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REVISED OECD HPV FORM 1 SIDS DOSSIER ON THE HPV PHASE......... CHEMICAL CAS No. Sponsor Country: DATE:............... Also fNfill,foil: 2 EXCH\MANUAL\96-2.DOC/May 1996 o CMA 119673 SIDS PROFILE CONTENTS Page SIDS SUMMARY 1. GENERAL INFORMATION 1.01 SUBSTANCE INFORMATION * A. CAS-NUMBER B. NAME (IUPAC-NAME) *C. NAME (OECD NAME) fD. CAS DESCRIPTOR E. EINECS-NUMBER F. MOLECULAR FORMULA * G. STRUCTURAL FORMULA H. SUBSTANCE GROUP I. SUBSTANCE REMARK J. MOLECULAR WEIGHT 1.02 OECD INFORMATION A. SPONSOR COUNTRY B. LEAD ORGANISATION C. NAME OF RESPONDER (COMPANY) 1.1 GENERAL SUBSTANCE INFORMATION A. TYPE OF SUBSTANCE B. PHYSICAL STATE C. PURITY 1.2 SYNONYMS 1.3 IMPURITIES 1.4 ADDITIVES 1.5 * QUANTITY 1.6 LABELLING AND CLASSIFICATION (USE AND/OR TRANSPORTATION) 1.7 * USE PATTERN A. GENERAL USE PATTERN B. USES IN CONSUMER PRODUCTS 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE 1.9 * SOURCES OF EXPOSURE 1.10 ADDITIONAL REMARKS A. OPTIONS OF DISPOSAL B. OTHER REMARKS. 2. PHYSICAL-CHEMICAL DATA 2.1 * MELTING POINT 2.2 * BOILING POINT 2.3 f DENSITY (RELATIVE DENSITY) 2.4 * VAPOUR PRESSURE 2.5 * PARTITION COEFFICIENT n-OCTANOL/WATER 2.6 * WATER SOLUBILITY A. SOLUBILITY B. pH VALUE, pKa VALUE 2.7 FLASH POINT (LIQUIDS) EXCH\MANUAL\96-2.DOC/May 1996 CMA 119674 2.8 2.9 2.10 2.11 2.12 2.13 AUTO FLAMMABILITY (SOLID/GASES) FLAMMABILITY EXPLOSIVE PROPERTIES OXIDISING PROPERTIES f OXIDATIONrREDUCTION POTENTIAL ADDITIONAL REMARKS A. PARTITION CO-EFFICIENT BETWEEN SOIL/SEDIMENT AND WATER (Kd) B. OTHER REMARKS 3. ENVIRONMENTAL FATE AND PATHWAYS 3.1 3.1.1 3.1.2 3.1.3 3.2 3.3 3.3.1 3.3.2 3.4 3.5 3.6 3.7 3.8 STABILITY * PHOTODEGRADATION * STABILITY IN WATER STABILITY IN SOIL * MONITORING DATA (ENVIRONMENT) * TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS TRANSPORT THEORETICAL DISTRIBUTION (FUGACITY CALCULATION) MODE OF DEGRADATION IN ACTUAL USE * BIODEGRADATION BOD-5, COD OR RATIO BOD-5/COD BIOACCUMULATION ADDITIONAL REMARKS A. SEWAGE TREATMENT B. OTHER 4. ECOTOXICITY 4.1 4.2 4.3 4.4 4.5 4.5.1 4.5.2 4.6 4.6.1 4.6.2 4.6.3 4.7 4.8 4.9 * ACUTE/PROLONGED TOXICITY TO FISH ACUTE TOXICITY TO AQUATIC INVERTEBRATES * A. DAPHNIA B. OTHER AQUATIC ORGANISMS * TOXICITY TO AQUATIC PLANTS e.g., ALGAE TOXICITY TO BACTERIA CHRONIC TOXICITY TO AQUATIC ORGANISMS CHRONIC TOXICITY TO FISH (*) CHRONIC TOXICITY TO AQUATIC INVERTEBRATES (e.g., DAPHNIA REPRODUCTION) TOXICITY TO TERRESTRIAL ORGANISMS TOXICITY TO SOIL DWELLING ORGANISMS TOXICITY TO TERRESTRIAL PLANTS TOXICITY TO OTHER NON-MAMMALIAN TERRESTRIAL SPECIES (INCLUDING BIRDS) BIOLOGICAL EFFECTS MONITORING (INCLUDING BIOMAGNIFICATION) BIOTRANSFORMATION AND KINETICS ADDITIONAL REMARKS EXCH\MANUAL\96-2.DOC/May 1996 CMA 119675 5. TOXICITY 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.2 5.2.1 5.2.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 * ACUTE TOXICITY ACUTE ORAL TOXICITY ACUTE INHALATION TOXICITY ACUTE DERMAL TOXICITY ACUTE TOXICITY BY OTHER ROUTES OF ADMINISTRATION CORROSIVENESS/IRRITATION SKIN IRRITATION/CORROSION EYE IRRITATION/CORROSION SKIN SENSITISATION * REPEATED DOSE TOXICITY * GENETIC TOXICITY IN VITRO A. BACTERIAL TEST B. NON-BACTERIAL IN VITRO TEST * GENETIC TOXICITY IN VIVO CARCINOGENICITY * TOXICITY TO REPRODUCTION * DEVELOPMENTAL TOXICITY / TERATOGENICITY OTHER RELEVANT INFORMATION A. SPECIFIC TOXICITIES (NEUROTOXICITY, IMMUNOTOXICITY etc.) B. TOXICODYNAMICS, TOXICOKINETICS * EXPERIENCE WITH HUMAN EXPOSURE 6. REFERENCES Note: *; Data elements in the SIDS t; Data elements specially required for inorganic chemicals EXCH\MANUAL\96-2.DOC/May 1996 n CMA 119676 1.01 A. 1.01 C. 1.01 D. 1.01 G. 1.5 1.7 SIDS PROFILE DATE: CAS No. CHEMICAL NAME (OECD None) CAS DESCRIPTOR STRUCTURAL FORMULA OTHER CHEMICAL IDENTITY INFORMATION QUANTITY USE PATTERN 1.9 SOURCES AND LEVELS OF EXPOSURE ISSUES FOR DISCUSSION (IDENTIFY, IF ANY) SIDS testing required: EXCH\MANUAL\96-2.DOC/May 1996 CMA 119677 OECD Study GI.P Other Study Estimation Method SIDS Testing Required CAS NO: SIDS SUMMARY DATE: I ! STUDY PHYSICAL-CHEMICAL DATA 2.1 Melting Point 2.2 Boiling Point 2.3 Density 2.4 Vapour Pressure 2.5 Partition Coefficient 2.6 Water Solubility pH and pKa values 2.12 Oxidation: Reduction potential OTHER P/C STUDIES RECEIVED ENVIRONMENTAL FATE and PATHWAY 3.1.1 Pbotodegndaiion 3.1.2 Stability in water 3.2 Monitoring data 3.3 Transport and Distribution 3.5 Biodegradation ontIER ENV FATE STUDIES RECEIVED ECOTOXICITY 4.1 Acute toxicity to Fish 4.2 Acute toxicity to Daphnia 4.3 Toxicity to Algae 4.5.2 Chronic toxicity to Daphnia 4.6.1 Toxicity to Soil dwelling organinns 4.6.2 Toxicity to Terrestrial plants 4.6.3 Toxicity to Birds OTHER ECOTOXICITY STUDIES RECEIVED TOXICITY 5.1.1 Acute Oral 5.1.2 Acute Inhalation 5.1.3 Acute Dermal 5.4 Repeated Dose 5.5 Genetic Toxicity in vitro . Gene mutation . Chromosomal aberration 5.6 Genetic Toxicity in vivo 5.8 Reproduction Toxicity 5.9 Development / Teratogenicity 5.11 Human experience OTHER TOXICITY STUDIES RECEIVED Y/N Y/N Y/N Y/N Y/N Y/N Y/N EXCH\MANUAL\96-2.DOC/May 1996 CMA 119678 1. GENERAL INFORMATION 1.01 *A. B. *C. fD. SUBSTANCE INFORMATION Cast number ..................... -...................-.......... Name (IUPAC name) .......................................................... Name (OECD name) ......................................................... CAS Descriptor (where applicablefor complex chemicals) E. EINECS-Number ....................... *...................-................ F. Molecular Formula .............................................................................................. G. Structural Formula (indicate the structuralformula in smiles code, ifavailable) H. Substance Group (ifpossible, onlyforpetroleum products, see HEDSET explanatory note) I. Substance Remark (Indicate the substance remark as prescribed in the EINECS Inventory, if possible) J. Molecular Weight 1.02 A. B. OECD INFORMATION Sponsor Country: ....... Lead Organisation: Name of Lead Organisation: Contact person:................... . Address: Street:..................... Postal code:............. Town:..................... . Country:.................. . Tel:.......................... Fax:.......................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119679 C. Name of responder (Information on a responder should be provided when companies respond to Lead Organisation or SIDS Contact Points.) Name:.................... Address:................. Street:........ Postal code: Town:........ Country:.... Tel:............ Fax:............ EXCH\MANUAL\96*2.DOC/May 1996 16 CMA 119680 u GENERAL SUBSTANCE INFORMATION A. Type of Substance element [ ]; inorganic [ ]; natural substance [ ]; organic [ ]; organometallic [ ]; petroleum product [ ] B. Physical State (at 20C and 1.013 hPa) gaseous [ ]; liquid [ ]; solid [ ] C. Purity (indicate the percentage by weigfrt/weight)........................................................ 1.2 SYNONYMS 1J IMPURITIES [Indicate CAS No., chemical name (IUPAC name is preferable), percentage, if possible EJNECS number.] CAS No: EINECS No: Name: Value: Remarks: ..................... -....................-............... ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ 1.4 ADDITIVES (e.g. stabilising agertis, 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: 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 EU Member states, only indicate the EU import figure. Give an estimation ofthe globalproduction quantity in the remarks field. Information on the number ofproducers in the country and the source ofinformation should also be given in the remarks field.) Remarks: (If possible, indicate if the substance was produced and/or imported during the 12 months following adoption of the EU regulation on existing chemicals.)....................................................................................... Reference: EXCH\MANUAL\96-2.DOC/May 1996 17 CMA 119681 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 ofEC Directive 67/548/EEC.- See HEDSET Explanatory Note.] Labelling Type: Specific limits: Symbols: Nota: R-phrases: S-phrases: Text of S-phrases: Remaiks: ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ Classification Type: Category of danger R-phrases: Remarks: ........................................................................................................................ ....................................................................................................................... ........................................................................................................................ ........................................................................................................................ *1.7 A. USE PATTERN Genera) [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, fertilisers, impregnation agents, surface-active, etc. If available, give an estimation of different uses in percentage terms] Type of Use: Category: (a) main industrial use ................................................................................. ........................................... ...................................... (b) main industrial use .......................................................................................... .................................................................................. .................................................................................. Remarks: (a) ........................................................................................................................ <b) Reference: EXCH\MANUAL\96-2.DOC/May 1996 1R CMA 119682 B. Uses in Consumer Products [If the chemical is present in consumerproducts as marketed, give details ofproducts'function (e.g. detergent, etc.), and percentage in product and physical state ofproduct as marketed (e.g. aerosol, powder or liquid)] Function Amount present Physical gtttt Remarks: Reference: 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE (Indicate the type ofoccupational exposure limit value including short-term exposure limit value. If a value does not exist, give the hygiene standard ofthe producer company ifavailable. See also 5.11.) Exposure limit value Type: ..................................................................................................................................... Value: ..................................................................................................................................... Short term exposure limit value Value: ...................................................................................................................................... Length of exposure period:.................................................................................................................. Frequency: ...................................................................................................................................... Remarks: ..................................................................................................................................... Reference: ..................................................................................................................................... * 1.9 SOURCES OF EXPOSURE Describe sources ofpotential 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 retease, indication of type of release (e.g. point source or diffuse), type of estimating (e.g. average or worst case), uncertainties in estimation), for all phases of the life cycle of the chemical, if available, including manufacturing and user areas. For environmental exposure, indicate the production process briefly, number of sites of manufacture and, the basisfor concluding that the process is "closed" ifapplicable. Also an indication of measured exposure levels (expressed in an 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, ifavailable.) Source: Remarks: Reference: Media of release:....................................................................... .................................. Quantities per media:................................................................................................... ...................... .............................................................................................................. ............................................................................................. EXCH\MANUAL\96-2.DOC/May 1996 19 CMA 119683 1.10 ADDITIONAL REMARKS A. Options for disposal [Mode of disposal (e.g. incineration, release to sewage system, etc.) for each category and type ofme, ifappropriate: recyclingpossibility] Remarks: Reference: ..................................................................................................................................... ..................................................................................................................................... B. Other remarks Remarks: Reference: ..................................................................................................................................... ..................................................................................................................................... 2. PHYSICAL-CHEMICAL DATA *2.1 MELTING POINT (Ifmore than one, identify the recommended value.) Value: Decomposition: Sublimation: ..................... C Yes[] No|] Ambiguous[) Yes[] No[j Ambiguous!] Method: [e.g. OECD, other (with the year ofpublication or updated ofthe method med)] GLP: Remarks: Reference: Yes (f No'h * ? [ ] ................................. ................................. *22 BOILING POINT (Ifmore than one, identify the recommended value.) Value: ..................... C Pressure: at................... hPa Decomposition: Yes [ ] No {] Ambiguous [ ] Method: [e.g. OECD, other (with the year ofpublication or updating ofthe method med)]. GLP: Remarks: Reference: Yes l) NoM ?[] ......................... ..................................................................................... .................................................. ........................................................... f2_3 DENSITY (relative density) (Where applicable, indicate the relative density ofthe substance.) Type: Bulk density [ ]; Density [ ]; Relative Density [ ] Value: .............................................................................................................. Temperature: ..................... C Method: [e.g. OECD, other (with the year ofpublication or updating ofthe method med)]. GLP: Remarks: Reference: Yes !] No | ] ? IJ ...................................... ........................................................................ ............................................................................................ *2.4 VAPOUR PRESSURE (ifmore than one, identify the recommended value) EXCH\MANUAL\96-2.DOC/May 1996 CMA 119684 Value; Temperature: Method: ..................... hPa ..................... C calculated [ ]; measured [ ] [e.g. OECD, other (with theyear ofpublication or updated ofthe method used)]. GLP: Remarks: Reference: Yes [ j" Ko (i "? [ ] ....................................................................................................................... ....................................................................................................................... *2.5 PARTITION COEFFICIENT log,,?.. (ifmore than one, identify the recommended value) Log Pow: Temperature: Method: ..................... ..................... C calculated [ ]; measured [ ] [e.g. OECD, other (with the year ofpublication or updating ofthe method used)]. GLP: Remarks: Reference: Yes [ i No 11 ? I ] ........................................................................................................................ ........................................................................................................................ *2.6 WATER SOLUBILITY (ifmore than one. identify the recommended value) A. Solubility Value: ..................... Temperature: ..................... C Description; Miscible [); Ofvery high solubility [J; Ofhigh solubility [ ]; Soluble [ ]; Slightly soluble [ ]; Of low solubility [ ]; Ofvery low solubility [ ]; Not soluble [ ] Method: [e.g. OECD, other (with the year ofpublication or updating ofthe method used)]. GLP: Remarks: Reference: Yesf] No (J ?(i ........................................................................................................................ ............................................................................................. .......................... B. pH Value, pKa Value pH Value: ..................... Concentration: ..................... Temperature: ..................... C Method: [e.g. OECD, other (with the year ofpublication or updating ofthe method used). GLP: Yes [ J No [J ?[] (Where applicable, enter values for the dissociation constants) and the conditions under which they were measured.) pKa value ..................... at 25C Remarks: ........................................................................................................................ Reference: ........................................................................................................................ 2.7 FLASH POINT (liquids) EXCH\MANUAL\96-2.DOC/May 1996 CMA 119685 Value: Type of test Method; GLP: Remarics: Reference: ..................... C Closed cup [ I; Open cup [ ]; Other [ J (with the year ofpublication or updating ofthe method used). YesfJ NofJ ?[ I ................................................................................................... ................................................................................................... 2.8 AUTO FLAMMABILITY (solid/gases) Value: Pressure: Method: ..................... C ..................... hPa (with the year ofpublication or updating ofthe method used). GLP: Remarks: Reference: Yes [ ] No[) ?[] ........................................................................................................................ ........................................................................................................................ 2.9 FLAMMABILITY Results: Method: GLP: Remarks; Reference: Extremely flammable [ ]; Extremely flammable - liquified gas [ J; Highly Flammable [ ]; Flammable [ J; Non flammable [ ]; Spontaneously flammable in air [ ]; Contact with water liberates highly flammable gases [ ]; Other [ ] (with the year ofpublication or updating ofthe method used)..................... Yes [ j No[J ? f j .................................................................................................................... . .................................................................................................................... 2.10 EXPLOSIVE PROPERTIES Results: Method: Explosive under influence of a flame[ ]; More sensitive to friction than m-dinitrobenzene [ J; More sensitive to shock than m-dinitrobenzene [ ]; Not explosive [ ]; Other [ 1 (with the year ofpublication or updating ofthe method used).................. GLP: Remarks: Reference: Yes [ J No[] ?[] ................................. ................................. EXCH\MANUAL\96-2.DOC/May 1996 CMA 119686 2.11 OXIDISING PROPERTIES Results: Maximum burning rate equal or higher than reference mixture [ j: Vigorous reaction in preliminary test ( ]; No oxidising properties [ ]; Other [ ] Method: GLP: Remarks: Reference: (with the year ofpublication or updating ofthe method used)......... Yes' l l" No7j" ? I \ ............................................................................................................. ................................................................................................ .......... > f2.12 OXIDATION: REDUCTION POTENTIAL (Where applicable, indicate the redox potential and the conditions under which it was measured.) Value: Method: ..................... mV (with the year ofpublication or updating ofthe method used) GLP: Remarks: Reference: YesI] No|] ?[] 2.13 ADDITIONAL DATA A. Partition co-effident between aoQ/sediment and water (Kd) Value: ..................... Method: fe.g. OECD, other (with the year ofpublication or updating ofthe method used)]. GLP: Remarks: Reference: Yes [] Nol] ? 11 ........................................................ ................................................................ ........................................................................................................................ B. Other data (eg. Henry's Law constant, fat solubility, surface tension (of aqueous solution), adsorption/desorption on soil, particle size distribution, etc.) Results: Remarks: Reference: ........................................................................................................................ ........................................................................................................................ ........................................................................................................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119687 3. ENVIRONMENTAL FATE ANDPATHWAYS [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 Type: Air [ J; Water [ J; Soil [ 1; Other [ J Light source: Sunlight! ]; Xenon lamp U; Other [J Light spectrum: ..................... nm Relative intensity: ..................... (based on intensity ofsunlight) 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 ofsensitizer ..................... Concentration of sensitizer...................... Rate constant (radical): ..................... cmVmolecule*sec Degradation: ..................... Method: calculated [ ]; measured [ ] [e.g. OECD, other (with the year of publication or updating of the method used)] GLP: Test substance: Remarks: Reference: Yes l ] No[] ?U *3.1.2 STABILITY IN WATER Type: Half life: Degradation: Abiotic (hydrolysis) [ ]; biotic (sediment)! ) ..................... atpH ........................at........................ C after Method: [e.g. OECD, other (with the year of publication or updating of the method usedV................................................................................. GLP: Test substance: Remarks: Yes I ] No [ ] ? 1 ] ..................... .. purity:..................... (e.g. CAS number, name andpercentage ofdegradation products) Reference: EXCH\MANUAL\96-2.DOC/May 1996 CMA 119688 3.13 STABILITY IN SOIL Type : Field trial [ ]; Laboratory 11; Other [ ] Radiolabel: Yes [ ] No [ ] ? [) Concentration: ..................... Soil temperature: ..................... C Soil humidity: ..................... Soil classification: DIN19863 M; NFX31-107[); USDA [ J; Other [ ) year............... Content of clay etc.: Clay...........%, Silt.............. %, Sand............ % Organic Carbon: ..................... Soil pH: ..................... Cation exchange capacity: ..................... Microbial biomass: Dissipation time: DT 50:..................... DT90:..................... Dissipation: ..................... % after.....................(time) Method: [e.g. OECD, other (with the year of publication or updating of the method used)] GLP: Test substance: Remarks: Reference: Yes f ] No [ ] ?[ 1 ..................... .. purity: *3.2 MONITORING DATA (ENVIRONMENTAL) Note that data on biological effects monitoring, including biomagnification, and biotransformation and kinetics in environmental species are 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 workplace or indoor environment should be reported under item 5.11. Type of Measurement: Background! 1; At contaminated site f ]; Other [ ] Media: ........................................................................................................................ Results: ........................................................................................................................ Remarks: ........................................................................................................................ 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 orfield observations.) EXCH\MANUAL\96-2.DOC/May 1996 CMA 119689 *33.1 TRANSPORT Type: Media: Method: Results: Remarks: Reference: Adsorption [ ]; Desorption [ ]; Volatility ( ]; Other [ ] ...................................................................................................................... . ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ *332 THEORETICAL DISTRIBUTION (FUGACITY CALCULATION) Media: Method: Air-biota [ ]; Air-biota-sediment-soil-water [ J; Soil-biota [ ]; Water-air [ ]; Water-biota [ ]; Water-soil [ ]; Other [ ] Fugacity level I {J; Fugacity level II ( J; Fugarity level in [ ]; Fugacity level IV [ }; Other (calculation) [ ); Other (measurement)! ] Results: Remarks: Reference: 3.4 IDENTIFICATION OF MAIN MODE OF DEGRADABILITY IN ACTUAL USE Results: Remarks: Reference; ......................................................................................................... ......................................................................................................... ......................................................................................................... *3.5 BIODEGRADATION Type: aerobic [ ]; anaerobic [ ] Inoculum: adapted [ J; non-adapted ( J;...................................................................... Concentration of die chemical:............... related to COD [ ); DOC f ]; test substance [ ] Medium: water [ ); water-sediment [ ]; soil [ ]; sewage treatment [ ] Degradation: (percentage reduction/exposure time) ................... % after.......................(time) Results: (see OECD Guidelines) readily biodeg. [ ]; inherently biodeg. [ ]; under test condition no biodegradation observed [ ], other [ ] Kinetic (e.g. Zafan-Wellens-Test)................... % in......................... (time) Method: [e.g. OECD, other (with the year of publication or updating of the method used)]. GLP: Test substance: Remarks: Yes [ ] No ( ] ? [ J ..................... , purity:....................... [In the case of poorly soluble chemicals, treatment given (nature, concentration, CAS number, name and percentage of degradation products etc.)]:. Reference: EXCH\MANUAL\96-2.DOC/May 1996 26 CMA 119690 3.6 BOD,, COD OR RATIO BOD^COD BOD, Method: Concentration: Value: GLP: ..................... ..................... related to COD [ ..................... tug Of\ Yes [ ] Not] ? [ ] ); DOC ( 1; Test substance [ J COD Method: Value: GLP: ..................... ..................... mg OJg Yes [ J No [] ? [ ] Ratio BODj/COD: Remarks: Reference: 3.7 BIOACCUMULATION Species: Exposure period: Temperature: Concentration: BCF: Elimination: Method: ..................... C ..................... ..................... Yes [ ] No [ ] ? [ ] fe.g. OECD, other (with the year of publication or updating of the method used)]. Type of test GLP: Test substance: Remarks: Reference: calculated [ ]; measured [ ] static {]; semi-static [ ]; flow-through [ ]; other (e.g. field test) [ ] Yes [] No U ? [ ] ..................... .. purity:..................... ............................................................................................................... .............................................................................................................. 3.8 ADDITIONAL REMARKS A. Sewage treatment (information on treatability ofthe substance) Results: Remarks: Reference: ' ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ B. Other information [information that will help to focus the exposure assessment (either qualitative or quantitative)] Results: Remarks: Reference: ........................................................................................................................ ........................................................................................................................ ........................................................................................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119691 4. ECOTOXICITY *4.1 ACUTE/PROLONGED TOXICITY TO FISH Type of test static I J; semi-static [ 1; flow-through [ ]; other (e.g. field test) [} open-system [ ]; closed-system [ ] Species: Exposure period: Results: LCm (24h) =.............. mg/1 LC,o(4Sh) =.............mg/1 10,0(7211)=.............. mg/1 LCM (96h) =.............. mg/1 NOEC =.................. mg/1 LOEC =.................. mg/1 Analytical monitoring; Yes [ ] No [ J ? I ] Method: fe.g. OECD, other (with the year of publication or updating of the method used)]. GLP: Test substance: Remarks: Reference: Yes[ ] No[] ?{J ....................... .. purity:..................... 4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES *A. Daphnia Type of test static [ ]; semi-static [ ); flow-through {]; other (e.g. field test) [ ]; open-system [ ]; closed-system [ ] Species: Exposure period: Results: ECM (24h) =...............mg/1 ECM (48h) =...............mg/1 ECn (.M) =............... mg/1 NOEC =..................... mg/1 Analytical monitoring: Yes [ ] No [ J ? () Method: [e.g. OECD, other (with the year of publication or updating of the method used)]. GLP: Test substance: Remarks: Reference: YesM No[] ?[] ..................... .. purity:........................ B. Other aquatic organisms Type of test: Species: Exposure period: static l ]; semi-static l ]; flow-through l ]; other (e.g. field test) l ]; open-system [ ]; closed-system ( ] EXCH\MANUAL\96-2.DOC/May 1996 C CMA 11969? Results: ECm (24h) =................ mg/1 ECM(48h)=................ mg/1 EC,, (~h) =................. mg/1 NOEC *.................... mg/1 Analytical monitoring: Yes [ I No [ ] ? [ J Method: [e.g. OECD, other (with the year of publication or updating of the method used)]. GLP: Test substance: Remarks: Reference: Yes I j No (j ? [ | ..................... .purity:.................. *43 TOXICITY TO AQUATIC PLANTS, e*. algae Species: Endpoint: Biomass [ ]; Growth rate [ ]; Other [ ] Exposure period: Results: ........................ ECm(......... i)=.............. mg/1 (Endpoint) ECn (......... j) =.............. mg/1 NOEC -............. mg/1 LOEC -............. mg/1 Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................. GLP: Test substance: Remarks: Reference: open-system 1 ]; closed-system [ ] Yes I] No[l ? 11 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 [ J; Field t 1; Soil [ J; Other [ 1 Species: Exposure Period: Results: ECm (...h) =............. mg/1 EC0 (... h) =.............mg/1 Analytical monitoring: Yes [ ) No [ ] ? [ ] Method: [e.g. OECD, other (with the year ofpublication or updating ofthe method used) GLP: Test substance: Remarks: Reference: Yes [] NoU ?[ ] ....................... , purity:................ .. 43 CHRONIC TOXICITY TO AQUATIC ORGANISMS EXCH\MANUAL\96-2.DOC/Mav 1996 CMA 119693 4.5.1 CHRONIC TOXICITY TO FISH (effects on reproduction, embryo/larva, etc.) Type of test static [ 1; semi-static [ J; flow-through ( ]; other (e.g. field test) [ J; open-system[ ]; closed-system! ] Species: Endpoint Length of fish [ ]; Weight of fish [ ]; Reproduction rate [ ]; Other ( ] Exposure period: Results: ................... ECJO(..d)=.............. mg/1 (Endpoint) ECa (..d) =................mg/1 NOEC *................ .mg/1 LOEC =............... mg/1 Analytical monitoring: Yes [ 1 No l ] ? 11 Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................. GLP: Test substance: Remarks: Reference: Yes| ] No[J ?[} ........................purity:....................... (*>4.5.2 CHRONIC TOXICITY TO AQUATIC INVERTEBRATES (e.g. daphnia reproduction. The need to conduct testsfor this endpoint will depend inter alia upon possible concernfor long term effects.) Type of test static [ ]; semi-static [ ]; flow-through [ ]; other (e.g. field test) [ ]; open-system! ];closed-system[) Species: Endpoint Mortality [ J; Reproduction rate [ ]; Other [ ] Exposure period: Results: (Endpoint) ECn (......... d)=...............mg/1 NOEC =............... mg/1 LOEC -............... mg/1 Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................. GLP: Test substance: Remarks: Reference: Yes t ] No ! ] ? IJ ..................... , purity:....................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119694 4.6 TOXICITY TO TERRESTRIAL ORGANISMS 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS Type : Artificial soil { J; Filter paper [ J; Other [ J Species: Endpoint Mortality [ ]; Weight ( ]; Other ( ] Exposure period: Results: ................... EC*,<........ d>-.............. mg/kg ('Endpoint) EC*, (.........d) =.............. mg/kg EC,,(........d)=.............. mg/kg NOEC =......................mg/kg LOEC =..................... mg/kg Method: [e.g. OECD, other (with the year of publication or updating of the method used)]. GLP: Test substance: Remarks; Reference: Yes [ J No [ 1 ? I 1 ..................... .. purity:..................... 4.6.2 TOXICITY TO TERRESTRIAL PLANTS (a) Species: Endpoint Exposure period: Results: Method: Emergence [ ]; Growth [ J; Other [ ] EC*, and/or LC*, (7d) =...............mg/1 EC*, and/or LC*,(i4d) =............... mg/1 ECn and/or LCn (xxd) *.............. mg/1 NOEC =.....................................jng/1 LOEC =..................................... mg/1 [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................. GLP: Test substance: Remarks: Reference: Yes [J No [] ? U ..................... .. purity:........................ (b) Species: Endpoint Exposure period: Results: Method: Emergence [ ]; Growth [ J; Other [ ] EC*, and/or LC*, (7d) =............. mg/1 EC*, and/or LC*,(i4d) =............... mg/1 EC,, and/or LCn (xxd) =.............. mg/1 NOEC -................................... mg/1 LOEC =................................... mg/1 [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................. EXCH\MANUAL\96-2.DOC/May 1996 CMA 119695 GLP: Test substance: Remarks: Reference: (c) Species: Endpoint Exposure period: Results: Method: GLP: Test substance: Remarks: Reference: Yes ( ] No l ] ? |] ..................... .. purity: .................................... .................................... Emergence { J; Growth [ J; Other [ ] EC*, and/or LC*, (7d) =.............mg/1 EC*, and/or LC*,(i4d) *.............. mg/I EC,, and/or LC,, (xxd) -............. .mg/1 NOEC =..................................mg/1 LOEC =.................................. jng/1 [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................. Yes { J No I ] ?[ J ........................purity: 4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES (INCLUDING AVIAN) Species: Endpoint Exposure period: Results: Method: Mortality [ ]; Reproduction rate ( ); Weight [ ]; Other [ ] LD,, or LCa (xxd) =............. mg/kg NOEC =.............mg/kg LOEC =.............mg/kg [e.g. OECD, other (with the year of publication or updating of the method used)] GLP: Test substance: Remarks: Reference: Yes { ] No ( ] ? ( ) ........... purity:.......... ................................... ................................... 4.7 BIOLOGICAL EFFECTS MONITORING (INCLUDING BIOMAGNIFICATION) (Studies on variation of predominant species in certain ecosystems (e.g. mesocosm) and monitoring ofbiological effects are included.) Results: Substance:..................................... ................................................................ Species or ecosystem studied:....................................................................... Effects monitored: ........................................................................................ Results:........................................................................................................... Chemical analysis:......................................................................................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119696 Remarks: Reference: (Information on environmental conditions (e.g. water characteristics: suspended matter, pH, temperature, hardness; soil/sediment characteristics: % organic matter, clay content) 4.8 BIOTRANSFORMATION AND KINETICS (Under this item, studies on absorption, distribution, metabolism and excretion etc. should be given.) Type: Results: Remarks: Reference: Animal [ ]; Aquatic [ ]; Plant [ ]; Terrestrial f ]; Other [ ] ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ 4.9 ADDITIONAL REMARKS Results: Remarks: Reference: .......... ......... ......... EXCH\MANUAL\96-2.DOC/May 1996 33 CMA 119697 5. TOXICITY (Where observations on humans are available, these should be entered in the impropriate "Comments" section or under section 5.11.) *5.1 ACUTE TOXICITY 5.1.1 ACUTE ORAL TOXICITY Type: Species/strain: Value: Method: GLP: Test substance: Remarks: Reference: LD, [ ]; LDI0# I ]; LD * { ]; LDL# t ]; Other [ J ........................................................................................................................ ................. mg/kg b.w.: Discriminating dose:..................................................................................... [e.g. OECD, other (with the year of publication or tqxlating of the method used)]................................................................................................ Yes I ] No ( j ? [ ] ..................... .. purity:..................... ........................................................................................................................ ........................................................................................................................ 5.12 ACUTE INHALATION TOXICITY Type: Species/strain: Exposure time: Value: Method: LC, [ J; LC,,, | J; LC,, [ J; LCL, [ ]; Other [ ] ........................................................................................................................ .................................................................... ................................................... ........................................................................................................................ /e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes [ ] No fj ? [ ] ..................... .. purity:..................... ........................................................................................................................ 5.1 J ACUTE DERMAL TOXICITY Type: Species/strain: Value: Method: LD, [ ]; LD1W [ ]; LD ,, [ ]; LDL0 [ ]; Other [ ] ........................................................................................................................ ............................mg/kg b.w. [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes [ ] No [ J ? [ ] ..................... .. purity:..................... ........................................................................................................................ ...................................................................... EXCH\MANUAL\96-2.DOC/May 1996 34 CMA 119698 5.1.4 ACUTE TOXICITY, OTHER ROUTES OF ADMINISTRATION (e.g. subcutaneous, intravenous, etc.) Type: LC0 [ 1; LCigo [ ]; LC [ ]; LCL0 [ ]; Other [ J LD,,l J; LD)00 []; LDW[ ]; LDL,[ J; Other! J Species/strain: ................................................................................................... Route ofAdministration: Lm. [ 1; i.p. [ J; i.v. [ J; infusion [ J; s.c. I J; other { J Exposure time: ................................................................................................... Value: ........................................................................................................................ Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes f) No [ j ? I J ..................... .. purity:..................... ........................................................................................................................ ........................................................................................................................ 5.2 CORROSIVENESS/IRRITATION 5.2.1 SKIN IRRITATION/CORROSION Species/strain: Results: Classification: Method: ..................................................... .................................................................. Highly corrosive ( J; Corrosive! J; Highly irritating [ ]; Irritating ( ]; Moderate irritating ( ]; Slightly irritating [ ]; Not irritating [ ] (Ifpossible, according to EC Directive 67/548/EEC) Highly corrosive (causes severe bums) [ ]; Corrosive (causes bums) [ ]; Irritating [ ]; Not irritating ( ] [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes I ] No I ] ? I J ..................... .. purity:................. ........................................................................................................... ............ ............................................................................................. .......................... 5.2.2 EYE IRRITATION/CORROSION Species/strain: Results: Classification: Method: ............................................................... ]....................................................... Highly corrosive [ ]; Corrosive ( ); Highly irritating { ]; Irritating [ ]; Moderate irritating [ ]; Slightly irritating [ ]; Not irritating [ ] (ifpossible, according to EC Directive 67/548/EEC) Irritating [ ]; Not irritating [ ]; Risk of serious damage to eyes [ ] [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Yes I) No[ ) ? f ] Test substance: ..................... .. purity:................. Remarks: ........................................................................................................................ Reference: ........................................................ 5.3 SKIN SENSITISATION EXCH\MANUAL\96-2.DOC/May 1996 CMA 119699 Type: Species/strain: Results: Classification; Method: GLP: Test substance: Remarks: Reference: ........................................................................................................... ........................................................................................................................ Sensitizing [ ]; Not sensitizing [ ]; Ambiguous [ ] (ifpossible, according to EC Directive 67/548/EEC) Sensitizing [ ]; Not sensitizing [ ] [e.g. OECD, other (with the year of publication or updating of the method used)] Yes [ ] No l J ? I ] ..................... .. purity: .................................... .................................... *5.4 REPEATED DOSE TOXICITY Species/strain: ....................................................................................................... ...... Sex: Female [ ]; Male [ ]; Male/Female [ J; No data [ ) Route ofAdministration: .................................................................................................. Exposure period: ............................................................................................................. Frequency oftreatment: ...................................................................................................... Post exposure observation period: .................................................................................. Dose: ............................................................................................................. Control group: Yes { ]; No [ J; No data { J; Concurrent no treatment [ ]; Concurrent vehicle f ]; Historical [ ] NOEL: .............................................................................................................. LOEL: .............................................................................................................. Results: .............................................................................................................. Method: [e.g, OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP. Test substance: Reference: Yes [ J No{ j ? [J .......................... purity;..................... ................................................................................. ...................................... *5.5 GENETIC TOXICITY IN VITRO A. BACTERIAL TEST Type: (e.g. Bacterial reverse mutation assay, Bacterial gene mutation study, Cytoggnetic Assay etc.)............................................. .................................... System of testing: ................................................................................................. Concentration: ................................................................................................. Metabolic activation: With f J; Without [ J; With and Without { J; No [ J Results: Cytotoxicity cone: With metabolic activation:...................................................... Without metabolic activation:................................................ Precipitation cone: ................................................................................................. Genotoxic effects: +?. EXCH\MANUAL\96-2.DOC/May 1996 CMA 119700 Method: GLP: Test substance: Remarks: Reference: With metabolic activation: [ ] [ ] [ ] Without metabolic activation: [] [] [] [e.g. OECD, other (with the year of publication or updating of the method used)] Yes [ j No [) ? {1 ........... purity:.......... .......... .......... B. NON-BACTERIAL IN VITRO TEST Type: (e.g. mammalian cell gene mutation assay, cytogenetic assay, etc.) System of testing: .............................................................................................. Concentration: .............................................................................................. Metabolic activation: With [ ]; Without [ ]; With and Without [ ]; No data [ ] Results: Cytotoxicity cone: With metabolic activation:................................................... Without metabolic activation:.............................................. Precipitation cone:............. ................................................................................. Genotoxic effects: +?- With metabolic activation: [][][] Without metabolic activation: [j [ j [j Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes [ ] No[] ?(] ..................... .. purity:...................... ........................................................................................................................ ....................................................................... ....... ......................................... * 5.6 GENETIC TOXICITY IN VIVO Type: (e.g. micronucleus assay, etc.) Species/stmin: .................................................................................... Sex: Female [ ]; Male [ ]; Male/Female [ ]; No data [ ] Route Of Administration: ..................................................................................... Exposure period: Doses: .................................................................................... .................................................................................... Results: Effect on mitotic index or P/N ratio: ............................................................................. Genotoxic effects: + ?- Method: IMHl [e.g. OECD, other (with the year of publication or updating of the method used)] GLP: Test substance: Remarks: Yes 11 No [ \ ? [\ ..................... .. purity: .................................... EXCH\MANUAL\96-2.DOC/May 1996 CMA 119701 Reference: 5.7 CARCINOGENICITY Species/strain: ................................................................................... Sex: Femalef ]; Male [ ); Male/Female [ ]; No data! ] Route of Administration: ............................................................................ . Exposure period: ................................................................................... Frequency of treatment: ............................................................................. Postexposure observation period:.................................................................... Doses: ........................................................................................................................ Control group: Yes l ]; No [ ]; No data [ J; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] Results: ........................................................................................................................ Method: [e.g. OECD, other (with the year of publication or updating of the method used)] GLP: Test substance: Remarks: Reference: Yes [] No [ ] ? [ ] ..................... .. purity:................. .... ........................................................................................................................ ........................................................................................................................ *5.8 TOXICITY TO REPRODUCTION Type: Fertility [ J; One-generation study [ ]; Two-generation study { 1; Other[ 1 Species/strain: ...................................................................................................................... Sex: Female ( ]; Male ( ]; Male/Female [ ]; No data [ ] Route of Administration:................................................................................................................... Exposure period: ...................................................................................................................... Frequency of treatment:.................................................................................................................... Post exposure observation period:.................................................................................................... Premating exposure period: male:..............................female:................................................... Duration of the test ...................................................................................................................... Doses: ...................................................................................................................... Control group: Yes [ 1; No I ]; No data l ]; Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical ( ] NOEL Parental: ...................................................................................................................... NOEL FI Of&pring: ...................................................................................................................... NOEL F2 Oflspring: ................................................................................... .................................. Results: ...................................................................................................................... General parental toxicity:............................................................................ Toxicity to oflspring: (weights oflitter, postnatal growth, viability, etc.) Method: [e.g, OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Yes I] No[] ?JJ ..................... , purity:....................... ................................................................ EXCH\MANUAL\96-2.DOC/May 1996 38 CMA119702 Reference; *5.9 DEVELOPMENTAL TOXICITY/ TERATOGENICITY Species/strain: ............................................................................................................. Sex: Female [ ]; Male [ ]; Male/Female [ ]; No data [ ] Route of Administration: ..................................................................................................... Duration of the test ............................................................................................................. Exposure period: ............................................................................................................. Frequency of treatment: ...................................................................................................... Doses: ............................................................................................................. Control group: Yes [ ]; No [ ]; No data [ ]; Concurrent no treatment ( ]; Concurrent vehicle [ ]; Historical [ ] NOEL Maternal Toxicity: ....................................................................................................... NOEL teratogenicity : ............. ............................................................................................... . Results: ........................................................................................................................ Maternal general toxicity:............................................................................. Pregnancy/litter data:..................................................................................... Foetal data:.................................................................................................... Method: [e.g. OECD, other (with the year of publication or updating of the method used)]................................................................................................ GLP: Test substance: Remarks: Reference: Yes [ J No [ ] ? M ..................... .. purity:..................... ........................................................................................................................ ........................................................................................................................ 5.10 A. B. OTHER RELEVANT INFORMATION Specific toxicities Type: (e.g. neurotoxicity, immunotoxicity, etc.) Results: Remarks: Reference: ........................................................... ........................................................... ........................................................... Toxicodynamics, toxicokinetics Type: (e.g. toxicodynamics. toxicokinetics) Results: Remarks: References: * 5.11 EXPERIENCE WITH HUMAN EXPOSURE (Describe information on workplace exposure such as concentration of chemicals in the workplace or indoor environment (manufacturing, maintenance and professional use), number of workers (in ranges for each situation), frequency and duration of exposure, if available. In EXCH\MANUAL\96-2.DOC/May 1996 CMA 119703 addition, enter details of effects of accidental or occupational exposure, epidemiological and clinical studies, case reports, etc.) Results: Remarks: Reference: ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ 6. REFERENCES (Indicate the name of the book, journal, etc. where the study appears; volume; page numbers; and date ofreport orpublication. In general, information should be takenfrom 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.) EXCH\MANUAL\96-2.DOC/May 1996 CMA 119704