ASTM E1882-10
(Test Method)Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique (Withdrawn 2019)
Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique (Withdrawn 2019)
SIGNIFICANCE AND USE
This procedure can be used to evaluate formulations containing ingredients intended to inhibit growth of bacteria on intact skin and measures the difference, post-product-exposure, between numbers of bacterial colonies on active test formulation plates and numbers on control plates, expressed as percent inhibition.
This procedure may also be used to test for persistence of activity, as a function of time elapsed between application of active test formulation and application of active test plates.
Because no procedure for neutralization of the antimicrobial action of active ingredients can be included in the test, the agar patch method is limited to the extent that results expressed as percent inhibition do not differentiate between bacteristatic and bactericidal effects and, hence, must not be portrayed as “reductions.”
SCOPE
1.1 This test method determines the antibacterial activity and persistence of test formulations, as measured by the inhibition of a test organism on an agar surface exposed to test sites on human skin treated with the formulations.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 It is the responsibility of the investigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) are required and to adhere to these practices, as appropriate.
1.4 In this test method, SI units are used for all applications except linear measure. In that case, inches are used and SI units follow in parentheses.
1.5 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. Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR, Ch. I, Parts 50 and 56 ).
WITHDRAWN RATIONALE
This test method determines the antibacterial activity and persistence of test formulations, as measured by the inhibition of a test organism on an agar surface exposed to test sites on human skin treated with the formulations.
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this test method was withdrawn in January 2019 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: E1882 − 10
Standard Test Method for
Evaluation of Antimicrobial Formulations by the Agar Patch
1
Technique
This standard is issued under the fixed designation E1882; 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 3.2 active ingredient—a substance added to a formulation
specifically for the inhibition or inactivation of microorgan-
1.1 This test method determines the antibacterial activity
isms.
and persistence of test formulations, as measured by the
3.3 active plate—inoculated agar plate that has been at-
inhibition of a test organism on an agar surface exposed to test
tached to a skin site treated with an active formulation.
sites on human skin treated with the formulations.
3.4 antibacterial activity—killing of bacteria or supression
1.2 A knowledge of microbiological techniques is required
of their growth or reproduction.
for these procedures.
3.5 controlformulation—aformulationthatdoesnotcontain
1.3 It is the responsibility of the investigator to determine if
an active ingredient.
Good Laboratory Practice (GLP) and Good Clinical Practice
3.6 control plate—inoculated agar plate that has been at-
(GCP) are required and to adhere to these practices, as
tached to an untreated skin site, or one treated with a control
appropriate.
formulation.
1.4 In this test method, SI units are used for all applications
3.7 inhibition—prevention of bacterial population growth,
exceptlinearmeasure.Inthatcase,inchesareusedandSIunits
either through lethality or through prevention of bacterial
follow in parentheses.
reproduction.
1.5 This standard does not purport to address all of the
3.8 inoculum determination plate—an inoculated plate that
safety concerns, if any, associated with its use. It is the
has not been exposed to any skin test site.
responsibility of the user of this standard to establish appro-
3.9 persistence—effectivenessofatestformulationininhib-
priate safety and health practices and determine the applica-
iting bacteria, defined in terms of time elapsed between
bilityofregulatorylimitationspriortouse.Performanceofthis
application of test formulation and application of test plates.
procedure requires the knowledge of regulations pertaining to
the protection of human subjects (see 21 CFR, Ch. I, Parts 50
3.10 resident microorganisms—microorganisms that sur-
and 56 ).
vive and multiply on the skin, forming a stable population.
3.11 transient microorganisms—microorganisms that con-
2. Referenced Documents
taminate the skin, but do not form a stable population.
2
3.12 volar aspect of the forearms—the surface of the fore-
2.1 Federal Standard
arm on the same side as the palm of the hand.
21 CFR, Ch. I, Parts 50 and 56Protection of Human
Subjects
4. Summary of Test Method
4.1 This test method is conducted on subjects selected from
3. Terminology
a group of volunteers who have refrained from using topical
3.1 active test formulation—a substance containing active
antimicrobials for at least one week and have minimal hair on
ingredient(s).
the test site. The test site should normally have a low number
4 2
of resident microorganisms (approximately 10 CFU/cm or
fewer) and be easily sampled.
1
This test method is under the jurisdiction of ASTM Committee E35 on
4.2 The surfaces of agar contact plates are inoculated with
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
the selected organism and placed in contact with skin sites that
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2010. Published April 2010. Originally
have been treated with active or control formulations, or left
approved in 1997. Last previous edition approved in 2005 as E1882–05. DOI:
untreated.After contact with the treated skin sites, these plates
10.1520/E1882-10.
2
are incubated and the colonies enumerated. Inhibitory activity
Available from Superintendent of Documents, U.S. Government Printing
Office, Washington, D.C. 20402. of the active test formulation is measured by comparing
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1882 − 10
differencesinmicrobialcolonycountsbetweenplatesthatwere 7.6 Sterile Disposable Culture Dishes, 1.4 × 0.4 in. (35 by
in contact with sites treated with an active formulation and 10 mm) and 4.0 × 0.8 in. (100 by 20 mm).
plates that were in contact with untreated sites, or sites treated
7.7 Sterile Test Tubes.
with a control formulation. Results are expressed as percent
3
7.8 Surgical Adhesi
...
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