ASTM E1589-05

Standard Test Method for Evaluation of First Aid Antiseptic Drug Products

SIGNIFICANCE AND USE
The procedures in this test method should be used for in vivo evaluation the antimicrobial activity of drug products applied topically to the skin that are intended to help prevent infection in minor cuts, scrapes and burns.
5.1.1 This test method is applicable for testing liquids, ointments, powders, films, or dressing containing or impregnated with an antimicrobial for their effect to reduce an enhanced skin microflora or their effects to suppress the growth of the skin flora, or both.
SCOPE
1.1 The tests described in this test method are designed to evaluate antimicrobial agents in formulations intended for use as first aid antiseptic products for their ability to reduce or suppress the growth, or both, of the skin microflora.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 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.
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (See CFR Parts 50 and 56.)

General Information

• Status: Historical
• Publication Date: 31-Oct-2005
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E1589-94 - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products (Withdrawn 2003)
• Effective Date: 01-Nov-2005
• Replaced By: ASTM E1589-05(2010) - Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
• Effective Date: 01-Apr-2010

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
Designation:E1589–05
Standard Test Method for
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Evaluation of First Aid Antiseptic Drug Products
This standard is issued under the fixed designation E1589; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2 neutralization, n—a process which results in quenching
or inactivating inactivation of the antimicrobial activity of a
1.1 The tests described in this test method are designed to
formulation. This may be achieved with dilution of the
evaluate antimicrobial agents in formulations intended for use
formulation, or with the use of chemical agents, called neu-
as first aid antiseptic products for their ability to reduce or
tralizers.
suppress the growth, or both, of the skin microflora.
3.3 neutralizer, n—a procedure or chemical agent used to
1.2 A knowledge of microbiological techniques is required
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
for these procedures.
an antimicrobial agent.
1.3 The values stated in SI units are to be regarded as the
3.4 resident microorganisms , n—microorganisms that live
standard.
and multiply on skin, forming a permanent population.
1.4 This standard does not purport to address all of the
3.5 sampling fluid, n—a recovery fluid that may or may not
safety concerns, if any, associated with its use. It is the
contain a neutralizer to inactivate the active ingredients in test
responsibility of the user of this standard to establish appro-
and internal reference formulations.
priate safety and health practices and determine the applica-
3.6 test formulation , n—a formulation containing an active
bility of regulatory limitations prior to use.
ingredient(s).
1.5 Performance of this procedure requires the knowledge
3.7 transient microorganisms, n—microorganisms that con-
of regulations pertaining to the protection of human subjects.
taminate but do not normally permanently colonize the skin.
(See CFR Parts 50 and 56.)
4. Summary of Test Methods
2. Referenced Documents
2
4.1 These test methods describe standard in vivo techniques
2.1 ASTM Standards:
to determine the following:
D1193 Specification for Reagent Water
4.1.1 Effect of the Test Formulation to Reduce anArtificially
E1054 Test Methods for Evaluation of Inactivators of An-
Enhanced Skin Microbial Flora—The forearms of subjects are
timicrobial Agents
3 occluded for 48 h prior to application of the test formulation to
2.2 Federal Standards:
increase the microbial population on the skin of the volar
CFR Parts 50 and 56
forearm surface. At treatment the occlusion material is re-
3. Terminology
moved and the skin is allowed to dry, the test formulation is
then applied to selected sites. At a pre-determined time(s)
3.1 active ingredient, n—a substance performing a function
following application, the sites are microbiologically sampled
defined by this method.
and the samples plated for total aerobic bacteria count. The
counts obtained from the treated sites are compared to counts
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This test method is under the jurisdiction of ASTM Committee E35 on
obtained from untreated occluded sites.
Pesticides and is the direct responsibility of Subcommittee E35.15 onAntimicrobial
4.1.2 Effect of the Test Formulation to Suppress the Growth
Agents.
Current edition approved Nov. 1, 2005. Published December 2005. Originally
of Normal Skin Flora When Applied As a Dressing—The
approved in 1994. Last previous edition approved in 1994 as E1589 - 94 which was
dressingsareappliedtotheforearmfor24h.Thedensityofthe
withdrawninJune2003andreinstatedinNovember2005.DOI:10.1520/E1589-05.
2 resident microorganisms that develop under the dressings are
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM comparedtothepopulationthatdevelopsonasimilaruntreated
Standards volume information, refer to the standard’s Document Summary page on
occluded site. Following 24 h of occlusion, the sites are
the ASTM website.
microbiologically sampled and the samples plated for total
3
Available from U.S. Government Printing Office, Superintendent of Docu-
aerobic bacteria count.
ments, Washington DC, 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E1589–05
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4.2 Theprincipalofthetestisthatthemicrofloraofforearm 7.9 Plating Medium—Soybean-casein digest agar medium
skin is sparse. The impermeable dressing will increase surface or commercial equivalent.
moisture by preventing diffusional water loss and thus expand 7.10 Personal Hyg
...