巴拉圭登記要求

1、 /6DocumentsneededforregistrationofpesticideinParaguay巴拉圭登記要求原藥的登記要求序號英文原文中文翻譯1LetterofAuthorization.(Noneedtobelegalized)授權(quán)信（無需使館認(rèn)證）2Registrationcertificate(LegalizedbyEmbassyofParaguay)登記證（ICAMA）（使館認(rèn)證）3Identity基本信息ApplicantManufacturerCommonname:acceptedbyISO,orproposed,initsorder,byBSI,ANSI,WSSAo

2、rthemanufacturer,untilitsacceptanceordenominationbyISO.SynonymousChemicalnameacceptedorproposedbyIUPACNumberCASEmpiricalformulaStructuralformulaNumberofexperimentalcodeChemical(s)group(s)SchematicdiagramofthemanufactureprocessMinimumcontentofactiveingredientIsomersMaximumlimitofeachpresentimpuritywh

3、osecontentisequalorsuperiorto1g/kg(basedonthedataofanalysisoffivelotslikeminimum).Theimpuritiesmustbeidentifiedandbequantified.Theidentifiedfractionoftheactivesubstancechemicaltechnicaldegreedoesnothavetosurpassthe20g/kg.Maximumlimitofeachexcellentimpuritywhosecontentisinferiorto1g/kgAdditives(ej.:e

4、stabilizantes)1）申請人2）制造商3）通用名4）同義的名稱IUPAC命名CAS號7）經(jīng)驗式8）化學(xué)式9）實驗代碼10）化學(xué)組11）生產(chǎn)工藝的原理圖12）活性成分的最低含量13）異構(gòu)體14）含量大于等于1g/kg的雜質(zhì)的最大含量15）含量小于1g/kg的雜質(zhì)的最大含量16）添加劑4GPSPositionOfTheMufacture工廠的地理坐標(biāo)5Fivebatchreport5批次報告6Certificateofanalysis.分析單7Compositioncertificatesignedbytheresponsibleofthemanufacturercompany組成8Ma

5、nufacturingprocess生產(chǎn)工藝Nameandaddressofthemanufacturer.Generalcharacterizationoftheprocess.Diagramofmanufacturewiththedifferent1）生產(chǎn)商的名稱和地址2）工藝的一般特征3）生產(chǎn)工藝流程圖（化學(xué)反chemicalreactionsthatarehappeningduringtheprocess.Identificationoftheusedmaterialsfortheproductionoftheproduct.Descriptionoftheusedequipment.

6、Generaldescriptionoftheconditions(forexample:temperature,pressure,pH,humidity)thatarecontrolledduringtheprocess.Descriptionofpossiblereactionaftertheformulationprocessbetweenactiveingredientsobetweenthisandotherscomponentsoftheformulationorthepackage.Possiblemigrationsofmaterialsofthepackageandthepr

7、oduct.應(yīng)式）4）生產(chǎn)原料的鑒定5）設(shè)備的描述6）工藝中的各條件7）生產(chǎn)中的副反應(yīng)及材料和產(chǎn)品的可能性遷移。9MSDSMSDS10ANALYTICALMETHOD(Analyticalmethodsforthecuali-quantitativedeterminationoftheactivesubstancepurechemistry,ofimpuritiesandthoseimpuritiesgreaterto0.1%and,whenitcorresponds,forthedeterminationofisomersandestabilizantes.)活性成分，雜質(zhì)、及相應(yīng)的異構(gòu)體的

8、定量分析方法。11PHISICALANDCHEMICALPROPERTIES(accordingtomethodsinternationallyrecognized)物化性質(zhì)（根據(jù)國際公認(rèn)的分析方法）Aspect:(Physicalstate,Color,Scent)PointofFusion(forsolidstoroomtemperature)Boilingpoint(forliquidstoroomtemperature)DensitySteampressureVolatilenessPhantomofabsorptionWatersolubilitySolubilityinreliab

9、leorganicCoefficientofpartitioninn-octanol/waterWaterstabilityInflammabilityorpointofignition(inthecaseofcombustibleincendiaryfuels)Surfacetension(aqueoussolutions)ExplosivepropertiesOxidatingproperties(corrosivity)ReactivitywiththematerialofpackagespHConstantofdissosciationinwaterViscosity(forliqui

10、dstoroomtemperature)物化狀態(tài)、顏色、狀態(tài)沸點（固體）沸點（液體）密度蒸汽壓揮發(fā)性吸附系數(shù)在水中的溶解性在有機(jī)溶劑中的溶解性正辛醇/水的比例系數(shù)在水中穩(wěn)定性可燃性面張力爆炸性氧化性（腐蝕性）包裝材料活潑性pH水中解離常數(shù)粘度（液體）12Toxicitydata毒理資料12.1.AcuteToxicityOral,Skin,InhalatoryCutaneousandocular.急性毒性（6項）短中期毒性irritation,CutaneousSensibilizacion.Toxicityintheshort/mediumtermCumulativeoral(28dayss

11、tudy)Oraladministrationinrodentsandnon-rodent(90days)Otherways:Inhalatory,DermalChronicleToxicityOraltolongtermCarcinogenicity6.4MutagenicityGeneticMutations(AmesTestorothers)ChromosomalaberrationsDNAperturbations.EffectsonReproductionaTeratogenicityb.Studiesofreproductiveeffectsinatleasttwogenerati

12、onsofmammalsMetabolisminMammalsa.Studyof:(afteroralanddermaladministration)Absorption;Distribution;Excretion.b.Understandingthemetabolicpathwaysa.經(jīng)口累積性毒性（28d）b.嚙齒和非嚙齒動物的90d經(jīng)口試驗c.其他：吸入，經(jīng)皮12.3慢性毒性a.慢性經(jīng)口試驗b.致癌性6.4誘變性a.基因突變b.染色體變異c.DNA變異.對繁殖的影響A.致畸性b.二代生殖的影響哺乳動物內(nèi)的新陳代謝a.經(jīng)口和經(jīng)皮處理后的研究：吸收分布排泄b.代謝路徑備注Ing.Agr.

13、FranciscoRegisMereles的PPT.江蘇好收成同行同事的咨詢。制劑登記要求序號英文原文中文翻譯1LetterofAuthorization.(Noneedtobelegalized)授權(quán)信（無需使館認(rèn)證）2IDENTITY基本信息NameoftheapplicantNameoftheformuladorCommercialnameNumberoftheregistryoftheactivesubstancechemicaltechnicaldegree.Classofusetothatitisdestined(herbicida,insecticide,etc.).Typeof

14、formulation(gravyable,concentrateddustemulsionable,etc.).申請者生產(chǎn)商商品名原藥的登記證號農(nóng)藥類型（殺菌劑、除草劑h殺蟲劑等）3Registrationcertificate-ICAMA/Certificateoforigin/OrManufacturingCertificateforexportCERTIFYBYCCPITandLegalizedbyEmbassyofArgentinainChina,preferably.ICAMA,或原產(chǎn)地證明，或生產(chǎn)證明（阿根廷使館認(rèn)證）4Certificateofanalysis.分析單序號英文原

15、文中文翻譯5Compositioncertificatesignedbytheresponsibleofthemanufacturercompany組成證明6Compositioncertificateoftheformulatedproductmadein5lots.5批次的組成證明7MSDSMSDS8Manufacturingprocess生產(chǎn)工藝9AnalyticalMethod分析方法。10PHISICALANDCHEMICALPROPERTIES(accordingtomethodsinternationallyrecognized)物化性質(zhì)（根據(jù)國際公認(rèn)的分析方法）AspectPh

16、ysicalstateColorScentStabilityinthestorage(respecttoitscompositionandtothephysicalpropertiesrelatedtotheuse).RelativedensityInflammabilityForliquids,pointofignitionForsolids,itmustbeclarifiediftheproductisornon-inflammable.Acidez/AlcalinidadandpH.Explosiveproperties.ASPECTSRELATEDTOITSUSEWettability

17、(fordispersiblepowders)Persistenceoffoam(productsthatareappliedwithwater)Suspensibility(forWP,SC)Particlesizeanalysisinwet(forWP,SC)Particlesizeanalysisindry(granulesandpowder)Emulsionstability(forEC)CorrosivityIncompatibilitywithotherproductsDensityat20oCing/mL(forliquids)FlashPoint(oilsandsolution

18、s)Viscosity(oils,suspensionsoremulsions)Indexofsulfonation(oils)Dispersion(forWG)n)Detachmentofgas(forgasgenerators)n)Easeandfluidity(fordrypowders)o)Iodineindexandindexofsaponification(oils)p)Watersolubilityq)Solubility/miscibilityinreliableorganic.u)Surfacetension(aqueoussolutions)外觀（狀態(tài)，顏色、氣味）儲存穩(wěn)定

19、性（組成和狀態(tài)等）相對密度可燃性9.4.1.著火點（液體）易燃性（固體）酸堿度爆炸性使用相關(guān)方面a）可濕性b）持久起泡性c）懸浮性d）粒度分析（濕篩）e）粒度分析（干篩）f）乳化穩(wěn)定性（EC）g）腐蝕性h）與其他產(chǎn)品的兼容性i）密度（液體，20oC）j）閃點k）粘度l）磺化指數(shù)（油）m）分散性n）氣體的脫離性n）粉末的松軟度和流動性。）皂化和碘化p）在水中的溶解性在有機(jī)溶劑中的溶解性u）表面張力11StudiesofToxiceffectsinmammalspecies:毒理報告序號英文原文中文翻譯Acutetoxicityformammals:Oral,Skin,Inhalatoria,Cu

20、taneousandocularirritation,CutaneousSensibilizaci6n.急性毒性（6項）經(jīng)口，經(jīng)皮，吸入，皮膚和眼睛腐蝕，致敏12OBLIGATORYMEDICALINFORMATION必要的醫(yī)學(xué)信息DiagnosisandsymptomsofpoisoningProposedtreatments.FirstaidAntidote1MedicalTreatment.ComplementaryinformationMedical(whentheyareavailable).Observationontheexhibitionofthepopulationingen

21、eralandstudiesepidemiologists.Directobservationofclinical,accidentalanddeliberatecases毒的癥狀推薦的治療急救解毒劑治療補(bǔ)充的醫(yī)學(xué)信息a.大體人口以及流行病專家研究的報告b.臨床、以外、人為的直接觀察13Dataoftheeffectsontheatmosphere.生態(tài)毒性.Acutetoxicitytonon-objectiveorganisms.AquaticorganismsBees1BirdsEffectsontheenvironmentBehaviorinsoilResidualityLeachin

22、gDegradabilityBehaviourinwaterandairResidualityDegradabilityVolatility.非靶標(biāo)生物的急性毒性水生生物蜜蜂鳥類環(huán)境行為a）在土壤中的行為殘留性瀝濾降解性b）在水和空氣中的行為殘留性降解性14Dataontheapplication應(yīng)用治療Scopeofapplication應(yīng)用范圍EffectsonpestsandinvegetablesConditionsinwhichtheproductmayormaynotbeappliedDoseNumberandtimesofapplicationf)Applicationmetho

23、dsInstructionsforuseTimeofre-entryintothetreatedareaWaitingperiodsEffectsonsubsequentcropsPhytotoxicityRegistrationStatusintheCOSAVEregionandinothera）應(yīng)用范圍b）作用的病害和蔬菜c）施用的條件d）劑量e）應(yīng)用的時間和次數(shù)f）施用方法g）使用說明h）施藥后可再進(jìn)入施藥區(qū)域的間隔時間（RET）i）等待期（PHI）j）對后茬植物的影響k）植物毒性1）在其他國家和地區(qū)的登記序號英文原文中文翻譯countriesm)ApprovedusesintheCOSA/Eregionandinothercountries狀態(tài)m）在其他國家和地區(qū)的使用方法15Proposedpackages包裝處理CONTAINERS:Type(Ex.:Drum,bottle,pouch,bags)Material(Ex