巴拉圭登记要求

1、 /6DocumentsneededforregistrationofpesticideinParaguay巴拉圭登记要求原药的登记要求序号英文原文中文翻译1LetterofAuthorization.(Noneedtobelegalized)授权信（无需使馆认证）2Registrationcertificate(LegalizedbyEmbassyofParaguay)登记证（ICAMA）（使馆认证）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）申请人2）制造商3）通用名4）同义的名称IUPAC命名CAS号7）经验式8）化学式9）实验代码10）化学组11）生产工艺的原理图12）活性成分的最低含量13）异构体14）含量大于等于1g/kg的杂质的最大含量15）含量小于1g/kg的杂质的最大含量16）添加剂4GPSPositionOfTheMufacture工厂的地理坐标5Fivebatchreport5批次报告6Certificateofanalysis.分析单7Compositioncertificatesignedbytheresponsibleofthemanufacturercompany组成8Ma

5、nufacturingprocess生产工艺Nameandaddressofthemanufacturer.Generalcharacterizationoftheprocess.Diagramofmanufacturewiththedifferent1）生产商的名称和地址2）工艺的一般特征3）生产工艺流程图（化学反chemicalreactionsthatarehappeningduringtheprocess.Identificationoftheusedmaterialsfortheproductionoftheproduct.Descriptionoftheusedequipment.

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

7、oduct.应式）4）生产原料的鉴定5）设备的描述6）工艺中的各条件7）生产中的副反应及材料和产品的可能性迁移。9MSDSMSDS10ANALYTICALMETHOD(Analyticalmethodsforthecuali-quantitativedeterminationoftheactivesubstancepurechemistry,ofimpuritiesandthoseimpuritiesgreaterto0.1%and,whenitcorresponds,forthedeterminationofisomersandestabilizantes.)活性成分，杂质、及相应的异构体的

8、定量分析方法。11PHISICALANDCHEMICALPROPERTIES(accordingtomethodsinternationallyrecognized)物化性质（根据国际公认的分析方法）Aspect:(Physicalstate,Color,Scent)PointofFusion(forsolidstoroomtemperature)Boilingpoint(forliquidstoroomtemperature)DensitySteampressureVolatilenessPhantomofabsorptionWatersolubilitySolubilityinreliab

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

10、dstoroomtemperature)物化状态、颜色、状态沸点（固体）沸点（液体）密度蒸汽压挥发性吸附系数在水中的溶解性在有机溶剂中的溶解性正辛醇/水的比例系数在水中稳定性可燃性面张力爆炸性氧化性（腐蚀性）包装材料活泼性pH水中解离常数粘度（液体）12Toxicitydata毒理资料12.1.AcuteToxicityOral,Skin,InhalatoryCutaneousandocular.急性毒性（6项）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.经口累积性毒性（28d）b.啮齿和非啮齿动物的90d经口试验c.其他：吸入，经皮12.3慢性毒性a.慢性经口试验b.致癌性6.4诱变性a.基因突变b.染色体变异c.DNA变异.对繁殖的影响A.致畸性b.二代生殖的影响哺乳动物内的新陈代谢a.经口和经皮处理后的研究：吸收分布排泄b.代谢路径备注Ing.Agr.

13、FranciscoRegisMereles的PPT.江苏好收成同行同事的咨询。制剂登记要求序号英文原文中文翻译1LetterofAuthorization.(Noneedtobelegalized)授权信（无需使馆认证）2IDENTITY基本信息NameoftheapplicantNameoftheformuladorCommercialnameNumberoftheregistryoftheactivesubstancechemicaltechnicaldegree.Classofusetothatitisdestined(herbicida,insecticide,etc.).Typeof

14、formulation(gravyable,concentrateddustemulsionable,etc.).申请者生产商商品名原药的登记证号农药类型（杀菌剂、除草剂h杀虫剂等）3Registrationcertificate-ICAMA/Certificateoforigin/OrManufacturingCertificateforexportCERTIFYBYCCPITandLegalizedbyEmbassyofArgentinainChina,preferably.ICAMA,或原产地证明，或生产证明（阿根廷使馆认证）4Certificateofanalysis.分析单序号英文原

15、文中文翻译5Compositioncertificatesignedbytheresponsibleofthemanufacturercompany组成证明6Compositioncertificateoftheformulatedproductmadein5lots.5批次的组成证明7MSDSMSDS8Manufacturingprocess生产工艺9AnalyticalMethod分析方法。10PHISICALANDCHEMICALPROPERTIES(accordingtomethodsinternationallyrecognized)物化性质（根据国际公认的分析方法）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)外观（状态，颜色、气味）储存稳定

19、性（组成和状态等）相对密度可燃性9.4.1.着火点（液体）易燃性（固体）酸碱度爆炸性使用相关方面a）可湿性b）持久起泡性c）悬浮性d）粒度分析（湿筛）e）粒度分析（干筛）f）乳化稳定性（EC）g）腐蚀性h）与其他产品的兼容性i）密度（液体，20oC）j）闪点k）粘度l）磺化指数（油）m）分散性n）气体的脱离性n）粉末的松软度和流动性。）皂化和碘化p）在水中的溶解性在有机溶剂中的溶解性u）表面张力11StudiesofToxiceffectsinmammalspecies:毒理报告序号英文原文中文翻译Acutetoxicityformammals:Oral,Skin,Inhalatoria,Cu

20、taneousandocularirritation,CutaneousSensibilizaci6n.急性毒性（6项）经口，经皮，吸入，皮肤和眼睛腐蚀，致敏12OBLIGATORYMEDICALINFORMATION必要的医学信息DiagnosisandsymptomsofpoisoningProposedtreatments.FirstaidAntidote1MedicalTreatment.ComplementaryinformationMedical(whentheyareavailable).Observationontheexhibitionofthepopulationingen

21、eralandstudiesepidemiologists.Directobservationofclinical,accidentalanddeliberatecases毒的症状推荐的治疗急救解毒剂治疗补充的医学信息a.大体人口以及流行病专家研究的报告b.临床、以外、人为的直接观察13Dataoftheeffectsontheatmosphere.生态毒性.Acutetoxicitytonon-objectiveorganisms.AquaticorganismsBees1BirdsEffectsontheenvironmentBehaviorinsoilResidualityLeachin

22、gDegradabilityBehaviourinwaterandairResidualityDegradabilityVolatility.非靶标生物的急性毒性水生生物蜜蜂鸟类环境行为a）在土壤中的行为残留性沥滤降解性b）在水和空气中的行为残留性降解性14Dataontheapplication应用治疗Scopeofapplication应用范围EffectsonpestsandinvegetablesConditionsinwhichtheproductmayormaynotbeappliedDoseNumberandtimesofapplicationf)Applicationmetho

23、dsInstructionsforuseTimeofre-entryintothetreatedareaWaitingperiodsEffectsonsubsequentcropsPhytotoxicityRegistrationStatusintheCOSAVEregionandinothera）应用范围b）作用的病害和蔬菜c）施用的条件d）剂量e）应用的时间和次数f）施用方法g）使用说明h）施药后可再进入施药区域的间隔时间（RET）i）等待期（PHI）j）对后茬植物的影响k）植物毒性1）在其他国家和地区的登记序号英文原文中文翻译countriesm)ApprovedusesintheCOSA/Eregionandinothercountries状态m）在其他国家和地区的使用方法15Proposedpackages包装处理CONTAINERS:Type(Ex.:Drum,bottle,pouch,bags)Material(Ex