1、Documents needed for registration of pesticide in Paraguay巴拉圭登記要求原藥的登記要求序號英文原文中文翻譯1Letter of Authorization. （No need to be legalized ）授權(quán)信（無需使館認(rèn)證）2Registration certificate （Legalized by Embassy of Paraguay）登記證（ICAMA）(使館認(rèn)證)3Identity 基本信息1) Applicant 2) Manufacturer 3) Common name: accepted by ISO, or

2、proposed, in its order, by BSI, ANSI, WSSA or the manufacturer, until its acceptance or denomination by ISO. 4) Synonymous 5) Chemical name accepted or proposed by IUPAC 6) Number CAS 7) Empirical formula 8) Structural formula 9) Number of experimental code 10) Chemical(s) group(s) 11) Schematic dia

3、gram of the manufacture process 12) Minimum content of active ingredient 13) Isomers 14) Maximum limit of each present impurity whose content is equal or superior to 1g/kg (based on the data of analysis of five lots like minimum). The impurities must be identified and be quantified. The identified f

4、raction of the active substance chemical technical degree does not have to surpass the 20 g/kg. 15) Maximum limit of each excellent impurity whose content is inferior to 1 g/kg 16) Additives (ej.: estabilizantes) 1) 申請人2) 制造商3) 通用名4) 同義的名稱5) IUPAC命名6) CAS 號7) 經(jīng)驗(yàn)式8) 化學(xué)式9) 實(shí)驗(yàn)代碼10) 化學(xué)組11) 生產(chǎn)工藝的原理圖12) 活

5、性成分的最低含量13) 異構(gòu)體14) 含量大于等于1 g/kg的雜質(zhì)的最大含量15) 含量小于1 g/kg的雜質(zhì)的最大含量16) 添加劑4GPS Position Of The Mufacture工廠的地理坐標(biāo)5Five batch report5批次報(bào)告6Certificate of analysis.分析單7Composition certificate signed by the responsible of the manufacturer company組成8Manufacturing process生產(chǎn)工藝1) Name and address of the manufacture

6、r.2) General characterization of the process. 3) Diagram of manufacture with the different chemical reactions that are happening during the process.4) Identification of the used materials for the production of the product.5) Description of the used equipment.6) General description of the conditions

7、(for example: temperature, pressure, pH, humidity) that are controlled during the process.7) Description of possible reaction after the formulation process between active ingredients o between this and others components of the formulation or the package. Possible migrations of materials of the packa

8、ge and the product.1) 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。9MSDSMSDS10ANALYTICAL METHOD（Analytical methods for the cuali-quantitative determination of the active substance pure chemistry, of impurities and those impurities greater to 0.1% and, when i

9、t corresponds, for the determination of isomers and estabilizantes.）活性成分，雜質(zhì)、及相應(yīng)的異構(gòu)體的定量分析方法。11PHISICAL AND CHEMICAL PROPERTIES (according to methods internationally recognized)物化性質(zhì)（根據(jù)國際公認(rèn)的分析方法）11.1. Aspect: (Physical state, Color, Scent )11.2. Point of Fusion (for solids to room temperature) 11.3. Bo

10、iling point (for liquids to room temperature) 11.4. Density 11.5. Steam pressure 11.6. Volatileness 11.7. Phantom of absorption 11.8. Water solubility 11.9. Solubility in reliable organic 11.10. Coefficient of partition in n-octanol/water11.11. Water stability 11.12. Inflammability or point of ignit

11、ion (in the case of combustible incendiary fuels) 11.13. Surface tension (aqueous solutions) 11.14. Explosive properties 11.15. Oxidating properties (corrosivity) 11.16. Reactivity with the material of packages 11.17. pH 11.18. Constant of dissosciation in water 11.19. Viscosity (for liquids to room

12、 temperature) 11.1. 物化狀態(tài)、顏色、狀態(tài)11.2. 沸點(diǎn)（固體）11.3.沸點(diǎn)（液體）11.4. 密度11.5. 蒸汽壓11.6.揮發(fā)性11.7. 吸附系數(shù)11.8. 在水中的溶解性11.9.在有機(jī)溶劑中的溶解性11.10.正辛醇/水的比例系數(shù)11.11. 在水中穩(wěn)定性11.12.可燃性11.13.表面張力11.14. 爆炸性11.15. 氧化性（腐蝕性） 11.16.包裝材料活潑性11.17. pH 11.18. 水中解離常數(shù)11.19.粘度（液體）12Toxicity data毒理資料12.1. Acute Toxicity Oral, Skin, Inhalatory

13、 Cutaneous and ocular irritation ,Cutaneous Sensibilizacion. 12.2 Toxicity in the short / medium term a. Cumulative oral (28 days study)b. Oral administration in rodents and non-rodent (90days)c. Other ways: Inhalatory, Dermal12.3 Chronicle Toxicity a. Oral to long term b. Carcinogenicity 6.4 Mutage

14、nicity a. Genetic Mutations (Ames Test or others) b. Chromosomal aberrations c. DNA perturbations 12.5. Effects on Reproduction a Teratogenicity b. Studies of reproductive effects in at least two generations of mammals 12.6 Metabolism in Mammals a. Study of: (after oral and dermal administration) Ab

15、sorption; Distribution; Excretion. b. Understanding the metabolic pathways 12.1.急性毒性（6項(xiàng)）12.2 短中期毒性a. 經(jīng)口累積性毒性 (28 d)b. 嚙齒和非嚙齒動物的90d經(jīng)口試驗(yàn)c. 其他: 吸入, 經(jīng)皮12.3 慢性毒性a. 慢性經(jīng)口試驗(yàn)b. 致癌性6.4 誘變性a. 基因突變b.染色體變異c. DNA 變異12.5.對繁殖的影響A. 致畸性b. 二代生殖的影響12.6 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. Francisco Regis M

16、ereles 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1Letter of Authorization. （No need to be legalized ）授權(quán)信（無需使館認(rèn)證）2IDENTITY 基本信息2.1. Name of the applicant 2.2. Name of the formulador 2.3. Commercial name 2.4. Number of the registry of the active substance chemical technical degree. 2.5. Class of use to that

17、it is destined (herbicida, insecticide, etc.). 2.6. Type of formulation (gravyable, concentrated dust emulsionable, etc.). 2.1 申請者2.2 生產(chǎn)商2.3 商品名2.4 原藥的登記證號2.5農(nóng)藥類型(殺菌劑、除草劑、殺蟲劑等)3Registration certificate-ICAMA/ Certificate of origin/ Or Manufacturing Certificate for export CERTIFY BY CCPIT and Legaliz

18、ed by Embassy of Argentina in China, preferably.ICAMA,或原產(chǎn)地證明，或生產(chǎn)證明（阿根廷使館認(rèn)證）4Certificate of analysis.分析單5 Composition certificate signed by the responsible of the manufacturer company組成證明6Composition certificate of the formulated product made in 5 lots.5批次的組成證明7MSDSMSDS8Manufacturing process生產(chǎn)工藝9Anal

19、ytical Method分析方法。10PHISICAL AND CHEMICAL PROPERTIES (according to methods internationally recognized)物化性質(zhì)（根據(jù)國際公認(rèn)的分析方法）10.1. Aspect10.1.1. Physical state 10.1.2. Color 10.1.3. Scent 10.2. Stability in the storage (respect to its composition and to the physical properties related to the use).10.3. Re

20、lative density 10.4. Inflammability 10.4.1. For liquids, point of ignition10.4.2. For solids, it must be clarified if the product is or non-inflammable. 10.5. Acidez/Alcalinidad and pH. 10.6. Explosive properties. 10.7.ASPECTS RELATED TO ITS USEa) Wettability (for dispersible powders) b) Persistence

21、 of foam (products that are applied with water) c) Suspensibility (for WP, SC) d) Particle size analysis in wet (for WP, SC)e) Particle size analysis in dry (granules and powder) f) Emulsion stability (for EC) g) Corrosivity h) Incompatibility with other productsi) Density at 20oC in g/mL (for liqui

22、ds) j) Flash Point (oils and solutions) k) Viscosity (oils, suspensions or emulsions) l) Index of sulfonation (oils) m) Dispersion (for WG) n) Detachment of gas (for gas generators) n) Ease and fluidity (for dry powders) o) Iodine index and index of saponification (oils) p) Water solubility q) Solub

23、ility/miscibility in reliable organic. u) Surface tension (aqueous solutions) 10.1. 外觀（狀態(tài)，顏色、氣味）10.2.儲存穩(wěn)定性（組成和狀態(tài)等）10.3. 相對密度10.4. 可燃性9.4.1. 著火點(diǎn)（液體）10.4.2. 易燃性（固體）10.5.酸堿度10.6. 爆炸性10.7.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(diǎn)k) 粘度l) 磺化指數(shù)(油)m) 分

24、散性n) 氣體的脫離性n) 粉末的松軟度和流動性o) 皂化和碘化p) 在水中的溶解性q)在有機(jī)溶劑中的溶解性u) 表面張力11Studies of Toxic effects in mammal species:毒理報(bào)告Acute toxicity for mammals：Oral, Skin, Inhalatoria, Cutaneous and ocular irritation, Cutaneous Sensibilizacin. 急性毒性（6項(xiàng)）經(jīng)口，經(jīng)皮，吸入，皮膚和眼睛腐蝕，致敏12OBLIGATORY MEDICAL INFORMATION必要的醫(yī)學(xué)信息12.1. Diagnos

25、is and symptoms of poisoning 12.2. Proposed treatments. 12.3. First aid 12.4. Antidote 1 12.5. Medical Treatment. Complementary information Medical (when they are available). a. Observation on the exhibition of the population in general and studies epidemiologists. b. Direct observation of clinical,

26、 accidental and deliberate cases12.1 中毒的癥狀12.2. 推薦的治療12.3. 急救12.4.解毒劑12.5.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(bào)告b. 臨床、以外、人為的直接觀察13Data of the effects on the atmosphere.生態(tài)毒性12.1. Acute toxicity to non-objective organisms. 12.1.1. Aquatic organisms 12.1.2. Bees 112.1.3. Birds12.2 Effects on the environmenta) Beh

27、avior in soilResidualityLeachingDegradability b) Behaviour in water and airResidualityDegradabilityVolatility12.1. 非靶標(biāo)生物的急性毒性 12.1.1. 水生生物 12.1.2. 蜜蜂12.1.3. 鳥類12.2 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14Data on the application應(yīng)用治療a) Scope of application 應(yīng)用范圍b) Effects on pests and in vegetablesc)

28、 Conditions in which the product may or may not be appliedd) Dose e) Number and times of application f) Application methodsg) Instructions for useh) Time of re-entry into the treated area i) Waiting periods j) Effects on subsequent crops k) Phytotoxicity l) Registration Status in the COSAVE region and in other countries m) Approved uses in the COSAVE region and in other countriesa) 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(shí)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(shí)間（RET）i) 等待期(PHI)j)對后茬植物的影響k) 植物毒性l)在其他國家和地區(qū)的登記狀態(tài)m) 在其他國家和地區(qū)的使用方法15Proposed packages 包裝處理a) CONTAINER