Cough Irritation by Deodorant Sprays

8/12/2019 Cough Irritation by Deodorant Sprays

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J. Soc.Cosmet. hem. 6, 509-522 1975) 1975Society f Cosmetic henistsf GreatBritain

Coughrritationby deodorantpraysE. M. STAAL, W. BREE and P. L. C. A. RIJNBEEK*

Synopsis--The causes of RESPIRATORY IRRITATION provoked by DEODORANTSPRAYS have been investigated.For this purpose, he irritant potential of severaldeodorantspray formulations was determined. The quantitative evaluation of cough stimulation wascarried out on a large number of subjects.The various features of the method are discussedin detail.This investigation as shown hat the main causes f coughstimulationby deodorantspraysare the antimicrobial agents ncluded n the formulae.

INTRODUCTION

Cough, triggeredby inhalation of an aerosol, s a common mani-festation,very tiresome or the user; it shouldbe considered s a technicaldefectof the aerosol,particularlywith aerosolsor cosmetic se sprayedtowards the body.Cougl is causedby irritation of the mucous membranesof the nose,throat and respiratory tract. With aerosols, n some circumstances,hesprayedcontentsmay trigger suchan irritation. The chemicaland pharma-cologicalbasesof this irritation are hardly known. Previous nvestigation(1, 2, 3, 4, 5, 6) refer mainly to inhalationtoxicity in general erms. Forthis reason, he investigation escribed ere on the causesof cough stimu-lation has been focused on formulation characteristics of aerosols and* ResearchLaboratory Drogerijen MaatschappijBrabantsestraat 7, Amersfoort, The Nether-lands.

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510 JOURNALOF THE SOCIETYOF COSMETIC HEMISTSparticularly to deodorantsprayswhich are known to induce coughingonsome occasions.

A methodwas developedn our laboratories o quantify this effect; hisso-calledConsumerTest Method derived he averagevalue or a numericalrating given by a number of test subjects,with respect o the featurebeinginvestigated.The different facets of this test method will be discussednmore detail.

The investigationwas carried out on 'wet' deodorant sprayswithoutantiperspirant ngredients.Such productsare designed o reduce he bac-terial skin flora, thereby preventing he productsof bacterial metabolismfrom giving rise to malodour. Deodorant sprayscontaininganti-oxidantsand odour-absorbers were excluded.Experience ad shown hat, in spiteof similarities n composition, herewere wide differences etween he irritant propertiesof commercialsprays.It thereforeseemed ikely that one or more factors responsibleor coughstimulationmight be identified.The spray ormulae nvestigatedor cough-stimulatingctivity ranged ncompositionwithin the following limits:

Fatty substances 0-0.30oPerfume 0-0.20oBactericides 0-0.25oSolvent 0-50oPropellant up to 100o

By changing he proportionsof the five main components, number ofdifferentdeodorantsprays ould be prepared,eachof whichwas tested orcough-stimulating otential. No formula without both fatty substancesndsolventswas studied, as this would have meant that the bactericide wouldhave been sprayedas a dry powder.

Fatty substances

Perfumes

MATERIALS

Isopropyl myristatePropyleneglycolIsopropyl isostearateIsopropyl palmitateVarious


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COUGH IRRITATION BY DEODORANT SPRAYS 511

Bactericides2,3,5,2',3',5' hexachloro-6,6'dihydroxydiphenylmethane2,4,4' trichloro-2' hydroxydiphenylether3,4,4' trichlorocarbanilide4,4' dichloro-3-trifluoromethylcarbanilide,3,5-dibromo-3' rifluoromethyl-salicylanilide,2,5,4' tribromosalicylanilide.

Solvent Absolute ethanol, not denaturedPropellant MonofluorotrichloromethaneF 11)Difluorodichloromethane F12)To test the influenceof the spraypattern and of the spray rate on coughstimulation,severalvalve combinations DeutschePr//zisions-Ventil)withdifferentactuator, stemand housingorificeswere used.

TEST METHOD

The cough-stimulatingotentialof eachdeodorant praywasdeterminedunderconditions s near to normal use as possible.Randomlychosen olunteerswere asked o give absoluteappraisals fthe irritant properties of the spray being tested. In this respect the testmethod deviates from the several standard methods which are used insensory esting 7).The value obtained by averaging he numerical ratings given by thetested ubjectss probably nfluenced y a combination f chemical, hysicalandpsychologicalactors,asoccursn practice.From thisangle, he methodoffers advantages omparedwith instrumentalanalyticalmethods,whichyield data influencedonly by physicaland/or chemical,but not psycho-logical, factors.

For optimum results n consumer esting, the following criteria areapplicable:Ten peopleor more shouldbe interrogated.All interrogatedsubjects houldcollaborateon a voluntary basis.Each test shouldbe completed s quicklyas possible, referablywithin

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512 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS

The assessmentrocedureor an individualsubject houldbe as briefas possible, voidingcomplicated r long and tediousprocedures;Not more than two testsshouldbe carried out daily with a givensubjectin the paneland the ntervalbetweenwo successiveests houldnot be essthan 4 h.

Each subject houldbe clearly old what characteristicsf the test pro-duct should be considered.The way in which the testingprocedures carriedout shouldbe chosenindividually by the subject.The investigatorshould ensure that subjectscannot influenceeachother'sopinion.During each est,eachsubject houldgivean absolute ppraisalaboutagiven eature;no comparisonmaterial whatevershouldbe availableat anytime during the test.The subject's ppraisalabout the feature being testedshouldbe ex-pressed y a rating: 0, 1, 2, 3 or 4 (4 = greatest ffect,whethergoodor bad).To find out if there is any significantdifferencebetween wo test series,the Wilcoxon's Q-test may be used, with a one-sideoverrun probabilityof 5 .For each consumer est, the ratings obtainedwere averagedand multi-pliedby 2.5. The figureso obtainedwascalled he factor for the aspect einginvestigated.Minimum value 0, maximum value 10.)The factor on a 0-10 scalegavea figuresuitable or ready nterpretationof cough stimulation. After statisticalanalysisby the Q-test it becameevident hat a difference f 1 point between wo factorswassignificant. llfactors, therefore, were rounded to 0.5.Observationsoncerninghe applicationof the testmethod o deodorant

spray cough stimulation were:The coughstimulation estpanel ncluded11 womenand 21 men, aged

between 18 and 45.No differenceappearedbetveenappraisalby men and by women, orbetweenage groups.Two sprayswere nvestigated ach day, one in the morning and one nthe afternoon.Hardly any difference ppeared etweenmorningand after-

noon tests.


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Each subjectwas free to choosehow to make the test.Two differentmethodswere used:somesubjects19o) tended o directthe aerosolspray owards he face from arm's length. The remainingsub-jectssprayedhorizontally n front of the body and then remained mmersedwithin the spray cloud.No overall difference n findings appearedbetween the two groupsalthough, with the secondmethod, the sprayedamounts of fluid weregenerally greater.Respiratory ract irritation wasexpresseds an integer,according o the

following table: 0 no cough,1 slight cough,2 moderate cough,3 strong cough,4 very strong cough.After averaging,multiplicationby 2.5 and rounding o 0.5, a valuewasobtained or each spray,givinga measureof the cough-stimulating oten-tial: the cough actor (CF).Cough-stimulatingctivitywasassessedwice or eachdeodorantsprayinvestigated.Reproducibilityappeared o be good.The whole investigationastedabout 2 yr, with a total of 212 irritation

tests.

EXPERIMENTAL

Preliminary studiesSinceat the beginningof this investigation othing was known aboutthe possible ough-stimulatingotentialof the various ngredients,irst thecough-stimulating ctivity of a deodorant spray with a composition ncommon use was determined


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514 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTSComposition 7oIsopropylmyristate 0.3Perfume 0.2Bactericide 0.2Ethanol 24.3F11 25.0F12 50.0

100.0The fragranceusedwas a green lowery type.The bactericidewaschosen rbitrarily rom the six ypes istedaboveandwas usedas the standardbactericide hroughout he investigation.The aerosolwas equippedwith a valvehavinga stemorificeof 0.45 mmand an actuator orifice of 0.50 mm; the spray angle was about 16.All preliminary estswerecarriedout with this deorodant pray; nitiallythe investigationwas designed o show whether the consumer est didactuallyensuregood quantitative eproducibilityof the cough-stimulating

irritation.This preliminary study ndicated hat the test method was suitable or

the purpose nd the spraymentionedabovegavea cough actor (CF) of 6.0.This standard praywasused or referencehroughout he main investi-gation, a run with it being ncluded n each arge test series.The standardspray was tested, overall on 22 occasions y the panel,leading to cough actorsas follows:4 times: CF = 5.5

12 times: CF = 6.06 times: CF = 6.5

Between he two extremevalues, 5.5 and 6.5, Wilcoxon's Q-test onlyonce showeda significantdifference.A number of screening ests were performed, in order to identify apossiblemain cause or cough stimulation.Several ormulae were tested,one ingredientbeing omitted each time. Table I gives a summaryof theformulaeused,with corresponding F values.Clearly the formulation without bactericidewas esscough-stimulatingthan the others.Formulae C, E and G (respectively ithout perfume,with-out ethanol and without F12) also gave significantly ower CF values hanthe standard, but not as low as the bactericide-free formula.


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COUGH IRRITATION BY DEODORANT SPRAYS

Table I. Elimination seriesof deodorant ingredients515

Composition: A B C D E F G*Isopropyl myristate 0.3 -- 0.3 0.3 0.3 0.3 0.3Perfume 0.2 0.2 -- 0.2 0.2 0.2 0.2Bactericide 0.2 0.2 0.2 -- 0.2 0.2 0.2Ethanol 24.3 24.6 24.5 24.5 -- 24.3 24.3F11 25.0 25.0 25.0 25.0 49.3 -- 75.0F12 50.0 50.0 50.0 50.0 50.0 75.0 --CF 6.0 6.0 4.5 1.5 4.5 6.5 4.5Difference rom the standard alue -- not sign. sign. sign. sign. not sign. sign.

* Aerosol brought to an internal pressureof 0.009 Nm - (= 8 atmospheres)with nitrogen.

To exclude a possiblecumulative effect of the irritant influencesofperfume,ethanol and F12 on the respiratory ract, the following formulawas also tested.Table 1I. Cumulative effect of perfume,

ethanol and propellantComposition: H*Isopropyl myristate 0.3Bactericide 0.2Fll 99.5CF 4.5Difference from standard sign.* Aerosol brought to an internal pres-

sure of 0.009 Nm - with nitrogen.

Further evidence s that formulae E, F, G and H are associatedwithspraypatternswhichare totally different rom that of the standard pray.Attemptsat reproducing praypatternsas closeas possible o that ofthe standardormulaby means f othervalves ndvariations f the pressureby meansof nitrogen,had only partial success.To determinewhetherdifferencesn the spraypattern and sprayrateinfluence espiratory ract irritation, severalaerosolswere tested,each imewith the standard ormula but completely ifferentvalves.Here attemptswere made to obtain spraypatterns hat were as differentas possible romeach other.


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516 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTSTable III. Effect of varying spray pattern

Valve specification:Housing orifice 2.0 mm 2.0-0.50 mm 2.0 mmStem orifice 0.45 mm 2 x 0.50 mm 0.45 mmActuator orifice 0.50 mm 0.50 mm 0.33 mmSpray rate 1 g s4 0.6 g s x 0.4 g s4Spray angle 16 10 12CF 6.0 5.5 6.0Difference from standard -- not sign. not sign.

The results show that a different spray pattern of the aerosolhardlyinfluenced oughstimulation seealso Table VII(a) and (b)).Further studiesof the influenceof the ethanol and propellantconcentra-tions,which nfluence he spraypattern,were thussimplified.Having completed he above screeningests,a systematicnvestigationinto the influenceof the ingredientsof the deodorantsprayon the respira-tory tract could then be performed.Influenceof fatty substances

During the preliminary tests, the presenceor absenceof isopropylmyristate n the standard ormula apparentlyhad no influenceon coughstimulation.

The influence f other atty substances as determined y replacingso-propylmyristate n the formula successivelyy: propyleneglycol, sopropylisostearate nd isopropylpalmitate,each ime at a concentration f 0.3.With all these prays oughstimulation orrespondedo that inducedbythe standard ormula (CF = 6.0).Since he irritant influenceof fatty substances ight interact with thatof bactericides,he above ormulae werere-tested n bactericide-free prays;no difference was found from formula D, the bactericide-freemodifiedformula (CF = 1.5).

Influenceof perfumesIt was ecidedot o est inglengredientsfperfumesorcoughtimu-lation, partly becausehe preliminary estshad shown hat perfumes nlyhad a limited influenceon respiratory ract irritation and also becausehegreat number of ingredientsused n perfumeswould have made a global

investigationmpossible.


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It was thereforeconsidered ufficient o test a number of perfumeswithdistinctive haracteristics'woody, green,spicy, ruity, floweryand cologne.Theseperfumeswere used in the standard ormula at a concentrationof0.2 ' none of thesespraysshowedany significantshift from the standardCF value (CF = 6.0).The above-mentionederfume ypeswere also ested n the bactericide-fi'ee ormula' here also the type of perfumewas shownnot to influence heCF give by formula D, the bactericide-freeow-irritation ormula (CF --1.5).The influenceof perfume concentrationwas also investigated.Variousconcentrations f a standard ragrancewere added to the standard ormulaand eachof thesesprayswas tested or coughstimulation.

The same set of concentrations was also tested in the bactericide-freeformula. The resultingCF valuesare given in Table IV.

Table IV. Effect of perfume concentrationPerfume Standard formula Standard formula

concentration with bactericide without bactericideO.2O 6.O 1.50.13 6.5 1.5O.O6 6.O 1.5O 4.5 O.5

Compared with the standard ormulae, the perfume-freespraysgavesignificantlyower CF values; hus, among thoseperfumesused n thesetestscough-stimulatingrritation is apparently nfluenced ot by the kindof perfume,but by the presence r absence f perfume.

Influenceof bactericidesDuring the preliminary ests, he standard actericide pparentlyhad astrong nfluenceon the irritant activity. For a better knowledgeof thisdependence,he cough-stimulatingctivity of a standard ormula withincreasing oncentrations f bactericidewas nvestigated.These measurements ere repeatedwith five other bactericides on-sidered or inclusion n deodorantsprays.The CF values ound are reported n Table V.


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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTSTable V. Effect of type and concentrationof bactericide

ConcentrationBactericide 0 0.05 0.10 0.15 0.20 0.25

Standard 3.0 4.5 6.0 6.5 7.0A I 2.0 2.5 4.0 6.5 7.5B 1.5 1.0 1.5 2.0 2.0 1.5C 1.5 1.5 1.5 2.5 2.5D I 1.5 4.0 5.0 7.0 7.0E 3.5 4.5 5.5 7.5 7.5After statisticalanalysisof the test results comparisonof Q-test) thefollowing conclusions ould be drawn:Throughout the chosenconcentration ange, no significantdifferenceappearsbetween he standardbactericide nd E, both being associatedwith strongcough stimulationeven at low concentration,B and C did not irritate the respiratory tract at any concentrationwithin the observation ange,A is not irritant at concentrationsp to 0.1 o; at higherconcentrationsthe CF quickly rises to that associatedwith the standard ormula,D is not irritant at concentrations p to 0.05; at higherconcentrationsthe CF quickly ncreaseso that associatedwith the standard ormula.

Influenceof solvents ndpropellantIn technicallywell-designed erosols, he percentages f solventsandpropellantcannot exceedcertain practical imits. The spraysconsidered

here sometimesad extreme ompositionshat could hardlybe used nnormal practice.The observedCF valuesclearly show,however,how cough-stimulatingactivity varied in suchcases Table Vl(a) and (b)).The resultsshowed hat ethanol and propellant only influencecoughstimulation to a small extent. However, sincehigh alcohol levels seemedslightly o reduce he irritant activity, the influenceof alcohol was furtherinvestigated.A number of sprayswith increasing lcohol evels was tested n twoserieswith 0.1 and with 0.2 of bactericide espectively.n addition,each


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of these ormulae was used o preparetwo aerosols'one with a standardvalve spray ate 1.0 g s-), and one with a valveensuring spray ate of0.5 g s .

Table VI (a). Effect of varying solventsand propellants bactericidepresent)Composition:lsopropyl myristate 0.3 0.3 0.3 0.3 0.3Perfume 0.2 0.2 0.2 0.2 0.2Bactericide 0.2 0.2 0.2 0.2 0.2Ethanol -- -- 24.3 39.3 39.3Fll -- 79.3 25.0 -- 50.0F12 99.3 20.0 50.0 60.0 10.0CF 5.0 5.5 6.0 5.0 3.5Difference rom standard not sign. not sign. -- not sign. sign.

Table VI(b). Effect of varying solventsand propellants (in absenceof bactericide)Composition:[sopropyl myristate 0.3 0.3 0.3 0.3 0.3Perfume 0.2 0.2 0.2 0.2 0.2Bactericide .....Ethanol -- -- 24.5 39.5 39.5Fll -- 79.5 25.0 -- 50.0F12 99.5 20.0 50.0 60.0 10.0CF 1.0 2.0 1.5 1.5 1.5Difference from Formula D not sign. not sign. -- not sign. not sign.

Each of thesesprayscontained0.2o of perfume,0.3 of isopropylmyristateand up to 100 propellant F1 l/F12: 60/40).The CF values ound are reported n Table VII(a) and (b).

Table VII(a). Influence of ethanol concentration at different spray ratesBactericide 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1Ethanol 3.0 3.0 6.0 6.0 12.0 12.0 25.0 25.0 50.0 50.0Spray rate (g s ) 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0CF 3.0 3.0 4.5 4.5 4.0 4.0 4.0 4.5 4.5 4.0 3.0 2.5


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520 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTSTable VII(b). Influence of ethanol concentration at different spray rates with bactericide at

increased concentrationBactericide 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2Ethanol 3.0 3.0 6.0 6.0 12.0 12.0 25.0 25.0 50.0 50.0Spray rate(gs -x) 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0 0.5 1.0CF 4.5 4.0 6.5 6.0 6.0 6.5 6.0 6.5 6.0 5.5 3.5 3.5

The recordedCF values ed to the following conclusions:In deodorantsprays,concentrations f ethanol rom 3.0 to 25o showed

no influenceon coughstimulation.At 50o concentration f ethanol, cough stimulationappears o havebeen slightlyreduced;ethanol-freespraysalso showeda slight reductionof CF.

A 50o reduction of the spray rate of thesedeodorant spraysdid notinfluencecough stimulation.

DISCUSSION

Before discussinghe results, t shouldbe clearly stated hat these estsand measurements re not all-embracing.There is a wide range of otherpossible ariations,e.g. other bactericides,nfluenceof importantperfumeraw materials, ormulae with other solvents, tc. When planning he tests,it was decided o remain within practical limits of importance o con-temporarycosmetic cience.The main advantageof the ConsumerTest Method is that it allowsdirect correlationbetween he propertiesof a product and the consumer'sappraisal, herebybypassinghe necessity f converting number,obtainedby instrumental observation, nto some kind of index correspondingoacceptance y the end consumer.n addition, the method s inexpensive ndrapid.Each subject nterrogated s expected o give a numerical appraisalexpressed s 0, 1, 2, 3 or 4. As he or she does this, it is essential hat nocomparisonmaterial be made available; n daily use of a product--here adeodorantspray--no comparisonmaterial will actually be available.Theabsoluteappraisal, n terms of these atings,relates o a givenproperty ofthe product, assesseds in daily use.


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In our evaluations, dispersion f valueswas noted in everytest. Inaddition, the frequencydistributionwas not normal, thereby making itimpossibleo compare wo seriesof measurementsy t-test. In an evalua-tion like this, the mostpreciseway is to use he (T) sign est n order torecognizesignificantdifferences.In interpretinghe data obtainedwith the consumerest,we preferred,however, o use he Q-testof Wilcoxon.Here eachsegment f the data n aseriess comparedwith the data obtained rom anotherseries. his yieldsa difference core,called Q-value, allowing the one-sideoverrun proba-bility to be determined y meansof tables.Using the Q-test nsteadof theT-testhas he advantage f allowingcomparison etween eries f differentlength.Experience as shown hat the average ating, as determinedwith theconsumer est method, has a maximum value of 3 to 3.5. Not only whenassessingoughstimulationdue o deodorants, ut in other ests, oo, thereappears o be somepersonaldislike or giving he maximummark for agiveneffect.This finding s in accordance ith the findings f several therinvestigators7, 8, 9).The conclusionswhich can be drawn for the sourcesof cough stimula-tion by deodorant prays re that this irritation is due to the type of bac-tericideusedand the percentage f bactericidencludedn the formula.Other actors, ike the spraypatternand spray ate, the concentrationsof solventsndperfumes, ppear o playa secondaryole.That respiratorytract rritationappears ot to dependon spray ate is quite ogical f it isrealized hat a test subject eels rritation from an aerosolcloudno matterhow this cloud has been ormed. This statements supported y the factthat the testprocedure asno influence n the actual rritationfelt by thesubjects.Wide differencesppear o existbetweenhe cough-stimulatingffectofdifferent bactericides. No correlation could be deduced between the bac-tericidal nd the rritantpropertiesor the different ompoundstudied, owe have only reportedour actual findings. (Received: 1stFebruary1975)

REFERENCES(1) Kinkel, H. J. Inhalation and toxicitystudies. . Soc. Cosmet.Chem.15 395 (1964).(2) Kiibler,H. Physiologicalroperties f propellants. . Soc.Cosmet.Chem.14 341 (1963).(3) Gloxhuber,C. Zur Methodikder oxikologischenrti ung von Kosmetika.J. Soc.Cosmet.

Chem.21 313 (1970).


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522 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS(4) O'Connor Ward, C. Current perspectives n aerosol toxicity. J. Soc. Cosmet.Chem. 25 271(1974).(5) Troy, W. R. Testing for inhalation toxicity. J. Soc. Cosmet.Chem. 25 283 (1974).(6) Joyner, B. D. and Holmes, C. L. Manufacturing Chemistp. 8l May 1970.(7) Amerine, M. A., Pangborn, R. M. and Roessler,E. B. Principlesof SensoryEvahationofFood (1965) (Academic Press,New York).(8) Guilford, J.P. PsychometricMethods (1954) (MacGraw-Hill, New York).(9) Ough, C. S. and Baker, G. A. Small panel sensory valuationsof winesby scoring. tilgardia30 587 (1961).

Cough Irritation by Deodorant Sprays

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