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J. Soc. Cosmet. Chem.

26, 509-522 (1975) 1975 Society of Cosmetic Chenists of Great Britain


Cough irritation by deodorant sprays
E. M. STAAL, W. BREE and P. L. C. A. RIJNBEEK*
Synopsis--The causes of RESPIRATORY IRRITATION provoked by DEODORANT
SPRAYS have been investigated. For this purpose, the irritant potential of several deodorant
spray formulations was determined. The quantitative evaluation of cough stimulation was
carried out on a large number of subjects. The various features of the method are discussed
in detail.
This investigation has shown that the main causes of cough stimulation by deodorant sprays
are the antimicrobial agents included in the formulae.
INTRODUCTION
Cough, triggered by inhalation of an aerosol, is a common mani-
festation, very tiresome for the user; it should be considered as a technical
defect of the aerosol, particularly with aerosols for cosmetic use sprayed
towards the body.
Cougl is caused by irritation of the mucous membranes of the nose,
throat and respiratory tract. With aerosols, in some circumstances, the
sprayed contents may trigger such an irritation. The chemical and pharma-
cological bases of this irritation are hardly known. Previous investigation
(1, 2, 3, 4, 5, 6) refer mainly to inhalation toxicity in general terms. For
this reason, the investigation described here on the causes of cough stimu-
lation has been focused on formulation characteristics of aerosols and
* Research Laboratory Drogerijen Maatschappij Brabantsestraat 17, Amersfoort, The Nether-
lands.
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particularly to deodorant sprays which are known to induce coughing on
some occasions.
A method was developed in our laboratories to quantify this effect; this
so-called Consumer Test Method derived the average value for a numerical
rating given by a number of test subjects, with respect to the feature being
investigated. The different facets of this test method will be discussed in
more detail.
The investigation was carried out on 'wet' deodorant sprays without
antiperspirant ingredients. Such products are designed to reduce the bac-
terial skin flora, thereby preventing the products of bacterial metabolism
from giving rise to malodour. Deodorant sprays containing anti-oxidants
and odour-absorbers were excluded.
Experience had shown that, in spite of similarities in composition, there
were wide differences between the irritant properties of commercial sprays.
It therefore seemed likely that one or more factors responsible for cough
stimulation might be identified.
The spray formulae investigated for cough-stimulating activity ranged in
composition within the following limits:
Fatty substances 0-0.30o
Perfume 0-0.20o
Bactericides 0-0.25o
Solvent 0-50o
Propellant up to 100o
By changing the proportions of the five main components, a number of
different deodorant sprays could be prepared, each of which was tested for
cough-stimulating potential. No formula without both fatty substances and
solvents was studied, as this would have meant that the bactericide would
have been sprayed as a dry powder.
Fatty substances
Perfumes
MATERIALS
Isopropyl myristate
Propylene glycol
Isopropyl isostearate
Isopropyl palmitate
Various
COUGH IRRITATION BY DEODORANT SPRAYS 511
Bactericides
2,3,5,2',3',5' hexachloro-6,6' dihydroxydiphenylmethane
2,4,4' trichloro-2' hydroxydiphenylether
3,4,4' trichlorocarbanilide
4,4' dichloro-3-trifluoromethylcarbanilide,
3,5-dibromo-3' trifluoromethyl-salicylanilide,
2,5,4' tribromosalicylanilide.
Solvent Absolute ethanol, not denatured
Propellant Monofluorotrichloromethane (F 11)
Difluorodichloromethane (F12)
To test the influence of the spray pattern and of the spray rate on cough
stimulation, several valve combinations (Deutsche Pr//zisions-Ventil) with
different actuator, stem and housing orifices were used.
TEST METHOD
The cough-stimulating potential of each deodorant spray was determined
under conditions as near to normal use as possible.
Randomly chosen volunteers were asked to give absolute appraisals of
the irritant properties of the spray being tested. In this respect the test
method deviates from the several standard methods which are used in
sensory testing (7).
The value obtained by averaging the numerical ratings given by the
tested subjects is probably influenced by a combination of chemical, physical
and psychological factors, as occurs in practice. From this angle, the method
offers advantages compared with instrumental analytical methods, which
yield data influenced only by physical and/or chemical, but not psycho-
logical, factors.
For optimum results in consumer testing, the following criteria are
applicable:
Ten people or more should be interrogated.
All interrogated subjects should collaborate on a voluntary basis.
Each test should be completed as quickly as possible, preferably within
lh.
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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS
The assessment procedure for an individual subject should be as brief
as possible, avoiding complicated or long and tedious procedures;
Not more than two tests should be carried out daily with a given subject
in the panel and the interval between two successive tests should not be less
than 4 h.
Each subject should be clearly told what characteristics of the test pro-
duct should be considered.
The way in which the testing procedure is carried out should be chosen
individually by the subject.
The investigator should ensure that subjects cannot influence each
other's opinion.
During each test, each subject should give an absolute appraisal about a
given feature; no comparison material whatever should be available at any
time during the test.
The subject's appraisal about the feature being tested should be ex-
pressed by a rating: 0, 1, 2, 3 or 4 (4 = greatest effect, whether good or bad).
To find out if there is any significant difference between two test series,
the Wilcoxon's Q-test may be used, with a one-side overrun probability
of 5%.
For each consumer test, the ratings obtained were averaged and multi-
plied by 2.5. The figure so obtained was called the factor for the aspect being
investigated. (Minimum value 0, maximum value 10.)
The factor on a 0-10 scale gave a figure suitable for ready interpretation
of cough stimulation. After statistical analysis by the Q-test it became
evident that a difference of 1 point between two factors was significant. All
factors, therefore, were rounded to 0.5.
Observations concerning the application of the test method to deodorant
spray cough stimulation were:
The cough stimulation test panel included 11 women and 21 men, aged
between 18 and 45.
No difference appeared betveen appraisal by men and by women, or
between age groups.
Two sprays were investigated each day, one in the morning and one in
the afternoon. Hardly any difference appeared between morning and after-
noon tests.
COUGH IRRITATION BY DEODORANT SPRAYS 513
Each subject was free to choose how to make the test.
Two different methods were used: some subjects (19o) tended to direct
the aerosol spray towards the face from arm's length. The remaining sub-
jects sprayed horizontally in front of the body and then remained immersed
within the spray cloud.
No overall difference in findings appeared between the two groups
although, with the second method, the sprayed amounts of fluid were
generally greater.
Respiratory tract irritation was expressed as an integer, according to the
following table:
0 no cough,
1 slight cough,
2 moderate cough,
3 strong cough,
4 very strong cough.
After averaging, multiplication by 2.5 and rounding to 0.5, a value was
obtained for each spray, giving a measure of the cough-stimulating poten-
tial: the cough factor (CF).
Cough-stimulating activity was assessed twice for each deodorant spray
investigated.
Reproducibility appeared to be good.
The whole investigation lasted about 2 yr, with a total of 212 irritation
tests.
EXPERIMENTAL
Preliminary studies
Since at the beginning of this investigation nothing was known about
the possible cough-stimulating potential of the various ingredients, first the
cough-stimulating activity of a deodorant spray with a composition in
common use was determined
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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS
Composition 7o
Isopropyl myristate 0.3
Perfume 0.2
Bactericide 0.2
Ethanol 24.3
F11 25.0
F12 50.0
100.0
The fragrance used was a green flowery type.
The bactericide was chosen arbitrarily from the six types listed above and
was used as the standard bactericide throughout the investigation.
The aerosol was equipped with a valve having a stem orifice of 0.45 mm
and an actuator orifice of 0.50 mm; the spray angle was about 16 .
All preliminary tests were carried out with this deorodant spray; initially
the investigation was designed to show whether the consumer test did
actually ensure good quantitative reproducibility of the cough-stimulating
irritation.
This preliminary study indicated that the test method was suitable for
the purpose and the spray mentioned above gave a cough factor (CF) of 6.0.
This standard spray was used for reference throughout the main investi-
gation, a run with it being included in each large test series.
The standard spray was tested, overall on 22 occasions by the panel,
leading to cough factors as follows:
4 times: CF = 5.5
12 times: CF = 6.0
6 times: CF = 6.5
Between the two extreme values, 5.5 and 6.5, Wilcoxon's Q-test only
once showed a significant difference.
A number of screening tests were performed, in order to identify a
possible main cause for cough stimulation. Several formulae were tested,
one ingredient being omitted each time. Table I gives a summary of the
formulae used, with corresponding CF values.
Clearly the formulation without bactericide was less cough-stimulating
than the others. Formulae C, E and G (respectively without perfume, with-
out ethanol and without F12) also gave significantly lower CF values than
the standard, but not as low as the bactericide-free formula.
COUGH IRRITATION BY DEODORANT SPRAYS
Table I. Elimination series of deodorant ingredients
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Composition: A B C D E F G*
Isopropyl myristate 0.3 -- 0.3 0.3 0.3 0.3 0.3
Perfume 0.2 0.2 -- 0.2 0.2 0.2 0.2
Bactericide 0.2 0.2 0.2 -- 0.2 0.2 0.2
Ethanol 24.3 24.6 24.5 24.5 -- 24.3 24.3
F11 25.0 25.0 25.0 25.0 49.3 -- 75.0
F12 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 4.5
Difference from the standard value -- not sign. sign. sign. sign. not sign. sign.
* Aerosol brought to an internal pressure of 0.009 Nm - (= 8 atmospheres) with nitrogen.
To exclude a possible cumulative effect of the irritant influences of
perfume, ethanol and F12 on the respiratory tract, the following formula
was also tested.
Table 1I. Cumulative effect of perfume,
ethanol and propellant
Composition: H*
Isopropyl myristate 0.3
Bactericide 0.2
Fll 99.5
CF 4.5
Difference from standard sign.
* Aerosol brought to an internal pres-
sure of 0.009 Nm - with nitrogen.
Further evidence is that formulae E, F, G and H are associated with
spray patterns which are totally different from that of the standard spray.
Attempts at reproducing spray patterns as close as possible to that of
the standard formula by means of other valves and variations of the pressure
by means of nitrogen, had only partial success.
To determine whether differences in the spray pattern and spray rate
influence respiratory tract irritation, several aerosols were tested, each time
with the standard formula but completely different valves. Here attempts
were made to obtain spray patterns that were as different as possible from
each other.
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Table III. Effect of varying spray pattern
Valve specification:
Housing orifice 2.0 mm 2.0-0.50 mm 2.0 mm
Stem orifice 0.45 mm 2 x 0.50 mm 0.45 mm
Actuator orifice 0.50 mm 0.50 mm 0.33 mm
Spray rate 1 g s 4 0.6 g s -x 0.4 g s 4
Spray angle 16 10 12
CF 6.0 5.5 6.0
Difference from standard -- not sign. not sign.
The results show that a different spray pattern of the aerosol hardly
influenced cough stimulation (see also Table VII(a) and (b)).
Further studies of the influence of the ethanol and propellant concentra-
tions, which influence the spray pattern, were thus simplified.
Having completed the above screening tests, a systematic investigation
into the influence of the ingredients of the deodorant spray on the respira-
tory tract could then be performed.
Influence of fatty substances
During the preliminary tests, the presence or absence of isopropyl
myristate in the standard formula apparently had no influence on cough
stimulation.
The influence of other fatty substances was determined by replacing iso-
propyl myristate in the formula successively by: propylene glycol, isopropyl
isostearate and isopropyl palmitate, each time at a concentration of 0.3.
With all these sprays cough stimulation corresponded to that induced by
the standard formula (CF = 6.0).
Since the irritant influence of fatty substances might interact with that
of bactericides, the above formulae were re-tested in bactericide-free sprays;
no difference was found from formula D, the bactericide-free modified
formula (CF = 1.5).
Influence of perfumes
It was decided not to test single ingredients of perfumes for cough stimu-
lation, partly because the preliminary tests had shown that perfumes only
had a limited influence on respiratory tract irritation and also because the
great number of ingredients used in perfumes would have made a global
investigation impossible.
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It was therefore considered sufficient to test a number of perfumes with
distinctive characteristics' woody, green, spicy, fruity, flowery and cologne.
These perfumes were used in the standard formula at a concentration of
0.2%' none of these sprays showed any significant shift from the standard
CF value (CF = 6.0).
The above-mentioned perfume types were also tested in the bactericide-
fi'ee formula' here also the type of perfume was shown not to influence the
CF give by formula D, the bactericide-free low-irritation formula (CF --
1.5).
The influence of perfume concentration was also investigated. Various
concentrations of a standard fragrance were added to the standard formula
and each of these sprays was tested for cough stimulation.
The same set of concentrations was also tested in the bactericide-free
formula. The resulting CF values are given in Table IV.
Table IV. Effect of perfume concentration
Perfume Standard formula Standard formula
concentration with bactericide without bactericide
O.2O% 6.O 1.5
0.13% 6.5 1.5
O.O6% 6.O 1.5
O% 4.5 O.5
Compared with the standard formulae, the perfume-free sprays gave
significantly lower CF values; thus, among those perfumes used in these
tests cough-stimulating irritation is apparently influenced not by the kind
of perfume, but by the presence or absence of perfume.
Influence of bactericides
During the preliminary tests, the standard bactericide apparently had a
strong influence on the irritant activity. For a better knowledge of this
dependence, the cough-stimulating activity of a standard formula with
increasing concentrations of bactericide was investigated.
These measurements were repeated with five other bactericides con-
sidered for inclusion in deodorant sprays.
The CF values found are reported in Table V.
JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS
Table V. Effect of type and concentration of bactericide
Concentration %
Bactericide 0 0.05 0.10 0.15 0.20 0.25
Standard 3.0 4.5 6.0 6.5 7.0
A I 2.0 2.5 4.0 6.5 7.5
B 1.5 1.0 1.5 2.0 2.0 1.5
C 1.5 1.5 1.5 2.5 2.5
D I 1.5 4.0 5.0 7.0 7.0
E 3.5 4.5 5.5 7.5 7.5
After statistical analysis of the test results (comparison of Q-test) the
following conclusions could be drawn:
Throughout the chosen concentration range, no significant difference
appears between the standard bactericide and E, both being associated
with strong cough stimulation even at low concentration,
B and C did not irritate the respiratory tract at any concentration
within the observation range,
A is not irritant at concentrations up to 0.1 o; at higher concentrations
the CF quickly rises to that associated with the standard formula,
D is not irritant at concentrations up to 0.05; at higher concentrations
the CF quickly increases to that associated with the standard formula.
Influence of solvents and propellant
In technically well-designed aerosols, the percentages of solvents and
propellant cannot exceed certain practical limits. The sprays considered
here sometimes had extreme compositions that could hardly be used in
normal practice.
The observed CF values clearly show, however, how cough-stimulating
activity varied in such cases (Table Vl(a) and (b)).
The results showed that ethanol and propellant only influence cough
stimulation to a small extent. However, since high alcohol levels seemed
slightly to reduce the irritant activity, the influence of alcohol was further
investigated.
A number of sprays with increasing alcohol levels was tested in two
series with 0.1 and with 0.2 of bactericide respectively. In addition, each
COUGH IRRITATION BY DEODORANT SPRAYS 519
of these formulae was used to prepare two aerosols' one with a standard
valve (spray rate 1.0 g s-), and one with a valve ensuring a spray rate of
0.5 g s -.
Table VI (a). Effect of varying solvents and propellants (bactericide present)
Composition:
lsopropyl myristate 0.3 0.3 0.3 0.3 0.3
Perfume 0.2 0.2 0.2 0.2 0.2
Bactericide 0.2 0.2 0.2 0.2 0.2
Ethanol -- -- 24.3 39.3 39.3
Fll -- 79.3 25.0 -- 50.0
F12 99.3 20.0 50.0 60.0 10.0
CF 5.0 5.5 6.0 5.0 3.5
Difference from standard not sign. not sign. -- not sign. sign.
Table VI(b). Effect of varying solvents and propellants (in absence of bactericide)
Composition:
[sopropyl myristate 0.3 0.3 0.3 0.3 0.3
Perfume 0.2 0.2 0.2 0.2 0.2
Bactericide .....
Ethanol -- -- 24.5 39.5 39.5
Fll -- 79.5 25.0 -- 50.0
F12 99.5 20.0 50.0 60.0 10.0
CF 1.0 2.0 1.5 1.5 1.5
Difference from Formula D not sign. not sign. -- not sign. not sign.
Each of these sprays contained 0.2o of perfume, 0.3 of isopropyl
myristate and up to 100 propellant (F1 l/F12: 60/40).
The CF values found are reported in Table VII(a) and (b).
Table VII(a). Influence of ethanol concentration at different spray rates
Bactericide 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1
Ethanol 3.0 3.0 6.0 6.0 12.0 12.0 25.0 25.0 50.0 50.0
Spray 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 1.0
CF 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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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS
Table VII(b). Influence of ethanol concentration at different spray rates with bactericide at
increased concentration
Bactericide 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Ethanol 3.0 3.0 6.0 6.0 12.0 12.0 25.0 25.0 50.0 50.0
Spray 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 1.0
CF 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 recorded CF values led to the following conclusions:
In deodorant sprays, concentrations of ethanol from 3.0 to 25o showed
no influence on cough stimulation.
At 50o concentration of ethanol, cough stimulation appears to have
been slightly reduced; ethanol-free sprays also showed a slight reduction
of CF.
A 50o reduction of the spray rate of these deodorant sprays did not
influence cough stimulation.
DISCUSSION
Before discussing the results, it should be clearly stated that these tests
and measurements are not all-embracing. There is a wide range of other
possible variations, e.g. other bactericides, influence of important perfume
raw materials, formulae with other solvents, etc. When planning the tests,
it was decided to remain within practical limits of importance to con-
temporary cosmetic science.
The main advantage of the Consumer Test Method is that it allows
direct correlation between the properties of a product and the consumer's
appraisal, thereby bypassing the necessity of converting a number, obtained
by instrumental observation, into some kind of index corresponding to
acceptance by the end consumer. In addition, the method is inexpensive and
rapid.
Each subject interrogated is expected to give a numerical appraisal
expressed as 0, 1, 2, 3 or 4. As he or she does this, it is essential that no
comparison material be made available; in daily use of a product--here a
deodorant spray--no comparison material will actually be available. The
absolute appraisal, in terms of these ratings, relates to a given property of
the product, assessed as in daily use.
COUGH IRRITATION BY DEODORANT SPRAYS 521
In our evaluations, a dispersion of values was noted in every test. In
addition, the frequency distribution was not normal, thereby making it
impossible to compare two series of measurements by t-test. In an evalua-
tion like this, the most precise way is to use the (T) sign test in order to
recognize significant differences.
In interpreting the data obtained with the consumer test, we preferred,
however, to use the Q-test of Wilcoxon. Here each segment of the data in a
series is compared with the data obtained from another series. This yields
a difference score, called Q-value, allowing the one-side overrun proba-
bility to be determined by means of tables. Using the Q-test instead of the
T-test has the advantage of allowing comparison between series of different
length.
Experience has shown that the average rating, as determined with the
consumer test method, has a maximum value of 3 to 3.5. Not only when
assessing cough stimulation due to deodorants, but in other tests, too, there
appears to be some personal dislike for giving the maximum mark for a
given effect. This finding is in accordance with the findings of several other
investigators (7, 8, 9).
The conclusions which can be drawn for the sources of cough stimula-
tion by deodorant sprays are that this irritation is due to the type of bac-
tericide used and the percentage of bactericide included in the formula.
Other factors, like the spray pattern and spray rate, the concentrations
of solvents and perfumes, appear to play a secondary role. That respiratory
tract irritation appears not to depend on spray rate is quite logical if it is
realized that a test subject feels irritation from an aerosol cloud no matter
how this cloud has been formed. This statement is supported by the fact
that the test procedure has no influence on the actual irritation felt by the
subjects.
Wide differences appear to exist between the cough-stimulating effect of
different bactericides. No correlation could be deduced between the bac-
tericidal and the irritant properties for the different compounds studied, so
we have only reported our actual findings.
(Received: 21st February 1975)
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JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS
(4) O'Connor Ward, C. Current perspectives on aerosol toxicity. J. Soc. Cosmet. Chem. 25 271
(1974).
(5) Troy, W. R. Testing for inhalation toxicity. J. Soc. Cosmet. Chem. 25 283 (1974).
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(7) Amerine, M. A., Pangborn, R. M. and Roessler, E. B. Principles of Sensory Evahation of
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