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草甘膦FAO标准


FAO SPECIFICATIONS AND EVALUATIONS FOR PLANT PROTECTION PRODUCTS 联合国粮农组织植保产品规格和评估

GLYPHOSATE N-(phosphonomethyl)glycine 草甘膦

2000/2001
FOOD AND AGRICULTURE ORGANIZAT

ION OF THE UNITED NATIONS 联合国粮食和农业组织

TABLE OF CONTENTS 目录 GLYPHOSATE 草甘膦 Page 页码 2 3

DISCLAIMER 声明 INTRODUCTIO 介绍 PART ONE 第一部分

SPECIFICATION GLYPHOSATE 草甘膦规格 GLYPHOSATE INFORMATI 草甘膦资料 GLYPHOSATE ACID TECHNICAL 草甘膦原药 GLYPHOSATE ACID TECHNICAL CONCENTRATES 草甘膦酸母药 GLYPHOSATE ISOPROPYLAMINE SALT TECHNICAL CONCENTRATES 草甘膦异丙胺盐母药 GLYPHOSATE SOLUBLE CONCENTRATES 草甘膦水剂 GLYPHOSATE WATER SOLUBLE GRANULES 草甘膦可溶粒剂 PART TWO 第二部分 2000 EVALUATION REPORT GLYPHOSATE 2000 年版草甘膦评估报告 2001 EVALUATION REPORT GLYPHOSATE 2001 年版草甘膦评估报告

5 6 8 10

12 14

17 33

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GLYPHOSATE 2000/2001

Disclaimer1 声明 FAO specifications are developed with the basic objective of ensuring that pesticides complying with them are satisfactory for the purpose for which they are intended so that they may serve as an international point of reference. The specifications do not constitute an endorsement or warranty of the use of a particular pesticide for a particular purpose. Neither do they constitute a warranty that pesticides complying with these specifications are suitable for the control of any given pest, or for use in a particular area. Owing to the complexity of the problems involved, the suitability of pesticides for a particular application must be decided at the national or provincial level. Furthermore, the preparation and use of pesticides complying with these specifications are not exempted from any safety regulation or other legal or administrative provision applicable thereto. FAO shall not be liable for any injury, loss, damage or prejudice of any kind that may be suffered as a result of the preparation, transportation, sale or use of pesticides complying with these specifications. Additionally, FAO wishes to alert users of specifications to the fact that improper field mixing and/or application of pesticides can result in either a lowering or complete loss of efficacy. This holds true even where the pesticide complies with the specification. Accordingly, FAO can accept no responsibility for the consequences of improper field mixing and/or application. FAO is not responsible for ensuring that any product claimed to comply with FAO specifications actually does so.

_____________________ 1 This disclaimer applies to all specifications published by FAO. Furthermore it does not undertake to insure anyone who utilizes this Manual or the specifications against liability for infringement of any Letters Patent nor assume any such liability. Page2of33 GLYPHOSATE 2000/2001

INTRODUCTION 介绍 FAO establishes and publishes specifications* for technical material and related formulations of plant protection products with the objective that these specifications may be used to provide an international point of reference against which products can be judged either for regulatory purposes or in commercial dealings. Since 1999 the development of FAO specifications follows the New Procedure, described in the 5 edition of the “ Manual on the development and use of FAO specifications for plant protection products” (FAO Plant Production and Protection Page No. 149). This New Procedure follows a formal and transparent evaluation process. It describes the minimum data package, the procedure and evaluation applied by FAO and the Experts of the “FAO Panel of Experts on Pesticide Specifications, Registration Requirements, Application Standards and Prior Informed Consent.” FAO Specifications now only apply to products for which the technical materials have been evaluated. Consequently from the year 2000 onwards the publication of FAO specifications under the New Procedure has changed. Every specification consists now of two parts namely the specifications and the evaluation report(s): Part One: The Specification of the technical material and the related formulations of the plant protection product in accordance with chapter 4, 5 and 6 of the 5 edition of the “Manual on the development and use of FAO specifications for plant protection products”. Part Two: The Evaluation Report(s) of the plant protection product reflecting the evaluation of the data package carried out by FAO and the Panel of Experts. The data are to be provided by the manufacturer(s) according to the requirements of Appendix A, annex 1 or 2 of the “Manual on the development and use of FAO specifications for plant protection products” and supported by other information sources. The Evaluation Report includes the name(s) of the manufacturer(s) whose technical material has been evaluated. Evaluation reports on specifications developed subsequently to the original set of specifications are added in a chronological order to this report. FAO Specifications under the New Procedure do not necessarily apply to nominally similar products of other manufacturer(s), nor to those where the active ingredient is produced by other methods of synthesis. FAO has the possibility to extend the scope of the specifications to similar products, but only when the Panel of Experts has been satisfied that the additional products are equivalent to those which formed the basis of the reference specification. * Footnote: The publications are available on Internet under (http://www.fao.org/WAICENT/FAOINFO/AGRICULT/AGP/AGPP/Pesticid/) or as hardcopy from the Plant Protection Information Officer.

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GLYPHOSATE 2000/2001

PART ONE SPECIFICATIONS 第一部分 规格
GLYPHOSATE 草甘膦 GLYPHOSATE INFORMATION 草甘膦资料 GLYPHOSATE ACID TECHNICAL MATERIAL (2000, 2001) 草甘膦酸原药 GLYPHOSATE ACID TECHNICAL CONCENTRATE (2000, 2001) 草甘膦酸母药 GLYPHOSATE ISOPROPYLAMINE SALT TECHNICAL 10 8 6 5

CONCENTRATE(2000) 草甘膦异丙胺盐母药 GLYPHOSATE SOLUBLE CONCENTRATES (2000) 草甘膦水剂 GLYPHOSATE WATER SOLUBLE GRANULES (2000) 草甘膦可溶粒剂

12

14

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GLYPHOSATE 2000/2001

FAO SPECIFICATIONS AND EVALUATIONS FOR PLANT PROTECTION PRODUCTS

联合国粮农组织植保产品规格和评估
GLYPHOSATE INFORMATION 草甘膦资料 COMMON NAME : Glyphosate (ISO) 通用名:草甘膦(ISO) Structural formula 结构式

EMPIRICAL FORMULA 分子式: C3H8NO5P

RMM 分子量:

169 1071-83-6

CAS REGISTRY NUMBER : CAS 编码 CIPAC CODE NUMBER: CIPAC 代码

284

CHEMICAL NAMES: N-(phosphonomethyl)glycine (IUPAC and CA) 化学名称:N-膦酸甲基甘氨酸(IUPAC and CA)

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GLYPHOSATE SPECIFICATIONS 2000/2001

GLYPHOSATE ACID TECHNICAL 284/TC (2000/2001) 草甘膦原药 This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturers whose names are listed in the evaluation reports (284/2000 + 2001). It should be applicable to relevant products of this manufacturer but it is not an endorsement of those products, nor a guarantee that they comply with the specifications. The specification may not be appropriate for the products of other manufacturers. The evaluation reports (284/2000 + 2001) as PART TWO forms an integral part of this publication. .1 DESCRIPTION 描述 The material shall consist of glyphosate (acid), together with related manufacturing impurities. It shall be a white dry powder, free from visible extraneous matter and added modifying agents. 该物质应包含草甘膦(酸) ,以及相关生产杂质。其为白色干燥粉末,无可见外来 杂质和添加剂。 .2 ACTIVE INGREDIENT 有效成分 .2.1 Identity tests (284/TC/(M)/2, CIPAC 1C, p.2132), (Note 1) 定性检测(284/TC/(M)/2, CIPAC 1C, p.2132), (备注 1) The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test. 有效成分应符合定性检测,如果鉴定存在疑问,则至少应采用一种其它附加测试 方法。 .2.2 Glyphosate acid (284/TC/(M)/3, CIPAC 1C, p.2132) (AOAC 983.10, 1990) 草甘膦酸(284/TC/(M)/3, CIPAC 1C, p.2132) (AOAC 983.10, 1990) The glyphosate acid content shall be declared (not less than 950 g/kg) and, when determined, the mean measured content shall not be lower than the declared minimum content. 应说明草甘膦酸的含量(不低于 950g/kg),检测时其平均含量应不低于最低含量。 .3 RELEVANT IMPURITIES 相关杂质 .3.1 Formaldehyde (Note 2) 甲醛(备注 2) Maximum 1.3 g/kg of the glyphosate acid content found under .2.2. ≤1.3 g/kg .3.2 N-Nitrosoglyphosate (Note 2) 亚硝基草甘膦(备注 2) Maximum 1 mg/kg ≤1 mg/kg

.3.3 Insolubles in 1 M NaOH (MT 71) 氢氧化钠不溶物(MT 71) Maximum: 0.2 g/kg ≤0.2 g/kg

Note 1 An additional identity test is available from the Plant Protection officer, Fao Plant Production and Protection Division, or click here to download the document . 备注 1: 附加鉴定方法可从联合国粮农组织植物种植保护部植保办公室获得, 或点 击此处下载文件。 Note 2 Method available from the Plant Protection Officer, Plant Production and Protection Division, or download Formaldehyde and N-Nitrosoglyphosate. . 备注 2: 该方法可从联合国粮农组织植物种植保护部植保办公室获得, 或可下载甲 醛和亚硝基草甘膦

GLYPHOSATE ACID TECHNICAL CONCENTRATES 284/TK (2000/2001) 草甘膦酸母药 This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturers whose names are listed in the evaluation reports (284/2000 + 2001). It should be applicable to relevant products of this manufacturer but it is not an endorsement of those products, nor a guarantee that they comply with the specifications. The specification may not be appropriate for the products of other manufacturers. The evaluation reports (284/2000 + 2001) as PART TWO forms an integral part of this publication. .1 DESCRIPTION 描述 The material shall consist of glyphosate (acid) together with related manufacturing impurities. It shall be a white to greyish wet cake, free from visible extraneous matter and added modifying agents. 该物质应包含草甘膦(酸)和相关生产杂质。其应为白色至灰色湿粉,无可见外 来杂质和添加剂。 .2 ACTIVE INGREDIENT 有效成分 2.1 Identity tests (284/TC/(M)/2, CIPAC 1C, p.2132), (Note 1) 鉴定试验(284/TC/(M)/2, CIPAC 1C, p.2132), (备注 1) The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test. 该有效成分应进行鉴定试验,如鉴定存在疑问,则应至少采用另外一种附加鉴定 方法。 .2.2 Glyphosate acid (284/TC/(M)/3, CIPAC 1C, p.2132) (AOAC 983.10, 1990) 草甘膦酸 The glyphosate acid content shall be declared (not less than 950 g/kg on a dry basis) and, when determined, the mean measured content obtained shall not differ from that declared by more than + 20 g/kg. 应声明草甘膦酸含量(不低于 950g/kg,干基) ,检测时平均含量于声明含量偏差应 不超过 20 g/kg. .3 IMPURITIES 杂质 .3.1 Formaldehyde (Note 2)甲醛(备注 2) Maximum 1.3 g/kg of the glyphosate acid content found under .2.2. ≤1.3 g/kg .3.2 N-Nitrosoglyphosate (Note 2) 亚硝基草甘膦(备注 2) Maximum 1 mg/kg ≤1 mg/kg .3.3 Loss on drying (MT 17.3, Sample weight: 10 g; temperature: 105 C, time: 3 hours.).The loss on drying shall be declared and, when measured the average loss shall be not more than 200 g/kg. 干燥减量(MT 17.3,样品量:10g;温度:105℃,时间:3 小时)

应公布干燥减量,检测时平均干燥减量应不高于 200 g/kg. 3.4 Insolubles in 1 M NaOH (MT 71) 氢氧化钠不溶物(MT 71) Maximum: 0.2 g/kg, dry weight basis ≤0.2 g/kg,以干基计 Note 1 An additional identity test is available from the Plant Protection officer, Fao Plant Production and Protection Division, or click here to download the document . 备注 1: 附加鉴定方法可从联合国粮农组织植物种植保护部植保办公室获得, 或点 击此处下载文件。 Note 2 Method available from the Plant Protection Officer, Plant Production and Protection Division, or download Formaldehyde and N-Nitrosoglyphosate. . 备注 2: 该方法可从联合国粮农组织植物种植保护部植保办公室获得, 或可下载甲 醛和亚硝基草甘膦 .

GLYPHOSATE ISOPROPYLAMINE SALT TECHNICAL CONCENTRATES 284 /TK (2000) 草甘膦异丙胺盐母药 This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturer whose name is listed in the evaluation report (284/2000). It should be applicable to relevant products of this manufacturer but it is not an endorsement of those products, nor a guarantee that they comply with the specifications. The specification may not be appropriate for the products of other manufacturers. The evaluation report (284/2000) as PART TWO forms an integral part of this publication. .1 DESCRIPTION 描述 The material shall consist of glyphosate (acid), complying with the requirements of FAO specification 284/TC, together with related manufacturing impurities in the form of the isopropylamine salt, and shall be a solution in water, free from visible extraneous matter and added modifying agents except for the diluent. 该物质应包含草甘膦(酸) ,并符合联合国粮农组织原药规格 284/TC;以及在生 成异丙胺盐过程产生的相关生产杂质;该物质应为水溶液,无可见外来杂质和除 稀释剂以外的添加剂。 .2 ACTIVE INGREDIENT 有效成分 2.1 Identity tests (284/TC/(M)/2, CIPAC 1C, p.2132), (Note 1) 鉴定试验 (284/TC/(M)/2, CIPAC 1C, p.2132), (备注 1) The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test. 有效成分应进行鉴定试验,如鉴定存在疑问,则应至少采用另外一种附加鉴定方 法进行鉴定。 .2.2 Glyphosate acid (284/TC/(M)/3, CIPAC 1C, p.2132) (AOAC 983.10, 1990) 草甘膦酸 The glyphosate acid content shall be declared, (g/l or g/kg at 20 ±2° C) and, when determined, the mean measured content shall not differ from that declared by more than the appropriate FAO proposed tolerance as given below: 应公布草甘膦酸含量,(g/l 或 g/kg 20 ±2° C),检测时平均含量应不超出联合国粮 农组织建议的范围,见下表: Declared content in g/kg or g/l at 20± 2° C Tolerance 公布含量 允许范围 以 g/kg 或 g/l 表示 20± 2° C above 250 up to 500 ± 5 % of the declared content 250-500 公布含量的± 5 % above 500 ±25 g/kg or g/l 大于 500 ±25 g/kg 或 g/l

.3 IMPURITIES 杂质 .3.1 Formaldehyde (Note 2)甲醛(备注 2) Maximum 1.3 g/kg of the glyphosate acid content found under .2.2. ≤1.3 g/kg .3.2 N-Nitrosoglyphosate (Note 2) 亚硝基草甘膦(备注 2) Maximum: 1 mg/kg ≤1mg/kg .3.3 Insolubles in Water (MT 10.2) 水不溶物(MT 10.2) Maximum: 0.1 g/kg, dry weight basis ≤0.1 g/kg,以干基计 .4 PHYSICAL PROPERTIES 物理性质 .4.1 pH range (MT 75) (Note 3) PH 范围(MT 75) (备注 3) pH 4.5 to pH 6.8 4.5-6.8 Note 1 An additional identity test is available from the Plant Protection officer, Fao Plant Production and Protection Division, or click here to download the document . 备注 1: 附加鉴定方法可从联合国粮农组织植物种植保护部植保办公室获得, 或点 击此处下载文件。 Note 2 Method available from the Plant Protection Officer, Plant Production and Protection Division, or download Formaldehyde and N-Nitrosoglyphosate. . 备注 2: 该方法可从联合国粮农组织植物种植保护部植保办公室获得, 或可下载甲 醛和亚硝基草甘膦 .

GLYPHOSATE SOLUBLE CONCENTRATES 284/SL (2000) 草甘膦水剂 This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturer whose name is listed in the evaluation report (284/2000). It should be applicable to relevant products of this manufacturer but it is not an endorsement of those products, nor a guarantee that they comply with the specifications. The specification may not be appropriate for the products of other manufacturers. The evaluation report (284/2000) as PART TWO forms an integral part of this publication. .1 DESCRIPTION 描述 The material shall consist of a solution of technical glyphosate, complying with the requirements of FAO specification 284/TC in the form of a soluble salt, dissolved in water, together with any necessary formulants. 该物质应为一种含有以草甘膦水溶性盐的形式存在的草甘膦溶液,并符合联合国 粮农组织原药规格 284/TC,其还含有其它必要的助剂成分。 It shall be in the form of a clear or opalescent liquid, free from suspended matter and sediment, to be applied as a true solution of the glyphosate salt in water. 该物质应为澄清透明液体,无可见悬浮物和沉淀物,使用时在水中形成草甘膦盐 的真溶液。 .2 ACTIVE INGREDIENT 有效成分 .2 ACTIVE INGREDIENT 有效成分 2.1 Identity tests (284/TC/(M)/2, CIPAC 1C, p.2132), (Note 1) 鉴定试验 (284/TC/(M)/2, CIPAC 1C, p.2132), (备注 1) The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test. 有效成分应进行鉴定试验,如鉴定存在疑问,则应至少采用另外一种附加鉴定方 法进行鉴定。 .2.2 Glyphosate (284/TC/(M)/3, CIPAC 1C, p.2132) (AOAC 983.10, 1990) 草甘膦 The glyphosate acid content shall be declared for each specific soluble concentrate (g/kg or g/l at 20 ±2 C, Note 2) and, when determined, the content measured shall not differ from that declared by more than the following amounts: 应声明草甘膦酸含量,(g/l 或 g/kg 20 ± 2° C,备注 2),检测时平均含量应不超出 联合国粮农组织建议的范围,详见下表: Declared content in g/kg or g/l Tolerance 声明含量 允许范围 以 g/kg 或 g/l 表示 up to 25 ±15 % of the declared content 0-25 声明含量的± 15 % 25 to 100 ± 10 % of the declared content 25-100 声明含量的± 10 %

100 to 250 100-250 250 to 500 250-500 above 500 大于 500 in each range the upper limit is included 上诉含量范围均包含上限

± 6 % of the declared content 声明含量的± 6 % ± 5 % of the declared content 声明含量的± 5% ±25 g/kg or g/l ±25 g/kg 或 g/l

.3 IMPURITIES 杂质 .3.1 Formaldehyde (Note 3)甲醛(备注 3) Maximum 1.3 g/kg of the glyphosate acid content found under .2.2. ≤1.3 g/kg .3.2 N-Nitrosoglyphosate (Note 2) 亚硝基草甘膦(备注 2) Maximum: 1 mg/kg ≤1mg/kg .4 PHYSICAL PROPERTIES (Note 4)物理性质(备注 4) .4.1 Solution stability (MT 41)稀释稳定性(MT 41) After the stability test at 54 C (.5.2), the product, after dilution with CIPAC Standard Water D and standing for 18 h. at 30 ±2 C (Note 5), shall give a clear or opalescent solution, free from more than a trace of sediment or, particles produced shall pass through a 45 μm test sieve. 经过 54℃热贮稳定性试验后的产品, 用 CIPAC 标准硬水 D 稀释后, 在 30 ±2 ℃ (备 注 5)静置 18 小时,其应为澄清透明溶液,无可见沉淀物,或产生的颗粒应能通 过 45 μm 试验筛。 .4.2 Persistent foam (MT 47.2)持久起泡性(MT 47.2) Maximum 60 ml after 1 minute. ≤60ml,1 分钟后 .5 STORAGE STABILITY 存贮稳定性 .5.1 Stability at 0 C (MT 39.3)低温稳定性(MT 39.3) After storage at 0 + 2 C for 7 days, the volume of solid and/or liquid which separates shall be not more than 0.3 ml. 在 0±2℃温度下存储 7 天,分离出来的固体或液体应≤0.3 ml. .5.2 Stability at elevated temperature (MT 46.3)热贮稳定性试验(MT 46.3) After storage at 54 + 2 C for 14 days, the average determined glyphosate content must not be lower than 95 % relative to the determined content found before storage and the product shall continue to comply with .3.3.1, 3.3.2 and .4.1. 在 54±2℃温度下存储 14 天,草甘膦含量的平均检测结果应大于热贮前含量的 95%,而且产品任应符合上诉 3.3.1, 3.3.2 and4.1.的要求。

Note 1 An additional identity test is available from the Plant Protection Officer, FAO Plant Production and Protection Division or click here to download. 备注 1: 附加鉴定方法可从联合国粮农组织植物种植保护部植保办公室获得, 或点 击此处下载文件。 Note 2 Where the buyer requires both g/kg and g/l at 20oC then, in case of dispute, the analytical results shall be calculated as g/kg. 当买方同时要求以 g/kg 和 g/l(20℃)表示时,为避免争端,分析结果应以 g/kg 计算。 Note 3 Method available from the Plant Protection Officer, Plant Production and Protection Division, or download Formaldehyde and N-Nitrosoglyphosate. 备注 2: 该方法可从联合国粮农组织植物种植保护部植保办公室获得, 或可下载甲 醛和亚硝基草甘膦 Note 4 In the case of isopropylamine salt containing formulations and depending on the climatical conditions the pH of the formulation has to be taken into account because the equilibrium glyphosate acid - glyphosate monoispropylamine salt - diisopropylamine salt and properties of the formulants added will determine the stability towards crystallisation of glyphosate acid 对于含草甘膦异丙胺盐的制剂,应考虑在不同气候条件下制剂的 PH 值,应为其 会影响草甘膦-草甘膦一异丙胺盐-草甘膦二异丙胺盐之间的化学平衡, 另外添加剂 的性质也会导致产生草甘膦酸结晶。 Note 5 Unless another temperature is specified. 除非另外规定温度。

GLYPHOSATE WATER SOLUBLE GRANULES 284/SG (2000) 草甘膦可溶粒剂 This specification, which is PART ONE of this publication, is based on an evaluation of data submitted by the manufacturer whose name is listed in the evaluation report (284/2000). It should be applicable to relevant products of this manufacturer but it is not an endorsement of those products, nor a guarantee that they comply with the specifications. The specification may not be appropriate for the products of other manufacturers. The evaluation report (284/2000) as PART TWO forms an integral part of this publication. .1 DESCRIPTION 描述 The material shall consist of granules containing technical glyphosate, complying with the requirements of FAO specification 284/TC, in the form a suitable salt, together with suitable carriers and formulants. It shall be homogeneous, free from visible extraneous matter and/or hard lumps, free flowing, and essentially non-dusty. The glyphosate salt shall be soluble in water (Note 1). Insoluble carriers and formulants shall not interfere with compliance with .4.2. .2 ACTIVE INGREDIENT 有效成分 .2.1 Identity test (284/SG/(M)/2, CIPAC H, p.182), (Note 2)鉴定试验 The active ingredient shall comply with an identity test and, where the identity remains in doubt, shall comply with at least one additional test. .2.2 Glyphosate (284/SG/(M)/3, CIPAC H, p.182)草甘膦 The glyphosate acid or salt content shall be declared (g/kg) and, when determined, the content obtained shall not differ from that declared by more than the following amounts: Declared content in g/kg Tolerance 声明含量 允许范围 以 g/kg 或 g/l 表示 100 to 250 ± 6 % of the declared content 100-250 声明含量的± 6 % 250 to 500 ± 5 % of the declared content 250-500 声明含量的± 5 % above 500 ±25 g/kg 大于 500 in each range the upper limit is included 上诉含量范围均包含上限

.3 IMPURITIES 杂质 .3.1 Formaldehyde (Note 3)甲醛(备注 3) Maximum 1.3 g/kg of the glyphosate acid content found under .2.2. ≤1.3 g/kg .3.2 N-Nitrosoglyphosate (Note 2) 亚硝基草甘膦(备注 2) Maximum: 1 mg/kg ≤1mg/kg .4 PHYSICAL PROPERTIES 物理性质 .4.1 Degree of dissolution and solution stability (MT 179) 溶解程度及溶液稳定性(MT 179) Residue of formulation retained on a 75 μm test sieve after dissolution in CIPAC Water D at 30 ±2° C (Note 4). Maximum: 2 % after 5 minutes. Maximum: 0.05 % after 18 hours. .4.2 Persistent foam (MT 47.2)持久起泡性(MT 47.2) Maximum: 40 ml after 1 minute. .4.3 Dustiness (MT 171)粉尘度(MT 171) Essentially non-dusty with a maximum of 15 mg (0.05 % wt) collected dust applying the gravimetric method. .4.4 Flowability (MT 172)流动性(MT 172) 98 % to pass a 5 mm test sieve after 20 drops of the sieve. .5 STORAGE STABILITY 存贮稳定性 .5.1 Stability at elevated temperatures (MT 46.3)热贮稳定性(MT 46.3) After storage at 54 + 2 C for 14 days, the average determined glyphosate content shall not be lower than 95 % relative to the determined content found before storage and the product shall continue to comply with .3.1, .3.2, .4.1, 4.3 and 4.4 as required. 在 54±2℃温度下存储 14 天,草甘膦含量的平均检测结果应大于热贮前含量的 95%,而且产品仍应符合上诉 3.3.1, 3.3.2 和 4.1.4.3,4.4 的要求。 Note 1 Glyphosate acid as the sodium- or ammonium salt. 草甘膦钠盐或铵盐 Note 2 An additional identity test is available from the Plant Protection Officer, FAO Plant Production and Protection Division 备注 2 附加鉴定方法可从联合国粮农组织植物种植保护部植保办公室获得 Note 3 Method available from the Plant Protection Officer, Plant Production and Protection Division 备注 3:该方法可从联合国粮农组织植物种植保护部植保办公室获得 Note 4 Unless another temperature is specified. 除非另外规定温度

PART TWO EVALUATION REPORT(S)

GLYPHOSATE 2000 Evaluation report based on joint submission of data from Monsanto and Cheminova (TC, TK, TK, SL, SG) 17 2001 Evaluation report based on submission of data from Syngenta (TC, TK) 33

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GLYPHOSATE EVALUATIONS 2000/2001

FAO SPECIFICATIONS AND EVALUATIONS FOR PLANT PROTECTION PRODUCTS GLYPHOSATE EVALUATION REPORT 284/2000 EXPLANATION Glyphosate was scheduled as an existing FAO specification to be reviewed in 1999 under the procedure introduced by FAO in 1998 (FAO Panel, 1998). The current FAO specifications for glyphosate acid technical concentrates (FAO Specification 284/TK/S, 1991) and glyphosate soluble concentrates (FAO Specification 284/SL/S , 1991) were published in 1992 (AGP:CP/301) with a correction in 1994 (AGP:CP/311). Glyphosate was evaluated for the first time by JMPR for toxicology and residues in 1986, for residues again in 1988 and 1994, and for toxicology and residues in 1997. The new draft specifications were submitted 1999 by Monsanto and Cheminova jointly. Data were provided by both companies. USES Glyphosate is a non-selective contact herbicide with a broad spectrum of applications in agriculture, horticulture viticulture, forestry orchards, plantation crops, amenities, home gardening and greenhouses for the control of annual and perennial grasses and broadleaved weeds. Furthermore it is used for weed control on aquatic areas, industrial areas, railroad tracks and on other non-cultivated areas. Besides the weed control it is used for root sucker control, for reseeding of grassland and to facilitate harvest. In addition there are uses in transgenic crops which are tolerant to glyphosate (rape, maize, soybeans, in sugar and fodder beets, cotton).

Page 17 of 33

GLYPHOSATE EVALUATIONS 2000/2001

IDENTITY ISO common name : Glyphosate Chemical name IUPAC: N-(phosphonomethyl)glycine CA: N-(phosphonomethyl)glycine CAS No: 1071-83-6 EINECS No: 213-997-4 CIPAC No: 284 Synonyms: MON 0573 CP 67573 Structural formula:

Molecular formula: C3H8NO5P Molecular weight: 169 Identity test: HPLC method (284/TC/(M)/3, CIPAC 1C, p.2132), retention time. Spectrophotometric method: Reaction of glyphosate under acidic conditions to form N-nitrosoglyphosate. UV determination at 243 nm. PHYSICAL AND CHEMICAL PROPERTIES OF PURE ACTIVE INGREDIENT Vapour pressure: 1.3×10-5 Pa at 25°C Method: EEC A4 Substance purity: 986 g/kg Melting point: 189.5° C ±0.5° C Method: OECD 102 Substance purity: 999 g/kg Temperature of decomposition: 199° C ±1° C Method: OECD 102 Substance purity: 999 g/kg Solubility in water: 10.5 g/l at 20° C Method OECD 105 Substance purity: 995 g/kg Octanol/water partition coefficient: log Kow = < -3.2 at 25° C -4 equivalent Kow = < 6 × 10 (same Kow was found at pH 5, 7 and 9) Method OECD 107 Substance purity: 974 g/kg Page 18 of 33 GLYPHOSATE EVALUATIONS 2000/2001

Hydrolysis: glyphosate can be considered hydrolytically stable at pH 3, 6 and 9 at 5 or 35° C (half-life >> 30 days). 14 C-glyphosate can be considered hydrolytically stable at pH 5, 7 and 9 at 25° C (half-life >> 30 days). Method US EPA similar to OECD 111. Substance purity: 974 g/kg Photolysis No change noted after 24 hours exposure to sunlight. Method: US EPA FIFRA subdivision D- no 63-13. CHEMICAL COMPOSITION AND PROPERTIES OF THE TECHNICAL MATERIAL (TC and TK) All necessary information on the manufacturing process and the impurity profile including batch analysis was presented by both of the data submitters in the proposal. Methods of manufacture – A summary of the commercially confidential manufacturing process was provided to the Meeting from both of the companies. The Meeting was also provided with information on the nature of the impurities at or exceeding 1 g/kg and their maximum limits in technical material. Purity (content of active ingredient): glyphosate content in technical material, not less than 950 g/kg. The impurity profile submitted by Monsanto was different from that provided to the German authorities before with regard to the maximum limits of the specified impurities, but no new impurities were specified. The impurity profile of Cheminova was in line with the information submitted to the German authorities. The impurity profiles have been compared by the German authorities and were regarded to be equivalent with regard to toxicological and ecotoxicological properties. The Meeting was provided with commercially confidential information on the manufacturing process and batch analysis data on impurities present at or above 1 g/kg, from both companies. The mean mass balances of the batches were 994.5 (Monsanto) and 1045 g/kg (Cheminova).

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GLYPHOSATE EVALUATIONS 2000/2001

HAZARD SUMMARY Evaluations referred to: JPMR 1986/97 ICPS Environmental Health Criteria 159 Agriculture Canada, Discussion Document 1991 Hazard classification. WHO: Unlikely to present acute hazard in normal use Table 1. Acute toxicity of glyphosate acid technical material Species Test Test result Rat Oral LD50 > 5000 mg/kg Rat Dermal LD50 > 5000 mg/kg Rabbit Skin irritancy essentially non-irritating Rabbit Eye irritancy moderate/severe irritation Guinea Pig Skin sensitization not a dermal sensitizer Table 2. Summary of NOAELs for studies on short term toxicity, long’ term toxicity and carcinogenicity (EHC 159, 1994*) Dose levels NOAEL mg kg-1 diet Effects, dose level (mg/kg (mg/kg diet) Species Test compound unless diet) mg kg-1 otherwise b.w.d-1 stated Short-term studies [10000] decreased growth and Technical 5000, 10000, 1890 m, Mouse increased weights in brain, glyphosate 50000 2730 f heart, kidneys (50000) Technical glyphosate Technical glyphosate Technical glyphosate reduced weight gain (50 3125, 6250, 000), [3125] 12500, 25000, lesions of salivary glands 507 50000 507(> 6250) [20000]** 1000, 5000, no adverse effects 1267**m 20000 1623**f [12500] 200to12500 no adverse effects NG** Increased AP and ALAT(>6250) increased haematocrit and red cell [< 3125] 3125, 6250, parameters (>12 500), <205m 12500, 25000, increased bile <213f 50000 acids,decreased sperm counts (>25000), histological

Mouse

Rat Rat

Rat

Technical glyphosate

alterations in salivary glands (>3 125), reduced weight gain (>25 000)

Dogs

Technical glyphosate

20, 100, 500 mg kg-1 bw

no adverse effects

500**

Cattle

Roundup

decreased feed intake 400, 500, 630, (>630 mg kg-1 bw d-1 ), 790 mg kg-1 diarrhoea(>500), increased bw bloodparameters (790)

400

Long-term studies Technical glyphosate 1000, 5000, 30000

Mouse

Technical glyphosate

Rat

2000, 8000, 20000

decreased growth (30 000), increased incidence of hepatocyte hypertrophy and [5000] necrosis (30000), increased 814 incidence of urinary bladder epithelial hyperplasia (30 000) technical decreased growth (20 000), glyphosate increased liver weights (20 000), increased incidences of [8000] degenerative lens changes 410 (20 000) and of gastric inflammation (8000 and 20 000) slightly decreased growth (600) a

Rat

Technical glyphosate

60, 200, 600

* note taken of corrigenda on the IPCS web site; m = males; f = females; ** Highest dose tested; NG, not given; a The slight effect at 600 mg/kg diet (32 mg/kg bw) is considered marginal in the light of the absence of an effect on growth at higher dose levels (2000 and 8000 mg/kg diet) in a more recent 2-year study in rats.

Table 3. Summary of teratogenicity and reproduction studies on glyphosate (EHC 159) NOAELa mg kg-1 b.w.d-1

Species

Test compound

Dose levels

Effects, dose level mortality, clinical signs and decreased growth in dams, early resorptions, decreased numbers of implantations and visible fetuses, decreased ossification of fetal sternebrae (all at 3500 only); no fetal malformations

Rat

Technical glyphosate

300,1000,3500 mg kg-1 diet d-1 gestation days 6-19

1000

Rat

Technical glyphosate

Rabbit

Technical glyphosate Technical glyphosate

Rat

75,175,350 Mg/kg body Diarrhoea and soft stools weight (350,slight at 175),nasal 175 gestation days Discharge(350) 6-27 3,10,30 Increased incidence Mg/kg body of renal tubular dilation in <30b Weight given in F3b male pups(30) diet,3 generations Soft stool of parents (30000),decreased litter 2000,10000,30000 100b Size(30000),decreased Mg/kg (2000mg/kg body weights of parents diet,2generation diet) And pups(30000and10000)

a Based on all observed effects (both in dams and offspring) b There is some discrepancy in the results, and in the NOAELs, of the two reproduction studies carried out with technical glyphosate; the renal effects in the 3-generation study were not reproduced in the more recent 2generation study with higher dose levels.

Table 4. Genotoxicity testing, in

Vitro Mutagenicity studies (Monsanto) Results negative

Test system Target cells Bacterial mutation Salmonella typhimurium assay with and TA98,TA100,TA1535 without TA1538;B,subtilis;E.coli Metabolic activation Mammalian cell gene mutation assay with and without Chinese Hamster ovary metabolic acticvation Mammalian cell Cytogenetic Assay Rat hepatocyte Culture unscheduled DNA synthesis assay Table 5. Test system Mouse bone marrow Micronucleus assay Human Lymphocytes (chromosomal aberrations) Rat hepatocytes UDS

negative

negative

negative

In vivo Mutagenicity studies (Monsanto) Target cells Results Mouse bone marrow negative

Acute toxicity Glyphosate acid and its salts exhibited a low acute toxicity in laboratory animals by the oral and dermal route with LD50 values greater than 5000 mg/kg bw Regarding primary irritation, glyphosate acid and the salts were found to be nonirritant, at least to intact skin. In contrast, undiluted glyphosate acid was found to be strongly irritant to rabbit eyes. There was markedly less eye irritation observed with the salts. Sensitization was not observed with either glyphosate acid or the salts. Short-term toxicity Subacute and subchronic oral toxicity studies also show a low toxicity of glyphosate. Repeated dermal exposure of rabbits and rats to glyphosate did not result in any systemic effects. Dermal irritation was not observed. Mutagenicity / carcinogenicity Glyphosate was examined for mutagenicity in a wide range of test systems covering all relevant endpoints in vitro as well as in vivo. From this large database, it can be concluded that the active ingredient does not exhibit a mutagenic risk to humans. It should be also taken into consideration that there is no evidence of carcinogenic effects in humans, although glyphosate products have been in world-wide use for many years. Reproduction toxicity Multigeneration studies in rats did not indicate a specific hazard of glyphosate for reproduction. Glyphosate is not teratogenic. The NOEL for developmental effects was 1000 mg/kg bw/day in rats and 175 mg/kg bw/day in rabbits. Metabolites The metabolite AMPA was investigated for acute and subchronic effects, mutagenicity and teratogenicity. These studies have shown that AMPA has a lower toxicity than the parent compound and is devoid of a mutagenic or teratogenic potential.

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GLYPHOSATE EVALUATIONS 2000/2001

Ecotoxicology Table 6. Acute and chronic toxicity of Glyphosate to aquatic organisms Species Test duration/type EC50/LC50 Assessment

Species Test EC50/LC50 Assessment duration/typ e Daphnia magna (with 48–hr EC50 37 mg/L Slightly toxic aeration) Daphnia magna (Without 48–hr EC50 24 mg/L Slightly toxic aeration) Daphnia magna 48-hr EC50 13 mg/L Slightly toxic Gammarus 48–hr EC50 42 mg/L Slightly toxic pseudolimnaeus (Flow-through water) Carp 96–hr EC50 19.mg/L Slightly toxic Bluegill Sunfish (Static 96–hr LC50 34.0 mg/L Slightly toxic water) Bluegill Sunfish 96–hr LC50 5.8 mg/L Moderately (Flow-through water) toxic Rainbow trout 96–hr LC50 15-26 mg/L Slightly toxic (Static water) Rainbow trout 96–hr LC50 8.2 mg/L Moderately (Flow-through water) toxic Channel Catfish 96–hr LC50 39 mg/L Slightly toxic Fathead minnow 96–hr LC50 23 mg/L Moderately toxic Coho Salmon 96–hr LC50 22mg/L Slightly toxic Chinook Salmon 96–hr LC50 20 mg/L Slightly toxic Pink Salmon 96–hr LC50 14-33mg/L Slightly toxic Table 7. Acute and chronic toxicity of Glyphosate to birds Bird Species Toxicity (mg a.i./kg) Bobwhite quail acute and 8-day LC 50 > 4640 mg/kg Non-toxic short term 14-day LD50 > 3851 mg/kg

Non toxic Bobwhite quail NOEC >1000 mg/kg diet Reproduction Mallard duck acute and LC 50 > 4640 mg/kg short term Non toxic Mallard duck Reproduction NOEC >1000 mg/kg diet Chicken LD 50 >2500 mg/kg Non-toxic Table 8. Toxicity* to bees Exposure Route Toxicity Response Oral LD50 > 100 μg/bee (Non-toxic) Dermal LD50 > 100 μg/bee (Non-toxic) * determined with formulated product Page 25 of 33 GLYPHOSATE EVALUATIONS 2000/2001 On the basis of toxicity data and application rates for the active substance glyphosate, the risks for birds, mammals, aquatic organisms, bees, earthworms and micro-organisms in soil in observance of corresponding risk management measures are regarded as slight.

FORMULATIONS Glyphosate liquid formulations (GIFAP code SL) and glyphosate water soluble granules (GIFAP code SG). Registered and sold in most countries of the world. METHODS OF ANALYSIS AND TESTING - Chemical analytical methods for active ingredient (including identity tests): AOAC-CIPAC method 284/TC/(M)/3, CIPAC 1C, p.2132, and AOAC 983.10, 1990. AOAC-CIPAC method 284/SG/(M)/3, CIPAC H, p. 182, and AOAC Official Method 996.12, 1997. The principle is HPLC using an anion exchange column, UV detection at 195 nm and quantification by external standardisation. Identity Tests - AOAC-CIPAC method 284/TC/(M)/2, CIPAC 1C, p.2132, retention time. - AOAC-CIPAC method 284/SG/(M)/2, CIPAC H, p.182 for SG's, retention time. - Record the UV scan of the main peak of the chromatogram and compare with an UV scan of the calibration solution. - Spectrophotometric method. Reaction of glyphosate with sodium nitrite under acidic conditions to form N-nitroso-glyphosate. UV determination at 243 nm. - Method(s) for determination of relevant impurities in the technical material Formaldehyde is determined by a reversed phase HPLC column, off-line derivatization with Hatzsch reagent and UV-VIS detection at 412 nm. This method has been validated from 10 - 300 ppm. (Monsanto Method No AQC 678-86). N-Nitroso-N-phosphonomethylglycine (NNG) is determined by strong anion exchange HPLC with UV-visible detection. Samples are dissolved in water and reacted with hydrobromic acid to form a nitrosyl cation; the nitrosyl cation reacts with N-(1-naphthyl)ethylenediamine and sulfanilamide to form a purple azo dye that is detected at 550 nm. Because nitrite ion will react with glyphosate to form NNG, all glassware and equipment must be rinsed with sulfamic acid. This method has been validated to 200 ppb in glyphosate technical and 100 ppb in formulated products (Monsanto method no AQC 684-86). - Physical testing methods: See the specifications. Page 27 of 33 GLYPHOSATE EVALUATIONS 2000/2001

- PHYSICAL PROPERTIES The proposers declared that glyphosate produced and commercialised by Monsanto and Cheminova complies with the FAO specifications (2000). The clause for specifying the pH range in the case of glyphosate isopropylamine salt concentrates (284.105/TK) and glyphosate soluble concentrates (284/SL) was introduced because, depending on the climatic conditions, the equilibrium glyphosate acid - glyphosate monoispropylamine salt - diisopropylamine salt will determine the potential crystallisation of glyphosate acid, which has lower water solubility than its salts. The clause specifying the flowability of soluble granules was changed from 100% to 98% because it was too stringent. Such granules sometimes have the tendency to form loose aggregates, which may remain on the sieve but readily disappear during dissolution in water. CONTAINERS AND PACKAGING No special requirements have been reported for containers and packaging but metal containers should not be used unless lined with suitable material to resist the products if they are acidic. EXPRESSION OF ACTIVE INGREDIENT (Sections 4.2.5 and 4.2.7 of the Manual) The active ingredient content is expressed as glyphosate (acid) in g/kg or g/l (for liquid formulations at 20° C). APPRAISAL The current FAO specifications for glyphosate acid technical concentrates (FAO Specification 284/TK/S, 1991) and glyphosate soluble concentrates (FAO Specification 284/SL/S, 1991) were based on data submitted from Monsanto and were published 1992 (AGP:CP/301) with a correction 1994 (AGP:CP/311). The proposers for the revised specification are Monsanto Agricultural Company and Cheminova Agro A/S. Glyphosate acid is a colourless crystalline solid without odour. It melts at 189.5 ° C. The acid is of medium water solubility (10 g/l), the salts are highly soluble in water. It is formulated as water soluble concentrates and water soluble granules, in both of which it is used as a salt (isopropylamine salt, ammonium salt or sodium salt). Glyphosate is stable to hydrolysis in the range of pH 5 to pH 9 and relatively stable to photodegradation. The Meeting was provided with commercially confidential information on the manufacturing process and batch analysis data on impurities present at or above 1 g/kg, from both of the companies. Two impurities were identified (formaldehyde and N-nitroso-N-phosphonomethylglycine, NNG) as relevant and maximum limits are specified. The same absolute limit of 1 mg/kg for NNG has been set for the TC, TK's and the formulations because this impurity may be formed during the synthesis of glyphosate acid, as well as during the subsequent steps of acid neutralisation (formation of the salt) and during the final steps of formulation. Page 28 of 33 GLYPHOSATE EVALUATIONS 2000/2001

During the synthesis, the presence of nitrites in the process water, or the presence of [NO]x in the air or oxygen, used in the oxidation process, are the main causes of the formation of N-nitrosoglyphosate (NNG). During the step of acid to salt conversion, the presence of free nitrites in the water being used, might increase the level of N-nitrosoglyphosate. Finally, the formulation or granulation steps, again might cause an increase in the NNG level due to the presence of free nitrites in the water used. Here also again, the [NO]x present in the air, e.g. hot air being used to dry the granules, might cause increase of NNG. For formaldehyde the limit was set to 1.3 g/kg on a glyphosate acid basis, according to the rules of FAO as published in the Manual. This limit corresponds closely to the limit in the US OSHA regulations which was set on "as is" basis and not on an acid basis. The differences in the impurity profiles of the two sources had been assessed by the German authorities and were regarded to be of no relevance with regard to toxicological or ecotoxicological properties. This assessment included all toxicological and ecotoxicological studies available to the German authorities. Taking the more detailed Monsanto impurity profile as the reference profile the Cheminova profile is equivalent to the Monsanto impurity profile according to the criteria given in the Manual. Glyphosate is of low acute toxicity and shows no adverse effects with regard to carcinogenicity, mutagenicity, teratogenicity or reproduction toxicity. The proposal for an ADI of 0.3 mg/kg bw for glyphosate based on long term studies in rats is in line with the value published by WHO based on the JMPR evaluation of 1986. Glyphosate is of low risk to birds, mammals, aquatic organisms, bees, earthworms and micro-organisms in soil. The proposers declared that glyphosate produced and commercialized by Monsanto and Cheminova comply with the FAO specifications (1999) RECOMMENDATIONS The draft specifications for glyphosate acid technical, glyphosate acid technical concentrates, glyphosate isopropylamine salt technical concentrates, glyphosate soluble concentrates and glyphosate water soluble granules, proposed jointly by Monsanto and Cheminova were regarded as acceptable by the Meeting. As the Cheminova impurity profile is covered by the Monsanto impurity profile is the Meeting recommended that the Monsanto profile should be the reference profile. REFERENCES - Manual on Development and Use of FAO Specifications for Plant Protection Products, January 1999, Rome. Page 29 of 33 GLYPHOSATE EVALUATIONS 2000/2001

- FAO Panel of Experts on Pesticide Specifications, Registration Requirements, Application Standards and Prior Informed Consent. Group of Experts on Pesticide Specifications, 3rd Session. 5 - 8 October 1998, Rome. - IPCS Environmental Health Criteria 159, WHO 1994, Geneva. - IPCS, The WHO Recommended Classification of Pesticides by Hazard and Guidelines to Classification 1998-1999, WHO 1999, Geneva. - CIPAC Handbook 1C, 1985 - CIPAC Handbook F, 1995 - CIPAC Handbook H, 1998 age 30 of 33 GLYPHOSATE EVALUATIONS 2000/2001

FAO SPECIFICATIONS AND EVALUATIONS FOR PLANT PROTECTION PRODUCTS GLYPHOSATE EVALUATION REPORT 284/2001 Explanation The data for glyphosate were evaluated in support of existing FAO specifications 284/TC, 284/TK, 284/SL, 284/SG (2000). The supporting data were provided by Syngenta to extend the scope of the existing specification to their product. Uses See Evaluation Report for glyphosate (2000). Identity ISO common name: Glyphosate Chemical name: IUPAC: N-(phosphonomethyl)-glycine CA: N-(phosphonomethyl)-glycine CAS No: 1071-83-6 CIPAC No: 284 Synonyms: none Structural formula:

Molecular formula: C3H8NO5P Relative molecular mass: 169.1 Identity tests: see FAO Specification 284/TC (2000) Page31of33 GLYPHOSATE EVALUATIONS 2000/2001

Physico-chemical properties of pure glyphosate See FAO Specification 284/TC (2000) Chemical composition and properties of glyphosate technical materials See FAO Specification 284/TC (2000) and confidential information to this report. Hazard summary See Evaluation Report for glyphosate (2000). It was recognised that the acute dermal toxicity given ( < 2000 mg/kg bw) by Syngenta was higher than stated in the Evaluation Report for glyphosate (2000) (< 5000 mg/kg bw). Justification submitted by Syngenta: The guideline used in the acute dermal study [CTL/P/4464] was OECD 402 as specified in 91/414/EEC. In accordance with this guideline the limit dose of 2000 mg/kg was applied following a range finding test to set the dose. A limit dose at this level is, from a technical perspective, appropriate as this is approaching the maximum quantity that can be applied with reasonable confidence that the totality of the dose applied will remain in contact with the rat skin for the duration of the exposure. Applications of amounts greater than 2000 mg/kg are less likely to result in the total dose achieving and/or maintaining contact with the rat skin during the exposure period. Hence a dermal topical application of 5000 mg/kg leading to an acute dermal MLD50 value of >5000 mg/kg does not signify a lower intrinsic acute dermal toxicity than an MLD50 of >2000 mg/kg resulting from a study using a limit dose of only 2000 mg/kg. The difference in endpoints being simply a reflection of limit dose set used in the individual studies. It is therefore reasonable to consider that acute dermal MLD50 values in the rat of >2000 and >5000 mg glyphosate acid/kg, where the variance is only a reflection of the differing limit doses of the individual studies, indicate an equivalent profile of the acute dermal toxicity. This justification was accepted by WHO. Formulations Not submitted by Syngenta Methods of analysis and testing Analytical method for the active ingredient (including identity tests): see FAO Specification 284/TC (2000). Fully validated analytical methods for the impurities were provided by Syngenta. Physical properties Page32of33 GLYPHOSATE EVALUATIONS 2000/2001

See FAO Specification 284/TC (2000) Containers and packaging See FAO Specification 284/TC (2000) Expression of the active ingredient See FAO Specification 284/TC (2000) Appraisal The data submitted by Syngenta were in accordance with the requirements of th the FAO Manual (5 edition) and supported the draft specification. The deviations from reference data set were justified by the proposer and regarded as acceptable by the evaluator. The Meeting was provided with commercially confidential information on the manufacturing process and batch analysis data on all impurities present at or above 1 g/kg. The manufacturing process and the impurity profile of Syngenta were different from those submitted with the reference specification. The deviations from reference data set were >50% or 3 g/kg in the case of R025029 and R290510 impurities. However, these differences do not lead to differences in toxicological assessment, as evidenced by the data submitted by the proposer for acute oral, dermal, inhalation, skin and eye irritation and sensitization. The Syngenta product is therefore considered to be equivalent to the products upon which the reference profile is based. Recommendations The draft specification for technical glyphosate proposed by Syngenta was accepted by the Meeting. The proposer had requested a specification for this material as a TC but the Syngenta product is considered to be equivalent to the existing TK specification. The difference between TC acid and TK acid is the water content only and therefore the extension of the TK specification is recommended. From the production Syngenta isolates the TK acid as a wet paste with a minimum content of 760 g/kg glyphosate. This is within the reference specification for the TK. References See Evaluation Report for glyphosate (2000). Page33of33 GLYPHOSATE EVALUATIONS 2000/2001


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