ASTM E1207-87(1997)
(Practice)Standard Practice for The Sensory Evaluation of Axillary Deodorancy
Standard Practice for The Sensory Evaluation of Axillary Deodorancy
SCOPE
1.1 This practice provides procedures which may be used in the design and analysis of studies to quantitatively assess the intensity of human axillary odor for the purpose of substantiating deodorant efficacy of personal care products.
1.2 This practice includes protocols for the selection and training of judges, selection of subjects, experimental design, and statistical analysis. This practice is limited to assessment of axillary odor by trained, second-party, judges. First-party or self-evaluation protocols are valid for selected sensory tasks but may be less sensitive.
1.3 With respect to the source of axillary odor, three groups of secretory glands are present in the axillae which participate to a greater or lesser extent in its production-eccrine, apocrine, and sebaceous. Axillary odor has been primarily ascribed to the apocrine gland secretion (1). Body odor intensity has been correlated with the volume of the secretory portion of the apocrine gland (2) and the density of the glands.
1.3.1 Apocrine glands are found primarily in the axillary vault in conjunction with axillary hairs (3). Pure apocrine sweat is sterile and odorless and axillary odor results from degradation of apocrine sweat by resident skin bacteria (4). High bacterial populations are found in moist regions of the body, especially in the axillae, providing the appropriate environment for growth (5).
1.3.2 Eccrine glands keep the axillae moist through thermally and emotionally induced secretions (6).
1.3.3 The sebaceous glands excrete higher molecular weight lipid materials which absorb and retain the volatile materials resulting from bacterial action (7). The aerobic diphtheroids are able to produce the typical acrid axillary odor and the micrococcaceae produce an isovaleric acid-like odor when incubated with apocrine sweat (8). Therefore, the most undesirable component of axillary odor is caused by degradation of apocrine sweat by particular bacteria normally found in the axillary vault.
1.4 Personal care products are sold and used primarily for their ability to reduce the perception of body odor not only by the individual using the product but also by individuals within the scope of contact. Deodorant protection may be achieved by these products through various modes of action. Antiperspirants achieve their primary efficacy by means of the action of inorganic salts on the eccrine gland production of sweat. Antimicrobial agents achieve deodorancy by inhibiting the growth and activity of the microflora in the axillary vault thus reducing the microbial decomposition of sweat and the consequent production of body odor. Absorbents function either by "binding" available moisture or malodorous substances. Fragrances are effective by altering the perception of malodor and increasing the degree of "pleasantness." Other modes of control become important from time to time, representing changes in the state-of-the-art in product development.
1.5 The studies discussed herein are interpreted through the use of statistical tests of hypotheses. These hypotheses are usually of the form:
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: E 1207 – 87 (Reapproved 1997)
Standard Practice for
The Sensory Evaluation of Axillary Deodorancy
This standard is issued under the fixed designation E 1207; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope the scope of contact. Deodorant protection may be achieved by
these products through various modes of action. Antiperspi-
1.1 This practice provides procedures which may be used in
rants achieve their primary efficacy by means of the action of
the design and analysis of studies to quantitatively assess the
inorganic salts on the eccrine gland production of sweat.
intensity of human axillary odor for the purpose of substanti-
Antimicrobial agents achieve deodorancy by inhibiting the
ating deodorant efficacy of personal care products.
growth and activity of the microflora in the axillary vault thus
1.2 This practice includes protocols for the selection and
reducing the microbial decomposition of sweat and the conse-
training of judges, selection of subjects, experimental design,
quent production of body odor. Absorbents function either by
and statistical analysis. This practice is limited to assessment of
“binding” available moisture or malodorous substances. Fra-
axillary odor by trained, second-party, judges. First-party or
grances are effective by altering the perception of malodor and
self-evaluation protocols are valid for selected sensory tasks
increasing the degree of “pleasantness.” Other modes of
but may be less sensitive.
control become important from time to time, representing
1.3 With respect to the source of axillary odor, three groups
changes in the state-of-the-art in product development.
of secretory glands are present in the axillae which participate
1.5 The studies discussed herein are interpreted through the
to a greater or lesser extent in its production—eccrine, apo-
use of statistical tests of hypotheses. These hypotheses are
crine, and sebaceous. Axillary odor has been primarily ascribed
2 usually of the form:
to the apocrine gland secretion (1). Body odor intensity has
The Deodorant Efficacy of Treatment A
been correlated with the volume of the secretory portion of the
= The Deodorant Efficacy of Treatment B
apocrine gland (2) and the density of the glands.
1.5.1 It should be noted that failure to reject this hypothesis
1.3.1 Apocrine glands are found primarily in the axillary
vault in conjunction with axillary hairs (3). Pure apocrine at a specified level of significance does not prove the hypoth-
esis, but merely that the weight of evidence provided by the
sweat is sterile and odorless and axillary odor results from
degradation of apocrine sweat by resident skin bacteria (4). experiment is not sufficient to reject the hypothesis. This could
occur because either: a) The hypothesis is close to truth and
High bacterial populations are found in moist regions of the
great experimental power would be required to reject it, or b)
body, especially in the axillae, providing the appropriate
The experiment by design was low in power and, therefore,
environment for growth (5).
incapable of rejecting the hypothesis; even when it is far from
1.3.2 Eccrine glands keep the axillae moist through ther-
true. This can occur due to design structure or low sample size.
mally and emotionally induced secretions (6).
These facts must be taken into consideration when interpreting
1.3.3 The sebaceous glands excrete higher molecular weight
study results.
lipid materials which absorb and retain the volatile materials
resulting from bacterial action (7). The aerobic diphtheroids
2. Referenced Documents
are able to produce the typical acrid axillary odor and the
2.1 ASTM Standards:
micrococcaceae produce an isovaleric acid-like odor when
E 253 Terminology Relating to Sensory Evaluation of Ma-
incubated with apocrine sweat (8). Therefore, the most unde-
terials and Products
sirable component of axillary odor is caused by degradation of
apocrine sweat by particular bacteria normally found in the
3. Terminology
axillary vault.
3.1 Definitions of Terms Specific to This Standard:
1.4 Personal care products are sold and used primarily for
3.1.1 5-alpha-androst-16-en-3-one (delta (5-alpha)
their ability to reduce the perception of body odor not only by
androsten-3-one) C H O—CAS No. 18339-17-7—
the individual using the product but also by individuals within
19 28
component of axillary odor which has a “urinous” character
and results from the action of certain skin bacteria on apocrine
This practice is under the jurisdiction of ASTM Committee E-18 on Sensory
secretion (9).
Evaluation of Materials and Products and is the direct responsibility of Subcom- 16
3.1.2 5-alpha-androst-16-en-3-alpha-ol (delta (5-alpha)
mittee E 18.07 on Personal Care and Household Evaluation.
Current edition approved Oct 30, 1987. Published February 1988.
The boldface numbers in parentheses refer to the list of references at the end of
this standard. Annual Book of ASTM Standards, Vol 15.07.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1207
androsten-3-alpha-ol) C H O—CAS No. 14152-27-3— which include deodorant and toilet soap bars, liquid bath soaps
19 30
component of axillary odor which has a “musky” character and and gels, deodorant sticks, antiperspirants, creams and lotions,
results from the action of certain skin bacteria on apocrine body talcs, and aerosol and pump delivery deodorants, antiper-
secretion (9). spirants, and body colognes.
3.1.3 apocrine gland—a highly coiled tubular system found 5.3 Procedures of the type described herein may be used to
primarily in axillary epidermis. These glands continuously aid in the communication of efficacy within and between
produce and store apocrine sweat for later excretion onto the manufacturers and to the consumer through the various public
skin surface via hair follicles. The excretion is activated by communications media. Guidelines are suggested due to the
androgenic sympathetic stimuli such as pain or fear (10). need to determine the relative or absolute performance of
3.1.4 deodorant effıcacy—the effectiveness or treatment, or experimental materials or of commercial products.
both, of a product in reducing axillary malodor. 5.4 These procedures may be used by persons who have
3.1.5 eccrine gland—a simple unbranched tube with a familiarized themselves with these procedures and have had
terminal coil. These glands are found in the epidermis over the previous experience with sensory evaluation.
entire body surface. The glands are controlled by the auto- 5.5 This practice provides suggested procedures and is not
nomic nervous system and serve as an evaporative cooling meant to exclude alternate procedures which may be effec-
mechanism. Although heat is the primary stimulus, localized tively used to provide the same clinical result.
eccrine sweating can also occur as a result of emotional stress
6. Subject Selection and Restrictions
and other physiological stimuli (3).
6.1 Criteria for Selection—The population should be de-
3.1.6 IVA, isovaleric acid (3-methylbutanoic acid) C
fined and subjects selected from this population in a random,
5H O ; (CH ) CHCH COOH. CAS No. 503-74-2—
10 2 3 2 2
and unbiased manner according to the experimental design
component of axillary odor which has a “sweaty, acid”
considerations defined in 8.10. If a test is being performed with
character and results from the action of certain skin bacteria on
the product directed at a subset of the consuming population,
apocrine secretion.
the subjects should be selected from a population representa-
3.1.7 judges—those individuals previously screened and
tive of the subset.
trained, whose purpose during a study is to detect odor
6.1.1 The subjects should have a recognizable body odor
differences or evaluate intensity of axillary malodor.
level when evaluated under the procedures given in this
3.1.8 right-left imbalance—a condition of some subjects
practice.
who have one axilla with notably more intense odor than the
6.1.2 In situations where it is desirable to enhance test
other axilla as determined from the control odor evaluation.
sensitivity, the following criteria may be adopted:
3.1.9 sebaceous gland—a gland closely related to the hair
6.1.2.1 Based on the control odor scores (see 8.3), subjects
follicle which produces sebum which combines with apocrine
who have low or extremely high odor should not be selected
secretion at the base of the follicle. Sebaceous glands are under
for the test. Subjects may be considered as having a “high’’
androgen control (6).
odor relative to a normal population if they develop an odor
3.1.10 sequential analysis—a statistical technique which
score in excess of 7.0 on a 10-point scale or 4.0 on a 5-point
may be used to screen potential judges for sensory acuity to a
scale. Likewise, subjects may be considered as having a “low”
specific stimulus. The judge is repeatedly tested until he or she
odor relative to a normal population if they develop an odor
passes or fails the test at a specified level of significance (11).
score below 3.0 on a 10-point scale or 1.5 on a 5-point scale.
3.1.11 subjects—those individuals recruited to participate in
A selection process which excludes “low” odor subjects or
a study as sample carriers.
“extremely high” odor subjects, or both, must be specified for
3.1.12 trigeminal response—a sensation caused by stimula-
each test and depends upon the number of subjects required for
tion of the trigeminal nerve. The sensation is that of a physical
the test and the relative odor scores of these subjects.
feeling, such as burning and tingling.
6.1.2.2 There should be no more than a small right-left odor
4. Summary of Practice
imbalance between axillae of each subject. On the basis of a
category, or interval scale, the consensus of the task group was
4.1 The protocols described provide for the designation of
that the control odor score differential should not be greater
panels of individuals suitably selected and trained to perform
than 30 % of the overall scale (that is, 3.0 units on a 10-point
the functions of judges and subjects for the purpose of
scale or 1.5 units on a 5-point scale).
assessing deodorant efficacy. Details of specific procedures are
given in Appendix X1-Appendix X3. Deodorant products 6.1.2.3 Appendix X1 contains additional information on the
acceptance/rejection history of experimental subject popula-
should be tested in a manner which maximizes test sensitivity
while still reflecting normal consumer-use conditions. Ex- tions. A selection process which excludes approximately 20 %
of the lowest odor intensity individuals of a normal population
amples are provided to assist the investigator in the design and
is generally recognized as appropriate.
performance of test protocols.
6.1.3 Chronic medications such as antibiotics, steroids, etc.,
5. Significance and Use
which may affect the test, should be restricted during all test
5.1 The procedures recommended in this practice can be phases as deemed appropriate by the sponsor.
used to clinically assess axillary deodorant efficacy of personal 6.1.4 In addition to the above restrictions it should be
care products. recognized that other factors which contribute to protocol
5.2 This practice is applicable to the product categories operating efficiency should be emphasized, including interest,
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1207
cooperation, commitment, and punctuality of the subjects. 7.2 Judges employed for assessing body odor intensity
6.2 Subject Restrictions—In order to achieve appropriate should be screened for the following attributes:
experimental control, the following restrictions should be 7.2.1 Interest and availability;
imposed upon all subjects during the conditioning and test 7.2.2 Qualitative and quantitative olfactory discrimination
phases. ability;
6.2.1 Conditioning Phase—This period is often referred to 7.2.3 Ability to carry out basic sensory tasks, and compe-
as the “washout” period and is that portion of the protocol tency with the scale used, and
preceding the actual test phase. The duration of the condition- 7.2.4 Specific anosmias. While it is desirable to identify any
ing phase should be a minimum of 7 days. The conditioning olfactory deficit which a judge may have, there is experience
phase for antiperspirants shall be 17 days as defined by the which indicates that specific anosmias may not detract from
FDA monograph on antiperspirants (12). accurate odor judgments. (See X2.6.3)
6.2.1.1 Subjects should use no antiperspirants, deodorants, 7.3 Recommended procedures are presented in Appendix
antibiotic creams, antibacterial ointments, or any other cos- X2 for the screening and selection of in vivo deodorancy
metic products on the axillae. No antibacterial products, judges.
including deodorant and medicated shampoos should be used. 7.4 Judge Training— In addition to the following points,
Care should be taken not to expose the axillae to any medicated the recommended procedures are given in Appendix X3 for the
product or product containing alcohol. training of in vivo deodorancy judges.
6.2.1.2 Subjects should use only the control cleansing 7.4.1 Judges should be exposed to the complete range of
agent(s) provided by the sponsor as instructed for personal quantitative and qualitative malodor stimuli which they will
hygiene. later be asked to rate. This establishes the context in which
6.2.1.3 Swimming should be stopped at least 7 days prior to ratings are to be assigned.
the test phase and during the entire test phase. 7.4.2 Judge Training for Category Scales:
6.2.1.4 Subjects who normally shave their axillae should 7.4.2.1 After being introduced to the rating scale procedure,
shave using the control cleansing agent no less than 24 h prior either 0 to 5 or 0 to 10 category scales, judges should assign
to the control evaluation and abstain from shaving for the ratings to the stimuli in an open discussion to obtain a
duration of the test. consensus rating for each stimulus.
6.2.1.5 Spicy foods, including garlic and onions should be 7.4.2.2 Judges should be drilled until the ratings they
restricted
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