ASTM E1207-2009 Standard Practice for The Sensory Evaluation of Axillary Deodorancy《腋下除臭剂的感官评定的标准实施规程》.pdf

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1、Designation: E 1207 09Standard Guide forSensory Evaluation of Axillary Deodorancy1This standard is issued under the fixed designation E 1207; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in pa

2、rentheses 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 inthe design and analysis of studies to quantitatively assess theintensity of human axillary odor

3、for the purpose of substanti-ating deodorant efficacy of personal care products.1.2 This guide includes protocols for the selection andtraining of assessors, selection of subjects, experimental de-sign, and statistical analyses. This practice is limited toassessment of axillary odor by trained asses

4、sors. Self-evaluation protocols are valid for selected sensory tasks butmay be less sensitive.1.3 With respect to the source of axillary odor, three groupsof secretory glands are present in the axillae which participateto a greater or lesser extent in its productioneccrine, apo-crine, and sebaceous.

5、Axillary odor has been primarily ascribedto the apocrine gland secretion (1).2Body odor intensity hasbeen correlated with the volume of the secretory portion of theapocrine gland (2) and the density of the glands.1.3.1 Apocrine glands are found primarily in the axillaryvault in conjunction with axil

6、lary hairs (3). Pure apocrinesweat is sterile and odorless and axillary odor results fromdegradation of apocrine sweat by resident skin bacteria (4).High bacterial populations are found in moist regions of thebody, especially in the axillae, providing the appropriateenvironment for growth (5).1.3.2

7、Eccrine glands keep the axillae moist through ther-mally and emotionally induced secretions (6).1.3.3 The sebaceous glands excrete higher molecular weightlipid materials which absorb and retain the volatile materialsresulting from bacterial action (7). The aerobic diphtheroidsare able to produce the

8、 typical acrid axillary odor and themicrococcaceae produce an isovaleric acid-like odor whenincubated with apocrine sweat (8). Therefore, the most unde-sirable component of axillary odor is caused by degradation ofapocrine sweat by particular bacteria normally found in theaxillary vault.1.4 Personal

9、 care products are sold and used primarily fortheir ability to reduce the perception of body odor not only bythe individual using the product but also by individuals withinthe scope of contact. Deodorant protection may be achieved bythese products through various modes of action. Antiperspi-rants ac

10、hieve their primary efficacy by means of the action ofinorganic salts on the eccrine gland production of sweat.Antimicrobial agents achieve deodorancy by inhibiting thegrowth and activity of the microflora in the axillary vault thusreducing the microbial decomposition of sweat and the conse-quent pr

11、oduction of body odor. Absorbents function either by“binding” available moisture or malodorous substances. Fra-grances are effective by altering the perception of malodor andincreasing the degree of “pleasantness.” Other modes ofcontrol become important from time to time, representingchanges in the

12、state-of-the-art in product development.1.5 The studies discussed herein are interpreted through theuse of statistical tests of hypotheses. These hypotheses areusually of the form:The Deodorant Efficacy of Treatment A= The Deodorant Efficacy of Treatment B1.5.1 It should be noted that failure to rej

13、ect this hypothesisat a specified level of significance does not prove the hypoth-esis, but merely that the weight of evidence provided by theexperiment is not sufficient to reject the hypothesis. This couldoccur because either: a) The hypothesis is close to truth andgreat experimental power would b

14、e required to reject it, or b)The experiment by design was low in power and, therefore,incapable of rejecting the hypothesis; even when it is far fromtrue. This can occur due to design structure or low sample size.These facts must be taken into consideration when interpretingstudy results.2. Referen

15、ced Documents2.1 ASTM Standards:3E 253 Terminology Relating to Sensory Evaluation of Ma-terials and ProductsE 1697 Test Method for Unipolar Magnitude Estimation ofSensory Attributes1This guide is under the jurisdiction of ASTM Committee E18 on SensoryEvaluation and is the direct responsibility of Su

16、bcommittee E18.07 on PersonalCare and Household Evaluation.Current edition approved Feb. 1, 2009. Published March 2009. Originallyapproved in 1987. Last previous edition approved in 2002 as E 1207 02.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.3For

17、 referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700

18、, West Conshohocken, PA 19428-2959, United States.3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 For definitions of terms relating to sensory evaluation,see Terminology E 253.3.1.2 5-alpha-androst-16-en-3-one (delta16(5-alpha)androsten-3-one) C19H28OCAS No. 18339-17-7componen

19、t of axillary odor which has a “urinous” characterand results from the action of certain skin bacteria on apocrinesecretion (9).3.1.3 5-alpha-androst-16-en-3-alpha-ol (delta16(5-alpha)androsten-3-alpha-ol) C19H30OCAS No. 14152-27-3component of axillary odor which has a “musky” character andresults f

20、rom the action of certain skin bacteria on apocrinesecretion (9).3.1.4 apocrine glanda highly coiled tubular system foundprimarily in axillary epidermis. These glands continuouslyproduce and store apocrine sweat for later excretion onto theskin surface via hair follicles. The excretion is activated

21、byandrogenic sympathetic stimuli such as pain or fear (1).3.1.5 deodorant effcacythe effectiveness or treatment, orboth, of a product in reducing axillary malodor.3.1.6 eccrine glanda simple unbranched tube with aterminal coil. These glands are found in the epidermis over theentire body surface. The

22、 glands are controlled by the auto-nomic nervous system and serve as an evaporative coolingmechanism. Although heat is the primary stimulus, localizedeccrine sweating can also occur as a result of emotional stressand other physiological stimuli (3).3.1.7 IVA, isovaleric acid (3-methylbutanoic acid)

23、C5H10O2; (CH3)2CHCH2COOH. CAS No. 503-74-2component of axillary odor which has a “sweaty, acid”character and results from the action of certain skin bacteria onapocrine secretion.3.1.8 right-left imbalancea condition of some subjectswho have one axilla with notably more intense odor than theother ax

24、illa as determined from the control odor evaluation.3.1.9 sebaceous glanda gland closely related to the hairfollicle which produces sebum which combines with apocrinesecretion at the base of the follicle. Sebaceous glands are underandrogen control (6).3.1.10 sequential analysisa statistical techniqu

25、e whichmay be used to screen potential assessors for sensory acuity toa specific stimulus. The assessor is repeatedly tested until he orshe passes or fails the test at a specified level of significance(10,11).3.1.11 trigeminal responsea sensation caused by stimula-tion of the trigeminal nerve. The s

26、ensation is that of a physicalfeeling, such as burning and tingling.4. Summary of Guide4.1 The protocols described provide for the designation ofpanels of individuals suitably selected and trained to performthe functions of assessors and subjects for the purpose ofassessing deodorant efficacy. Detai

27、ls of specific procedures aregiven in Appendix X1-Appendix X3. Deodorant productsshould be tested in a manner which maximizes test sensitivitywhile still reflecting normal consumer-use conditions. Ex-amples are provided to assist the investigator in the design andperformance of test protocols.5. Sig

28、nificance and Use5.1 The procedures recommended in this practice can beused to clinically assess axillary deodorant efficacy of personalcare products.5.2 This practice is applicable to the product categorieswhich include deodorant and toilet soap bars, liquid bath soapsand gels, deodorant sticks, an

29、tiperspirants, creams and lotions,body talcs, and aerosol and pump delivery deodorants, antiper-spirants, and body colognes.5.3 Procedures of the type described herein may be used toaid in the communication of efficacy within and betweenmanufacturers and to the consumer through the various publiccom

30、munications media. Guidelines are suggested due to theneed to determine the relative or absolute performance ofexperimental materials or of commercial products.5.4 These procedures may be used by persons who havefamiliarized themselves with these procedures and have hadprevious experience with senso

31、ry evaluation.5.5 This practice provides suggested procedures and is notmeant to exclude alternate procedures which may be effec-tively used to provide the same clinical result.6. Subject Selection and Restrictions6.1 Criteria for SelectionThe population should be de-fined and subjects selected from

32、 this population in a random,and unbiased manner according to the experimental designconsiderations defined in 8.11. If a test is being performed withthe product directed at a subset of the consuming population,the subjects should be selected from a population representa-tive of the subset.6.1.1 The

33、 subjects should have a recognizable body odorlevel when evaluated under the procedures given in thispractice.6.1.2 In situations where it is desirable to enhance testsensitivity, the following criteria may be adopted:6.1.2.1 Based on the control odor scores (see 8.3), subjectswho have low or extrem

34、ely high odor should not be selectedfor the test. Subjects may be considered as having a “high”odor relative to a normal population if they develop an odorscore in excess of 7.0 on a 0- to 10-point scale or 3.5 on a 0-to 5-point scale. Likewise, subjects may be considered ashaving a “low” odor relat

35、ive to a normal population if theydevelop an odor score below 3.0 on a 0- to 10-point scale or 1.5on a 0- to 5-point scale. A selection process which excludes“low” odor subjects or “extremely high” odor subjects, or both,must be specified for each test and depends upon the number ofsubjects required

36、 for the test and the relative odor scores ofthese subjects.6.1.2.2 There should be no more than a small right-left odorimbalance between axillae of each subject. On the basis of acategory, or interval scale, the consensus of the task group wasthat the control odor score differential should not be g

37、reaterthan 20 % of the overall scale (that is, 2.0 points on a 10-pointscale or 1.0 points on a 5-point scale).E12070926.1.2.3 Appendix X1 contains additional information on theacceptance/rejection history of experimental subject popula-tions. A selection process which excludes approximately 20 %of

38、the lowest odor intensity individuals of a normal populationis generally recognized as appropriate.6.1.3 Chronic medications such as antibiotics, steroids, etc.,which may affect the test, should be restricted during all testphases as deemed appropriate by the sponsor.6.1.4 In addition to the above r

39、estrictions it should berecognized that other factors which contribute to protocoloperating efficiency should be emphasized, including interest,cooperation, commitment, and punctuality of the subjects.6.2 Subject RestrictionsIn order to achieve appropriateexperimental control, the following restrict

40、ions should beimposed upon all subjects during the conditioning and testphases.6.2.1 Conditioning PhaseThis period is often referred toas the “washout” period and is that portion of the protocolpreceding the actual test phase. The duration of the condition-ing phase should be a minimum of 7 days. Th

41、e conditioningphase for antiperspirants shall be 17 days as defined by theFDA monograph on antiperspirants (11).6.2.1.1 Subjects should use no antiperspirants, deodorants,antibiotic creams, antibacterial ointments, or any other cos-metic products on the axillae. No antibacterial products,including d

42、eodorant and medicated shampoos should be used.Care should be taken not to expose the axillae to any medicatedproduct or product containing alcohol.6.2.1.2 Subjects should use only the control cleansingagent(s) provided by the sponsor as instructed for personalhygiene.6.2.1.3 Swimming should be stop

43、ped at least 7 days prior tothe test phase and during the entire test phase.6.2.1.4 Subjects who normally shave their axillae shouldshave using the control cleansing agent no less than 24 h priorto the control evaluation and abstain from shaving for theduration of the test.6.2.1.5 Spicy foods, inclu

44、ding garlic and onions should berestricted 24 h before the control evaluation and during the testphase.6.2.1.6 It is acceptable to use smokers as subjects, but theyare required to refrain from smoking for 2 h before allevaluations.6.2.2 Test PhaseIn addition to the conditions detailed forthe subject

45、s during the conditioning phase, the followingrestrictions are required of the subjects during the test phase:6.2.2.1 Subjects should use no perfumed substances on thebody such as perfume, after shave, lotions, bath oils, andhairspray.6.2.2.2 Pre-laundered wearing apparel (see 8.6) may beworn by eac

46、h subject at the option of the test sponsor. Shirtsshould be collected and laundered in accordance with auniform laboratory procedure.6.2.2.3 If specified by the test sponsor, laundry additivessuch as bleach, fabric softeners, etc., may be used on subjectsouter clothing.6.2.2.4 Subjects should minim

47、ize physical exertion such astennis 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 andalcoholic b

48、everages 8 h before an evaluation.6.2.2.6 Subjects should not wash the axillae during the testweek at home.Axillae should only be washed at the test site inaccordance with a supervised wash procedure. Care should betaken not to get the axillae wet during bathing or showering athome.7. Assessor Selec

49、tion and Training7.1 GeneralThe selection process should include theprinciples embodied in Ref (12).The assessors task is to detectdifferences and rate the intensity of perceived axillary odor.7.2 Assessors employed for assessing body odor intensityshould be screened for the following attributes:7.2.1 Interest and availability;7.2.2 Qualitative and quantitative olfactory discriminationability;7.2.3 Ability to carry out basic sensory tasks, and compe-tency with the scale used, and7.2.4 Specific anosmias. While it is desirable to identify anyolfactory deficit which