1、Designation: E2169 12 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 terminology
4、 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.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)D3946 Test Method for Evaluating the Bacteria Resistanceof Water-Dilutable Metalworkin
7、g Fluids (Withdrawn2004)3D4478 Test Methods for Oxygen Uptake (Withdrawn 1994)3D5465 Practice for Determining Microbial Colony Countsfrom Waters Analyzed by Plating MethodsE686 Method for Evaluation of Antimicrobial Agents inAqueous Metal Working Fluids (Withdrawn 2004)3E1302 Guide for Acute Animal
8、Toxicity Testing of Water-Miscible Metalworking FluidsE1326 Guide for Evaluating Nonconventional Microbiologi-cal Tests Used for Enumerating BacteriaE1497 Practice for Selection and Safe Use of Water-Miscible and Straight Oil Metal Removal FluidsE2144 Practice for Personal Sampling and Analysis of E
9、n-dotoxin in Metalworking 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 S
10、pecial ProgramsAdministration, 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. Termino
11、logy3.1 active ingredient (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, re
12、gis-tered under 40 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.1This practice is under the jurisdiction of ASTM Committee E34 on
13、Occupa-tional Health and Safety and is the direct responsibility of Subcommittee E34.50 onHealth and Safety Standards for Metal Working Fluids.Current edition approved Nov. 1, 2012. Published November 2012. Originallyapproved in 2001. Last previous edition approved in 2007 as E2169 - 01 (2007).DOI:
14、10.1520/E2169-12.2For referenced 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 historica
15、l standard is referenced onwww.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 States13.4 bactericide, nantimicrobial pesticide spec
16、ifically orprimarily 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(biomas
17、s) in a system.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 c
18、ommercial 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 res
19、ult of microbial 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, adjability to withstand biological attack.3.9.1 DiscussionBioresistant, or recalcitrant, chemicalsar
20、e not readily 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 propert
21、ies. The difference 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
22、factors that 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
23、temperature.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 lethal
24、 dose, nconcentration at which treatment killsat least one of test subjects.3.15.1 DiscussionThe LD50is the term used in toxicologydefining 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 init
25、ial concentration.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 gro
26、w in all 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 path
27、ogenic 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
28、withthe 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 represen
29、tativesfrom 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, minima
30、lly, 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, hand
31、ling 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. Genera
32、l 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 antimicro
33、bial 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 antimicrobia
34、lpesticide selection process, reviewing technical and regulatory5Organization Resources Counselors. Management of the Metal Removal FluidEnvironment. Web site: http:/www.aware- 122considerations inherent in the process. It complements andamplifies information provided in Practice E1497.5.1.1 Steps i
35、n 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 i
36、ts 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 orplan
37、t 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 r
38、equirements in one or more fluid end-use applications.6.1.1 Antimicrobial pesticide needs typically fall into 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 employeeexposur
39、e to potentially pathogenic microbes or allergenicmicrobial constituents such as endotoxins (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 of meta
40、lworking 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 based on t
41、heir 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 sump life a
42、re 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 otherperformance
43、 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 described inGuid
44、e 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 both (see 7
45、.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 chemicalsli
46、sts.6.2.7 Will the microbicide, either in-formulation or astank-side additive be used domestically only, 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 regio
47、nsor vice versa. Moreover, registration and reporting require-ments vary amongst nations. Global acceptability 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 S
48、trategies7.1 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)
49、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 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 dilute
