ASTM_E_1589_-_05_2015.pdf

Designation:E158905(Reapproved 2015)Standard Test Method forEvaluation of First Aid Antiseptic Drug Products1This standard is issued under the fixed designation E1589;the number immediately following the designation indicates the year oforiginal adoption or,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 The tests described in this test method are designed toevaluate antimicrobial agents in formulations intended for useas first aid antiseptic products for their ability to reduce orsuppress the growth,or both,of the skin microflora.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects.(See CFR Parts 50 and 56.)1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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 regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents2.2 Federal Standards:3CFR Parts 50 and 563.Terminology3.1 active ingredient,na substance performing a functiondefined by this method.3.2 neutralization,na process which results in quenchingor inactivating inactivation of the antimicrobial activity of aformulation.This may be achieved with dilution of theformulation,or with the use of chemical agents,called neu-tralizers.3.3neutralizer,na procedure or chemical agent used toinactivate,neutralize,or quench the microbiocidal properties ofan antimicrobial agent.3.4resident microorganisms,nmicroorganisms that liveand multiply on skin,forming a permanent population.3.5 sampling fluid,na recovery fluid that may or may notcontain a neutralizer to inactivate the active ingredients in testand internal reference formulations.3.6 test formulation,na formulation containing an activeingredient(s).3.7 transient microorganisms,nmicroorganisms that con-taminate but do not normally permanently colonize the skin.4.Summary of Test Method4.1 These test methods describe standard in vivo techniquesto determine the following:4.1.1 Effect of the Test Formulation to Reduce an ArtificiallyEnhanced Skin Microbial FloraThe forearms of subjects areoccluded for 48 h prior to application of the test formulation toincrease the microbial population on the skin of the volarforearm surface.At treatment the occlusion material is re-moved and the skin is allowed to dry,the test formulation isthen applied to selected sites.At a pre-determined time(s)following application,the sites are microbiologically sampledand the samples plated for total aerobic bacteria count.Thecounts obtained from the treated sites are compared to countsobtained from untreated occluded sites.4.1.2 Effect of the Test Formulation to Suppress the Growthof Normal Skin Flora When Applied As a DressingThedressings are applied to the forearm for 24 h.The density of theresident microorganisms that develop under the dressings arecompared to the population that develops on a similar untreatedoccluded site.Following 24 h of occlusion,the sites aremicrobiologically sampled and the samples plated for totalaerobic bacteria count.4.2 The principal of the test is that the microflora of forearmskin is sparse.The impermeable dressing will increase surface1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2015.Published November 2015.Originallyapproved in 1994.Last previous edition approved in 2010 as E1589 05(2010).DOI:10.1520/E1589-05R15.2For 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.3Available from U.S.Government Publishing Office,732 N.Capitol St.,NW,Washington DC,20401-0001,http:/www.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 moisture by preventing diffusional water loss and thus expandtransient resident skin microorganisms population.A signifi-cant antimicrobial effect by the test agent will be reflected bysignificantly lower population recovered from the nontreatedsite.5.Significance and Use5.1 The procedures in this test method should be used for invivo evaluation the antimicrobial activity of drug productsapplied topically to the skin that a