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Refi Ning Procedures for the Administration of Substances

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Refi Ning Procedures for the Administration of Substances WORKINGPARTY REPORT Rening procedures for theadministration of substances Report of the BVAAWF =FRAME=RSPCA=UFAW JointWorking Group on Renement Members of theJoint Working Groupon Renement: D.B.Morton (Chairman), M.Jennings (Secretary),A. Buckwell, R.Ewbank, C.Godfrey, B.Holgate, I. Inglis, R.James, C.Page,I. Sharman, R.Verschoyle, L.Westall &A.B.Wilson Contents Preface 2 3.6 Intraperitoneal 19 1Introduction and aimsof thereport 2 3.7 Intratracheal 20 3.8 Intravaginal 20 2Generalprinc iplesof `good practice’ 3 2.1 Planningand preparation 3 3.9 Intravenous and intra-arterial 21 2.1.1 Experimental aims 3 3.10 Oral routes 25 2.1.2 Theroute 3 3.10.1 Inclusionin an animal’s food orwater 25 2.1.3 Thesubstance 3 3.10.2 Dosingdirectly into 2.1.4 Theanimal 5 the pharynx 27 2.1.5 Thetechnique 7 3.10.3 Oral gavage 28 2.1.6 Staff and training 7 3.11 Osmotic minipumps 30 2.2 Technical preparation 3.12 Respiratory routes 31 andaftercare 8 3.12.1 Wholebody exposure 31 2.3 Generalre® nem entfor 3.12.2 Noseonly =Snout only all routes 9 exposure 32 3Re®nem entfor individual routes 3.12.3 Mask exposure 33 and procedures 13 3.13 Subcutaneous 34 3.1 Intra-articular 13 3.14 TopicalÐderm al 35 3.2 Intracerebral (intracerebro- 3.15 TopicalÐoc ular 36 ventricular) 14 3.16 Footpad 37 3.3 Intradermal 16 3.17 Uncommonroutes 38 3.4 Intramuscular 16 4Special considerations for wildanimals 38 3.5 Intranasal 18 References 39 Correspo ndenceandre q uestsfo rreprintst o:ProfessorD.B.Morton,DepartmentofBiomedicalSciences & BiomedicalEthic s, TheMed icalScho ol,UniversityofBirm ingham,Ed gbaston,Birm inghamB152TT, UK Accepted 14July 2000 # LaboratoryAnimals Ltd. LaboratoryAnimals (2001) 35, 1­ 41 2 Joint Working Groupon Renement Preface viously beenc ollated and werenot available inthe literatu re. Thisworkshop report isthe® fth intheseries It ishoped th at thereport willbe widely producedby theJoint WorkingGroupon circulated inan international forum,and that Re®nem entorgan ized by theBri tish Veter- therec ommendations willbe adopted as inary AssociationAnim al Welfare Founda- currentgood practice. tion(BV AAWF),theFundfor the Replacementof Animals inMedical Experi- ments(FRAME),theRoyal Society for the 1Introductionand aims ofthe report Preventionof Cruelty toAnimals (RSPCA) and theU niversitiesFederation for Animal Theproceduresin volved inth eadministra- Welfare (UFAW).Theworkshopsare based on tion ofsubstancesto animals can have a theimportant principlet hat whenever signi®cant effectonthewelfare oftheani mal animalsare usedin laboratories ,minimizing and thescient i®c value of theresults Ðif any pain and distress shouldbe as important carried out incorrectlythenboth can be an objectiveas achieving theexperimental compromised. Re®ning adm inistrationpro- results.Thisis essen tial for humanitarian cedurestherefore provides opport unitiesfor concerns. It isalso necessary inord erto improving both welfare and science.The satisfy thebroad legal principlesi nnational welfare bene®ts are widely recognized; the and international legislation,and toproduce scienti®c bene®ts resultfrom better quality reliable and reproducible scienti®cdata. data obtained from morecareful lyprepared Them embers ofeachWorking Party are experiments, usingless stresse d,more`nor- drawn from thescient i®ccommunity, from mal’ animals (Manser 1992, Vogel 1993, industry, academiaand animal welfare orga- Poole1997 ). nizations. Someoftheorganizat ionspartici- Theadm inistration of substancesis a very pating (for example,th eRoyal Society for the broad topicÐmanydifferent kinds ofsub- Preventionof Cruelty toAnimals) are stance are administered by many different opposedto theuse of animals inexperiments techniquesan droutesand for avariety of that may causethe anim als pain, suffering, purposes.T hemethodsinvolved are descri- distress orlasting harm,and this particular bed inanumber ofpublications (e.g.Paget& workshopwas a dif®cult onefor anyonein Thomson1979, Kirk &Bistner 1985, Poole suchapositionto be involved withbec ause 1987, Rollin& Kessel1990, Waynforth & ofthenature oftheproc eduresdiscusse d. Flecknell1992, Tuffery 1995, Wolfensohn& (Note: participation inthis Workshopdoes Lloyd 1998)and guidelineson g ood practice not indicate endorsementby theSoc iety of have recently beenprod uced by theLabora- researchrequi ring theuse of theproc edures tory Animal ScienceAssociation (1998).This described.) However,the c ommonaim isto reporti sintended tocomplementt heexist- reduceanimal sufferingwhereverit occurs ing literature by identifyingpotential prob- and thereport is intended tohelpac hieve lemswithindividual methods and proce- this,partic ularly ifread inconjun ctionwith duresan dfocusingon how t hesec an be otherrec entreportson the rec ognition, re®ned to reduceadverse effectsand develop measurementand alleviationof painordis- best practice.Them ost commonlyused tressin anim als. routesin t hecom monlaboratory speciesare Thispart icular workshopalso proved coveredwith notes on add itional methods or extremely dif®cult toreport, partlybecause otherspec ieswh ereappropriate. The ofthebreadth of thesubject andthenum bers emphasisison tec hniquesc arried out in ofprocedureswe set out tocover.In addition, biomedical researchand testing but someof althoughmany ofthetec hniquesare descri- theprin ciplesalso have clinical application bed brie¯y elsewhere, thesort ofdetailed inveterinary medicine. information required regardingpotential Thereport shouldprovide usefuli nforma- problemsand solutions,and about ways of tion for anyoneplannin gorcarrying out furtherre® n ing techniques, had not pre- procedures,or whohas todeal withth eir LaboratoryAnimals (2001) 35 Administration of substances 3 consequences.General principlesof `good animal, thepossibl eeffects ofthedosi ng practice’whenadm inisteringasubstanceby techniqueon th eanimal and theexpec ted any route are set out inSec tion 2,together frequencyofdosing. Thechoiceoftechnique withrecommendationsfor re®nem ent and, whererelevant ,thesite selectedare both withregard tothesubstanceadministered, also in¯uencedby suchfactors. equipmentand techniques.Section 3then Someroutesand techniquesare more describes speci®cre®nem entswithi nindivi- stressfulthan othersand theleast severe dual routesand techniques.Thereport consistent with theexperi mental aims concludeswith a section addressingspec ial shouldbe selected(seeTable 2). considerationswhenadm inisteringsub- stancestowild animals. 2.1.3 Thesubstance Thereport i sbased onth epublishedlit- Thereare constraintson the form ulations erature wherethi sisavailable and ont he that can be usedfor any particular route. consideredexpert opi nionof theworking Both thesubstanc e and thedosing vehicle group and theirc olleagues. must be appropriate for theroute, thespeci es and thepurpose of theexperim ent. Detailed 2Generalprinciples of `goodpractice’ informationon fac tors tobe consideredis available int heliteratu re(see for example, Whenadm inistering asubstancetoan Sanderson1959, Spiegel&Noseworthy1963, animal by any routetheai mshouldbe to TheMerck Index 1968, Claasen 1994, achieve`best practice’, sincemistakes at any Waynforth 1995, Reynolds 1996)and the = stage can causeavoidable suffering and or followingbrief summary isintended only as waste animals’ lives. Best practicedepends astarting point. onm inimizingoravoiding adverse effects, minimizingthenumber of animals used,and maximizing thequality and applicability of Physicochemicalproperties :Thephysic o- = results. chemical propertiesof thesubstanc eand or its vehiclem ay adversely affect animals. 2.1Planning and preparation Theseinc lude: theform ulation,sol ubility, viscosity, pH, biocompatibility, purity, Thelikeli hood ofdif®culties arising is stability, standardization and microbial reducedby thorough preparation. Con- contamination.Backgrounddata onsuc h tingencyplanssh ould always be prepared in propertiestog etherwith any extraneous case problemsdooccur. A`checklist’ for effects(e.g. irritancy),shouldalways be planningproceduresis given inTable 1. investigated. Theexpected effect may be altered by concentration anddosevol umeso 2.1.1 Experim entalaims thisshouldbe checked too. Ausefulrefer- Thescienti®c aimsmust be metby theroute encedocumentis the Dictionary ofSub- and administrationreg imeselected, soit is stancesand theirEffects (Richardson 1993, important tocheckthis® rst. Thelikely Claasen 1994). pattern ofresultsshould be considered, together with theway they relatetothe Solutions and solvents :Wheresubstanc es study’s goals and what willsubsequen tly be are dosed as solutions,water for injectionor donewith the result sandwiththeanim als. physiological salineare thecommonest and At this stage itisimportanttoconsidernot simplestsolvents .For water-insoluble com- only whethertheexperim ent can be done but poundsa suitable organic solventm ay be also whether,given thelikely effects onth e employed. Ideally this shouldlack pharma- animals, it sh ould be done. cological effects, be stable underc onditions ofuse,non-toxi c,non-irritant and non-sen- 2.1.2 Theroute sitizing. Theviscosity shouldbe suitable for Thech oiceofrouteisdeterm inedby the easeof injection. Thesolvent m ust remain purposeof theexperiment, thespeci esof the ¯uid at thetem peraturesat whichit willbe LaboratoryAnimals (2001) 35 4 Joint Working Groupon Renement Table1 Checklistwhen planning procedures Experimental aims Whatare you trying to achieve scientically? Will theadministration regime selectedmeet the aims of theexperiment? Consider not just whetherit can bedone
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