- A6/1 - APPENDIX 6. Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Classification and Labelling
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1 - A6/1 - APPENDIX 6 FORMAT FOR THE LISTING OF END POINTS TO BE INCLUDED IN THE REASONED STATEMENT OF THE OVERALL CONCLUSIONS DRAWN BY THE REGULATORY AUTHORITY (LEVEL 2) Chaptr 1: Proposd Idntity, Physical and Chmical Proprtis, Dtails of Uss, Furthr Information, and Classification and Lablling Activ substanc (ISO Common Nam) Function (.g. mating disruption) Idntity (Data point numbr IIP, point 1) Activ Ingrdint Componnt 1 (to b compltd for vry Activ Ingrdint Componnt) Chmical nam (IUPAC) Chmical nam (CA) CIPAC No CAS No EEC No (EINECS or ELINCS) FAO Spcification (including yar of publication) Minimum purity of th activ substanc as manufacturd (g/kg) Idntity of rlvant impuritis (of toxicological, nvironmntal and/or othr significanc) in th activ substanc as manufacturd (g/kg) Molcular formula Molcular mass Structural formula
2 Physical-chmical proprtis (Data point numbr IIP, point 2) Tchnical Grad of th Activ Ingrdint (TGAI) Mlting point (stat purity) Boiling point (stat purity) Apparanc (stat purity) Rlativ dnsity (stat purity) Vapour prssur (in Pa, stat tmpratur) Hnry s law constant (Pa m 3 mol -1 ) Solubility in watr (g/l or mg/l, stat tmpratur) Solubility in organic solvnts (in g/l or mg/l, stat tmpratur) Partition co-fficint (log P OW ) (stat ph and tmpratur) Hydrolytic stability (DT 50 ) (stat ph and tmpratur) UV/VIS absorption (max.) (if absorption > 290 nm stat ε at wavlngth) Photostability (DT 50 ) (aquous, sunlight, stat ph)
3 - A6/3 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Activ Ingrdint Componnt 1 (to b compltd for vry Activ Ingrdint Componnt) Mlting point (stat purity) Boiling point (stat purity) Apparanc (stat purity) Rlativ dnsity (stat purity) Vapour prssur (in Pa, stat tmpratur) Hnry s law constant (Pa m 3 mol -1 ) Solubility in watr (g/l or mg/l, stat tmpratur) Solubility in organic solvnts (in g/l or mg/l, stat tmpratur) Partition co-fficint (log P OW ) (stat ph and tmpratur) Hydrolytic stability (DT 50 ) (stat ph and tmpratur) UV/VIS absorption (max.) (if absorption > 290 nm stat ε at wavlngth) Photostability (DT 50 ) (aquous, sunlight, stat ph)
4 OECD Monog raph Guida nc Phro mons and Smioc hmica ls - Sptm br 2002 Summary of intndd uss
5 Crop and/ or situation Mmbr Stat or Country Product nam F G or I Psts or Group of psts controlld Formulation Application Application rat pr tratmnt PHI (days) Rmarks: - A6/4 - Appndix 6 F or m at fo r th lis ti n g of s n d p oi nt to b in cl u d d in th R a so n d St at m nt of th O v ra ll C o
6 Typ Conc. mthod growth numbr intrval kg as/hl watr L/ha kg as/ha of as kind stag & min max btwn sason applications min max min max min max (a) (b) ) (d-f) (I) (f-h) (j) (k) (min) (l) (m) (a) For crops, th EU and Codx classifications (both) should b usd; whr (h) Kind,.g. ovrall, broadcast, arial spraying, row, individual plant, btwn th plant - typ of rlvant, th us situation should b dscribd (.g. fumigation of a structur) quipmnt usd must b indicatd (b) Outdoor or fild us (F), glasshous application (G) or indoor application (I) (I) g/kg or g/l ).g. biting and suckling inscts, soil born inscts, foliar fungi, wds (j) Growth stag at last tratmnt (BBCH Monograph, Growth Stags of Plants, 1997, Blackwll, (d).g. wttabl powdr (WP), mulsifiabl concntrat (EC), granul (GR) ISBN ), including whr rlvant, information on sason at tim of application () GCPF Cods - GIFAP Tchnical Monograph No 2, 1989 (k) Indicat th minimum and maximum numbr of application possibl undr practical conditions of us (f) All abbrviations usd must b xplaind (l) PHI - minimum pr-harvst intrval (g) Mthod,.g. high volum spraying, low volum spraying, sprading, dusting, (m) Rmarks may includ: Extnt of us/conomic importanc/rstrictions drnch
7 - A6/7 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Classification and proposd lablling with rgard to physical/chmical data with rgard to toxicological data with rgard to fat and bhaviour data with rgard to cotoxicological data Chaptr 2: Mthods of Analysis Analytical mthods for th activ substanc (Data point numbr IIP, point and 4.2.3) Tchnical as (principl of mthod) Impuritis in tchnical as (principl of mthod) Plant protction product (principl of mthod) Chaptr 3: Impact on Human and Animal Halth Acut toxicity (Data point numbr IIP, point 5.2) Rat LD 50 oral Rat LD 50 drmal Rat LC 50 inhalation Skin irritation Ey irritation Skin snsitization (tst mthod usd and rsult)
8 - A6/8 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Accptabl xposur scnarios (including mthod of calculation) Oprator Workrs Bystandrs Consumr Chaptr 4: Rsidus (not normally rquird) Chaptr 5: Fat and Bhaviour in th Environmnt Soil adsorption/dsorption (Data point numbr IIP, point 7.4.1) K f /K oc K d ph dpndnc (ys / no) (if ys typ of dpndnc) Mobility in soil (Data point numbr IIP, point 7.4.3) Column laching Rout and rat of dgradation in watr (Data point numbr IIP, point 7.6) Photolytic dgradation of activ substanc and rlvant mtabolits Volatility (Data point numbr IIP, point 7.4.9) Laboratory study
9 - A6/9 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Monitoring data, if availabl (Data point numbr IIP, point 7.12) Soil (indicat location and typ of study) Surfac watr (indicat location and typ of study) Ground watr (indicat location and typ of study) Air (indicat location and typ of study) Chaptr 6: Effcts on Non-targt Spcis Effcts on trrstrial vrtbrats (Data point numbr IIP, point 8.1, Data point numbr IIIP, points 10.1 and 10.3) Acut toxicity to mammals Ditary toxicity to birds Toxicity/xposur ratios for trrstrial vrtbrats (Data point numbr IIIP, points 10.1 and 10.3) Application rat (kg as/ha) Crop Catgory (.g. insctivorous bird) Tim-scal TER Data point numbr VI Triggr
10 - A6/10 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Toxicity data for aquatic spcis (most snsitiv spcis of ach group) (Data point numbr IIP, point 8.2.1, 8.3, 8.4 and 8.6, Data point numbr IIIP, point 10.2) Group Tst substanc Tim-scal Endpoint Toxicity (mg/l) Laboratory tsts Microcosm or msocosm tsts Toxicity/xposur ratios for th most snsitiv aquatic organisms (Data point numbr IIIP, point 10.2) Application rat (kg as/ha) Crop Organism Tim-scal Distanc (m) TER Data point numbr VI Triggr Effcts on honybs (Data point numbr IIP, point 8.7, Data point numbr IIIP, point 10.4) Acut oral toxicity Acut contact toxicity
11 - A6/11 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Hazard quotints for hony bs (Data point numbr IIIP, point 10.4) Application rat (kg as/ha) Laboratory tsts Crop Rout Hazard quotint Data point numbr VI Triggr Fild or smi-fild tsts Effcts on othr arthropod spcis (Data point numbr IIP, point 8.8, Data point numbr IIIP, point 10.5) Spcis Stag Tst Substanc Laboratory tsts Dos (kg as/ha) Endpoint Effct Data point numbr VI Triggr Fild or smi-fild tsts Effcts on arthworms (Data point numbr IIP, point 8.9, Data point numbr IIIP, point 10.6) Acut toxicity Rproductiv toxicity
12 - A6/12 - Appndix 6 Format for th listing of nd points to b includd in th Rasond Statmnt of th Ovrall Conclusions Drawn by th Rgulatory Authority (Lvl 2) Rgulatory Authority Month and yar Activ Substanc (Nam) pag of Toxicity/xposur ratios for arthworms (Data point numbr IIIP, point 10.6) Application rat (kg as/ha) Crop Tim-scal TER Data point numbr VI Triggr Effcts on soil micro-organisms (Data point numbr IIP, point 8.10, Data point numbr IIIP, point 10.7) Nitrogn minralization Carbon minralization Effcts on trrstrial vascular plants (Data point numbr IIP, point 8.12, Data point numbr IIIP, point 10.8)
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