: 

 .1 a study on hydrolysis at pH 5, 7, and 9 under aerobic conditions according to 

OECD guideline 111; 

 .2 a study on ready biodegradability according to OECD guideline 301 

(Ready Biodegradability) or equivalent guidelines if the Active Substance is 

discharged only into fresh water; 

 .3 a study on ready biodegradability according to OECD guideline 306 

(Biodegradability in Seawater) or equivalent guidelines if the Active Substance is 

discharged only into marine water; and 

 .4 studies on ready biodegradability according to OECD guideline 301 

(or equivalent guidelines) and OECD guideline 306 (or equivalent guidelines) 

if the Active Substance is discharged into estuarine water (e.g., inland harbour 

with contact to seawater). 

3.4.1.2 If the active Active Substance is not readily biodegradable, then the following higher 

tier studies should be conducted: 

 .1 a study on aerobic and anaerobic transformation in aquatic sediment systems 

according to OECD guideline 308 (Aerobic and Anaerobic Transformation in 

Aquatic Sediment Systems) or equivalent guidelines if Koc >500 L/kg, using fresh 

or marine water depending on kind of aquatic ecosystem where discharge is 

intended. At least one system with high organic matter/nutrient content and one 

with low organic matter/nutrient content should be tested (see above); 

 .2 a study on aerobic transformation of low concentrations of organic contaminants 

according to OECD guideline 309 (Aerobic Mineralization in Surface Water 

– Simulation Biodegradation Test) or equivalent guidelines, using fresh or marine 

water depending on the kind of aquatic ecosystem where discharge is intended; 

and 

 .3 where relevant, a study on photo-transformation in water e.g., US EPA 

OPPTS 835.2210 (1998) and/or OECD Guidance document 

on photo-transformation in water (1997). 

3.4.1.3 Such information on the modes of degradation should be provided for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.4.2.1 Testing should include: 

 .1 data on bioconcentration and biomagnification, which have already been detailed 

earlier in this document; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 19 

I:\MEPC\57\2-10.doc 

 .2 a study into the log Pow according to OECD guideline 107 (Partition 

Coefficient (n-octanol/water): Shake Flask Method), OECD 

guideline 117 (Partition coefficient – n-octanol/water HPLC method) or 

equivalent test guidelines. For very hydrophobic compounds, a slow stirring 

method is appropriate (e.g., OECD 123 (Partition coefficient – slow stirring 

method)); and 

 .3 the partition coefficient between solids and liquids should be 

determined e.g., according to EU Technical Guidance Document on Risk 

Assessment (2003) for at least three inocula, including freshwater sediment, 

marine sediment, and particulate matter (sludge) (OECD 106). If no measured 

data are available for a specific adsorbing material, it is assumed that all 

adsorption can be related to the organic matter of the medium, viz. standardization 

to Koc. This is only valid for non-ionic substances. For ionic substances, the 

Kp values and the test characteristics (%clay, CEC, %o.c., pH) should be reported. 

3.4.2.2 Such information on bioaccumulation and partition coefficients should be provided for: 

 .1 Active Substances; 

 .2 any other components of preparations; and 

 .3 Relevant Chemicals. 

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

(ballast water, marine and fresh waters) 

3.4.3.1 The route of degradation in the higher tier simulation tests specified under 

section 3.4.1 of this document should be characterized based on a mass balance, including 

mineralization and formation of bound residues. Reaction or transformation products formed 

that may be considered as Relevant Chemicals should be identified. 

3.4.3.2 Such information on persistence and metabolites should be provided for: 

 .1 Active Substances; 

 .2 any components of preparations; and 

 .3 Relevant Chemicals. 

3.4.4 Reaction with organic matter 

3.4.4.1 The reaction of radicals produced by the action of Active Substances1 with organic 

matter should be addressed qualitatively as to identify products of concern to the environment 

and, where possible, quantitatively as to identify environmental concentrations. 

3.4.4.2 Radical producing chemicals are capable of forming halogenated (chlorinated, 

brominated) hydrocarbons that may be of concern to environmental or human health, in the 

presence of organic matter. For these substances, the freely and otherwise reasonably available 

information should be presented and discussed in relation to the proposed manner of application, 

since they are subject to the decision-making criteria. 

 

1 MEPC 55/2/6, paragraph 33. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 20 

I:\MEPC\57\2-10.doc 

3.4.4.3 Such information on the reaction with organic matter should be provided for: 

 .1 Active Substances; and 

 .2 Relevant Chemicals. 

3.4.5 Potential physical effects on wildlife and benthic habitats 

3.4.5.1 Data requirements consist of physical-chemical properties also required later. Further 

guidance can be found in the MEPC-approved hazard evaluation procedure published as 

GESAMP Reports and Studies No.64. 

3.4.5.2 Such data on the potential physical effects on wildlife and benthic habitats should be 

provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substance; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.4.6 Potential residues in seafood

3.4.6.1 As appropriate, data should be submitted to assess the risk that residues of the Active 

Substance end up in seafood, the possible impact on consumer safety and the level of residues 

that may be tolerated in seafood. Any available monitoring data on residues of the substance in 

seafood should be submitted. 

3.4.6.2 Such data on potential residues in seafood should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.4.7 Any known interactive effects

3.4.7.1 Any knowledge (or absence of this knowledge) on interactive effects of the Relevant 

Chemicals with the ballast water, with other preparations to be used in ballast water, with other 

physical or chemical management of the ballast water, or with the receiving environment, should 

be reported. 

3.4.7.2 Such information on known interactive effects should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 21 

I:\MEPC\57\2-10.doc 

3.5 Physical and chemical properties for the Active Substances and preparations and 

treated ballast water, if applicable (G9: 4.2.1.4) 

Data should be submitted for the Active Substances, preparations including any of its 

components, the treated ballast water on board and the Relevant Chemicals to allow for the 

identification of hazards to the crew, the ship and the environment. 

3.5.1 Melting point

Data on the melting point should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active substances. 

3.5.2 Boiling point 

Data on the boiling point should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.3 Flammability (flashpoint) 

Data on the flash point should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.4 Density (relative density) 

Data on the density should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Treated ballast water. 

3.5.5 Vapour pressure, vapour density

Data on the vapour pressure and vapour density should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 22 

I:\MEPC\57\2-10.doc 

3.5.6 Water solubility/dissociation constant 

Data on the water solubility and dissociation constants should be provided for: 

.1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.7 Oxidation/reduction potential

Data on the oxidation/reduction potentials should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.5.8 Corrosivity to the materials or equipment of normal ship construction

Data on the corrosivity to materials of construction should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.5.9 Auto-ignition temperature 

Data on the auto-ignition temperature should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.10 Explosive properties 

Data on the explosive properties should be provided for: 

 .1 Preparations;2

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

 

2 MEPC 55/2/6, paragraph 34. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 23 

I:\MEPC\57\2-10.doc 

3.5.11 Oxidizing properties 

Data on the oxidizing properties should be provided for: 

 .1 Preparations; 

 .2 Active Substances; and 

 .3 Relevant Chemicals. 

3.5.12 Surface tension 

Data on the surface tension should be provided for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.5.13 Viscosity 

Data on the viscosity should be provided for: 

 .1 Preparations; and 

 .2 Active Substances. 

3.5.14 Thermal stability and identity of relevant breakdown products

Data on the melting point should be provided for: 

 .1 Preparations including any of its components; and 

 .2 Active Substances. 

3.5.15 Reactivity towards container material

Data on the reactivity towards container materials should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.5.16 pH 

Data on the pH should be provided for: 

 .1 Preparations; and 

 .2 Treated ballast water. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 24 

I:\MEPC\57\2-10.doc 

3.5.17 Salinity 

Data on the salinity should be provided for: 

 .1 Treated ballast water. 

3.5.18 TOC, DOC, % particulate matter

Data on the TOC, DOC and % of particulate matter should be provided for: 

 .1 Treated ballast water. 

3.5.19 Other known relevant physical or chemical hazards 

Data on the any other known relevant physical or chemical hazards should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substances; 

 .3 Relevant Chemicals; and 

 .4 Treated ballast water. 

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) 

Recognizing that some methods may only cover a range of chemicals e.g., TRO, analytical 

methods at environmentally relevant concentrations should be provided for: 

 .1 Preparations including any of its components; 

 .2 Active Substance; and 

 .3 Relevant Chemicals. 

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION 

4.1 The manner of application 

4.1.1 The proposal should include the manner of application of the Active Substance or the 

preparation for the Ballast Water Management (BWM), including required dosage and retention 

time (G9: 4.2.6). 

4.1.2 In relation to point 7 of the Procedure, the dossier should contain the necessary data 

addressing the following items: 

 .1 the technical manual or instructions by the Administration, including the product 

specification, process description, operational instructions, details of the major 

components and materials used, technical installation specifications, system 

limitations, and routine maintenance should be provided (BWWG), including 

quantity to be added to ballast water and maximum concentration of the Active 

Substance therein; 

 .2 recommended methods and precautions concerning handling, use, storage, and 

transport; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 25 

I:\MEPC\57\2-10.doc 

 .3 procedures to be followed in case of fire, and the nature of reaction products, 

combustion gases, etc.; 

 .4 emergency measures in case of an accident; 

 .5 an indication of the possibility of destruction or decontamination following release 

in the marine environment; 

 .6 procedures of waste management of the Active Substance; 

.7 the possibility of reuse or recycling; 

 .8 the possibility of neutralization; 

 .9 conditions for controlled discharge; and 

 .10 the amount of substance on board ship. 

4.1.3 Appropriate risk management measures (e.g., for neutralization of the Active Substance 

in case of emergency or if PEC/PNEC at discharge >1) should be described. These management 

measures are an integral part of the Ballast Water Management System and should be evaluated 

in the assessment. 

4.1.4 The risk management measures proposed should be evaluated in respect to the hazards to 

ship, personnel and the environment. 

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) 

5.1 With respect to the classification of hazards, a detailed technical guidance document has 

been prepared for the United Nations Globally Harmonized System of Classification and 

Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. 

Reference is also made to the MEPC-approved hazard evaluation procedure published as 

GESAMP Reports and Studies No.64 under the title “The Revised GESAMP Hazard Evaluation 

Procedure for Chemical Substances Carried by Ships”, which reflects the GHS for marine 

environmental protection aspects. The Administration is referred to this document for a more 

detailed guidance on hazard identification. 

5.2 The Classification under GHS and the (Material) Safety Data Sheet ((M)SDS) should be 

given for all components of a Preparation (G9: 6.3.2). Where a component is not classified as 

hazardous under GHS, this should also be clearly stated. 

5.3 The same information should also be given for Relevant Chemicals and other by-products 

produced by the system unless a clear justification is provided e.g., the half-life of the by-product 

is so short that the hazards cannot be determined. Key data for these should be summarized in 

the Key Data Summary Table. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 26 

I:\MEPC\57\2-10.doc 

6 RISK CHARACTERIZATION 

6.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1) 

6.1.1 Persistence (G9: 5.1.1.1) 

6.1.1.1 Persistence is preferably assessed in simulation test systems to determine the half-life 

under relevant conditions. Biodegradation screening tests may be used to show that the 

substances are readily biodegradable. The determination of the half-life should include 

assessment of Relevant Chemicals. 

6.1.1.2 For persistence and degradation data, see 3.4.1 and 3.4.3 of this document. 

6.1.2 Bioaccumulation (G9: 5.1.1.2)

6.1.2.1 The assessment of the bioaccumulation potential should use measured bioconcentration 

factors in marine (or freshwater organisms). Where test results are not available, the assessment 

of the bioaccumulation potential of an organic substance may be based on the log Pow. 

For bioaccumulation data, see 3.2.5 and 3.4.2 of this document. 

6.1.3 Toxicity tests (G9: 5.1.2.3) 

6.1.3.1 Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages, 

should be used for the assessment of the toxicity criterion. 

6.1.3.2 For ecotoxicity data, see 3.2 of this document. 

6.1.3.3 It is necessary to consider, whether an effect assessment based on tests in freshwater 

species offers sufficient certainty that sensitive marine species will be covered by any risk 

assessment. 

6.1.4 Does the Active Substance and/or preparation meet all three criteria for PBT? 

See G9: Table 1. 

Criterion PBT criteria 

Persistence Half-life: 

> 60 days in marine water, or 

> 40 days in fresh water,*

 or 

> 180 days in marine sediments, or 

> 120 days in freshwater sediments 

Bioaccumulation Experimentally determined BCF > 2,000, or if 

no experimentally BCF has been determined, 

Log Pow≥3 

Toxicity Chronic NOEC < 0.01 mg/l 

*

 For the purpose of marine environmental risk assessment half-life data in fresh water and freshwater sediment 

can be overruled by data obtained under marine conditions. 

Active Substances or Preparations identified as PBT substances will not be recommended for 

approval in accordance with paragraph 6.4.1 of the Procedure. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 27 

I:\MEPC\57\2-10.doc 

6.2 Evaluation of the treated ballast water (G9: 5.2)

The advantage of toxicity testing on the ballast water discharge is that it integrates and addresses 

the potential aquatic toxicity of the Active Substance, preparation including any of its 

components and Relevant Chemicals formed during and after application of the BWMS. 

6.2.1 Basic Approval

6.2.1.1 Testing should be performed in laboratory of a sample prepared by simulation of the 

BWMS (G9: 5.2.1). 

6.2.1.2 A system using Active Substances or Preparations that have received Basic Approval 

by the Organization may be used for evaluation of Ballast Water Management Systems using 

Active Substances or Preparations for Final Approval (G9: 8.2.1). 

6.2.2 Final Approval

6.2.2.1 Full-scale land-based toxicity tests with samples of ballast water treated with the 

BWMS under test conditions and a scale as defined in Guidelines (G8) during on-board testing 

should be conducted (G9: 5.2.2). 

6.2.2.2 In accordance with Regulation D-3.2, a Ballast Water Management System using an 

Active Substance or Preparation to comply with the Convention (that received basic approval) 

must be approved by the Organization. 

6.2.3 Determination of holding time 

6.2.3.1 The test data should be used to determine the no adverse-effect concentration upon 

discharge, i.e., the necessary dilution of the treated ballast water. The half-life, decay and dosage 

rates, system parameters and toxicity should be used to determine the amount of time needed to 

hold the treated ballast water before discharge (5.2.7). An indication of the uncertainty of the 

holding time should be given, taking into account variables (e.g., temperature, pH, salinity and 

sediment loading). 

6.3 Risk characterization and analysis 

6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4)

6.3.1.1 The reaction with organic matter of Active Substances and preparations including any 

of its components should be addressed qualitatively and quantitatively, so as to identify Relevant 

Chemicals that may be of concern to the environment. 

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

6.3.2.1 The route and rate of abiotic and biotic degradation of the Active Substances 

and Preparations, including any of its components, under aerobic and anaerobic conditions 

(see 2.4.1 above) should be assessed, resulting in the characterization of the Active Substances, 

Preparations including any of its components and Relevant Chemicals in terms of degradation 

rates under specified conditions (e.g., pH, redox, temperature). 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 28 

I:\MEPC\57\2-10.doc 

6.3.3 Prediction of discharge and environmental concentrations 

6.3.3.1 Based on the information on fate and behaviour of Active Substances, Preparations 

including any of its components and Relevant Chemicals, the discharge concentrations at 

selected time intervals should be predicted (G9: 5.3.8). 

6.3.3.2 Environmental concentrations after discharge of treated ballast water under controlled 

conditions during development and type approval tests should be estimated (e.g., by a suitable 

model simulating the test conditions) and provided in the application dossier for Basic Approval. 

Concentrations of treated ballast water, Active Substances, Relevant Chemicals and other 

components of Preparations, as appropriate, should be estimated. 

6.3.3.3 Environmental concentrations, under suitable emission scenarios to be developed 

describing typical full-scale use and discharge situations, should also be estimated for 

treated ballast water, Active Substances, Relevant Chemicals and other components of 

Preparations, as appropriate. 

6.3.4 Assessment of potential for bioaccumulation 

6.3.4.1 For Active Substances, Preparations including any of its components and Relevant 

Chemicals, the potential for bioaccumulation should be assessed in marine or freshwater 

organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (log Pow) 

is >3 (G9: 5.3.7). 

6.3.5 Effects assessment 

6.3.5.1 The effect assessment of the Active Substances, Preparations including any of its 

components and Relevant Chemicals is initially based on a dataset of acute and/or chronic 

ecotoxicity data for aquatic organisms, being primary producers (algae or sea grasses), 

consumers (crustaceans), predators (fish) (G9: 5.3.9). 

6.3.5.2 An effect assessment could also be prepared on secondary poisoning to mammalian 

and avian top-predators where relevant. Only toxicity studies reporting on dietary and oral 

exposure are relevant, as the pathway for secondary poisoning refers exclusively to the uptake of 

chemicals through the food chain. It might be necessary to extrapolate threshold levels for 

marine species from terrestrial species assuming there are interspecies correlations between 

laboratory bird species and marine predatory bird species and between laboratory mammals 

(e.g., rats) and the considerably larger marine predatory mammals. An assessment of secondary 

poisoning is redundant if the substance of concern demonstrates a lack of bioaccumulation 

potential (e.g., BCF < 500 L/kg wet weight for the whole organism at 6% fat) (G9: 5.3.10). 

6.3.5.3 An assessment of effects to sediment species should be conducted unless the potential 

of the substance of concern to partition into the sediment is low (e.g., Koc < 500 L/kg) 

(G9: 5.3.11). 

6.3.5.4 The effect assessment of the Active Substances, Preparations and Relevant Chemicals, 

taking the indicated information into account, should be based on internationally recognized 

guidance (e.g., OECD) (G9: 5.3.13). 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 29 

I:\MEPC\57\2-10.doc 

6.3.6 Effects on aquatic organisms 

6.3.6.1 For assessment of effects to the aquatic environment, appropriate 

Predicted No-Effect Concentrations (PNEC) should be derived. A PNEC is typically derived at a 

level that, when not exceeded, protects the aquatic ecosystem against toxic effects of long-term 

exposures. However, for situations where only short-term exposures are expected, an additional 

PNEC for short-term exposure may be useful. PNEC values are normally derived from 

short-term and/or long-term aquatic toxicity results for relevant aquatic species by dividing the 

lowest available effect concentration with an appropriate assessment factor. For the aquatic 

effect assessment, the assessment factors, given in Table 2, should be guiding although these may 

be altered on a case-by-case basis based on expert judgement. In cases where a comprehensive 

data-set is available, the PNEC may be derived with a mathematical model of the sensitivity 

distribution among species. 

6.3.6.2 PNEC values should be derived for any substances that may be found in treated ballast 

water in concentrations that may be of concern for the aquatic environment. The relevance of 

deriving PNEC values for Active Substances, any other components of preparations and/or 

Relevant Chemicals should thus be considered. 

6.3.6.3 When aquatic toxicity data are available only for freshwater species but a PNEC for the 

marine environment (PNEC saltwater) is needed, this may be derived by applying a higher 

assessment factor than for the derivation of a PNEC fresh water to reflect the greater uncertainty 

in protecting sensitive species in saltwater environments. Where data are available for additional 

taxonomic groups, for example, rotifers, echinoderms or molluscs, the uncertainties in the 

extrapolation are reduced and the magnitude of the assessment factor applied to a dataset can 

be lowered. 

6.3.6.4 For naturally occurring Active Substances not meeting PBT-Criteria and being rapidly 

degradable, the PNEC could be set along the background concentration in the environmental 

compartment under consideration. 

Table 2 – Effect assessment for deriving PNECs for fresh water and saltwater

 Assessment Factor 

Data-set PNEClong PNECshort 

Freshwater assessment 

Lowest short-term L(E)C50 from freshwater 

species representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

10 

Saltwater assessment 

Lowest short-term L(E)C50 from marine species 

representing three trophic levels 

1000 10-100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

100 

Lowest chronic NOEC from three saltwater 

species representing three trophic level 

100 

Lowest chronic NOEC from three freshwater or 

saltwater species representing three trophic levels 

+ at least two chronic NOECs from additional 

marine taxonomic groups 

10 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 30 

I:\MEPC\57\2-10.doc 

6.3.7 Effects on sediment 

6.3.7.1 Because sediment constitutes an important compartment of ecosystems, it may be 

important to perform an effects assessment for the sediment compartment for those substances 

that are likely to transfer substantially into the sediment. Most of the existing whole sediment 

tests measure acute toxicity and only a few measure long-term, sub-lethal endpoints. Only the 

latter tests are considered applicable to risk assessment because of the long-term exposure of 

benthic organisms to sediment-bound substances that occur under field conditions. Due to the 

generally long-term exposure of benthic organisms to sediment-bound substances, long-term 

tests with sub-lethal endpoints like reproduction, growth, emergence, sediment avoidance and 

burrowing activity are regarded as most relevant. It is recommended to use pooled marine and 

freshwater sediment toxicity data for effect assessment for the sediment compartment. However, 

when sufficient data for ecologically relevant saltwater species are available, lower assessment 

factors can be applied. Since there are no chronic marine sediment test methods that are 

internationally accepted, the results from any tests should always be evaluated with caution. 

Table 3 – Effect assessment for deriving PNECs for sediment 

Data-set Assessment factor 

Freshwater assessment 

Three chronic sediment tests with species representing different 

living and feeding conditions 

10 

Saltwater assessment 

Three chronic sediment tests with species representing different 

living and feeding conditions 

50 

Lowest chronic NOEC from three freshwater or saltwater 

species representing different living and feeding conditions 

including at least two chronic NOECs from marine species 

10 

6.3.8 Comparison of effect assessment with discharge toxicity 

The results of the effect assessment of the substances that are likely to be present in the treated 

ballast water at discharge are compared to the results of the toxicity testing of the treated ballast 

water. Any unpredicted results (e.g., lack of toxicity or unexpected toxicity in the treated ballast 

water at discharge) should give rise to a further elaboration on the effect assessment (G9: 5.3.14). 

7 RISK ASSESSMENT 

7.1 Risk to safety of ship 

7.1.1 The potential risk to the safety of the ship and crew raised by the operation of the BWMS 

should be assessed, taking into account the identified risk mitigation measures to be applied and 

any relevant legislative requirements such as provided in SOLAS and MARPOL. Potential risk 

to the ship/crew may include, inter alia: 

 .1 increased corrosion; 

 .2 fire and explosion; 

 .3 storage and handling of the substances; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 31 

I:\MEPC\57\2-10.doc 

 .4 contact with, or inhalation of, process products; and 

 .5 noise. 

7.2 Risks to human health

7.2.1 The human health risk assessment should follow generally accepted guidelines including 

acute and long-term exposure situations. The risk assessment should entail hazard identification 

and, as appropriate, dose (concentration) – response (effect) assessment, exposure assessment 

and risk characterization. The population groups deemed to be at risk and so to be examined 

should include crew, passengers and all personnel, including the public, in ports. Potential health 

risks connected to the exposure of consumers via seafood or persons at the coast (e.g., beach) 

after discharge should be evaluated. Special attention should be given to service and repair of the 

system by technicians and accidental situations on board (e.g., specific personal protection 

equipment). The evaluation of the risks to human health should include risk reduction 

(risk management) by regulations based on the SOLAS Convention as well as specific measures 

proposed by the manufacturer and of the Ballast Water Management System that should then be 

assessed by the Administration concerned. 

Health effects in humans 

7.2.2 The effect assessment of the Active Substances, Preparations and Relevant Chemicals 

should include a screening on carcinogenic, mutagenic and endocrine disruptive properties. 

If the screening results give rise to concerns, this should give rise to a further effect assessment 

(G9: 5.3.12). 

Human Exposure Scenario 

7.2.3 A Human Exposure Scenario (HES) should be provided by the applicant as part of the 

risk assessment procedure for ballast water management systems, using the guidance contained 

in Appendix 1 of this document. 

7.2.4 There are normally four stages when carrying a quantitative risk assessment: 

 .1 Hazard identification – what are the substances of concern and what are their 

effects? 

 .2 Dose (concentration) – response (effect) relation – what is the relationship 

between the dose and either the severity or the frequency of the effect? 

 .3 Exposure assessment – what is the intensity, and the duration or frequency of 

exposure to an agent? 

 .4 Risk characterization – how to quantify the risk from the above data? 

7.2.5 The identification of ‘unit operations’ in the whole BWM process of each system is 

important to the understanding human exposures. The term ‘unit operation’ is used in chemical 

process engineering to describe a basic step in a process. A chemical or other 

manufacturing/treatment process may have many unit operations. Occupational hygienists 

depend on knowledge of such unit operations to be able to determine exposure to chemicals 

involved in each step of a process. A similar approach is proposed with regard to 

BWMS evaluations. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 32 

I:\MEPC\57\2-10.doc 

7.2.6 The risk assessment should include a description of the ballast water treatment process 

associated with their system as a set of unit operations, i.e., in doing so, identifying clearly which 

individual system components of a BWMS are likely to lead to human exposure to Active 

Substances, Relevant Substances and by-products. For each system component, including 

connecting piping, a description of such exposures needs to be provided, e.g., chemical storage, 

chemical application, processing of treated ballast water, ballast tank operations, including 

associated piping, as well as discharge operations. The risk assessment should also include the 

risk reduction measures envisaged for all of the above-defined unit operations, i.e., stating clear 

Personal Protective Equipment requirements for each step in the process. 

7.2.7 Maintenance, equipment failure and accident situations should be considered separately 

from conditions of normal operation. 

7.3 Risks to the aquatic environment

7.3.1 The potential risks to the aquatic environment during experimental development and type 

approval testing should be assessed. 

7.3.2 When no aquatic toxicity of the treated ballast water at discharge is found either through 

direct testing of the treated ballast water or if the estimates ratios between predicted 

concentrations of the Active Substance, components of preparations or Relevant Chemicals, as 

appropriate, and the respective PNEC values are below 1, no further assessment of direct toxic 

effects to the aquatic environment is necessary. 

7.3.3 In other cases, the dilution necessary to ensure that the PNEC values are not exceeded 

should be calculated by an appropriate model for relevant controlled use and discharge scenarios. 

7.3.4 The potential risks to the aquatic environment resulting from full-scale deployment 

on board ships and discharge of treated ballast water under representative conditions should be 

assessed. The specific assessment might await further development of an appropriate Emission 

Scenario Document for discharge of treated ballast water. 

8 ASSESSMENT REPORT (G9: 4.3)

The Assessment report referred to in point 4.3 of the Procedure should at least provide: 

 .1 an overview of the data and endpoints on which the risk characterization 

according to section 6 of the Procedure is based including a description of the 

quality of test reports; 

 .2 an assessment of risks to the safety of ships, crew (human health), the 

environment and resources (e.g., fisheries) during development and type approval 

testing as well as during full-scale deployment on board ships in accordance with 

section 6 of the Procedure; 

 .3 if any monitoring has been conducted, a summary of the results of that 

monitoring, including information on the analytical methodology used, ship 

movements and a general description of the area monitored; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 33 

I:\MEPC\57\2-10.doc 

 .4 a summary of the available data on environmental exposure and any estimates of 

environmental concentrations developed through the application of mathematical 

models, using all available environmental fate parameters, preferably those that 

were determined experimentally, along with an identification or description of the 

modelling methodology; 

 .5 an evaluation of the association between the Ballast Water Management System 

making use of Active Substances or preparations containing one or more Active 

Substances to comply with the Convention in question, the related adverse effects 

and the environmental concentrations, either observed or expected based on the 

risk assessment and the effluent testing; 

 .6 a qualitative statement of the level of uncertainty in the evaluation referred to 

under the preceding paragraph; and 

 .7 a detailed description of risk management possibilities, e.g., for neutralization of 

the Active Substance in case of emergency or if PEC/PNEC at discharge >1. 

These management measures are an integral part of the Ballast Water 

Management System. 

9 MODIFICATION TO THE APPLICATION

9.1 Administrations should report any modifications in names, including trade and technical 

name, composition or use of the Active Substances and Preparations in the Ballast Water 

Management Systems approved by the Organization, to the Member of the Organization. 

The Member of the Organization should inform the Organization accordingly (G9: 8.4.1). 

9.2 Administrations intending to significantly change any part of a Ballast Water 

Management System that has been approved by the Organization or the Active Substances and 

Preparations used in it should submit a new application (G9: 8.4.2). 

10 FINAL APPROVAL

10.1 In accordance with paragraph 5.2.1 of the Procedure (G9) for Final Approval, the 

discharge testing should be performed as part of the land-based type approval process using the 

treated ballast water discharge. 

10.2 In order to obtain Final Approval in accordance with paragraph 8.2 of Procedure (G9), 

the following criteria have to be met: 

.1 Basic Approval has to be given first; 

.2 the Member of the Organization, submitting an application should conduct the 

Type Approval tests in accordance with Guidelines for Approval of Ballast Water 

Management Systems (G8). Although Guidelines (G8) are concerned with efficacy 

testing, paragraph 1.6.4 of part 1 of its annex provides the link between the 

Guidelines (G8) and the Procedure (G9) and consequently the test results from both 

Guidelines (G8) and Procedure (G9) would be used by MEPC to grant 

Final Approval. This would then allow the Administration to issue a 

Type Approval Certificate as shown in the appendix to Guidelines (G8). In this 

context Type Approval of any equipment used onboard ship should be given when 

the relevant approval body is satisfied that the Quality Assurance programme 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 34 

I:\MEPC\57\2-10.doc 

employed by the manufacturer will ensure that the equipment can be produced 

consistently to the required specification and the risks to the ship and crew have 

been adequately addressed; 

.3 apart from any other conditions required for Type Approval, the full scale land based 

tests, using the system in the same way that fulfilled the efficacy requirements, would 

need to show that the residual toxicity of the treated ballast water is no worse than the 

results obtained for Basic Approval; 

 .4 toxicity testing should be done on two types of seawater at two appropriate time 

intervals after treatment (preferably immediately after treatment and after a 

24 or 48-hour interval), and organisms normally found in the selected types of 

seawater should be used in the toxicity testing; 

.5 all information related to Total Residual Oxidants (TROs), Total Residual 

Chlorine (TRC) and the chemicals included in such groupings, including their 

concentrations, should be provided to the GESAMP-BWWG for Final Approval 

when requested as part of its evaluation for Basic Approval; 

.6 in addition to the basic data set needed for the treated ballast water and the 

individual chemicals produced by the system – as identified in the Methodology 

for Basic Approval – a generated meaningful PEC/PNEC ratio would be required 

for Final Approval; and 

.7 the application for Final Approval should reflect the concerns identified during 

consideration of Basic Approval. This would mean that in some cases only acute 

toxicity testing would be needed for Final Approval and in some cases chronic 

toxicity might be needed whilst in others both acute and chronic data might 

be required. 

* * * 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 35 

I:\MEPC\57\2-10.doc 

APPENDIX 1 

KEY DATA SUMMARY FORM FOR GESAMP-BWWG TECHNICAL EVALUATION 

OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE 

SUBSTANCES TO COMPLY WITH THE CONVENTION 

(For each piece of data selected for the Summary Form, the range of data that this has been 

chosen from should be included as an appendix e.g., If the Summary Form includes an 

Acute Oral LD50 for a Rat, the appendix should include the complete list of values identified in 

the literature from which this value was chosen as a proposal to the BWWG.) 

1 CHEMICAL IDENTIFICATION 

Trade Name of Preparation 

Composition of Preparation 

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

 

*

 Indicate whether the chemical is believed to be one of the following, giving justification for 

each proposal: 

AS = Active Substance 

RC = Relevant Chemical 

Other = Any other Chemical e.g., solvent 

List of ALL potential by-products produced in ballast water 

Chemical Name CAS Number Concentration 

(%)

(bio)degradation 

rate or half-life 

 

Notes: 1 A separate index for the Active Substance(s) and all by-products should be created 

unless a scientific explanation is provided to justify not including them. 

2 A chemical analysis should also be provided to show the concentration of possible 

by-products produced in the treated ballast water. Such analyses should be carried 

out to a level of detection commensurate with the level of naturally occurring 

chemical in seawater and/or the level that could be justified as not being 

hazardous to human health or the environment, where appropriate. 

 3 A clear description of, or reference to, the chemical analysis should be provided 

along with the length of time, after treatment, that the analysis was carried out. It 

is recommended that there should be: 

 .1 one analysis carried out following the shortest possible time that the 

treated ballast water would be permitted to be discharged; and 

 .2 one analysis carried out [5] five days later. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 36 

I:\MEPC\57\2-10.doc 

Data on each component of the 

Preparation and by-product produced in ballast water

Chemical Name 

................................................................................................. 

Where the applicant considers that it is not necessary to complete the data form for a 

given chemical, a full justification should be given (e.g., the 1⁄2-life of the chemical is only 

a few seconds and so will have disappeared by the time the ballast water is discharged 

into the sea). 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Species LC50 

(mg/l/duration) 

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.2 Chronic Aquatic Toxicity Data 

Species LC50(mg/l/duration) 

or 

NOEC(mg/l/duration

Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.3 Information on Endocrine Disruption 

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.4 Sediment Toxicity 

Species Information Reference/Comments/Justification 

for missing data 

Fish 

Crustacea 

Algae 

2.5 Bioavailability/Biomagnification/Bioconcentration 

Log Pow Reference/Comments/Justification 

for missing data 

BCF 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 37 

I:\MEPC\57\2-10.doc 

2.6 Food Web/Population Effects 

A description of potential food web and population effects should be provided supported 

by a full justification. 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity

 Value Species Reference/Comments/Justification

for missing data 

Oral LD50 (mg/l) 

Dermal LD50 (mg/l) 

Inhalation LC50 (mg/l/4h) 

3.2 Corrosion/Irritation 

 Species Method Results 

(including 

scores where 

available) 

Reference/Comments/Justification 

for missing data

Skin 

Eye 

3.3 Sensitization 

 Species Method 

(e.g., Buehler, 

M&K) 

Results 

(Sensitizer 

Y/N) 

Reference/Comments/Justification 

for missing data

Skin 

Inhalation 

3.4 Repeated-Dose Toxicity 

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 38 

I:\MEPC\57\2-10.doc 

3.5 Development and Reproductive Toxicity 

Exposure Route 

Exposure Duration 

Exposure dose 

Species 

Method 

Results 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity 

 Species Method Details Results Reference/Comments/ 

Justification for 

missing data 

Carcinogenicity 

Mutagenicity 

Reprotoxicity 

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/ 

Justification for 

missing data 

Hydrolysis 

at pH 5 

 

Hydrolysis 

at pH 7 

Hydrolysis 

at pH 9 

Biodegradation 

1/2-Life NR 

4.2 Partition Coefficients 

 Method Results Reference/Comments/Justification 

for missing data

Log Pow 

Koc 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 39 

I:\MEPC\57\2-10.doc 

4.3 Persistence and Identification of Main Metabolites 

 Method Results Reference/Comments/Justification 

for missing data

Persistence 

 

4.4 Reaction with Organic Matter 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.6 Potential Residues in Seafood 

4.7 Any Known Interactive Effects 

5 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) 

Boiling point (°C) 

Flammability (flash point for liquids; °C) 

Density (20 °C; kg/m3) 

Vapour pressure (20 °C; Pa) 

Vapour density (air = 1) 

Water solubility (temp; effect of pH; mg/l) 

pH in solution 

Dissociation constant (pKa) 

Oxidation-reduction potential 

Corrosivity to material or equipment 

Reactivity to container material 

Auto-ignition temperature (°C) 

Explosive properties 

Oxidising properties 

Surface tension 

Viscosity 

Thermal stability and identity of 

breakdown products 

Other physical or chemical properties 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 40 

I:\MEPC\57\2-10.doc 

6 OTHER INFORMATION 

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Method 

Applicability 

Sensitivity 

Reference/Comments/Justification for 

missing data 

6.2 Material Safety Data Sheet provided (Yes/No)................................................ 

6.3 GHS Classification .................................................................................. 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/ Justification for 

missing data 

 

* * * 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 41 

I:\MEPC\57\2-10.doc 

APPENDIX 2 

HUMAN EXPOSURE ASSESSMENT 

1 INTRODUCTION 

1.1 In risk assessment for human health, the normal procedure is to compare the exposure 

levels to which the population is exposed or likely to be exposed with those levels at which no 

toxic effects are expected to occur. 

1.2 There are normally four stages when carrying a quantitative risk assessment: 

 .1 Hazard identification – what are the substances of concern and what are their 

effects. 

 .2 Dose (concentration) – response (effect) relation – what is the relationship 

between the dose and either the severity or the frequency of the effect. 

 .3 Exposure assessment – what is the intensity, and the duration or frequency of 

exposure to an agent. 

 .4 Risk characterization – how to quantify the risk from the above data. 

1.2 The greatest part of information about the potential human toxic effects of chemical 

substances is obtained from studies on animals. 

1.3 In assessing an acceptable level of a particular substance, the procedure usually follows 

moving from an experiment database of animal or preferably human data (e.g., epidemiological 

studies) giving a No Observed Adverse Effect Level (NOAEL) or a Lowest Observed Adverse 

Effect Level (LOAEL) to deriving exposure limit at a lower exposure value, to allow for the 

uncertainties in the data. Comparison of this exposure limit with a measured or estimated 

exposure level is then used to judge whether the situation is satisfactory or whether risk 

management measures are required. 

2 THE MARGIN OF SAFETY (MOS) OR MARGIN OF EXPOSURE (MOE) 

APPROACH 

2.1 In this procedure the ratio of NOAEL determined in the animal studies and expressed in 

mg/kg/day is compared with the level to which a human may be exposed: 

 MOS or MOE = NOAEL mg/kg/d

 Exposure mg/kg/d 

2.2 Assuming that the exposure of a human population to a substance in drinking water 

is 1 mg/L, for 60 kg woman consuming on average 2 L of water/day, then: 

 Exposure= 1mg/L x 2 L/day = 0.03 mg/kg/day 

 60 kg 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 42 

I:\MEPC\57\2-10.doc 

2.3 The next step in the MOS approach is to derive and apply a so-called “reference MOS” 

(MOSref). The MOSref is an overall assessment factor (AF) addressing differences between 

animal experimental data and real human exposure situation, taking into account variability and 

uncertainty. Normally, the value for each AF is based on substance-specific information or, 

if missing, on default values. It is common in Human Risk Assessment to use an MOSref 

of 100 (10 for interspecies variability – between animals and humans – and 10 for intraspecies 

variability – among humans). 

2.4 Example: taking into account the exposure value referred in 2.2. (0.03mg/kg/day) and, 

for instances, a NOAEL for developmental toxicity of 100 mg/kg/day, the MOS will be 100/0.03, 

i.e., 3333, a reassuring large value comparing to MOSref (100). However, if this value was much 

lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and a 

unacceptable human risk towards this adverse effect. 

2.5 The selection of the critical NOAEL for RA will depend on the extent, duration and 

route of human exposure and the selection of the most critical adverse effect. 

3 EXPOSURE ASSESSMENT 

3.1 The aim of assessing human exposure is to obtain a realistic estimate of total human 

exposure, expressed in terms of dose per unit weight, e.g., mg/kg. 

3.2 In principle, the exposure of a human population could be assessed by representative 

monitoring data and/or model calculations based on available information on substances with 

analogous uses and exposure patterns or properties. 

3.3 The predictions of exposure levels should describe a reasonable worst case situation, 

covering normal use patterns and where general public or workers may be exposed to the same 

substance. It is important to assess the reliability and the representativeness of the exposure 

measurements. 

3.4 Where data are of an unsatisfactory quality, it is useful to conduct an assessment using 

“worst case” assumptions. If this indicates a risk of no concern, the assessment needs no further 

refinement. 

3.5 The most probable scenarios for human exposure to BWMS still need to be properly 

identified. However, one can assume two potential groups, with some characteristics of each and 

expected route of exposure as follows: 

 .1 Crew (exposed occupationally): 

 .1.1 exposure assumed during working week – 8h day, 5 days per week; 

 .1.2 relatively healthy part of general population; and 

 .1.3 exposure routes: normally inhalation and dermal. 

 .2 General public/Human exposure via environment – Users of coastal amenities, 

beach coastlines and offshore installations and harbours: 

 .2.1 exposure intermittent – needs to be estimated; 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 43 

I:\MEPC\57\2-10.doc 

 .2.2 exposures may not be controlled; 

 .2.3 exposure routes: oral, inhalation and/or dermal; and 

 .2.4 includes vulnerable groups, e.g., children and elderly people. 

3.6 Normally occupational exposure will be an external exposure, i.e., the amount in contact 

with the skin, inhaled, or the concentration in the atmosphere. Where the conclusion is that this 

level “is of concern”, it may be necessary to determine internal exposure, i.e., the amount taken 

into the tissues of the body, or its bioavailability. 

3.7 The predictions of the consequences of exposure have to be carried out for each exposed 

human population (e.g., workers, general public) and for each effect. 

4 OCCUPATIONAL EXPOSURE 

4.1 The most common routes of exposure in the workplace are by inhalation or by absorption 

through intact skin. Dermal exposure may also result in local effects, such as irritation or 

dermatitis. 

4.2 Exposure should always be assessed in the first instance for the unprotected worker and, 

if appropriate, a second assessment, should be made taking PPE (personal protective equipment) 

into account. 

4.3 Of primary importance in developing the assessment of occupational exposure is a full 

understanding of the processes and unit operations in which exposure occurs, and of the actual 

work activities resulting in exposure. With this background knowledge, the following questions 

have to be answered: 

 .1 what is the population of potentially exposed individuals? 

 .2 what are the magnitude, frequency and duration of inhalation and dermal 

exposures? 

 .3 what personal protective equipment and control measures are used to reduce or 

mitigate exposure? and 

 .4 how effective are they in reducing exposure? 

4.4 The overall assessment of each type of exposure should be repeated for all the various 

production processes and uses made for the chosen chemical, and from a knowledge of the 

frequency and duration of exposure the “worst case” highlighted. 

4.5 If “real” data are missing for a chosen substance, as an alternative to modelling it may be 

possible to substitute data from another chemical with a similar pattern of exposure. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 44 

I:\MEPC\57\2-10.doc 

4.6 The following major factors can affect exposure potential: 

 .1 size of activity – the greater the quantity of the substance involved or the higher 

the concentration in solution, the greater the potential for exposure is likely to be. 

Any potential hazard from 10 tons is likely to be much greater than that of 10 mg; 

 .2 physical characteristics of the activity – particle size of a solid or volatility of a 

liquid are also likely to affect the exposure, as is the presence of barriers to the 

exposure and containment of the substance away from human contact. Procedures 

involving elevated temperature, particularly with substances with significant 

vapour pressures, may engender an enhanced inhalation exposure; and 

 .3 time of exposure – the duration and frequency of exposure to an activity will also 

be a factor – the longer the time of exposure the higher the exposure potential. 

4.7 The quantitative human exposure assessment results in a reasonable worst-case estimate 

for external exposure via the inhalation and dermal route (the main routes of concern for 

occupational exposure) that are taken forward to the risk characterization. 

4.8 These estimates are obtained for all relevant scenarios that have been identified taking 

into account all relevant available information. 

4.9 In the risk characterization phase these estimates are combined with the results of the 

effects assessment and conclusions are drawn whether or not there is a concern for any scenarios 

assessed. 

5 CONTROL OF THE RISK 

5.1 When a risk assessment results in the conclusion that the risk is too high, consideration 

has to be given to introducing the following controls that will lower this risk to acceptable levels: 

 .1 prevention that includes: 

 .1.1 elimination; 

 .1.2 substitution; and 

 .1.3 good hygiene practice. 

 .2 Physical segregation that includes: 

 .2.1 complete enclosure with extraction; 

 .2.2 local exhaust ventilation with or without partial enclosure; and 

 .2.3 screening. 
GESAMP-BWWG 5/9 

ANNEX 4 

Page 45 

I:\MEPC\57\2-10.doc 

.3 Personal protection that includes: 

 .3.1 respiratory protective equipment including respirators and self-contained 

breathing apparatus; and 

 .3.2 protective clothing (eye and head protection, gloves, shoes, etc.). 

6 OCCUPATIONAL EXPOSURE QUESTIONS 

6.1 Questions need to be addressed by the applicant in the Application for Basic Approval of 

a BWMS are as follows: 

.1 What are the chemical substances/products used/generated at the workplace and 

what is their physical-state (gas, liquid or solid) and concentration? 

.2 Where and how the substances/products are used/generated at the workplace? 

.3 By whom the substances/products will be directly used (primary exposure)? 

.4 Description of the operator tasks, frequency and duration at each operation unit – 

please include the relevant tasks in the process flow chart. 

.5 What are the expected measures to reduce worker exposure (PPE, RPE)? 

.6 Who else may be exposed (secondary exposure)? 

7 REFERENCES 

 .1 Chemical Risk Assessment – UNEP/IPCS, WHO, 1999; and 

 .2 Technical Guidance Document on Risk Assessment, European Chemicals Bureau 

(ECB) – Part I, European Communities, 2003. 

*** 

GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 5 

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE 

Resource Ballast Technologies System 

Submitted by South Africa

0 SUMMARY 

0.1 The Group agreed to recommend that Basic Approval be given to the Resource Ballast 

Technologies System submitted by South Africa. 

0.2 The Group noted that the Resource Ballast Technologies System (RBT) uses 

electro-chemical treatment, ozonation cavitation and filtration to treat ballast water. The dossier 

states that the electrochemical unit produces the Active Substance hypochlorite in the ballast 

water stream up to a maximum allowable concentration of 1 mg/L, while the Active Substance 

ozone is generated separately on board and injected into the ballast pipe up to an allowable 

concentration of 1 mg/L. The Group noted that ballast water is treated on uptake only. 

0.3 The Group noted that the active substances identified by the dossier were ozone and 

hydroxyl radicals, while relevant chemicals were chlorine gas, hydrogen gas and hypobromous 

acid. Hypobromite ions, bromate ions and bromoform are the resultant by-products of the system 

when used under seawater conditions. Resultant by-products and relevant chemicals when used 

in fresh water ballast situations are not identified and information should be provided in the Final 

Approval application. 

0.4 Having considered the Active Substances and each of the Relevant Chemicals, the Group 

agreed that: 

 .1 due to its very short half-life, ozone does not present any environmental threat and 

whilst it is very toxic by inhalation, it should be safe to use providing that strict 

control measures are applied to ensure that human exposure is prevented; 

 .2 the concentration of bromate ions in the treated ballast water is unknown. 

Bromate ions are deemed to be genotoxic/carcinogenic and information regarding 

human exposure (HES, MEPC 56/2/2, annex 9) should be provided in the 

application for Final Approval. 

 .3 bromoform is relatively persistent and is both toxic and irritant to mammals. 

Chemical analysis of the treated ballast water showed that bromoform was found 

in concentrations of 0 – 9 μg/L. More detailed chemical analysis should be 

provided in the Final Approval application. 

0.5 The Group concluded that chlorinated and brominated disinfection by-products are the 

toxicologically relevant compounds generated by the process as they have a potential for human 

genotoxicity/carcinogenicity. Therefore they will have to be kept below toxicologically critical 

levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for 

Drinking Water Quality, 2003). 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 2 

I:\MEPC\57\2-10.doc 

0.6 The Group noted that the applicant did not provide information concerning the Human 

Exposure Scenario (MEPC 56/2/2, annex 9) and therefore the risk characterization for human 

health could not be adequately performed. This should be included in an application for 

Final Approval. 

0.7 The lowest explosion limit for hydrogen gas is 4% under standard conditions. The amount 

of hydrogen gas produced by the electro-chemical unit should be documented in the application 

for Final Approval. The same applies to chlorine gas. The Group recommends that a de-aeration 

component is added immediately following the electrolytic unit and that a hydrogen gas monitor 

is included in the system. 

0.8 The Group noted that the applicant did not carry out chronic ecotoxicity studies, which is 

normally unacceptable. However, the Group also noted that the acute ecotoxicity data was quite 

extensive and generated under flow-through conditions covering six species from four groups, 

including three trophic levels. 

0.9 The applicant should carefully consider the effect of organic matter levels on the 

production of by-products for the final operational mode(s) of the system and demonstrate this by 

appropriate measurements. 

0.10 The applicant indicates that the filter system is located downstream of the ballast water 

pumps and the treatment reactor, as opposed to many other systems where filtration is carried out 

directly on uptake. The Group considered that the filter cake could contain treatment by-products 

and should therefore be considered as a waste stream warranting further investigation as part of 

the Final Approval process. 

0.11 The application indicated that ozone would be dosed at 1 μg/L during treatment, however 

subsequent correspondence with the applicant confirmed that, in fact, this is 1 mg/L. The Group 

will evaluate any application for Final Approval on the basis of this latter value. 

0.12 As there is currently no information on the estimated Predicted Environmental 

Concentration it is required that the applicant establishes a PEC estimation in order to determine 

a PEC/PNEC ratio to identify a possible risk for the environment for the relevant chemicals in the 

application. 

1 INTRODUCTION 

1.1 The data for this product were extracted from original data supplied by South Africa to 

support its submission MEPC 56/2/3 and the confidential dossier issued to the Organization. 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that information about the following subjects had been included in the 

application dossier: 

 .1 an overview of the ballast water management system (BWMS) with description of 

the components of the system; 

 .2 ecotoxicity tests with seawater treated with the Resource BWMS; and 

 .3 results of chemical analysis of treated water. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 3 

I:\MEPC\57\2-10.doc 

2.2 The description and diagram of the system are insufficiently clear regarding the sequence 

and the conditions (e.g., seawater, freshwater) in which the treatment technologies are to be used, 

including how the reactor is operated. Clear information on the operation of the entire system is 

required in order to be able to assess the hazards and risks in the application for Final Approval. 

2.3 The control system should be described in detail including the sensors for ozone and 

chlorine monitoring. 

2.4 The Group does not consider that the list of possible disinfection by-products provided by 

the applicant is complete, not does it cover the possible operating modes of the system, 

e.g., ozonation alone, electrochemical treatment alone or both together. 

2.5 A more comprehensive, measured dataset on both the electrochemical and ozone 

generation systems plus a thorough evaluation of Active Substances, Relevant Chemicals and 

by-products should be provided in the application for Final Approval. 

2.6 It was noted that the Applicant did not carry out chronic aquatic toxicity tests; this should 

be included in the dossier for final approval. 

2.7 The Group noted that several values for ozone dosage were provided and that some of the 

values were lower than natural levels of ozone in the environment. Only the highest 

value (1 mg/L) was considered by the Group to be correct and therefore included in this 

summary dossier. 

3 DESCRIPTION OF RESOURCE BALLAST TECHNOLOGIES SYSTEM 

3.1 Overview of the system 

3.1.1 The Group noted that the RBTS treats ballast water by filtration, cavitation, 

electro-chemical treatment (Chlorine) and ozone. 

3.1.2 Ozone is injected into the ballast water by utilizing a Venturi system to promote the 

cavitational effect and to ensure the disinfection performance, when operating in fresh water. The 

maximum level of ozone after treatment is 1 mg/L. The ozone gas is produced by two generators 

that only become operational once the RBT Reactor is powered. 

3.1.3 The Group noted that the applicant had provided in the submission a description of the 

system including: 

 .1 a description of the ozone generator and safety aspects; 

 .2 a general description of the electro-chemical treatment; and 

 .3 a general description of cavitation. 

3.1.4 It was further noted that the electro-chemical treatment consists of electrodes, which 

create sodium hypochlorite (<1 mg/L) to additionally support the cavitational effect. 

3.1.5 The sequence of the treatment is unclear to the Group. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 4 

I:\MEPC\57\2-10.doc 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 The Group noted that Active Substances used for treatment of ballast water with the RBT 

Reactor include ozone, which is produced by a generator provided on board, and an 

electrochemical system producing disinfectants such as hydroxyl radicals and hypochlorite 

in situ. The submission indicates that it is the intention to dose ozone to result in a concentration 

of 1 mg/L ballast water. 

3.2.2 Whilst recognizing that ozone is routinely used to disinfect drinking water when it is 

injected into seawater, the following Relevant Chemicals will be formed due to the presence of 

bromide ions that are not present in drinking water: 

 .1 bromate ion (BrO3

-

) is produced from the reaction of ozone with bromides in 

seawater. It will be found as an equilibrium between bromate ion, hypobromous 

acid and sodium bromate; 

 .2 bromoform (CHBr3) is produced from the reaction of ozone with naturally 

occurring organic matter in water used for ballast; and 

 .3 hypobromous acid (HOBr)/hypobromite ion (OBr-) that, together are referred to as 

Total Residual Oxidant (TRO). 

3.2.3 Several other by-products have been reported in open literature from the reactions 

between organic matter and TRO. 

3.2.4 The following table provides information on the identity of the Active Substance and 

Relevant Chemicals: 

Chemical 

name 

CAS 

number 

Molecular 

Mass 

Empirical 

formula 

Structural 

formula 

Maximum 

concentration 

in treated 

ballast water 

AS 

RC 

other 

Ozone 10028-15-6 48 O3 O=O–O 1 mg/L AS 

Bromate ion 7758-01-2 167 KBrO3 RC 

Bromoform 75-25-2 252.73 CHBr3 0 - 9 μg/L RC 

Hydroxyl 

radical 3352-57-6 17.01 HO O*H AS 

Chlorine gas 7782-50-5 70.9 Cl2 Cl–Cl RC 

Sodium 

hypochlorite 7681-52-9 74.4 NaClO Na–OCl 1 mg/L RC 

Total residual 

oxidants - - - - RC 

Hydrogen gas 01333-74-0 2.015 H2 H – H RC 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 5 

I:\MEPC\57\2-10.doc 

3.2.5 The Group noted the following chemical reactions associated with the treatment of ballast 

water with ozone by the proposed system: 

.1 O3 + Br- Æ O2 + OBr- 

.2 O3 + OBr- Æ 2 O3 + Br- 

.3 2 O3 + OBr- Æ 2 O2 + BrO3 

–

 

.4 Br- + O3 ÅÆ OBr- + O2 

.5 OBr- + H+ ÅÆ HOBr 

.6 HOBr + Organic Matter Æ CHBr3 

.7 HOBr + NH3 ÅÆ NH2Br 

where O3 and OBr- are considered the real Active Substances. 

3.2.6 The Applicant states that reactions 6 and 7 do not occur in water with a pH higher 

than 8 or in water with high contents of bromium compounds. 

3.2.7 Reactions of ozone with organic matter are described in appendix 1, 4.4. 

3.2.8 The Group noted that a normal operation procedure would result in a concentration 

of 1 μg O3/L, which is very low, compared to other BWTS making use of ozone as Active 

Substance. Later correspondence with the manufacturer confirmed that this was in fact 1 mg/L 

and this was used by the Group to evaluate the ozone generation part of the system. 

3.2.9 The Group noted that the ozone generator used in this system creates ozone from ambient 

air, so that maximum gas concentration of ozone is limited to 12% by weight. 

3.2.10 In addition, it was noted that ozone interacts with naturally occurring bromide ions to 

produce very low quantities of bromoform, hypobromous acid/hypobromite and bromate ion 

together with other halogenated compounds. These bromide ions break down slowly in the dark 

(half life of 1-2 d) but react quicker with seawater under the influence of UV radiation. 

3.2.11 The Group concluded that the main components to take into account for the risk 

assessment would be bromate, Total Residual Oxidants (TRO), bromoform and other 

halogenated compounds. 

3.2.12 Details of the evaluation of each chemical employed or generated by this system are 

shown in the appendices as indicated below: 

 .1 Ozone – Appendix 1 

 .2 Bromate ions – Appendix 2 

 .3 Bromoform – Appendix 3 

 .4 Free Active Chlorine – Appendix 4 

 .5 Hydrogen – Appendix 5 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 6 

I:\MEPC\57\2-10.doc 

4 HUMAN HEALTH ASSESSMENT

4.1 Taking into consideration the concentrations of Active Substance and Relevant Chemicals 

associated with the disinfection process described in the South Africa’s Application Dossier, the 

Group was able to reach the following conclusions: 

.1 Ozone is very toxic by inhalation as well as being irritant to eyes. Whilst not 

being classified as a carcinogen, there are concerns about its mutagenic potential. 

As a result, strict mitigation measures should be applied to avoid human exposure 

by inhalation during the treatment process. 

 .2 The applicant claims that in the RBT system ozone is only generated when the 

ballast water pumps are running. Ozone gas is sucked directly into the ballast 

water being treated. A non-return/one way valve, situated on the corona reactor 

ensures that no ozone gas escapes. 

 .3 Bromate (potassium bromate): exhibits a high potential for 

mutagenicity/carcinogenicity in humans. It is classified under the Globally 

Harmonized System as a carcinogen – may cause cancer category 1 B. The current 

MCL (Maximum Contaminant Level) in the United States is 10 μg/L and the 

maximum contaminant level is zero, because of the possibility that bromate may 

be a genotoxic carcinogen. No data about bromate concentrations were provided 

by the applicant, but the formation of bromate is very likely. The Group 

considered that the risks to human health could be of concern and therefore risk 

mitigation measures should be put in place in order to minimize 

occupational exposure. 

.3.1 It was noted that the applicant claimed that bromate ions will form in the ballast 

water. The water is pumped into the ship’s ballast tanks mechanically and 

therefore there will be no human contact on board the ship with treated ballast 

water. Providing the treated water is released more than 12 hours (the half life of a 

bromate ion) after it was treated, bromate ions will pose no threat to human health 

outside of the ship. The applicant should consider the practicality of this, as it 

would imply that ballast water tanks could not be inspected before 12 h have 

elapsed and that de-ballasting operations may be necessary on the time 

scale-scales shorter than 12 h. 

.3.2 However, the Group recognized that, apart from the crew, members of the public 

need to be taken into consideration as exposure could occur both by ingestion and 

inhalation when swimming in the sea. In this context, it was noted that the 

U.S.EPA regulates the level of bromate in drinking water to 10 μg/L 

(WHO, Guidelines for Drinking water Quality, 2003). 

.4 Bromoform is toxic both by oral ingestion and inhalation as well as being irritant 

to skin, eyes and the respiratory tract. It is classified under GHS as toxic if inhaled 

(Acute tox 3), causes serious eye irritation (Eye irrit. 2) and causes skin irritation 

(Skin irrit 2). The primary routes of exposure are ingestion and inhalation 

(from volatilized compounds) and dermal exposure during bathing. Bromoform is 

readily absorbed from the gastrointestinal tract and may be absorbed through the 

respiratory tract and skin. They are rapidly distributed throughout the body. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 7 

I:\MEPC\57\2-10.doc 

Principal health effects associated with inhalation or oral exposure to bromoform 

are central nervous system depression and liver and kidney damage. The Group 

considered that bromoform represents a potential risk for human health. 

 .4.1 There is strong evidence that the hepatotoxicity of bromoform is due to its 

metabolism into reactive intermediates and highly reactive trihalomethyl free 

radicals. 

 .4.2 Oral MRL (Minimal Risk Levels) have been derived for: 

 - acute-duration oral exposure (14 days or less) of 0.7 mg/kg/d; 

 - intermediate-duration exposure (15-364 days) of 0.2 mg/kg/d; 

 - chronic-duration exposure (365 days or more) of 0.02 mg/kg/d. 

As a result, human exposure to this compound must be kept under critical 

toxicological levels. 

 .4.3 Bromoform concentrations in the treated ballast water ranged 

from 0 – 9 μg/L. However the applicant should carry out further testing with 

seawater from a variety of sources, which will clarify the range of bromoform 

concentrations to be generated by the system. 

 .5 Free Active Chlorine (FAC, from hypochlorite) can cause irritation, pain and 

inflammation of mucoses when swallowed. In severe cases it can cause ulceration 

and perforation of the gastro intestinal tract. Vapours are not easily formed 

although under certain conditions, high concentration solutions in low pH mixed 

with acids, may produce chlorine gas which can cause severe irritation of the nose 

and throat. The Group recommends measuring the concentration of chlorine gas 

emitted from the treated ballast water tank. 

 .5.1 The Applicant states that sodium hypochlorite will be produced in situ and will be 

pumped directly into the ballast tanks. Chlorine has a rapid half life and 

presumably does not pose a risk to humans once the treated ballast water has 

been released. 

 .5.2 The Group considered that the critical health effects related to FAC exposure 

are mostly acute in nature; however, some concerns are also addressed in 

literature (EHC 216, WHO, 2000) related to toxicity to respiratory, 

developmental/reproductive function and carcinogenicity, depending on the 

severity of exposure and presumably under long term exposures 

(e.g., occupational scenarios). Therefore, the Group recommended measuring the 

concentration of chlorine gas emitted from the treated ballast water tank. 

 .6 Hydrogen is not toxic, but if released in large enough quantities it may displace 

oxygen leading to unconsciousness or asphyxiation. It is also highly explosive in 

high concentrations. The Group recommends measuring the concentration of 

hydrogen gas emitted from the treated ballast water tank. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 8 

I:\MEPC\57\2-10.doc 

 .6.1 The Applicant states that the amount of hydrogen produced by the 

electro-chemical electrodes is minuscule small and would not reach any dangerous 

levels. Any excess that is not already absorbed/dissolved into the ballast water 

would be vented into the atmosphere via the vents in the ballast tanks. 

 .7 As a result of the above evaluation, the Group considered that, from the human 

health perspective provided the above recommendations are taken into account, 

the system may be recommended for Basic Approval. 

5 RISK TO SAFETY OF SHIP 

5.1 It was noted that there is an increased risk of corrosion arising from the oxidizing 

properties of ozone and hypochlorite produced in the RBT reactor. The applicant should carry 

out appropriate corrosion tests for Final Approval. 

5.2 The Applicant states that it will be ensured that the machinery producing the ozone and 

the piping leading into the ballast water is coated with a ceramic coating and/or constructed of 

and appropriate non-corrosive material. 

5.3 The Group noted that with systems using electrochemical treatment there is an increased 

risk of explosion following the potential accumulation of hydrogen gas generated by the system. 

The hazards associated with the potential for generation of chlorine gas during the process is also 

in need of a further evaluation. Monitoring of levels of these substances and additional 

appropriate safety procedures should be required as a minimum for the opening of treated ballast 

tanks and personnel tank entry until it has been verified that such precautions are unnecessary. 

5.4 The Applicant claims that there are no risks associated with the handling of active 

chemical as the Active Substances and the relevant chemicals are produced in situ and are 

therefore not handled. 

5.5 It had been noted that the application for Basic Approval only described generic safety 

requirements for an ozone system and that no indication had been given on how these 

requirements will be applied when such a system would be used on board a ship. 

5.6 As a result, the Group considered that, from the ship perspective provided the above 

recommendations are taken into account, the system may be recommended for Basic Approval. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 9 

I:\MEPC\57\2-10.doc 

6 RISKS TO THE AQUATIC ENVIRONMENT 

6.1 Assessment Of Persistence (P), Bioaccumulation (B) And Toxicity (T) 

6.1.1 The products identified as Active Substances were assessed regarding their Persistence 

(P), Bioaccumulation potential (B) and their Toxicity (T). The assessment of these products is 

shown below: 

Compound Persistence (P) 

Half life: 

>60d in seawater 

>40d in fresh water 

>180d in sea sediment 

>120d in fw sediment 

Bioaccumulation (B) 

Log Pow >3 

Toxicity (T) 

Chronic NOEC<0.01 mg/L 

Ozone No

(Half life=5.8 sec) 

No

(Log Pow=-0.87) No 

Bromate ion No? No

(Log Pow=-7.18) No 

Bromoform 

Yes

(Half life 340d in 

sediment) 

No 

(Log Pow=2.4&BCF=14) 

No

(4.8 mg/L) 

Chlorine 

(Cl2) 

No No Yes 

FAC No No Yes 

Hydrogen No No No 

6.1.2 The Group agreed that, although no information was available on the Bioaccumulation 

characteristics of ozone, it was not expected that any of these substances would meet the criteria 

and therefore none of these substances should be classified as a PBT substance. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 The Group noted that experiments to determine the concentrations of Active Substances 

(Chlorine) and Relevant Chemicals (THM) in freshly treated ballast water yielded the 

following results: 

Concentration 

(mg/L) 

References 

Ozone N.D. 

Total Residual Oxidant as 

Free Chlorine 

Total Chlorine 

0.32 – 0.57 

0.08 – 0.32 

0.12 – 0.35 

Appendix 1 Application Dossier 

Appendix 3 Application Dossier 

Appendix 3 Application Dossier 

Bromate ion N.D. 

Chloroform <0.0008 Appendix 4 Application Dossier 

Bromodichloromethane <0.0001 Appendix 4 Application Dossier 

Dibromochloromethane <0.0001 Appendix 4 Application Dossier 

Bromoform 0 – 0.009 Appendix 1 Application Dossier 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 10 

I:\MEPC\57\2-10.doc 

7.2 From these data the Group concludes that the maximum concentration relevant for the 

environment would be TRO and bromoform. The maximum concentration for TRO of 0.57 mg/L 

and for bromoform 0.009 mg/L would be relevant to take into account for further exposure of the 

aquatic environment. 

7.3 In this context, it was noted that the applicant recommended carrying out further tests 

with different waters to ascertain the results. 

7.4 Acute toxicity of treated ballast water 

7.4.1 Six local marine and/or estuarine species, a marine sea weed, a crustacean, two species of 

gastropod mollusc and two species of fish were exposed to treated ballast water. The results are 

listed in the following table (Reference MEPC 56/2/3, appendix 1): 

 Species LC50 at TBW% 

Seaweed Gracilaria verrucosa Ca. 50% no consistent results 

Crustacean Diogenes brevirostris 100% 

Mollusc Bullia digitalis 100% 

Mollusc Haliotis midae 100% 

Fish Liza richardsonii 72% 

Fish Psammogobius knysnaensis 35% 

7.4.2 Immediately after treatment, the total chlorine levels in the simulation ballast tanks 

were 0.99 mg/L and bromoform levels measured ~4 hours after treatment were 5.5 μg/L. 

7.5 Chronic toxicity

7.5.1 The Group noted that the applicant did not carry out chronic toxicity studies, which is 

normally unacceptable. However, the Group also noted that the acute toxicity studies were 

carried out under flow-through conditions and covered six species including three trophic levels. 

It is recommended to carry out chronic toxicity studies for the full-scale testing for 

Final Approval. 

8 ENVIRONMENTAL RISK ASSESSMENT 

 The Group noted that the half life for ozone in seawater was reported as only 5 s in 

seawater and 30 min in fresh water and so would be degraded prior to being released into the 

marine environment. 

8.1 Derivation of a Predicted No Effect Concentration (PNEC) 

8.1.1 The Applicant claims that it is only relevant to evaluate PNEC values for ozone in fresh 

water and bromoform in seawater for this study. 

8.1.2 For ozone there is only one chronic value available, which is 5 μg/L. An assessment 

factor of 100 is applied to this value resulting in a PNEC chronic = 0.05 μg/L. There are 2 values 

available for acute data, the lowest of which is 60 μg/L. Apply a factor of 1000 to this yields a 

PNECacute = 0.06 μg/L. Of these two data the lowest value is taken as the resulting PNEC: 

PNEC = 0.05 μg/L as ozone. In the case of ozone introduced to fresh water a total time of at 

least 8 hours is required before the ballast water can safely be discharged. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 11 

I:\MEPC\57\2-10.doc 

8.1.3 For bromoform there is one chronic value available. An assessment factor of 100 is 

applied to this value resulting in a PNECchronic = 48 μg/L and 3 for the acute data, the lowest of 

which is 7.1 mg/L. Using an assessment factor of 1000 the PNECacute is established at 7.1 μg/L. 

Of these two data the lowest value is taken as the resulting PNEC: PNEC = 7.1 μg/L as 

bromoform. The half life of bromoform is in the order of 1-2 month and delaying release of 

ballast water is not considered feasible. 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the Active 

Substance and Relevant Chemicals

8.2.1 The Group noted that the applicant had not used any model to calculate the predicted 

environmental concentrations of Active substances or Relevant Chemicals. 

8.2.2 The Applicant uses the concentration of bromoform in the treated ballast 

water (19.6 μg/L) and concludes that this is only marginally higher than the PNEC 

value (7.1 μg/L) and hence no major risk to the environment is expected. 

8.2.3 The Group realizes that the resulting PEC/PNEC >1. However, taking initial dilution 

rates into account, the PEC/PNEC could be significantly lower. The Group recommends applying 

a ballast water discharge model for Final Approval. 

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship

9.1.1 It was agreed that there is a potential risk of explosion due to the possible excess 

hydrogen being produced. There is also a potential risk of corrosion to parts of the ship caused 

by the possible high levels of chlorine generated by the system. 

9.2 Risks to the crew and general public

9.2.1 The Group concluded that chlorinated and brominated disinfection by-products are the 

toxicologically relevant compounds generated by the RBT as they have a potential for human 

genotoxicity/carcinogenicity; therefore they will have to be kept below toxicological critical 

levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for 

Drinking Water Quality, 2003). 

9.2.2 The Group noted that the applicant did not provide information concerning the Human 

Exposure Scenario (MEPC 56/2/2, annex 9) of the RBT. This information has to be provided to 

the Group for Final Approval in order to enable an appropriate human health risk 

characterization. 

9.3 Risks to the environment

9.3.1 The Group noted that the applicant did not carry out chronic ecotoxicity studies, which is 

normally unacceptable. However the Group also noted that the acute ecotoxicity data was 

generated under flow-through conditions and covered six species from four groups, including 

three trophic levels. Due to the lack of data on chronic aquatic toxicity, the PEC/PNEC was 

based on acute toxicity data only. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 12 

I:\MEPC\57\2-10.doc 

9.3.2 The applicant should carefully consider the effect of organic matter levels on the 

production of by-products and demonstrate this by appropriate measurements. 

9.3.3 As there is currently no information on the estimated Predicted Environmental 

Concentration it is required that the applicant establishes a PEC estimation in order to determine 

a PEC/PNEC ratio to identify a possible risk for the environment for the relevant chemicals in the 

application. 

9.4 Conclusions 

After critical review of the submission, the Group agreed to recommend that Basic Approval be 

given to the Resource Ballast Technologies System submitted by South Africa. 

* * * 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 13 

I:\MEPC\57\2-10.doc 

APPENDIX 1 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION 

AND BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: OZONE 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.1.1) 

A summary of the acute aquatic toxicity data for ozone is shown in the table below: 

Species LC50 

(mg/l/duration) 

Reference/Comments/Justification 

for missing data 

Fish Lepomis macrochirus 

Bluegill 

0.06 

24 h 

Paller and Heidinger (1979) 

Fish Morone saxatilis 

Striped bass

0.15 

6 h 

Hall et al. (1981) 

Fish Pimephales promelas 

Fathead minnow

0.1 

0.03 h 

Asbury and Coler (1980) 

Mollusc Dreissena polymorpha 

Zebra Mussel 

0.52-0.54 

5.78 h 

Harrington et al. (1997) 

The acute toxicity of ozone (LC50) used as an Active Substance for this system is 8.1 μg/L in 

fresh water and 50 μg/L in seawater (PAN pesticides database). 

2.2 Chronic Aquatic Toxicity Data 

The concentration of ozone will break down to <11 μg/L (NOEC for Daphnia magna, Leynan 

et al. 1997) within 40 seconds in seawater and within 3.5 hours in fresh water, and to <0.14 μg/L 

(natural background levels) within 75 seconds in seawater and 6.5 hours in fresh water. Thus, it 

is supposed that ozone has no chronic aquatic toxicity. 

2.3 Information on Endocrine Disruption

There have been no documented studies on the endocrine disruptive properties of ozone. Due to 

its rapid dissolution, it is considered not to be an endocrine disruptor. 

2.4 Sediment Toxicity 

The decomposition speed of ozone is high enough so that there is no concern of toxicity to 

benthic organisms. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 14 

I:\MEPC\57\2-10.doc 

2.5 Bioavailability/Biomagnification/Bioconcentration

Ozone decomposes very rapidly in natural water. Therefore there is no risk that ozone may 

concentrate in organisms. 

2.6 Food Web/Population Effects 

Ozone does not persist or concentrate in organisms therefore there is no concern of effect on any 

animal high up the food chain. 

3 MAMMALIAN TOXICITY 

The toxicity of ozone to mammals is based on its strong oxidizing property. Ozone causes 

irritation to the eyes and to the pharynx, trachea, bronchi and bronchiole when inhaled. 

3.1 Acute mammalian Toxicity 

A summary of the mammalian toxicity data for ozone is shown in the table below: 

 Value 

[ppm] 

Species Reference/Comments/Justification 

 for missing data 

Inhalation LC50

(mg/L; 4 h) 

5.9-6.8 Mice Cheminfo by Canadian Centre for Occupational 

Health and Safety (CCOHS) 

The Group considers that ozone is very toxic by inhalation. 

Inhalation LC50

(mg/L; 4 h) 

5.9-6.8 mice Cheminfo by Canadian Centre for 

Occupational Health and Safety 

3.2 Corrosion/Irritation 

3.2.1 Effects on skin and eye

Ozone gas can probably cause skin irritation in humans due to its oxidizing ability, but only at 

concentrations capable of causing severe respiratory injury (CCOHS, 2007). 

Ozone concentrations greater than 2 mg/L can be irritating to human eyes within minutes 

(CCOHS, 2007). Based on existing information, the primary site of acute effects is considered to 

be the lung causing pulmonary congestion and increasing its sensitivity to other irritants. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 15 

I:\MEPC\57\2-10.doc 

3.3 Sensitization 

3.4 Repeated-Dose Toxicity 

A summary of the repeated dose toxicity data for ozone is shown in the table below: 

Exposure Route Inhalation 

Exposure Duration a) 105 to 130 weeks 

b) 3-18 months

Exposure dose a) 0.01-0.02 mg/kg bw/d 

b) 0.003-0.013 mg/kg bw/d

Species a) Mice 

b) Monkeys

Method 

Results a) increased incidence of non-carcinogenic lesions of 

the nose and lungs 

b) alterations to lungs, many changes seemed 

irreversible six months after exposure had stopped

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing data 

a) NTP, 1994

Although the reference NTP, 1994 was not submitted, the Group concluded that the observed 

critical effects in the repeated toxicity studies mentioned by the applicant (MEPC 56/2/3) were 

mainly non-carcinogenic lesions in the respiratory tract (nose and lungs). 

The Group was unable to find the reference referred to above. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 16 

I:\MEPC\57\2-10.doc 

3.5 Development and Reproductive Toxicity

3.5.1 A summary of the development and reproductive toxicity data for ozone is shown in the 

table below: 

Exposure Route Inhalation 

Exposure Duration a) 4 d in middle or late pregnancy 

b) d 7 -17 of pregnancy 

c) not stated 

d) from six days prior to mating to postnatal day 22 

Exposure dose a) continuously 0.020 or 0.03 mg/kg bw 

b) 0.024 mg/kg bw 

c) 0.03 and 0.04 mg/kg bw, 

d) not referred 

Species a) rat 

b) mouse 

c) rat 

d) mouse 

Method 

Results 

observed adverse effects 

a) reduced growth rates after birth and delayed 

behavioural development, no maternal toxicity 

b) decrease in fetal body weight gain and signs of 

maternal toxicity were observed 

c) Embryo toxicity in the form of increased 

resorption. Maternal toxicity was not reported. 

d) reduced body weight in the offspring and slight 

effects in neurobehaviour development of the 

offspring; maternal tox. Not evaluated 

NOAEL a) not referred 

b) not referred 

c) not referred 

d) not referred 

NOEL 

Reference/Comments/ 

Justification for missing data 

a), b), c), d) – CCOHS 

The Group considers that there are some concerns of reprotoxicity effects by inhalation exposure, 

namely neurobehavioural development, in the submitted studies. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 17 

I:\MEPC\57\2-10.doc 

3.6 Carcinogenicity/Mutagenicity 

3.6.1 A summary of the Carcinogenicity/Mutagenicity toxicity data for ozone is shown in the 

table below:

 Species Method Details Results 

(Yes/No) 

Reference 

Carcinogenicity 

a) rats Rats 

b) mice 

0.0021, 0.01 and 

0.02 mg/kg bw 

105-130 weeks 

a) no evidence for 

carcinogenicity in rats 

b) no evidence as tumor 

promoter 

Mutagenicity 

a) lymphocytes of 

hamsters 

b) lung macrophages 

female rats 

c) bacteria, 

mammalian, and 

human cells 

a) 0.0048-0.086 

mg/kg bw for 5 h 

b) 0.0024-0.016 

mg/kg bw for 

6 hours 

a) cytogenetic aberrations 

b) cytogenetic aberrations 

c) evidence for 

mutagenicity in 

bacteria, mammalian 

and human cells 

NTP, 1994 

Mutation 

Research, 

1992 

The Group concluded that there is evidence of mutagenicity concern, in line with existing 

scientific literature. 

3.7 Toxicokinetics 

Ozone is absorbed in both the upper and lower respiratory tract. It is a potent oxidant that reacts 

with protein and lipids, particularly within biological membranes. A small amount of ozone is 

absorbed into the blood. The Group considers that due to the short life and the high reactivity, 

Ozone has low potential for bioaccumulation of ozone limits its ability to accumulate. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

A summary of the modes of degradation data for ozone is shown in the table below:

 Seawater or 

Fresh Water 

Test 

Duration 

Results Breakdown 

products 

Reference/Comments/ 

Justification for missing 

data 

1⁄2 - Life FW 10-30min O2 MEPC 56/2/3, 3.1 

1⁄2 - Life SW 5 s O2 MEPC 56/2/3, 3.1 

4.1.1 The Group recognized that ozone breaks down in an abiotic process into oxygen (O2). 

In pure (fresh) water ozone has a half life of 10-30 minutes. In seawater the half-life is reduced 

to 5.3 seconds. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 18 

I:\MEPC\57\2-10.doc 

4.2 Partition Coefficients

 Method Results Reference/Comments/ Justification 

for missing data

Log Pow 

Koc <1 MEPC 56/2/3, 3.1.7.2 

4.3 Persistence and Identification of Main Metabolites

 Method Results Reference/Comments/ Justification 

for missing data

Persistence N.D. 

4.4 Reaction with Organic Matter 

Cyclo addition (Criegee mechanism) 

Consequentially to its dipolar structure, an ozone molecule can undergo a 1-3 dipolar 

cyclo-addition with saturated compounds (double or triple bonds). This leads to the formation of 

a compound called ozonide. 

Dipolar cyclo-addition (Lenntech database) 

In a protonic solution, such as water, primary ozonide disintegrates into an aldehyde, a keton or a 

zwitter ion. The zwitter ion will eventually be disintegrated further into hydrogen peroxide and 

carboxyl compounds. 

Disintegration of ozonide (Lenntech database) 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 19 

I:\MEPC\57\2-10.doc 

Electrophilic reactions 

Electrophilic reactions occur in molecular solutions that have a high electronic density and 

mainly in solutions that contain a high level of aromatic compounds. Aromatic compounds that 

are substituted by electron donors (such as OH and NH2), have a high electronic density on the 

carbon compounds in ortho and para position. Consequentially, in these positions aromatic 

compounds react actively with ozone. Is an example of a reaction between ozone and Phenol. 

Phenol groups react with ozone relatively quickly. 

Reaction between phenol and ozone (Lenntech database) 

Nucleophilic reactions 

Nucleophilic reactions mainly take place where there is a shortage of electrons and particularly at 

carbon compounds that contain electron-retreating groups, such as –COOH and –NO2. 

For electron-retreating groups, the reaction speed is much lower. 

From the above-mentioned data, it appears that direct oxidation of organic matter by ozone is a 

selective reaction mechanism, during which ozone reacts quickly with organic matter that 

contains double bonds, activated aromatic groups or amines. It is also stated that ozone reacts 

quicker with ionized and dissociated organic compounds than with the neutral 

(non-dissociated) type. 

For most inorganic compounds in drinking water, the reaction speed is relatively high. The main 

reaction mechanism for oxidation of inorganic compounds is determined by transfer of the extra 

oxygen atom of ozone to the inorganic compounds. For inorganic compounds, reaction speed is 

also higher for ionized and dissociated compounds. 

In summary, ozone oxidizes organic compounds selectively and partly. A large number of 

inorganic compounds are oxidized fast and completely. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

As the half life of ozone is 5 seconds in seawater and 30 minutes in fresh water, it decomposes 

too quickly for the treated ballast water to have any potential effects on wildlife and 

benthic habitats. 

4.6 Potential Residues in Seafood 

As ozone is not accumulated, there will be no risk of residue in seafood. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 20 

I:\MEPC\57\2-10.doc 

4.7 Any Known Interactive Effects 

Ozone produces oxygen when decomposed in water. As a result it increases the amount of 

oxygen dissolved in the water which helps aquatic organisms. In a closed system, such as a 

seawater aquaculture system, ozone removes nitrogen in the form of ammonia that is discharged 

from fish. 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Physical property Value 

Name Ozone 

CAS number 10028-15-6 

Molecular weight (g/Mol) 48 

Melting point (°C) -193 

Boiling point (°C) -112 

Flash point (C°) Non-combustible but promotes 

burning of other substances 

Density (g/mL at 20oC) N.D. (1.5 at -183 °C) 

Vapour pressure (Pa at 20°C) >100,000 

Vapour Density (air=1) 1.6 

Water solubility/dissociation constant (pKa) Definition for liquid; no relation with 

gas 

pH Not Required 

Octanol/water partition coefficient (log Pow) 

see p.22 

N.D. (-0.87) 

Dissociation constant (pKa) N.A. 

Oxidation/reduction potential (V) 2.07 

Corrosivity to the materials Yes 

Autoignition temperature (oC) Non-combustible but promotes 

burning of other substances 

Explosive properties May cause fire or explosion when 

heated or coming into contact with a 

combustible material (alkene, ether) 

Oxidizing properties Yes 

Surface tension (N/mm at -183oC) 3.84 x 10-2

Viscosity (Pa.s at -183oC) 1.5 x 10-3

Thermal stability and identity of relevant 

breakdown products 

Oxygen 

Other known relevant physical or chemical 

hazards 

Reactivity towards container material 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 21 

I:\MEPC\57\2-10.doc 

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: Not classified under GHS classification, Annex VI, 

COM (2007) 355 final. 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification for 

missing data 

No No Yes MEPC 56/2/3, 7.1, table 7 

* * * 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 22 

I:\MEPC\57\2-10.doc 

APPENDIX 2 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: BROMATE 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.2.1, table 4) 

A summary of the acute aquatic dose toxicity data for bromate is shown in the table below:

Species LC50 

(mg/l/; 

duration) 

Reference 

Fish Cymatogaster aggregater 

Shiner Perch 

880 

72 h 

Crecelius (1979) 

Fish OncorhynchusKeta 

Chum salmon 

512 

96 h 

Crecelius (1979) 

Mollusc Crassostrea gigas 

Pacific oyster 

30 

48 h 

Crecelius, 1979 

Mollusc Macoma inquinata 

Bent-nosed clam 

880 

72 h 

Crecelius (1979) 

Mollusc Protothaca staminea 

Littleneck clam 

880 

72 h 

Crecelius (1979) 

Mollusc Crassostrea virginica 

American oyster 

1 

48 h 

Stewart et al. (1979) 

Crustacean Pandalus danae 

Coon stripe shrimp 

880 

72 h 

Crecelius (1979) 

Crustacean Neomysis awatschnsis 

Opossum shrimp 

176 

24 h 

Crecelius (1979) 

2.1.1 Ozone reacts with bromide in seawater to form the bromate ion (BrO3

-

). The half life of 

the bromate ion is approximately 12 hours. Fresh water typically contains a very low 

concentration of the bromide ion and therefore the production of the bromate ion does not occur 

in fresh water. 

2.2 Chronic Aquatic Toxicity Data 

No chronic toxicity data were delivered, probably due to the short half life of bromate, which is 

approximately 12 h. 

2.3 Information on Endocrine Disruption

No instances have been reported for the endocrine disruptive properties of bromate ions. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 23 

I:\MEPC\57\2-10.doc 

2.4 Sediment Toxicity

Soil adsorption factor of bromate ion is estimated as follows from the relation with the 

octanol/water partition coefficient, Pow: 

Based on the following (QSAR): 

Koc = 0.41 x log (Pow)

8

 

And using a log Pow of -7.18 a Koc = 2.8 L/kg is calculated. This value will be used in 

further calculations if needed. 

This estimate of Koc: 2.8 L/kg is below the value of anticipated toxicity to benthic organisms and 

there is therefore no risk of toxicity to benthic organisms. 

The Group recommends that the applicant checks and re-considers the above. 

2.5 Bioavailability/Biomagnification/Bioconcentration

The octanol/water partition coefficient log value of bromate ion is -7.18 and is therefore 

considered not to pose a risk of concentration in organisms. 

Log Pow: -7.18 Reference/Comments/Justification for missing data 

BCF: No risk MEPC 56/2/3, 3.2.4 

2.6 Food Web/Population Effects 

The bromate ion does not accumulate and there will therefore be no effect on organisms high in 

the food chain. 

3 MAMMALIAN TOXICITY 

The toxicity of the bromate ion to mammals is based on its strong oxidizing properties. Bromate 

ions may affect the skin and eyes by exposure and cause coughing, pharynx pain, nausea, 

vomiting, abdominal pain, diarrhea or central nervous system disturbance if taken orally. 

3.1 Acute mammalian Toxicity 

 Value 

(mg/kg)

Species Reference/Comments/Justification 

 for missing data 

Oral LD50 321 Rat Sinochem chemical data sheet 

Bromate (potassium bromate) is toxic if swallowed (GHS classification, Annex VI, 

COM (2007) 355 final).

3.2 Corrosion/Irritation

Bromate (potassium bromate) is irritating to eyes, skin and mucous membranes 

(MSDS Sinochem). 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 24 

I:\MEPC\57\2-10.doc 

3.3 Sensitization 

No information available. 

3.4 Repeated-Dose Toxicity 

The exposure of rats to bromate for 15 weeks demonstrated a No Observed Adverse Effect Level 

(NOAEL) of 30 mg/kg bw/d. 

3.4.1 Chronic toxicity 

A summary of the chronic mammalian toxicity data for bromate (potassium bromate) is shown in 

the table below:

Species Dose Effect Reference/Comments

/Justification for 

missing data 

Male 

B6C3F1 

mice 

0, 0.08, 0.4, or 0.8g/L 

KBrO3, drinking 

water, 100 weeks 

No effects observed on incidence 

on non-neoplastic lesions 

NOAEL of 0.8g/L 

De Angelo, 1998 

(WHO, 2005) 

Male F344 

rats 

0, 0.02, 0.1, 0.2, or 

0.4 g/L KBrO3

NOAEL of 0.02g/L based on 

kidney effects 

De Angelo, 1998 

(WHO, 2005) 

The Group concluded that from existing and submitted information (WHO, 2005) there are concerns 

related to nephropathy under long term exposure to potassium bromate. 

3.5 Development and Reproductive Toxicity 

A summary of the development and reproductive toxicity data for bromate (sodium bromate) is 

shown in the table below:

Exposure Route Oral 

Exposure Duration 35 d 

Exposure dose 0, 2.2, 7.7 and 22 mg of bromate/kg bw/d 

Species Rat 

Method 

Results Decrease in epididymal sperm density (at 22 mg/kg bw/d), 

otherwise no indication of the developmental endpoints or any 

effects were observed. 

NOAEL 7.7 mg/kg/d 

LOAEL 22 mg/kg/d 

NOEL 

Reference/Comments/ 

Justification for missing data 

Wolf and Kaiser, 1996 in WHO, 2005 

From the submitted information, the Group concluded that there are some fertility concerns 

related to exposure of rats to sodium bromate. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 25 

I:\MEPC\57\2-10.doc 

3.6 Carcinogenicity/Mutagenicity

A summary of the Carcinogenicity/Mutagenicity data for bromate (potassium bromate) is shown 

in the table below:

 Species Method 

Details 

Bromate 

alone 

Results Reference/Comments

/ Justification for 

missing data 

Carcinogenicity Rat Oral 32.3 mg 

KBrO3/kg 

average daily 

consumption 

104 weeks 

(drinking 

water) 

Increased dysplastic 

foci, renal adenomas, 

adenocarcinomas, 

thyroid follicular cell 

tumors, peritoneal 

mesotheliomas 

Kurata et al. 1992 in 

(WHO, 2005) 

Mutagenicity V79 

chinese 

hamster 

cells 

Micronucleus, 

CA, HPRT 

gene 

mutation, 

alkaline 

comet assay 

cytotoxic, increased 

the frequency of cells 

with micronuclei, 

chromosome 

aberrations, DNA 

migration, increased 

levels of 8 

oxodeoxyguanosine, 

gene mutations and 

gene mutation at 

HPRT locus 

Speit et al. 1999 in 

(WHO, 2005) 

From the submitted and existing information (WHO, 2005), bromate (potassium bromate) 

produces tumours at multiple sites in rats, including the kidney (adenomas and carcinomas), the 

thyroid gland (follicular cell adenomas and carcinomas) and the peritoneum (mesotheliomas) 

(Kurokawa et al., 1986 a,b, 1987; Kurata et al. 1992; DeAngelo et al., 1998). Further, a clear 

dose-response relationship exists in tumour incidence and the severity/progression of tumours. 

The weight of evidence from the rat bioassays clearly indicates that bromate (potassium bromate) 

has the potential to be a human carcinogen. 

Bromate (potassium bromate) is classified as carcinogen – may cause cancer category 1 B 

(GHS classification, Annex VI, COM (2007) 355 final) 

In addition, and according to existing literature, the Group considered that the weight of evidence 

demonstrates that bromate (potassium bromate) is clearly mutagenic in in vitro assays. These 

positive findings show that this mutagenicity is also expressed in vivo. Thus, bromate (potassium 

bromate) should be considered a mutagenic disinfection by-product. 

3.7 Toxicokinetics 

3.7.1 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. 

Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, 

although only a small amount appears to be reduced in this way. Bromate is excreted mainly by 

urine as bromate and bromide and some may also be eliminated by faeces. Bromate concentrations 

in urine peak at about 1 hour, and bromate is not detectable in plasma after 2 hours. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 26 

I:\MEPC\57\2-10.doc 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

The Group noted that Bromine is removed from seawater by several mechanisms 

(Perrins et al. 2006). HOBr/OBr_OBr-

 reacts with natural organic matter to form bromoform 

(CHBr3) by the haloform reaction. In the presence of ammonia, HOBr/OBr-

 will react rapidly to 

form monobromamine, which can subsequently disproportionate to NHBr2 and NH3 or with 

excess HOBr/OBr- it can react further to form N2 and bromide. The rate of these reactions varies 

light and salinity concentration. 

4.2 Bioaccumulation/Partition Coefficients

The established octanol/water partition coefficient of bromate (Log Pow=-7.18) is very low. 

Therefore, the Group concludes that bromate has no risk of bioconcentration. 

4.3 Persistence and Identification of Main Metabolites

Compare 4.1. 

4.4 Reaction with Organic Matter 

Bromate does not volatilize and is only slightly adsorbed onto soil or sediment. Because it is a 

strong oxidant, its most likely fate is reaction with organic matter, leading to the formation of 

bromide ion (WHO, 2005). 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

The Group noted that the half life of the bromate ion in seawater is fairly short 

(~12 hours) and its estimated adsorption coefficient is very low (2.8). There is no potential of 

effects on benthic organisms. The bromate ion is not accumulated and therefore will not affect 

high-order organisms in a food chain. 

4.6 Potential Residues in Seafood 

The bromate ion is not accumulated and therefore there will be no potential residues in seafood. 

4.7 Any Known Interactive Effects 

Under normal environmental conditions, it is difficult for the bromate ion to be reduced. 

However, it may be reduced to the bromide ion where ferrous ions, activated carbon or other 

carbonaceous substances exist. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 27 

I:\MEPC\57\2-10.doc 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Physical property Value 

Name Potassium bromate 

CAS number 7758-01-2 

Molecular weight (g/Mol) 167 

Melting point (°C) 350 

Boiling point (°C) 370 

Flash point (C°) N/A 

Density (g/mL at 20oC) 3.27 

Vapour pressure (Pa at 20°C) 

Vapour Density (air=1) 5.8 

Water solubility (g/L) 

Dissociation constant (pKa) 8.62 

pH 

Octanol/water partition coefficient (log Pow) -7.18 

Oxidation/reduction potential (V) 

Corrosivity to the materials Yes 

Autoignition temperature (oC) 

Explosive properties 

Oxidizing properties Yes 

Surface tension (N/mm at -183oC) 

Viscosity (Pa.s at -183oC) 66.6-67.6 

Thermal stability and identity of relevant breakdown products 

Other known relevant physical or chemical hazards 

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 

Carc 1B, Acute Tox. 3 (hazard statement codes: H350, H301) 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification for 

missing data 

No No Yes MEPC 56/2/3, 7.1, table 7 

* * * 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 28 

I:\MEPC\57\2-10.doc 

APPENDIX 3 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION 

AND BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: BROMOFORM 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

2.1.1 A summary of the acute aquatic toxicity data for bromoform is shown in the table below: 

Species LC50 

(mg/l/ 

duration) 

Reference/Comments/Justification 

for missing data 

Fish Brevoortia tyrannus

Atlantic menhaden 

9 

96 h 

Anderson (1979) 

Fish Cyprinodon 

variegates 

Sheepshead minnow 

16 

48 h 

Heitmuller et al. (1981) 

Fish Lepomis macrochirus 

Blue Gill 

33 

24 h 

Buccafusco et al. (1981) 

Mollusc Crassostrea virginica 

American oyster 

40 

96 h 

Gibson et al. (1981) 

Mollusc Mercenaria 

mercenaria 

Hard clam 

140 

96 h 

Gibson et al. (1981) 

Crustacea Penaeus aztecus 

Brown shrimp 

20 

96 h 

Gibson et al. 1981 

Algae Selenastrum 

capricornutum 

Green algae 

18.7 

24 h 

US EPA, 1978 

Algae Selenastrum 

capricornutum 

Green algae 

28.2 

96 h 

US EPA, 1978 

2.2 Chronic Aquatic Toxicity Data 

2.3 Information on Endocrine Disruption

No information is available on disruption of endocrine functions by bromoform. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 29 

I:\MEPC\57\2-10.doc 

2.4 Sediment Toxicity

Bromoform and dibromochloromethane have a minor tendency to be adsorbed by soils 

and sediments. Calculated and measured values of Koc (the organic carbon/water partition 

coefficient, an index of the relative mobility of a material in water-soil systems) for 

bromoform range from 62 to 126 (Hassett et al. 1983; Hutzler et al. 1986; Mabey et al. 1982 

in U.S. Agency for Toxic Substances and Disease Registry, 2005). These relatively low values 

imply that bromoform will exhibit only a minor affinity for soil materials and will tend to be highly 

mobile (Roy and Griffin 1985 in U.S. Agency for Toxic Substances and Disease Registry, 2005). 

This low tendency for adsorption to soil has been confirmed in laboratory studies 

(Curtis et al. 1986 in U.S. Agency for Toxic Substances and Disease Registry, 2005) and in field 

studies by (Roberts et al., 1986 in U.S. Agency for Toxic Substances and Disease Registry, 2005). 

2.5 Bioavailability/Biomagnification/Bioconcentration

 Reference/Comments/Justification for missing data 

Log Pow - 

BCF: between <1 and 10 

times the water 

concentration

Gibson et al 1979; 28 day uptake and depuration tests with 

shrimps and fish 

BCF: 7.6 Oyster (Crassostrea virginica) 90 μg/L 

It was concluded that the rate of uptake and depuration was dependent on the individual, the 

species and the concentration of bromoform in the water. 

2.6 Food Web/Population Effects 

There is inconclusive evidence as to whether bromoform is concentrated up the food chain but it 

appears unlikely that bromoform persists in organisms. 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity

A summary of the acute mammalian toxicity data for bromoform is shown in the table below: 

 Value Species Reference/Comments/Justification 

 for missing data 

Oral LD50 (mg/kg) 1475 Mouse Bowman et al., 1978 in Melnick, 1989 

1268 Rat Chu et al., 1980 in Melnick, 1989 

3.1.1 The LD50 values presented in submitted studies, indicate that bromoform is harmful if 

swallowed. In addition and according to GHS classification, bromoform is toxic if inhaled. 

3.2 Corrosion/Irritation

3.2.1 Bromoform is classified under GHS as an eye irritant (Eye irrit 2) and skin irritant (Skin irrt 2). 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 30 

I:\MEPC\57\2-10.doc 

3.3 Sensitization 

3.3.1 The Group noted that sensitization data had not been provided for bromoform. However, 

the Applicant states that direct contact with bromoform in liquid form causes redness and pain. 

3.4 Repeated-Dose Toxicity

A summary of the repeated toxicity data evaluated by the Group for bromoform is shown in the 

table below: 

Exposure 

Route 

a) Oral (gavage) 

b) Oral (gavage) 

c) Oral (gavage) 

Exposure 

Duration 

a) 5 times weekly for 13 weeks 

b) 14 d 

c) 14 d 

Exposure 

dose 

a) 0, 12, 25, 50, 100, or 200 mg/kg (rat), 0, 25, 50, 100, 200, or 400 

mg/kg (mouse) 

b) 50, 125, or 250 mg/kg d 

c) 72, 145, or 289 mg/kg d 

Species a) Rat and Mouse 

b) Mouse 

c) Mouse 

Method 

Results a) All male rats treated with 100 or 200 mg/kg and all female rats 

treated with 200 mg/kg were lethargic. Dose-related increases of 

cytoplasmic vacuolization of hepatocytes were observed in males of 

both species, but not in females. 

b) depressed humoral and cellular immunity in male mice only. Liver 

weights and serum glutamate oxaloacetate transaminase levels were 

increased and serum glucose and blood urea nitrogen levels were 

decreased in the high-dose animals. 

c) Elevated serum glutamate-pyruvate transaminase in high dose animals. 

 Histological changes in the kidneys and liver including hyperplasia 

of tubular epithelial cells, hypertrophy and degenerative changes of 

the glomeruli in the kidney, and centrilobular cytoplasmic pallor and 

slight focal inflammation of the liver. 

NOAEL N.D. 

NOEL N.D. 

Reference/ 

Comments 

a) NTP, 1989 in Faust, 1995 

b) Munson et al. 1982 in Faust, 1995 

c) Condie et al. 1983 in Fasut, 1995 

The Group concluded that from existing and submitted information there are concerns related to 

nephropathy and hepatopathy under repeated exposure to bromoform. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 31 

I:\MEPC\57\2-10.doc 

3.4.1 Chronic toxicity 

3.4.1.1 The Group considered the study submitted by the applicant (90d study) to be a 

sub-chronic test. A summary of the chronic toxicity data evaluated by the Group for bromoform 

is shown in the table below: 

Exposure Route Oral 

Exposure Duration 90 d 

Exposure dose 5,50, 500, 2500 mg/L

Species Rat 

Method 

Results Liver lesions (male rats 2,500 mg/L, in female rats 500 

and 2500 mg/L). 

NOAEL 

NOEL 

Reference/Comments/ 

Justification for missing 

data 

Chu et al., 1982 in Melnick, 1989 

The Group concluded that from existing and submitted information there are concerns related to 

hepatopathy under sub-chronic exposure (90 days) to bromoform with gender specific effects. 

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 Ruddick et al. 1983 EHC 216 (2000) 

The Group concluded from the submitted and existing information (EHC 216, 2000) that there 

may be some reprotox concerns (fetotoxicity) related to exposure to bromoform. No effects were 

observed on fertility parameters. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 32 

I:\MEPC\57\2-10.doc 

3.6 Carcinogenicity/Mutagenicity

The Group evaluated the carcinogenicity and mutagenicity data submitted for bromoform and 

concluded that there are positive animal data indicating that bromoform can cause liver and 

intestinal tumours. 

3.7 Toxicokinetics 

3.7.1 The Group noted that bromoform can be absorbed by inhalation, ingestion and dermal 

routes of exposure. In humans and laboratory animals, bromoform is generally absorbed quickly 

(Backer et al. 2000). Although bromoform is lipophilic, it does not appear to accumulate in 

adipose tissue (Stanley 1986). 

3.7.2 Bromoform is primarily excreted via exhalation as the parent compound or carbon 

dioxide (Mink et al. 1986 in U.S. Agency for Toxic Substances and Disease Registry, 2005). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

In the following table an overview is given of the environmental fate and behaviour data of 

bromoform: 

 Seawater 

or Fresh 

water 

Test 

Duration

DT50 

Results Breakdown 

products 

Reference/Comme

nts/ Justification 

for missing data 

Biodegradatio

n 

N.D. 

1/2 – Life Air N.D. 1-2 

months 

concentration in 

air indicate that 

levels are 

<10 ppt). 

 ATSDR, 1990 

volatilization 

4.1.1 The Group noted that bromoform tends to volatilize from water when exposed to the air, 

where it is relatively stable with a half life of 1-2 months. Most measurements of the 

concentration of bromoform in air indicate that levels are quite low (<10 ppt). 

4.2 Partition Coefficients 

4.2.1 In the following table an overview is given of the partition coefficients of bromoform: 

 Method Results Reference/Comments/Justification 

for missing data

Log Pow 

Koc range from 62 

to 126 

 Mabey et al. 1982 in U.S. Agency for 

Toxic Substances and Disease Registry, 

2005 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 33 

I:\MEPC\57\2-10.doc 

4.2.2 The Group noted that bromoform may be slightly bioconcentrated by aquatic organisms. 

The magnitudes of the Kow value suggest that the chemicals will tend to partition to fat tissues of 

aquatic organisms (U.S. Agency for Toxic Substances and Disease Registry, 2005). 

4.3 Persistence and Identification of Main Metabolites

4.4 Reaction with Organic Matter 

4.4.1 It was noted by the Group that trihalomethanes such as bromoform are formed as a 

by-product when chlorine or bromine are used to treat ballast water by reaction with organic 

matter in the water. However, once the bromoform is formed it does not appear to have any 

further reactions with organic matter. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

No information is available on the effects of bromoform on wildlife or benthic habitats. 

4.6 Potential Residues in Seafood 

No information is available on bromoform residues in seafood. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 34 

I:\MEPC\57\2-10.doc 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Property Value 

Name bromoform

CAS number 75-25-2 

Molecular weight (g/Mol) 252.73 

Melting point (°C) 8.3 

Boiling point (°C) 150 

Flash point (°C) >107 

Density (g/mL at 20oC) 

Vapour pressure (Pa at 20°C) 640 

Vapour Density (air=1) 8.7 

Water solubility (g/L) 

Dissociation constant (pKa) 

pH - 

Octanol/water partition coefficient (log Pow) 

Oxidation/reduction potential (V) 2.06 

Corrosivity to the materials Yes 

Autoignition temperature (oC) 

Explosive properties 

Oxidizing properties 

Surface tension (N/mm at -183oC) 

Viscosity (Pa.s at -183oC) 

Thermal stability and identity of relevant breakdown products 

Other known relevant physical or chemical hazards 

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 ......... Acute Tox. 3, Eye irritation 2, Skin irritation 2 (hazard 

statement codes: H331, H319, H315) 

6.4 Risk Characterization 

Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification for 

missing data 

Yes No Yes MEPC 56/2/3, 7.1, table 7 

* * * 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 35 

I:\MEPC\57\2-10.doc 

APPENDIX 4 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: FREE ACTIVE CHLORINE 

The following compounds are all treated under this heading: 

- Chlorine gas (Cl2) 

- HOCl and ClO- (Sodium hypochlorite) 

- Total Residual Oxidants (TRO) 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.4.1, Table 6) 

2.1.1 A summary of the acute aquatic toxicity data for Free Active Chlorine is shown in the 

table below: 

Organism Species LC50 

(mg/l/dur

ation) 

Reference/Comments/Justification for 

missing data 

Chlorine 

Fish Salvelinus fontinalis 

Brook trout 

0.35 

9h 

Dandy, (1972) 

Fish Morone saxatilis

Striped bass 

0.61 

6 h 

Bills et al. (1992) 

Mollusc Crassostrea gigas 

Pacific oyster 

0.556 

1 h 

Chien and Chow, 1989 

Mollusc Mercenaria mercenaria 

Hard Clam 

0.05 

48 h 

Bellanca and Bailey, 1977 

Crustaceans Asellus aquaticus 

Aquatic sowbug 

0.754 

24 h 

Kaniewska-Prus, 1982 

Crustaceans Callinectus sapidus 

Blue crab 

0.75 

48 h 

Vreenegoor et al. 1977 

Algae Chlorophyceae 

Green Algae 

0.1 

24 h static 

Toetz et al. 1977 

Sodium 

hypolchlorite 

 

Fish Clupea pallasii 

Pacific herring 

0.065 

96 h 

Thatcher, 1978 

Mollusc Lepomis macrochirus 

Bluegill 

0.58 

96 h 

Office of pesticide programs, 2000 

Mollusc Dreissena polymorpha 

Zebra mussel 

0.090 

17.7 h 

Harrington et al., 1997 

Mollusc Crassostrea virginica 

American oyster 

0.12 

0.5 

Capuzzo, 1979 

Crustaceans Clibanarius humilis 

Hermit crab 

2.5 

96 h 

Best, 1991 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 36 

I:\MEPC\57\2-10.doc 

Organism Species LC50 

(mg/l/dur

ation) 

Reference/Comments/Justification for 

missing data 

Crustaceans Hemigrapsus nudus 

Shore crab 

1.418 

96 h 

Thatcher, 1978 

Algae Chlorella sorokiniana 

Green algae 

0.2 

20 h 

Kott and Edlis, 1969 

Algae Plankton 0.09 

96 h 

Best, 1991 

2.2 Chronic Aquatic Toxicity Data 

2.3 Information on Endocrine Disruption 

No information is available on endocrine disruption by chlorine 

2.4 Sediment Toxicity

2.4.1 The Group noted that chlorine may react with soil and sediment components to form 

chlorides, which, depending on their water solubility, are easily washed out. (Seiler et al. 1988). 

2.5 Bioavailability/Biomagnification/Bioconcentration 

2.5.1 It was noted that there is no potential for the bioaccumulation or bioconcentration of 

chlorine (HSDB, 1994). 

2.6 Food Web/Population Effects 

2.6.1 The Group noted that that as there is no potential for bioconcentration of chlorine, 

animals high in the food chain will not be affected. 

3 MAMMALIAN TOXICITY 

3.1 Acute Toxicity 

The acute toxicity effects of Free active chlorine (FAC) are irritation, pain, inflammation of 

mucoses. In severe cases causes ulceration and perforation of gastro intestinal tract. 

Mild irritation to corrosive injury by dermal route depending on the concentration. Vapours are 

not easily formed however with more concentrated solutions and high pH or if mixed with acids 

higher % of chlorine may be released causing mild to severe irritation of nose and throat. Lethal 

effects can also occur, derived from aspiration of sodium hypochlorite solution into the lungs. 

Health effects depend on concentration and pH of the solution. 

Chlorine has irritant effects on mucoses and skin. Acute inflamatory effects of chlorine gas 

towards the respiratory tract are also well reported and seem to be reversible in 1-4 weeks after 

exposure. The severity of the health effects will depend on concentration of chlorine and pH of 

the solution. Chlorine is classified under GHS as toxic if inhaled (Acute tox 3). 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 37 

I:\MEPC\57\2-10.doc 

3.2 Corrosion/Irritation

3.2.1 Effects on skin and eye 

Free active chlorine (NaClO- ) can cause mild skin irritation to corrosive injury depending on the 

duration of contact, concentration and pH of the solution. Sodium hypochlorite does not easily 

form vapours however in more concentrated solutions and at high pH, form mists that can cause 

mild to severe irritation of the nose and throat. 

Sodium hypochlorite is classified under GHS as skin corrosive 1B. 

Chlorine is considered a primary irritant to the mucous membranes of the eyes, nose, and throat 

and to the linings of the entire respiratory tract (Stokinger 1982). Acute inflammatory effects to 

exposed skin are reported. The extent of acute injury to humans depends on the concentration and 

duration of exposure as well as the water content of the tissue involved and the presence of 

underlying cardiopulmonary disease (HSDB 1994). 

Chlorine is classified under GHS as eye irritant (Eye irr 2) and skin irritant (Skin irr 2). 

3.3 Repeated dose toxicity 

Several rodent studies with administered sodium hypochlorite in drinking-water have suggested 

immunological changes. Exon et al. (1987) examined immunotoxicological effects of sodium 

hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per day) in the drinking water of 

male Sprague-Dawley rats for 9 weeks. The effects on macrophage activity suggest that some 

impairment does occur at relatively low levels of sodium hypochlorite although the significance 

of which is still unknown. Modification of macrophage function seems to be one of the most 

sensitive responses identified in studies of chlorine or hypochlorite in experimental animals 

(EHC 216, WHO, 2000). 

A study from Daniel et al. (1990a) evaluated the toxicity of chlorine prepared by 

bubbling chlorine gas into distilled water and adjusting pH to 9.4. The nominal 

concentrations of chlorine were approxim. 0, 3, 10, 16 or 21 mg/kg bw per day, 

administered as drinking-water to both male and female Sprague-Dawley rats 

(10 per sex per dose) for 90 days. No deaths occurred in any treatment group. A NOEL 

(No Observed Effect Level) of 10 mg/kg bw per day was identified by the authors based on 

reduced body weight gain however this cannot be considered a true toxicological end-point as 

can be associated to a reduced palatability of the drinking-water. 

3.4 Chronic toxicity 

In a 2-year study (NTP, 1992) using chlorine up to 14 mg/kg bw/d in drinking-water of F344 rats 

and B6C3F1 mice. The only treatment-related non-tumour pathology was found to be a dilatation 

of renal tubules in male mices at the highest dose level (14mg/kg bw/d). No non-neoplasic 

lesions were observed in either male or female rats. A NOAEL could be derived of 

approximately 15 mg/kg bw per day in the 2-year studies in rats and mice. 

Chronic exposure to chlorine gas may cause dyspnea, palpitations, chest pain reactive, upper 

airways dysfunction syndrome. It is one of the most frequent causes of occupational asthma. 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 38 

I:\MEPC\57\2-10.doc 

3.5 Carcinogenicity/Mutagenicity 

In most animal studies available for carcinogenicity evaluation (EHC 216, WHO, 2000) there is a 

lack of statistical evaluation of the results and lack of dose-response relationship. Sodium 

hypochlorite is not classified by IARC as to their carcinogenicity to humans (Group 3). 

Several studies have shown that sodium hypochlorite produces mutagenic responses in bacterial 

systems and mammalian cells in vitro. However, there is no evidence of activity in mammalian 

test systems in vivo. It is not clear to what extent this is influenced by the formation of 

mutagenic by-products as a result of reactions with components of the incubation media 

(Rosenkranz et al., 1976). 

3.6 Developmental and reproductive toxicity 

Some indicative effects of altered sperm shape have been detected in several studies with 

chlorinated drinking-water. Meier et al. (1985b) reported that oral administration of sodium 

hypochlorite (pH 8.5) prepared from chlorine gas and administered 

at 4 or 8 mg/kg bw per day for 5 weeks increased the incidence of sperm abnormalities in 

B6C3F1 mice. 

Some animal studies have demonstrated no reproductive or teratogenic effects of chlorine 

(Druckrey, 1968). A number of subsequent studies have studied the effects of chlorine or 

hypochlorite however there is insufficient information to draw conclusions about the potential for 

developmental toxicity (EHC 216, WHO, 2000). 

3.7 Toxicokinetics 

Hypochlorite does not accumulate in the body; it reacts with tissues and apparently is readily 

absorbed in serum and eliminated from plasma with a half-life of 44 h (EHC 216, WHO, 2000). 

Chlorine is a strong oxidizing agent, and it must be presumed that the toxicological mode of 

action induced at high doses by either gaseous chlorine or solutions of hypochlorite is at least 

partially related to this property. 

In conclusion, from the above information, the Group considers that the critical health effects 

related to FAC exposure are mostly acute in nature; however, some concerns are also addressed 

in literature (EHC 216, 2000; WHO, 2000) related to toxicity to respiratory and 

developmental/reproductive function and carcinogenicity, depending on the severity of exposure 

and presumably under long term exposures (e.g., occupational scenarios). 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 39 

I:\MEPC\57\2-10.doc 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 The following table summarizes the results for development and carcinogenicity 

mutagenicity and reprotoxicity of FAC: 

 Seawater or 

Fresh 

Water 

Test 

Dura

tion 

Results Break-down 

products 

Reference

Hydrolysis 

at pH 7 

Fresh and 

waste-water 

 Rate constants 

range: 1.5 x 10-4 at 

0 °C to 4.0 x 10-4 

at 25 °C 

hypochlorous 

acid and 

chloride ion 

hypochlorite 

and H+

U.S. EPA 

1989 

1/2 - Life natural 

waters, 

0.005 s 

NR U.S. EPA 

1989 

4.1.2 The Group notes that at pH values >5, OCl- predominates; at pH values <5, HOCl 

predominates (U.S. EPA 1989). Free active chlorine (Cl2, HOCl, and OCl-) reacts rapidly with 

inorganics such as bromide and more slowly with organic material present in natural waters. 

These reactions yield chloride, oxidized organics, chlorooganics (including trihalomethanes), 

oxygen, nitrogen, chlorate, bromate and bromoorganics. 

4.2 Partition Coefficients 

There is no potential for the bioaccumulation or bioconcentration of chlorine 

(HSDB 1994). 

4.3 Persistence and Identification of Main Metabolites

4.4 Reaction with Organic Matter 

The Group noted that chlorine reacts slowly with organic material present in natural waters. 

These reactions yield chloride, oxidized organics, chloroganics 

(including trihalomethanes), oxygen, nitrogen, chlorate, bromate and bromoorganics. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 The following table summarizes the result for potential physical effects on wildlife and 

benthic habitats of FAC: 

Species Method 

Details 

Results Reference 

Phytoplankton 

Salmonella 

typhimurium 

strains TA1530 

and TA100 

chlorination 

of 0.05 to 

0.15 mg/L 

shifts in the species 

composition of marine 

phytoplankton 

communities 

U.S. EPA, 

1994 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 40 

I:\MEPC\57\2-10.doc 

4.5.2 The Group recognized that chlorine has been shown to have high acute toxicity to many 

organisms (U.S. EPA, 1994). Chlorine is phytotoxic but is also essential to plant growth; crops 

need around 5 pounds or more of chlorine per acre. Acute toxicity to plants is characterized by 

defoliation with no leaf symptoms and, in higher plant forms, by spotting of the leaves 

(at 1.5 mg/m3) and marginal and interveinal injury (at 150-300 mg/m3) (Seiler et al. 1988 

in U.S. EPA, 1994). 

4.5.3 No data were available regarding the toxicity of chlorine to terrestrial animals. However, 

the data from experimental studies indicate that injury to animals would occur only in the 

presence of high concentrations of chlorine, either in drinking water or the ambient atmosphere 

(U.S. EPA, 1994). 

4.5.4 As chlorine and chlorine compounds do not persist in sediments, it is not expected to 

affect benthic habitats unless directly applied in high concentrations. 

4.6 Potential Residues in Seafood 

As there is no potential for the bioaccumulation or bioconcentration of chlorine, there is no risk 

of potential residues in seafood 

4.7 Any Known Interactive Effects 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Property Value Value 

Name Chlorine gas Sodium hypochlorite 

CAS number 7782-50-5 7681-52-9 

Molecular weight (g/Mol) 70.9 74.4 

Melting point (°C) N/A -20 to -30 oC 

Boiling point (°C) N/A 96-120 oC 

Flash point (°C) Nonflammable 

N/A 

Density (g/mL at 20oC) 1.1 (relative density) 

Vapour pressure (Pa at 20°C) 780 000 Pa 

Vapour Density (air=1) 

Water solubility (g/L) 

Dissociation constant (pKa) 

pH - - 

Octanol/water partition coefficient 

(log Pow) 

 

Oxidation/reduction potential (V) 1.5V 1.7V 

Corrosivity to the materials Yes Yes 

Autoignition temperature (oC) Forms 

explosive 

mixtures with 

flammable 

gases and 

mixtures 

 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 41 

I:\MEPC\57\2-10.doc 

Explosive properties Anhydrous sodium 

hypochlorite is explosive 

Oxidizing properties Yes 

Surface tension (N/mm at -183oC) 

Viscosity (Pa.s at -183oC) 

Thermal stability and identity of 

relevant breakdown products 

 

Other known relevant physical or 

chemical hazards 

 Incompatibility with Nitrogen 

compounds, ammonium salts, 

acids, methanol. Copper, 

Nickel and cobalt speed up 

decomposition of NaOCl 

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 

Chlorine: Acute tox 3, Eye irr 2, Skin irr 2, STOT single 3 (Hazard statements codes: H331; 

H319; H315; H335) 

Sodium hypochlorite: Skin corr 1B (Hazard statement code: H314). 

6.4 Risk Characterization 

Persistent (y/n) Bioaccumulative 

(y/n) 

Toxic (y/n) Reference/Comments/Justification for 

missing data 

No No Yes MEPC 56/2/3, 7.1, table 7 

* * * 
GESAMP-BWWG 5/9 

ANNEX 5 

Page 42 

I:\MEPC\57\2-10.doc 

APPENDIX 5 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: HYDROGEN 

The Group noted that hydrogen gas is produced in the electrochemical cell of the RBT reactor as 

a byproduct of hydroxyl radicals. 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

There is no data on acute aquatic toxicity of hydrogen. 

2.2 Chronic Aquatic Toxicity Data 

2.3 Information on Endocrine Disruption

None of the available data indicate toxicity for exposures of any duration. 

2.4 Sediment Toxicity

There is no data on sediment toxicity of hydrogen. 

2.5 Bioavailability/Biomagnification/Bioconcentration

Hydrogen does not bioconcentrate in the tissues of organisms. 

2.6 Food Web/Population Effects 

Hydrogen does not bioconcentrate or accumulate in the tissues of organisms therefore there is no 

risk to organisms up the food chain. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

Hydrogen exists naturally in the atmosphere and will be dissipated rapidly in well 

ventilated areas. 

4.2 Partition Coefficients

Hydrogen rapidly dissipates so there is no bioaccumulation. 

4.3 Persistence and Identification of Main Metabolites
GESAMP-BWWG 5/9 

ANNEX 5 

Page 43 

I:\MEPC\57\2-10.doc 

4.4 Reaction with Organic Matter 

Hydrogen is not known to react with organic matter. 

4.5 Potential Physical Effects on Wildlife and Benthic Habitats 

4.5.1 The Group noted that no adverse ecological effects are expected. Hydrogen does not 

contain any Class I or Class II ozone depleting chemicals (40 CFR Part 82). Hydrogen is not 

listed as a marine pollutant by DOT (49 CFR Part 171). 

4.6 Potential Residues in Seafood 

Hydrogen does not bioaccumulate so there is no risk of hydrogen residues in seafood. 

4.7 Any Known Interactive Effects 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Property Value

Name Hydrogen gas 

CAS number 01333-74-0 

Molecular weight (g/Mol) 2.015

Melting point (°C) -259

Boiling point (°C) -253

Flash point (°C) N/A

Density (g/mL at 20oC) 0.0899x10-3

Vapour pressure (Pa at 20oC) 

Vapour Density (air=1) 0.0695

Water solubility (g/L)

Dissociation constant (pKa)

pH -

Octanol/water partition coefficient (log Pow)

Oxidation/reduction potential (V) 

Corrosivity to the materials 

Autoignition temperature (oC) 565.5

Explosive properties Extremely especially at high 

temperatures 

Oxidizing properties Yes

Surface tension (N/mm at -183oC) -

Viscosity (Pa.s at -183oC) -

Thermal stability and identity of relevant breakdown 

Other known relevant physical or chemical hazards
GESAMP-BWWG 5/9 

ANNEX 5 

Page 44 

I:\MEPC\57\2-10.doc 

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/Justification for 

missing data 

No No No MEPC 56/2/3, 7.1, table 7 

*** 
GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 6 

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE 

GloEn-PatrolTM Ballast Water Management System 

Submitted by the Republic of Korea 

0 SUMMARY 

0.1 The Group recommends that Basic Approval be granted to the GloEn-PatrolTM Ballast 

Water Management System. Despite the many problems encountered in evaluating this dossier, 

the Group decided to recommend approval as the system, should it be shown to be efficacious, 

would have a high degree of environmental acceptability. 

0.2 The decision to approve the system was based primarily on the expertise within the Group 

itself and knowledge available in the public literature, rather than on the information contained in 

the submission. Although UV treatment of ballast water on uptake (following filtration) and 

discharge would be unlikely to cause any harm to the environment and providing precautions are 

taken to prevent UV radiation escaping from the system, is expected to have little impact on 

human health, it is still the responsibility of the applicant to demonstrate clearly that it is 

harmless in the Final application. 

0.3 The Group noted that the proposed system is based on a technology using filtration 

followed by high intensity medium pressure ultra violet (MPUV) light for disinfection of 

micro-organisms and operates in situ during ballast water uptake and discharge. The Group 

recognized that this system is not augmented by the use of titanium dioxide or any other catalyst 

to increase efficacy. Should any other treatment mechanism, e.g., a titanium dioxide catalyst, 

ozonation or electrochemical treatment be needed to boost the efficacy of the current system, 

then the whole system would need to be re-evaluated for Basic Approval. 

0.4 The Group emphasizes that the ballast water treatment system presented here has been 

evaluated on the basis of its current capacity, i.e., MPUV treatment of 50 m3

/h with a maximum 

UV dose of 300 mJ/cm2

 at wavelengths of 200 – 400 nm. Any other specifications would require 

re-evaluation. 

0.5 The Group noted that the dossier identified photons as the Active Substance and hydroxyl 

radicals as Relevant Chemicals. In addition, a number of by-products from reactions between 

hydroxyl radicals and naturally occurring compounds in the treated water were analysed but not 

detected. However, it was not possible to check the validity of the analytical chemistry in the dossier. 

0.6 The Group noted that no ecotoxicity tests had been carried out by the applicant. In this 

particular case the lack of ecotoxicity data in the dossier is not a reason for refusal of 

Basic Approval, as UV treatment is often used in the aquaculture industry to sterilize water for 

rearing sensitive marine organisms for human consumption. The Group considered that the 

applicant had made insufficient effort to review such data from the literature. 

0.7 The Group strongly recommends that whole effluent ecotoxicity testing and related 

chemical analysis of the exposure conditions be carried out for Final Approval as with any other 

system. Samples should be taken during efficacy tests to meet G8 standards (Ref. G9, 5.2.1). The 

purpose is to demonstrate conclusively both the lack of any ecotoxicity and the lack of any 

disinfection by-products. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 2 

I:\MEPC\57\2-10.doc 

0.8 The Group noted that the submission identified that the only potential for human health 

risk in the GloEn-PatrolTM system was related to exposure to UV irradiation from the treatment 

unit. The Group recommends that appropriate risk mitigation measure be put in place. 

1 INTRODUCTION 

1.1 The data for this product were extracted from the submission of the Republic of Korea to 

MEPC (MEPC 57/2/4) and the application dossier. 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that the following documents have been included in the application 

dossier for Basic Approval: Quality Assurance Project Plan (QAPP) for analytical methods and 

sampling procedures, physical properties of the UV lamp, studies on degradation of hydrogen 

peroxide and a GloEn-PatrolTM instruction manual. 

2.2 The Applicant submitted background information on the possible formation of 

by-products in UV treatment, which are H2O2, HOCl/OCl-

, HOBr/OBr-, THMs, HAAs and other 

halogenated organics. 

2.3 The following information was identified by the Group as missing: 

 .1 The Group noted that a QAPP had been submitted, but the exact procedures 

for e.g., sampling and handling of the samples for chemical analysis were not 

included. The Group was therefore not able to evaluate the reliability of the low 

detection limits reported by the applicant. 

 .2 Furthermore, the origin of the samples taken for chemical analysis, the ballast 

water treatment conditions applied in the test and the water quality parameters 

pertaining were also not included. 

 .3 No ecotoxicity tests with the treated ballast water were carried out by the 

applicant. In this particular case the lack of ecotoxicity data in the dossier is not a 

reason for refusal of Basic Approval, as UV treatment is often used in other 

applications such as aquaculture to sterilize water for rearing sensitive organisms. 

However, the Group considered that the applicant had made insufficient effort to 

review data from the literature to support their contention. 

 .4 No information about the potential risk of gas production such as hydrogen or 

hydrogen in situ was delivered by the applicant. After request of the Group, the 

applicant explained that MPUV light theoretically does not produce hydrogen gas, 

as it is not a photo-catalytic process. 

 .5 The Group noted that Material Safety Data Sheets would not be required for this 

particular application. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 3 

I:\MEPC\57\2-10.doc 

3 DESCRIPTION OF GloEn-PatrolTM BALLAST WATER MANAGEMENT SYSTEM 

3.1 Overview of the system 

3.1.1 GloEn-PatrolTM Ballast Water Management System uses medium-pressure ultra violet 

(MPUV) light for disinfection of micro-organisms and operates in situ during uptake and 

discharge of the ballast water. The ballast water treatment system consists of the following 

components: 

 .1 A filter unit runs automatically but only during uptake of ballast water as a 

pre-treatment. The filtered material is flushed with water and returned to the 

seawater. 

 • Maximum flow rate: 300 m3/h 

 • Filtration degree: 50 μm 

 .2 A UV unit, which employs high-intensity, medium-pressure ultra violet (MPUV) 

lamps in the wavelength range of 200 - 400 nm to destroy living micro-organisms 

present in the liquid being treated. UV Disinfection system as a main treatment 

installed with: 

• UV Reactor (SS316L, flow rate: 50-65 m3/h) 

• Medium pressure UV lamps 

• UV monitor 

• Temperature sensor 

• Automatic washing wiper for quartz sleeves 

3.1.2 The Group emphasizes that the ballast water treatment system presented here has been 

evaluated on the basis of its current capacity (filtration 300 m3/h and MPUV treatment 50 m3/h) 

and maximum UV dose of 300 mJ/cm2. To meet the 300 m3/h as treatments rated capacity 

defined in G8, several MPUV treatment units have to be combined. 

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 Active Substances 

3.2.1.1 It was noted that the proposed system involves filtration followed by a system for 

producing free radicals in situ with the aid of UV light. As a result, chemicals are neither stored 

on board nor generated on demand.

3.2.1.2 The Applicant defines Photons as the Active Substance in the GloEn-PatrolTM Ballast 

Water Management System. 

3.2.2 Relevant chemical (•OH) 

3.2.2.1 The submission states that the MPUV light generates hydroxyl radicals (•OH). 

Therefore, hydroxyl radicals are defined as the “Relevant Chemical” in the GloEn-PatrolTM

Ballast Water Management System. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 4 

I:\MEPC\57\2-10.doc 

Chemical name CAS 

number 

Molecular 

Mass 

[g/mol] 

Empirical 

formula 

Structural 

formula 

Max. initial 

concentration 

anticipated in 

ballast water 

AS 

RC 

other

Hydroxyl radical 3352-57-6 17.01 HO HO Not detected RC 

3.2.3 Other Chemicals, by-products

3.2.3.1 The Group noted that both the Active Substance (Photon) and Relevant Chemical (•OH) 

are not residual in both of treated ballast water. 

3.2.3.2 The Group noted that the MPUV-based GloEn-PatrolTM system might produce other 

chemicals such as H2O2, HOCl/OCl-

, HOBr/OBr, which could react with dissolved organic 

matters (DOM) in seawater, forming several harmful halogenated organics such as 

Thrihalomethanes (THMs), Haloacetic acid (HAAs) and other halogenated organics. 

To investigate the possibility of their production, halogenated organic compounds were analysed 

in the treated ballast water. 

3.2.3.3 The Group noted that experiments to determine the concentrations of Active Substances 

and Relevant Chemicals in the single treated ballast water yielded the following results: 

Compound Concentration 

(mg/L) 

Detection limit 

(mg/L) 

Chloroform N.D. 0.0001 

dibromochloromethane N.D. 0.001 

bromodichloromethane N.D. 0.001 

Bromoform N.D. 0.001 

chloroacetic acid N.D. 0.005 

bromoacetic acid N.D. 0.005 

dichloroacetic acid N.D. 0.005 

trichloroacetic acid N.D. 0.005 

bromochloroacetic acid N.D. 0.005 

dibromoacetic acid N.D. 0.005 

1,1,1-trochloroethene N.D. 0.001 

Tetrachloroethane N.D. 0.001 

1,2-dibromo-3-

chloropropane 

N.D. 0.001 

N.D. = not detected. 

3.2.3.4 It was not possible for the Group to evaluate the chemical analysis due to lack of 

supporting information. 

3.2.3.5 The submission further states that the main UV spectra emitted from MPUV lamps used 

in GloEn-PatrolTM system are in the range of 200 - 400 nm. Hydrogen gas can be produced in the 

photo-catalysis process such as TiO2/UV, but the MPUV system is not a photo-catalysis process. 

Therefore, hydrogen or oxygen gas is not expected to be produced in the GloEn-PatrolTM system. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 5 

I:\MEPC\57\2-10.doc 

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the submission identified that the only potential for human health 

risk in the GloEn-PatrolTM system was related to exposure to UV irradiation from the treatment 

unit. The Group recommends that all operators follow the safety instruction manuals provided 

by the manufacturer. 

4.2 In addition the applicant states that there are no detectable concentrations of disinfection 

by-products by the GloEn-PatrolTM system. Therefore, the Group considers that at this stage 

there seems to be no risk resulting from human exposure to these compounds. 

5 RISK TO SAFETY OF SHIP 

5.1 The submission states that GloEn-PatrolTM does not create any corrosive by-products, 

such as TRO or acidic compounds. Further, the ORP value does not change during ballast water 

treatment (378 mV). 

5.2 The Group noted that the electric power requirement of the system will not be an 

insignificant additional ship service demand. The applicant states that the electric power 

consumption is not of any concern in relation to normal ship operations. The applicant 

confirmed that the equipment meets regulatory standards, but this needs to be documented, both 

with regard to construction and the prevention of electric shock to personnel. 

5.3 The Group raised some concerns regarding overheating of the treatment unit from 

the MPUV lamps, which is designed to be monitored and equipped with an alarm system. 

However, the Group recommends that an automatic shut-down system in case of overheating 

should be considered. 

6 RISKS TO THE AQUATIC ENVIRONMENT 

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 persistency, bioaccumulation 

and toxicity of any chemicals produced by the system as they were either short-lived or not 

detectable. Assessment of the PBT-criteria is therefore considered not required. 

6.1.2 Due to fact that chemical analysis for disinfection by-products (DBP) could not be fully 

evaluated, the Group could not assess PBT criteria for DBP. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 Chemical analysis 

7.1.1 The Group noted that chemical analysis was carried out with filtered natural seawater and 

single treated seawater collected from the pilot plant. The Group regards the single treated water 

as not representative for treated ballast water discharge, as the submission informs that the ballast 

water would undergo a second treatment during the discharge process. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 6 

I:\MEPC\57\2-10.doc 

7.1.2 The Applicant investigated HOCl/OCl-, HOBr/OBr- and H2O2 concentrations in the 

treated water, but only a some residual H2O2 was detected, which was very close to the detection 

limit LOQ = 10 μg/L. Due to lack of the documentation of QA, the Group was not able to 

evaluate this. 

7.1.3 The Group noted that experiments to determine the concentrations of disinfection 

by-products yielded the results described in section 3.2.3.3. However, it was not possible to 

check the validity of the analytical chemistry in the dossier. 

7.2 Acute and chronic toxicity of treated ballast water 

7.2.1 The Group noted that due to their short lifetime, photons and also hydroxyl radicals will 

not be present in the discharged ballast water. 

7.2.2 The Group noted that no ecotoxicity tests were carried out by the applicant. The Group 

noted that the Applicant states that the GloEn-PatrolTM treated water does not contain any toxic 

matter. This fact was used by the applicant to justify not submitting ecotoxicity studies. 

The Group cannot agree to this approach and for Final Approval therefore strongly recommends 

that whole effluent ecotoxicity testing should be undertaken with samples taken during efficacy 

tests to meet G8 standards (Ref. G9, 5.2.1). 

8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 Derivation of a Predicted No Effect Concentration (PNEC) 

8.1.1 The Group noted that no data or analysis of PNEC were delivered with the submission. 

Due to the lack of toxicity testing the Group can not evaluate a PNEC. 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the 

Active Substance and Relevant Chemicals 

8.2.1 The Group noted that no PEC was found by the applicant. However the Group requests 

confirmation that a 100% concentration of treated ballast water discharge would be acceptable 

under any situation. 

8.3 Calculation of the PEC/PNEC ratios 

8.3.1 The Group noted that neither the PEC nor the PNEC had been derived. 

9 CONCLUSIONS AND RECOMMENDATIONS 

The information received for the evaluation of the proposed BWMS under G9 was not considered 

sufficient for a Basic Approval under normal circumstances. Based on the expertise of the Group and 

available knowledge in the public literature only could Basic Approval be granted. 

The following information is missing in the dossier and should be provided for Final Approval: 

- chemical analysis of treated ballast water with appropriate QA 

- identification of relevant substance resulted from chemical analysis above 

- results of toxicity testing of the treated ballast water described in sec. 5.2 in G9 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 7 

I:\MEPC\57\2-10.doc 

9.1 Risks to the safety of the ship

The Group recommends that an automatic shut-down system in case of overheating should be 

considered. 

9.2 Risks to the crew and general public

The Group recommends that appropriate risk mitigation measures be put in place to minimize 

human exposure to UV irradiation from the treatment unit. Furthermore, no other risk to human 

health was identified. 

9.3 Risks to the environment

The submission did not contain any ecotoxicity data. Therefore a full evaluation of the risk to the 

environment was not possible. However, based on existing knowledge, the Group concluded that 

there was no risk or only a minor risk deriving from the proposed BWMS. 

9.4 Conclusions

The Group recommends Basic Approval to be granted to the GloEn-PatrolTM Ballast Water 

Management System. 

The Group emphasized to MEPC that the standard for a dossier submitted for Basic Approval is 

generally insufficient as the submission lacks much of the required information. 

The Group noted that no ecotoxicity tests were carried out by the applicant and considered that 

the applicant had made insufficient effort to review data from the literature to support their case. 

The Group strongly recommends that whole effluent ecotoxicity testing and appropriate chemical 

analysis of samples taken during efficacy tests to meet G8 standards (Ref. G9, 5.2.1) are strongly 

recommended as part of the Final Approval application. 

The Group emphasizes that the ballast water treatment system presented here has been evaluated 

on the basis of its current capacity (filtration 250 m3

/h and MPUV treatment 50 m3/h) and 

maximum UV dose of 300 mJ/cm2

. 

* * * 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 8 

I:\MEPC\57\2-10.doc 

APPENDIX 1 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION 

AND BY-PRODUCT PRODUCED IN BALLAST WATER

2 EFFECTS ON AQUATIC ORGANISMS 

For the “Active Substance”, “Relevant Chemical” and “Treated Water”, data are presented and 

discussed either on the basis of toxicological tests or existing toxicological knowledge for each 

end point listed. 

Required data Active substance 

(Photon) 

Relevant chemicals 

(•OH) 

2.1 Acute aquatic toxicity 

2.2 Chronic aquatic toxicity 

2.3 Endocrine disruption 

2.4 Sediment toxicity 

2.5 Bioavailability/biomagnification/ 

 bioconcentration 

2.6 Food web/population effects 

N.A.a

 N.A.a

N.A.: Not applicable. 

a. Photons and hydroxyl radicals will not be present at the time of ballast water discharge. 

3 MAMMALIAN TOXICITY 

Required data Active substance 

(Photon) 

Relevantchemicals 

(•OH) 

3.1 Acute toxicity 

3.2 Corrosion/Irritation 

3.3 Sensitization 

3.4 Repeated-dose toxicity/chronic toxicity 

3.5 Developmental and reproductive 

 Toxicity 

N.A.a N.A.a
GESAMP-BWWG 5/9 

ANNEX 6 

Page 9 

I:\MEPC\57\2-10.doc 

3.6 Carcinogenicity/Mutagenicity/genotoxicity 

3.7 Toxicokinetics 

 

N.A.: Not applicable. 

a. Since photons and hydroxyl radicals generated in the MPUV reactor, mammalians will 

not be exposed. 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC 

CONDITIONS 

4.1 Modes of degradation (biotic; abiotic) 

Hydroxyl radicals can be formed during the UV process. However, the formed •OH is 

instantaneously scavenged by several specific chemical reactions with basic components present 

in seawater as described below (Jayson and Parsons, 1973; Zehavi and Rabani, 1972; 

Buxton et al., 1988; Hoigne and Bader, 1979). 

4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

Not applicable. 

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

The half-life of •OH is close to 10-9 sec in water. 

4.4 Reaction with organic matter 

4.4.1 The Active Substance (Photon) and Relevant Chemical (•OH) can react with organic 

matter, but this will only occur in the MPUV reactor, and not in the ballast water and the ballast 

water discharge due to their high reactivity. 

4.4.2 Hydroxyl radicals react with organics at extremely high rates ranging 108

~1010 M-1s

-1

(Buxton et al., 1988). These reactions of •OH with organics are possible under the continuously 

•OH-produced condition, which can be provided by advanced oxidation processes (AOPs), such 

as ozone/high pH, ozone/H2O2, UV/H2O2, ozone/UV, UV/TiO2, gamma-ray, sonication, (Photo) 

Fenton, etc. (Arbon et al., 1994; Kang and Hoffmann, 1998; Park et al., 2001; Moraes 

et al., 2004; Garoma and Gurol, 2005; Oh et al, 2005; Chen et al., 2006). In general, these AOPs 

can produce high amounts (10-9~10-11 M) of •OH. So, it should be noted that the amount of •OH 

produced from the MPUV irradiation of seawater is significantly low, at most 10-13~10-15 M, 

which is not a significant level to affect any change in background organics present in seawater. 

4.5 Potential physical effects on wildlife and benthic habitats 

Not applicable. 

4.6 Potential residues in seafood 

Not applicable. 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 10 

I:\MEPC\57\2-10.doc 

4.7 Any known interactive effects

Not applicable. 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

Physical property 

Active 

substance 

(Photon) 

Relevant 

chemicals 

(•OH) 

CAS number - 3352-57-6 

Molecular weight (g/Mol) - 17.01 

Melting point (°C) N.A. - 

Boiling point (°C) N.A. - 

Flash point (°C) N.A. N.A. 

Density (g/mL at 20°C) N.A. N.A. 

Vapour pressure (Pa at 20°C) N.A. N.A. 

Vapour Density (air=1) N.A. N.A. 

Water solubility/dissociation 

constant (pKa) N.A. N.A./11.9 

pH - - 

Octanol/water partition coefficient 

(log Pow) N.D. N.D. 

Oxidation/reduction potential (V) N.A. 2.7 

Corrosivity to the materials N.A. N.A. 

Autoignition temperature (°C) N.A. N.A. 

Explosive properties N.A. N.A. 

Oxidizing properties N.A. Non-selectivea

, 

Various routes 

Surface tension (N/mm at -183°C) N.A. - 

Viscosity (Pa.s at -183°C) N.A. - 

Thermal stability and identity of 

relevant breakdown products N.Ab

 - 

Other known relevant physical or 

chemical hazards N.A. N.A. 

N.A.: Not applicable. 

a. The hydroxyl radical (•OH) is one of the most powerful oxidizing agents known 

(E ̊ = +2.7 V in acid solution) and reacts with most organic compounds at almost 

diffusion- controlled rates (Letterman, 1999; Bolton, 2001). 
GESAMP-BWWG 5/9 

ANNEX 6 

Page 11 

I:\MEPC\57\2-10.doc 

b. The applied UV dose in the MPUV system is 300 mJ/cm2 as a maximum condition. 

It is too small to break down any dissolved organics. Buchanan et al (2004) reported that 

more than 10000 mJ/cm2

 is required for just 5% reduction of DOC. It should be noted 

that photonated by-products are not produced under the condition of the MPUV radiation 

in the system. 

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

Not delivered. 

6.2 Material Safety Data Sheet provided: N.A. 

6.3 GHS Classification .................................................................................. 

*** 

GESAMP-BWWG 5/9 

I:\MEPC\57\2-10.doc 

ANNEX 7 

REVIEW OF PROPOSAL FOR FINAL APPROVAL OF THE BALLAST WATER 

MANAGEMENT SYSTEM 

SEDNA® using PERACLEAN® OCEAN 

Submitted by Germany 

0 SUMMARY 

0.1 Final Approval of the SEDNA® using PERACLEAN® OCEAN Ballast Water 

Management System is recommended, based on the submission provided by Germany. 

0.2 The Group noted that the proposed system treats the ballast water on uptake only. 

The ballast water is filtered and then treated by injection of PERACLEAN® Ocean into the 

ballast line from a storage tank. Chemicals are stored in a container onboard but the quantities 

required are not indicated in the dossier. The Group considers that the preparation 

PERACLEAN® Ocean contains the Active Substances peracetic acid and hydrogen peroxide. 

0.3 The required concentration of PERACLEAN® Ocean to achieve Regulation D-2 

compliance is given by the submission as 150 mg/L. The Group therefore considers 150 mg/L as 

the Maximum Dosage for the purpose of this evaluation. 

0.4 The Group considered that the use of PERACLEAN® Ocean in the treatment of ballast 

water was unlikely to produce any unacceptable quantities of disinfection by-products. 

0.5 The Group noted that the dossier only contained a generic description of the monitoring 

and control system to ensure that the maximum designed concentration is maintained for a 

sufficient period of. The control system was based on monitoring of flow rates and did not 

include information about different dosing depending on varying water qualities. The Group 

recommends that such a safeguard be included in the system prior to the granting of 

Type Approval by the Administration. 

0.6 Careful consideration should be given by the applicant to safe conditions of storage and 

the location of tanks containing PERACLEAN® Ocean on board. The Administration is strongly 

advised to pay special attention to ensure that adequate safety conditions for a range of potential 

locations and storage situations are met prior to granting Type Approval. In the absence of other 

guidance on safe storage, the IMDG code and the PERACLEAN® Ocean manufacturers 

land-based requirements for safe storage should be employed. 

0.7 The PEC and PNEC calculations provided by the applicant rely on a worst case for the 

dissipation of PAA and H2O2 concentrations on board and in one harbour, used as an example. 

Accepting the applicants’ contention that there are no tailor-made models available for assessing 

the risks from ballast water discharges, the Group nonetheless stressed the importance for 

applicants of providing adequate examples to illustrate the potential risk to the marine 

environment, which should include any relevant models. 

0.8 The Group accepts that PAA dissipates sufficiently rapidly as not to be of concern and 

therefore focused on the risks of H2O2. The selection of the PNEC then becomes critical: the 

Group felt that the PNEC value of 10 μg/L chosen in the EU risk assessment (2003) may be more 

representative than the PNEC derived by the applicant from one of the chronic fish tests, as the 

background levels in seawater may be high in any case. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 2 

I:\MEPC\57\2-10.doc 

0.9 Using the above PNEC, and the PEC calculation provided by the applicant for 

Richards Bay harbour in South Africa, plus an additional calculation based on the port 

characteristics of Rotterdam, representing a more enclosed harbour, the group concluded that the 

PEC/PNEC ratios would remain below 1. 

0.10 Approval is granted to the SEDNA® using PERACLEAN® Ocean Ballast Water 

Management System on the understanding that the system will not be operated at dosed 

concentrations of greater than 150 mg/L. Immediate discharge of ballast water following 

treatment is not acceptable, as PAA, the main component of PERACLEAN® Ocean, will not yet 

have dissipated sufficiently. The group considered a 24-h delay before discharge of treated 

ballast water would therefore be essential to avoid any environmental effects. 

0.11 The Group recommends that an occupational health medical surveillance plan according 

to the Guidelines on the Basic Elements of a Shipboard Occupational Health and Safety 

Programme (SOHSP), IMO, May 2006 should be put in place to address possible inhalation and 

dermal toxicity under occupational exposure situations. 

0.12 The Group considers that a cooling system for the storage tanks in case temperatures 

exceed the 35oC limit should be part of a multi level risk mitigation scheme. The Administration 

should ensure that such a system be implemented, including at least the following: 

- an active cooling system (air-conditioning) 

- separate temperature sensors monitor the temperature of the PERACLEAN® Ocean 

inside of the tank as well as the air temperature in the tank room. 

- an active ventilation system 

- a tank spraying device (sprinkler) in case the temperature reaches critical levels 

- a signal is given to the vessels central alarm system via potential-free contact. 

0.13 Prior to granting Type Approval, the Administration is recommended to check 

documentation on corrosion and tank coating compatibility referred to in the application but for 

which no reports were included in the dossier. 

1 INTRODUCTION 

1.1 The data for this product were extracted from the submission of Germany to 

MEPC (MEPC 57/2/5), the confidential application dossier and additional information received 

following request of the Group to the applicant. 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that the following documents have been included in the application 

dossier for Basic Approval: 

.1 A general report with summaries of studies carried out with PERACLEAN®

Ocean and ballast water treated with the SEDNA® System according to 

Guidelines (G8) and Procedure (G9); 

.2 A Germanischer Lloyd certificate confirming appropriate safety management of 

the installed SEDNA® system as required by GESAMP-BWWG in 

document MEPC 54/2/12; 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 3 

I:\MEPC\57\2-10.doc 

.3 A Germanischer Lloyd certificate confirming compatibility, i.e., non-corrosivity, 

to ballast water tank coating; 

.4 An extract of the Quality Assurance Project Plan for full scale type approval 

testing according to Guidelines for approval of ballast water management systems 

(G8) and the Procedures (G9); and 

.5 An assessment report of full scale land-based testing. 

2.2 The Group noted that the Applicant has carried out extensive ecotoxicity studies on both, 

the Active Substances and treated ballast water. 

2.3 Furthermore, for the purpose of human health assessment, the Applicant submitted studies 

on skin irritation and acute oral exposure to PERACLEAN® Ocean. 

2.4 Corrosion tests on coated and uncoated steel panels were carried out under aeration and 

with artificial seawater. Both conditions do not represent the typical situation in ballast water 

tanks. Under these circumstances, no anaerobic corrosion will take place, and the typical marine 

bacteria being responsible for corrosion are not present in artificial seawater. 

2.5 No model for environmental exposure was applied. The calculations proposed by 

BLG 11/4/11 and BLG 11/4/15 were submitted. 

2.6 The Group identified the following information and documentation as missing in 

the Dossier: 

- Description of the control and monitoring system to be applied on board ships. 

A conceptual description is provided. 

- Operational manual. 

- BWMS Drawings and instructions for installation on board ships. 

- Maximum level of dosage. 

- Maximum allowable discharge level. 

2.7 Questions and answers plus missing information asked for at Basic Approval by the 

Group can be found in appendix 3. 

3 DESCRIPTION OF BWMS AND DATA-SET REQUIRED IN THE APPLICATION 

3.1 Description of the ballast water management system 

3.1.1 The submission informs that PERACLEAN® Ocean is applied to the ballast water at 

uptake only by an automated dosing system that addresses the variations in flow rates of ballast 

pumps. The chemicals are dosed after a two-stage filtration process designed for pre-separation 

of solids above 50 μm. 

3.1.2 PERACLEAN® Ocean is specified as scheduled in the IMDG Code under UN No. 3109, 

organic peroxide Type F, liquid, with a classification of 5.2. It is stored onboard in special 

designed containers. Due to its explosive nature the temperature is monitored in the containers 

and a sprinkler system is installed in case the temperature exceeds 35oC. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 4 

I:\MEPC\57\2-10.doc 

3.1.3 The recommended application of PERACLEAN® Ocean is a concentration 

of 150 mg/L in the ballast water. This corresponds to initial concentrations of peracetic acid of 

around 23 mg/L, hydrogen peroxide of around 21 mg/L and acetic acid of around 38 mg/L. 

3.1.4 The Group noted that the control system was based on monitoring flow rates of ballast 

water and automatic PERACLEAN® Ocean dosage. 

3.2 Identification of Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 The Group noted that the product PERACLEAN® Ocean was defined as the Active 

Substance in the dossier. This is a proprietary formulation based on peroxygen chemistry. 

The main components are: 

• peracetic acid (PAA) [79-21-0] H3C–C(=O) –O–OH 14 - <17% 

• hydrogen peroxide [7722-84-1] H–O–O–H 13 - <15% 

• acetic acid [64-19-7] CH3–COOH 24 - <29% 

• stabilizer (acidic) < 1% 

• water H2O <39 - 49% 

3.2.2 At the request of the Group, the applicant reported that the stabilizer consisted of a 

mixture of acids .............. (Section deemed to be confidential and removed at the request of the 

submitting Administration).................... The total concentration of additives is below 1%. 

3.2.3 The Group noted that peracetic acid is produced by reacting hydrogen peroxide (H2O2) 

with acetic acid in aqueous solution. In this process, peracetic acid is not obtained as a pure 

substance but in the form of aqueous equilibrium solutions containing peracetic acid, acetic acid, 

hydrogen peroxide and water: 

CH3COOH + H2O2 CH3CO(O2)H + H2O 

3.2.4 The Group noted that the Relevant Chemicals were principally those listed above. 

The applicant further describes the measurement of a range of disinfection by-products in 

samples from the land-based testing. 

3.2.5 The assessment of the treated ballast water regarding Active Substances and Relevant 

chemicals is described under 7.1.4. 

4 HUMAN HEALTH ASSESSMENT 

4.1 The submission indicates that when using the system following the recommended 

operating and maintenance instructions, workers and ship crew will not be directly exposed to 

PERACLEAN® Ocean during the regular ballast water treatment, since the SEDNA® system 

runs in a separated room or compartment via an automated, closed dosing system 

(Evonik Degussa Gmb H, 2007n). 

4.2 The applicant informs that (re)filling of the PERACLEAN® Ocean storage tank on board 

is the same or a similar procedure to picking up other consumables such as bunkers or lubricants. 

PERACLEAN® Ocean is delivered as a typical bulk chemical. The product is pumped for 

maximum 2 hours, e.g., from a large storage tank on the pier or from a tank truck, to a smaller 

storage tank on board the ship. Leakage-free couplings are used for hose connections. 

After filling of the PERACLEAN® Ocean tank, residual product in the hose is removed by a 

pressured air device or other appropriate equipment. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 5 

I:\MEPC\57\2-10.doc 

4.3 The Group noted that possible fumes (e.g., a vinegar smell from acetic acid) developed 

during the (re)filling process of the PERACLEAN® Ocean tank are removed by a ventilation 

extraction unit. 

4.4 The Group noted that incidental exposure can occur for a short time during connecting 

and disconnecting the hose pipe, in case of spillage or for maintenance works. In these cases, the 

recommended personal protection equipment consists of coverall, gloves, goggles, boots and, 

if required, respiratory protection. 

4.5 The submission informs that the SEDNA® system including the PERACLEAN® Ocean 

dosing system and the storage tank on board a newly-built container vessel have been checked 

regarding safety aspects and accident prevention and received approval by Germanischer Lloyd 

(Germanischer Lloyd 2006) and by the Federal Maritime and Hydrographic Agency (BSH 2006). 

4.6 The Applicant stated that during Basic Approval the (MEPC 54/2/12) the Group 

recommended to perform a chronic inhalation study in rats however the Group noted that this 

was not the case as it was recommended then “that the irritation effects in the respiratory tract 

triggered in some inhalation studies (Janssen, 1989; Janssen and Van Doorn, 1994) should be 

further investigated in a repeated dose inhalation study in order to assess the toxicity of the 

substance at lower dose exposure. Additionally, a dermal absorption study in vitro with non 

damaged skin at lower doses (diluted concentrations) should be conducted to anticipate the risk 

of occupational exposure in non accidental situations”. 

4.7 Human exposure calculations were submitted subsequently by the Applicant, for pouring 

of the liquid which is considered to be the task of concern in terms of human exposure, using the 

Manual Mixing and Loading model (EU, TnG, 2002, Model 7), thereby estimating exposure to 

the active substance at maximum of 7% of the TLV 0.6 mg/m3 based on Gagnaire et al, 2002 

study. The Group accepted the indicative values as supporting information for a risk assessment. 

4.8 In conclusion, the Group considers that further animal testing is not necessary but 

recommends that an occupational health medical surveillance plan according to the Guidelines on 

the Basic Elements of a Shipboard Occupational Health and Safety Programme (SOHSP), IMO, 

May 2006, should be put in place to address possible inhalation and dermal toxicity under 

occupational exposure situations (irritation at the site of contact namely the respiratory tract and 

skin and secondary systemic effects namely impairment of lung and liver functions). 

5 RISK TO SAFETY OF SHIP 

5.1 Corrosivity 

5.1.1 The Group noted that PERACLEAN® Ocean is classified as corrosive and oxidizing. 

5.1.2 The Group noted that a number of corrosion tests were included in the dossier using 

artificial seawater that was changed daily. The tests included the determination of resistance 

against liquids according to ISO 2812-2 and the determination of extent of blistering according to 

ISO 4628-2. Duration was 120 days. Further tests were done on cathodic disbonding according 

to ASTM G8-96 (duration 30 days) (Evonik Degussa GmbH 2007g). In the tests no effect on the 

coating system was found, but for uncoated steel plates the corrosion rates increased by 10-25% 

in water treated with PERACLEAN® Ocean. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 6 

I:\MEPC\57\2-10.doc 

5.1.3 In addition to the aforementioned studies on corrosion (MEPC 53/2/12), a major supplier 

of ballast tank coatings conducted tests in their own laboratory and confirmed that the common 

Epoxy-based coatings are compatible with the use of PERACLEAN® Ocean (Jotun 2005). 

The test documentation was however not included in the dossier and should be checked by the 

Administration prior to granting type approval. 

5.2 Explosive properties 

5.2.1 The Group noted that PERACLEAN® Ocean under the influence of heat or catalytically 

active substances is liable to rapid exothermic decomposition. A general description of a 

mitigating scheme was given in the application dossier. 

5.2.2 After an additional request of the Group the Applicant informed that a cooling system for 

the storage tanks in case temperatures exceed the 35oC limit is part of a multi level risk 

mitigation scheme, which has been approved by Germanischer Lloyd for this specific ballast 

water treatment system. The risk mitigation measures include, but are not limited to, the 

following points: 

.1 The Applicant submitted an operating manual of the SEDNA® System including 

detailed risk mitigation measures for the storage and handling of PERACLEAN®

Ocean which are based on the Guideline for storage of PERACLEAN® Ocean that 

has been developed by Evonik Degussa GmbH. 

2. As a standard feature of all SEDNA® Systems, the PERACLEAN® Ocean tank 

room is equipped with an active cooling system (air-conditioning). Separate 

temperature sensors monitor the temperature of the PERACLEAN® Ocean inside 

of the tank as well as the air temperature in the tank room. The air-conditioning 

and the temperature sensors are fully implemented in the PLC steering of the 

SEDNA® system. 

5.2.3 Furthermore, the applicant informed that: 

.1 an active ventilation system allows a minimum of 10-fold exchange of the tank 

room volume per hour, which is installed with every PERACLEAN® Ocean tank 

system; 

2. the ventilation system will start automatically, when a temperature of 35°C is 

reached in the tank room; 

.3 the air from the tank room is released in places where they can not harm crew 

members. The exact location depends on the installation details of the specific 

ship and is subject to plan approval of the class as it is a mandatory part of the risk 

mitigation system; and 

4. if the tank temperature reaches 40°C a tank spraying device (sprinkler) is started 

to condense vapors and cool down the tank. Furthermore, a signal is given to the 

vessels central alarm system via potential-free contact. 

5.2.4 The applicant describes the general design of the tank and dosing facilities, the location 

and the safety features depend on the conditions of the individual vessel and they have to be 

decided in co-operation with the relevant authorities and the classification society. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 7 

I:\MEPC\57\2-10.doc 

5.3 Storage of PERACLEAN® Ocean on board 

5.3.1 With regard to the safety considerations of chemicals stored on board ships for the 

purpose of ballast water treatment, the Group considered that regulations for the transport of 

Packaged Goods by Sea are relevant, i.e., the IMDG code. However, best practice in the storage 

of PAA on land, e.g., at manufacturing sites will also be very important. The applicant has 

outlined a series of safety measures applicable to a range of potential storage situations on 

board ship. 

5.3.2 The IMDG code indicates that PAA falls under Class 5.2, i.e., Organic Peroxides (liquid) 

and tanks containing PAA should therefore be stored on deck when carried as packaged goods 

cargo. The application indicates a variety of possible storage locations depending on the design 

of the ship, including on-deck and below deck. 

5.3.3 Careful consideration should be given by the applicant to safe conditions of storage and 

location, should they decide to deviate from the guidance of the IMDG code. The Administration 

is strongly advised to pay special attention to ensure that adequate safety conditions for a range 

of potential tank sizes, locations and storage situations are met prior to granting Type Approval. 

6 RISKS TO THE AQUATIC ENVIRONMENT 

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

The active components of PERACLEAN® Ocean do not fulfill the PBT criteria as outlined in 

Methodology (MEPC 56/2/2, annex 4) and Procedure (G9) (MEPC 53/24/Add.1, annex 4): 

Persistence (P) 

Due to the ready biodegradability and the abiotic degradation of the active components of 

PERACLEAN® Ocean, it can be concluded that it is not persistent in the environment. 

Environmental half-lives are in the order of hours or a few days at the maximum. 

Bioaccumulation (B) 

Due to the high water solubility and the low octanol water partition coefficients of the 

active components of PERACLEAN® Ocean, there is no concern for a possible 

bioaccumulation potential of the product. (log Kow below 0). 

Toxicity (T) 

One active component of PERACLEAN® Ocean has a NOEC level below 0.01 mg/L. 

However, no indications for relevant effects concerning carcinogenicity, mutagenicity or 

reproductive toxicity as well endocrine disruption are found. 

The Group agrees that none of the ingredients of PERACLEAN® Ocean are considered to be 

PBT substances. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 8 

I:\MEPC\57\2-10.doc 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 Chemical analysis of treated ballast water 

7.1.1 The Group noted that die-away or dissipation tests with peracetic acid and hydrogen 

peroxide were carried out by the applicant during the land-based G8 efficacy tests. In all tests 

peracetic acid was completely degraded within less than 20 h. In brackish water, the half-life was 

about 4.5 h, in high saline water 3.5 h, respectively. 

7.1.2 Hydrogen peroxide was found to degrade slower than peracetic acid. It took on average 

four days (96 h) until hydrogen peroxide had completely disappeared. In the test runs 7 to 12, the 

detection limit of H2O2 was reached after about three days. The estimated half-lives found 

were 24 h in brackish water and 19.5 h in high saline water, respectively (NIOZ 2007b). 

Landbased Testing at NIOZ / Texel, testrun 5, start 

on 10th of May 2007 

0

2

4

6

8

10

12

14

16

18

20

22

24

0 12 24 36 48 60 72 84 96 108 120 132 144

time (h)

content (ppm)

PAA

H2O2

 detection limit

Landbased Testing at NIOZ / Texel, testrun 10, 

start on 14th of June 2007 

0

2

4

6

8

10

12

14

16

18

20

22

24

0 12 24 36 48 60 72 84 96 108 120 132 144

time (h)

content (ppm)

PAA

H2O2

 detection limit

Figure 1: Die-away of PERACLEAN® Ocean components in the land-based tests at NIOZ. Left 

figure: salinity 22 PSU, right figure: salinity 33 PSU 

7.1.3 The Group noted that the die-away of PAA and H2O2 observed in fresh water is 

generally slower. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 9 

I:\MEPC\57\2-10.doc 

7.1.4 The Group noted that one analysis of treated ballast water was provided with samples 

collected from land-based G8 test no. 11 with high salinity water and low organic loading 

(<2 mg TOC/L). The analysis yielded the following results (Evonik Degussa GmbH, 2007k): 

 Untreated BW 

[μg/L] 

Treated BW 

[μg/L] 

AOX n.d. n.d. 

AOX solid phase extraction < 20 28 

EOX < 0.01 <0.01 

Chlorophenols 

2,3,4,5-tetrachlorophenol <0.1 <0.1 

phenol <0.1 <0.1 

pentachlorophenol <0.1 <0.1 

4-chlorophenol <0.1 <0.1 

3-chlorophenol <0.1 <0.1 

3,5- dichlorophenol <0.1 <0.1 

3,4-cichlorophenol <0.1 <0.1 

3,4,5-trichlorophenol <0.1 <0.1 

2-chlorophenol <0.1 <0.1 

2,6-dichlorophenol <0.1 <0.1 

2,4- u. 2,5-dichlorophenol <0.1 <0.1 

2,4,6-trichlorophenol <0.1 <0.1 

2,4,5-trichlorophenol <0.1 <0.1 

2,3-dichlorophenol <0.1 <0.1 

2,3,6-trichlorophenol <0.1 <0.1 

2,3,5-trichlorophenol <0.1 <0.1 

2,3,5,6-tetrachlorophenol <0.1 <0.1 

2,3,4-trichlorophenol <0.1 <0.1 

2,3,4,6-tetrachlorphenol <0.1 <0.1 

Highly volatile halogenated 

hydrocarbons 

 

trichloromethane <0.3 <0.3 

dibromochloromethane <0.1 0.2 

bromodichloromethane <0.1 <0.1 

tribromomethane <0.2 1.5 

total of determined LHKW -/- 1.7 

n.d: Not determined (if amount of chloride is >15 g/L, the SPE-AOX has to be 

determined). 

7.1.5 From the tested compounds, only slightly increased amounts of AOX, bromoform and 

dibromochloromethane could be detected in the ballast water treated with PERACLEAN® Ocean 

(Evonik Degussa GmbH 2007e). These results are contradictory to previous findings showing 

that trihalomethanes were not formed even under extreme conditions. Nevertheless, since these 

values are potencies below recent limit values in drinking water, they can be considered as 

negligible. The Group could accept the above argumentation. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 10 

I:\MEPC\57\2-10.doc 

7.2 Acute toxicity of treated ballast water 

7.2.1 Low Salinity 

7.2.1.1 The Group noted that acute ecotoxicity tests were carried out with ROTOX®, Microtox 

basic test, algae and oyster larvae using ballast water, which had been stored for 5 days. 

An acute fish test was not performed due to the low sensitivity towards hydrogen peroxide. 

The results on the toxicity of ballast water of low salinity (22 PSU) are summarized in the 

following table: 

Trophic 

level 

Species Endpoint Storage in 

the ballast 

water tank 

[d] 

Result 

[% treated 

ballast water1] 

Reference

Rotifer Brachionus 

plicatilis 

24 h EC50, static,

mortality 

5 Undiluted: no 

effects 

(Evonik 

Degussa 

GmbH 

2007d) 

Bacteria Vibrio 

fischeri 

5 min EC50, 

luminescence 

5 17.94% 

inhibition with 

50% treated 

ballast water2

(Evonik 

Degussa 

GmbH 

2007c) 

Algae Skeletonema 

costatum 

72 h chronic study

growth rate (limit 

test) 

5 Undiluted: no 

effects 

(Evonik 

Degussa 

GmbH 

2007m) 

Oyster Crassostrea 

gigas 

48 h EC50, static

development 

5 Restrictedly 

usable 

(Sneekes 

2007) 

1

 treated ballast water: treated ballast water. 

2

 Based on the given method of the Microtox basic test, the highest test concentration 

is 50% (1:1 dilution).

All tests performed at low salinity showed no adverse effects related to the treated ballast water. 

Only in the MICROTOX basic assay, some inhibitory effects (17.94%) were detected at the 

highest treated ballast water solution (Evonik Degussa GmbH 2007c; Evonik Degussa 

GmbH 2007d; Evonik Degussa GmbH 2007m). The oyster larvae, which were also investigated, 

showed a very low development rate in the control and the test is considered as restrictedly 

usable. In undiluted treated ballast water, the development was again similar to the control 

(Sneekes 2007). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 11 

I:\MEPC\57\2-10.doc 

7.2.2 High salinity 

7.2.2.1 The effects of treated ballast water with high salinity (>31 PSU) are described in the 

following table: 

Trophic 

level 

Species Storage in the 

ballast water 

tank [days] 

Endpoint Result 

[% treated 

ballast water1

] 

Reference 

Acute

Rotifer Brachionus 

plicatilis 

1 

5 

EC50 (24 h), 

static, mortality 

58.8% 

Undiluted: 

no effects 

(Evonik 

Degussa 

GmbH 

2007d) 

Bacteria Vibrio 

 Fischeri 

1 

5 

EC50 (5 min), 

luminescence 

11.95% inhibition 

with 50% treated 

ballast water2

Hormesis 

(Evonik 

Degussa 

GmbH 

2007c) 

Fish Solea solea 

Juvenile 

5 LC50 (96 h), 

static, mortality 

Undiluted: 

no effects 

(Evonik 

Degussa 

GmbH 

2007b) 

Oyster Crassostrea 

gigas 

1 EC50 (48 h), 

 static 

development 

aerated: 36.0% 

unaerated: 35.7% 

(Evonik 

Degussa 

GmbH 

2007a) 

Oyster Crassostrea 

gigas 

5 EC50 (48 h), 

static 

development 41.5% 

(Evonik 

Degussa 

GmbH 

2007a) 

Algae Skeletonema 

costatum 

1 

2 

33

5 

EC50 (72 h) 

growth rate 

31.6% 

35.4% 

Undiluted: 

no effects 

Undiluted: 

no effects 

(Evonik 

Degussa 

GmbH 

2007m) 

Oyster Crassostrea 

gigas 

1 NOEC (48 h), 

development 

static 

aerated: 31.6% 

unaerated: 31.6% 

Evonik 

Degussa 

GmbH, 

2007f 

Oyster Crassostrea 

gigas 

5 NOEC (48 h), 

development 

 static 

31.6 (Evonik 

Degussa 

GmbH 

2007a) 

Algae Skeletonema 

costatum 

1 

2 

33

5 

NOEC (72 h) 

growth rate 

17.8% 

17.8% 

Undiluted: 

no effects 

Undiluted: 

no effects 

(Evonik 

Degussa 

GmbH 

2007m) 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 12 

I:\MEPC\57\2-10.doc 

Trophic 

level 

Species Storage in the 

ballast water 

tank [days] 

Endpoint Result 

[% treated 

ballast water1

] 

Reference 

Fish Solea solea 5 NOEC (6 days) 

Egg hatch 

success 

Mortality 

31.6% 

31.6% 

(Evonik 

Degussa 

GmbH 

2007l) 

7.2.3 Bacterial Screening assays 

The EC50 value found in the ROTOX® test kit of the day-1 treated ballast water was 58.8% 

treated ballast water, whereas the day-5 treated ballast water did not show increased mortality, 

compared to the untreated ballast water control. (Evonik Degussa GmbH 2007d). Peracetic acid 

was degraded completely. Therefore, the toxicity of day-1 treated ballast water correlates to the 

hydrogen peroxide concentration found. 

In the MICROTOX basic assay, no EC50 values could be calculated. While for the day-1 treated 

ballast water the highest treated ballast water solutions showed slight inhibitory effects (11.95%), 

incubation of the day-5 water resulted in increasing hormesis effect with increased amounts 

treated ballast water compared to the NaCl control or untreated ballast water controls, 

respectively (Evonik Degussa GmbH 2007c). 

7.2.4 Acute fish test 

In an acute toxicity study in juvenile fish (96 h, static conditions) with day-5 treated ballast 

water, no mortality occurred up 100% treated ballast water. (Evonik Degussa GmbH 2007b). 

7.2.5 Oyster larvae development test 

7.2.5.1 The Group noted that development tests with oyster larvae were carried out. Some of the 

test vessels were additionally aerated during incubation, as a rapid decrease of oxygen in tests 

with oysters was measured in former tests. 

7.2.5.2 The treated ballast water (day 1) did not affect the development of oyster larvae in 

concentrations up to 31.6% treated ballast water (NOEC), regardless whether aeration was 

performed or not. In higher treated ballast water concentrations, the development of larvae was 

influenced resulting in EC50 values of 36.0% treated ballast water for aerated samples and 35.7% 

for the unaerated samples, respectively. With a concentration of 5.9 mg H2O2/L found in the 

treated ballast water sample at test start, the EC50 and NOEC of treated ballast water correspond 

to 2.1 and 1.86 mg H2O2, respectively. These values are in the range of the effect and no effect 

concentrations of pure hydrogen peroxide solutions determined in parallel as toxicant control 

(EC50 2.6 mg H2O2/L; NOEC: < 2.4 mg/L). 

7.2.5.3 The Group noted that the day-5 treated ballast water showed inhibitory effects in a 

similar concentration range (EC50 41.5%, NOEC: 31.6%; Evonik Degussa GmbH, 2007a) 

The Applicant assumes a different reason, other than Active Substance concentrations, since the 

peracetic acid and hydrogen peroxide levels were below the detection limit in the 5-day treated 

ballast water. Oyster larvae are known to be very sensitive towards even slight changes 

of environmental conditions like pH or temperature or other water parameters 

(Douillet and Langdon 1993). It can not be excluded, that the observed bacteria re-growth 

(see also NIOZ 2007b) might also play a role in the development of D-Larvae. Therefore, results 

from the performed tests with ballast water and oyster larvae might be questionable. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 13 

I:\MEPC\57\2-10.doc 

7.2.6 Algal growth inhibition test 

7.2.6.1 The Group noted that the algae Skeletonema costatum was used for toxicity testing of 

treated ballast water day-1, -2, -3 and -5. Day-1 and day-2 treated ballast water did not contain 

peracetic acid any more, but had hydrogen peroxide concentrations of 5.9 and 6.0 mg H2O2/L, 

respectively. The treated ballast water related EC50 values for both treated ballast waters were 

quite similar (31.6 and 35.4% respectively), as well as the NOECs (17.8% for both). 

7.2.6.2 Further it was recognized that the day-3 and day-5 treated ballast water (no peracetic 

acid and hydrogen peroxide detectable), did not show any growth inhibition compared to the 

control (Evonik Degussa GmbH 2007m). Therefore, it can be assumed, that the main toxicity of 

treated ballast water is due to hydrogen peroxide. 

7.3 Long-term Fish test 

7.3.1 A fish early life stage test, according to OECD 210 adapted for Sole, did not meet valid 

criteria because the untreated ballast water control had a mortality of 100% after 18 days. 

This might have happened due to the aeration system installed during the test. Despite of that, 

during the egg and early larvae stage, the survival rate (up to test day 6) was high enough that 

some observations could be used for further hazard assessment. Furthermore, unaerated controls 

were also tested (untreated ballast water and undiluted treated ballast water) and in this case, the 

survival rate of the untreated ballast water control was 77.5% after 18 days, the treated ballast 

water-treated fish eggs died up to test day 6. 

7.3.2 The egg hatch success and early mortality of the aerated samples were only affected 

above 31.6% treated ballast water (NOEC) (Evonik Degussa GmbH 2007l). 

7.3.3 The applicant states that based on existing findings, it might be concluded that fish is not 

the most sensitive species. 

7.4 Conclusions on aquatic toxicity 

7.4.1 Treated ballast water was tested in various species. The observed toxicity of the day-1 

and day-2 treated ballast water correlates well with the hydrogen peroxide level in the water 

sample, observed for rotifer, algae and oyster, leading to an overall NOEC of 17.8% treated 

ballast water. 

7.4.2 With the algae, the toxicity decreased with increasing storage time of the ballast water 

indicating that no secondary toxicity is present. However, treated ballast water on day-5 caused 

some toxic effects towards oyster and fish larvae suggesting that either bacteria re-growth, a well 

known phenomenon (Douillet and Langdon 1993; Vaughn 2006), was responsible for the toxicity 

or other water parameters like pH or oxygen level disturbing oyster larvae and fish eggs in their 

development. 

7.4.3 The most sensitive species found were the oyster and fish larvae yielding a NOEC 

of 31.6% treated ballast water. 

7.4.4 No adverse effects were observed in the low saline environment under tested conditions,

but this might be restricted due to the limited number of results. Because of the extreme algae 

bloom in May, no further tests could be performed under low saline conditions. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 14 

I:\MEPC\57\2-10.doc 

7.4.5 The Group can generally accept the above arguments, but wishes to note that the 

guidance given in G8 for using a 5-day delay before testing ballast water may be too long. 

8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 Derivation of a Predicted No Effect Concentration (PNEC) 

8.1.1 The Group noted that the results for marine algae indicate that marine algae are less 

sensitive towards PERACLEAN® Ocean than fresh water species (refer to MEPC 53/2/12). 

All mentioned studies indicate a very steep dose response curve. However, fish larvae were 

much more sensitive than Daphnia magna (long-term NOEC of 0.05 mg/L) leading to an overall 

NOEC of 2.25 μg PAA/L based on the results of the fish test. Using an assessment factor of 10, 

a PNEC of 0.225 μg/L can be derived corresponding to a PNEC of 1.5 μg PERACLEAN®

Ocean/L. 

8.1.2 The Group also noted that the EU also established a PNEC value of 10 μg/L for H2O2. 

Despite this value the Group will use a value of 1.5 μg/L PERACLEAN® Ocean as the 

PNEC value in the risk assessment below. 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the Active 

Substance and Relevant Chemicals

First case 

8.2.1 The Group noted that the Maximum Allowable Discharge Concentration for 

PERACLEAN® Ocean was not clearly stated in the submission. However, based on the 

PEC calculations and information received in the application the Group considers 21 mg/L of 

residual hydrogen peroxide as the Maximum Allowable Discharge Concentration. 

8.2.2 The applicant states that release of PERACLEAN® Ocean into the aquatic environment 

during ballast water treatment is considered unlikely due to the short degradation time. Peracetic 

acid degrades within 12 - 24 h. Therefore, it is unlikely that considerable amounts will attain to 

the aquatic environment if PERACLEAN® Ocean is used in recommended manner. Even if the 

ship has to discharge all ballast water immediately after treatment, there will be no build-up of 

this component. However, measurable hydrogen peroxide might be released into the 

environment, when ballast water is discharged 24 to 96 h after treatment. The Group generally 

concurs with this assessment. 

8.2.3 After confirmation by the Ballast Water Review Group at MEPC 56 that none of the 

software currently available meets the requirements for modeling an Emission Scenario, 

calculations were carried out based upon information provided by documents BLG 11/4/11 

and BLG 11/4/15. 

8.2.4 The Group would have preferred somewhat wider interpretation of the BLG advice cited 

above with some more examples. 

8.2.5 The Group noted that the harbor of Richards Bay, SA has been used to calculate the total 

release of H2O2, which was 434 t/a (assuming that all the ballast water contains 21 mg H2O2/L). 

This would generate a concentration of 1.66 mg H2O2/L, if no degradation at all took place. 

Considering just one day with 4.75 incoming ships and 56,616 tons ballast water on average, the 

resulting H2O2 concentration in the port area would be 0.0045 mg/L (=PEC). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 15 

I:\MEPC\57\2-10.doc 

Second case 

8.2.6 The Applicant also describes a second case, where the build-up of H2O2 in the harbor 

water was calculated. According to the results of the land-based testing (salinity 22 PSU, 

temperature 15.6°C), the half-life of H2O2 is estimated to be 24 h. This approach can be 

considered as conservative since the trials at NIOZ were conducted in cleaned tanks and after 

filtration of the water by the SEDNA® system. Under realistic harbor area conditions the 

degradation is significantly accelerated by suspended solids, sediments and sunlight. Even after 

one year, the build-up of the peroxide concentration in the harbor does not exceed a level 

of 0.009 mg/L. 

8.2.7 Calculations disregarding any means of degradation at the time of release demonstrated 

that even if instantaneously discharged at berth the concentration of the Active Substance under 

consideration is 3 orders of magnitude lower than the acute NOEC of the most sensitive species. 

8.2.8 It could be demonstrated that even after continuous release of ballast water immediately 

after treatment with PERACLEAN® Ocean from all incoming ships after 365 days, the 

PEC value in the receiving waters remained one order of magnitude below the PNEC. 

8.2.9 The Group concluded that the estimated build-up of the concentration of H2O2 to a level 

of 0.009 mg/L can be considered acceptable as a reasonable estimate. The Group adopts this 

value of 0.009 mg H2O2/L as a worst case exposure concentration. 

8.3 Calculation of PEC/PNEC ratios

The Group considered the PNEC of 0.010 mg/L for H2O2 as sufficiently conservative (related to 

continuous long term exposures) and is adopted from the EU Risk Assessment in 2003 

(see Chapter 2.5.3 of the submission for Final Approval). In consequence, the PEC/PNEC ratio 

after one day is 0.0045/0.01 = 0.45. 

Using the PEC of the second case (0.009 mg/L H2O2), the PEC/PNEC ratio will 

be 0.009/0.010 = 0.9. 

Comparing the cumulative value of 9 μg/L with naturally occurring hydrogen peroxide found in 

seawater (0.5 to 14 μg/L, see EU Risk Assessment, 2003), they are in the same range. 

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship

Careful consideration should be given by the applicant to safe conditions of storage and the 

location of tanks containing PERACLEAN® Ocean. The Administration is strongly advised to 

pay special attention to ensure that adequate safety conditions for a range of potential tank sizes, 

locations and storage situations are met prior to granting Type Approval. 

The Group considers that a cooling system for the storage tanks in case temperatures exceed 

the 35oC limit should be part of a multi-level risk mitigation scheme. The Administration should 

ensure that such a system be implemented: 

- an active cooling system (air-conditioning) 

- separate temperature sensors monitor the temperature of the PERACLEAN® Ocean 

inside of the tank as well as the air temperature in the tank room 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 16 

I:\MEPC\57\2-10.doc 

- an active ventilation system 

- a tank spraying device (sprinkler) in case the temperature reaches 40°C 

- a signal is given to the vessels central alarm system via potential-free contact. 

9.2 Risks to the crew and general public

Being severely corrosive to skin and eyes and severely irritating to mucous membranes of the 

respiratory tract, the Group considered that direct contact to PERACLEAN® Ocean during 

system operations should be minimized by the recommended handling procedures that include 

the appropriate personal protective equipment, gloves, goggles and respiratory protection. 

In addition, the Group considers that PERACLEAN® Ocean due to its toxicokinetic properties is 

unlikely to be systemically available beyond the site of contact, showing also a low genotoxic 

concern. However, according to existing and submitted information (JACC No40) there is some 

concern related to the carcinogenicity potential of PAA acting as a tumour promoter. 

The observed effects are considered to be secondary to local irritation (Greaves and 

Barsoum, 1990). 

The Group recommends that a human health surveillance program according to the Guidelines on 

the Basic Elements of a Shipboard Occupational Health and Safety Programme (SOHSP), IMO, 

May 2006, should be put in place to address possible inhalation and dermal toxicity under 

occupational exposure situations (irritation at the site of contact in particular skin and respiratory 

tract and secondary systemic effects as impairment of the lung function). 

9.3 Risks to the environment

Exposure modeling has been performed based upon information provided by documents 

BLG 11/4/11 and BLG 11/4/15. However, the outcome of the calculations was not presented, 

which hinders the evaluation of the reliability of the model results. 

The PEC and PNEC calculations provided by the applicant rely on a worst case for the 

dissipation of PAA and H2O2 concentrations on board and in one harbour, used as an example. 

Accepting the applicants’ contention that there are no tailor-made models available for assessing 

the risks from ballast water discharges, the Group nonetheless stressed the importance for 

applicants of providing adequate examples to illustrate the potential risk, which should include 

any relevant models. 

The Group accepts that PAA dissipates sufficiently rapidly as not to be of concern and therefore 

focussed on the risks of H2O2. The selection of the PNEC then becomes critical: the Group felt 

that the PNEC value chosen in the EU risk assessment of H2O2 (10 μg/L) completed in 2003 may 

be more representative than the PNEC derived by the applicant from one of the chronic fish tests, 

as the background in seawater may be high in any case. 

Using the above PNEC, and the PEC calculation provided by the applicant for Richards Bay 

harbour in South Africa, plus an additional calculation based on the port characteristics of 

Rotterdam, representing a more enclosed harbour, the group concluded that the PEC/PNEC ratios 

would remain below 1. 

Based on the assumptions made in the application (e.g., example harbor) and by the Group 

(i.e., PNEC) it can be concluded that the discharge of the treated ballast water is not likely to 

present an environmental risk to the receiving waters. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 17 

I:\MEPC\57\2-10.doc 

9.4 Conclusions

Approval is granted to the SEDNA® using PERACLEAN® OCEAN Ballast Water Management 

System on the understanding that the system will not be operated at dosed concentrations of 

greater than 150 mg/L. Immediate discharge of ballast water following treatment is not 

acceptable, as PAA, the main component of PERACLEAN® Ocean, will not yet have dissipated 

sufficiently. The group considered a 24-h delay before discharge of treated ballast water would 

therefore be essential. 

The Group noted that the proposed system treats the ballast water on uptake only. The ballast 

water is filtered and then treated by injection of PERACLEAN® Ocean into the ballast line from 

a storage tank. Chemicals are stored in a container onboard, but the quantities are not indicated 

by the dossier. The Group considers that the preparation PERACLEAN® Ocean contains the 

Active Substances peracetic acid and hydrogen peroxide. 

The required concentration of PERACLEAN® Ocean to achieve Regulation D-2 compliance is 

given by the submission as 150 mg/L. The Group therefore considers 150 mg/L as the 

Maximum Dosage. 

The Group considered that the use of PERACLEAN® Ocean in the treatment of ballast water was 

unlikely to produce any unacceptable quantities of disinfection by-products. 

The Group noted that only a generic description of the monitoring and control system which 

could ensure that the maximum designed concentration is maintained for a sufficient period of 

time was included in the dossier. The control system was based on monitoring of flow rates and 

did not include information about different dosing depending on varying water qualities. 

The Group recommends that such a safeguard be included in the system prior to the granting of 

Type Approval by the Administration. 

* * * 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 18 

I:\MEPC\57\2-10.doc 

APPENDIX 1 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: PERACLEAN® Ocean 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.1.1) 

2.1.1 Fresh water species 

2.1.1.1 A summary of the acute aquatic toxicity data for PERACLEAN® Ocean on fresh water 

species is shown in the table below: 

Result 

EC50 [mg PAA/L]1 Trophic 

level 

Species Endpoint 

100 ppm 

PERACLEAN®

Ocean 

200 ppm 

PERACLEAN®

Ocean 

300 ppm 

PERACLEAN

® Ocean 

Product 0.74 0.46 0.42 

Bacteria Vibrio fischeri 

light 

inhibition 

(15 min) 

MicrotoxTM PAA 0.111 0.069 0.063 

Product 1.4 1.5 < 1.5 

Algae Selenastrum 

capricornutum 

Growth 

inhibition 

(72 h) PAA 0.21 0.225 < 0.225 

Product 7.1 7.0 7.8 Cladoceran Daphnia magna 

Immobilisation 

(48 h) PAA 1.065 1.17 1.05 

Product < 0.78 1.22 < 2.34 Microcrustacea 

Thamnocephalu

s platyurus 

Acute 

mortality 

(24 h) PAA < 0.112 0.183 < 0.351 

Product > 12.5 38.4 31.8 

Hydra Hydra attenuata 

Acute 

mortality/ 

Submortality PAA > 1.5 5.76 3.96 

Product 16.2 14.2 13.2 

Fish Oncorhynchus 

mykiss 

Acute 

mortality PAA 2.43 2.16 1.98 

These values were calculated on the basis of the values given in Table 7 for the 2 h treated 

ballast water. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 19 

I:\MEPC\57\2-10.doc 

The results of the toxicity tests for different fresh water species show differences in sensitivity. 

Small organisms are more sensitive towards PERACLEAN® Ocean than higher organisms, 

except for the Microcrustacea, which was also found very sensitive. This ranking is not 

surprising since the active compound peracetic acid is a well known bactericide. Comparing the 

results of daphnia, fish and algae with recent findings (ECETOC 2001), the now presented values 

correspond very well. 

2.1.2 Marine species 

2.1.2.1 Additional studies for marine water species, requested by and conducted under 

supervision of Washington State Department of Ecology, USA, are summarized in Table 2. 

2.1.2.2 A summary of the acute aquatic toxicity data for PERACLEAN® Ocean on fresh water 

species is shown in the table below: 

Trophic 

level 

Species Method Endpoint Results 

EC50

(PERACLEA

N® Ocean) 

Results 

EC50

(PAA) 

Reference 

Algae Macrocy

stis 

pyrifera 

EPA/600/

R-95/136 

static 

EC50

Germination 

EC50

Germ tube 

length 48 h 

7.91 mg/L 

4 mg/L 

1.19 mg/L 

0.6 mg/L

(Evonik 

Degussa 

GmbH 

2005a) 

Algae Skeletone

ma 

costatum 

E1218-97a 

static 

EC50

 Growth 

inhibition, 

96 h 

> 16 mg/L > 2.4 mg/L (Evonik 

Degussa 

GmbH 

2005a) 

Fish 

16 PSU 

Clupea 

pallasi 

Not stated 

Semistatic 

EC50 

96 h 

> 16 mg/L > 2.4 mg/L (Evonik 

Degussa 

GmbH 

2005b) 

2.1.2.3 All tests were performed according to guidelines and protocols of Washington State 

Department of Ecology without GLP. 

2.1.2.4 The acute effects of PERACLEAN® Ocean were investigated in two marine algae 

species, Macroystis pyrifera and Skeletonema costatum. The EC50 values (48 h) in Macroystis 

pyrifera were 7.91 mg PERACLEAN® Ocean /L for germination and 10.9 mg PERACLEAN®

Ocean/L for germ tube length, corresponding to 1.19 and 1.64 mg PAA/L, respectively. 

The species Skeletonema costatum, exposed for 96 h, was found less sensitive with an EC50 value 

of EC50 > 16 mg PERACLEAN® Ocean/L, corresponding to 2.4 mg PAA/L (Evonik Degussa 

GmbH 2005a). 

2.1.2.5 In an additional acute toxicity test with PERACLEAN® Ocean (test duration 96 h, water 

renewal after 48 h), using the pacific herring (Clupea pallasi), no toxic effects were observed up 

to the highest test concentration of 16 mg PERACLEAN® Ocean/L. Therefore, the LC50 

is > 16 mg PERACLEAN® Ocean/L, which corresponds to > 2.4 mg PAA/L. (Evonik Degussa 

GmbH 2005b). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 20 

I:\MEPC\57\2-10.doc 

2.1.3 Conclusions on acute toxicity 

2.1.3.1 All findings are in the same range of previous data already presented in the application 

for Basic Approval (MEPC 53/2/12). Compared to the results obtained in fresh water, the 

sensitivity of marine fish is similar. 

2.1.3.2 Comparing available results obtained for the three trophic levels (not restricted to 

PERACLEAN® Ocean), fish was found less sensitive (lowest acute LC50 is 1.6 mg PAA/L). 

For invertebrates the lowest EC50 was obtained for Daphnia magna, with 0.5 mg PAA/L. 

The acute toxicity appears to be related to the size of the test organism. 

2.1.3.3 Embryonic stages of oysters and mussels were found most sensitive with 48 h EC50

values of 0.27 to 0.54 mg PAA/L. 

2.2 Chronic Aquatic Toxicity Data 

2.2.1 Further new reports on chronic aquatic toxicity of PERACLEAN® Ocean were obtained 

which are summarized in Table 3. 

2.2.2 A summary of the chronic aquatic toxicity data for PERACLEAN® Ocean on fresh water 

species is shown in the table below: 

Trophic 

level 

Species Method Endpoint Results (NOEC) 

(PERACLEAN®

Ocean) 

Results 

(NOEC) 

(PAA) 

Reference 

Fresh water 

Fish Danio 

rerio 

OECD 210 

Flow 

through 

conditions 

(GLP) 

Hatch 

success, 

Development 

Mortality 

15 μg/L 2.25 μg/L (Evonik 

Degussa 

GmbH 

2007j) 

Seawater 

Fish 

(16 

PSU) 

Clupea 

pallasi 

Not stated 

Semi-static 

Hatching 

success 

16 days 

1.9 mg/L 29 mg/L (Evonik 

Degussa 

GmbH 

2005b) 

Algae Macroc

ystis 

pyrifera 

EPA/600/ 

R-95/136 

static 

Germ tube 

length 

48 h 

 4 mg/L 6 mg/L (Evonik 

Degussa 

GmbH 

2005a) 

Algae Skeleton

ema 

costatum 

E1218-97a 

static 

Growth 

inhibition, 

96 h 

8 mg/L 2 mg/L (Evonik 

Degussa 

GmbH 

2005a) 

2.2.3 A fish early life stage test with the fresh water fish Danio rerio was performed according to 

OECD 210. Neither effects on hatching success nor behavioral and morphological changes were 

observed. Surprisingly, the only effect was a reduced survival in the two highest concentrations 

(50 and 150 μg/L PERACLEAN® Ocean) in a time range 5 to 12 days post hatching which is 

considered to be a rather insensitive life stage of fish larvae. No dose dependency was observed. 

The overall NOEC is considered to be 2.25 μg PAA/ L (Evonik Degussa GmbH 2007j). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 21 

I:\MEPC\57\2-10.doc 

2.2.4 Based on a specific study protocol (non-GLP), recommended by Washington State 

Department of Ecology, a 16-day fish embryo development test using pacific herring (Clupea pallasi) 

gametes with PERACLEAN® Ocean was performed. The NOEC (endpoint: percentage of hatched 

larvae) was 1.9 mg PERACLEAN® Ocean /L (0.29 mg PAA /L) (Evonik Degussa GmbH 2005b). 

2.2.5 The NOEC for Macroystis pyrifera (germination tube length) was 4 mg PERACLEAN®

Ocean /L (0.6 mg PAA/L). The species Skeletonema costatum was found less sensitive with an 

NOEC of 8 mg PERACLEAN® Ocean/L (1.2 mg PAA/L) (Evonik Degussa GmbH 2005a). 

2.3 – 2.6 

No new information (refer to MEPC 53/2/12). 

3 MAMMALIAN TOXICITY 

3.1 Acute mammalian Toxicity 

3.1.1 The Group noted that no additional information for the acute mammalian toxicity of 

PAA 15% was submitted for Final Approval. 

3.1.2 The predominant effect in all acute toxicity studies is local irritation at the site of contact. 

The extent depends on the concentration and the composition of the applied test solution. 

3.2 Corrosion/Irritation 

3.2.1 The Group noted that no additional information for the corrosion/irritation of 

PAA 15% was submitted for Final Approval. 

3.2.2 PERACLEAN® Ocean should be considered severely corrosive to skin and eyes and 

severely irritating to mucous membranes of the respiratory tract. The RD50 for an aerosol 

generated from a product with a similar composition was 21.5 to 24.1 mg/m3

. 

3.3 Sensitization 

3.3.1 The submitted information in Basic Approval showed that PAA 15% is not a sensitizer.

3.4 Repeated-Dose Toxicity 

3.4.1 The Applicant stated that repeated dose studies with diluted equilibrium PAA solutions 

are relevant for PERACLEAN® Ocean to which the Group is in agreement. 

3.4.2 The Group considers that there are still concerns to be clarified related to human exposure 

to PAA by inhalation under occupational situations (repeated exposure). 

3.4.3 However, the Group is of the opinion that further animal testing are not required and 

therefore recommends that an occupational health medical surveillance plan according to the 

Guidelines on the Basic Elements of a Shipboard Occupational Health and Safety Programme 

(SOHSP), IMO, May 2006 should be implemented to address possible inhalation and dermal 

toxicity (irritation at the site of contact namely the respiratory tract and skin and secondary 

systemic effects namely impairment of lung and liver functions). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 22 

I:\MEPC\57\2-10.doc 

3.5 Developmental and reproductive toxicity 

3.5.1 The Group evaluated a developmental toxicity study performed according to OECD 414 

(Müller 2005) submitted by the Applicant, in rats with 35% peracetic acid solution administered 

in drinking water and concluded that the observed liver effects in fetuses were shown to be dose 

dependent (12.5, 30.4 and 48.1mg/kg bw/d). No NOEL was derived as there was a slight effect at 

the lowest dose group. 

3.6 Carcinogenicity 

3.6.1 The Applicant states that due to the toxicokinetics, it is unlikely that PERACLEAN®

Ocean is systemically available and the absence of a genotoxic potential in the majority of the 

genotoxicity studies, it is unlikely that the product has a relevant carcinogenic potential for 

humans, and further testing is not warranted. However, according to existing and submitted 

information (JACC No40) there is still some concern related to the carcinogenicity potential of 

PAA acting as a tumor promoter. The observed effects are considered to be secondary to local 

irritation (Greaves and Barsoum, 1990). 

3.7 Mutagenicity 

3.7.1 The weight of evidence, in particular in the more recent studies in in vitro experiments in 

mammalian cell cultures, indicates that equilibrium peracetic acid does not have a significant 

genotoxic potential and does not cause gene mutations and chromosomal aberrations both in the 

presence and absence of a metabolic activation system. Only in one chromosomal aberration 

assay in vitro a positive result was obtained at highly cytotoxic concentrations. However, a 

recent in vitro chromosomal aberration assay (JACC No40) did not show such an effect even at 

cytotoxic concentrations suggesting that the earlier findings may have been an artifact. PAA did 

not induce micronuclei in in vivo mouse micronucleus tests (Wallat Dr., 1984b) when 

administered by gavage up to the maximum tolerated dose levels and did not induce unscheduled 

DNA synthesis in a recent rat in vivo UDS assays when administered by gavage up to the 

maximum tolerated dose level (Haddouck, 2002). 

According to the above information, the Group concluded that PERACLEAN® Ocean is unlikely 

to have a genotoxic or mutagenic potential. 

3.8 Toxicokinetics 

3.8.1 As it was referred in Basic Approval it is considered that PAA due to its intrinsic 

physical-chemical properties and in case of damaged skin can efficiently diffuse and be absorbed 

in the cells of mucous membranes lining the gastrointestinal and respiratory tract. This process is 

assumed not to induce target organ toxicity, perhaps with exception of stomach – where pH is 

around 2 and PAA can be stable – nor bioaccumulate as the parent compound will rapidly be 

absorbed, distributed in the body fluids and metabolized by catalases into HOAc and H2O 

and O2, being further eliminated by the different routes (urine, faeces and exhaled air). 

The Group concluded that the short rapid degradation limits the systemic availability of both 

peracetic acid and hydrogen peroxide. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 23 

I:\MEPC\57\2-10.doc 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS 

4.1 Modes of degradation (biotic and abiotic) 

It has been already shown and discussed in the application for Basic Approval (MEPC 53/2/12), 

that both active ingredients of PERACLEAN® Ocean, peracetic acid and hydrogen peroxide 

rapidly degrade under abiotic as well as under biotic conditions. Therefore, only some recently 

performed studies will be discussed here. 

4.1.1 Degradation of PERACLEAN® Ocean 

4.1.1.1 The primary and ultimate biodegradability in seawater in the Shake Flask Test (OECD 

Guideline 306) was determined for PERACLEAN® Ocean over a period of 28 days. Beginning 

of biodegradation (10% level) was observed after 10 days of adaptation time and the pass 

level (>50%) was reached after 12 days. After 21 days, there was an almost complete 

mineralization. The elimination/primary degradation of peracetic acid was rapid (after two days 

below limit of detection) corresponding with an elimination rate of >94%. The elimination of 

hydrogen peroxide reached 71% after 7 days and came to >88% (limit of detection) on day 14. 

Therefore, PERACLEAN® Ocean is considered as ultimately biodegradable in seawater 

(Evonik Degussa GmbH 2007i). 

4.1.1.2 In a non-guideline study performed by Environment Canada, degradation of peracetic 

acid and hydrogen peroxide over 7 days at 6 °C was analytically investigated in dependence of 

salinity (0 - 27 PSU) and presence or absence of sediment taken from a ballast tank aboard the 

ship Canadian Provider. This sediment contained large amounts of rust particles and debris 

from ballast tank corrosion. In unfiltered fresh water, the concentration of PAA and H2O2 was 

reduced by 30% and 12.5% after 7 days. 

4.1.1.3 In the presence of sediment, PAA was degraded by 91% and H2O2 by 62% after 7 days, 

respectively. In salt water (> 7 PSU), PAA and H2O2 were degraded by 92 and 52%, 

respectively. In the presence of sediments, PAA became undetectable (< 0.5 mg/L) after 3 days 

and the degradation rate of H2O2 was 93%. (DeLafontaine and Despatie 2006). 

4.1.1.4 Large-volume (4.5 m3) experiments with PERACLAEN® Ocean were also conducted at 

very cold water temperatures (1 - 2 °C) in salt and fresh water. In the fresh water experiment, 

PAA degraded gradually down to 51 to 66% over the course of the test. In salt water, the 

detection limit was very high (10 mg/L) and degradation could not been properly monitored. 

However, only at concentration of 300 mg/L PERACLEAN® Ocean, levels above 10 mg/L were 

observed. Levels of H2O2 remained more or less stable in fresh and salt water over time until 

catalase was added which dropped the H2O2 level down to zero under both, fresh and salt water 

conditions. The levels found in fresh water were always higher than in salt water (DeLafontaine 

and Despatie 2006). 

4.1.1.5 After addition of PERACLEAN® Ocean, the average pH immediately dropped 

from 7.5 (fresh water control) to 6.7, 6.16 and 5.56 in the 100, 200 and 300 mg/L treated tanks, 

respectively. The average pH in salt water dropped from 8.2 (control tank) to 7.3, 6.75 

and 6.2 with the addition of 100, 200 and 400 mg/L PERACLEAN® Ocean. The pH of the 

treated waters remained stable over time and did not vary significantly. Very high levels of 

dissolved Oxygen were noted in all treated tanks across both experiments. Furthermore, a 

concentration dependent increase of dissolved organic Carbon (DOC) was found, which can be 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 24 

I:\MEPC\57\2-10.doc 

ascribed to the Carbon introduced by peracetic acid and Acetic acid. However, that increase was 

found less in salt water than in fresh water at the 100 and 200 mg/L treatment level 

(DeLafontaine and Despatie 2006). 

4.1.1.6 Gregg and Hallegraeff investigated the degradation of PERACLEAN® Ocean in filtered 

seawater (28.6 PSU and 23.7 PSU) at 17°C storage temperature using an indirect method by testing 

the effectiveness against vegetative microalgae in different seawater samples and different light 

conditions. At concentrations of 200 mg/L PERACLEAN® Ocean, PERACLEAN® Ocean 

samples were found to degrade to a level non-toxic to marine microalgae within 2-6 weeks. In the 

dark, degradation rate was lower even in presence of sediment (Gregg and Hallegraeff 2007). 

4.1.1.7 The viability of the microalgae re-increased up to >90% within one (high salinity) or 

two weeks (lower salinity) post treatment. With sediment, the control level (100% viability) was 

achieved within one week. The performance of the degradation test is not usual and questionable 

because the authors did not measure the actual content of PAA and H2O2, e.g., by photometric 

determination. Therefore, it is not sure whether PAA and H2O2 were actually still present or 

whether the effects found were caused by other influences, e.g., the pH-level, the presence of 

nutrients or bacteria or the Oxygen content. 

4.1.2 Conclusion 

4.1.2.1 PERACLEAN® Ocean is readily (bio)degradable under conditions according to the 

OECD guidelines. Peracetic acid showed a rapid degradation especially in salt water and 

presence of sediment and light. Hydrogen peroxide degraded slower but, in presence of sediment 

and salt water, degradation significantly increased. 

4.1.2.2 In fresh water, both components are more stable especially under extremely cold 

conditions. Also, the presence of peracetic acid can be observed over a longer period of time. 

The presence of sediments facilitates degradation in fresh water, too. 

4.1.2.3 Under realistic conditions, it can be assumed that sediment, which is usually present in 

ships’ ballast water tanks, enhances degradation. When the ballast water is discharged, 

photo-degradation additionally occurs. Therefore, the actual environmental concentrations are 

most probably lower than measured under laboratory conditions. 

4.2 Partition Coefficients

4.2.1 From the n-octanol-water partition coefficients of the Active Substances PAA and 

hydrogen peroxide, the organic carbon normalized distribution coefficient can be derived using 

the following equations according to the EU technical guidance document on risk 

assessment (EC, 2003). 

For organic acids, the following equation can be used: 

log Koc = 0.6 log Kow + 0.32 

For peracetic acid with a log Kow of -0.26 at pH 7 (Evonik Degussa GmbH 2007h), a log 

Koc of 0.164 (Koc = 1.45 L/kg) is derived. 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 25 

I:\MEPC\57\2-10.doc 

The following equation for non-hydrophobics may be used for hydrogen peroxide: 

log Koc = 0.52 log Kow + 1.02 

Using that equation, a log Koc of 0.2 (Koc = 1.58 L/kg) was derived for hydrogen peroxide 

(EU, 2003). 

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

indicate a very low adsorption potential to soil and sediment. This is confirmed by the Mackay 

level equilibrium distribution (see document for Basic Approval, MEPC 53/2/12). 

Furthermore, it can be assumed that bioaccumulation for PERACLEAN® Ocean is negligible. 

4.3 Persistence and Identification of Main Metabolites

No new information (MEPC 53/2/12). 

4.4 Reaction with Organic Matter 

4.4.1 In addition to the presented studies on disinfectant by-products of peracetic acid in water 

treatment (see MEPC 53/2/12), Nurizzo et al. (2005) has published investigations of effluents 

from municipal wastewater treatment plant and surface water. 

4.4.2 Only under extreme high bromide content (0.9 mg/L) and a high content of oxidizable 

organic carbon (3.2 - 4.9 mg/L), a distinct amount of aldehydes was observed. No formation of 

total tribromomethanes was observed under any condition (Nurizzo et al. 2005). 

4.4.3 Additional laboratory findings indicate that no brominated and chlorinated phenol will be 

formed during waste water disinfection with peracetic acid (Dell’Erba et al. 2007; Kitis 2004). 

4.4.4 For that reason, peracetic acid is gaining more and more interest as an alternative to 

replace other Active Substances in municipal waste water treatment plants. 

4.5 – 4.7 Potential Physical Effects on Wildlife and Benthic Habitats 

No new information (MEPC 53/2/12). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 26 

I:\MEPC\57\2-10.doc 

5 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

(Ref. MEPC 56/2/3, 2.3, table 2) 

The relevant physical chemical properties were already presented in the application for 

Basic Approval (see MEPC 53/2/12). Some new data were determined in the meantime, 

summarized in table 6. 

Table 1: Physical chemical properties of PERACLEAN® Ocean 

Property Value Reference/comment 

pH value (23°C) 0.39 (Evonik Degussa GmbH 2006a) 

relative density 1.122 (20°C) (Evonik Degussa GmbH 2006a) 

Kinematic viscosity at 20°C 1.77 mm2/s (Evonik Degussa GmbH 2006a) 

Kinematic viscosity at 40°C 1.13 mm2/s (Evonik Degussa GmbH 2006a) 

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

6.1.1 The quantitative reaction of peracetic acid (PAA) with methyl ptolyl sulphide (MTS) 

yields the corresponding sulfoxide (MTSO). To prevent the reaction of the active ingredient 

hydrogen peroxide (H2O2) with MTS, triphenylphosphine (TPP) is added. Analytical evaluation 

of MTSO is carried out via LC-MS/MS on a reversed-phase column (C8) using acetic 

acid/methanol as mobile phase in gradient mode. Detection is carried out with an electrospray 

tandem mass spectrometer in positive mode using an external standard. 

6.2 Material Safety Data Sheet provided: Yes 

6.3 GHS Classification: 

Acute tox 4 (inhalation, dermal, ingestion), skin corrosion 1A 

(Hazard statement codes: H332, H312, H302, H314). 

6.4 Risk Characterization 

* * * 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 27 

I:\MEPC\57\2-10.doc 

APPENDIX 2 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: HYDROGEN PEROXIDE 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.1.1) 

2.1.1 The aquatic toxicity data of hydrogen peroxide were already summarized in the 

application for Basic Approval (MEPC 53/2/12). No new information on acute aquatic toxicity 

on fresh water species (refer to MEPC 53/2/12). 

2.1.2 Based on the intended use, some additional marine species were tested and the 

corresponding results on the effects of H2O2 are summarized in Table 4. 

2.1.3 A summary of the acute aquatic toxicity data for hydrogen peroxide on marine species is 

shown in the table below: 

Trophic 

level 

Species Guideline Endpoint Result 

[mg/L] 

Reference 

Rotifer Brachionus 

plicatilis 

Rotox®

Manual 

EC50 (24 h), 

static, 

mortality 

4.8 (Evonik 

Degussa 

GmbH 2007k) 

Bacteria Vibrio 

fischeri. 

MICROTOX 

basic manual 

EC50 (15 min), 

luminescence 

20.6 (Evonik 

Degussa 

GmbH 2007k) 

Fish Solea solea 

larvae 

OECD 203 LC50 (96 h), 

static, 

mortality 

> 151 < 268 (Evonik 

Degussa 

GmbH 2007k) 

Fish Solea solea 

juvenile 

OECD 203 LC50 (96 h), 

static, 

mortality 

> 84 < 150 (Evonik 

Degussa 

GmbH 2007b) 

Oyster Crassostrea 

gigas 

EPA/600/R95/136 EC50 (48 h), 

static 

development 

3.2 (Evonik 

Degussa 

GmbH 2007k) 

Chaetocaros 

gracilis 

OECD 201 EC50 (72 h) 

growth rate 

3.2 (Evonik 

Degussa 

GmbH 2007k) 

Algae 

Skeletonema 

costatum 

OECD 201 EC50 (72 h) 

growth rate 

2.7 - 3.4 (Evonik 

Degussa 

GmbH 2007m) 

2.1.4 The same study (Evonik Degussa GmbH 2007k) informs about NOECs of the same 

organisms with lowest NOEC = 1.9 mg/L for algae.

2.1.5 In the ROTOX® test kit, the EC50 value was 4.8 mg/L. In the MICROTOX basic assay the 

EC50 found was 20.6 mg/L (Evonik Degussa GmbH 2007k). 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 28 

I:\MEPC\57\2-10.doc 

2.1.6 In an acute toxicity study in fish larvae, no mortality occurred up to 151 mg/L H2O2. 

But with a concentration of 268 mg/L, all larvae were found dead (Evonik Degussa 

GmbH 2007k). The juvenile fish (Solea solea) was found more sensitive under same conditions 

with a LC50 between 84 and 150 mg H2O2/L (Evonik Degussa GmbH 2007b). 

2.1.7 The development into D-larvae was inhibited with a corresponding EC50 value of 3.2 mg 

H2O2/L (Evonik Degussa GmbH 2007k). The two algal species – Chaetocaros gracilis and 

Skeletonema costatum – showed comparable sensitivity towards hydrogen peroxide, resulting in 

an EC50 value of approximately 3 mg/L (Degussa 2007k; Degussa 2007m). 

2.2 Chronic Aquatic Toxicity Data 

2.2.1 In a 21-day continuous exposure study on Daphnia magna conducted by the USGS 

(United States Geological Survey, USA), the chronic no observable effect concentration (NOEC) 

for reproduction was 0.63 mg H2O2 /L and for mortality it was 1.25 mg H2O2/L 

(Meinertz et al. 2007; Vaughn 2006). 

2.2.2 The results of toxicity tests performed in different marine species are summarized in the 

following table: 

Trophic 

level 

Species Guideline Endpoint Results 

NOEC 

[mg/L] 

Reference 

Oyster Crassostrea 

gigas 

EPA/600/R95/136 NOEC (48 h), static 

development 

2.8 (Evonik 

Degussa 

GmbH 

2007k) 

Chaetocaros 

gracilis 

OECD 201 72 h chronic study, 

growth rate 

1.9 (Evonik 

Degussa 

GmbH 

2007k) 

Algae 

Skeletonema 

costatum 

OECD 201 72 h chronic study 

growth rate 

1 (Evonik 

Degussa 

GmbH 

2007m) 

Fish Solea solea 

larvae 

OECD 210 

(adapted) 

18 days, semi-static mortality, 

egg hatch, development 

48 (Evonik 

Degussa 

GmbH 

2007l) 

2.2.3 Hydrogen peroxide did not affect the development of oyster larvae, in concentrations up 

to 2.8 mg/L (NOEC) (Evonik Degussa GmbH 2007k). 

Of the two tested algal species – Chaetocaros gracilis and Skeletonema costatum – the latter 

showed sensitivity slightly towards hydrogen peroxide, resulting in an NOEC of 1 mg/L (Evonik 

Degussa GmbH 2007k; Evonik Degussa GmbH 2007m). 

2.2.4 In an 18-day fish embryo development test (Solea solea) with water renewal 

every 2 days, mortality, behavior, hatching success and development were observed during the 

course of the test. In the highest concentration of 148 mg/L no egg survived (day 6). 

At concentrations of 98 mg/L, hatching was not affected, but only 25% of the larvae survived 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 29 

I:\MEPC\57\2-10.doc 

into free-swimming stage (day 6 to 10) and nearly all larvae died until day 18. Lower 

concentrations of hydrogen peroxide did not show any effects. Therefore, the NOEC can be set 

to 48 mg/L under conditions tested (Evonik Degussa GmbH 2007l). 

2.3 Conclusion 

2.3.1 Algae were found as the most sensitive species towards hydrogen peroxide. These 

findings confirm previous studies (e.g., EU Risk Assessment, 2003). The toxicity of the oyster 

larvae was slightly lower than that of algae. This is in accordance with the results of fresh water 

invertebrates, already discussed in the application for Basic Approval (MEPC 53/2/12). With a 

view to the test kits used, the sensitivity of the ROTOX® assay is more comparable to that of the 

oyster larvae and algae than that of the MICROTOX basic assay. The fish larvae and juveniles 

were the less sensitive species, as expected, even in the long term study performed. 

2.3.2 In the EU Risk Assessment (2003), a PNEC of 10 μg/L for hydrogen peroxide was 

derived. However, this value appears to be very conservative and is related to continuous 

long-term exposures. When deriving a tolerable level for hydrogen peroxide in ballast water 

applications, some considerations about the chemistry and occurrence of the substance should be 

taken into account, already discussed in the application for Basic Approval (MEPC 53/2/12). 

H2O2 acts as an oxidant and, therefore, its adverse effects are only local and short term. 

Hydrogen peroxide is a normal metabolite in nearly all organisms and naturally produced by 

sunlight in water. Therefore, almost all organisms are particularly well equipped in defense 

mechanisms against hydrogen peroxide and other Active Oxygen species. 

2.3.3 In seawater, the available natural concentrations – ranged from 0.5 to 14 μg hydrogen 

peroxide/L, in lakes values > 100 μg/L – were reported. 

2.4 – 2.5: No information 

3 MAMMALIAN TOXICITY 

3.1 The Group considered that mammalian toxicity data concerning Hydrogen peroxide 

individually was not relevant for Human Health Risk Assessment of PERACLEAN® Ocean as a 

full toxicological dataset was provided for the chemical preparation as generated by the system. 

4 OTHER INFORMATION

4.1 Analytical Methods for Measuring the Concentration at environmentally Relevant 

Concentrations 

4.1.1 The quantitative reaction of hydrogen Peroxide (H2O2) with potassium bis (oxalato) 

oxotitanate (IV) yields a yellowish peroxidetitan-complex with a maximum of absorption 

at 385 nm. Analytical evaluation of the complex is done spectro-photometrically using external 

standard (Evonik Degussa GmbH 2007i). 

* * * 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 30 

I:\MEPC\57\2-10.doc 

APPENDIX 3 

ADDITIONAL INFORMATION REGARDING THE SEDNA® USING PERACLEAN®

OCEAN BALLAST WATER MANAGEMENT SYSTEM 

(EVONIK DEGUSSA GmbH) 

During the fifth GESAMP BWWG meeting, the Group had the following questions to the 

applicant: 

1 Active Substance, Relevant Chemicals 

1.1 Does the preparation contain any stabilizers? 

“YES, PERACLEAN® Ocean contains a mix of acids as stabilizers.........(Section deemed to be 

confidential and removed at the request of the submitting Administration.)......... The total 

concentration of additives is below 1%.”

1.2 How do you maintain a concentration of 150 mg/L PERACLEAN® Ocean in the tanks? 

Is there any monitoring device? Please deliver information. 

“The concentration of Peraclean Ocean in the storage tank is stable (15% PAA + 14.3% H2O2) 

throughout at least one year. After that a slow loss of activity occurs. The ballast Water is 

mixed with 150 mg/L Peraclean Ocean at uptake via the described automated volumetric dosing 

unit. The dosing of Peraclean Ocean is adjusted to the actual flow of the ballast water at any 

time during the entire ballast water operation (see pages 21 to 26 of the Technical Manual). 

Once the treated ballast water entered the ballast water tank the active components are degraded 

as described in the application for Final Approval.”

1.3 Is 150 mg/L the maximum allowable discharge concentration? 

“The addition of 150 mg/L PERACLEAN® Ocean during ballast water uptake means a 

concentration of 22.5 PAA and 21.5 mg/L H2O2, respectively. The concentration of the main 

active ingredient Peracetic Acid at discharge should be <1 mg/L. Half-life was 3.5 and 4.5 hrs 

depending on the salinity. 

As measured during the land based testing at NIOZ, PAA could no longer be detected after less 

than 20 hrs. For H2O2, the bacteriostatic compound, the half-life were 19.5 and 24 hrs, 

respectively. At discharge the concentration of Hydrogen peroxide should not exceed 12 ppm. 

These concentrations provide that the PNEC values confirmed by GESAMP in 

document MEPC 54/2/12 are not exceeded taking into account dilution an instantaneous 

degradation.” 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 31 

I:\MEPC\57\2-10.doc 

2 Human Health 

2.1 The Group wants to understand where human exposure could occur, even though the 

system is fully automated. 

“The risk of any human exposure is minimized by multi level Risk Mitigation Measures 

(RMM; see pages 27 to 32 of the Technical Manual). Even the filling of the Peraclean Ocean 

storage tank is fully automated (see pages 43 to 46 of the Technical Manual). Furthermore, the 

valve between the supply hose and the storage tank is especially designed for this purpose and 

prevents even dropping when the hose is disconnected after discharge. The storage tank itself is 

in a separate room which must not be entered by crew members or other human beings 

(see additional information provided by attached manual extract).”

2.2 Exposure assessment: What were the input parameters and which model was used for 

human exposure, as we cannot trace TnG, 2002, Model 7? 

“The highest inhalation exposure expressed as mg Peracetic acid/m3 was found 

during mixing/loading, i.e., during pouring and filling procedures. The estimated amount 

was 0.0435 mg/m3 without respiratory protection. The inhalation exposure during this operation 

is, thus, well below the proposed occupational exposure limit of 0.6 mg Peracetic acid/m3 and 

corresponds to about 7.25% of the OEL if no respiratory protective equipment (RPE) is used. 

For the use of diluted disinfection solutions during the application, inhalation exposure of 

workers/operators towards Peracetic acid during application and post-application of diluted 

Peracetic acid does not occur the exposure and accompanying risk assessments performed for 

industrial uses of Peracetic acid as a disinfectant demonstrated that the proposed OEL of 0.6 

mg/m3 which was derived from a sensory irritation study performed by Gagnaire et al (2002), is 

not exceeded for the intended industrial use without taking into consideration any form of 

respiratory protection.”

2.3 Could we have any available sub-chronic inhalation toxicity studies e.g., 28 or 90 days 

please? 

No answer. 

3 Ship safety 

3.1 The Group strongly requests drawings of the system for further consideration of the 

submission. These should cover: 

- An overall drawing showing the installation components 

- Installation of the tanks 

- Piping and venting 

- Possibly you have an installation manual, which you can deliver. 

“A 3-D drawing of the installation on the test ship is attached. Furthermore, the attached 

extractions of the Technical Manual contain more detailed descriptions of individual sections of 

the SEDNA® System, especially the PERACLEAN® Ocean section. All of this information has to 

be treated strictly confidential. The drawing of the installation as approved by the competent 

authority “Germanischer Lloyd” follows ASAP but has to be treated absolutely confidential.”
GESAMP-BWWG 5/9 

ANNEX 7 

Page 32 

I:\MEPC\57\2-10.doc 

3.2 Did you plan to install a cooling system for the storage tanks, in case temperatures exceed 

the 35oC limit? 

“YES, the control of the temperature is part of a multi level risk mitigation scheme, which has 

been approved by Germanischer Lloyd for this specific BWT system. The risk mitigation 

measures include, but are not limited to, the following points: 

(1) The operating manual of the SEDNA® System includes detailed risk mitigation 

measures for the storage and handling of PERACLEAN® Ocean which are based 

on the Guideline for storage of PERACLEAN® Ocean that has been developed by 

Evonik Degussa GmbH (see attached “Evonik Degussa GmbH 2007n Concept for 

storage onboard ships”). 

(2) As a standard feature of ALL SEDNA® Systems, the PREACLEAN® Ocean tank 

room is equipped with an active cooling system (air-conditioning). Separate 

temperature sensors monitor the temperature of the PERACLEAN® Ocean inside 

of the tank as well as the air temperature in the tank room. The air-conditioning 

and the temperature sensors are fully implemented in the PLC steering of the 

SEDNA® system.”

3.3 In case of toxic fumes development, how are the aeration and de-aeration valves regulated 

(e.g., by pressure) and where will the gases be released? 

(1) “Moreover the above risk mitigation measures, an active ventilation system that 

allows a minimum of 10-folt exchange of the tank room volume per hour is 

installed with every PERACLEAN® Ocean tank system. 

(2) The ventilation system will start automatically, when a temperature of 35°C is 

reached in the tank room. 

(3) The air from the tank room is released in places where they can not harm crew 

members. The exact location depends on the installation details of the specific 

ship and is subject to plan approval of the class as it is a mandatory part of the 

risk mitigation system. 

(4) If the tank temperature reaches 40 °C a tank spraying device (sprinkler) is started 

to condense vapors and cool down the tank. Furthermore, a signal is given to the 

vessels central alarm system via potential-free contact. Generally, the design of 

the tank and dosing facilities, the location and the safety features depend on the 

conditions of the individual vessel and they have to be decided in co-operation 

with the relevant authorities and the classification society.”

3.4 Corrosion test: Was PERACLEAN® Ocean also added to the seawater at a concentration 

of 200 mg/L daily? 

“Yes, PERACLEAN® Ocean was added daily (working days) at a concentration of 200 ppm.” 
GESAMP-BWWG 5/9 

ANNEX 7 

Page 33 

I:\MEPC\57\2-10.doc 

3.5 Why were the immersion tests carried out under aeration and with artificial seawater? 

Answered by Germanischer Lloyd: 

“Artificial seawater according to ASTM D1141-98 has been used to have a standardized 

test solution, since in both test solutions (with and without PERACLEAN®) the same test 

conditions are needed to compare them. Aeration has been used because it is stated 

in ISO 2812-2 and to accelerate the amount of oxygen, which leads to stricter test 

conditions due to higher corrosion. According to our experience anaerobic corrosion is 

not the dominant type of corrosion in ballast tanks.” 

3.6 The Group has concerns regarding the layer formation and shallow pit formation of the 

uncoated steel panels especially in the gas phase, plus the increased corrosion rate after addition 

of PERACLEAN® Ocean. One of the results was that PERACLEAN® increases the corrosion 

rate of uncoated steel especially of the test panels in the gas phase, which were immersed in the 

test solution (with and without PERACLEAN®). Can you please explain? 

“Generally, it should be considered that PERACLEAN® Ocean is a strong oxidant. Therefore the 

main concern was to check whether there could be an oxidative break-down of common ballast 

tank coatings or any other any negative effect such as on blistering, corrosion, discoloration, 

adhesion or hardness. 

Regarding aeration and the use of artificial seawater, here is a comment from Dr. Marcel 

Veldhuis, Royal Netherlands Institute for Sea Research (NIOZ): 

“This answer to the above indicated question relate to additional experiments conducted 

during the G9 and G8 certification procedure as conducted in the harbor of NIOZ under 

the supervision of the BSH in spring and early summer of 2007. Experiment conducted at 

NIOZ showed that the addition of 150 mg/L of PERACLEAN® Ocean significantly 

increased the concentration of dissolved oxygen in the treated ballast water. When the 

active ingredients (Peracetic acid and Hydrogen peroxide) were degraded, the growth of 

heterotrophic bacteria started. As a result of bacterial growth, the oxygen concentration 

started to decline. Extreme low oxygen levels, resulting in anoxic conditions, can only be 

expected after >> 5 days of retention time. Typical anoxic conditions are accompanied by 

the production of the gas H2S, which has a typical smell. But during the tests we did 

observe this only in the control tank which contained a high sediment load. In contrast, 

the treated tanks were almost free of sediment and the oxygen level never dropped to 

<10% of the saturation value. Considering the elevated oxygen level in the treated water 

and the fact that PERACLEAN® Ocean eliminates almost all the natural bacterial 

population, it is highly unlikely that there will be an anaerobic corrosion or a growth of 

bacteria responsible for corrosion.”” 

4 Risk to the aquatic environment (PEC/PNEC) 

4.1 Can you please deliver more details about your PEC calculations? 

“Carrying out the emission scenario the applicant used the principle described in BLG 11/4/15. 

In order to also satisfy the recommendations provided in document BLG/11/4/11 the Port of 

Richards bay was chosen allowing to also describe an acute scenario. All details were sent to 

GESAMP for consideration and are attached as annex 1.”
GESAMP-BWWG 5/9 

ANNEX 7 

Page 34 

I:\MEPC\57\2-10.doc 

Worst Case Scenario Calculation:

Calculating the figures for the harbor of Richards Bay the total release of H2O2 is 434 

tons/year (assuming that all the ballast water contains 21 mg H2O2/L). This would 

generate a concentration of 1.66 mg H2O2/L, if no degradation at all took place. 

Considering just one day with 4.75 incoming ships and 56,616 tons ballast water on 

average, the resulting H2O2 concentration in the port area would be 0.0045 mg/L 

(=PEC). The PNEC of 0.010 mg/L for H2O2 is very conservative (related to continuous 

long term exposures) and derived from the EU Risk Assessment in 2003 

(see Chapter 2.5.3, page 10 of the submission for Final Approval) In consequence the 

PEC/PNEC ratio after one day is 0.0045/0.01 = 0.45. The following calculation 

describes the build-up of H2O2 in the harbor water. According to the results of the 

land-based testing (salinity 22 PSU, temperature 15.6°C), the half-life of H2O2 is 

estimated at 24 hrs. This approach can be considered as conservative since the trials at 

NIOZ were conducted in cleaned tanks and after filtration of the water by the SEDNA®

system. Under realistic harbor area conditions the degradation is significantly 

accelerated by suspended solids, sediments and sunlight. The following figure on page 3 

of Annex 1 illustrates that even after one year, the build-up of the peroxide concentration 

in the harbor does not exceed a level of 0.009 mg/L. Using that level as PEC, the 

PEC/PNEC ratio will be 0.009 / 0.010 = 0.9. Comparing the cumulative value of 9 μg/L 

with naturally occurring Hydrogen peroxide found in seawater (0.5 to 14 μg/L, see EU 

Risk Assessment, 2003), they are in the same range.”

4.2 The Group has concerns regarding the environmental exposure scenario (PEC). Did you 

run a model for the discharge of ballast water like MAM-PEC? 

“A model for discharge using MAM-PEC was run in connection with the application for 

Basic Approval. Since several experts confirmed that this or other existing models are not 

appropriate for Ballast Water Emission Scenarios (see BLG 11/16 §4.26) the applicant drafted 

an ESD along ideas developed and adopted at BLG 11 and MEPC 56. 

The ESD provided for the Basic Approval dossier is calculated as daily instantaneous discharge 

of treated Ballast Water just treated without any degradation of the Active Substance by various 

ship types throughout one year. In order to fulfill the requirements to also consider an acute ES 

from one ship along the berth as well as possible chronic emission by large bulk carriers (see 

attached BLG 11/4/11), the port of Richards Bay was chosen for the ESD in the current 

application for Final Approval.”

4.3 The Group does not understand the units being used in tables 1 and 7 of your application 

dossier. Is it % treated BALLAST WATER or mg PAA/L in table 7, or is mg PAA/L in table 1 

correct? Is there any relation between table 1 and 7? And if yes, how do they relate? 

“There is a direct correlation between the tables 1 and 7 in the Final Approval document. 

The data figures for table 7 are directly taken from the “deLafontaine 2006” publication (Tables 

in appendix) or table 1 the figures for 2 h retention time were used (assuming that there is no or 

only very low degradation in fresh water in the first 2 h at this low temperature) and transformed 

from %TBW to mg PAA/L.” 

*** 
GESAMP-BWWG 5 

I:\MEPC\57\2-10.doc 

ANNEX 8 

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE 

OceanSaver® Ballast Water Management System 

Submitted by Norway

0 SUMMARY 

0.1 The Group agreed to recommend that Basic Approval be granted to the OceanSaver®

Ballast Water Treatment System submitted by Norway. 

0.2 The group noted that the OceanSaver® Ballast Water Treatment System comprises a 

number of different processes, which include cavitation, nitrogen super-saturation and 

disinfection by electrochemical treatment. The application indicates that the sequence of the 

different treatment elements may be varied. In any application for final approval, the Group 

would require a definite configuration to be submitted for evaluation. 

0.3 The group is mainly concerned with any configuration in which the system uses 

electrochemical treatment, as this would produce Active Substances and by-products, as well as 

the nitrogen treatment which reduces oxygen concentration in the ballast water and requires 

mitigation procedures prior to discharge. 

0.4 If the original intention of the applicant was to apply physical treatment (filtration, 

cavitation, and nitrogen purging) to reduce the need for sterilization through electrochemical 

treatment, this is not reflected in lower chlorine concentrations dosed to the ballast water with 

this system, which are within the range of those used by other electrochemical systems submitted 

for Basic Approval. 

0.5 Where the use of Nitrogen is concerned, the Group considers that high nitrogen levels and 

subsequent oxygen depletion in the headspace of ballast tanks could form a hazard to human 

health and that deoxygenated ballast water could form a hazard to the environment unless 

adequately oxygenated prior to discharge. 

0.6 Bromoform concentrations as representative of disinfection by-products and measured in 

fresh and stored ballast water were at levels similar to those observed in other ballast water 

management systems based on electrolysis. 

0.7 The applicant claims that TRO had disappeared in less than 24 h. However it needs to be 

explained why the reported ecotoxicity tests all showed toxicity even 5 days after treatment. 

0.8 The applicant provided information on an initial dilution model as part of the 

environmental risk assessment but was unable to calculate a PEC value. The Group strongly 

recommends that the applicant will provide a complete environmental risk assessment as part of 

an application for Final Approval. 

0.9 The Group considered that the mitigation steps included in the application i.e., re-aeration 

prior to discharge would be an important factor, in reducing the discharge concentrations of a 

variety of Active Substances and by-products. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 2 

I:\MEPC\57\2-10.doc 

1 INTRODUCTION 

1.1 The data for this product were extracted from the submission of Norway to 

MEPC (MEPC 57/2/5) and the application dossier. 

2 COMPLETENESS OF THE DOSSIER 

2.1 The Group noted that the following documents have been included in the application 

dossier for Basic Approval: 

.1 Technical information about the nitrogen generator, ballast water filter, 

C3T Hydro Cavitation unit, C2E Electrolyte unit including drawings. 

Furthermore, the submission included specifications for prototype operation, a 

safety manual, installation procedures, a ballast water management plan and 

additional background information regarding hydrodynamic cavitation. 

.2 The applicant submitted test results for acute ecotoxicity on one marine algae and 

fish larvae. A test using a similar electrochemical unit to OceanSaver® was used 

to assess chronic toxicity to Daphnia. 

.3 Furthermore, the submission includes a detailed chemical analysis of Active and 

Relevant chemicals created by electrolytic disinfection. 

2.2 However, the Group noted that some information was not submitted: 

.1 The Group found that the applicant had not performed an appropriate human 

health risk assessment taking into account the Human Exposure Scenario 

(MEPC 56/2/2, annex 9; GESAMP BWWG 4, 7.1), having only submitted 

information related to hazards identification (Active Substances and 

Relevant Chemicals). 

.2 No information was delivered about the gas sensors and the possible development 

of hydrogen and chlorine gas by the electrochemical system. 

.3 Corrosion tests were carried out with the nitrogen saturated water; no information 

was provided for the system as a whole. 

.4 The Group noted that no Quality Assurance Project Plan for chemical analysis and 

ecotoxicity testing was available. 

.5 The applicant provided no estimate of the PEC. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 3 

I:\MEPC\57\2-10.doc 

3 DESCRIPTION OF OCEANSAVER® BALLAST WATER MANAGEMENT SYSTEM 

3.1 Overview of the system 

3.1.1 The applicant proposes a combined ballast water management system (BWMS) that 

applies pre-filtration, cavitation, nitrogen super-saturation and electrochemical disinfection as its 

main working principles. 

3.1.2 The Mechanical Filtration Unit used includes an automatic back flushing process, which 

removes trapped residue (particles, organisms) >50 μm. Discharge following back-flushing takes 

place only when the filter is in use at the location of ballast water uptake. 

3.1.3 The hydrodynamic cavitation unit (C3T Unit) is a specially designed circumferential 

hydrodynamic cavitation chamber which is able to generate, harness and control intense pressure 

pulses arising from cavitation. The cavitation involves formation and implosion of cavitation bubbles 

and thereby generates forces and shockwaves, which affect particles and organisms in the water. 

The dimensions of the cavitation unit have been optimized to effectively break down 

micro-organisms having a size of larger than 10 μm, but also organisms outside this range 

will be affected. 

3.1.4 The electrochemical disinfection unit (C2E Unit) produces electrochemically activated 

water by generating controlled amounts and variations of Active Substances in situ in a side 

stream of the main ballast water stream (typically <0.5% by volume) without adding any 

additional chemicals to the water. The Group noted that the prototype was operated at 0.2% by 

volume. The treated water is re-injected into the ballast water line. Other than the main ballast 

water stream there is also a possibility of using other sources of water like an external source of 

brine or saltwater or bypassed water, presumably for operation in fresh water. 

3.1.5 The nitrogen (N2) super-saturation unit is provided for the injection of nitrogen (N2) gas 

into the ballast water. Nitrogen may be injected into all or a part of the water flow (typically less 

than 15% of the total water flow) with the main criteria being that the nitrogen is injected in 

sufficient amounts to ensure that the treated water when reaching the ballast tanks is 

super-saturated with nitrogen to a level of around 120-135%. This way dissolved oxygen is 

reduced in the ballast water down to <2.5 mg/L leading to hypoxic conditions and preventing 

re-growth of organisms that are dependent on oxygen for their survival. The Group noted that a 

side stream for nitrogen injection was not indicated in the system specification and that 

furthermore there was an indication in the dossier of applying nitrogen gas directly into the 

ballast water tanks. This needs further clarification. The Group noted that the positioning and 

exhausting of the nitrogen generator might require attention. 

3.1.6 The Group noted that the 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 Filter/C3T/C2E/N2 Super-Saturation 

 .2 Filter/C2E/N2 Super-Saturation 

 .3 Filter/C3T/N2 Super-Saturation 

 .4 Filter/C3T/C2E (or C2E/ C3T). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 4 

I:\MEPC\57\2-10.doc 

However, for the evaluation of the system the Group is only concerned with the functioning of 

the electrochemical unit, as this is the only part using Active Substances. In considering an 

application for Final Approval the Group would also consider the effects of discharging 

de-oxygenated ballast water on the environment. 

Figure 2: The OceanSaver® BWMS main Components: Water flow at uptake of Ballast Water. 

(Mechanical filter, C2E unit and nitrogen super-saturation are not used at ballast water discharge) 

3.1.7 The Group noted that the treated water is aerated during ballast water discharge to avoid 

discharge of hypoxic water and that the discharge water is also treated with the C3T cavitation 

unit. The Group was unable however to find details and data on either of the above statements. 

3.1.8 The submission informs that the principle process of the electrochemical activation unit is 

that of applying an electric potential difference between two electrodes to the water flow 

separated by a membrane/diaphragm (electrodialytic process). The ion selective membrane 

separates the anolyte and the catholyte flows and forms metastable ions and free radicals. 

In conventional electrolysis, hypochlorous acid is the dominant stable constituent formed. In this 

application the anolyte has superior sterilizing and disinfectant properties, since the reactive 

species present in the solution are more effective in destroying micro-organisms and organic 

molecules than chlorine alone. The catholyte effluent is alkaline (pH ~10-12) and the anolyte 

effluent is acidic (pH ~ 2.4-4). The pH in the anolyte may be adjusted by mixing some or all of 

the catholyte into the effluent. In the C2E unit approximately 50% of the catholyte is mixed with 

the anolyte resulting in a pH around 3 before the side stream is injected into the ballast line. 

Catholyte is re-circulated in the cell avoiding waste issues. From the point of view of the 

production of by-products the Group could see no distinction between this system and others 

using electrolytic disinfection. If this unit is indeed more efficient, then the Group would have 

expected to see lower dosing levels. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 5 

I:\MEPC\57\2-10.doc 

3.1.9 The submission informs that the ratio between the overall amount of water and the amount of 

water flowing into and out of the electrochemical activation cell is nearly constant, thus the dosage of 

the C2E disinfectant by volume is constant. Any necessary alterations regarding the concentration of 

Active Substances in the disinfectant produced over the cells are achieved by changing the level of 

applied electrical current (amperage) and adjusting the injection of catholyte. Changes to the 

necessary settings are indicated by comparing the Oxygen Reduction Potential (ORP), 

Free Available Chlorine levels and pH measured in a calibration loop to measurements taken from 

a monitoring point downstream of the injection point (main ballast line). The ranges for desired 

values of ORP and FAC may be 350 – 800 mV and 0.05 – 2 mg/L, respectively, but more 

preferably 350 – 550 mV and 0.5 – 1.5 mg/L. 

As the ballast water is stored for a period of time after treatment, this allows for the Active 

Substances from the product of the electrochemical activation cell to have full effect on any 

micro-organisms and other unwanted matter in the water. Experience has verified the short 

duration in which these characteristic values (ORP/ FAC) are elevated. FAC levels are typically 

halved within 6 – 8 hours.

3.2 Active Substances, Relevant Chemicals and Other Chemicals 

3.2.1 Active Substances 

Treated water 

High salinity 

34 PSU 

Brackish water 

17 PSU 

Surface water 

20 PSU 

total chlorine (Cl2) mg/L 1010 870 970 

free chlorine (Cl2) mg/L 980 800 930 

combined chlorine (Cl2) mg/L 30 70 40 

ozone (O3) mg/L 13.7 5.4 10.9 

hydrogen peroxide (H2O2) mg/L 2.7 2.1 3.6 

3.2.2 Other Active Substances 

Component 

Chemical Name 

CAS 

Number 

UN 

Number 

Molecular 

Weight 

(g/mol) 

Empirical 

formula 

Structural 

formula 

hypochlorous acid 7790-92-3 n/a 52.460 HOCl 

hydrogen peroxide 7722-84-1 2015 34.015 H2O2

ozone 10028-15-6 47.998 O3

chlorine dioxide 10049-04-4 9191 69.5 ClO2
GESAMP-BWWG 5/9 

ANNEX 8 

Page 6 

I:\MEPC\57\2-10.doc 

3.2.3 Relevant chemicals 

Component 

Chemical Name 

CAS 

Number 

UN 

Number 

Molecular 

Weight 

(g/mol) 

Empirical 

formula 

Structural 

formula 

bromoform 75-25-2 2515 252.731 CHBr3

dibromochloromethane 124-48-1 2810 208.290 CHBr2Cl 

dichlorobromomethane 75-27-4 8027 163.83 CHBrCl2

2, 4, 6 – tribromophenol 118-79-6 2811 330.82 C6H3Br3O 

dibromoacetonitrile 3252-43-5 2810 198.86 C2HBr2N 

monobromoacetic 

acid 

79-08-3 1938 138.94802 C2H3BrO2

3.2.4 Other chemicals 

Component 

Chemical Name 

CAS 

Number 

UN 

Number 

Molecular 

Weight 

(g/mol) 

Empirical 

formula 

Structural 

formula 

nitrogen gas 7727-37-9 1066 28.013 N2

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the Active Substances and Relevant Chemicals produced in the 

OCEANSAVER® BWMS can be toxic to humans. The liquid solution produced by the C2E unit 

contains chemical formulations that can be irritating to eyes, skin and digestive tract. 

4.2 In many electrochemical processes involving saline water, hydrogen gas may be formed. 

There is no release of any produced gas from the process to the atmosphere. The unit is 

ventilated as a safety precaution in case of leakage and also due to cooling purposes. Integrated 

gas detectors will detect any gas leakage. In the case of gas detection or pressure loss in the 

pressurized system, the electrical supply will be disconnected automatically and thus, the system 

will shut down. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 7 

I:\MEPC\57\2-10.doc 

4.3 The Group noted that the system is further protected by limiting the electrical supply to 

the electrodialytic cell as a function of their flow capacity making it impossible to build up 

explosive atmospheres (concentrations above 4% hydrogen). Note also that the tanks when filled 

are also inerted due to the nitrogen super-saturation feature. 

4.4 The applicant states that the C2E unit produces disinfectant on demand in a pressurized 

enclosed closed circuit; therefore there are no handling or storage issues. There are safety 

measures built into the system in case of failure causing leakage and thus the potential exposure 

to humans. In case of leakage, the system will automatically shut down. 

4.5 The Group noted that the applicant had delivered a list of safety precautions, hazard 

identifications, emergency measures and first aid instructions. 

4.6 The Applicant informs that there is a danger to ship, crew and shore personal of nitrogen 

gas escaping or migrating into spaces as follows: ballast tanks, air ventilation pipes from tanks, 

cable trunks, nitrogen generating area, piping and electrical cable penetrations. 

Taking the above into consideration, the Group recommends that for Final Approval, the 

Applicant should submit the BWTS Human Exposure Scenario (HES), namely to address 

nitrogen exposure as there is an identified risk in several areas adjacent to a nitrogen-filled space. 

4.7 The Group concluded that chlorinated and brominated disinfection by-products are the 

toxicologically relevant compounds generated by the electrochemical process (C2E unit) as they 

have a potential for uptake and human genotoxicity/carcinogenicity concerns; therefore they 

will have to be kept below toxicological critical levels (bromoform <100 μg/L, Ref. WHO, 

Guidelines for drinking water quality, 2003). 

4.8 The Group recommends that for Final Approval description of the operation units where 

human exposure can take place should be submitted according to HES (MEPC 56/2/2, annex 9). 

5 RISK TO SAFETY OF SHIP 

5.1 The Group noted that two different corrosion tests for nitrogen saturated water were 

carried out by the applicant: one coated test panel exposure in a ballast tank on board of a ship, 

and a lab test. Both tests were carried out with de-oxygenated water (nitrogen saturation) and 

untreated seawater. In the lab test no difference between de-oxygenated and untreated seawater 

regarding coating performance has been observed. The untreated seawater test showed a higher 

anode consumption and electrical current demand. 

5.2 The Group noted that results from independent full scale testing suggest that the 

OCEANSAVER® BWMS largely eliminates potential creep corrosion in ballast tanks. 

5.3 The Group noted that no corrosion tests were carried out with the complete OceanSaver®

treated ballast water, which would include electrochemical activation and cavitation. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 8 

I:\MEPC\57\2-10.doc 

6 RISKS TO THE AQUATIC ENVIRONMENT 

6.1 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND 

TOXICITY (T) 

6.1.1 The P criterion 

None of the Active Substances or the Relevant Chemicals has a half-life exceeding 60 days in 

marine water. Subsequently, there is no Active Substance or Relevant Chemical within the 

OCEANSAVER® BWMS that fulfils the P criterion for being persistent. 

6.1.2 The B criterion 

6.1.2.1 Based on the log Kow values provided in the appendix (section 4.2.2) it may be 

concluded that only for the substance 2,4,6-tribromophenol a slight bioaccumulation potential 

may be expected. 

6.1.2.2 The Group concluded that none of the chosen Active Substances or Relevant Chemicals 

can be addressed as being bio accumulative. 

6.1.3 The T criterion 

To fulfill the T criterion the NOEC value of the substance shall be <0.01 mg/L. According to the 

ECOTOX database search presented in Section 4, only chlorine fits that criterion with an LC50

for the Acartia tonsa of 5 μg/L. 

6.1.4 Conclusion 

The Group concluded that none of the Active Substances or Relevant Chemicals should be 

classified as a PBT compound. 

7 ASSESSMENT OF TREATED BALLAST WATER 

7.1 Concentrations of Active Substances and Relevant chemicals in the treated ballast 

water 

7.1.1 Residual oxidant level 

7.1.1.1 The Applicant has carried out measurements of free and total residual oxidants in the 

treated ballast directly after treatment and at discharge (5 days) from a small-scale 

installation (35 m3/h). Oxidant decay was monitored following treatment of seawater with water 

qualities corresponding to the requirements in the G8 guideline (intermediate salinity). 

Three tests were carried out with varying dosages of anolyte of 3, 6, and 9 L/m3, whereas the 

latter two correspond to the dosage that is used in the full-scale version. No TRO and Free 

oxidant was detectable after <24 hours. 

7.1.1.2 Further tests carried out showed similar results with rapid decay of TRO and Free 

oxidants in less than 6 hours. In water samples from the surface layer of the Oslo fjord and low 

content of organic compounds and particles, low levels of oxidants were detectable after more 

than 24 hours.
GESAMP-BWWG 5/9 

ANNEX 8 

Page 9 

I:\MEPC\57\2-10.doc 

7.1.2 Measurement of by-products and relevant chemicals 

7.1.2.1 The Group noted that the applicant has determined the formation of disinfection 

by-products and relevant chemicals in a land-based installation (>200 m3/h) directly after 

treatment and after 5 days of storage. The following table shows the results of treated and 

untreated water: 

Chemical Name Control 

day 0 

Control 

day 5 

Test 

day 0 

Test 

day 5 

 μg/L μg/L μg/L μg/L 

AOX 29 <500 386 1290 

EOX <50 <50 <50 <50 

2-monochlorophenol <0.1 <0.1 <0.1 <0.1 

3- monochlorophenol <0.1 <0.1 <0.1 <0.1 

4- monochlorophenol <0.1 <0.1 <0.1 <0.1 

2,3-dichlorophenol <0.1 <0.1 <0.1 <0.1 

2,4+2,5-dichlorophenol <0.2 <0.2 <0.2 <0.2 

2,6-dichlorophenol <0.1 <0.1 <0.1 <0.1 

3,4-dichlorophenol <0.1 <0.1 <0.1 <0.1 

3,5-dichlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,4-trichlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,6-trichlorophenol <0.1 <0.1 <0.1 <0.1 

2,4,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 

2,4,6-trichlorophenol <0.1 <0.1 <0.1 <0.1 

3,4,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,4,5-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,4,6-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 

2,3,5,6-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 

pentachlorophenol <0.1 <0.1 <0.1 <0.1 

trichloromethane/chloroform <0.3 <0.3 <0.3 <0.3 

tribromomethane/bromoform <0.2 0.822 385 398 

dibromochloromethane <0.1 <0.1 14.7 17.8 

dichlorobromomethane <0.1 <0.1 0.297 0.337 

tetrachloromethane <0.05 <0.05 <0.05 <0.05 

tribromomethane 0.03 0.29 170 170 

trichloromethane <0.05 <0.05 <0.05 <0.05 

dibromochloromethane <0.02 0.02 4.2 4.5 

dichlobromomethane <0.05 <0.05 0.13 0.11 

trichlorethane <0.3 <0.3 <0.3 <0.3 

tetrachloroethane <0.05 <0.05 <0.05 <0.05 

tribromoethane? <0.05 <0.05 1.5 1.4 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 10 

I:\MEPC\57\2-10.doc 

7.2 Acute and chronic toxicity of treated ballast water 

7.2.1 The Group noted that initial acute toxicity tests with C2E unit (electrochemically) treated 

ballast water was carried out by the applicant. Four tests with Skeletonema costatum and 

two tests with Scophthalmus maximus were carried out. The applicant states that acute toxicity 

tests were carried out from full scale land-based tests with a salinity of 35 PSU. 

FCA Species Salinity 

[PSU] 

Days 

after 

treatment 

Concentration of 

treated water 

References/ 

Comments 

A Skeletonema 

costatum 35 0 NOEC: <10% 

EC50: 18% 

NIVA 2007, reports 502 

File 2 chapter 1 

A Skeletonema 

costatum 35 5 NOEC: 32% 

EC50: 55% 

NIVA 2007, reports 500 

File 2 chapter 2 

A Skeletonema 

costatum 35 0 NOEC: 3.2% 

EC50: 11% 

NIVA 2007, reports 499 

File 2 chapter 5 

A Skeletonema 

costatum 35 5 NOEC: 56% 

EC50: >100% 

NIVA 2007, reports 501 

File 2 chapter 4 

F Scophthalmus 

maximus 32 0 

96 h, semi-static1) 

NOEC: 10% 

LC50: 13.4% 

NIVA 2007, report 499; 

File 2 chapter 3 

F Scophthalmus 

maximus 32 1 

96 h, semi-static1) 

NOEC: 18% 

LC50: 32% 

NIVA 2007, report 499B; 

File 2 chapter 6 

1) semi-static: 1 complete water exchange per day 

7.2.2 The Group noted that samples taken immediately after electrochemical treatment 

(C2E unit, day 0) show aquatic toxicity as do samples after 5 days. 

7.2.3 The applicant further states that full toxicity assessment will be provided for the final 

approval. 

7.2.4 The applicant further submitted acute toxicity studies with Daphnia magna of a similar 

system comparable to the C2E unit in the OCEANSAVER® BWMS, which has been performed 

by the Institute of Chemistry at Tallinn Technical University (Munter et al. 1999). Initial free 

active chlorine concentrations were ~350 and ~500 mg/L anolyte. No acute effects were found 

for the anolyte diluted by 1:500 or more and no significant differences between the two anolyte 

qualities were observed. The Group was unable to interpret the above data in the context of the 

proposed bw treatment system and the same applies to the chronic aquatic toxicity test. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 11 

I:\MEPC\57\2-10.doc 

8 ENVIRONMENTAL RISK ASSESSMENT 

8.1 Derivation of a Predicted No Effect Concentration (PNEC) 

8.1.1 The Group noted that not for all Active Substances and Relevant Chemicals sufficient 

data were available for estimating PNEC values. Derived PNEC values are given in the 

table below: 

Toxic substance Available data Assessment 

factor PNEC 

hypochlorous acid 

Two long-term NOECs from freshwater 

or salt-water species representing two 

trophic levels 

500 0.096 μg/L 

bromoacetic acid 

Two long-term NOECs from freshwater 

or salt water species representing two 

trophic levels 

500 0.12 μg/L 

tribromomethane 

One short-term EC50 from each of three 

trophic levels of the base set (fish, 

Daphnia and algae), but where at least the 

acute toxicity for Daphnia is determined. 

10 000 0.29 μg/L 

2-bromophenol One long-term NOEC from freshwater or 

salt water crustacean reproduction 1000 0.22 μg/L 

chlorine dioxide 

LC50 values from two freshwater fish 

species, marine crustacean and marine 

algae 

10 000 0.25 μg/L 

ozone LC50 values from 6 freshwater fish 10 000 0.93 ng/L 

bromoform 

LC50 from two freshwater fish, one 

freshwater and one marine crustacean and 

one freshwater algae 

1000 0.29 μg/L 

dibromochlorometh

ane 

LC50 from one fish species 10 000 5.2 μg/L 

2,4,6 

tribromophenol 

LC50 from one fish species (3 studies), 

one crustacean and one algae. Chronic 

effects from one algae 

1000 0.5 μg/L 

dibromoacetonitrile LC50 from one fish species, chronic 

effects from two algae 10 000 0.055 μg/L 

monobromoacetic 

acid 

LC50 from 2 fish species and one 

crustacean. Chronic effects on one 

crustacean and one algae 

1000 1.6 μg/L 

8.1.2 The Group further noted that the lowest PNEC value is derived for ozone (0.93 ng/L), but 

ozone has a half-life around 5 seconds in seawater and is produced in low concentrations of 

the C2E unit. Ozone was therefore not regarded as relevant in the PNEC assessment. The most 

relevant chemical compound has been decided to be hypochlorous acid with a PNEC 

value of 0.096 μg/L. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 12 

I:\MEPC\57\2-10.doc 

8.2 Calculation of the Predicted Environmental Concentration (PEC) for the 

Active Substance and Relevant Chemicals 

8.2.1 The Applicant claims that predicted environmental concentration (PEC) of Active 

Substances and relevant chemicals in discharged ballast water from ships can be estimated from 

direct measurements of chemicals in treated sea water or estimated indirectly by measuring the 

oxidant level in the treated water (see chapters 7.1.1 and 7.1.2). However, no PEC data were 

estimated. The Free Chlorine in the treated BW has been found to be >3 mg/L, which is higher 

than it will be in normal operation (approx. 2 mg/L). Further tests will be carried out by 

the applicant. 

8.2.2 The Group noted that initial dilution calculations had been carried out with the 

US-EPA Visual Plume model. Initial dilution of the effluent in a near-zone (300 m along the 

quay and 200 m from the ship side will be >20 times at a BW discharge rate of 6,000 m3/h and a 

total ballast water volume of 50,000 m3. Further, the flux out of this near-zone is minimal 

with 0.42 m/h without any the water currents in the harbor. No PEC data were concluded from 

this study. 

8.2.3 The Group emphasizes that for Final Approval a reasoned PEC value will be required for 

the environmental risk assessment. 

8.3 Calculation of PEC/PNEC ratios

8.3.1 The applicant informs that the preliminary results based on available data from pre-tests 

with higher oxidant levels than in normal operation indicate that several of the chemicals in 

paragraph 8.1.1 may have a PEC/PNEC ratio larger than 1 in treated ballast water discharge. 

With a dilution factor around 100 the discharged ballast water will have PEC/PNEC below 1. 

8.3.2 The Group was not able to calculate a provisional PEC and therefore the establishment of 

a PEC/PNEC ratio was not possible.

9 CONCLUSIONS AND RECOMMENDATIONS 

9.1 Risks to the safety of the ship

The Group noted that no corrosion tests were carried out with the complete OceanSaver® treated 

ballast water, which would include electrochemical activation and cavitation. 

9.2 Risks to the crew and general public

The Group recommended that for Final Approval, the Applicant should submit a BWTS HES 

where unit operations for the nitrogen system and electrochemical system are described in 

terms of where, when and how human exposure can take place (please see HES, 

MEPC 56/2/2, annex 9). 

The Group concluded that chlorinated and brominated disinfection by-products are the 

toxicological relevant compounds generated by the electrochemical process (C2E unit) as they 

have a potential for uptake and human genotoxicity/carcinogenicity concerns; therefore they will 

have to be kept below toxicological critical levels (bromoform <100 μg/L, 

Ref. WHO, Guidelines for drinking water quality, 2003). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 13 

I:\MEPC\57\2-10.doc 

In addition, the Group considered that high nitrogen levels and consequent oxygen depletion in 

the headspace of ballast tanks could form a hazard to human health therefore aeration procedures 

or other risk mitigation measures should be put in place. 

9.3 Risks to the environment

The group is mainly concerned with a configuration in which the system uses electrochemical 

treatment, as this would produce Active Substances and by-products, as well as the nitrogen 

treatment which reduces oxygen concentration in the ballast water and requires mitigation prior 

to discharge. 

Bromoform concentrations as representative of disinfection by-products and measured in fresh 

and stored ballast water were at levels similar to those observed in other ballast water 

management systems based on chlorine. 

The applicant claims that TRO had disappeared in less than 24 h. However it requires 

explanation why the ecotoxicity tests carried out all showed ecotoxicity even 5 days after 

treatment. 

The applicant provided information on an initial dilution model as part of the risk assessment but 

was unable calculate a PEC value. The Group expects that the applicant will provide a complete 

environmental risk assessment as part of an application for Final Approval. 

The Group considered that the mitigation steps included in the application i.e., re-aeration prior 

to discharge would be an important factor, in reducing the discharge concentrations of a variety 

of Active Substances and by-products. 

9.4 Conclusions

The group noted that the OceanSaver® ballast water management system comprises a number of 

different processes, which include cavitation, nitrogen super-saturation and disinfection by an 

electrochemical activation. The application indicates that the sequence of the different treatment 

elements may be varied. In any application for final approval, the Group would require a definite 

configuration to be submitted for evaluation. 

If the original intention of the applicant was to apply physical treatment (filtration, cavitation, 

and nitrogen purging) to reduce the need for sterilization through electrochemical treatment, this 

is not reflected in lower chlorine concentrations dosed to the ballast water with this system, 

which are within the range of those used by other electrochemical systems submitted for 

Basic Approval. 

* * * 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 14 

I:\MEPC\57\2-10.doc 

APPENDIX 1 

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION AND 

BY-PRODUCT PRODUCED IN BALLAST WATER

1 PHYSICAL AND CHEMICAL PROPERTIES FOR THE ACTIVE SUBSTANCES, 

PREPARATIONS AND TREATED BALLAST WATER IF APPLICABLE 

Available data describing the properties of the chemicals is highly variable and when sufficient 

data have not been obtainable, the chemical is not presented. 

1.1 Active Substances 

Property hypochlorous 

acid 

sodium 

hypochlorite 

hydrogen 

peroxide 

ozone chlorine 

dioxide 

Melting point ( ̊C) - -25 -33 

35% w/w in water 

-526.5 -59 

Boiling point ( ̊C) - 107 108 at 1013 hPa 

35% w/w in water 

-112 11 

Flash point ( ̊C) - N/A 

Density kg/m3 at 20 ̊C - 1.21 1.1-1.2 

35% w/w in water 

2.144 

(0o

C) 

1.01 (4o

C) 

Vapor pressure at 

20 ̊C (hPa) 

- 17.4-20 0.48 at 30°C 5.5E4 

(-12 °C) 

1420 

Vapor density (air = 1) - - - - 2,3 

Water solubility (g/L) Soluble 293 100% miscibility 

at any ratio 

 7.5 

pH in solution - - - - 2-3 (8 g/L) 

Dissociation constant 

(pKa) 

7.5 - - - - 

Octanol/water 

partition constant 

(log Kow) 

-0.87 -3.42 -0.296 - - 

Corrosivity to 

material or 

equipment 

- - Reacts with rust, 

brass, zinc, nickel , 

copper , iron and 

their alloys 

- - 

Explosive properties - - Vapor in 

equilibrium with 

aqueous solutions 

above 70% by 

weight can 

explode 

- Explosive 

with or 

without 

contact with 

air 

Oxidizing properties - One of the 

more 

commonly 

used 

oxidizing 

agent 

Classified as 

oxidizing agent for 

transport 

- Strong 

oxidizing 

agent 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 15 

I:\MEPC\57\2-10.doc 

1.2 Relevant chemicals 

Property bromoform Dibromochloromethane Bromodichloromethane 2,4,6 - 

tribromophenol 

dibromo 

acetonitrile 

Bromo

acetic 

acid 

Melting point 

( ̊C) 

8.0-8.5 -20 -55 93 67 49 

Boiling point 

( ̊C) 

149.5 119-120 90.1 290 at 994.58 

hPa 

67 at 

3.2E3 Pa 

206 

Flammability 

( ̊C) 

N/A - - non-flammable. >93 - 

Density 

(kg/m3

) 

2.89 - - 2.55 - - 

Vapor 

pressure at 

20 ̊C (hPa) 

667 7.4 66.7 - 2.6 at 50°C ; 

20 at 70°C; 

17.8 at 95°C 

- 

Vapor density 

(air = 1) 

8.72 

(calculated) 

2.451 - - - - 

Water 

solubility (g/L) 

Slight 4 5-10 at 19°C 50 at 20 °C 5-10 at 

21.5°C 

miscible

Octanol/water 

partition 

coefficient 

(log Kow) 

0.38 2.08 1.88 4.02 N/A 0.295 

Dissociation 

constant pKa 

2.06 2.16 - - - - 

Corrosivity to 

material or 

equipment 

Not 

corrosive 

- - - - - 

2 EFFECTS ON AQUATIC ORGANISMS 

2.1 Acute Aquatic Toxicity Data 

Ecotoxicological data have not been found for all substances, and not all data can be considered 

relevant for estimating the short- and long-term effects. n/a indicates that sufficient data was not 

available. 

2.1.1 Hypochlorous acid 

FCA Species End point Reference 

F Oncorhynchus kisutch, Coho 

salmon LC50: 32 μg/L/4 d Thatcher 1978 

C Acartia tonsa, Calanoid copepop LC50: 403 μg/L/1 d Bradley et al. 1997 

C Americamysis bahia, Opossum 

shrimp LC50: 143.6 μg/L/7 d Fischer et al. 1994 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 16 

I:\MEPC\57\2-10.doc 

2.1.2 Hydrogen peroxide 

FCA Species End point Reference 

Oncorhynchus 

mykiss, Rainbow 

trout

LC50: 10 000 μg/L/4 d Office of Pesticide Programs, 

2000 

F 

Lepomis 

macrochirus, Bluegill LC50: 18 000 μg/L/4 d Office of Pesticide Programs, 2000 

A 

Alexandrium 

tamarense, 

Dinoflagellate

LC50: 10 000-50 000 μg/L/0-

3 d, reproductionGermination 

Ichikawa, S, Wakao, Y, 

Fukuyo, Y. 1993 

2.1.3 Ozone 

FCA Species End point Reference 

Lepomis macrochirus, Bluegill LC50: 60 μg/L/24 h Paller & Heidinger 1979 

Morone saxatilis, Striped bass LC50: 150 μg/L/6 h Hall et al., 1981 

Pimephales promelas, Fathead 

minnow LC50: 100 μg/L/0.03h Asbury & Coler 1980 

Salmo gairdneri, Rainbow trout LC50: 9.3 μg/L/96 h Wedemaier et al., 1979 

Perca flavescens, Yellow perch LC50: 210 

μg/L/24 h/embryo Coler & Asbury 1980 

F 

Salmo gairdneri, Rainbow trout LC50: 190-310 μg/L/ 

embryo 

2.1.4 Chlorine dioxide 

FCA Species End point Reference 

Salmo trutta, Brown trout LC50: 10 000 000 

μg/L/48 h Woodiwiss, FS, Fretwell, G. 1974 F 

Rasbora heteromorpha, 

Harlequinfish, red rasbora 

LC50: 7 000 000 

μg/L/24 h 

Tooby, TE, Hursey, PA, Alabaster, 

JS. 1975. 

C Carcinus maenas, Green/ 

European shore crab 

LC50: 500 000 

μg/L/48 h Portmann, JE, Wilson, KW, 1971 

C Crangon crangon, Common 

shrimp 

LC50: 500 000 

μg/L/48 h Portmann, JE, Wilson, KW, 1971 

A Macrocystis pyrifera, Giant 

kelp 

LC50: 2500 

μg/L/48 h 

Hose, JE, Fiore Di, D, Parker, HS, 

Sciarrotta, T. 1989 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 17 

I:\MEPC\57\2-10.doc 

2.1.5 Bromoform 

FCA Species End point Reference 

Cyprinodon variegates, 

Sheapshead minnow 

NOEC: 2900 μg/L/ 4 d Heitmuller PT. 

et al., 1981 

Cyprinodon variegates,

Sheapshead minnow 

LC50: 18000 μg/L/96 h 

Lepomis macrochirus, 

 Bluegill 

LC50: 29000 μg/L/96 h Boccafusco 

et al., 1981 

F 

Oryzias latipes, Japanese 

killifish/Medaka 

LC50: 40400 μg/L/48 h MITI 1992 

C Penaeus aztecus, Brown shrimp LC50: 20000 μg/L/4 d Gibson, CI. 

et al., 1981 

Daphnia magna, 

Water flea

LC50: 46000 μg/L/48 h LeBlanc 1980 

A Selenastrum capricornutum, 

Green algae

LC50: 18.7 μg/L/24 h 

Chlorophyll 

US EPA 1978 

 

A Selenastrum capricornutum, 

Green algae 

LC50: 28.1 μg/L/96 h 

Population changes, general 

US EPA 1978 

 

2.1.6 Dibromochloromethane 

FCA Species End point Reference 

F Cyprinus carpio, Common camp LC50: 52 000 μg/L/45 min Mattie, JS. et al.,1981

2.1.7 2,4,6-Tribromophenol 

FCA Species End point Reference 

Pimephales promelas, 

Feathered minnow 

LC50: 6250 μg/L/96 h, Broderius, SJ, Kahl, MD, 

Hoglund, MD, 1995 

Pimephales promelas, 

Feathered minnow 

LC50: 6540 μg/L/96 h Geiger, DL, Northcott, CE, 

Call, DJ, Brooke, LT. 1985 

F 

Pimephales promelas, 

Feathered minnow 

LC50: 4500 μg/L/ 8 d Phipps, GL. et al., 1981 

C Daphnia magna 

Water flea 

LC50: 1290 μg/L/2 d Carlson, R. M, Caple, R. 1977 

A Bacillariophyceae, 

Diatom 

LC50: 500 μg/L/48 h, 

Physiology 

Erickson, SJ, Hawkins, CE, 

1980 

2.1.8 Dibromoacetonitrile 

FCA Species End point Reference 

F Pimephales promelas, 

Feathered minnow 

LC50: 710 μg/L/24 h 

550 μg/L/96 h 

Mayes, MA, Blanchard FA, 

Hopkins, DL, Takahashi, IT, 1985 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 18 

I:\MEPC\57\2-10.doc 

2.1.9 Monobromoacetic acid 

FCA Species End point Reference 

Cyprinus carpio, 

Common carp 

LC50: 326 mg/kg (100% mortality after 

1.5 h, force-fed), 222 mg/kg LT100 

(100% mortality after 5 h, force-fed) 

Loeb, HA, Kelly, WH, 

1963 

F 

Lepomis 

macrochirus, 

Bluegill 

LC50: 5 mg/L/24 h (Solvents: Ethanol, 

2-Propanone, Multiple effects reported 

as one result) 

Applegate, VC, 

Howell, JH, Hall Jr. 

AE, Smith, MA, 1957 

C Daphnia magna, 

Water flea

EC50: 65 000 μg/L/24 h, behaviorequilibrium, intoxication-immobile) 

Kuhn, R. 1988, 

Kuhn, R. Pattard, M, 

Pernak K-D, Winter, A, 

1989 

2.2 Chronic Aquatic Toxicity Data 

2.2.1 Hypochlorous acid 

FCA Species End point Reference 

F Oncorhynchus gorbuscha, 

Pink salmon

NOEC: 42 μg/L/23 d, 

mortality Holland et al., 1960 

Americamysis bahia, 

Opossum shrimp

NOEC: 47.8 μg/L/7 d, 

reproduction Fischer et al., 1994 

Americamysis bahia, 

Opossum shrimp

NOEC: 65.5 μg/L/7 d, 

Development Fischer et al., 1994 

C 

Americamysis bahia, 

Opossum shrimp

NOEC: 81.2 μg/L/7 d, 

Growth Fischer et al., 1994 

A Porphyra yezoensis, Red 

algae

EC50: 1400 μg/L/10 d, 

Growth Maruyama et al., 1988 

2.2.2 Hydrogen peroxide 

FCA Species End point Reference 

C Americamysis bahia,

Opossum shrimp

LC50: 47.8 μg/L/7 d, 

reproduction Fischer et al., 1994 

A Porphyra yezoensis, Red 

algae LC50: 1400 μg/L/10 d, Growth Maruyama, T et al., 

1988 

2.2.3 Bromoform 

FCA Species End point Reference 

F Cyprinodon variegatus, 

Sheepshead minnow 

LC50: >4800<8500 μg/L/>28 d, 

Mortality, maximum acceptable 

Toxicant Concentration 

Ward, GS. 

Parrish, PR, 

Rigby, RA, 1981 

Daphnia magna,

Water flea 

EC50: 5400 μg/L/15 d, Reproduction Canton, JH. 

et al., 1983 

C 

Penaeus aztecus,

Brown shrimp 

LC50: 30-290 μg/L 1-28 d, 

Accumulation, general 

Gibson, CI. 

et al., 1981 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 19 

I:\MEPC\57\2-10.doc 

2.2.4 2,4,6-Tribromophenol 

FCA Species End point Reference 

A Thalassiosira pseudonana, 

Diatom 

LC50: 16 000 μg/L/7 d, 

population changes, general 

Erickson, SJ, 

Freeman, AE, 1978 

2.2.5 Dibromoacetonitrile 

FCA Species End point Reference 

Glenodinium halli,

Dinoflagellate 

LC50: 16 000 μg/L/7 d, 

Population changes, general 

Erickson, SJ, 

Freeman, AE, 1978 

A 

Scenedesmus subspicatus, 

Green algae 

EC50: 1400 μg/L/72h, 

(Population changes, general) 

Kuhn, R, Pattard, M, 

1990 

2.2.6 Monobromoacetic acid 

FCA Species End point Reference 

C Daphnia magna, 

Water flea 

NOEC: 1600 μg/L/21 d, 

Reproduction Kuhn, R. et al., 1989 

A Monoraphidium griffithii, 

Green algae 

EC50: 60 μg/L/4 d, growth Eloranta, V 1982 

2.3 Information on Endocrine Disruption: N.D.

2.4 Sediment Toxicity: N.D. 

2.5 Bioavailability/Biomagnification/Bioconcentration: N.D.

2.6 Food Web/Population Effects: ND 

3 MAMMALIAN TOXICITY 

3.1 Sodium hypochlorite 

3.1.1 Corrosion/irritation 

Exp. route Species Method Results Reference 

Skin Rabbit OECD 404 2% slight 

20% severe 

Sodium hypochlorite IUCLID 

2000 GESAMP-BWWG 3/9 

Eye Rabbit n/a 5.25% irritant 

0.5% slight irritant 

0.05% NOEC 

Sodium hypochlorite IUCLID 

2000 GESAMP-BWWG 3/9 

According to the presented data, sodium hypochlorite is to be regarded as a skin and eye irritant. 

Sodium hypochlorite is classified under GHS as skin corrosive 1B (GHS classification, 

Annex VI, COM (2007) 355 final). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 20 

I:\MEPC\57\2-10.doc 

3.1.2 Repeated-dose toxicity 

Exp 

route 

Exp 

duration

Exp dose Species NOAEL Reference

Oral 90 d 200 mg/L in drinking 

water Sodium 

hypochlorite 

Mouse 50 mg/L 

(10-12 mg/kg/d) 

MEPC 56/2 para. 

2.3.3.1 (Daniel 

et al., 1991) 

According to existing and submitted data, the Group concluded the following: 

Several rodent studies with administered sodium hypochlorite in drinking-water have 

suggested immunological changes. Exon et al. (1987) examined immunotoxicological 

effects of sodium hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per day) in 

the drinking water of male Sprague-Dawley rats for 9 weeks. The effects on macrophage 

activity suggest that some impairment does occur at relatively low levels of sodium 

hypochlorite although the significance of which is still unknown. Modification of 

macrophage function seems to be one of the most sensitive responses identified in studies 

of chlorine or hypochlorite in experimental animals (EHC 216, WHO, 2000). 

A study from Daniel et al. (1990a) evaluated the toxicity of chlorine prepared by 

bubbling chlorine gas into distilled water and adjusting pH to 9.4. The nominal 

concentrations of chlorine were approximately 0, 3, 10, 16 or 21 mg/kg bw per day, 

administered as drinking-water to both male and female Sprague-Dawley rats 

(10 per sex per dose) for 90 days. No deaths occurred in any treatment group. A NOEL 

(No Observed Effect Level) of 10 mg/kg bw per day was identified by the authors based 

on reduced body weight gain however this cannot be considered a true toxicological 

end-point as can be associated to a reduced palatability of the drinking-water. 

3.1.3 Sensitization data 

Exp route Species Method Results Reference 

Skin Guinea pig n/a 2.8% NOEC Sodium hypochlorite 

IUCLID 2000 GESAMPBWWG 3/9 

According to existing data sodium hypochlorite does not show a potential to cause delayed 

contact hypersensitivity (draft Risk Assessment Report (RAR) on sodium hypochlorite, 

EU Assessment 793/93). 

3.1.4 Developmental and reproductive toxicity

Exp route Exp duration Exp dose Species NOAEL Reference

Oral 7 generations 100 mg sodium 

hypochlorite/L 

Rats 100 

mg/L 

GESAMP 

BWWT 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 21 

I:\MEPC\57\2-10.doc 

According to existing and submitted data the Group concluded the following: 

Some indicative effects of altered sperm shape have been detected in several studies with 

chlorinated drinking-water. Meier et al. (1985b) reported that oral administration of sodium 

hypochlorite (pH 8.5) prepared from chlorine gas and administered at 4 or 8 mg/kg bw per day 

for 5 weeks increased the incidence of sperm abnormalities in B6C3F1 mice. 

Some animal studies have demonstrated no reproductive or teratogenic effects of chlorine 

(Druckrey, 1968). A number of subsequent studies have studied the effects of chlorine or 

hypochlorite however there is insufficient information to draw conclusions about the potential for 

developmental toxicity (EHC 216, WHO, 2000). 

3.1.5 Carcinogenicity 

Effect Species Method Results Reference 

Carcinogenicity Not carcinogenetic GESAMP BWWT 

MEPC 56/2, para. 2.3.7.1 

Mutagenicity Not mutagenic GESAMP BWWT 

MEPC 56/2, para. 2.3.7.1 

According to existing and submitted data the Group concludes the following: 

In most animal studies available for carcinogenicity evaluation (EHC 216, WHO, 2000) there is a 

lack of statistical evaluation of the results and lack of dose-response relationship. 

Sodium hypochlorite is not classified by IARC as to their carcinogenicity to humans (Group 3). 

Several studies have shown that sodium hypochlorite produces mutagenic responses in bacterial 

systems and mammalian cells in vitro. However, there is no evidence of activity in mammalian 

test systems in vivo. It is not clear to what extent this is influenced by the formation of 

mutagenic by-products as a result of reactions with components of the incubation media 

(Rosenkranz et al., 1976). 

3.2 Hydrogen peroxide 

Source: EU-risk assessment report – Hydrogen Peroxide 

3.2.1 Acute Toxicity 

Exp route Species Method Results Reference 

Dermal Rat Whole body, 4 hours LC50: 2000 mg/m3 Kondrashov 

1977 

Inhalation Mouse Aerosols (70% H2O2), 5 min 

-2 h, exp at 12 000-13 000 

mg/m3

50% lethality after 

10-15 min 

Punte et al., 

1953 

Hydrogen peroxide is classified under GHS as harmful if inhaled or swallowed 

(GHS classification, Annex VI, COM (2007) 355 final). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 22 

I:\MEPC\57\2-10.doc 

3.2.2 Repeated dose toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL NOEL Reference

Inhalation 28 d 0-33 

mg/m3

Rat 6 h daily 

for 5 d 

per week 

Respiratory 

tract 

irritation, 

necrosis and 

inflammation 

of nasal 

cavity 

epithelium 

2.9 

mg/m3

14.6 

mg/m3

CEFIC 

Peroxygen 

Sector 

Group 

2002 

Oral 12 

weeks 

0-506 

mg/kg 

bw/d 

Rat Stomach 

tube 6 d 

per week 

Decreased 

bw gain, 

erythrocyte 

count, 

hemoglobin 

conc. 

Gastric 

mucosal 

erosions, 

eschars and 

round cell 

infiltration 

 56.2 

mg/kg 

bw/d 

Ito et al., 

1976 

Oral 0-90 d 0-3000 

mg/L 

Mouse Drinking 

water 

Decreased 

bw gain, 

reduced 

blood total 

protein, 

reduced 

food and 

water 

consumption, 

duodenal 

mucosal 

hyperplasia 

100 

mg/L 

300 

mg/L 

FMC 

1997 

According to the presented data, there seemed to be relevant toxicological concerns towards 

repeated exposure to hydrogen peroxide. This is also confirmed in the RAR on hydrogen 

peroxide (EU Assessment). 

3.2.3 Sensitization 

Exp route Species Method Results Reference 

Skin Human Vapor, 5 min-4 h 

exposure 

NOAEL: 10 mg/m3, Effect 

conc/dose: 20 mg/m3

Kondrashov 

1977 

Inhalation Human Face mask (nose 

inhalation) 

NOAEL: 5 mg/m3, Effect 

conc/dose: 10 mg/m3

Kondrashov 

1977 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 23 

I:\MEPC\57\2-10.doc 

According to existing data (RAR, hydrogen peroxide), there is not enough evidence to classify 

hydrogen peroxide as a sensitizer. The potential of hydrogen peroxide to cause skin sensitization 

is extremely low (there are two reported cases of positive patch tests as well as uncertainty 

surrounding an outdated animal study, with a negative result). 

3.2.4 Developmental and reproductive toxicity 

Exp 

route 

Exp duration Species Method Results Reference

Oral 90 d Mouse Drinking water No effects FMC 1997 

According to existing data ((RAR, hydrogen peroxide) there are no appropriate animal studies 

available for a complete evaluation of reproductive and developmental toxicity. Two limited 

studies with mice and rats exposed to hydrogen peroxide in drinking water suggested no grave 

disturbances on the male or female reproductive functions (Wales et al, 1959, Hankin, 1958). 

With regards to developmental toxicity a decision was reached on the presumption that 

conventional study protocols (e.g., administration in drinking water) were unlikely to show 

specific embryonal or fetal effects firstly, because it is doubtful whether hydrogen peroxide 

(as opposed to its degradation products oxygen and water) would reach the fetus and secondly, 

because local effects in the mother, possibly causing nutritional disturbances and general toxicity, 

are expected. 

3.2.5 Carcinogenicity 

Species Method Results Reference 

Mouse Drinking water Increased incidence of erosions 

and ulcer in the glandular 

stomach and duodenal 

hyperplasia 

Ito et al., 

1981a, Ito 

et al., 1982b 

Hamster Painting of left buccal 

pouch twice weekly with 

DMBA* and H2O2

Development of carcinomas, 

hyperkeratosis and hyperplasia 

Weitzman 

et al., 1986 

Mouse Dermal, treatment on 

dorsal skin with DMB*A 

and H2O2 and/or acetone 

twice weekly 

H2O2 functioned as an extremely 

weak tumor promoter 

Klein-Szanto 

and Slaga 

1982 

*

 9, 10-dimethyl-1,2-bentzanthracene 

According to existing data (RAR, hydrogen peroxide) it can be concluded that the special nature 

of demonstrated carcinogenicity of hydrogen peroxide, and the overall evidence available, cast 

some doubt on whether hydrogen peroxide should be regarded as a carcinogen of practical 

significance. The weak effect found in complete carcinogenesis studies in mice as well as in 

some promotion studies suggest promotion type of activity and possible underlying genotoxic 

mechanisms. Given the fact that mammalian cells have of necessity built defences against 

reactive oxygen species arising in endogenous metabolism, the injuries caused by hydrogen 

peroxide may well be non-stochastic, i.e., have a dose/dose rate threshold. This evidence 

however is not sufficient to trigger classification. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 24 

I:\MEPC\57\2-10.doc 

3.2.6 Mutagenicity/genotoxicity 

Species Strain Measured 

endpoint 

Test 

conditions 

Results 

without 

activation 

Results 

with 

activation 

Reference 

Escherichia 

coli 

WP2 

(uvrA) 

Ames test H2O2, 

1.0-3333.3 

μg/plate 

- - SRI 

International 

1980 

Salmonella 

typhimurium 

TA1535

/pS 

K1002 

DNA damage 

and repair 

H2O2, 45 

μg/mL 

+ NT Nakamura 

et al., 1987 

African green 

monkey 

Kidney 

cells 

(CV-1) 

Mammalian 

cell-line 

mutation – 

(supF locus of 

the pZ189 

plasmid 

mutations) 

H2O2, 0.5-

10 mM 

+ NT Moraes 

et al., 1990 

Chinese 

hamster 

V79-

379A 

cells 

DNA damage 

and repair–

DNA single 

and doublestrand breaks 

H2O2, 10-

1000 μM 

+ NT Prise 

et al., 1989 

According to a conclusion in existing literature (RAR on hydrogen peroxide) hydrogen peroxide 

is a mutagen and genotoxicant in a variety of in vitro test systems. 

3.3 Ozone 

3.3.1 Acute mammalian Toxicity 

Exp route Species Method Results Reference 

Oral Human Inhalation 0.021-0.124 

mg/m3

/29 min 

Decremented FVC, 

FEV1, PEFR 

Spektor et al., 

1988 

Oral Human Inhalation 0.08 

mg/m3

/6.6 h 

Decremented FVC, 

FEV1Increased SRaw 

McDonnell et al., 

1991 

The Group considers that ozone is very toxic by inhalation. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 25 

I:\MEPC\57\2-10.doc 

3.3.2 Developmental and reproductive toxicity 

Exp 

duration

Exp 

dose

Species Results Reference

8 h/d day 6-9, 9-

12 and 6-15 of 

gestation 

1.97 

mg/m3

Rat Increased resorption rate Kavlock 

et al., 

1979 

day 17-20 of 

gestation 

1.0 or 1.5 

mg/m3

Rat Offspring with retarded of reflex 

development and slowing in 

open field behavior 

Kavlock 

et al., 

1980 

Exp 

duration

Exp 

dose

Species Method Results Reference

Day 17-20 

of gestation 

2 and 2.9 

mg/m3

Rat (offspring) Maternal 

exposure 

Retarded reflex 

development, slowing 

open field behavior 

Kavlock 

et al., 

1980 

7 h/d, 5 

d/week 

0.4 

mg/m3

Mouse (fetus) Maternal 

exposure 

Blepharophimosis and 

jaw anomalies 

Veninga 

1967 

6 h 2 mg/m3 Rat 

(pregnant/lacta

ting) 

 Enhanced sensitivity to 

o3 pulmonary 

inflammation 

Gunnison 

et al., 

1992 

The Group considers that there are some concerns of reprotoxicity effects by inhalation exposure, 

namely neuro-behavioural development, in the submitted studies. 

3.3.3 Carcinogenicity/Mutagenicity 

Ozone is not considered as carcinogenic (The American Conference of Governmental Industrial 

Hygienists (ACGIH)), however, the Group concluded that there is evidence of mutagenicity 

concern, in line with existing scientific literature. 

3.4 Chlorine dioxide 

Very limited data available, probably due to the fact that chlorine dioxide is readily decomposed 

to chlorine and oxygen in the environment. 

3.4.1 Acute toxicity 

Species Exp route Type Value Reference 

Rat Oral LD50 292 mg/kg bw Finnish Chemicals Oy Äetsä 

Rat Inhalation LC50 500 mg/kg Finnish Chemicals Oy Äetsä 

The Group noted that according to GHS classification (GHS, Annex VI, COM (2007) 355 final) 

chlorine dioxide is fatal if inhaled. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 26 

I:\MEPC\57\2-10.doc 

3.4.2 Skin and eye irritation 

Organ Species Remark Reference 

Skin Human May irritate skin very slightly Finnish Chemicals Oy 

Äetsä 

Eye Human Vapours may irritate eyes Finnish Chemicals Oy 

Äetsä 

Chlorine dioxide is classified under GHS as skin corrosive 1B (GHS classification, Annex VI, 

COM (2007) 355 final). 

3.4.3 Carcinogenicity 

Chlorine dioxide is not classified as a carcinogenic (Finnish Chemicals Oy Äetsä). 

3.5 Bromoform 

3.5.1 Acute toxicity

Exp route Value Species Reference/comments 

Oral LD50 (mg/L) 707-1550 Rats & Mice EHC 216, 2000 GESAMP 

BWWT 

Inhalation LC50

(mg/L/4h) 

7000 μ/L Dogs Death after 1 h GESAMP 

BWWT 

The LD50 values presented in submitted studies, indicate that bromoform is harmful if 

swallowed. In addition and according to GHS classification, bromoform is toxic if inhaled. 

3.5.2 Repeated dose toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species NOAEL Reference

Oral 13 weeks 25 mg/kg/d (rat), 

100 mg/kg/d (mice) 

Rats and 

Mice 

25 mg/kg/d (rat), 

100 mg/kg/d 

(mice) 

EHC 216 

(2000) 

The Group concluded that from existing and submitted information there are concerns related to 

nephropathy and hepatopathy under repeated exposure to bromoform. 

3.5.3 Corrosion/Irritation 

Exp route Species Method Results Reference 

Skin Human Not specified Irritant MSDS GESAMP BWWT 

Eye Human Not specified Irritant MSDS GESAMP BWWT 

Inhalation LC50

(mg/L/4h) 

Human 0.03-1.2 

μg/L 

Irritant MSDS GESAMP BWWT 

Bromoform is classified under GHS as an eye irritant (Eye irrit 2) and skin irritant (Skin irrit 2). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 27 

I:\MEPC\57\2-10.doc 

3.5.4 Developmental and reproductive toxicity 

Exp100 

route 

Exp 

duration

Exp 

dose

Species Results Reference

Oral At days 

6-15 of 

gestation 

50, 100 

and 200 

mg/kg/d 

Rats Evidence of foetotoxic 

response. No foetal 

malformations observed 

EHC 216 

(2000) 

Oral 105 d Rats 

(male and 

female 

pairs) 

No detectable effect on 

fertility, litters/pair, live 

pups/litter, proportion of pups 

born alive, sex or body weights 

EHC 216 

(2000) 

The Group concluded from the submitted and existing information (EHC 216, 2000) that 

although there were no observed effects on fertility parameters, there may be some reprotox 

concerns (fetotoxicity) related to exposure to bromoform. 

3.5.5 Carcinogenicity/Mutagenicity 

Effect Species Method Results Reference 

Carcinogenicity Rats 5 d exposure/week 

for 2 years 

No evidence 

observed 

NTP, 

1989a 

Mutagenicity Bacteria 

Not identified 

(Ames test) In vivo Mutagenic 

Inconclusive 

The Group evaluated the carcinogenicity and mutagenicity data submitted for bromoform and 

concluded that there are positive animal data indicating that bromoform can cause liver and 

intestinal tumours. 

3.6 Dibromochloromethane

Trihalomethanes in drinking water (Ref. WHO/SDE/WSH/05.08/64). 

3.6.1 Acute toxicity 

Exp route Value Species Reference 

800 Mouse MEPC 56/2, para. 2.3.1.2, 

GESAMP BWWT 

Oral 

LD50 (mg/L) 

1186/848 

(male/female) 

Rat Chu et al., 1980 

The LD50 values presented in submitted studies, indicate that dibromochloromethane is harmful 

if swallowed. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 28 

I:\MEPC\57\2-10.doc 

3.6.2 Repeated dose toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL Reference

Oral 90 d 0-200 

mg/kg/d 

Rat Solved 

in corn 

oil, 

gavage 

Decrease in 

body weight at 

200 mg/kg/d, 

elevated alanine 

aminotransferas

e, centrilobular 

hepatic 

necrosis, kidney 

proximals 

tubule cell 

degeneration 

50 

mg/kg/d 

MEPC 56/2, 

para. 2.3.1.2 

GESAMP 

BWWT, 

Daniel 

et al., 1990 

Oral 90 d 0-250 

mg/kg 

bw/d 

Rat Solved 

in corn 

oil, 

gavage 

Depressed body 

weight, 

increased 

hepatic 

vacuolation, 

kidney and liver 

toxicity 

30 mg/kg 

bw 

NTP 1985 

Oral 90 d 0-250 

mg/kg 

bw/d 

Mouse Solved 

in corn 

oil, 

gavage 

Kidney and 

liver toxicity 

125 mg/kg 

bw 

NTP 1985 

The Group concluded that from existing and submitted information there are concerns related to 

nephropathy and hepatopathy under repeated exposure to dibromochloromethane. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 29 

I:\MEPC\57\2-10.doc 

3.6.3 Developmental and reproductive toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL NOEL Reference

Oral 2 generations 0.4 

mg/L 

Mice At 4 mg/L 

decreased 

fertility. 

No dominant 

lethal or 

teratogenic 

effects 

observed. 

n/a n/a MEPC 

56/2, para. 

2.3.5.2, 

GESAMP 

BWWT 

Oral 35 d/ 

generation 

0-685 

mg/kg 

bw 

(0-

4000 

mg/L) 

Mice Ad 

libitum,

multigen

erational 

Decreased 

body weight, 

enlarged 

livers with 

gross 

morphological 

changes, 

decreased 

litter size, 

decreased pup 

viability, 

reduced 

fertility and 

reduced F1

generation 

survival 

17 

mg/kg 

bw/d 

n/a Borzelleca 

& 

Carchman 

1982 

The Group concluded from the submitted and existing information that there are observed effects 

on fertility parameters, as well as some reprotox concerns (fetotoxicity) related to exposure to 

dibromochloromethane. 

3.6.4 Carcinogenicity/Mutagenicity 

Effect Species Method Results Reference 

Carcinogenicity Human Probable 

human 

carcinogen 

US EPA (Iris) 

MEPC 56/2, 

para. 2.3.6.2, GESAMP 

BWWT 

Mutagenicity Salmonella 

typhimurium 

Ames Positive and 

negative 

results 

MEPC 56/2, 

para. 2.3.7.2, GESAMP 

BWWT 

Genotoxicity Chinese hamster 

ovary cells 

Human 

lyphocytes 

Chromosomal 

aberration test 

SCE-test 

Positive 

Positive 

Ishidate et al., 1982 

Morimoto & Koizumi 

1983 

The Group noted that the carcinogenicity and mutagenicity data submitted for suggests that there 

are positive data indicating that dibromochloromethane may act as a mutagen as well as a 

carcinogen. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 30 

I:\MEPC\57\2-10.doc 

3.7 Dichlorobromomethane 

Trihalomethanes in drinking water (Ref. WHO/SDE/WSH/05.08/64). 

3.7.1 Acute toxicity 

Exposure route Value Species Reference 

Oral LD50 (mg/L) 916/969 (male/female) Rat Chu et al., 1980 

 

The LD50 values presented in submitted studies, indicate that dichlorobromomethane is harmful 

if swallowed. 

3.7.2 Repeated dose toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL Ref.

Oral 90 d 0-300 

mg/kg 

bw/d 

Rat Gavage Decreased body 

weight, 

centrilobular 

degeneration of 

liver, 

degeneration 

and necrosis of 

kidney 

75 and 150 

mg/kg bw/d 

(bw reduction 

and 

hepatic/renal 

lesions 

respectively) 

NTP 

1987 

Oral 90 d 0-100 

(m) /0-

400 (f) 

Mouse 

(m/f) 

Gavage Centrilobular 

degeneration of 

liver (f), 

degeneration 

and necrosis of 

kidney (m) 

50 mg/kg 

bw/d 

NTP 

1987 

The Group concluded that from existing and submitted information there are concerns related to 

nephropathy and hepatopathy under repeated exposure to dichlorobromomethane.
GESAMP-BWWG 5/9 

ANNEX 8 

Page 31 

I:\MEPC\57\2-10.doc 

3.7.3 Developmental and reproductive toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL Reference

Oral 15 d 

(d 6-21 of 

gestation) 

0-82 

mg/kg 

bw/d 

Rat Ad 

libitum

Water 

consumption, 

body weight 

gain and feed 

consumption 

reduced 

18.4 mg/kg 

bw/d 

(maternal) 

45 mg/kg 

bw/d 

(developmental) 

Christian 

et al.,

2001 

Oral 23 d 

(d6-29 of 

gestation) 

0-55.3 

mg/kg 

bw/d 

Rabbit Ad 

libitum

Body weight 

gain and feed 

consumption 

reduced 

13.4 mg/kg 

bw/d 

(maternal) 

55.3 mg/kg 

bw/d 

(developmental) 

Christian 

et al., 

2001 

Oral 52 weeks 22 and 

39 

mg/kg 

bw/d 

Rats Ad 

libitum

Decreased mean 

straight line 

average path 

and curvilinear 

velocities of 

sperm 

 IPCS 

2000 

From the submitted data, some reproduction toxicological concern was observed regarding 

fertility parameters. 

3.8 2,4,6-Tribromophenol 

3.8.1 Acute mammalian toxicity 

Exp route Species Method Results Reference 

Skin (LD50) Rabbit 

Rabbit 

 >2000 mg/kg 

bw 

>8000 mg/kg 

bw 

IRDC 1973 

IRDC 1974a 

Inhalation LC50

(mg/L/4h) 

Rat 

Rat 

4 h 

1 h 

50 000 mg/m3

200 000 mg/m3

IRDC 1974a 

IRDC 1973 

The LD50 values presented in submitted studies, indicate that 2,4,6-tribromophenol is not 

classified according to its acute toxic properties. However self-classification by a major supplier 

(Great Lakes, UK) suggests that 2,4,6-tribromophenol is harmful if swallowed. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 32 

I:\MEPC\57\2-10.doc 

3.8.2 Repeated dose toxicity 

Exp 

route

Exp 

duration

Exp 

Dose

Species Method Results NOAEL Reference

Oral 48 d 100-

1000 

mg/kg 

bw/d 

Rat Gavage Salivation, 

suppressed bw gain, 

decreased food 

consumption, 

increased liver 

weight, increased 

kidney weight, 

increased total 

protein, decreased 

bilirubin and 

potassium in blood, 

decreased thymus 

weight, hepatocyte 

hypertrophy, 

decreased hepatic 

fatty change, renal 

papillary necrosis and 

dilatation of tubules, 

lymphocyte 

infiltration 

100 

mg/kg 

bw

Tanaka 

et al., 1999 

The Group concluded that from existing and submitted information there are concerns related to 

nephropathy and hepatopathy under repeated exposure to 2,4,6-tribromophenol. 

3.8.3 Corrosion/irritation 

Exp route Species Method Results Reference 

Skin Rabbit OECD TG 404 

One dosage (0.5g) 

24h 

Not irritating DSBG/BCL (1985b) 

Eye Rabbit OECDTG 405 

One dosage 

(100mg) 

Moderately 

irritating 

DSBG/BCL (1997b) 

The Group noted that the presented data suggests that 2,4,6-tribromophenol is irritation to eyes 

(self-classification made by a major supplier (Great Lakes, UK) also suggests that it is irritating 

to skin). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 33 

I:\MEPC\57\2-10.doc 

3.8.4 Developmental and reproductive toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL NOEL Reference

Oral Day 0 

and day 4 

100, 

300 and 

1000 

mg/kg/d 

Rat Repeated 

dose 

toxicity, 

reproduction/ 

development 

Reduced 

viability 

and body 

weight 

 1000 

mg/kg/

d 

mother 

300 

mg/kg/

d pups 

Tanaka 

et al., 1999 

Oral 20 d 10-3000 

mg/kg/d 

Rat Decreased 

weight 

gain, 

increased 

post 

implantation loss, 

decreased 

fetus 

viability 

 1000 

mg/kg/

d 

mother 

300 

mg/kg/

d pups 

IRDC, 

1978b 

Inhalation21 d of 

gestation 

0.03-1.0 

mg/m3

Rat Whole 

body 

inhalation 

Pre and 

post 

implantation 

embryo 

losses, 

decreased 

fetal body 

weight 

<0.03m

g/m3

 Lyubimov 

et al., 1998 

From the submitted data, some reproduction toxicological concern was observed regarding 

developmental parameters. 

3.8.5 Carcinogenicity 

No long-term exposure or carcinogenicity studies on brominated phenols were identified. 

3.8.6 Genotoxicity

Effect Species Method Dose Results Reference 

Genotoxicity CHL/IU 

cells 

Chromosomal 

aberration test 

(in vitro) 

1.6 mg/ml Positive Sasaki 

et al., 1999 

Genotoxicity Mouse, 

bone 

marrow 

Micronucleus test 

(in vivo) 

75-300 mg/kg 

intraperitoneally 

Negative DSBG/BCL 

(2002) 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 34 

I:\MEPC\57\2-10.doc 

3.9 Dibromoacetonitrile 

Halogenated Acetonitriles in Drinking-water (Ref: WHO/SDE/WSH/03.04/98) 

3.9.1 Repeated dose toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL Reference

Oral 13 weeks 0.9-12.6 

mg/kg 

bw/d 

Rat Drinking 

water 

ad libitum

Decreased 

water 

consumption, 

decreased 

body weight 

11.3 

(females) 

and 12.6 

(males) 

mg/kg 

bw/d 

NTP, 2001b 

and 

2002 a,b 

Oral 14 d 23-280 

mg/kg 

bw 

Rat Gavage Decreased 

body weight 

in males, 

increased 

liver weight in 

females 

23 

mg/kg 

bw/d 

Hayes et al., 

1986 

The Group concluded that from submitted information apparently there are no concerns related to 

repeated exposure to dibromoacetonitrile. 

3.9.2 Developmental and reproductive toxicity 

Exp 

route 

Exp 

duration

Exp 

dose

Species Method Results NOAEL Reference

Oral 14 d 2-18 

mg/kg 

bw/d 

Rat Drinking 

water, 

ad libitum

Decreased 

testes 

weight and 

testicular 

atrophy 

12 

mg/kg 

bw/d 

NTP, 

2000c 

14 d 

(gestation 

d 7-21) 

50mg/kg 

bw/d 

Rat Intubation Decreased 

maternal 

weight 

gain, 

decreased 

birth 

weight*

50 

mg/kg 

bw/d**

Smith 

et al., 

1987 

*

 Dibromoacetonitrile were solved in tricaprylin which is proven to be a development toxicant and hence 

possibility of potentiating developmental effects of trihaloacetonitriles and probably other haloacetonitriles. 

** Only one dose administered. 

From the submitted data, some reproduction toxicological concern was observed regarding 

fertility parameters. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 35 

I:\MEPC\57\2-10.doc 

3.9.3 Genotoxicity 

Effect Species Method Results Reference| 

DNA damage Escherichia coli SOS chromotest Weakly positive 

(without metabolic 

activation) 

Le Curieux et al., 

1995 

Sister 

chromatid 

exchange 

Chinese 

hamster ovary 

cells 

Exogenous 

metabolic 

activation 

Induction Bull et al., 1985 

 Human 

lymphoblastic 

cells 

 DNA strand breaks Daniel et al., 

1986 

The Group noted that the mutagenicity data submitted suggests that there are positive data 

indicating that dibromoacetonitrile may act as a mutagen. 

3.10 Monobromoacetic acid 

No data on mammalian toxicology for monobromoacetic acid from the current databases is 

available. 

The Group noted that monobromoacetic acid is classified according to GHS as acute tox 3 

(inhalation, skin contact, ingestion, and as skin corr. 1 A (hazard statements; H332, H312, H302 

and H314). 

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND 

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) 

4.1.1 Bromoform 

In air, brominated trihalomethanes (THMs) may be degraded by photo-oxidative interaction with 

atmospheric hydroxyl radicals; their typical atmospheric half-life is about 2 months. The main 

route of loss of THMs from the water phase has been reported to be through volatilization, with a 

recorded volatilization half-life ranging from 0.5 hours to 24 days. (WHO, 1996, Taylor 2006). 

The reported biodegradation half-life under aerobic conditions has been reported to 

around 1 month (Taylor, 2006). Under anaerobic conditions, brominated trihalomethanes are 

readily bio-degraded within days in the presence of methane-producing bacteria and 

under denitrifying and sulfate-reducing conditions (Taylor, 1996). Adsorption to suspended 

matter and abiotic degradation (e.g., via hydrolysis) have been reported as negligible 

(Taylor, 2006); the estimated half-life through hydrolysis in aqueous media is 686 years for 

bromoform, (WHO, 1996). 

During experiments in open (air exposed) reaction vessels (150 L) concentrations of THMs in 

chlorinated seawater decreased from 15 mg/L to <0.25 mg/L over 7 days (In closed reaction 

vessels only a small decrease of THMs in chlorinated water was observed). The following first 

order rate constant (k) and half-life (t0.5) were determined for Bromoform: 

Total loss: k = 0.027 h-1 t0.5 = 26 h; 

Net volatilization loss: k = 0.024 h-1 t0.5 = 28 h. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 36 

I:\MEPC\57\2-10.doc 

The potential toxicity (pT) of open vessels of chlorinated seawater declined to non-chlorinated 

intake levels within 2–3 days. Thereafter the pT remained relatively constant. In a closed system 

no significant decrease in pT was observed. Although samples were tested for genotoxicity the 

results were equivocal: local inputs, probably from other industrial activities, were sufficient to 

mask any influence of low-level chlorination (Taylor 2006). 

Bromoform should be regarded relatively persistent once released into the environment 

(also stated in GESAMP-BWWG 3/9 draft). 

4.1.2 Dibromochloromethane 

(As for Bromoform; THMs in general). 

In Taylor (2006), the following first order rate constant (k) and half-live (t0.5) were determined 

for DBCM (in sea water): 

Total loss: k = 0.040 h-1 t0.5 = 17 h; 

Net volatilization loss: k = 0.031 h-1 t0.5 = 22 h. 

Adsorption to suspended matter and abiotic degradation (e.g., via hydrolysis) have been reported 

as negligible (Taylor, 2006); estimated half-live through hydrolysis in aqueous media 

is 274 years for DBCM (WHO, 1996), (See also MEPC 56/2), thus DBCM should be regarded 

relatively persistent once released into the environment. 

4.1.3 Dichlorobromomethane 

(As for Bromoform; THMs in general). 

In Taylor (2006), the following first order rate constant (k) and half-life (t0.5) were determined for 

DCBM (in sea water): 

Total loss: k = 0.080 h-1 t0.5 = 9 h. 

Adsorption to suspended matter and abiotic degradation (e.g., via hydrolysis) have been reported 

as negligible (Taylor, 2006); estimated half-life through hydrolysis in aqueous 

media is 1000 years for DCBM (WHO, 1996), thus DCBM should be regarded relatively 

persistent once released into the environment. 

4.1.4 Tribromophenol 

Halophenols have been known to be partially ionized at ambient pH values. The volatilization 

half-lives of 2,4-dichlorophenol and 2,4,6-trichlorophenol have been reported as 2 weeks. 

Halophenols have been known to be susceptible to photo-degradation and this has been 

understood to be the major fate process, with a half-life of several days (Taylor 2006). 

Volatilization of non-dissociated 2,4,6-TBP from water surfaces is not expected to be an 

important fate process (Danske Miljøministeriet, 2000). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 37 

I:\MEPC\57\2-10.doc 

Tribromophenol is not regarded as readily biodegradable (49% of BOD, 4w, 100 mg/L 

substance, 30 mg/L sludge) (Danske Miljøministeriet, 2000), however, adapted communities of 

microorganisms and specialist communities (such as anaerobic or sulfidogenic) may degrade the 

compounds (WHO, 2005). Biodegradation half-lives have been reported as being 7 days and the 

degree of adsorption to suspended solids and sediments (and bioconcentration) has been reported 

as moderate (Taylor, 2006, WHO, 2005). 

4.1.5 Dibromoacetonitrile 

The half-lives of dihaloacetonitriles such as dibromoacetonitrile (DBAN) have been reported as 

being of the order of several days, dependent on pH, with the primary route being gradual 

hydrolysis into dihaloacetic acids. Adsorption to solids has been reported as negligible 

(Taylor, 2006). 

In Taylor (2006) for both open and closed reaction vessels (sea water), >90% dibromoacetonitrile 

was lost in 40 h giving k = 0.050 h-1 and t0.5 = 14 h. The potential toxicity (pT) of open vessels 

of chlorinated seawater declined to non-chlorinated intake levels within 2–3 days. Thereafter 

the pT remained relatively constant. In a closed system no significant decrease in pT was 

observed. Although samples were tested for genotoxicity the results were equivocal: local inputs, 

probably from other industrial activities, were sufficient to mask any influence of low-level 

chlorination (Taylor 2006). 

4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient 

4.2.1 Hypochlorous acid 

 Results 

Log Kow -0.87 hypochlorous acid 

-3.42 sodium hypochlorite 

Koc 14.3 hypochlorous acid 

14.3 sodium hypochlorite 

1⁄2-life 0.8 h hypochlorous acid 

1.4 h sodium hypochlorite 

Hypochlorous acid and sodium hypochlorite can not be considered as bioaccumulative based on 

given data. As the log Kow values for sodium hypochlorite and hypochlorous acid are very low, it 

is considered unlikely that these substances should accumulate through the food chain. 

4.2.2 Hydrogen peroxide 

Results Reference 

Log Kow H2O2 does not accumulate in cells of living organisms IUCLID 2000 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 38 

I:\MEPC\57\2-10.doc 

4.2.3 Bromoform, Dibromochloromethane, Dichlorobromomethane 

 Log 

Kow

Results Reference 

Bomoform 

Dibromochloromethane 

Dichlorobromomethane 

2.38 

2.08 

1.88 

Some bioaccumulation of bromoform in sea 

bass was noted, but this accumulation rapidly 

dissipated. No impacts on growth were 

observed and no damage to liver tissues was 

observed. 

 Taylor (2006) 

4.2.4 2,4,6-Tribromophenol 

Measured values suggest that the potential for bioconcentration of 2,4,6-TBP in aquatic 

organisms is moderate to high. Octanol/water partition coefficient (log Kow) is 4.02. 

Exposure of bluegills (Lepomis macrochirus) to 14C-labelled 2,4,6- TBP for 28 days resulted 

in 20-fold bioaccumulation in edible tissue and 140-fold bioconcentration in viscera. 

Plateau levels were reached by 3–7 days of exposure. The half-life for residues was less 

than 24 h following termination of exposure (WHO, 2005). 

As described in Taylor (2006) for coastal and estuarine power stations cooling water, the 

influence of long-term exposure by chlorination residues (including 2,4,6-Tribromophenol) on 

sea bass (Dicentrarchus labrax) was found to be very limited. Although some bromoform 

bioaccumulation was noted during annual chlorination seasons, this accumulation rapidly 

dissipated thereafter. No impacts on growth were observed and no damage to liver tissues. 

4.2.5 Dibromoacetonitrile 

Adsorption to sediment and bioconcentration in aquatic organisms is stated in WHO (2004) 

stated as “not expected”. 

As described in Taylor (2006) for coastal and estuarine power stations cooling water, the 

influence of long-term exposure by chlorination residues (including dibromoacetonitrile) on sea 

bass (Dicentrarchus labrax) was found to be very limited. Although some bromoform 

bioaccumulation was noted during annual chlorination seasons, this accumulation rapidly 

dissipated thereafter. No impacts on growth were observed and no damage to liver tissues. 

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

(ballast water, marine and fresh waters) 

4.3.1 Bromoform, Dibromochloromethane, Bromodichloromethane 

Bromodichloromethane (BDCM) is metabolized to phosgene, whereas dibromochloromethane 

(DBCM) and bromoform are metabolized to brominated analogues of phosgene. The rate of 

metabolism of these compounds to carbon monoxide both in vivo and in vitro generally follows 

the halide order: namely, bromoform >> DBCM > BDCM >> chloroform. IPCS (2000) 

postulated that the brominated THMs may be more rapidly and more extensively metabolized 

than their chlorinated counterparts. Although this may be true for BDCM, support for this 

statement, as it pertains to DBCM or bromoform, is difficult to determine from the limited 

literature currently available. The majority of the comparative metabolism studies conducted to 

date are limited to chloroform or BDCM. Nonetheless, it would appear that the 

toxicity of BDCM and likely other brominated THMs is mediated through a bioactivation 

pathway (from WHO, 2005). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 39 

I:\MEPC\57\2-10.doc 

No information on persistence of metabolites has been found. According to MEPC 56-2, 

no persistent substance is formed by DBCM. 

4.3.2 2,4,6-Tribromophenol 

TBP is in itself a natural metabolite from infauna in marine pristine soft bottom habitats 

(for example from Acorn worms (enteropneusta)). However, no information was found on the 

metabolites of TBP (same conclusion in WHO, 2005). 

4.3.3 Dibromoacetonitrile 

Halogenated acetonitriles are metabolized via oxidative dehalogenation and dehydration to 

carbon dioxide and cyanide, which is then further metabolized to thiocyanate. The first step in 

this reaction is catalysed by a mixed-function oxidase (such as a cytochrome P-450) and results 

in production of a halocyanomethanol. It is proposed that the halocyanomethanols then 

dehydrate to form halocyanoformaldehydes or lose cyanide to form haloformaldehydes, 

including phosgene. The cyanide carbon group is more readily excreted in the urine, whereas the 

halomethyl carbon group is excreted nearly equally in expired air and in urine; excretion in 

faeces is low (WHO 2004). 

Data on persistence of main metabolites have not been found. 

4.4 Reaction with organic matter 

4.4.1 Bromoform

When chlorine or bromine is used to treat ballast water, trihalomethanes such as bromoform are 

formed as a by-product. They result from the reaction of chlorine and/or bromine with organic 

matter in the water being treated. However, once the bromoform is formed it does not appear to 

have any further reactions with organic matter (MEPC 56/2/3). 

4.4.2 Dibromochloromethane 

When chlorine or bromine is used to treat ballast water, THMs are formed as a by-product. 

They result from the reaction of chlorine and/or bromine with organic matter in the water being 

treated. However, once the THM is formed it does not appear to have any further reactions with 

organic matter. 

4.4.3 Dichlorobromomethane 

When chlorine or bromine is used to treat ballast water, THMs are formed as a by-product. 

They result from the reaction of chlorine and/or bromine with organic matter in the water being 

treated. However, once the THM is formed it does not appear to have any further reactions with 

organic matter. 

4.4.4 2,4,6-Tribromophenol 

Bromophenols can be formed during the chlorination of natural water and wastewater containing 

phenol and bromide ions. No information has been found on further reactions with 

organic matter. 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 40 

I:\MEPC\57\2-10.doc 

4.5 Potential physical effects on wildlife and benthic habitats 

4.5.1 Bromoform 

No information is available on the effects on wildlife or benthic habitats (MEPC 56/2/3), 

however significant physical effects have not been considered relevant for this substance. 

4.5.2 Dibromochloromethane 

DBCM has a higher specific gravity than seawater (2.451 (20°C)) and a low solubility 

(2.7g/L (20°C)). Therefore, according to evaluation based on GESAMP hazard evaluation 

(GESAMP (2002)), the compound is classified as Rating S (substances having a potential effect 

on benthic habitats) (MEPC 56/2). 

4.5.3 Dichlorobromomethane 

No information has been available on physical effects on wildlife and benthic habitats, however, 

significant physical effects have not been considered relevant for this substance. 

4.5.4 2,4,6-Tribromophenol 

No information has been available on physical effects on wildlife and benthic habitats, however, 

significant physical effects have not been considered relevant for this substance. 

4.6 Potential residues in seafood 

4.6.1 Bromoform 

No information has been found on bromoform residues in seafood (see also MEPC 56/2/3). 

4.6.2 Dibromochloromethane 

As DBCM is considered to have low bioaccumulation potential, its persistence in seafood is 

expected to be low. According to studies, DBCM was not detected in oysters, clam and the 

sediment of the Ariho River and the Yoshinaga River (MEPC 56/2). 

4.6.3 Dichlorobromomethane 

DBCM is not a common food contaminant but has been found in trace amounts in some 

samples: 1.2 μg/kg in one dairy composite and 7 μg/kg in butter (WHO, 1996). However, 

information on potential residues in seafood has not been found. 

4.6.4 2,4,6-Tribromophenol 

2, 4, 6-tribromophenol has been measured in wild-harvested prawns, and ocean fish, 

Eastern Australia. The levels ranged from 0.1 to 230 ng/g in fish (gut, flesh) and 0.12-460 ng/g 

in prawns (head, tail) (Danske Miljøministeriet, 2000). In biota likely to form part of human 

diets, edible portions contain mean 2,4,6-TBP concentrations up to 198 and 2360 μg/kg dry 

weight in molluscs and crustaceans, respectively, and up to 39 μg/kg dry weight in marine fish. 

Brominated phenols have been detected in human milk, blood, and adipose tissue (WHO, 2005). 
GESAMP-BWWG 5/9 

ANNEX 8 

Page 41 

I:\MEPC\57\2-10.doc 

4.7 Interactive effects 

No information has been found on interactive effects. 

Physical and chemical properties for the Actives Substances and preparations and treated ballast 

water (G9: 4.2.1.4). 

____________