1、Designation: E2169 17 An American National StandardStandard Practice forSelecting Antimicrobial Pesticides for Use in Water-MiscibleMetalworking Fluids1This standard is issued under the fixed designation E2169; the number immediately following the designation indicates the year oforiginal adoption o
2、r, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice provides recommendations for selectingantimicrobial pesticides (
3、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 theconcepts and terminolog
4、y uses by chemists, microbiologists,toxicologists, formulators, plant engineers, and regulatoryaffairs specialists involved in antimicrobial pesticide selectionand application. Instead, it provides a general understanding ofthe selection process and its supporting considerations.1.3 The values in SI
5、 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-bility of regulator
6、y limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1067 Test Methods for Acidity or Alkalinity of WaterD1293 Test Methods for pH of WaterD3519 Test Method for Foam in Aqueous Media (BlenderTest) (Withdrawn 2013)3D3946 Test Method for Evaluating the Bacteria Resistanceof Water-Dil
7、utable Metalworking Fluids (Withdrawn2004)3D4478 Test Methods for Oxygen Uptake (Withdrawn 1994)3D5465 Practices for Determining Microbial Colony Countsfrom Waters Analyzed by Plating MethodsE686 Method for Evaluation of Antimicrobial Agents inAqueous Metal Working Fluids (Withdrawn 2004)3E1302 Guid
8、e for Acute Animal Toxicity Testing of Water-Miscible Metalworking FluidsE1326 Guide for Evaluating Non-culture MicrobiologicalTestsE1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal FluidsE2144 Practice for Personal Sampling and Analysis of En-dotoxin in Meta
9、lworking Fluid Aerosols in WorkplaceAtmospheres2.2 Government Standards:29 CFR 1910 Occupational Safety and Health Standards440 CFR 152 Pesticide Registration and Classification Proce-dures440 CFR 158 Pesticide Programs Data Requirements forRegistration449 CFR 100-180 Research and Special ProgramsAd
10、ministration, 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 in
11、gredient (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 4
12、0 CFR 152, for use to inhibit growth,proliferation, or both of microorganisms.3.3.1 DiscussionAntimicrobial pesticides are registeredfor one or more end-use applications, or sites, for use within anapproved dose range.1This practice is under the jurisdiction of ASTM Committee E34 on Occupa-tional He
13、alth and Safety and is the direct responsibility of Subcommittee E34.50 onHealth and Safety Standards for Metal Working Fluids.Current edition approved March 1, 2017. Published March 2017. Originallyapproved in 2001. Last previous edition approved in 2012 as E2169 12. DOI:10.1520/E2169-17.2For refer
14、enced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced on
15、www.astm.org.4Code of Federal regulations available form United States Government PrintingOffice, Washington, DC.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with international
16、ly recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.4 bactericide, nantimicrobial pesticide specifically o
17、rprimarily effective against bacteria.3.5 biocide, nany chemical intended for use to kill orinhibit organisms.3.5.1 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 sy
18、stem.3.6.1 DiscussionTypically bioburden is defined in termsof either biomass or numbers of cells per unit volume 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
19、value, per-formance characteristics, or both of a product (metalworkingfluid) or material (coolant system or finished parts) throughbiological processes.3.8 biofilm, na film or layer composed of microorganisms,biopolymers, water, and entrained organic and inorganic debristhat forms as a result of mi
20、crobial growth, proliferation, andexcretion of polymeric substances at phase interfaces (liquid-liquid, liquid-solid, liquid-gas, and so forth). (Synonym: skin-nogen layer.)3.9 bioresistant, adjable to withstand biological attack.3.9.1 DiscussionBioresistant, or recalcitrant, chemicalsare not readil
21、y metabolized by microorganisms.3.10 biostatic, adjable to prevent existing microbial con-taminants from growing or proliferating, but unable to killthem.3.10.1 DiscussionBiostatic additives may be registeredantimicrobial pesticides or unregistered chemicals with otherperformance properties. The dif
22、ference between biocidal andbiostatic performance may be attributed to dose, chemistry, orboth.3.11 contamination control, nmaintenance of bioburden atan operationally defined level, at or below which the bioburdendoes not affect the fluid or system adversely.3.12 demand, nthe sum of all factors tha
23、t contribute todecreasing the effective concentration of antimicrobial pesti-cide.3.12.1 DiscussionProcesses contributing to demandinclude, but are not limited to, reaction with microbes, reac-tions with other chemicals in the fluid, adsorption ontosurfaces, absorption into materials, and temperatur
24、e.3.13 dose, nconcentration of antimicrobial pesticideadded to treated solution.3.13.1 DiscussionDose is generally 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 half-life (T12 )
25、, ntime required for concentration of amicrobicide to diminish to one-half its initial concentration.3.16 lethal dose, nconcentration at which treatment killsat least one of test subjects.3.16.1 DiscussionThe LD50is the term used in toxicologydefining the dose that kills fifty percent of the test po
26、pulation.3.17 microbicide, nsynonymous with antimicrobial pesti-cide.3.18 minimum inhibitory concentration (MIC), 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
27、 water-miscible metal-working fluids including water-miscible metal removal fluids,a subset of the broader class of metalworking fluids. Conse-quences of uncontrolled microbial contamination in metal-working fluids may include biodeterioration, rancidity, andaerosolization of potentially pathogenic
28、microbes and toxic orallergenic microbial cell constituents. Consequently, microbialcontamination control is desirable 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 withth
29、e use of water-miscible metalworking fluids. They may beused in-drum, on-site, or both. Antimicrobial pesticides workeither by killing microbes, inhibiting specific undesirablemicrobial activities, or both in the treated fluid. Antimicrobialpesticides used in metalworking fluids include representati
30、vesfrom a number of chemical groups. Consequently, antimicro-bial pesticides vary widely in their mode of action, compat-ibility with other fluid components, and other performanceproperties.4.3 The process of selecting an antimicrobial pesticide foruse in metalworking fluids shall include, minimally
31、, confirma-tion that the product is (1) approved for the intended applica-tion; (2) compatible with other fluid and system constituents;and (3) effective. Other considerations including, but notlimited to intended application, target microbes, desired speedof action, performance persistence, handlin
32、g precautions, toxi-cological properties, water and oil miscibility, and wastetreatability may affect microbicide selection.4.4 Microbicide selection begins with a fundamental under-standing of the coolant formulation chemistry, biodeteriorationcontrol strategy, and specific customer needs. General
33、back-ground information5regarding MWF system management isavailable in Practice E1497 and elsewhere. Armed with thisinformation, candidate microbicides can be selected for furtherevaluation. Products that meet all of the selection criteria areultimately tested in field application. Since antimicrobi
34、al pes-ticide efficacy can diminish over time, the selection processmay be viewed as cyclic. Moreover, since microbicides can betoxic, they require rigorous and competent product stewardshipthroughout their use cycle.5. Significance and Use5.1 This practice summarizes the steps in the antimicrobialp
35、esticide selection process, reviewing technical and regulatory5Organization Resources Counselors. Management of the Metal Removal FluidEnvironment. Web site: http:/www.aware- 172considerations inherent in the process. It complements andamplifies information provided in Practice E1497.5.1.1 Steps in
36、the antimicrobial selection process include:needs identification, use strategy selection, efficacy testing,chemical compatibility testing, regulatory considerationreview, handling, and disposal issue review.5.2 This practice provides stakeholders in the microbicideselection process an overview of it
37、s complexities, including theprocess of obtaining pesticide registration from cognizantgoverning bodies.5.3 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
38、 management will gain insight to the tradeoffs attendantwith antimicrobial use and selection.6. Needs Information6.1 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 re
39、quirements in one or more fluid end-use applications.6.1.1 Antimicrobial pesticide needs typically fall into eitheror 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
40、to potentially pathogenic microbes or allergenicmicrobial constituents such as endotoxins (Practice E2144).6.2 Once 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
41、of metalworking fluid formulation requiresmicrobicidal augmentation? Antimicrobials vary in their re-spective oil and water solubilities. Moreover, chemical incom-patibilities exist between certain antimicrobials and othermetalworking fluid constituents. Microbicides that are deemedinappropriate bas
42、ed on their incompatibility with the otherformulation components need not be considered further. (See9.1.)6.2.2 What are the desired performance-life and biodegrad-ability criteria for the finished formulation? Bioresistance andbiodegradability need to be balanced. Waste treatability andextended sum
43、p life are both important considerations. (SeeSection 8.)6.2.3 What respective roles should antimicrobial pesticidesand bioresistant performance additives play in achieving thosecriteria? Metalworking fluid formulators can select from agrowing number of bioresistant corrosion inhibitors and otherper
44、formance additives that confer greater overall formulationbioresistance. Two caveats affect bioresistant additive 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 describ
45、ed inGuide E1302) and environmental fate profiles of a bioresistant,putatively non-biocidal, performance additive shall be morebenign 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
46、both? (See 7.1.)6.2.6 Will the microbicide, either in-formulation or astankside additive be used at a single or multiple end-use sites?Approved chemical lists vary among companies conductingmetalworking operations. Antimicrobials to be considered foruse should be listed on prospective users approved
47、 chemicalslists.6.2.7 Will the microbicide, either in-formulation or astankside additive be used domestically only, or will it be tradedinternationally? Industrial pesticide regulations differ aroundthe world. Not all products approved by the U.S. EPA areapproved in Canada, Europe, or other industri
48、alized regions orvice versa. Moreover, registration and reporting requirementsvary amongst nations. Global acceptability may be an impor-tant consideration (see Section 10).6.3 Completion of this needs analysis step will facilitate thebalance of the microbicide selection process.7. Antimicrobial Pes
49、ticide Use Strategies7.1 Microbicides may be added either in-formulation, tank-side or both. Users, understanding 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 oreliminate the requirement for subsequent tankside addition. Italso protects high water-content formulations from spoilaged
