1、Designation: E 2169 01 (Reapproved 2007)An American National StandardStandard Practice forSelecting Antimicrobial Pesticides for Use in Water-MiscibleMetalworking Fluids1This standard is issued under the fixed designation E 2169; the number immediately following the designation indicates the year of
2、original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides recommendations for selectingantimi
3、crobial pesticides (microbicides) for use in water-miscible metalworking fluids (MWF). It presents informationregarding regulatory requirements, as well as technical factorsincluding target microbes, efficacy and chemical compatibility.1.2 This guide is not an encyclopedic compilation of all theconc
4、epts and terminology uses by chemists, microbiologists,toxicologists, formulators, plant engineers and regulatory af-fairs specialists involved in antimicrobial pesticide selectionand application. Instead, it provides a general understanding ofthe selection process and its supporting considerations.
5、1.3 The values in SI units are to be regarded as the standard.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica
6、-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 1067 Test Methods for Acidity or Alkalinity of WaterD 1293 Test Methods for pH of WaterD 3519 Test Method for Foam in Aqueous Media (BlenderTest)D 3946 Test Method for Evaluating the Bacteria Resistanceof Wat
7、er-Dilutable Metalworking Fluids3D 4478 Test Methods for Oxygen Uptake3D 5465 Practice for Determining Microbial Colony Countsfrom Waters Analyzed by Plating MethodsE 686 Method for Evaluation of Antimicrobial Agents inAqueous Metal Working Fluids3E 1302 Guide for Acute Animal Toxicity Testing of Wa
8、ter-Miscible Metalworking FluidsE 1326 Guide for Evaluating Nonconventional Microbio-logical Tests Used for Enumerating BacteriaE 1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal FluidsE 2144 Practice for Personal Sampling and Analysis ofEndotoxin in Metalwor
9、king Fluid Aerosols in WorkplaceAtmospheres2.2 Government Standards:29 CFR 1910 Occupational Safety and Health Standards440 CFR 152 Pesticide Registration and Classification Pro-cedures440 CFR 158 Pesticide Programs Data Requirements forRegistration449 CFR 100-180 Research and Special Programs Admin
10、is-tration, Department of Transportation4PR Notice 2000-1 Applicability of the Treated ArticlesExemption to Antimicrobial PesticidesDirective 98/8/EC of the European Parliament and of theCouncil of 16 February 1998 concerning the placing ofbiocidal products on the market3. Terminology3.1 active ingr
11、edient (a.i.), nthe chemical component orcomponents of an antimicrobial pesticide that provides itsmicrobicidal performance.3.2 activity spectrum, nvariety or range of microbesagainst which an antimicrobial pesticide is effective.3.3 antimicrobial pesticide, nchemical additive, regis-tered under 40
12、CFR 152, for use to inhibit growth, proliferationor both of microorganisms.3.3.1 DiscussionAntimicrobial pesticides are registeredfor one or more end-use applications, or sites, for use within anapproved dose range.3.4 bactericide, nantimicrobial pesticide specifically orprimarily effective against
13、bacteria.3.5 biocide, nany chemical intended for use to kill orinhibit organisms.1This practice is under the jurisdiction of ASTM Committee E34 on Occupa-tional Health and Safety and is the direct responsibility of Subcommittee E34.50 onHealth and Safety Standards for Metal Working Fluids.Current ed
14、ition approved April 1, 2007. Published June 2007. Originallyapproved in 2001. Last previous edition approved in 2001 as E 2169 - 01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume infor
15、mation, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.4Code of Federal regulations available form United States Government PrintingOffice, Washington, DC.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.
16、5.1 DiscussionBiocide is a term commonly used syn-onymously with the preferred antimicrobial pesticide or mi-crobicide.3.6 bioburden, nthe level of microbial contamination(biomass) in a system.3.6.1 DiscussionTypically bioburden is defined in termsof either biomass or numbers of cells per unit volum
17、e or massor surface area material tested (g biomass/mL sample; gbiomass/g sample; cell/mL sample, colony forming units(CFU)/mL, and so forth).3.7 biodeterioration, nthe loss of commercial value, per-formance characteristics or both of a product (metalworkingfluid) or material (coolant system or fini
18、shed parts) throughbiological processes.3.8 biofilm, na film or layer composed of microorgan-isms, biopolymers, water, and entrained organic and inorganicdebris that forms as a result of microbial growth, proliferation,and excretion of polymeric substances at phase interfaces(liquid-liquid, liquid-s
19、olid, liquid-gas, and so forth). (synonym:skinnogen layer).3.9 bioresistant, adjability to withstand biological attack.3.9.1 DiscussionBioresistant, or recalcitrant, chemicalsare not readily metabolized by microorganisms.3.10 biostatic, adjable to prevent existing microbial con-taminants from growin
20、g or proliferating, but unable to killthem.3.10.1 DiscussionBiostatic additives may be registeredantimicrobial pesticides or unregistered chemicals with otherperformance properties. The difference between biocidal andbiostatic performance may be attributed to dose, chemistry orboth.3.11 contaminatio
21、n control, nmaintenance of bioburdenat an operationally defined level, at or below which thebioburden does not affect the fluid or system adversely.3.12 demand, nthe sum of all factors that contribute todecreasing the effective concentration of antimicrobial pesti-cide.3.12.1 DiscussionProcesses con
22、tributing to demand in-clude, but are not limited to, reaction with microbes, reactionswith other chemicals in the fluid, adsorption onto surfaces,absorption into materials and temperature.3.13 dose, nconcentration of antimicrobial pesticideadded to treated solution.3.13.1 DiscussionDose is generall
23、y expressed as eitherppm active ingredient (a.i.) or ppm as supplied (a.s.).3.14 fungicide, nantimicrobial pesticide specifically orprimarily effective against fungi.3.15 lethal dose, nconcentration at which treatment killsat least one of test subjects.3.15.1 DiscussionThe LD50is the term used in to
24、xicologydefining the dose that kills fifty-percent of the test population.3.16 half-life (T12 ), ntime required for concentration of amicrobicide to diminish to one-half its initial concentration.3.17 microbicide, nsynonymous with antimicrobial pesti-cide.3.18 minimum inhibitory concentration (MIC),
25、 nlowesttreatment-dose that will prevent test population from growing,proliferating or otherwise contributing to biodeterioration.4. Summary of Practice4.1 Microorganisms can grow in all water-miscible metal-working fluids including water-miscible metal removal fluids,a subset of the broader class o
26、f metalworking fluids. Conse-quences of uncontrolled microbial contamination in metal-working fluids may include biodeterioration, rancidity andaerosolization of potentially pathogenic microbes and toxic orallergenic microbial cell constituents. Consequently microbialcontamination control is desirab
27、le from both operational andindustrial hygiene perspectives.4.2 Antimicrobial pesticides are used to prevent biodeterio-ration and may also reduce the risk of disease associated withthe use of water-miscible metalworking fluids. They may beused in-drum, on-site or both. Antimicrobial pesticides work
28、either by killing microbes, inhibiting specific undesirablemicrobial activities or both in the treated fluid. Antimicrobialpesticides used in metalworking fluids include representativesfrom a number of chemical groups. Consequently, antimicro-bial pesticides vary widely in their mode of action, comp
29、at-ibility with other fluid components and other performanceproperties.4.3 The process of selecting an antimicrobial pesticide foruse in metalworking fluids shall include, minimally, confirma-tion that the product is (1) approved for the intended applica-tion; (2) compatible with other fluid and sys
30、tem constituents;and (3) effective. Other considerations including, but notlimited to intended application, target microbes, desired speedof action, performance persistence, handling precautions, toxi-cological properties, water and oil miscibility, and wastetreatability may affect microbicide selec
31、tion.4.4 Microbicide selection begins with a fundamental under-standing of the coolant formulation chemistry, biodeteriorationcontrol strategy and specific customer needs. General back-ground information5regarding MWF system management isavailable in Practice E 1497 and elsewhere. Armed with thisinf
32、ormation, candidate microbicides can be selected for furtherevaluation. Products that meet all of the selection criteria areultimately tested in field application. Since antimicrobial pes-ticide efficacy can diminish over time, the selection processmay be viewed as cyclic. Moreover, since microbicid
33、es can betoxic, they require rigorous and competent product stewardshipthroughout their use-cycle.5. Significance and Use5.1 This practice summarizes the steps in the antimicrobialpesticide selection process, reviewing technical and regulatoryconsiderations inherent in the process. It complements an
34、damplifies information provided in Practice E 1497.5.1.1 Steps in the antimicrobial selection process include:needs identification, use strategy selection, efficacy testing,chemical compatibility testing, regulatory consideration re-view, handling and disposal issue review.5Organization Resources Co
35、unselors. Management of the Metal Removal FluidEnvironment. Web site: http:/www.aware- 2169 01 (2007)25.2 This practice provides stakeholders in the microbicideselection process an overview of its complexities, including theprocess of obtaining pesticide registration from cognizantgoverning bodies.5
36、.3 Personnel responsible for antimicrobial pesticide selec-tion will be able to use this practice as a roadmap through theprocess.5.4 Personnel responsible for industrial hygiene, product orplant management will gain insight to the tradeoffs attendantwith antimicrobial use and selection.6. Needs Inf
37、ormation6.1 The first step in the microbicide selection process is therecognition of a need. Recognition may come as a consequenceof new metalworking fluid formulation development or evolv-ing requirements in one or more fluid end-use applications.6.1.1 Antimicrobial pesticide needs typically fall i
38、nto either,or both of the following categories:6.1.1.1 Biodeterioration PreventionThe various strategiesused to enhance coolant life.6.1.1.2 Health and SafetyReducing the risk of employeeexposure to potentially pathogenic microbes or allergenicmicrobial constituents such as endotoxins (E 2144).6.2 O
39、nce the need has been recognized, the next step is todefine the need operationally. This is achieved by determiningthe answers to the needs analysis questions, for example:6.2.1 What type of metalworking fluid formulation requiresmicrobicidal augmentation? Antimicrobials vary in their re-spective oi
40、l and water solubilities. Moreover, chemical incom-patibilities exist between certain antimicrobials and othermetalworking fluid constituents. Microbicides that are deemedinappropriate based on their incompatibility with the otherformulation components need not be considered further (see9.1).6.2.2 W
41、hat are the desired performance-life and biodegrad-ability criteria for the finished formulation? Bioresistance andbiodegradability need to be balanced. Waste treatability andextended sump life are both important considerations. (seeSection 8).6.2.3 What respective roles should antimicrobial pestici
42、desand bioresistant performance additives play in achieving thosecriteria? Metalworking fluid formulators can select from agrowing number of bioresistant corrosion inhibitors and otherperformance additives that confer greater overall formulationbioresistance. Two caveats affect bioresistant additive
43、 selec-tion.6.2.3.1 Bioresistant additives should have some demon-strable performance benefit other than inhibiting biodeteriora-tion.6.2.3.2 The toxicological (for example those described inGuide E 1302) and environmental fate profiles of a bioresis-tant, putatively non-biocidal, performance additi
44、ve shall bemore benign than those of the microbicides they are replacing.6.2.4 What are the target microbes (see 7.3)?6.2.5 Will the microbicide be added into the formulation,tankside or both (see 7.1)?6.2.6 Will the microbicide, either in-formulation or astankside additive be used at a single or mu
45、ltiple end-use sites?Approved chemical lists vary among companies conductingmetalworking operations. Antimicrobials to be considered foruse should be listed on prospective users approved chemicalslists.6.2.7 Will the microbicide, either in-formulation or astank-side additive be used domestically onl
46、y, or will it betraded internationally? Industrial pesticide regulations differaround the world. Not all products approved by the U.S. EPAare approved in Canada, Europe or other industrialized regionsor vice versa. Moreover, registration and reporting require-ments vary amongst nations. Global accep
47、tability may be animportant consideration (see Section 10).6.3 Completion of this needs analysis step will facilitate thebalance of the microbicide selection process.7. Antimicrobial Pesticide Use Strategies7.1 Microbicides may be added either in-formulation, tank-side or both. Users, understanding
48、how the metalworking fluidsthey use are formulated, should select an appropriate pesticideuse-strategy for each end-use application.7.1.1 In-formulation microbicide use means that antimicro-bial(s) are formulated into coolant concentrate.7.1.1.1 Microbicide addition at this stage may reduce orelimin
49、ate the requirement for subsequent tankside addition. Italso protects high water-content formulations from spoilageduring storage and transport.7.1.1.2 When formulated into coolant, microbicides areadded at concentrations sufficient to provide adequate a.i. oncethe formulation has been diluted to end-use strength. In-drumdemand may reduce the residual microbicide concentrationavailable by the time coolant concentrate is diluted for end-use.7.1.1.3 With coolants intended for a variety of end-useapplications, each requiring different
