ASTM E2752-10(2015)
(Guide)Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
SIGNIFICANCE AND USE
5.1 The procedure is used to evaluate personal cleansing products containing antibacterial ingredients that are intended to reduce the number of organisms on intact skin. It also may be used to demonstrate the effect of residual antibacterial activity by means of inhibition of the proliferation of bacteria on the skin after contact.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing product in reducing the numbers of a marker organism (representing transients) both immediately and after prolonged exposure to (cleansing) washing when used as recommended under simulated use conditions. The method demonstrates the effect of residual antibacterial activity by means of inhibition of proliferation of bacteria on the skin after the contact period. Antimicrobial activity is compared with a vehicle or to a baseline organism count.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR Parts 50 and 56).
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2752 − 10 (Reapproved 2015)
Standard Guide for
Evaluation of Residual Effectiveness of Antibacterial
Personal Cleansing Products
This standard is issued under the fixed designation E2752; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Federal Document:
21 CFR Parts 50 and 56Code of Federal Regulations:
1.1 This guide is designed to demonstrate the effectiveness
Protection of Human Subjects; Institutional Review
of an antibacterial personal cleansing product in reducing the
Boards
numbers of a marker organism (representing transients) both
immediatelyandafterprolongedexposureto(cleansing)wash-
3. Terminology
ing when used as recommended under simulated use condi-
tions. The method demonstrates the effect of residual antibac- 3.1 Definitions of Terms Specific to This Standard:
terialactivitybymeansofinhibitionofproliferationofbacteria
3.1.1 marker organism, n—an applied inoculum of an or-
on the skin after the contact period. Antimicrobial activity is
ganism that has characteristics that allow it to be readily
compared with a vehicle or to a baseline organism count.
identified or differentiated. Marker organisms are used to
simulate transient microorganisms.
1.2 A knowledge of microbiological techniques is required
for these procedures. 3.1.2 occlusion, n—covered and sealed from the outside
environment.
1.3 Performance of this procedure requires the knowledge
of regulations pertaining to the protection of human subjects 3.1.3 occlusive chamber, n—a covering that protects the
sampling surface without contacting the sampling surface.
(21 CFR Parts 50 and 56).
3.1.4 personal cleansing products, n—products used for
1.4 The values stated in SI units are to be regarded as
personal hygiene such as soaps, hand sanitizers, towelettes,
standard. No other units of measurement are included in this
body washes, and so forth.
standard.
3.1.5 transient organisms, n—organisms from the environ-
1.5 This standard may involve hazardous materials,
operations, and equipment. This standard does not purport to ment that contaminate but do not normally permanently
address all of the safety concerns, if any, associated with its colonize skin.
use. It is the responsibility of the user of this standard to
3.1.6 vehicle, n—a formulation for delivery of the antimi-
establish appropriate safety and health practices and deter-
crobial agent.
mine the applicability of regulatory limitations prior to use.
4. Summary of Test Method
2. Referenced Documents
4.1 Thisguideisconductedonagroupofvolunteersubjects
2.1 ASTM Standards:
who refrained from using oral and topical antimicrobials for at
E1054Test Methods for Evaluation of Inactivators of Anti-
least one week.
microbial Agents
4.2 The test sites are washed multiple times with the
E1874Test Method for Recovery of Microorganisms From
cleansing product or vehicle. After washing, the sites are
Skin using the Cup Scrub Technique
inoculatedwithamarkerorganismandoccludedforaspecified
period of time after which the sites are sampled and enumer-
atedforthemarkerorganism.Activityofthecleansingproduct
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
is measured by comparing microbial counts from treated sites
Subcommittee E35.15 on Antimicrobial Agents.
to those derived from the sites treated with vehicle or to an
Current edition approved Oct. 1, 2015. Published November 2015. Originally
untreated baseline organism count.
approved in 2010. Last previous edition approved in 2010 as E2752–10. DOI:
10.1520/E2752–10R15.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on DLA Document Services Building 4/D 700 Robbins Avenue Philadelphia, PA
the ASTM website. 19111-5094 http://quicksearch.dla.mil/
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2752 − 10 (2015)
5. Significance and Use 7.10 Bacterial Cultures—Such as Staphylococcus aureus
ATCC 27217 or Escherichia coli ATCC 11229, or others as
5.1 The procedure is used to evaluate personal cleansing
appropriate.
products containing antibacterial ingredients that are intended
to reduce the number of organisms on intact skin. It also may 7.11 Test Formulations—With directions for use.
be used to demonstrate the effect of residual antibacterial
7.12 Sampling and Dilution Fluid—Sterile Butterfield’s
activity by means of inhibition of the proliferation of bacteria
phosphate buffered water, containing an antimicrobial inacti-
on the skin after contact.
vator specific for the test formulation as determined by Test
Method E1054.
6. Apparatus
7.13 Plating Medium—Soybean-casein digest agar or
6.1 Colony Counter—Use any of several types.
equivalent as appropriate with neutralizers, as determined by
Test Method E1054.
6.2 Incubator—Any incubator capable of maintaining a
suitable temperature 62°C.
7.14 Sterile Culture Tubes, or equivalent with closures of
appropriate capacity.
6.3 Sterilizer—Any suitable steam sterilizer capable of pro-
ducing the conditions of sterilization.
8. Test Control and Baseline Skin Sites
6.4 Timer (Stop Clock)—One that displays hours and min-
8.1 Select skin sites appropriate for target flora and the test
utes.
material’s intended use. Where possible, a contralateral site is
6.5 Table—Any elevated surface, such asa1by2-m table
recommended for application of the vehicle or for the micro-
withmattressorsimilarpaddingtoallowthesubjecttorecline,
organism count control.
when applicable. NOTE 5—Forearms are a convenient site for most applications.
6.6 Handwashing Sink—A sink of sufficient size to permit
9. Subjects
panelist to wash without touching hands to the sink surface or
9.1 Number of Subjects—The number of subjects required
other panelist.
depends on the statistical confidence for the expected test
6.7 Water Faucet(s)—To be located above the sink at a
results,thevariabilityencounteredinthestudy,andtherelative
height that permits the hands to be held higher than the elbows
efficacy of the antibacterial agent evaluated.
during the washing procedure.
9.1.1 Recruitasufficientnumberofhealthyadultvolunteers
who have no clinical evidence of dermatoses, open wounds, or
6.8 Tap Water Temperature Regulator and Temperature
other skin disorders that affect the integrity of the test.
Monitor—To monitor and regulate water temperature.
9.2 Instructthesubjectstoavoidcontactwithantimicrobials
7. Reagents and Materials
for at least one week prior to the test. This restriction includes
antimicrobial-containing antiperspirants, deodorants,
7.1 Bacteriological Pipettes—Sterile, of appropriate capac-
shampoos,lotions,andsoaps,alsosuchmaterialasacidsbases
ity.
and solvents. Bathing in biocide-treated pools, hot tubs, spas,
NOTE 1—Presterilized/disposable bacteriological pipettes are available
from most laboratory supply houses.
and so forth, should be avoided. Provide volunteers with a kit
of non-antimicrobial personal care products for exclusive use
7.2 Water Dilution Bottles—Any sterilizable container hav-
during the test. Volunteers must wear rubber gloves when
ing a 100 to 200-mL capacity and tight closure.
contact with antimicrobial agents cannot be avoided.
NOTE2—Milkdilutionbottlesof160-mLcapacityhaveascrew-capped
closure and are available from most local laboratory supply houses.
10. Procedure
7.3 Scrub Cups—Sterilecylinders,heightapproximately2.5
10.1 Treatment(s) Application Procedure:
cm,insidediameterofconvenientsize.Usefulsizesrangefrom
10.1.1 Application of test material is assigned by a prede-
approximately 1.5 to 4.0 cm.
termined randomized application schedule. Each subject will
7.4 Teflon Policeman or Rubber Policeman—Can be fash-
have an active and a vehicle or no vehicle treatment site.
ioned in the laboratory or purchased.
10.1.2 Application of test and vehicle material consists of
7.5 Pipettor—With disposable tips capable of delivering 10
an equal number of washes. For demonstration of residual
µL. activity, more than one test material application may be
required. Schedule applications at least one hour apart.
7.6 Graduated Cylinders—Sterile, of appropriate capacity.
10.1.3 Perform all washes under supervision of a technician
7.7 Beakers—Sterile, of appropriate capacity.
trained in the methodology. The following are suggested
treatment procedures for evaluating two rinse-off products, a
7.8 Occlusive Chamber—For covering inoculated test sites.
bar soap product, and a liquid soap product; and two no-rinse
NOTE3—Occlusivechambersorplasticweighboatsofappropriatesize
available from laboratory supply houses
products, a liquid gel product and a pre-wetted towelette.
10.1.4 Bar Soap Products and Vehicle—Check, record, and
7.9 Adhesive Dressing—For securing the occlusive cham-
maintainthetemperatureofthewaterat35to38°Cbeforeeach
ber.
wash. Water flow should be 4L/min. Remove all jewelry from
NOTE 4—Adhesive dressings such as adhesive tape, surgical tape, or
others secural devices. hands and wrists prior to start of wash procedure. Subjects can
E2752 − 10
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