北京协和建昊医药技术开发有限责任公司BeijingUuion-GeniusPharmaceuticalTechnologyLtd项目领域Testingfield序号No.项目名称Nameofstudy方法号MethodcodeOECD编号OECDcode所需样品量(克)Neededsample(g)所需时间(天)NeededTime(d)健康毒理HealthEffects1急性经口毒性试验AcuteOralToxicityTest40140120~30282急性经皮毒性试验AcuteDermalToxicityTest40240210~20283急性吸入毒性试验AcuteInhalationToxicityTest40340320~30284急性皮肤刺激性/腐蚀性试验AcuteDermalIrritation/CorrosionTest40440410~20285急性眼刺激性/腐蚀性试验AcuteEyeIrritation/CorrosionTest40540510~20286皮肤致敏试验SkinSensitizationTest40640620~30407啮齿类动物28天反复经口毒性试验RepeatedDose28-dayOralToxicityStudyinRodents407407600~8001508啮齿类动物亚慢性(90天)经口毒性试验RepeatedDose90-dayOralToxicityinRodents4084081000~20002109非啮齿类动物亚慢性(90天)经口毒性试验RepeatedDose90-dayOralToxicityinNonrodents4094092000~400021010反复经皮毒性:21/28天试验RepeatedDoseDermalToxicity:21/28-dayStudy410410600~80015011亚慢性经皮毒性:90天试验SubchronicDermalToxicity:90-dayStudy4114111000~200021012反复吸入毒性:28天或14天试验RepeatedDoseInhalationToxicity:28/14-dayStudy412412600~80015013亚慢性吸入毒性:90天试验SubchronicInhalationToxicity:90-dayStudy4134131000~200021014致畸试验Teratogenicity414414500~80012015一代繁殖毒性试验One-GenerationReproductionToxicityStudy4154151000~200018016两代繁殖毒性试验Two-GenerationReproductionToxicityStudy4164161000~200024017毒物动力学试验ToxicokineticsStudy417417200~40012018有机磷化合物急性染毒的迟发性神经毒性试验DelayedNeurotoxicityofOrganophosphorusSubstancesFollowingAcuteExposure41841830~409019有机磷化合物亚慢性(28天)染毒的迟发性神经毒性实验DelayedNeurotoxicityofOrgarophosphorusSubstances:28-dayRepeatedDoseMethod419419200~40015020急性经口毒性:固定剂量法AcuteOralToxicity-FixedDoseMethod42042020~402821生殖和发育毒性筛选试验Reproduction/DevelopmentalToxicityScreeningTest421421300~50015022结合反复染毒毒性研究的生殖发育毒性筛选试验CombinedRepeatedDoseToxicityStudywiththeReproduction/DevelopmentalToxicityScreeningTest422422500~80021023急性经口毒性:急性毒性的阶层法AcuteOralToxicity-AcuteToxicClassMethod42342350~604024啮齿类动物的神经毒性试验NeurotoxicityStudyinRodents424424300~5009025急性经口毒性:上下增减剂量法AcuteOralToxicity:UpandDownProcedure42542550~604026致癌试验CarcinogenicityStudies4514515000~800072027慢性毒性试验ChronicToxicityStudies4524523000~600036028慢性毒性与致癌性联合试验CombinedChronicToxicity/CarcinogenicityStudies4534535000~800072029细菌回复突变试验BacterialReverseMutationTest471,472471,47210~206030体外哺乳动物细胞染色体畸变试验InvitroMammalianChromosomeAberrationTest47347310~206031哺乳动物红细胞微核试验MammalianErythocyteMicronucleusTest47447430~503532哺乳动物骨髓染色体畸变试验MammalianBoneMarrowChromosomeAberrationTest47547510~206033体外哺乳动物细胞基因突变试验InvitroMammalianCellGeneMutationTest47647610~209034黑腹果蝇伴性隐性致死试验Sex-linkedRecessiveLethalTestinDrosophilaMelanogaster,SLRL47747710~209035啮齿类动物显性致死试验RodentDominantLethalTest478478200~4009036哺乳类动物细胞姐妹染色单体互换体外试验InvitroSisterChromatidExchangeAssayinMammalianCells47947910~209037酿酒酵母基因突变试验Saccharomycescerevisiae,GeneMutationAssay48048010~206038酿酒酵母有丝分裂重组试验SaccharomycesCerevisiaeMitoticRecombinationAssay48148110~206039哺乳类动物细胞DNA损害与修复/程序外DNA合成体外试验DNADamageandRepair/UnscheduledDNASynthesisinMammalianCellsinvitro48248210~209040哺乳动物精原细胞染色体畸变试验MammalianSpermatogonialChromosomeAberrationTest48348310~209041小鼠斑点试验MouseSpotTest484484100~2009042小鼠可遗传易位试验MouseHeritableTranslocationAssay485485200~4009043体内哺乳动物肝细胞程序外DNA合成(UDS)试验UnscheduledDNASynthesis(UDS)TestwithMammalianLiverCellsinvivo48648610~209044空斑形成细胞试验(PFC)PlaqueFormingCellAssay49049010~209045迟发型超敏反应试验DelayedTypeHypersensitivityTest491491100~2009046自然杀伤细胞活性试验NaturalKillerCellActivityAssay49249210~2090理化性质Physical-chemicalproperty47紫外-可见吸收光谱US-VISAbsorptionSpectra1011011006048熔点/熔点范围MeltingPoint/MeltingRange1021021003049沸点BoilingPoint1031032006050蒸汽压VapourPressure10410410018051水溶解度WaterSolubility1051051009052吸附/解析Adsorption/Desorption1061065012053分配系数(正辛醇/水)-摇瓶法PartitionCoefficient(n-octanol/water-PolarographicMethod)1071071009054液体和固体的密度DensityofLiquidsandSolids109109200ml/200g6055颗粒物粒度分布/纤维长度和直径分布ParticleSizeDistribution/FibreLengthandDiameterDistributions1101101006056与PH有关的水解作用HydrolysisasaFunctionofPh1111115030057分配系数(正辛醇/水)-高效液相色谱法PartitionCoefficient(n-octanol/water-HPLCMethod1171175090生态毒理Eco-toxicity58藻类生长抑制试验AlgaGrowthInhibitionTest201201206059溞类24hEC50急性活动抑制试验Daphniasp.24hEC50AcuteImmobilizationTest202202204560鱼类急性毒性试验FishAcuteToxicityTest20320320010061鱼类14天延长毒性试验Fish,ProlongedToxicityTest:14-dayStudy20420420010062鸟类日粮毒性试验AvianDietaryToxicityTest205205251463鸟类繁殖试验AvianReproductionTest2062062309064蚯蚓急性毒性试验Earthworm,AcuteToxicityTest207207709065活性污泥呼吸抑制试验ActivatedSludge,RespirationInhibitionTest209209204566大型溞繁殖试验DaphniamagnaReproductionTest21121120018067蜜蜂急性经口毒性试验Honeybees,AcuteoralToxicityTest2132131009068蜜蜂急性接触毒性试验Honeybees,AcuteContactToxicityTest2142141006069快速生物降解性ReadyBiodegradability301301109070改进的MITI试验(I)ModifiedMITITestI301C301C1010071密闭瓶试验ClosedBottleTest301D301D1010072改进的OECD筛选试验ModifiedOECDScreeningTest301E301E1010073改进的半连续活性污泥(SCAS)试验InherentBiodegradability:ModifiedSCASTest302A302A2010074改进的MITI试验(II)ModifiedMITITestII302C302C2010075土壤固有生物降解能力InherentBiodegradabilityinSoil304A304A10012076流水式鱼类试验Bioconcentration:Flow-ThroughFishTest305305100021077连续静态鱼类试验Bioconcentration:SequentialStaticFishTest305A305A100021078半静态鱼类试验Bioconcentration:Semi-S