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WHOMonographsonSelectedMedicinalPlantsVolume2
(2004358pages)
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WHOMonographsonSelectedMedicinalPlantsVolume1
WHOMonographsonSelectedMedicinalPlantsVolume3
WHOMonographsonSelectedMedicinalPlantsVolume4
WHOMonographsonMedicinalPlantsCommonlyUsedintheNewlyIndependentStates(NIS)
TableofContents
Introduction
Generaltechnicalnotices
RadixAlthaeae
HerbaAndrographidis
RadixAngelicaeSinensis
FlosCalendulae
FlosCaryophylli
RhizomaCimicifugaeRacemosae
FoliumcumFloreCrataegi
RadixEleutherococci
AetheroleumEucalypti
FoliumEucalypti
CortexFrangulae
FoliumetCortexHamamelidis
SemenHippocastani
HerbaHyperici
AetheroleumMelaleucaeAlternifoliae
FoliumMelissae
AetheroleumMenthaePiperitae
FoliumMenthaePiperitae
FoliumOcimiSancti
OleumOenotheraeBiennis
RhizomaPiperisMethystici
CortexPruniAfricanae
CortexRhamniPurshianae
FlosSambuci
RadixSenegae
FructusSerenoaeRepentis
FructusSilybiMariae
HerbaTanacetiParthenii
RadixUrticae
FoliumUvaeUrsi
Annex:ParticipantsintheSecondWHOConsultationonSelectedMedicinalPlants

AetheroleumMelaleucaeAlternifoliae
Definition

Espaol

AetheroleumMelaleucaeAlternifoliaeistheessentialoilobtainedbysteamdistillationoftheleavesandterminalbranchletsof
Melaleucaalternifolia(MaidenandBetche)Cheel(Myrtaceae)(13).
Synonyms
Noinformationavailable.
Selectedvernacularnames
Australianteatree,teatree(15).
Geographicaldistribution
IndigenoustoAustralia,whereitisgrowncommercially(6,7).
Description
Anarrowleavedtreenotexceeding6m.Entireplantglabrousleavesalternate.Flowersscatteredinaninterruptedspike
stamensmorethan12mmlongunitedattheirbasestoform5distinctbundlescapsulepersistingwithinfruitinghypanthium(6
8).
Plantmaterialofinterest:essentialoil
Generalappearance
Acolourlesstopaleyellowliquid(13).
Organolepticproperties
Odour:myristic(1,2).
Microscopiccharacteristics

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Notapplicable.
Powderedplantmaterial

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Notapplicable.
Generalidentitytests

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Physicochemicalproperties,thinlayerandgaschromatography(1,2).
Puritytests
Microbiological

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TestsforspecificmicroorganismsandmicrobialcontaminationlimitsareasdescribedintheWHOguidelinesonqualitycontrol
methodsformedicinalplants(9).
Chemical
Refractiveindex:1.4751.482(13)
Opticalrotation:+5to+15(13)
Relativedensity:0.8850.906(13)
Solubilityinalcohol:solubleintwovolumesof85%ethanolat20C(13).
Pesticideresidues
Therecommendedmaximumlimitofaldrinanddieldrinisnotmorethan0.05mg/kg(10).Forotherpesticides,seetheEuropean
pharmacopoeia(10),andtheWHOguidelinesonqualitycontrolmethodsformedicinalplants(9)andpesticideresidues(11).
Heavymetals
Formaximumlimitsandanalysisofheavymetals,consulttheWHOguidelinesonqualitycontrolmethodsformedicinalplants
(9).
Radioactiveresidues
Whereapplicable,consulttheWHOguidelinesonqualitycontrolmethodsformedicinalplants(9)fortheanalysisofradioactive
isotopes.

Chemicalassays
Containsnotlessthan30%(w/w)ofterpinen4ol(4terpineol)andnotmorethan15%(w/w)of1,8cineole(alsoknownascineol,
cineoleoreucalyptol)(1,2).Theoilmustcontain:notlessthan3.5%sabine16%terpinene1028%terpinene0.512.0%
pcymenenotlessthan30%terpinen4oland1.58.0%terpineol,asmeasuredbygaschromatography(13).
Majorchemicalconstituents
Themajorconstituentsareterpinen4ol(2945%),terpinene(1028%),terpinene(2.713.0%)and1,8cineole(4.516.5%)(8,
1215).Othermonoterpenespresentinsignificantquantities(15%)includepinene,limonene,pcymeneandterpinolene.The
structuresofthemajormonoterpenesarepresentedbelow.

1,8cineole(eucalyptol)

terpinene

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terpinene

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andenantiomerterpinen4ol(4terpineol)

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Medicinaluses
Usessupportedbyclinicaldata
Topicalapplicationforsymptomatictreatmentofcommonskindisorderssuchasacne,tineapedis,bromidrosis,furunculosis,
andmycoticonychia(onychomycosis),andofvaginitisduetoTrichomonasvaginalisorCandidaalbicans,cystitisandcervicitis
(1623).
Usesdescribedinpharmacopoeiasandintraditionalsystemsofmedicine
Asanantisepticanddisinfectantforthetreatmentofwounds(5).
Usesdescribedinfolkmedicine,notsupportedbyexperimentalorclinicaldata
Symptomatictreatmentofburns,colitis,coughsandcolds,gingivitis,impetigo,nasopharyngitis,psoriasis,sinuscongestion,
stomatitisandtonsillitis(24,25).
Pharmacology
Experimentalpharmacology
Antimicrobialactivity

AetheroleumMelaleucaeAlternifoliaeinhibitedthegrowthinvitroofEscherichiacoli,vancomycinresistantEnterococcus
faecium,Staphylococcusaureus,metacillinresistantStaphylococcusaureus,andavarietyofStreptomycesspecies(MIC0.04
0.50%)(2630).ItalsoinhibitedthegrowthinvitroofTrichophytonmentagrophytes,Trichophytonrubrum,Microsporumcanis,
Malasseziafurfur,Candidaalbicans,Cryptococcusneoformans,PityrospermumovaleandTrichosporoncutaneum(MIC1.1
2.2mg/ml)(3135).Thesusceptibilityof32strainsofPropionibacteriumacnestotheessentialoilwasdeterminedusingabroth
dilutionmethod.TheMICwas0.25%forfivestrains,and0.50%fortheotherstrains(36).Severalchemicalconstituentsofthe
oil,linalool,terpinen4ol,terpineol,terpinene,terpinoleneand1,8cineole,inhibitedthegrowthinvitroofawidevarietyof
microorganisms,includingCandidaalbicans,EscherichiacoliandStaphylococcusaureus(MIC0.060.50%v/v)(27).
Toxicology
Thedermalmedianlethaldose(LD 50 )oftheessentialoilinrabbitsis>5.0mg/kgbodyweight,since5.0mg/kgresultedinthe
deathsoftwooutof10treatedrabbits(37).TheoralLD 50 inratsis1.9g/kgbodyweight(rangeofdoses1.42.7g/kg)(24,25,37,
38).Thesignsofseveretoxicityarerespiratorydistress,andcomawithdiarrhoea(26,38).Afewcasesoftoxicosisaftertopical
applicationofhighdosesoftheessentialoiltodogsandcatshavebeenreported.Symptomsincludedcentralnervoussystem
depression,weakness,andlackofcoordinationandmuscletremorsthatwereresolvedwithin23daysaftersupportivetreatment
(39).
Clinicalpharmacology
Vaginitisandcervicitis
Astudywithoutcontrolsassessedthesafetyandefficacyofa40%emulsifiedsolutionofAetheroleumMelaleucaeAlternifoliae
in13%isopropylalcoholinthetreatmentof130womenwithcervicitisorvaginitisduetoTrichomonasvaginalisorvaginitisdue
toCandidaalbicans.Intravaginalapplicationoftamponssaturatedwitha20%emulsifiedsolutionhealedcervicitisdueto
Trichomonasvaginalisafterfourweeklytreatments.InpatientswithvaginitisduetoTrichomonasvaginalis,intravaginal
applicationofa1%emulsifiedsolutionusingasaturatedtampon,aswellasvaginaldouching,resultedinclinicalcuresand
restorationofthecervix(21).Inanotherstudywithoutcontrols,28womenwithvaginitisduetoCandidaalbicansweretreated
withvaginalpessaries(containing0.2gessentialoil)everynightfor90days.After30daysoftreatment,24patientswere
alreadyfreeofsymptomssuchasleukorrhoeaandburningsensation,and21werefreeofCandidaalbicans(17).
Cystitis

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Arandomized,doubleblind,placebocontrolledtrialassessedtheefficacyoftheessentialoilinthetreatmentof26womenwith
chronicideopathiccolibacillicystitis.Patientsweretreatedwith8mgessentialoil,inanentericcapsuleform,orallythreetimes
dailyfor6months.Aftertreatment,54%oftheessentialoiltreatedgroupwerefreeofsymptoms,comparedwithonly15%inthe
placebogroup.However,approximately50%oftheasymptomaticpatientsstillshowedevidenceofcolibacilliandleukocytesin
theirurine(17).
Acne

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Arandomized,singleblind,comparisontrialevaluatedthesafetyandefficacyoftopicalapplicationofagelcontainingeither5%
essentialoilor5%benzoylperoxideinthetreatmentofmildtomoderateacnein119patients.Theresultsdemonstratedthat
bothpreparationssignificantlyreducedthenumberofinflamedandnoninflamedlesions(openandclosedcomedones)after3
monthsofdailytreatment(P<0.001),althoughtheonsetofactionofthegelcontainingtheessentialoilwasslowerthanthatof
thegelcontainingbenzoylperoxide.Patientstreatedwiththeoilcontaininggelreportedfewersideeffectsthanthosetreatedwith
thebenzoylperoxidecontaininggel(16).

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Footproblems
Arandomizeddoubleblind,placebocontrolledclinicaltrialevaluatedtheefficacyofacreamcontainingeither10%(w/w)
essentialoil,1%tolnaftateoraplacebointhetreatmentof104patientswithtineapedisduetoTrichophytonrubrum,T.
mentagrophytesandEpidermophytonfloccosum.Afterapplicationofthecreamtwicedailyfor4weeks,30%oftheessentialoil
treatedpatients,85%ofthetolnaftatetreatedpatientsand21%oftheplacebotreatedpatientsshowedconversiontoanegative
culture(P<0.001).Boththeessentialoiltreatedgroupandtolnaftatetreatedgroupdemonstratedsignificantimprovementinthe
clinicalsymptomsofscaling,inflammation,itchingandburningsensation,comparedwiththeplacebogroup(P<0.001).The
creamcontainingtheessentialoilreducedsymptomatologyoftineapedisaseffectivelyasthatcontainingtolnaftate,butwasno
betterthantheplaceboinachievingamycologicalcure(22).Astudywithoutcontrolsassessedtheefficacyofthreeproductsin
thetreatmentof60patientswithtineapedisduetoTrichophytonrubrum,T.mentagrophytesandEpidermophytonfloccosum,as
wellasotherconditionssuchasbromidrosis,inflamedcorns,calluses,bunions,fissuresandmycoticonychia(onychomycosis)
ofthetoenails.Eightpatientsweretreatedwith100%essentialoil,40patientsweretreatedwitha40%emulsifiedsolutionofthe
essentialoilin13%isopropylalcoholand12weretreatedwithanointmentcontaining8%essentialoil,twicedailyfor3weeksto
4years.The100%essentialoilwasassessedasfairtopoorinthetreatmentofmycoticonychia.The40%emulsifiedsolution
reducedthesymptomsofbromidrosis,andinflammationofcorns,callusesandbunions.The8%ointmentwaseffectiveinthe
symptomatictreatmentoftineapedisduetoT.mentagrophytesandEpidermophytonfloccosum,butwaslesseffectiveagainst
T.rubrum(23).
Arandomized,doubleblind,multicentrecomparisontrialassessedtheefficacyof100%essentialoilor1%clotrimazoleinthe
treatmentof117patientswithdistalsubungualmycoticonychia.Patientsreceivedtwicedailyapplicationsfor6months,and
debridementandclinicalassessmentwereperformedat0,1,3and6months.After3months,approximately50%ofeachgroup
reportedimprovements.After6months,clinicalassessmentshowedpartialorfullresolutioninapproximately60%ofeachgroup
(19).

Theefficacyoftheessentialoilwasassessedinanopenstudyof35patientswithfurunclesontheaxilla,back,ear,face,
forearm,neckandscalp.Thefuruncleswerepaintedwiththeessentialoiltwoorthreetimesdaily,afterthoroughcleaning.Inthe
grouptreatedwiththeessentialoil,onlyonefurunclerequiredincision,andin15patients,thefuruncleswerecompletelycured
after8daysoftreatment.Theonlyadversereactionwasslighttemporarystingingreportedbythreepatients.Intheuntreated
controlgroup,furunclesonfiveofthe10patientsrequiredincisionandtheinfectedsiteofthefuruncleswasstillapparentafter8
days(20).
Contraindications
AetheroleumMelaleucaeAlternifoliaeiscontraindicatedincasesofknownallergytoplantsoftheMyrtaceaefamily.
Warnings
Notforinternaluse.Keepoutofreachofchildren(seeAdversereactions).
Precautions
Noinformationavailableongeneralprecautionsorprecautionsconcerningdruginteractionsdrugandlaboratorytestinteractions
carcinogenesis,mutagenesis,impairmentoffertilityteratogenicandnonteratogeniceffectsinpregnancynursingmothersor
paediatricuse.Therefore,AetheroleumMelaleucaeAlternifoliaeshouldnotbeadministeredduringpregnancyorlactationorto
childrenwithoutmedicalsupervision.
Adversereactions
AllergiccontactdermatitisafterexternalapplicationandingestionofAetheroleumMelaleucaeAlternifoliaehasbeenreported(26,
4044).Noadversereactionswerereportedintwopatchtestsusingpreparationscontainingupto5%essentialoil(45,46).
Accidentalingestionof10mlessentialoilcausedconfusion,disorientationandlossofcoordinationina23montholdchild(47).
Ingestionof2.5mlessentialoilbya60yearoldmanresultedinasevererashandageneralfeelingofmalaise(48).Inductionof
acomatosestatelasting12hours,followedby36hoursofasemiconsciousstateaccompaniedbyhallucinations,wasreported
inonepatientafteringestionofapproximatelyhalfacup(120ml)oftheessentialoil.Abdominalpainanddiarrhoealastingupto
6weekswerealsoreported(38).
Dosageforms
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Essentialoil(1,2).Storeinawellfilled,airtightcontainer,protectedfromheatandlight.

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Posology
(Unlessotherwiseindicated)
Externalapplicationoftheessentialoilatconcentrationsof5100%,dependingontheskindisorderbeingtreated(1623).

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References
1.EssentialoilsoilofMelaleuca,terpinen4oltype.AS27821997.Sydney,StandardsAssociationofAustralia,1997.
2.DeutscherArzneimittelCodex,Suppl.8.Stuttgart,GoviVerlag,1996.

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3.OilofMelaleuca,terpinen4oltype(teatreeoil).ISO4730:1996(E).Geneva,InternationalOrganizationforStandardization,
1996.
4.FarnsworthNR,ed.NAPRALERTdatabase.Chicago,UniversityofIllinoisatChicago,IL,March17,1998production(anonline
databaseavailabledirectlythroughtheUniversityofIllinoisatChicagoorthroughtheScientificandTechnicalNetwork[STN]of
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6.CribbAB,CribbJW.UsefulwildplantsinAustralia.Sydney,Fontana/Collins,1981.
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9.Qualitycontrolmethodsformedicinalplantmaterials.Geneva,WorldHealthOrganization,1998.
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12.GuentherE.Australianteatreeoils.PerfumeryandEssentialOilsRecord,1968:642644.

13.SwordsG,HunterGLK.CompositionofAustralianteatreeoil(Melaleucaalternifolia).JournalofAgriculturalandFood
Chemistry,1978,26:734737.
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Australia,1990,153:455458.
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18.BlackwellAL.Teatreeoilandanaerobic(bacterial)vaginosis.Lancet,1991,337:300.
19.BuckDSetal.Comparisonoftwotopicalpreparationsforthetreatmentofonychomycosis:Melaleucaalternifolia(teatree)oil
andclotrimazole.JournalofPharmacyPractice,1994,38:601605.
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22.TongMMetal.Teatreeoilinthetreatmentoftineapedis.AustralasJournalofDermatology,1992,33:145149.
23.WalkerM.ClinicalinvestigationofAustralianMelaleucaalternifoliaoilforavarietyofcommonfootproblems.Current
podiatry,1972,18:715.
24.AltmanPM.Australianteatreeoil.AustralianJournalofPharmacy,1988,69:276278.
25.AltmanPM.Australianteatreeoil:anaturalantiseptic.AustralianJournalofBiotechnology,1989,3:247248.

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26.CarsonCF,RileyTV.ToxicityoftheessentialoilofMelaleucaalternifoliaorteatreeoil.JournalofToxicology(Clinical
Toxicology),1995,32:193194.
27.CarsonCF,RileyTV.AntimicrobialactivityofthemajorcomponentsoftheessentialoilsofMelaleucaalternifolia.Journalof
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28.CarsonCF,RileyTV.InvitroactivityoftheessentialoilofMelaleucaalternifoliaagainstStreptococcusspp.Journalof
AntimicrobialChemotherapy,1996,37:11771178.

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29.ChanCH,LoudonKW.ActivityofteatreeoilonmethacillinresistantStaphylococcusaureus(MRSA).JournalofHospital
Infection,1998,39:244245.
30.NelsonRRS.InvitroactivitiesoffiveplantessentialoilsagainstmethacillinresistantStaphylococcusaureusand
vancomycinresistantEnterococcusfaecium.JournalofAntimicrobialChemotherapy,1997,40:305306.

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31.ConchaJMetal.AntifungalactivityofMelaleucaalternifolia(teatree)oilagainstvariouspathogenicorganisms.Journalof
theAmericanPodiatryMedicalAssociation,1998,88:489492.
32.HammerKAetal.Invitroactivityofessentialoils,inparticularMelaleucaalternifolia(teatree)andteatreeoilproducts,
againstCandidaspp.JournalofAntimicrobialChemotherapy,1998,42:591595.
33.NenoffPetal.AntifungalactivityoftheessentialoilofMelaleucaalternifolia(teatreeoil)againstpathogenicfungiinvitro.
SkinPharmacology,1996,9:388394.
34.ViollonC,ChaumontJP.AntifungalpropertiesofessentialoilsandtheirmaincomponentsuponCryptococcusneoformans.
Mycopathologia,1994,128:151153.
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36.CarsonCF,RileyTV.SusceptibilityofPropionibacteriumacnestotheessentialoilofMelaleucaalternifolia.LettersinApplied
Microbiology,1994,19:2425.
37.CarsonCFetal.Efficacyandsafetyofteatreeoilasatopicalantimicrobialagent.JournalofHospitalInfection,1998,
40:175178.
38.SeawrightA.Teatreeoilpoisoning(comment).MedicalJournalofAustralia,1993,159:831.
39.VillarDetal.ToxicityofMelaleucaoilandrelatedessentialoilsappliedtopicallyondogsandcats.VeterinaryandHuman
Toxicology,1994,36:139142.

40.AptedJH.Contactdermatitisassociatedwiththeuseofteatreeoil.Australasjournalofdermatology,1991,32:177.
41.DeGrootACetal.Systemiccontactdermatitisfromteatreeoil.ContactDermatitis,1992,27:279280.
42.KnightTE,HausenBM.Melaleucaoil(teatreeoil)dermatitis.JournaloftheAmericanAcademyofDermatology,1994,
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43.SelvaagEetal.Contactallergytoteatreeoilandcrosssensitizationtocolophony.ContactDermatitis,1994,31:124125.
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138:823825.
45.DeGrootAC.Airborneallergiccontactdermatitisfromteatreeoil.ContactDermatitis,1996,35:304305.
46.BhushanM,BeckMH.Allergiccontactdermatitisfromteatreeoilinawartpaint.ContactDermatitis,1997,36:117118.
47.JacobsMR,HornfeldtCS.Melaleucaoilpoisoning.JournalofToxicology(ClinicalToxicology),1994,32:461464.
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