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ASTM E640-06(2019)

(Test Method)

Standard Test Method for Preservatives in Water-Containing Cosmetics

Standard Test Method for Preservatives in Water-Containing Cosmetics

SIGNIFICANCE AND USE
4.1 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

General Information

Status
Published
Publication Date
31-Dec-2018
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(2012) - Standard Test Method for Preservatives in Water-Containing Cosmetics
Effective Date
01-Jan-2019
Refers
ASTM E1054-08 - Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
Effective Date
01-Apr-2008
Refers
ASTM E1054-02 - Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
Effective Date
10-May-2002
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-Jan-2019
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-Jan-2019

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ASTM E640-06(2019) - Standard Test Method for Preservatives in Water-Containing CosmeticsASTM E640-06(2019) - Standard Test Method for Preservatives in Water-Containing Cosmetics
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ASTM E640-06(2019) - Standard Test Method for Preservatives in Water-Containing Cosmetics
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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: E640 − 06 (Reapproved 2019)
Standard Test Method for
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 4. Significance
1.1 This test method covers the determination of the suit- 4.1 This test method should be used to determine if a
abilityofpreservativesforuseincosmeticformulations.Itsets preservative or preservative system has application for the
preservation of water-miscible cosmetic products.
minimal requirements for preservative performance in model
formulations.
5. Materials
1.2 The values stated in SI units are to be regarded as
5.1 Test Formulations—Formulations that the submitter
standard. No other units of measurement are included in this
feels are appropriate for demonstration of preservative activity
standard.
shall be included in the test. Non-preserved (control) samples
1.3 This standard does not purport to address all of the
of these formulas shall also be included. Incompatibility of the
safety concerns, if any, associated with its use. It is the
preservative(s) with any of the formulations or formulation
responsibility of the user of this standard to establish appro-
components shall be noted.
priate safety, health, and environmental practices and deter-
5.2 Test Microorganisms (Suggested Panel):
mine the applicability of regulatory limitations prior to use.
5.2.1 Other test microorganisms or equivalent species may
1.4 This international standard was developed in accor-
be included as appropriate and if standardized cultures from
dance with internationally recognized principles on standard-
cosmetic isolates become available. The primary function of
ization established in the Decision on Principles for the
these cultures is to provide a common basis for comparison of
Development of International Standards, Guides and Recom-
different preservatives.
mendations issued by the World Trade Organization Technical
5.2.1.1 Pseudomonas aeruginosa ATCC 9027.
Barriers to Trade (TBT) Committee.
5.2.1.2 Burkolderia cepacia ATCC 25416.
5.2.1.3 Escherichia coli ATTC 8739.
2. Referenced Documents
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
in neutralizing the preservative present to permit the optimum
This test method is under the jurisdiction of ASTM Committee E35 on
recovery of surviving microorganisms. The choice of diluents
Pesticides, Antimicrobials, and Alternative Control Agentsand is the direct respon-
is dependent of the diluents ability to meet the neutralization
sibility of Subcommittee E35.15 on Antimicrobial Agents.
requirements specified in 5.3.3. The following suggested di-
Current edition approved Jan. 1, 2019. Published January 2019. Originally
luents have been found to be suitable for this purpose:
approvedin1978.Lastpreviouseditionapprovedin2012asE640–06(2012).DOI:
10.1520/E0640-06R19.
5.3.1.1 Buffered 1% Peptone in physiological saline
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
(0.85% NaCl).
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.3.1.2 Dey/Engley (D-E) neutralizing broth.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 5.3.1.3 Eugon Broth.
Copyright ©ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA19428-2959. United States
E640 − 06 (2019)
5.3.1.4 Letheen Broth. using a verified aerobic fungal plate count. Harvested mold
5.3.1.5 Modified Letheen Broth. spore cultures may be used immediately or stored at 2 to 5°C
for up to four weeks.
5.3.1.6 Nutrient Broth.
6.1.4 Preparation of Inocula:
5.3.1.7 Phosphate Buffer (pH 7.0).
6.1.4.1 Mixed Culture Method:
5.3.1.8 TAT Broth.
(1)Mixed Bacteria—Mix equal portions of selected bacte-
5.3.1.9 Trypticase Soy Broth.
ria and label “Bacteria 1.”
5.3.2 Recovery Media—Arecovery medium should provide
(2)Optional Mixed Bacteria Pools—Mix separate bacteria
adequate nutritional support for the growth of the selected test
pools for gram-positive bacteria, gram-negative fermenter
microorganisms.Thefollowingsuggestedagarrecoverymedia
bacteria, and gram-negative non-fermenter bacteria. Pooled
have been found to be suitable for this purpose:
cultures may be used immediately or stored at 2 to 5°C for up
5.3.2.1 For Bacteria:
to 72 hours.
EugonAgar
LetheenAgar (3)Fungi (Mold and Yeast)—Mix equal parts of fungal
Microbial ContentAgar
suspensions thoroughly and label “Fungi #2.”
Modified LatheenAgar
6.1.4.2 Pure Culture Method—Optionally, challenges may
Plate CountAgar
Trypticase SoyAgar
also be performed using single (pure) cultures. If this method
ischosen,preparetheculturesusedforchallengesasdescribed
in 6.1 and use directly as described in 6.3. Label sample jars
5.3.2.2 For Fungi:
appropriately according to the test microorganisms used to
MaltAgar
challenge that sample.
MaltAgar Extract
6.1.5 Determination of Challenge Inocula Levels—Pre pare
MycophilAgar
Potato DextroseAgar
serial dilutions of the challenge inocula (6.1.4.1). Plate out in
duplicate using Letheen agar. Incubate bacteria and yeast at
5.3.3 Preservative Neutralization—
...

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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.  
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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.
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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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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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SCOPE
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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.
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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.  
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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).  
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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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1.6 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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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.  
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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.  
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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
ASTM E1207-14(2022)(Guide)
Standard Guide for Sensory Evaluation of Axillary Deodorancy

SIGNIFICANCE AND USE
5.1 The procedures recommended in this practice can be used to clinically assess axillary deodorant efficacy of personal care products.  
5.2 This practice is applicable to the product categories which include deodorant and toilet soap bars, liquid bath soaps and gels, deodorant sticks, antiperspirants, creams and lotions, body talcs, and aerosol and pump delivery deodorants, antiperspirants, and body colognes.  
5.3 Procedures of the type described herein may be used to aid in the communication of efficacy within and between manufacturers and to the consumer through the various public communications media. Guidelines are suggested due to the need to determine the relative or absolute performance of experimental materials or of commercial products.  
5.4 These procedures may be used by persons who have familiarized themselves with these procedures and have had previous experience with sensory evaluation.  
5.5 This practice provides suggested procedures and is not meant to exclude alternate procedures which may be effectively used to provide the same clinical result.
SCOPE
1.1 This guide provides procedures which may be used in the design and analysis of studies to quantitatively assess the intensity of human axillary odor for the purpose of substantiating deodorant efficacy of personal care products.  
1.2 This guide includes protocols for the selection and training of assessors, selection of subjects, experimental design, and statistical analyses. This practice is limited to assessment of axillary odor by trained assessors. Self-evaluation protocols are valid for selected sensory tasks but may be less sensitive.  
1.3 With respect to the source of axillary odor, three groups of secretory glands are present in the axillae which participate to a greater or lesser extent in its production—eccrine, apocrine, and sebaceous. Axillary odor has been primarily ascribed to the apocrine gland secretion (1) .2 Body odor intensity has been correlated with the volume of the secretory portion of the apocrine gland (2) and the density of the glands.  
1.3.1 Apocrine glands are found primarily in the axillary vault in conjunction with axillary hairs (3). Pure apocrine sweat is sterile and odorless and axillary odor results from degradation of apocrine sweat by resident skin bacteria  (4). High bacterial populations are found in moist regions of the body, especially in the axillae, providing the appropriate environment for growth (5).  
1.3.2 Eccrine glands keep the axillae moist through thermally and emotionally induced secretions (6).  
1.3.3 The sebaceous glands excrete higher molecular weight lipid materials which absorb and retain the volatile materials resulting from bacterial action (7) . The aerobic diphtheroids are able to produce the typical acrid axillary odor and the micrococcaceae produce an isovaleric acid-like odor when incubated with apocrine sweat (8). Therefore, the most undesirable component of axillary odor is caused by degradation of apocrine sweat by particular bacteria normally found in the axillary vault.  
1.4 Personal care products are sold and used primarily for their ability to reduce the perception of body odor not only by the individual using the product but also by individuals within the scope of contact. Deodorant protection may be achieved by these products through various modes of action. Antiperspirants achieve their primary efficacy by means of the action of inorganic salts on the eccrine gland production of sweat. Antimicrobial agents achieve deodorancy by inhibiting the growth and activity of the microflora in the axillary vault thus reducing the microbial decomposition of sweat and the consequent production of body odor. Absorbents function either by “binding” available moisture or malodorous substances. Fragrances are effective by altering the perception of malodor and increasing the degree of “pleasantness.” Other modes of control become important from time...

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ASTM
ASTM E1593-21(Guide)
Standard Guide for Assessing the Efficacy of Consumer Products in Reducing the Perception of Malodor

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to assess the ability of consumer products to reduce malodor intensity from a control state. Several experimental hypotheses are possible, depending on the objective of the test. Possible objectives with respective hypotheses are given in Appendix X1.  
5.2 Many consumer products are sold commercially with the intent of providing a means of improving the odor quality of a volume of air, or the odor quality of a substrate such as fabric or household surfaces, relative to some existing environmental condition. In the case of air care products, this typically involves the application of an odorous substance into the air space by means of some active or passive mechanism (for example, by spraying, or by evaporation). This procedure is also applicable to other mechanisms of odor reduction (for example, air filtration, chemical reactions, etc.).  
5.3 Selection of representative malodor sources is of critical importance. The malodor source must be readily available and of a consistent odor quality. A reasonable malodor source should be chemically and aesthetically correct. The experimenter and client must agree upon the appropriateness of a malodor source before further details of the test design are worked out. Experimental variation will be reduced by using uniform malodor sources. Information collected on malodor reduction will thus be more comparable from experiment to experiment and from laboratory to laboratory.  
5.4 The procedure recommended can be used for assessment of the malodor reduction and elimination efficacy of consumer products including: air fresheners, air filtration products, aerosol/spray and continuous/solid air freshener products, candles, fabric care products including detergents and fabric enhancing/conditioning products, surface care products including carpet care products, surface cleaning products such as sprays etc., pet care products, and other products intended to deliver a malodor reduction benefit. It s...
SCOPE
1.1 This guide covers standard procedures for the quantitative sensory assessment of perceived olfactory intensity of malodors for the purpose of assessing the malodor reduction efficacy of consumer products including, but not limited to, air care, fabric care, home care, pet care, and similar products.  
1.2 This guide is not intended to cover axillary deodorancy; refer instead to Guide E1207.  
1.3 Malodors may be from natural or synthetic sources.  
1.4 This guide is a compendium of information or series of options that does not recommend a specific course of action. The user of this guide is responsible for identifying the most appropriate test design and using the appropriate statistical tools to address the experimental design.  
1.5 This guide is designed to provide guidance in product formulation and new product development, and for quality control issues.  
1.6 The scope of this guide does not include all guidance necessary to support claims. For further guidance the researcher may refer to Guide E1958. The usage of methods described in this guide can be used as part of a comprehensive claims support strategy for technical types of claims (such as claims that the product will create a sensory change when used on malodor). However, this guide does not address other important elements of the claim support strategy, including determining the statistical confidence requirements, or determination of the consumer relevance of the data obtained, as discussed in 1.7.  
1.7 The testing of products designed to reduce malodors via sensory testing as outlined in the present Guide can yield technical support for products’ efficacy claims. The methods described in this guide—assesors with identified sensory acuity and trained, malodors that may be lab-created or synthetic, and controlled exposure to malodors in a controlled indoor environment—can deliver results with high internal validity. Internal validity refers to s...

  • Guide
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  • Guide
    13 pages
    English language
    sale 15% off