* This document was prepared by the OECD Secretariat based on a paper discussed at the 18th Joint Meeting of the Chemicals Group and Management Committee in November 1992. It has been revised to reflect agreements reached in the context of the Existing Chemicals Programme from then and up to April 1996. EXCH\ MANUAL\ 96 5. DOC/ May 1996 2 ( a) an indication of what data need to be collected, generated and/ or analysed; ( b) the rationale behind this requirement; ( c) the relative priority for this work as compared with that on other post SIDS chemicals; ( d) the Member country( ies) to monitor progress and oversee developments in this work; ( e) a suggestion for a provisional time schedule for completion of this work.

The Steering Group will review at the first occasion the conclusions reached at the SIAM, together with proposals on how to follow up on the recommendations of SIAM.

7. The overall responsibility for undertaking any work as outlined in paragraph 5. will rest with industry. Industry has the most knowledge about their chemicals and is in the best position to negotiate ways and means of sharing the burden of the administrative and operational costs involved.

8. The Member country( ies) overseeing the work and monitoring progress is encouraged, in collaboration with the chemical industry, BIAC and other international chemical industry associations such as ICCA, to:

( a) promote the formation of consortia by ( inter) national producer and user industries to undertake the work and share the burden of the inherent costs; ( b) discuss plans and progress with the responsible industry/ association/ institute, etc. identified to conduct the work; ( c) ensure that any necessary testing under 5( b) is conducted according to OECD GLP Principles and, where possible, using the appropriate OECD Test Guideline; ( d) monitor progress in meeting the time schedule suggested under 6( e); ( e) investigate the possibilities of participation, on a case by case basis, of interested non industry parties; and ( f) circulate the final report of the work to the OECD Secretariat and Member countries.

9. The OECD Secretariat will liaise with Member countries to avoid duplication of testing and assessments of chemicals in which they have a mutual interest.

10. As in many SIDS chemicals may be produced or used in non Member countries, they will be encouraged to participate in the programme and share the burden.

11. When all the additional post SIDS information has been gathered, generated and collated, the chemical will be discussed at a post SIDS Assessment Meeting, which will have a similar format and participation to that of a SIDS Initial Assessment Meeting: i. e. SIDS Contact Points, experts from non Member countries, BIAC, IPCS and IRPTC, as well as companies which have participated in the post SIDS work. EXCH\ MANUAL\ 96 5. DOC/ May 1996 3 12. As in SIDS work, relevant reports arising from post SIDS work would be made publicly available through IRPTC and published as a contribution to IOMC.

13. Although chemicals for which the recommendations are similar to that described in paragraph 2( d) are not candidates for post SIDS work, their potential risk and any further activities recommended for follow up in OECD should be carefully identified. The Joint Meeting will confirm the recommendations and discuss the modalities of further action on these chemicals, such as responsible care activities by the chemical industry or any risk reduction activities. Such activities will, in the first instance, be the responsibility of industry, which would report to the Joint Meeting, through BIAC, on progress made. EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 ANNEX 1 OECD Decision Recommendation of the Council on the Co operative Investigation and Risk Reduction of Existing Chemicals [ C( 90) 163/ FINAL] EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 ORGANISATION FOR ECONOMIC GENERAL DISTRIBUTION CO OPERATION AND DEVELOPMENT Paris, drafted: 31 JAN 1991 OLIS: 31 JAN 1991 dist.: 01 FEB 1991 C( 90) 163/ FINAL COUNCIL DECISION RECOMMENDATION OF THE COUNCIL on the Co operative Investigation and Risk Reduction of Existing Chemicals ( adopted by the Council at its 750th Session on 31st January 1991)

32132 C( 90) 163/ FINAL EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 2 THE COUNCIL,

Having regard to Articles 5 a) and 5 b) of the Convention on the Organisation for Economic Co operation and Development of 14th December 1960;

Having regard to the conclusions concerning the control of existing chemicals reached at the First, Second and Third High Level Meetings of the Chemicals Group of 12th May 1980, 15th November 1982 and 17th March 1987, respectively;

Having regard to the conclusion of the Second High Level Meeting of the Chemicals Group concerning the importance of animal welfare with respect to the testing of chemicals;

Having regard to the Resolution of the Council concerning a Procedure for Notification and Consultation on Measures for Control of Substances Affecting Man and the Environment [( C( 71) 73( Final)];

Having regard to the Recommendation of the Council of 31st January 1991 on Integrated Pollution Prevention and Control [ C( 90) 164/ FINAL] and, in particular, the Recommendation that Member countries practice integrated pollution prevention and control, taking into account the effect of activities and substances on the environment as a whole and the whole commercial and environmental life cycles of substances when assessing the risks they pose and when developing and implementing controls to limit their release;

Having regard to the Decision Recommendation of the Council of 26th June 1987 on the Systematic Investigation of Existing Chemicals [ C( 87) 90( Final)];

Having regard to the Recommendation of the Council of 14th November 1974 on the Assessment of the Potential Environmental Effects of Chemicals [ C( 74) 215];

Having regard to point 6 of the Declaration on " Environment: Resource for the Future", of 20th June 1985, adopted by the governments of OECD Member countries and of Yugoslavia which states that more effective control of both new and existing chemicals from their manufacture to ultimate disposal will be achieved through shared and co ordinated efforts;

Having regard to the Recommendations of the World Commission on Environment and Development of 1987 that major chemical producing countries should reinforce on going efforts to obtain international agreement on the selection of existing chemicals for priority testing, on criteria and procedures for their assessment, and on a system for international sharing of the tasks and the resources required;

Having regard to the Bergen Ministerial Declaration on Sustainable Development in the ECE Region of 16th May 1990, in particular to point IV, 15c and point V, 16c;

Considering the experience gained to date by Member countries in the co operative investigation of existing chemicals which has led to the initiating of concerted data collection, testing and evaluation of the first group of priority existing chemicals;

Considering that concerted identification, assessment and management of existing chemicals can produce more efficient utilisation of national and international resources towards reduction of any risks to the environment and/ or to the health of the general public or workers uncovered in all phases of the life cycle of the chemicals; C( 90) 163/ FINAL EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 3 Considering that assessments of the effects on health and the environment for the purpose of reducing risks should include evaluation of the risks and benefits of using the substance and its substitutes and the economic effects of any control action;

Considering that co operative international efforts constitute an efficient and innovative way to apply economic and regulatory approaches for the systematic investigation and reduction of the risks of hazardous existing chemicals;

Considering that strengthened national and co operative international efforts to investigate systematically and reduce the risks of hazardous existing chemicals will substantially alleviate threats of serious or irreversible damage to the environment and/ or the health of the general public or workers;

Considering that the co operative work underway on selected chemicals of concern to Member countries to assess, to develop risk reduction strategies and, where appropriate, to take actions to reduce their risks will be of value for further efforts in this regard;

On the proposal of the 15th Joint Meeting of the Management Committee of the Special Programme on the Control of Chemicals and the Chemicals Group of the Environment Committee, as approved by the 4th Meeting of the Environment Committee at Ministerial Level:

I. Co operative Investigation and Risk Reduction of Existing Chemicals A. Co operative Investigation 1. DECIDES that Member countries shall co operatively investigate high production volume ( HPV) chemicals* in order to identify those which are potentially hazardous to the environment and/ or to the health of the general public or workers.

2. DECIDES that Member countries, in undertaking the task set out in paragraph I. A. 1 shall:

i) co operatively select the HPV chemicals for investigation;

ii) acquire an agreed upon basic data set needed to make an informed judgement concerning the potential hazards of each chemical through collection of available data or by ensuring that testing is undertaken; and iii) co operatively make an initial assessment of the potential hazards of each chemical based on the basic data set.

3. RECOMMENDS that Member countries undertake additional co operative activities including the generation of further data and the completion of more in depth, systematic assessments of the hazards and risks posed by those HPV chemicals found in the initial assessment to be potentially hazardous.

4. RECOMMENDS that Member countries also co operate in undertaking work on the investigation of those non HPV existing chemicals for which they share a concern.

* For purposes of this Decision Recommendation HPV chemicals are those chemicals included in the OECD Representative List of High Production Volume ( HPV) Chemicals, as established and updated regularly. C( 90) 163/ FINAL EXCH\ MANUAL\ 96 AN1. DOC/ May 1996 4 5. DECIDES that Member countries shall make information obtained from the co operative investigation of existing chemicals publicly available via the United Nations Environment Programme's  International Register of Potentially Toxic Chemicals ( UNEP/ IRPTC), respecting legitimate claims for protection of confidential data.

6 INVITES the International Programme on Chemical Safety ( IPCS) to use the results of the investigations of existing chemicals by OECD Member countries in preparing its assessments of the health and environmental impacts of existing chemicals.

B. Risk Reduction 1. DECIDES that Member countries shall establish or strengthen national programmes aimed at the reduction of risks from existing chemicals to the environmental and/ or the health of the general public or workers.

2. RECOMMENDS that Member countries collaborate to develop common criteria to determine which chemicals, among those which are included in the co operative investigations referred to in Section I. A and/ or the procedures foreseen in paragraph II. 1. ii, are suitable candidates for concerted risk reduction activities.

3. RECOMMENDS that, where appropriate, Member countries undertake concerted activities to reduce the risks of selected chemicals taking into account the entire life cycle of the chemicals. These activities could encompass both regulatory and non regulatory measures including: the promotion of the use of cleaner products and technologies; emission inventories; product labelling; use limitations; economic incentives; and the phase out or banning of chemicals.

II. Implementation 1. INSTRUCTS the Management Committee of the Special Programme on the Control of Chemicals, having regard to the work of other international organisations:

i) to pursue a programme of work designed to facilitate the practical implementation of this Decision Recommendation; and ii) to establish procedures for the notification of, and exchange of information on activities in Member countries, to reduce the risks of existing chemicals;

iii) to the extent that Member countries undertake concerted risk reduction activities pursuant to paragraph I. B. 3, to propose, where appropriate, agreements on reducing the risk of specific chemicals or groups of chemicals.

2. INVITES the Secretary General to take the necessary steps to ensure that this work is carried out in cooperation with other international organisations and, in particular, in collaboration with the UNEP/ IRPTC and the IPCS.

3. INSTRUCTS the Management Committee of the Special Programme on the Control of Chemicals to review, by the end of 1994, the actions taken by Member countries in pursuance of the Decision Recommendation. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 ANNEX 2 Model SIDS Dossier This Model SIDS Dossier is intended to show how the data will be described in the SIDS Dossier in an appropriate fashion. Good examples of data description are presented in general but in some cases data which is considered to be inappropriate are included for the purpose of comparison.

The format of the Model Dossier is following the Revised HPV Form 1, which is virtually identical with the HEDSET. It should be noted that the data used are not real ones although most of them have been taken from Dossiers of Phase 1 and 2 chemicals originally. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 i MODEL SIDS DOSSIER ON THE HPV PHASE ...... CHEMICAL ....................

CAS No. xxxx xx x Sponsor Country: OECD DATE: July 1994 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 ii CONTENTS Page SIDS PROFILE....................................................................................................................................................... 1 SIDS SUMMARY.................................................................................................................................................. 2 1. GENERAL INFORMATION................................................................................................................................. 3 1.01 SUBSTANCE INFORMATION........................................................................................................................ 3 * A. CAS NUMBER.................................................................................................................................... 3 B. NAME ( IUPAC NAME)...................................................................................................................... 3 * C. NAME ( OECD NAME)....................................................................................................................... 3 * D. CAS DESCRIPTOR............................................................................................................................. 3 E. EINECS NUMBER.............................................................................................................................. 3 F. MOLECULAR FORMULA................................................................................................................. 3 * G. STRUCTURAL FORMULA................................................................................................................ 3 H. SUBSTANCE GROUP......................................................................................................................... 3 I. SUBSTANCE REMARK..................................................................................................................... 3 J. MOLECULAR WEIGHT..................................................................................................................... 3 1.02 OECD INFORMATION.................................................................................................................................... 3 A. SPONSOR COUNTRY ....................................................................................................................... 3 B. LEAD ORGANISATION..................................................................................................................... 3 C. NAME OF RESPONDER ( COMPANY)............................................................................................. 4 1.1 GENERAL SUBSTANCE INFORMATION.................................................................................................... 5 A. TYPE OF SUBSTANCE...................................................................................................................... 5 B. PHYSICAL STATE.............................................................................................................................. 5 C. PURITY................................................................................................................................................ 5 1.2 SYNONYMS.......................................................................................................................... 5 1.3 IMPURITIES.......................................................................................................................... 5 1.4 ADDITIVES........................................................................................................................... 5 1.5 * QUANTITY....................................................................................................................................................... 5 1.6 LABELLING AND CLASSIFICATION ( USE AND/ OR TRANSPORTATION) .......................................... 6 1.7 * USE PATTERN.................................................................................................................................................. 6 A. GENERAL USE PATTERN................................................................................................................. 6 B. USES IN CONSUMER PRODUCTS.................................................................................................. 7 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE ............................................................................................ 7 1.9 * SOURCES OF EXPOSURE ............................................................................................................................. 7 1.10 ADDITIONAL REMARKS............................................................................................................................... 8 A. OPTIONS OF DISPOSAL.................................................................................................................... 8 B. OTHER REMARKS............................................................................................................................. 8 2. PHYSICAL CHEMICAL DATA........................................................................................................................... 9 2.1 * MELTING POINT.............................................................................................................................................. 9 2.2 * BOILING POINT............................................................................................................................................... 9 2.3 * DENSITY ( RELATIVE DENSITY).................................................................................................................. 10 2.4 * VAPOUR PRESSURE....................................................................................................................................... 10 2.5 * PARTITION COEFFICIENT n OCTANOL/ WATER...................................................................................... 10 2.6 * WATER SOLUBILITY...................................................................................................................................... 10 A. SOLUBILITY ...................................................................................................................................... 10 B. pH VALUE, pKa VALUE.................................................................................................................... 11 2.7 FLASH POINT ( LIQUIDS)............................................................................................................................... 11 2.8 AUTO FLAMMABILITY ( SOLID/ GASES)..................................................................................................... 12 2.9 FLAMMABILITY ............................................................................................................................................. 12 2.10 EXPLOSIVE PROPERTIES .................................................................................................. 12 2.11 OXIDIZING PROPERTIES............................................................................................................................... 12 2.12 * OXIDATION: REDUCTION POTENTIAL....................................................................................................... 13 2.13 ADDITIONAL REMARKS............................................................................................................................... 13 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 iii A. PARTITION CO EFFICIENT BETWEEN SOIL/ SEDIMENT AND WATER ( Kd).......................... 13 B. OTHER REMARKS............................................................................................................................. 13 3. ENVIRONMENTAL FATE AND PATHWAYS................................................................................................... 14 3.1 STABILITY ....................................................................................................................................................... 14 3.1.1 * PHOTODEGRADATION.................................................................................................................................. 14 3.1.2 * STABILITY IN WATER................................................................................................................................... 15 3.1.3 STABILITY IN SOIL......................................................................................................................................... 15 3.2 * MONITORING DATA ( ENVIRONMENT)..................................................................................................... 16 3.3 * TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS................ 17 3.3.1 TRANSPORT..................................................................................................................................................... 17 3.3.2 THEORETICAL DISTRIBUTION ( FUGACIT CALCULATION).................................................................. 17 3.4 MODE OF DEGRADATION IN ACTUAL USE............................................................................................. 18 3.5 * BIODEGRADATION........................................................................................................................................ 18 3.6 BOD 5, COD OR RATIO BOD 5/ COD............................................................................................................ 18 3.7 BIOACCUMULATION .................................................................................................................................... 19 3.8 ADDITIONAL REMARKS .............................................................................................................................. 20 A. SEWAGE TREATMENT..................................................................................................................... 20 B. OTHER................................................................................................................................................. 20 4. ECOTOXICITY................................................................................................................................................. 21 4.1 * ACUTE/ PROLONGED TOXICITY TO FISH........................................................................ 21 4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES................................................................................. 21 * A. DAPHNIA............................................................................................................................................. 21 B. OTHER AQUATIC ORGANISMS...................................................................................................... 22 4.3 * TOXICITY TO AQUATIC PLANTS e. g., ALGAE.......................................................................................... 22 4.4 TOXICITY TO BACTERIA.............................................................................................................................. 23 4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS..................................................................................... 23 4.5.1 CHRONIC TOXICITY TO FISH...................................................................................................................... 23 4.5.2 (*) CHRONIC TOXICITY TO AQUATIC INVERTEBRATES3 ( e. g., DAPHNIA REPRODUCTION)................................................................................................................. 24 4.6 TOXICITY TO TERRESTRIAL ORGANISMS............................................................................................... 24 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS .......................................................................................... 24 4.6.2 TOXICITY TO TERRESTRIAL PLANTS........................................................................................................ 25 4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES ( INCLUDING BIRDS)...................................................................................................................................... 26 4.7 BIOLOGICAL EFFECTS MONITORING ( INCLUDING BIOMAGNIFICATION)...................................... 27 4.8 BIOTRANSFORMATION AND KINETICS.................................................................................................... 27 4.9 ADDITIONAL REMARKS............................................................................................................................... 27 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 iv 5. TOXICITY.............................................................................................................................................................. 28 5.1 * ACUTE TOXICITY........................................................................................................................................... 28 5.1.1 ACUTE ORAL TOXICITY............................................................................................................................... 28 5.1.2 ACUTE INHALATION TOXICITY................................................................................................................. 28 5.1.3 ACUTE DERMAL TOXICITY......................................................................................................................... 29 5.1.4 ACUTE TOXICITY BY OTHER ROUTES OF ADMINISTRATION............................................................ 30 5.2 CORROSIVENESS/ IRRITATION.................................................................................................................... 30 5.2.1 SKIN IRRITATION/ CORROSION .................................................................................................................. 30 5.2.2 EYE IRRITATION/ CORROSION.................................................................................................................... 31 5.3 SKIN SENSITISATION.................................................................................................................................... 33 5.4 * REPEATED DOSE TOXICITY......................................................................................................................... 32 5.5 * GENETIC TOXICITY IN VITRO..................................................................................................................... 36 A. BACTERIAL TEST.............................................................................................................................. 36 B. NON BACTERIAL IN VITRO TEST.................................................................................................. 37 5.6 * GENETIC TOXICITY IN VIVO....................................................................................................................... 37 5.7 CARCINOGENICITY....................................................................................................................................... 38 5.8 * TOXICITY TO REPRODUCTION................................................................................................................... 38 5.9 * DEVELOPMENTAL TOXICITY / TERATOGENICITY................................................................................. 40 5.10 OTHER RELEVANT INFORMATION............................................................................................................ 40 A. SPECIFIC TOXICITIES ( NEUROTOXICITY, IMMUNOTOXICITY etc.)....................................... 40 B. TOXICODYNAMICS, TOXICOKINETICS....................................................................................... 40 5.11 * EXPERIENCE WITH HUMAN EXPOSURE................................................................................................... 41 6. REFERENCES........................................................................................................................................................ 42 Note: *; Data elements in the SIDS *; Data elements specially required for inorganic chemicals EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 1 S I D S P R O F I L E DATE:

1.01 A. CAS No. xxxx xx x 1.01 C. CHEMICAL NAME ( OECD Name) Phosphonic acid, ( nitrilo tris( methylene)) tris 1.01 D. CAS DESCRIPTOR Not applicable in this case 1.01 G. STRUCTURAL FORMULA N( CH2PO3H2) 3 OTHER CHEMICAL IDENTITY INFORMATION 1.5 QUANTITY In Country A approx 1,700 tonnes in 1989. Estimated global production was 5,000 tonnes in 1989.

1.7 USE PATTERN ( a) Non dispersive use in chemical industry as an intermediate in synthesis ( 85 % was used in a factory in Town B in 1989)

( b) Wide dispersive use in personal and domestic use as cosmetics ( 10 % was used as an ingredients of a nail lacquer in Country A in 1988.)

( c) Gloss agent, approx. 3% as paste 1.9 SOURCES AND LEVELS OF EXPOSURE 1. Amount released from production site to water is < 0.5 kg/ year in Country A. All leaks and spills are contained and cleaned up in an appropriate manner, i. e., water treatment or incineration.

2. Amount released to air from production site is negligible in Country A.

3. Information on consumer exposure is not available.

ISSUES FOR DISCUSSION ( IDENTIFY, IF ANY) SIDS testing required: NONE EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 2 S I D S S U M M A R Y DATE:

CAS NO: ..................

STUDY Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N PHYSICAL CHEMICAL DATA 2.1 2.2 2.3 2.4 2.5 2.6 2.12 Melting Point Boiling Point Density Vapour Pressure Partition Coefficient Water Solubility pH and pKa values Oxidation: Reduction potential OTHER P/ C STUDIES RECEIVED ENVIRONMENTAL FATE and PATHWAY 3.1.1 3.1.2 3.2 3.3 3.5 Photodegradation Stability in water Monitoring data Transport and Distribution Biodegradation OTHER ENV FATE STUDIES RECEIVED ECOTOXICITY 4.1 4.2 4.3 4.5.2 4.6.1 4.6.2 4.6.3 Acute toxicity to Fish Acute toxicity to Daphnia Toxicity to Algae Chronic toxicity to Daphnia Toxicity to Soil dwelling organisms Toxicity to Terrestrial plants Toxicity to Birds OTHER ECOTOXICITY STUDIES RECEIVED TOXICITY 5.1.1 5.1.2 5.1.3 5.4 5.5 5.6 5.8 5.9 5.11 Acute Oral Acute Inhalation Acute Dermal Repeated Dose Genetic Toxicity in vitro . Gene mutation . Chromosomal aberration Genetic Toxicity in vivo Reproduction Toxicity Development / Teratogenicity Human experience OTHER TOXICITY STUDIES RECEIVED EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 3 1. GENERAL INFORMATION 1.01 SUBSTANCE INFORMATION * A. CAS Number xxxx xx x B. Name ( IUPAC name) Phosphonic acid, ( nitrilo tris( methylene)) tris * C. Name ( OECD name) Phosphonic acid, ( nitrilo tris( methylene)) tris * D. CAS Descriptor ( where applicable for complex chemicals) Not applicable in this case E. EINECS Number xxx xxx x F. Molecular Formula C3 H12 N O9 P3 * G. Structural Formula ( indicate the structural formula in smiles code, if available) N ( CH2 PO3H2) 3 H. Substance Group ( if possible, only for petroleum products, see HEDSET Explanatory note) Not applicable I. Substance Remark ( indicate the substance remark as prescribed in the EINECS Inventory, if possible)

.......................................................................................................................................

J. Molecular Weight 299 1.02 OECD INFORMATION A. Sponsor Country: OECD B. Lead Organisation: Name of Lead Organisation: Environment Directorate Contact person: Ms A. N. OTHER Address: 2, rue André Pascal 75775 Paris Cedex 16 France Tel: 33 1 <IP_ADDRESS> Fax: 33 1 <IP_ADDRESS> EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 4 C. Name of responder ( Information on a responder should be provided when companies respond to Lead Organisation or SIDS Contact Points)

Name: I. M. Nobody Address: XYZ Company 15 Boulevard de L'Amiral Bruix 75116 Paris France Tel: ............................................................................................................................... Fax: .............................................................................................................................. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 5 1.1 GENERAL SUBSTANCE INFORMATION A. Type of Substance element [ ]; inorganic [ ]; natural substance [ ]; organic [ X ]; organometallic [ ]; petroleum product [ ]

B. Physical State ( at 20 ° C and 1.013 hPa) gaseous [ ]; liquid [ ]; solid [ X ]

C. Purity ( indicate the percentage by weight/ weight) 82% weight/ weight Products are supplied as aqueous solutions containing approx 50% of the substance.

1.2 SYNONYMS Amino tris ( methylene phosphonic acid) ATMP Dequest 2000 TM Briquest 301 500 TM 1.3 IMPURITIES ( indicate CAS No., chemical name ( IUPAC name is preferable) , percentage, if possible EINECS number)

CAS No: 123 45 7 EINECS No: ....................................................................................................................................... Name: Amino bis ( methylene phosphonic acid); Value: ca. 10% Remarks: .......................................................................................................................................

1.4 ADDITIVES ( e. g. stabilizing agents, inhibitors etc. Indicate CAS No., chemical name ( IUPAC name is preferable) , percentage, if possible EINECS number), the component of the UVCB ( Substance with no defined composition) should be indicated here)

CAS No: ....................................................................................................................................... EINECS No: ....................................................................................................................................... Name: ....................................................................................................................................... Value: None Remarks: .......................................................................................................................................

* 1.5 QUANTITY ( Information on production or import levels should be provided in figures or ranges ( e. g., 1,000  5,000, 5,000 10,000 tonnes, etc.) per responder or country and the date for which those ranges apply should be given. For EEC Member states only indicate the Community import figure. Give an estimation of the global production quantity in the remarks field. Information on the number of producers in the country and the source of information should also be described in the remarks field)

Remarks: ( If possible, indicate if the substance has been produced and/ or imported during the 12 month after adoption of the EEC regulation on existing chemicals) There is only one manufacturing site in Country A. Estimated global production was 5,000 tonnes in 1989. Reference: Chemical News, 1990 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 6 1.6 LABELLING AND CLASSIFICATION ( If possible, enter information on labelling and classification such as labelling and classification system, existence of specific limit, symbols, nota, R Phrases and S Phrases of EC Directive 67/ 548/ EEC, See HEDSET Explanatory note.)

Labelling Type: Directive 67/ 548// EEC Specific limits: no data Symbols: Xi Nota: ....................................................................................................................................... R phrases: 36/ 37/ 38 43 S phrases: 24 26 37 Text of S phrases: Avoid contact with skin, In case of contact with eyes, rinse immediately with plenty of water and seek medical advice, Wear suitable gloves Remarks: .......................................................................................................................................

Classification Type: Directive 67/ 548/ EEC Category of danger: irritant R phrases: 36/ 37/ 38/ 43 Remaks: Text of R phrases, irritating to eyes, irritating to respiratory system, irritating to skin, may cause sensitization by skin contact * 1.7 USE PATTERN A. General ( Data on use pattern have to be given by assigning main types according to their exposure relevance ( i. e. Non dispersive use, Use in closed systems, Use resulting in inclusion into or onto matrix and Wide dispersive use), industrial categories ( e. g. Basic chemical industry, Chemical industry, Agricultural industry, Personal and domestic use) and use categories such as Colouring agents, Intermediates, Solvents, Adhesives, Cleaning/ washing agents, Fertilizers, Impregnation agents, Surface active, etc. If available, give an estimation of different uses in percentage terms.)

Type of Use: Category:

( a) main Non dispersive use industrial Chemical Industry: used in synthesis use Intermediate ( b) main Wide dispersive use industrial Personal and domestic use use Cosmetics ( Nail lacquer)

Remarks: ( a) 85 % was used in a factory in Town B in 1989 ( b) 10 % was used as an ingredients of a nail lacquer in the Country C in 1988  Information on use in other countries is not available.

Reference: Kirk Othmer, 1991 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 7 B. Uses in Consumer Products ( If the chemical is present in consumer products as marketed give details of form of products function ( e. g. detergent etc.), and percent in product and physical state of product as marketed ( e. g. aerosol, powder or liquid))

Function Amount present Physical state Gloss agent approx 3% Paste Remarks: Information on use in other countries is not available. Reference: Danish Product Register, 1988 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE ( Indicate the type of the occupational exposure limit value including Short term exposure limit value. If a value does not exist, give the hygiene standard of the producer company if available. See also 5.11)

Exposure limit value Type: LV, MAK( DE), MSC( NL), MEL( UK) Value: mg/ m3 ( approx. 135 ppm)

Short term exposure limit value Value: ....................................................................................................................................... Length of exposure period: ........................................................................................................................ Frequency: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: ACGIH, Threshold Limit Value 1987 * 1.9 SOURCES OF EXPOSURE Describe sources of potential human, ( other than concentration of chemicals in the workplace and indoor environment ( see 5.11)), or environmental exposure including emission data ( e. g. quantities per media with information such as time dimensions of release, indication of type of release ( e. g. point source or diffuse), type of estimating ( e. g. average or worst case) uncertainties in estimation), if available for all phases of the life cycle of the chemical including manufacturing and user areas.

For environmental exposure, indicate the production process briefly, number of sites of manufacture and the basis for concluding that the process is " closed" if applicable.

Also an indication of measured exposure levels ( expressed in and appropriate form e. g., geometric mean and standard deviation) can be mentioned here. Any information that will help to focus the assessment of exposure ( either quantitative or quantitative in nature can be mentioned, if available)

( a) Source: Media of release: Water from a production site Quantities per media: < 0.5 kg/ year at the production site in Country A.

Remarks: ABCDE is produced in batches of 12 tonnes in only one factory in the country A. From each batch 740 litres of filter washing water saturated with ABCDE (< 0.5 mg/ l) is released into a effluent treatment plant and subsequently released into a river B ( average flow is 500 m 3/ sec). Assuming a production of 1000 batches per annum, less than 0.5 kg per annum eventually reach the river B, even removal by the treatment plant is not taken into account. All leaks and spills are contained and cleaned up in an appropriate manner ( water treatment or incineration). Reference: Unpublished report of XYZ corporation, 1989 ( b) Source: Media of release: Air from a production site Quantities per media: Negligible at the production site in Country A. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 8 Remarks: All process ventilation are treated by incineration. Then they will pass a gas scrubber before release to the air. Also incinerator used for disposal of production waste is equipped with a scrubber. References: Unpublished report of XYZ corporation.

( c) Remarks: Exposure information in other countries is not available.

1.10 ADDITIONAL REMARKS A. Options for disposal ( Mode of disposal ( e. g., incineration, release to sewage system, etc.) for each category and type of use, if appropriate; recycling possibility)

Remarks: The substance can be incinerated at quite low temperatures ( 300 ° C), but is photooxidised to phosphoric acid and methyl amine in sunlight. Reference:

B. Other remarks Remarks: No studies located Reference: EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 9 2. PHYSICAL CHEMICAL DATA * 2.1 MELTING POINT ( if more than one, identify the recommended value)

( a) Preferred result Value: = 139 ° C Decomposition: Yes [ ] No [ X] Ambiguous [ ] Sublimation: Yes [ ] No [ X] Ambiguous [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method usd)) Other GLP: Yes [ ] No [ ] ? [ X] Remarks: Substance used for the measurement is described in 1.1 C., purity 82%. Result is the mean of 12 determinations by differing methods Reference: University of Michigan, 1982 ( b) Value: = 137.5 ° C Decomposition: Yes [ ] No [ X] Ambiguous [ ] Sublimation: Yes [ ] No [ X] Ambiguous [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used) OECD TG 102 ( 1981) GLP: Yes [ ] No [ ] ? [ X] Remarks: Substance used for the measurement is described in 1.1 C., purity 82%. Reference: Monsanto, 1987 * 2.2 BOILING POINT ( if more than one, identify the recommended value)

( a) Preferred result Value: = 198 ° C Pressure: at 30.6 hPa Decomposition: Yes [ ] No [ X] Ambiguous [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used) ) Other GLP: Yes [ ] No [ ] ? [ X] Remarks: Substance used for the measurement is described in 1.1 C., purity 82% Reference: Monsanto, 1987 ( b) Value: = 296 ° C Pressure: at . . . . . . . hPa ( approx atmospheric) Decomposition: Yes [ ] No [ X] Ambiguous [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 103 ( modified) ( 1981) GLP: Yes [ ] No [ ] ? [ X] Remarks: Substance used for the measurement was " ABCDE", purity was not stated, but believed to be 82% Extrapolation from higher pressures Reference: University of Michigan, 1982 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 10 * 2.3 DENSITY ( Relative density) ( Where applicable, indicate the relative density of the substance)

Type: Bulk density [ ]; Density [ ]; Relative Density [ X] Value: 1.02 kg/ m3 Temperature: 20 ° C Method: ( e. g. OECD, other ( with the year of publication or updated of the method used) OECD TG 109 ( 1981) GLP: Yes [ X] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: Monsanto, 1992 * 2.4 VAPOUR PRESSURE ( if more than one, identify the recommended value)

Value: = 0.004 hPa Temperature: 60 ° C Method: calculated [ ]; measured [ X] ( e. g. OECD, other ( with the year of publication or updated of the method used) OECD TG 104 ( 1981) GLP: Yes [ ] No [ ] ? [ X] Remarks: Purified substance ( 98%) used Reference: Albright & Wilson, 1986 * 2.5 PARTITION COEFFICIENT log10Pow ( if more than one, identify the recommended value)

Log Pow: = 2.49 Temperature: 20 ° C Method: calculated [ X]; measured [ ] ( e. g. OECD, other ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: Based on calculations in MedChem database, USA Reference: .......................................................................................................................................

* 2.6 WATER SOLUBILITY ( if more than one, identify the recommended value)

A. Solubility ( a) Preferred result Value: 234  240 mg/ l Temperature: 25 ° C Description: Miscible[ ]; Of very high solubility [ ]; Of high solubility [ ]; Soluble [ ]; Slightly soluble [ ]; Of low solubility [ X]; Of very low solubility [ ]; Not soluble [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used): OECD TG 105 ( 1981) GLP: Yes [ ] No [ ] ? [ X] Remarks: Solvent extraction. Range of 5 tests Reference: Jones, A. Z and Roberts, P. Q, 1991 ( b) Value: 456.9 mg/ l Temperature: 50 ° C Method: ( e. g. OECD, other ( with the year of publication or updated of the method used) Other GLP: Yes [ ] No [ X] ? [ ] Remarks: HPLC method Reference: DoE laboratory report, 1989 B. pH Value, pKa Value EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 11 ( a) Preferred result pH Value: = 5.6, measured Concentration: 200 mg/ l Temperature: Not stated Method: ( e. g. OECD, other ( with the year of publication or updated of the method used) Other GLP: Yes [ ] No [ ] ? [ X] ( Where applicable, enter values for the dissociation constant( s) and the conditions under which they were measured.) pKa value = 3.9 calculated at 25 ° C Remarks: Measurement method of pH is not stated, but assumed to be hydrogen electrode. pKa calculated from Henderson equation; temp. = 20 ° C Reference: Jones, A. Z and Roberts P. Q, 1991 ( b) pH Value: = 6, measured Concentration: " saturated" aqueous solution Temperature: 25 ° C Method: ( e. g. OECD, other ( with the year of publication or updated of the method used): Other GLP: Yes [ ] No [ ] ? [ X] ( Where applicable, enter values for the dissociation constant( s) and the conditions under which they were measured.) pKa value Not given Remarks: Measurement method is not stated, but assumed to be pH papers " saturated" assumed to be approx. 250 mg/ l Reference: Bozetto, 1981 2.7 FLASH POINT ( liquids)

Value: . . . . . . . . . ° C Type of test: Closed cup [ ]; Open cup [ ]; Other [ ] Method: ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: Not tested. Substance is a solid Reference: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 12 2.8 AUTO FLAMMABILITY ( solid/ gases)

Value: . . . . . . . . . ° C Pressure: . . . . . . . . . hPa Method: ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: No studies located Reference: .......................................................................................................................................

2.9 FLAMMABILITY Results: Extremely flammable [ ]; Extremely flammable  liquified gas [ ]; Highly Flammable [ ]; Flammable [ ]; Non flammable [ ]; Spontaneously flammable in air [ ]; Contact with water liberates highly flammable gases [ ]; Other [ ] Method: ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: No studies located, but not expected from the structure to be flammable Reference: .......................................................................................................................................

2.10 EXPLOSIVE PROPERTIES Results: Explosive under influence of a flame[ ]; More sensitive to friction than m dinitrobenzene [ ]; More sensitive to shock than m dinitrobenzene [ ]; Not explosive [ ]; Other [ ] Method: ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: No studies located, but not expected from structure to be explosive Reference: .......................................................................................................................................

2.11 OXIDIZING PROPERTIES Results: Maximum burning rate equal or higher than reference mixture [ ]; Vigorous reaction in preliminary test [ ]; No oxidizing properties [ ]; Other [ ] Method: ( with the year of publication or updated of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: No studies located, but not expected from structure to have oxidizing properties Reference: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 13 * 2.12 OXIDATION: REDUCTION POTENTIAL ( Where applicable, indicate the redox potential and the conditions under which it was measured.)

Value: 12.75 ± 0.04 mV Method: ( with the year of publication or updated of the method used) Electroanalytical GLP: Yes [ ] No [ ] ? [ X] Remarks: Result taken from international reference book Reference: Handbook of Chemistry & Physics, 1985 2.13 ADDITIONAL DATA A. Partition co efficient between soil/ sediment and water ( Kd)

Value: ....................................................................................................................................... Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: No studies located Reference: .......................................................................................................................................

B. Other data ( e. g., Henry's law constant, fat solubility, surface tension ( of aqueous solution), adsorption/ desorption on soil, particle size distribution etc.)

Results: No studies located Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 14 3. ENVIRONMENTAL FATE AND PATHWAYS ( Reporting of studies should give the test method, test conditions ( laboratory versus field studies), test results ( e. g., % degradation in specified time period) and reference. Information on breakdown products ( transient and stable) should be provided when available.)

3.1 STABILITY * 3.1.1 PHOTODEGRADATION ( a) Type: Air [ X ]; Water [ ]; Soil [ ]; Other [ ] Light source: Sun light [ ]; Xenon lamp [ ]; Other [ ] Light spectrum: . . . . . . . . . . nm Relative intensity: . . . . . . . . . . ( based on intensity of sunlight0 Spectrum of substance: ( e. g. lambda ( max.)[> 295nm] and epsilon[ max] or epsilon [ 295nm]) . . . . . . . . . . nm Concentration of Substance: ........................................................................................................................ Temperature: . . . . . . . . . . ° C Direct photolysis: Half life: . . . . . . . . . . Degradation: . . . . . . . . .% ( weight/ weight) after . . . . . . . . . . ( exposure time) Quantum yield: . . . . . . . . . . Indirect Photolysis: Type of sensitizer: OH Concentration of sensitizer: . . . . . . . . . . Rate constant ( radical): . . . . . . . . . . cm3/ molecule* sec Degradation: 50% after 7  8.8 hour Method: calculated [ X ]; measured [ ] ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other ( calculated, according to Atkinson 1986) GLP: Yes [ ] No [ ] ? [ ] Test substance: Substance grade, purity: not specified. Remarks: Half life ( 7  8.8 hour) is calculated based on measured values of reaction rate constants with OH radicals, ( 55* 10 12) molecules 1 s 1 ( 1), 43.7* 10 12 molecules 1 s 1 ( 2).

Reference: ( 1) Atkinson, R., 1986. ( 2) Witte, F. and Zetsch, C., 1988 ( b) Type: Air [ ]; Water [ X ]; Soil [ ]; Other [ ] Light source: Sun light [ ]; Xenon lamp [ ]; Other [ ] Light spectrum: ....................................................................................................................................... Relative intensity: ....................................................................................................................................... Spectrum of substance; ( e. g. lambda ( max.)[> 295nm] and epsilon[ max] or epsilon [ 295nm]) ....................................................................................................................................... Concentration of Substance: .................................................................................................................................... Temperature: . . . . . . . . . . ° C Direct photolysis: Half life: ....................................................................................................................................... Degradation: . . . . . . . . . . % ( weight/ weight) after . . . . . . . . . .( exposure time) Quantum yield: ....................................................................................................................................... Indirect Photolysis: Type of sensitizer: ............................................................................................................................... Concentration of sensitizer: ........................................................................................................................ Rate constant ( radical): . . . . . . . . . . . . cm3/ molecule* sec Degradation: . . . . . . . . . . % after . . . . . . . . . . . ( exposure period) Method: calculated [ X ] measured [ ] ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other, Not specified. ( Based on Photolysis in water by using Hg lamp ( 253 nm)) EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 15 GLP: Yes [ ] No [ ] ? [ X ] Test substance: as prescribed by 1.1 1.4, purity: = 82% Remarks: Data on Half life is not available. Formation of Cl, CO2, CO and methylene chloride were observed. pH of the test solution is not specified. Reference: Baxter, J. N. and Johnson, F. J., 1968 * 3.1.2 STABILITY IN WATER Type: Abiotic ( hydrolysis) [ X ]; biotic ( sediment)[ ] Half life: 2.8 min at pH not specified at 40 ° C Degradation: . . . . . . . at pH . . . . . . . at . . . . . . . ° C after . . . . . . ( exposure time) Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other, Not specified GLP: Yes [ ] No [ ] ? [ X ] Test substance: as prescribed by 1.1 1.4, purity: = 82% Remarks: ( e. g. CAS number, name and percentage of degradation products) CH3COOH and CH3OH are formed as a result of hydrolysis. The rate Reference: The Condensed Chemical Dictionary, 1981.

3.1.3 STABILITY IN SOIL Type: Field trial [ ]; Laboratory [ X]; Other [ ] Radiolabel: Yes [ X ] No [ ] ? [ ] Concentration: 0.1 mg/ kg Soil temperature: 25 ° C Soil humidity: 75% of field capacity Soil classification: DIN19863 [ ]; NF X31 107 [ ]; USDA [ ]; Other [ X ] year . . . . . . . . . Content of clay etc.: Clay 30%, Silt 50%, Sand 20% Organic Carbon: 1.0 % Soil pH: 6.9 Cation exchange capacity: 25 m mol/ kg Microbial biomass: ............................................................................................................................... Dissipation time: DT 50: 3 days DT 90: > 50 days Dissipation: 10 % after 1 day, 37% after 2 days, 60% after 4 days Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 304A ( 1981) GLP: Yes [ ] No [ ] ? [ X ] Test substance: as prescribed by 1.1 1.4, purity: = 82% Remarks: ............................................................................................................................... Reference: XYZ Corporation, 1988 * 3.2 MONITORING DATA ( ENVIRONMENT)

Note that Data on Biological Effects Monitoring including Biomagnification, and Biotransformation and Kinetics in Environmental Species is to be reported in section 4.7 and 4.8 respectively. Nonetheless concentration in various biota should be reported here. Data on concentration in the work place or indoor environment should be reported under item 5.11.

( a) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] Media: Air Results: ND ( ND = Not detected, Detection limits: 0.5 mg/ m 3,) in 17 areas in Japan in 1990 Remarks: ....................................................................................................................................... Reference: Environment Agency of Japan, 1977 and 1992 ( b) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 16 Media: Surface water Results: ND  0.028 ( Detection limits: 0.01 0.2 mg/ l) in 23 areas in Japan in 1976, ND  0.058 ( Detection limits: 0.02 mg/ l) in 16 areas in Japan in 1990 Remarks: ....................................................................................................................................... Reference: Environment Agency of Japan, 1977 and 1992 ( c) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] Media: Surface water Results: 0.01  0.05 mg/ l in 5 samples in 1989, see 4.7 Remarks: ....................................................................................................................................... Reference: XYZ Institute, 1991 ( d) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] Media: Soil Results: ND  0.018 ( Detection limits: 0.0002 0.0016 mg/ l) in 23 areas in Japan in 1976 Remarks: ....................................................................................................................................... Reference: Environment Agency of Japan, 1977 and 1992 ( e) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] Media: Sediment Remarks: ND ( Detection limits: 0.02 mg/ g) in 19 areas in Japan in 1990 Reference: Environment Agency of Japan, 1977 and 1992 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 17 ( f) Type of Measurement: Background [ X ]; At contaminated site [ ]; Other [ ] Media: Biota ( specify species) Remarks: ND  0.0046 ( Detection limits: 0.002 mg/ g) in 18 areas in Japan in 1990, mussel and bar were used for the research. Reference: Environment Agency of Japan, 1977 and 1992 ( g) Type of Measurement: Background [ ]; At contaminated site [ ]; Other [ ] Media: Surface water and food Remarks: No data located. Reference: .......................................................................................................................................

3.3 TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS ( e. g. during the chemical life cycle). The information should indicate whether the calculation is on a global basis or is site specific, and whether it is based on laboratory measurements or field observations.)

* 3.3.1 TRANSPORT Type: Adsorption [ X ]: Desorption [ ]; Volatility [ ]: Other [ ] Media: Water Soil Method: OECD TG 106 Results: Adsorption coefficient 19.0 l/ kg Remarks: Compound ABCDE in 10 ml aquaous solytion was suspendid with 2.5 g silt loam ( 1.2 % o. m.; pH 6.7). Suspensions shaken for 24 hr. Adsorption coefficients calcualted using Freundlich equation ( 1/ n: 0.9; Koe: 1580) Reference: XYZ Corporation, 1992.

* 3.3.2 THEORETICAL DISTRIBUTION ( FUGACITY CALCULATION)

Media: Air biota [ ]; Air biota sediment soil water [ X]; Soil biota [ ]; Water air [ ]; Water biota [ ]; Water soil [ ]; Other [ ] Method: Fugacity level I [ X]; Fugacity level II [ ]; Fugacity level III [ ]; Fugacity level IV [ ]; Other ( calculation) [ ]; Other ( measurement)[ ] Generic Model of OECD ( FUGMOD, 1992) Results: 70.7 % to Air 28.8 % to Water 0.11 % to Sediment 0.49 % to Soil 0.000028 % to Biota ( Fish) 0.0037 % to Suspended Solid in Water Remarks: The Global Reference model of OECD Existing Chemicals Programme was used for calculation. Default values for the environmental parameters were not changed. Water solubility 230mg/ l, vapour pressure 0.004 hPa and Pow 2.49 were used for the calculation. Reference: OECD Secretariat, 1992 a EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 18 3.4 IDENTIFICATION OF MAIN MODE OF DEGRADABILITY IN ACTUAL USE Results: No studies located. Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 3.5 BIODEGRADATION Type: aerobic [ X ]; anaerobic [ ] Inoculum: adapted [ ]; non adapted [ X ]; activated sludge, 30 mg/ l as suspended solid Concentration of the chemical: 100 mg/ l related to COD [ ]; DOC [ ]; Test substance [ X ]; Medium: water [ X ]; water sediment [ ]; soil [ ]; sewage treatment [ ] Degradation: ( percentage reduction/ exposure time) 2.5 % after 7 days ( based on BOD) 2.4 % after 14 days ( based on BOD) 4 % after 14 days ( based on DOC) 3 % after 14 days ( based on HPLC analysis) Results: ( see OECD Guidelines) Readily biodeg. [ ]; Inherently biodeg. [ ]; under test condition no biodegradation observed [ X ], Other [ ] Kinetic ( e. g. Zahn Wellens Test) . . . . . . . . . . % in . . . . . . . . . . . ( time) Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 301C ( 1992) GLP: Yes [ X ] No [ ] ? [ ] Test substance: As prescribed by 1.1  1.4, purity: > 99% Remarks: ( In the case of poorly soluble chemicals, treatment given ( nature, concentration, CAS number, name and percentage of degradation products etc.)): The results indicate that the chemical is not readily biodegradable. Concentration of activated sludge and that of the chemical are 30 mg/ l and 100 mg/ l respectively as shown in the TG. The chemical was analyzed by HPLC. Reference: Chemical Inspection and Testing Institute of Japan, 1992 3.6 BOD5, COD OR RATIO BOD5/ COD BOD5 Method: Other ( 1960) Concentration: 3 mg/ l related to COD [ ]; DOC [ ]; Test substance [ X ]; Value: = 0.66 mg O2/ l GLP: Yes [ ] No [ ] ? [ X ]

COD Method: Other ( 1960) Value: = 2.31 mg O2/ g GLP: Yes [ ] No [ ] ? [ X ] EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 19 Ratio BOD5/ COD: 0.286 Remarks: Methods used followed those given in the 11th Edition of Standard Methods for the Examination of Water and Wastewater, 1960 The seed material used for BOD testing was filtered 437 Secondary Effluent ( effluent form the Midland plant of the Michigan Division general wastewater treatment system.)

Reference: XYZ Corporation ( 1992)

3.7 BIOACCUMULATION ( a) Species: Pimephales promelas ( Fathead minnow) Exposure period: 28 days Temperature: 18 ° C Concentration: ca. 1 mg/ l BCF: 17.7 ± 5.2 ( Steady state) Elimination: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD Guideline 305E ( 1981) Type of test: [ ] calculated; [ X ] measured static [ ]; semi static [ ]; flow through [ X ]; other ( e. g. field test) [ ] GLP: Yes [ ] No [ ] ? [ X ] Test substance: Synthesised for the test, purity:> 99%, radio labelled by using 14 C Remarks: 4 weeks exposure to test material followed by 2 weeks depuration. The mean BCF increased slowly after 1 week exposure and reached a plateau with an average BCF of 24 after 2 3 weeks. Following incubation in pure dilution water a rapid decrease of BCF values based on whole body, wet weight. Half life was ca. 3 days. BIOFAC computer model is used for calculation of BCF. Reference: Steber J. and Wierich P., 1987 ( b) Species: Cyprinus carpio ( Carp) Exposure period: 8 weeks Temperature: 25 ° C Concentration: 20 mg/ l and 2 mg/ l BCF: 362 636 ( 20 mg/ l, Steady state) 357 718 ( 2 mg/ l, Steady state) Elimination: Yes [ ] No [ ] ? [ X ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method OECD Guideline 305C ( 1992) Type of test: [ ] calculated; [ X ] measured static [ ]; semi static [ ]; flow through [ X ]; other ( e. g. field test) [ ] GLP: Yes [ ] No [ ] ? [ X ] Test substance: Substance grade, purity:> 99%, Remarks: Stock solution of the test substance was prepared by using 40 times weight of Ethyl alcohol of the test substance. Reference: Chemical Inspection and Testing Institute of Japan, 1992 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 20 3.8 ADDITIONAL REMARKS A. Sewage treatment ( information on treatability of the substance)

Results: Waste water containing ABCDE can be treated with NH3, NH4 + salts or amines which split off NH3 at reaction temperature. After these treatments, the suspended solids will be separated. Remarks: ....................................................................................................................................... Reference: Hazardous Substance Data Base, 1992 B. Other information ( information that will help to focus the exposure assessment ( either qualitative or quantitative)

Results: No studies located Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 21 4. ECOTOXICOLOGICAL DATA * 4.1 ACUTE/ PROLONGED TOXICITY TO FISH Type of test: static [ ]; semi static [ ]; flow through [ X ]; other ( e. g. field test) [ ] open system [ X ]; closed system [ ] Species: Oncorhynchus mykiss Walbaum ( Rainbow trout) Exposure period: 96 hr Results: LC50 ( 24h) = 2.3 mg/ l LC50 ( 48h) = 1.5 mg/ l LC50 ( 96h) = 1.5 mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 203 ( 1992) GLP: Yes [ X ] No [ ] ? [ ] Test substance: As prescribed by 1.1  1.4, purity: = 82% Remarks: Groups of ten rainbow trout were exposed to mean analyzed treatment levels of 0.20, 0.33, 0.56, 0.94, 1.7 and 3.1 mg/ l active ingredient ( a. i.), DMF ( N, Ndimethylformamide controls and laboratory water controls. The LC50 ( 96h) was determined to be 1.5 mg/ l with a 95 % confidence level of 0.94 to 3.1 mg/ l. Reference: Weinberg, J. T., et. al., 1991 4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES * A. Daphnia Type of test: static [ X ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ X ] Species: Daphnia Magna Straus Exposure period: 48 hr Results: EC50 ( 24h) = 1.85 mg/ l EC50 ( 48h) = 2.13 mg/ l ECxx (.. h) = . . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 202 ( 1984) GLP: Yes [ X ] No [ ] ? [ ] Test substance: As prescribed by 1.1 1.4, purity: = 82% Remarks: Thirty daphnids ( 3 replicates; 10 organisms per replicate) were exposed to analyzed treatment level of 0.87, 1.27, 2.14, 4.25, 8.44 and 15.9 mg/ l. A DMF control and daphnid water control were also included. 95% confidence levels for 48 hr EC50 were 1.13 to 4.56 mg/ l . Reference: Milazzo, D. P., Servinski, M. F. and Rick, D. L., 1992 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 22 B. Other aquatic organisms Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ ] Species: ....................................................................................................................................... Exposure period: ....................................................................................................................................... Results: EC50 ( 24h) = . . . . . . mg/ l EC50 ( 48h) = . . . . . . mg/ l ECxx (.. h) = . . . . . . . mg/ l NOEC = . . . . . . . . . mg/ l LOEC = . . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . . . . . . . . . . . . . ., purity:............................................................................ Remarks: No studies located Reference: .......................................................................................................................................

* 4.3 TOXICITY TO AQUATIC PLANTS e. g. Algae Species: Selenastrum capricornutum Printz End point: Biomass [ X ]; Growth rate [ X ]; Other [ ] Exposure period: 72 hours Results: Biomass: EC50 ( 24h) = 14.3 mg/ l EC50 ( 72h) = 14.1mg/ l NOEC = 3.3 mg/ l LOEC = . . . . . . . mg/ l Growth: EC50 ( 24h) = 11.7 mg/ l EC50 ( 72h) = 8.8 mg/ l NOEC = not calculated LOEC = . . . . . . . mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 201 ( 1984) open system [ ]; closed system [ X ] GLP: Yes [ X ] No [ ] ? [ ] Test substance: As prescribed by 1.1  1.4, purity: > 99% Remarks: Static test. The EC50 values for biomass ( total cell count/ ml) and for growth rate (% inhibition) were calculated based on nominal concentrations. Chemical analysis show that 94% to 133% ( mean, 114%) of added ABCDE remained in the solution after 72 hours. Reference: Milazzo, D. P. and Servinski, M. F., 1991 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 23 4.4 TOXICITY TO BACTERIA ( Single species tests and tests on overall processes such as nitrification or soil respiration are included in this item.)

Type: Aquatic [ X ]; Field [ ]; Soil [ ]; Other [ ] Species: Activated Sludge Exposure Period: . . . . . . . . . . . Results: EC10 ( 3 h) = 490.5 mg/ l EC50 ( 3 h) = > 1,000 mg/ l EC100 ( 3 h) = >> 1,000 mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Directive 88/ 302/ EEC, Part C, Respiration inhibition Test ( 1986) GLP: Yes [ ] No [ ] ? [ X ] Test substance: as prescribed by 1.1 1.4, but purified; purity: >= 99% Remarks: ABCDE was added directly to diluent water. No toxic effects were observed for saturated solution. Measured concentrations were 83 106 % of nomincal concentration. Reference: XYZ Corporation, 1987.

4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS 4.5.1. CHRONIC TOXICITY TO FISH ( effects on reproduction, embryo/ larva etc.)

Type of test: static [ ]; semi static [ ]; flow through [ X ]; other ( e. g. field test) [ ]; open system [ X ]; closed system [ ] Species: Pimephales promelas ( Fathead Minnow) End point: Length of fish [ ]; Weight of fish [ ]; Reproduction rate [ ]; Other [ ] Exposure period: 274 days Results: Mortality: LC50 (.. d) = . . . . . . . mg/ l LCxx (.. d) = . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Growth: EC50 ( 274 d) = 0.50 mg/ l ( incl. Reproduction) ECxx (... d) = . . . . . . . mg/ l NOEC = 0.15 mg/ l LOEC = 0.25 mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 204 ( 1984) GLP: Yes [ X ] No [ ] ? [ ] Test substance: Substance grade , purity: > 99% Remarks: EC50 ( 274 d) was calculated for weight of young fish and reproduction rate of two generations ( F0 and F1). Analytical monitoring of the concentrations of the chemical was carried out during the test period. ABCDE ( no solvent used) was tested at 5 concentrations ( 0.075  1.5 mg/ l) in tapwater ( pH: 7.4, hardness: 130 mgCaCO3 / l). Flow rate equivalent to 5 replacements/ day. NOEC, LOEC ( both at p < 0.05) and EC50 values based on nominal concentrations. Measured concentrations were 86 97 % of nominal concentrations. Mean measured concentrations were used for the determination of EC50. Reference: Springborn Laboratories, U. S., 1992 (*) 4.5.2. CHRONIC TOXICITY TO AQUATIC INVERTEBRATES ( e. g. daphnia reproduction. The need to conduct tests for this end point will depend inter alia upon concern for long term effects.)

Type of test: static [ ]; semi static [ X ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ X]; closed system [ ] Species: Daphnia Magna Strauss End point: Mortality [ X ]; Reproduction rate [ X ]; Other [ X ] EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 24 Exposure period: 21 day Results: Immobility: EC50 ( 48 h) > 2.67 mg/ l EC50 ( 21 d) = 2.48 mg/ l NOEC = 1.18 mg/ l LOEC = 1.78 mg/ l Mortality: LC50 ( 48 h) > 2.67 mg/ l LC50 ( 21 d) = 1.94 mg/ l NOEC = 0.31 mg/ l LOEC = 0.61 mg/ l Reproduction: EC50 ( 21 d) = 1.10 mg/ l NOEC = 1.18 mg/ l LOEC = 1.78 mg/ l Growth: EC50 ( 21 d) > 2.67 mg/ l NOEC = 1.78 mg/ l LOEC = 2.68 mg/ l Analytical monitoring: Yes [ X ] No [ ] ? [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD Test Guideline 202 ( 1984) GLP: Yes [ X ] No [ ] ? [ ] Test substance: As prescribed by 1.1 1.4; purity: = 82% Remarks: ABCDE ( solvent: acetone at < 0.1ml/ l) was tested at 5 concentrations ( 0.25 2.5 mg/ l) in dechlorinated pond water ( pH: 7.9; hardness: 200 mg CaCO3/ l). LC50, NOEC and LOEC are based on concentration adjusted to 100% active ingredient. Renewal each day. NOEC, LOEC ( both at p < 0.05) and EC50 values based on measured concentrations. Mean maesured concentrations were 24 29 % below nominal ones. Less than 10% mortality in control and solvent control. Reference: Milazzo, D. P., Servinski, M. F., Rick, D. L. and Martin M. D. ( 1992)

4.6 TOXICITY TO TERRESTRIAL ORGANISMS 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS Type: Artificial soil [ ]; Filter paper [ ]; Other [ X ] Species: Eisenia foetida ( Worm ( Annelida)) End point: Mortality [ X ]; Weight [ ]; Other [ ] Exposure period: 14 day Results: LC50 ( 7d) = 685 mg/ kg LC50 ( 14d) = 668 mg/ kg ( dry weight of substance) LCxx (.. d) = . . . . . . mg/ kg NOEC = 316 mg/ kg LOEC = 562 mg/ kg Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 207 ( 1984) GLP: Yes [ ] No [ ] ? [ X ] Test substance: As prescribed by 1.1 1.4, purity: = 82% Remarks: Nominal concentrations. Analytical monitoring was not carried out. Following soil was used for the test; Soil type: Clay 20%, Silt 50%, Sand 30%, Soil pH: 6.5, Contents of organic matter 4%, Cation exchange capacity 4 me/ 100g, Microbial biomass: not measured. Reference: XYZ corporation, 1990.

4.6.2 TOXICITY TO TERRESTRIAL PLANTS ( a) Species: Oryza sativa ( Rice, Toyonishiki) End point: Emergence [ X ]; Growth [ X ]; Other [ ] Exposure period: 14 day Results: EC50 and/ or LC50 ( 7d) = > 100 mg/ l EC50 and/ or LC50( 14d) = > 100 mg/ l EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 25 ECxx and/ or LCxx ( xxd) = . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD Test Guideline 208 ( 1984) GLP: Yes [ ] No [ X ] ? [ ] Test substance: As prescribed by 1.1 1.4, purity: = 82% Remarks: EC50 for Growth inhibition and LC50 for germination are expressed as nominal concentration adjusted to 100% active ingredient. The substance is practically insoluble. Following soil was used for the test; Soil type: Clay 20%, Silt 50%, Sand 30%, Soil pH: 6.5, Contents of organic matter 4%, Cation exchange capacity 4 meq/ 100g dry soil, Microbial biomass: not measured. Reference: Environment Agency of Japan, 1991 ( b) Species: Brassica rapa ( Turnip, Hikari) End point: Emergence [ X ]; Growth [ X ]; Other [ ] Exposure period: 14 day Results: EC50 and/ or LC50 ( 7d) = > 100 mg/ l EC50 and/ or LC50( 14d) = > 100 mg/ l ECxx and/ or LCxx ( xxd) = . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD Test Guideline 208 ( 1984) GLP: Yes [ ] No [ X ] ? [ ] Test substance: As prescribed by 1.1 1.4, purity: = 82% Remarks: C50 for Growth inhibition and LC50 for germination are expressed as nominal concentration adjusted to 100% active ingredient. The substance is practically insoluble. Following soil was used for the test; Soil type: Clay 20%, Silt 50%, Sand 30%, Soil pH: 6.5, Contents of organic matter 4%, Cation exchange capacity 4 meq/ 100g dry soil, Microbial biomass: not measured. Reference: Environment Agency of Japan, 1991 ( c) Species: Lactuca sativa ( Lettuce, Top mark) End point: Emergence [ X ]; Growth [ X ]; Other [ ] Exposure period: 14 day Results: EC50 and/ or LC50 ( 7d) = > 100 mg/ l EC50 and/ or LC50( 14d) = > 100 mg/ l ECxx and/ or LCxx ( xxd) = . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD Test Guideline 208 ( 1984) GLP: Yes [ ] No [ X ] ? [ ] Test substance: As prescribed by 1.1 1.4, purity: = 82% Comments: EC50 for Growth inhibition and LC50 for germination are expressed as nominal concentration adjusted to 100% active ingredient. The substance is practically insoluble. Following soil was used for the test; Soil type: Clay 20%, Silt 50%, Sand 30%, Soil pH: 6.5, Contents of organic matter 4%, Cation exchange capacity 4 meq/ 100g dry soil, Microbial biomass: not measured. Reference: Environment Agency of Japan, 1991 4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES ( INCLUDING AVIAN)

Species: Conturnix conturnix End point: Mortality [ ]; Reproduction rate [ ]; Weight [ ]; Other [ X ] Exposure period: 28 days Results: LDxx or LCxx ( xxd) = . . . . . . . mg/ kg EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 26 NOEC = 5 mg/ kg food LOEC = . . . . . . . mg/ kg Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD TG 206 ( 1984) GLP: Yes [ X ] No [ ] ? [ ] Test substance: purity: > 98% Remarks: Quails, 4 5 weeks old, were tested at 5 concentrations ( 1.5 to 50 mg/ kg food). No effects on survival, body weight and egg laying rate were observed. Blood and brain cholinesterase activities were significantly affected ( p < 0.05) at concentrations >= 15 mg/ kg food. Reference: Schafer, E. W. et al., ( 1985). EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 27 4.7 BIOLOGICAL EFFECTS MONITORING ( INCLUDING BIOMAGNIFICATION) ( Studies on variation of predominant species in certain ecosystems ( e. g. mesocosm) and monitoring of biological effects are included.)

Results Substance: ABCDE Species or ecosystem studied: Mytilus edulis ( common mussel) in 5 points in coastal region. Effects monitored: Concentration of the substance in the body and malformation of the shell. Results: The range of concentration in the body was 0.06  0.75 ppm in 1989 which is almost the same as the results in 1987. Malformation of the shell was not observed. Chemical analysis: ABCDE was analyzed by using Atomic Absorption Analysis. Remarks: ( Information on environmental conditions ( e. g. water characteristics: suspended matter, pH, temperature, hardness. Soil/ sediment characteristics: % organic matter, clay content.) Concentration of the chemical in surface water where the organism were gathered is presented in 3.2.

Reference XYZ Institute, 1991 4.8 BIOTRANSFORMATION AND KINETICS ( Under this item, studies on absorption, distribution, metabolism and excretion etc. should be given.)

Type: Animal [ ]; Aquatic [ ]; Plant [ ]; Terrestrial [ ]; Other [ ] Results: No studies located Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.9 ADDITIONAL REMARKS Results: No studies located Remarks: Reference: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 28 5. TOXICITY ( Where observations on humans are available these should be entered in the appropriate " Comments" section or under section 5.11)

* 5.1 ACUTE TOXICITY 5.1.1 ACUTE ORAL TOXICITY ( a) Preferred Result Type: LD0 [ ]; LD100 [ ]; LD 50 [ X ]; LDL0 [ ]; Other [ ] Species/ strain: Rat ( Wistar) Value: = 500 ( mg/ kg): Discriminating dose: N/ A Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD 401. 1981 GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: Administered at 0, 250, 500, or 750 mg/ kg in corn oil by oral gavage. Apathy, reeling, dyspnoea, cyanosis, incoordination, ataxia, reduced mobility, and prostration in the 500 and 750 mg/ kg groups. The surviving animals recovered within 2 to 3 days of administration. Dissection revealed gastro intestinal irritation and residues of the substance in the abdominal cavity and a " yellowish brown" liver. Reference: Brutus el al., 1986.

( b) Type: LD0 [ ]; LD100 [ ]; LD 50 [ X ]; LDL0 [ ]; Other [ ] Species/ strain: Mouse ( strain and sex not given) Value: <= 750 mg/ kg Discriminating dose: N/ A Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ ] ? [ X] Test substance: Substance grade and purity not stated Remarks: Mice were administered 0, 750, or 1500 mg/ kg by gavage. Convulsions and body tremors were observed in both treatment groups. All mice died in the high 1500 mg/ kg group. Old study with poor study design. Vehicle and recovery period not stated. Reference: Jacks et al., 1974 5.1.2 ACUTE INHALATION TOXICITY ( a) Preferred Result Type: LC0 [ ]; LC100 [ ]; LC50 [ X ]; LCL0 [ ]; Other [ ] Species/ strain: Rat ( Wistar) Exposure time: 4 hours Value: > 750 mg/ m3 Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD 402 ( 1987) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: Exposed to 0, 250, 500, or 750 mg/ m3 There were no deaths. Signs of poisoning were reduced motility, slight to moderate dyspnoea, and moderate irritation of the eyes, nose, pharynx and snout. The symptoms had subsided 1 hour after exposure. On dissection, macroscopically slight haemorrhages were found in the lungs. Reference: Ajax et al., 1989.

( b) Type: LC0 [ ]; LC100 [ ]; LC50 [ X ]; LCL0 [ ]; Other [ ] Species/ strain: Mouse ( strain and sex not given) EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 29 Exposure time: ....................................................................................................................................... Value: Not stated Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ ] ? [ X] Test substance: Grade and purity not stated. Remarks: Exposure for 8 hr to 0, 750, or 1500 mg/ m3 At 1500 mg/ m3 respiratory rate was decreased by over 50%. No further details are given. The quality of this study cannot be properly evaluated as experimental details are not documented. Reference: Smyth et al., 1976.

5.1.3 ACUTE DERMAL TOXICITY ( a) Preferred Result Type: LD0 [ ]; LD100 [ ]; LD 50 [ X ]; LDL0 [ ]; Other [ ] Species/ strain: Rabbit ( New Zealand white) Value: 650 ( mg/ kg b. w.) Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD 403 ( 1981) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Comments: None Remarks: 0, 250, 500, or 750 mg/ kg applied in corn oil. Symptoms of systemic poisoning and deaths occurred in the 750 mg/ kg group. Moderate irritant effects developed at the application site in the 250 and 500 mg/ g groups. Reference: Moreno, 1987.

( b) Type: LD0 [ ]; LD100 [ ]; LD 50 [ X ]; LDL0 [ ]; Other [ ] Species/ strain: Guinea pig ( strain and sex not given) Value: Not reported ( mg/ kg b. w.) Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ ] ? [ X] Test substance: Substance grade and purity not stated. Remarks: Guinea pigs ( number not stated) had 0 or 1250 mg/ kg applied to their skin. Moderate skin irritation occurred but vehicle used, application method and washing are not documented. No mention of any deaths. Study details are inadequate to properly evaluate this study. Reference: Luck et al., 1978.

5.1.4 ACUTE TOXICITY, OTHER ROUTES OF ADMINISTRATION ( e. g. subcutaneous, intravenous etc.)

Type: LC0 [ ]; LC100 [ ]; LC50 [ ]; LCL0 [ ]; Other [ ] LD0 [ ]; LD100 [ ]; LD 50 [ X ]; LDL0 [ ]; Other [ ] Species/ strain: Rats ( strain, sex and number not given) Route of Administration: i. m. [ ]; i. p. [ ]; i. v. [ X ]; infusion [ ]; s. c. [ ]; other [ ] Exposure time: N. A. Value: < 1500 mg/ kg Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ X] ? [ ] Test substance: Substance grade not stated, purity: unknown Remarks: Rats were administered a single dose of 1500 mg/ kg i. v. All the rats died within five minutes after administration Reference: Jacksson et al., 1974 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 30 5.2 CORROSIVENESS/ IRRITATION 5.2.1 SKIN IRRITATION/ CORROSION ( a) Preferred Result Species/ strain: Rabbit ( New Zealand White) Results: Highly corrosive [ ]; Corrosive [ ]; Highly irritating [ X ]; Irritating [ ]; Moderate irritating [ ]; Slightly irritating [ ]; Not irritating [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Highly corrosive ( causes severe burns) [ ]; Corrosive ( caused burns) [ ]; Irritating [ ]; Not irritating [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD 404 ( 1992) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: Single application of 500 mg/ kg in corn oil Severe irritation with reddening, oedema and scar formation ( irritation index measured as 6.75 on a scale of 0 to 8) Reference: Clayton et al., 1987 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 31 ( b) Species/ strain: Rabbit ( New Zealand White) Results: Highly corrosive [ ]; Corrosive [ ]; Highly irritating [ X ]; Irritating [ ]; Moderate irritating [ X ]; Slightly irritating [ ]; Not irritating [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Highly corrosive ( causes severe burns) [ ]; Corrosive ( caused burns) [ ]; Irritating [ ]; Not irritating [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other, under occlusion. GLP: Yes [ ] No [ ] ? [ X] Test substance: Grade and purity not documented Remarks: Single application of 2.6 g/ kg to intact or abraded skin for 24 hr Reference: Moreno, 1967 5.2.2 EYE IRRITATION/ CORROSION ( a) Preferred results Species/ strain: Rabbit ( New Zealand White) Results: Highly corrosive [ ]; Corrosive [ ]; Highly irritating [ X ]; Irritating [ ]; Moderate irritating [ X ]; Slightly irritating [ ]; Not irritating [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Irritating [ ]; Not irritating [ ]; Risk of serious damage to eyes [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) OECD 405 ( 1987) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: 500 mg/ l instilled in a solution of 50% corn oil. Moderately severe symptoms of irritation of the cornea, iris and conjunctiva ( irritation index 28.59 on a scale of 0 to 110) Reference: Carpenter et al., 1988.

( b) Species/ strain: Rat ( strain and sex not given) Results: Highly corrosive [ ]; Corrosive [ ]; Highly irritating [ X ]; Irritating [ ]; Moderate irritating [ X ]; slightly irritating [ ]; not irritating [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Irritating [ ]; Not irritating [ ]; Risk of serious damage to eyes [ ]; Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ ] ? [ X] Test substance: Substance grade and purity not stated. Remarks: Instillation of one drop of a 12.5, 25 or 50% solution in oil ( no further details) or of undiluted substance. The 25 and 50% solution or undiluted chemical produced reddening and swelling of the conjunctiva, lacrimation and mucous secretion, but there was no damage to the cornea. Recovery occurred within 8 to 96 hours, depending on the concentration. The 12.5% solution caused no signs of irritation. Original study is not available Reference: Chemical Abstracts, 1987.

5.3 SKIN SENSITISATION ( a) Type: Maximisation Species/ strain: Rabbit ( New Zealand White) Results: Sensitizing [ X ]; Not sensitizing [ ]; ambiguous [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Sensitizing [ ]; Not sensitizing [ ] EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 32 Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Similar to OECD 406 GLP: Yes [ ] No [ X] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: No. of animals with skin reaction at challenge: Treated: 4/ 10 Control group: 0/ 10 The chemical is classified as a moderate skin sensitizer Reference: Kligman, 1966.

( b) Type: Patch Test Species/ strain: Human Results: Sensitizing [ X ]; Not sensitizing [ ]; ambiguous [ ] Classification: ( If possible, according to EC Directive 67/ 548/ EEC) Sensitizing [ ]; Not sensitizing [ ] Method: ( e. g. OECD, other ( with the year of publication or updated of the method used)) Other GLP: Yes [ ] No [ X] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: In an attempt to induce sensitization using the maximization procedure, 29 volunteers were given five 48 hr covered patch tests ( over a 10 day period) with 4% in petrolatum. The attempt was unsuccessful since none of the subjects gave local reactions when challenged 10 14 days after the induction phase by a final 48 hr covered patch test with the 4% petrolatum mixtures. Reference: Kligman, 1966; Kligman & Epstein, 1975; Epstein, 1976. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 33 * 5.4 REPEATED DOSE TOXICITY ( a) Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: oral feed Exposure period: 28 days Frequency of treatment: 7 days/ week Post exposure observation period: 14 days Dose: 0, 125, 500 or 750 mg/ kg ( 10 animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ X ]; Concurrent vehicle [ ]; Historical [ ] NOEL: 125 mg/ kg LOEL: ....................................................................................................................................... Results: On the 10th day a slight reddening and crusting of the skin was evident. The body weights on the 9th and 10th day, and the relative and absolute thymus weights on the 28th day, were significantly ( p £ 0.05) reduced. There were no effects on the weights of the heart, liver, spleen or kidneys, the levels of protein, albumin, and a1, ß1 and gamma globulin contents in the serum, or the activity of alanine aminotransferase in the serum. Histologically, the following effects on organs were observed in the 500 and 750 mg/ kg groups as compared with controls: Liver Histiocytic and inflammatory granulomas, peripheral fine droplet fatty degeneration Lungs Interstitial pneumonia, bronchiectasis, severe round cell bronchitis Kidneys Epithelial cell necrosis, cysts, basophilic" balloon nuclei" Heart Inter and intracellular oedema, necrobiotic muscle fibres, interstitial oedema Testes Interstitial oedema, reduced spermiatogenesis Thymus Increased " colloidocytes" Adrenals Cortex very rich in lipids Histochemical investigation of the liver showed raised succinate dehydrogenase activity and reduced lactate dehydrogenase activity. Tests on acid phosphatase and non specific a naphthylacetate esterase activity and on fat coloration gave no indications of any change. Method: OECD 412 ( 1981) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Reference: Ganning et al., 1987.

( b) Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ ]; No data [ X ] Route of Administration: oral feed Exposure period: 10 days Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Dose: 0, 500 or 1000 mg/ kg ( 5 animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] NOEL: ....................................................................................................................................... LOEL: ....................................................................................................................................... Results: Significantly increases in absolute liver weights, levels of cytoplasmic and microsomal epoxide hydrolase, glutathione S transferase activity and also cytoplasmic and microsomal protein content in the liver were found, all at a p value of < 0.05 Method: Other GLP: Yes [ ] No [ X] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: 5 rats per group and sex received 0, 500 or 1000 mg/ kg in the diet for 10 days followed by sacrifice. Clinical signs were recorded and at sacrifice gross and histopathological examination and biochemical tests were performed. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 34 Reference: Hammock et al., 1977 ( c) Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ ]; No data [ X ] Route of Administration: oral feed Exposure period: 90 days Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Dose: 0, 125, 500 or 750 mg/ kg ( 10 animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] NOEL: ....................................................................................................................................... LOEL: ....................................................................................................................................... Results: Increased relative stomach weights occurred in males in the 500 and 125 mg/ kg/ day groups. No effects on relative and absolute testicular weight or microscopic lesions were observed. Method: OECD: 411 ( 1981) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: ....................................................................................................................................... Reference: Rhodes, 1987.

( d) Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: gavage Exposure period: 90 days Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Dose: 0, 25, 125, 250 or 500 mg/ kg/ day ( 3 animals / sex / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] NOEL: 125 mg/ kg LOEL: ....................................................................................................................................... Results: Decreased feeding and body weight occurred in animals in the high dose group. Cyanideinsensitive palmitoyl CoA oxidation was induced in the livers of both sexes in the 250 and 500 mg/ kg/ day groups. Testicular weights were normal. Method: Other GLP: Yes [ ] No [ ] ? [ X] Substance: Industrial, purity: 80% Remarks: " Limited study" with three rats per sex per group. It is not clear whether the micropathological examination of the testes was conducted. Reference: Ota et al., 1977.

( e) Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ ]; No data [ X ] Route of Administration: oral feed Exposure period: 24 month Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Dose: 0, 75,125 or 500 mg/ kg/ day (. . . . . . . animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] NOEL: . . . . . . . . . . . mg/ kg LOEL: . . . . . . . . . . . mg/ kg Results: The animals given 500 mg/ kg showed signs of liver and kidney damage. The absolute and relative liver weights were increased in both sexes. At dissection, the livers of the female rats were hyperaemic and/ or swollen and degenerative changes were evident EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 35 in the kidneys of the males. Histological examination revealed slight and reversible changes to the liver and kidneys. The testes were scheduled for examination but the results are not documented. Method: Other GLP: Yes [] No [ ] ? [ X] Test substance: Commercial, purity: 96,5% Remarks: Confirmation that no effects on the testes occurred is being sought. See also " Section 5.7" Reference: James et al., 1978.

( f) Species/ strain: Rat: ( Crl: CD ( SD) BR VAF7 Plus strain) Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: oral Exposure period: 4 and 6 weeks Frequency of treatment: ............................................................................................................................... Postexposure observation period: .......................................................................................................................... Dose: 0, 500 or 1,000 mg/ kg/ day ( 10 animals / sex / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] NOEL: 1,000 mg/ kg for 6 weeks ( female) 500 mg/ kg for 2 weeks ( male) LOEL: . . . . . . . . . . . mg/ kg Results: Signs of toxicity were not observed in males. Females showed no signs of toxicity during premating ( 0 2 weeks). During pregnancy ( 0 20 days) bodyweight decreased by 6 9% in the 1,000 mg × kg 1 × day 1 group. Method: OECD Preliminary Screening Test for Reproductive and Repeated Dose Toxicity. GLP: Yes [ X] No [ ] ? [ ] Test substance: Industrial: 96.2% Remarks: " General toxicity" or effects on male reproduction were not observed. Reference: Powell, 1992.

* 5.5 GENETIC TOXICITY IN VITRO A. BACTERIAL TEST ( a) Type: ( e. g. Bacterial reverse mutation assay, Bacterial gene mutation study, Cytogenetic Assay etc.) Bacterial reverse mutation assay System of testing: Species/ strain: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 Concentration: 0, 50, 250, 1000 or 5000 mg/ plate Metabolic activation: With [ ]; Without [ ]; With and Without [ X ]; No data [ ] Results: Cytotoxicity conc: With metabolic activation: 1000 mg/ plate Without metabolic activation: 1000 mg/ plate Precipitation conc: > 5000 mg/ plate Genotoxic effects: + ?  With metabolic activation: [ X] [ ] [ ] Without metabolic activation: [ ] [ ] [ X] Method: OECD 471 ( 1983) GLP: Yes [ X] No [ ] ? [ ] Teat substance: Commercial, purity: 96.5% Remarks: Procedure: Pre incubation. Plates/ test: 1 Activation system: Liver S 9 fraction from Aroclor 1254 pretreated male SD rats with NADPH generating system Media: Histidine selective No. replicates: 2 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 36 Reference: Kirby et al., 1988.

( b) Type: ( e. g. Bacterial reverse mutation assay, Bacterial gene mutation study, etc.) Bacterial reverse mutation assay System of testing: Species/ strain: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 Concentration: 0, 50, 250, 1000 or 5000 mg/ plate Metabolic activation: With [ ]; Without [ ]; With and Without [ X ]; No data [ ] Results: Cytotoxicity conc: With metabolic activation: Not stated Without metabolic activation: Not stated Precipitation conc: Not stated Genotoxic effects: + ?  With metabolic activation: [ ] [ X] [ ] Without metabolic activation: [ ] [ X] [ ] Method: Other GLP: Yes [ ] No [ ] ? [ X] Test substance: Grade and purity not stated Remarks: Procedure: Not stated Plates/ test: Not stated Activation system: Liver S 9 fraction from Aroclor 1254 pretreated male SD rats with NADPH generating system Media: Histidine selective No. replicates: Not stated Test of little use in assessment Reference: Carol et al., 1988.

B. NON BACTERIAL IN VITRO TEST Type: ( e. g. Mammalian cell gene mutation assay, Cytogenetic Assay etc.) Cytogenetics Assay System of testing: Species/ strain: Human lymphocytes Concentration: Incubated with 0, 124, 500, 1000 or 2500 mg/ plate Metabolic activation: With [ ]; Without [ ]; With and Without [ X ]; No data [ ] Results: Cytotoxicity conc: With metabolic activation: 1000 mg/ plate Without metabolic activation: 500 mg/ plate Precipitation conc: not stated Genotoxic effects: + ?  With metabolic activation: [ X] [ ] [ ] Without metabolic activation: [ ] [ X] [ ] Method: OECD 473 ( 1983) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity 96.2% dissolved in physiological medium Remarks: Human lymphocytes cultured in vitro were used. Fixation time: Minimum of at least 2 hr. Dose levels: 100 800 mg × ml 1 Plates/ test: 2 Activation system: S 9 fraction from the liver of Aroclor 1254 induced male SD derived rats with NADPH generating system Media: RPMI 1640 medium plus 10% foetal calf serum plus phytohaemagglutinin No. replicates: 1 Reference: Fischer, 1978.

5.6 GENETIC TOXICITY IN VIVO Type: Micronucleus assay Species/ strain: Mice; B6 C3 F1 EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 37 Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: i. p. injection Exposure period: .......................................................................................................................................

Doses: 0, 456 mg/ kg/ day ( 6 animals / sex / group) Results: Effect on mitotic index or P/ N ratio: 50% increase Genotoxic effects: + ?  [ X] [ ] [ ] Method: OECD 474 ( 1983) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity 96.2% dissolved in medium Remarks: Micronucleus test ( erythrocytes): single i. p. injection of 456 mg/ kg, or the same dose twice with a 24 hour interval. A control group ( 6 animals/ sex) received the solvent maize oil, and a positive control group received triethylene melamine ( TEM) The substance has the potential to cause mutagenic events. Reference: Kirby et. al., 1988 5.7 CARCINOGENICITY Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: oral feed Exposure period: 24 months Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Doses: 0, 75, 125 or 500 mg/ kg ( 50 animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ X ]; Concurrent vehicle [ ]; Historical [ ] Results: Carcinogenic effects were not observed. The animals given 500 mg/ kg showed signs of liver and kidney damage. The absolute and relative liver weights were increased in both sexes. At dissection, the livers of the female rats were hyperaemic and/ or swollen and degenerative changes were evident in the kidneys of the males. Histological examination revealed slight and reversible changes to the liver and kidneys. The testes were scheduled for examination but the results are not documented. Method: OECD 451 ( 1981) GLP: Yes [ X] No [ ] ? [ ] Test substance: Commercial, purity: 96.5% Remarks: Confirmation that no affects on the testes occurred is being sought. See also " Section 5.4" Reference: James et al., 1978.

* 5.8 TOXICITY TO REPRODUCTION ( a) Type: Fertility [ ]; One generation study [ ]; Two generation study [ ]; Other [ X ] Species/ strain:  Rat slc: SD Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: gavage Exposure period: Males for 42 days; females from 14 days before mating to day 3 of lactation. Frequency of treatment: ............................................................................................................................... Postexposure observation period: ........................................................................................................ Premating exposure period: male: . . . . . . . . . . . . . ., female: ..................................................................... Duration of the test: ....................................................................................................................................... Doses: 0, 100, 300, or 1000 mg/ kg ( 12 / animals / sex/ group) Control group: Yes [ X ]; No [ ]; No data [ ]; EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 38 Concurrent no treatment [ X ]; Concurrent vehicle [ ]; Historical [ ] NOEL Parental: = 100 mg/ kg/ day NOEL F1 Offspring: = 1,000 mg/ kg/ day NOEL F2 Offspring: N/ A Results: There were no effects on mating, fertility and oestrus cycle or on dams during the lactation period. External examination of pups revealed no increase in appearance of abnormal pups. Body weight gain of pups was normal. Stillborn, dead pups and pups killed at day 4 showed no abnormal gross findings. General parental toxicity: see section 5.4. For toxicity to offspring: ( weights of litter, postnatal growth, viability, etc.) ....................................................................................................................................... Method: Combined Repeated Dose and Reprotox. Screening GLP: Yes [ X] No [ ] ? [ ] Test substance: ABCDE purity 99.15% Remarks: ....................................................................................................................................... Reference: Unpublished report from Biosafety Research Center, ( An pyo Center), Japan.

( b) Type: Fertility [ ]; One generation study [ X ]; Two generation study [ ]; Other [ ] Species/ strain: Rat ( Wistar) Sex: Female [ ]; Male [ ]; Male/ Female [ X ]; No data [ ] Route of Administration: oral feed Exposure period: ....................................................................................................................................... Frequency of treatment: ............................................................................................................................... Postexposure observation period: .......................................................................................................................... Premating exposure period: male: . . . . . . . . . ., female: ............................................................................. Duration of the test: ....................................................................................................................................... Doses: 0, 250, 500 or 750 mg/ kg ( 24/ animals / sex/ group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ X ]; Concurrent vehicle [ ]; Historical [ ] NOEL Parental: = 250 mg/ kg/ day NOEL F1 Offspring: < 250 mg/ kg/ day NOEL F2 Offspring: N/ A Results: General parental toxicity: 9.8% decreased bodyweight gain for females given 750 mg/ kg during pregnancy. This was not associated with decreased food intake or decreased energy efficiency compared with controls. Effects were not observed in the other dose groups. NOEL = 500 mg/ kg Repro. toxicity ( parental): A significant number of resorptions occurred in the 500 and 750 mg/ kg groups. Repro. toxicity ( offspring) ( weights of litter, postnatal growth, viability, etc.): Litter weight was significantly decreased for all dose groups Method: OECD 415 ( 1983) GLP: Yes [ X] No [ ] ? [ ] Test substance: Industrial: purity: 82% Remarks: None Reference: .......................................................................................................................................

* 5.9 DEVELOPMENTAL TOXICITY/ TERATOGENICITY Species/ strain: Rabbit, strain not stated Sex: Female [ X ]; Male [ ]; Male/ Female [ ]; No data [ ] Route of Administration: gavage Duration of the test: Sacrifice on the 20 days Exposure period: 12th day of gestion Frequency of treatment: Single oral ( gavage) administration of on the 12th day of gestation. Doses: 100 or 550 mg/ kg ( 12 / animals / group) Control group: Yes [ X ]; No [ ]; No data [ ]; Concurrent no treatment [ X ]; Concurrent vehicle [ ]; Historical [ ] NOEL Maternal Toxicity: = 100 mg/ kg EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 39 NOEL teratogenicity: ....................................................................................................................................... Results: Maternal general tox: Decreased maternal feed intake in the 500 mg/ kg group, NOEL: 100 mg/ kg Pregnancy/ litter data: Resorptions in the 500 mg/ kg group, NOEL: 100 mg/ kg Foetal data: All pups born dead in the 500 mg/ kg group NOEL: 100 mg/ kg Method: Other GLP: Yes [ ] No [ X] ? [ ] Test substance: Not stated, but probably commercial grade 92% Remarks: The effects seen require a good deal of follow up work Reference: .......................................................................................................................................

5.10 OTHER RELEVANT INFORMATION A. Specific toxicities Type: ( neurotoxicity, immunotoxicity etc.) ....................................................................................................................................... Results: No studies located Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

B. Toxicodynamics, toxicokinetics Type: ( Toxicodynamics, toxicokinetics) ....................................................................................................................................... Results: No studies located Remarks: ....................................................................................................................................... References: ....................................................................................................................................... EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 40 * 5.11 EXPERIENCE WITH HUMAN EXPOSURE ( Describe information on work place exposure such as concentration of chemicals in the work place or indoor environment ( manufacturing, maintenance and professional use), number of workers ( in ranges for each situation), frequency and duration of exposure, if available. In addition, enter details of effects of accidental or occupational exposure, epidemiological and clinical studies, case reports, etc.) ( a) Results: Source: Maintenance Work Number of Workers exposed: approx. 20 Frequency and duration of exposure: 3 times per day for 15 min each Emission estimated: 5 mg/ m3 Year: 1989 Remarks: ....................................................................................................................................... Reference: XYZ Company data, 1988 ( b) Results: No reproductive health effects on women exposed to ABCDE in their working place is reported. Remarks: Exposure is not estimated quantitatively. Reference: Unpublished internal report of XYZ company ( 1990) EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 41 6. REFERENCES ( Indicate the name of the book, journal etc. where the study appears; volume; page numbers; and date of report or publication. In general information should be taken from primary sources and quoting from secondary references such as a review article should be avoided. Where appropriate indicate " unpublished report", its authors and their affiliation.)

ACGIH, Threshold Limit Values, 1987 Albright & Wilson ( 1986), Report apw/ 43/ 1986.

Atkinson, R. ( 1986), Tabellietre Einzelbestimmeungen organisher Stoffe in der Umwelt. Research Report .

Baxter, J. N. and Johnson, F. J., ( 1968), Radiat. Res., 33, 303 310.

Bozetto ( 1981), Laboratory report 23/ 81.

Chemical Inspection and Testing Institute of Japan ( 1992), Unpublished Report.

Chemical News, 10, June 1990, page 27 Danish Product Register, 1988 DoE laboratory report ( 1989), 23/ 89.

Environment Agency of Japan ( 1977 and 1992), Chemicals in the Environment: Report of Environmental Survey and Wildlife Monitoring of Chemicals Environment Agency of Japan ( 1991), Unpublished Reports on Toxicity of ABCDE to Plants.

Handbook of Chemistry & Physics ( 1985), 66th Ed, p 479.

Hazardous Substance Data Base ( 1992), Online searching on ABCDE.

Jones, A. Z and Roberts ( 1991), P. Q Toxicological Letters, 29, 110 112.

Kirk Othmer, 1991, p 76 Milazzo, D. P. and Servinski, M. F.( 1991), ABCDE: The toxicity to the Green Alga, Selenastrum capricornutum Milazzo, D. P., Servinski, M. F. and Rick, D. L.( 1992), ABCDE: Evaluation of the Acute Toxicity to the Daphnid, Daphnia magna Straus. Unpublished Report of XYZ Corporation.

Milazzo, D. P., Servinski, M. F., Rick, D. L. and Martin, M. D.( 1992). ABCDE: Evaluation of the Chronic Toxicity to the Daphnid, Daphnia magna Straus. Unpublished Report of XYZ Corporation.

Monsanto ( 1985), internal report bp/ 3.

Monsanto ( 1987), Internal report MS/ mp 223.

Monsanto ( 1992), Material Safety Data Sheet.

OECD Secretariat ( 1992 a), The Explanatory Note for Diskette of the Global Reference Model OECD Secretariat ( 1992 b), The Explanatory Note for Diskette of the Local Reference Models Printz, A. 1983 Unpublished Report of XYZ Corporation. Schafer, E. W. et al;.( 1985), Arch. Environm. Contam. Toxicol. 12, 355 382. EXCH\ MANUAL\ 96 AN2. DOC/ May 1996 42 Springborn Labs. U. S. ( 1992), ABCDE: Chronic toxicity of the fathead minnow during full life cycle exposure, ( No. 92 7 4324)

Steber J. and Wierich P. ( 1987), Chemosphere, 16( 6), 1323 1337 The Condensed Chemical Dictionary,( 1981), 10th ed. Gessener G. Hawley editor, Van Nostrand Teinhold Company, New York, 6 7.

University of Michigan ( 1982), Report entitled " Properties of chelating agents", page 23.

Weinberg, J. T., Richardson, C. H., Rick, D. L. and Mayes, M. A.( 1991), ABCDE: Evaluation of the Acute Toxicity to the Rainbow Trout, Oncorhynchus mykiss Walbaum. Unpublished Report of XYZ Corporation.

Witte, F. and Zetsch, C. ( 1988), Messung der OH Geschwindigkeitskonstaten der Reaktionen von ausgewahlten umweltrelevanten Altstoffen. Forschungsbericht, Berlin.

XYZ Corporation ( 1987), ABCDE: Toxicity to Bacteria, Unpublished report ( No. V 87 514).

XYZ Corporation ( 1988), ABCDE: Stability in Soil, Unpublished report ( No. V 88 520).

XYZ Corporation ( 1990), ABCDE: Toxicity to Soil Dwelling Organisms, Unpublished report ( No. V 90 567).

XYZ Corporation ( 1992), ABCDE: Calculation for Equilibrium Constant, Unpublished report ( No. V 92 150).

XYZ Institute ( 1991), The report on Environmental Survey and Wild life Monitoring of Chemicals in 1989. EXCH\ MANUAL\ 96 AN3. DOC/ May 1996 1 ANNEX 3 Synopsis of OECD Test Guidelines for Studies Included in the SIDS*

This document provides a summary of the information which should be reported for specific tests of the Screening Information Data Set ( SIDS) as extracted from the appropriate OECD Test Guidelines. It is not intended to be inclusive or exhaustive; in cases of uncertainty over the interpretation of the acceptability of a study, evaluators should consult the relevant guideline or other guidance documents such as the following, or flag the issue for further discussion at the SIDS review process:

· Quality of and Access to Data Used to Prepare SIDS Dossiers ( Section 3.2); · Considerations for Developing SIDS Testing Plans ( Section 3.3); · Guidance for Meeting the SIDS Requirements ( The SIDS Guide) ( Section 3.4); and · Considerations Concerning Adequacy of Data in the SIDS ( Section 3.5).

Figures in [ ] correspond to the data elements in the HEDSET and the Revised OECD HPV Form 1.

* This document was prepared by the OECD Secretariat based on the agreements reached in the OECD Test Guideline and the Existing Chemicals Programme up to April 1996. EXCH\ MANUAL\ 96 AN3. DOC/ May 1996 2 1. GENERAL INFORMATION Each study should report full identity and the necessary references.

2. PHYSICAL CHEMICAL DATA General Considerations Each study should report:

 full identification of substance tested ( state, structural formula, spectra, purity, impurities stabilizers, etc. should be identified as completely as possible including percentage, potential impact where known, indicating sensitivity of tests in relation to impurities and their potential impact on health or the environment).

Note: In SIDS work, tests for physical chemical properties should be conducted in principle on the purified substance to avoid interference form impurities etc.

 methods: apparatus, procedure employed, sensitivity and accuracy of results, use of reference standards/ controls, statistical analysis, any limitations or difficulties.

Note: In SIDS work, when a standard test method such as OECD Test Guideline has been used, the method should be identified and it is not necessary to repeat details of the test in the HEDSET or in Revised OECD HPV Form 1.

 results: all results and all information relevant to interpretation of results.

Specific Consideratoins for Individual Data Elements [ 2.1] MELTING POINT Ref. OECD TG 102  m. p. or melting range expressed as ° C;  mean of at least 2 measurements ± range of accuracy of method;  if decomposition occurs, the temperature of decomposition should be stated; for viscous liquids, " pour point" may be an acceptable alternative.

[ 2.2] BOILING POINT Ref. OECD TG 103  mean of at least 2 measurements ± b. p. or b. p. range expressed as ° C at a given pressure ( KPa);  measured values corrected to standard pressure;  if substance decomposes before boiling, the temperature of decomposition should be stated.

[ 2.3] DENSITY Ref. OECD TG 109  density expressed as kg/ m 3, preferably at 20 ° C, as mean of at least 2 measurements;  temperature at which the measurement was carried out, method of measurement in the Test Guideline, physical state of the substance should be reported. [ 2.4] VAPOUR PRESSURE Ref. OECD TG 104  v. p. should be determined for at least 3 temperatures in the range 0 50 ° C, and a mean v. p. expressed as Pascal units ( N/ m 2) at 20 or 25 ° C. This value should preferably be experimental but may be interpolated or extrapolated if necessary;  transitions ( change of state, decomposition) should be reported, giving temperature at which the change occurs at atmospheric pressure, and vapour pressure at 10 and 20 ° C below and above transition. EXCH\ MANUAL\ 96 AN3. DOC/ May 1996 3 [ 2.5] PARTITION COEFFICIENT N OCTANOL/ WATERRef. OECD TG 107 and 117  results expressed as log Pow at ° C ( measured or calculated, Annex of TG 117 can be used for calculation.)  for TG 107, measurement concentrations in both phases for each determination ( suggest 12 concentrations be reported ( duplicate determinations of concentrations in n octanol and in water under 3 different conditions)  for TG 117, average retention data as mean of at least 2 measurements be reported in addition to details on fitted regression line, calibration methods, deadtime etc.  any special considerations ( e. g. if compound is surface active, dissociative, insoluble in water, metal organic)

[ 2.6. A.] WATER SOLUBILITY Ref. OECD TG 105  results expressed as mg/ l at ° C, at least 2 5 replicates/ trial, full test report should include calibration data for the chosen method and the readings for the test solutions;  nature of carrier used for insoluble compounds;  if the substance is insoluble in water the detection limits of the analytical method should be indicated.

[ 2.6. B.] PH VALUE AND PKA VALUE Ref. OECD TG 112  For pKa, results expressed as pKa at ° C, at least 3 replicates/ trial.

 Full report should include all measured data and statistical parameters used for the calculation of pKa in addition to calibration data for the chosen method.

[ 2.12] OXIDATION  REDUCTION POTENTIAL  OECD Test Guideline is not available for the measurement. However where applicable, indicate the redox potential and the conditions under which it was measured.

[ 2.13. A.] ADSORPTION/ DESORPTION TO SOIL Ref. OECD TG 106  Koc at ° C, tests should be made for 3 soil types, at least 2 replicates/ trial at one concentration in the screening test and at 4 concentration in the advanced test.

 Result of adsorption test, desorption test in the screening test, mass balance and adsorption isotherm data should be included in the full report.

3. ENVIRONMENTAL FATE AND PATHWAYS [ 3.1] STABILITY [ 3.1.1] PHOTODEGRADATION Ref. OECD TG 113  For SIDS, estimation is sufficient. However, if a study is provided, methods used to measure degradation over time ( 14 days) should be discussed, including reference standards ( if used), temperature, method of analysis, sensitivity, reproducibility etc.

 Results: changes observed on treated sample after testing; if possible, nature of decomposition products.

[ 3.1.2] STABILITY IN WATER ( HYDROLYSIS) Ref. OECD TG 111  should be examined at pH levels likely to be found in the environment ( pH 4 9).

Test Methods: should include information on identity and purity of test compound, reference standards, control, if used; detailed test procedures including test medium, temperature, pH, Buffer for each set of experiments, extraction method and recovery data if an extraction methods is used; EXCH\ MANUAL\ 96 AN3. DOC/ May 1996 4 Results: should be expressed in terms of half life ( t ½ ) in days, or for unstable compounds ( in hours).

i) Initial Test  soluble substances, should be carried out at 50 ° C for 5 days to indicate stability ( solubility > 10  6 g/ l) at a range of pH ( 4.0, 7.0, 9.0).

Results: if < 10% hydrolysis is seen after 5 days, ( t1/ 2 > 1 year) the product is considered hydrologically stable and no further testing is required. If the substance is unstable at environmentally relevant temperatures, e. g. if t1/ 2 < 1 day at 25 ° C, no further testing is required.

ii) Further testing For unstable compounds ( 1 year > t1/ 2 > 1 day ), further testing at 2 3 appropriate temperatures may be required.

[ 3.3] TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS  Methods for estimating environmental concentrations and fate are presented in " Guidance for Initial Assessment of Environmental Exposure", " Report of the OECD Workshop on the Application of Simple Models for Environmental Exposure Assessment ( OECD Monograph No. 69)" and " Compendium of Environmental Exposure Assessment Methods for Chemicals" ( OECD Environment Monograph No. 27). Diskettes of PC programme of models in the guidance document are available from the SIDS Contact Points or the Secretariat ( see Section 4.3 of this Manual).

 Calculation of distribution by a Fugacity Level 1 type model should be provided. [ 3.5] BIODEGRADATION  Choice of testing protocols should be determined by physical chemical properties ( e. g., solubility, volatility) and structure of test substances, e. g.,  for soluble/ insoluble substances tests based on dissolved organic carbon ( DOC) or oxygen depletion and carbon dioxide generation. For volatile substances a closed system may need to be employed.