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ASTM E640-06(2012)

(Test Method)

Standard Test Method for Preservatives in Water-Containing Cosmetics

Standard Test Method for Preservatives in Water-Containing Cosmetics

SIGNIFICANCE AND USE
This test method should be used to determine if a preservative or preservative system has application for the preservation of water-miscible cosmetic products.
SCOPE
1.1 This test method covers the determination of the suitability of preservatives for use in cosmetic formulations. It sets minimal requirements for preservative performance in model formulations.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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

Status
Historical
Publication Date
31-Mar-2012
ICS
71.100.70 - Cosmetics. Toiletries
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaces
ASTM E640-06 - Standard Test Method for Preservatives in Water-Containing Cosmetics
Effective Date
01-Apr-2012
Replaced By
ASTM E640-06(2019) - Standard Test Method for Preservatives in Water-Containing Cosmetics
Effective Date
01-Jan-2019
Referred By
ASTM E723-13(2019) - Standard Practice for Evaluation of Antimicrobials as Preservatives for Aqueous-Based Products Used in the Paper Industry (Bacterial Spoilage)
Effective Date
01-Apr-2012
Referred By
ASTM D4783-01(2021) - Standard Test Methods for Resistance of Adhesive Preparations in Container to Attack by Bacteria, Yeast, and Fungi
Effective Date
01-Apr-2012

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ASTM E640-06(2012) - Standard Test Method for Preservatives in Water-Containing CosmeticsASTM E640-06(2012) - Standard Test Method for Preservatives in Water-Containing Cosmetics
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ASTM E640-06(2012) - Standard Test Method for Preservatives in Water-Containing Cosmetics
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E640 − 06 (Reapproved 2012)
Standard Test Method for
1
Preservatives in Water-Containing Cosmetics
This standard is issued under the fixed designation E640; 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 5. Materials
5.1 Test Formulations—Formulations that the submitter
1.1 This test method covers the determination of the suit-
feels are appropriate for demonstration of preservative activity
abilityofpreservativesforuseincosmeticformulations.Itsets
shall be included in the test. Non-preserved (control) samples
minimal requirements for preservative performance in model
of these formulas shall also be included. Incompatibility of the
formulations.
preservative(s) with any of the formulations or formulation
1.2 The values stated in SI units are to be regarded as
components shall be noted.
standard. No other units of measurement are included in this
5.2 Test Microorganisms (Suggested Panel):
standard.
5.2.1 Other test microorganisms or equivalent species may
1.3 This standard does not purport to address all of the
be included as appropriate and if standardized cultures from
safety concerns, if any, associated with its use. It is the
cosmetic isolates become available. The primary function of
responsibility of the user of this standard to establish appro-
these cultures is to provide a common basis for comparison of
priate safety and health practices and determine the applica-
different preservatives.
bility of regulatory limitations prior to use.
5.2.1.1 Pseudomonas aeruginosa ATCC 9027.
5.2.1.2 Burkolderia cepacia ATCC 25416.
2. Referenced Documents
5.2.1.3 Escherichia coli ATTC 8739.
2
5.2.1.4 Staphylococcus aureus ATCC 6538.
2.1 ASTM Standards:
5.2.1.5 Candida albicans ATCC 10231.
E1054Test Methods for Evaluation of Inactivators of Anti-
5.2.1.6 Enterobacter gergoviae ATCC 33028.
microbial Agents
5.2.1.7 Aspergillus niger ATCC 16404.
5.2.1.8 Eupenicillium levitum ATCC 10464.
3. Summary of Method
5.2.2 If available, cosmetic spoilage microorganisms and/or
3.1 This test method involves a microbiological challenge
microorganisms obtained from the cosmetic manufacturing
test of preservatives incorporated into model formulations at
environment may be used in addition to those microorganisms
recommended efficacy levels. Routine microbiological proce-
suggested in 5.2.
dures are used to determine the antimicrobial activity of
5.3 Culture Maintenance—The microorganisms listed in
preservativesinformulations.Thismethodrequirestheknowl-
5.2.1 shall be maintained as specified by ATCC.
edge of standard microbiological techniques.
5.3.1 PlatingDiluents—Platingdiluentsareusedtodisperse
the test sample in preparation for plating and, if necessary, aid
4. Significance
in neutralizing the preservative present to permit the optimum
4.1 This test method should be used to determine if a
recovery of surviving microorganisms. The choice of diluents
preservative or preservative system has application for the
is dependent of the diluents ability to meet the neutralization
preservation of water-miscible cosmetic products.
requirements specified in 5.3.3. The following suggested di-
luents have been found to be suitable for this purpose:
5.3.1.1 Buffered 1% Peptone in physiological saline
1
(0.85% NaCl).
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agentsand is the direct respon-
5.3.1.2 Dey/Engley (D-E) neutralizing broth.
sibility of Subcommittee E35.15 on Antimicrobial Agents.
5.3.1.3 Eugon Broth.
Current edition approved April 1, 2012. Published June 2012. Originally
5.3.1.4 Letheen Broth.
approved in 1978. Last previous edition approved in 2006 as E640–06. DOI:
10.1520/E0640-06R12.
5.3.1.5 Modified Letheen Broth.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.3.1.6 Nutrient Broth.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.3.1.7 Phosphate Buffer (pH 7.0).
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 5.3.1.8 TAT Broth.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
1

---------------------- Page: 1 ----------------------
E640 − 06 (2012)
5.3.1.9 Trypticase Soy Broth. (2)Optional Mixed Bacteria Pools—Mix separate bacteria
5.3.2 Recovery Media—Arecovery medium should provide pools for gram-positive bacteria, gram-negative fermenter
adequate nutritional support for the growth of the selected test bacteria, and gram-negative non-fermenter bacteria. Pooled
...

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5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate fungal contamination from experimentally-contaminated hands. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for culturable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test.  
5.2 Whereas this practice is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838) and vegetative bacteria (Test Method E2276).  
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5.5 The level of contamination with culturable fungi on each fingerpad after the drying of the inoculum should be at least 104 CFU so that it would permit the detection of up to a 4-log10 reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.
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1.1 This practice is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands (3) . This practice is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).  
1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation.3  
1.3 The practice should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 (4).  
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ASTM E2011-21(Test Method)
Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand

SIGNIFICANCE AND USE
5.1 This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and enables alternative product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E1838, which gives precise reductions in viral infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E1838.  
5.2 This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.
Note 2: Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.
SCOPE
1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce or eliminate viable viruses from the skin of human hands.
Note 1: A knowledge of virological techniques is required for this test method.  
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ASTM E2870-19(Practice)
Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling

SIGNIFICANCE AND USE
5.1 Hand hygiene is important for preventing the spread of many types of infections.  
5.2 During routine activities, it is primarily the palmar surface, comprising palms, fingers, and finger pads, of the hands that may become contaminated with transient microorganisms. The contamination could then be transferred to articles touched or handled or to other parts of the body. Palmar contamination is used in Test Method E2784.  
5.3 In Test Method E1174, incomplete drying of the experimentally contaminated hands dilutes the applied test product, thus compromising its activity. Application of a smaller volume of the microbial test suspension keeps the soil load to a reasonable level while allowing the hands to become visibly dry prior to application of the test material and reference formulation. These modifications are aimed at producing a better approximation of in-use conditions and a more realistic assessment of the test substance, thus providing a more reliable indication of product performance.  
5.4 Unlike Test Methods E1174, E2755, and E2784, this practice enables a direct comparison between two formulations on the same subject. The practice also uses a mechanical scrubbing machine in conjunction with the glove juice technique for more efficient recovery of viable test bacteria from the palms. The mechanical sampling results in greater recovery of bacteria from the palms than conventional recovery methods, such as massaging.
SCOPE
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Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate selected types of bacteria from experimentally contaminated skin of the hands of adult subjects. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for viable bacteria remaining after the inoculum has been allowed to dry (two), bacteria eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the bacteria-eliminating efficiency of the product under test. No more than 100 µL of the test bacterial suspension is required to complete one test. The results of testing with this test method may form the basis for confirmatory tests using a suitable whole-hand test protocol, such as Test Method E1174.  
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4.1 The procedure should be used to test the degerming effectiveness of antimicrobial hand washing products used by health care personnel that are intended for frequent use, and that are intended to reduce the level of contamination acquired through contact with contaminated objects or people.  
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SCOPE
1.1 This test method can be used to determine the effectiveness of antimicrobial handwashing agents (including handrubs) in the reduction of transient bacterial flora with particular emphasis on the fingernail region.  
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Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
5.1 This in vivo procedure is designed to test the ability of hygienic handwash and handrub agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adults. Since the two thumbpads and all eight fingerpads can be contaminated with virus and used in a given test, it allows for the incorporation of a wet inoculum input control, dried virus recovery control, and up to three replicates to assess the virus-eliminating efficiency of a test or control agent, or a vehicle material. No more than 100 μL of the virus suspension are required to complete one test.  
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5.6 The level of viable virus in the dried inocula the control fingerpads should not be less than 104 infectious units which would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by the test product under the conditions of this test method.
SCOPE
1.1 Human skin is not known to carry viruses as a part of its resident microbiota, with the notable exception of papilloma viruses (10). Hands transiently contaminated with viruses can, however, act as vehicles for the spread of many types of viral infections. Hand hygiene is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reductions in the virus load may be due to a combination of virus inactivation and mechanical removal of infectious virus from the skin.  
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Note 1: The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2 (11).  
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Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination

SIGNIFICANCE AND USE
5.1 This procedure has been designed to evaluate handwash products using a palmar surface only contamination method. This method is an alternative contamination procedure to that listed in Test Method E1174. The current contamination procedure in Test Method E1174 describes a standardized procedure for contaminating the entire hand, palmar surface and back, directly using a marker organism. The contamination procedure in Test Method E1174 does not necessarily represent real world hand contamination. During routine activities it is only the palmar surface, comprising palms, fingers, and finger pads of the hands that becomes contaminated by contact with transient microorganisms. These microorganisms can then be transferred to food or objects. Methods to measure the amount of microorganisms transferred to food or objects can be found in Fischler et al5 and Fuls et al6 and will be developed into a future ASTM standard.
SCOPE
1.1 This test method covers the determination of the effectiveness of antimicrobial handwashing agents for the reduction of transient microbial flora when used in a handwashing procedure.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 This test method may be used to evaluate topical antimicrobial handwash formulations.  
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.2  
1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and SI units follow in parentheses.  
1.6 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. For more specific precautionary statements see 8.5.

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ASTM E2613-23(Practice)
Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate fungal contamination from experimentally-contaminated hands. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for culturable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test.  
5.2 Whereas this practice is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838) and vegetative bacteria (Test Method E2276).  
5.3 The levels of culturable microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (5). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid fungal removal by the drying process itself.  
5.4 This practice is not designed to test surgical hand scrubs or preoperative skin preps.  
5.5 The level of contamination with culturable fungi on each fingerpad after the drying of the inoculum should be at least 104 CFU so that it would permit the detection of up to a 4-log10 reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.
SCOPE
1.1 This practice is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands (3) . This practice is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).  
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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.  
1.6 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.

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ASTM E3288-22(Guide)
Standard Guide for Screening and Training of Assessors and a General Approach for the Sensory Evaluation of Oral Care Products: Toothpaste and Toothbrushes

SIGNIFICANCE AND USE
5.1 The approaches to the evaluation of toothbrushes and toothpaste recommended in this guide can be used to assess the sensory characteristics of toothpaste in use and after use (or a series of uses). This guide is meant to address the evaluation of standalone toothbrush and toothpaste products and does not address packaging, product/package interaction, dispensing, or overall clinical effect or benefit of the product. The procedures outlined in this guide are to be used by assessors that have been specifically screened for sensory and descriptive ability and trained in the evaluation of toothbrushes or toothpaste or both. The procedures described in this guide can be used to guide product development within a manufacturer and communicate information regarding the product to the consumer through the media or on product packaging.  
5.2 Additionally, language and ideas from two additional ASTM International sensory guides (Guides E1490 and E2082) as well as the Lexicon for Sensory Evaluation: Aroma, Flavor, Texture, and Appearance (DS72-2ND)4 are used throughout this guide.
SCOPE
1.1 This guide provides guidelines for the selection and training of expert assessors for the sensory evaluation of toothpaste and toothbrushes as well as a basic framework for the sensory evaluation of the same. Sensory evaluation of toothpaste and toothbrushes can be used to define the sensory attributes of the products and then to measure those attributes quantitatively for the purposes of new product development, product optimization, competitive benchmarking, and claims substantiation.  
1.2 A general framework for both toothpaste and toothbrush descriptive analysis is provided to guide the reader in the design and execution (including sample preparation and presentation, facility and testing environment, and specific evaluation protocols) for such evaluations.  
1.3 This guide provides suggested protocols and approaches to the evaluation of the indicated products/samples and in no way excludes any alternate approaches that may be effective in providing such perceptual evaluations.  
1.4 This guide does not address other oral care products including, but not limited to, whitening agents, oral rinses, mouthwashes, dental flosses, denture adhesive, floss picks, or other oral care products.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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.

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