1、Designation: E1207 09E1207 14Standard Guide forSensory Evaluation of Axillary Deodorancy1This standard is issued under the fixed designation E1207; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number
2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides procedures which may be used in the design and analysis of studies to quantitatively assess the intensityof human axillar
3、y odor for the purpose of substantiating deodorant efficacy of personal care products.1.2 This guide includes protocols for the selection and training of assessors, selection of subjects, experimental design, andstatistical analyses. This practice is limited to assessment of axillary odor by trained
4、 assessors. Self-evaluation protocols are validfor 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 toa greater or lesser extent in its productioneccrine, apocrine, and seba
5、ceous. Axillary odor has been primarily ascribed to theapocrine gland secretion (1).2 Body odor intensity has been correlated with the volume of the secretory portion of the apocrinegland (2) and the density of the glands.1.3.1 Apocrine glands are found primarily in the axillary vault in conjunction
6、 with axillary hairs (3). Pure apocrine sweat issterile and odorless and axillary odor results from degradation of apocrine sweat by resident skin bacteria (4). High bacterialpopulations are found in moist regions of the body, especially in the axillae, providing the appropriate environment for grow
7、th (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 materialsresulting from bacterial action (7). The aerobic diphtheroids are able
8、to produce the typical acrid axillary odor and themicrococcaceae produce an isovaleric acid-like odor when incubated with apocrine sweat (8). Therefore, the most undesirablecomponent of axillary odor is caused by degradation of apocrine sweat by particular bacteria normally found in the axillary vau
9、lt.1.4 Personal care products are sold and used primarily for their ability to reduce the perception of body odor not only by theindividual using the product but also by individuals within the scope of contact. Deodorant protection may be achieved by theseproducts through various modes of action. An
10、tiperspirants achieve their primary efficacy by means of the action of inorganic saltson the eccrine gland production of sweat. Antimicrobial agents achieve deodorancy by inhibiting the growth and activity of themicroflora in the axillary vault thus reducing the microbial decomposition of sweat and
11、the consequent production of body odor.Absorbents function either by “binding” available moisture or malodorous substances. Fragrances are effective by altering theperception of malodor and increasing the degree of “pleasantness.” Other modes of control become important from time to time,representin
12、g 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 usuallyof the form:The Deodorant Efficacy of Treatment A= The Deodorant Efficacy of Treatment B1.5.1 It should be noted t
13、hat failure to reject this hypothesis at a specified level of significance does not prove the hypothesis,but merely that the weight of evidence provided by the experiment is not sufficient to reject the hypothesis. This could occurbecause either: a) The hypothesis is close to truth and great experim
14、ental power would be required to reject it, or b) The experimentby design was low in power and, therefore, incapable of rejecting the hypothesis; even when it is far from true. This can occurdue to design structure or low sample size. These facts must be taken into consideration when interpreting st
15、udy results.1 This guide is under the jurisdiction of ASTM Committee E18 on Sensory Evaluation and is the direct responsibility of Subcommittee E18.07 on Personal Care andHousehold Evaluation.Current edition approved Feb. 1, 2009March 1, 2014. Published March 2009March 2014. Originally approved in 1
16、987. Last previous edition approved in 20022009 asE1207 02.E1207 09. DOI: 10.1520/E1207-09.10.1520/E1207-14.2 The boldface numbers in parentheses refer to the list of references at the end of this standard.This document is not an ASTM standard and is intended only to provide the user of an ASTM stan
17、dard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by AST
18、M is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12. Referenced Documents2.1 ASTM Standards:3E253 Terminology Relating to Sensory Evaluation of Materials and ProductsE1697 Test Method for Unip
19、olar Magnitude Estimation of Sensory Attributes3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 For definitions of terms relating to sensory evaluation, see Terminology E253.3.1.2 5-alpha-androst-16-en-3-one (delta16(5-alpha) androsten-3-one) C19H28OCAS No. 18339-17-7component
20、of axillaryodor which has a “urinous” character and results from the action of certain skin bacteria on apocrine secretion (9).3.1.3 5-alpha-androst-16-en-3-alpha-ol (delta16 (5-alpha) androsten-3-alpha-ol) C19H30OCAS No. 14152-27-3componentof axillary odor which has a “musky” character and results
21、from the action of certain skin bacteria on apocrine secretion (9).3.1.4 apocrine glanda highly coiled tubular system found primarily in axillary epidermis. These glands continuously produceand store apocrine sweat for later excretion onto the skin surface via hair follicles. The excretion is activa
22、ted by androgenicsympathetic stimuli such as pain or fear (1).3.1.5 deodorant effcacythe effectiveness or treatment, or both, of a product in reducing axillary malodor.3.1.6 eccrine glanda simple unbranched tube with a terminal coil. These glands are found in the epidermis over the entirebody surfac
23、e. The glands are controlled by the autonomic nervous system and serve as an evaporative cooling mechanism.Although heat is the primary stimulus, localized eccrine sweating can also occur as a result of emotional stress and otherphysiological stimuli (3).3.1.7 IVA, isovaleric acid (3-methylbutanoic
24、acid) C5H10O2; (CH3)2CHCH2COOH. CAS No. 503-74-2component of axillaryodor which has a “sweaty, acid” character and results from the action of certain skin bacteria on apocrine secretion.3.1.8 right-left imbalancea condition of some subjects who have one axilla with notably more intense odor than the
25、 otheraxilla as determined from the control odor evaluation.3.1.9 sebaceous glanda gland closely related to the hair follicle which produces sebum which combines with apocrinesecretion at the base of the follicle. Sebaceous glands are under androgen control (6).3.1.10 sequential analysisa statistica
26、l technique which may be used to screen potential assessors for sensory acuity to aspecific stimulus. The assessor is repeatedly tested until he or she passes or fails the test at a specified level of significance (10,1111).).3.1.11 trigeminal responsea sensation caused by stimulation of the trigemi
27、nal nerve. The sensation is that of a physicalfeeling, such as burning and tingling.4. Summary of Guide4.1 The protocols described provide for the designation of panels of individuals suitably selected and trained to perform thefunctions of assessors and subjects for the purpose of assessing deodora
28、nt efficacy. Details of specific procedures are given inAppendix X1 Appendix X3. Deodorant products should be tested in a manner which maximizes test sensitivity while stillreflecting normal consumer-use conditions. Examples are provided to assist the investigator in the design and performance of te
29、stprotocols.5. Significance and Use5.1 The procedures recommended in this practice can be used to clinically assess axillary deodorant efficacy of personal careproducts.5.2 This practice is applicable to the product categories which include deodorant and toilet soap bars, liquid bath soaps and gels,
30、deodorant sticks, antiperspirants, creams and lotions, body talcs, and aerosol and pump delivery deodorants, antiperspirants, andbody colognes.5.3 Procedures of the type described herein may be used to aid in the communication of efficacy within and betweenmanufacturers and to the consumer through t
31、he various public communications media. Guidelines are suggested due to the needto determine the relative or absolute performance of experimental materials or of commercial products.5.4 These procedures may be used by persons who have familiarized themselves with these procedures and have had previo
32、usexperience with sensory evaluation.3 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.E1207 1425.5 This practi
33、ce provides suggested procedures and is not meant to exclude alternate procedures which may be effectively usedto provide the same clinical result.6. Subject Selection and Restrictions6.1 Criteria for SelectionThe population should be defined and subjects selected from this population in a random, a
34、ndunbiased manner according to the experimental design considerations defined in 8.11. If a test is being performed with the productdirected at a subset of the consuming population, the subjects should be selected from a population representative of the subset.6.1.1 The subjects should have a recogn
35、izable body odor level when evaluated under the procedures given in this practice.6.1.2 In situations where it is desirable to enhance test sensitivity, the following criteria may be adopted:6.1.2.1 Based on the control odor scores (see 8.3), subjects who have low or extremely high odor should not b
36、e selected for thetest. Subjects may be considered as having a “high” odor relative to a normal population if they develop an odor score in excessof 7.0 on a 0- to 10-point scale or 3.5 on a 0- to 5-point scale. Likewise, subjects may be considered as having a “low” odor relativeto a normal populati
37、on if they develop an odor score below 3.0 on a 0- to 10-point scale or 1.5 on a 0- to 5-point scale.Aselectionprocess which excludes “low” odor subjects or “extremely high” odor subjects, or both, must be specified for each test and dependsupon the number of subjects required for the test and the r
38、elative odor scores of these subjects.6.1.2.2 There should be no more than a small right-left odor imbalance between axillae of each subject. On the basis of acategory, or interval scale, the consensus of the task group was that the control odor score differential should not be greater than20 % of t
39、he overall scale (that is, 2.0 points on a 10-point scale or 1.0 points on a 5-point scale).6.1.2.3 Appendix X1 contains additional information on the acceptance/rejection history of experimental subject populations.Aselection process which excludes approximately 20 % of the lowest odor intensity in
40、dividuals of a normal population is generallyrecognized as appropriate.6.1.3 Chronic medications such as antibiotics, steroids, etc., which may affect the test, should be restricted during all test phasesas deemed appropriate by the sponsor.6.1.4 In addition to the above restrictions it should be re
41、cognized that other factors which contribute to protocol operatingefficiency should be emphasized, including interest, cooperation, commitment, and punctuality of the subjects.6.2 Subject RestrictionsIn order to achieve appropriate experimental control, the following restrictions should be imposedup
42、on all subjects during the conditioning and test phases.6.2.1 Conditioning PhaseThis period is often referred to as the “washout” period and is that portion of the protocol precedingthe actual test phase. The duration of the conditioning phase should be a minimum of 7 days. The conditioning phase fo
43、rantiperspirants shall be 17 days as defined by the FDA monograph on antiperspirants (11).6.2.1.1 Subjects should use no antiperspirants, deodorants, antibiotic creams, antibacterial ointments, or any other cosmeticproducts on the axillae. No antibacterial products, including deodorant and medicated
44、 shampoos should be used. Care should betaken not to expose the axillae to any medicated product or product containing alcohol.6.2.1.2 Subjects should use only the control cleansing agent(s) provided by the sponsor as instructed for personal hygiene.6.2.1.3 Swimming should be stopped at least 7 days
45、 prior to the test phase and during the entire test phase.6.2.1.4 Subjects who normally shave their axillae should shave using the control cleansing agent no less than 24 h prior to thecontrol evaluation and abstain from shaving for the duration of the test.6.2.1.5 Spicy foods, including garlic and
46、onions should be restricted 24 h before the control evaluation and during the test phase.6.2.1.6 It is acceptable to use smokers as subjects, but they are required to refrain from smoking for 2 h before all evaluations.6.2.2 Test PhaseIn addition to the conditions detailed for the subjects during th
47、e conditioning phase, the following restrictionsare required of the subjects during the test phase:6.2.2.1 Subjects should use no perfumed substances on the body such as perfume, after shave, lotions, bath oils, and hairspray.6.2.2.2 Pre-laundered wearing apparel (see 8.6) may be worn by each subjec
48、t at the option of the test sponsor. Shirts should becollected and laundered in accordance with a uniform laboratory procedure.6.2.2.3 If specified by the test sponsor, laundry additives such as bleach, fabric softeners, etc., may be used on subjects outerclothing.6.2.2.4 Subjects should minimize ph
49、ysical exertion such as tennis and jogging.6.2.2.5 Subjects should refrain from the use of breath mints, toothpaste, mouth rinses and sprays, chewing gum, and fromdrinking coffee or tea at least 1 h prior to each evaluation. Smoking should be restricted 2 h prior to each evaluation and alcoholicbeverages 8 h before an evaluation.6.2.2.6 Subjects should not wash the axillae during the test week at home.at home for the duration of the test. Axillae shouldonly be washed at the test site in accordance with a supervised wash procedure. Care should be taken not to
