• Title/Summary/Keyword: 대체 시험법

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Perspective Views of Evaluation Methods of Cosmetic Safety and Efficacy (화장품의 유효성, 안전성시험법의 현황과 전망)

  • 김종일
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.23 no.1
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    • pp.159-184
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    • 1997
  • 인체에 안전하고 유효한 화장품을 개발하고 제품의 질을 평가하기 위하여 표준화된 안전성 및 유효성 시험방법이 필요하며, 기능성 화장품 등 제품의 개발 환경에 맞추어 신규 시험방법의 개발이 요구되고 있다. 또한 유럽에서부터 시작되고 있는 화장품 영역에서의 동물실험을 줄이려는 경향에 따라 동물대체 실험 법도 동시에 요구되고 있는 실정이다. 이에 일반 화장품 및 기능성 제품 개발에 필요한 피부에서의 안전성 및 유효성 시험 법에 대한 현황과 표준화의 필요성에 대한 제안과 새로운 시험법의 개발 전망에 대하여 알아보고, 동물 대체 실험 법에 대한 연구 동향과 전망에 관해 기술하였다.

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Interlaboratory Validation Study of In Vitro Alternatives to the Draize Eye Irritation Test : HET-CAM Test and Cytotoxicity Test for 20 Cosmetic Ingredients

  • Lee, Ho;Kim, Ju-Hyun;Hong, Jin-Cheon;Kim, Gi-Mun;Park, Mun-Eok;Ryu, Chang-Seok;Jeong, Min-Seok;Kim, Jong-Il
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.25 no.2
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    • pp.129-138
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    • 1999
  • 피부 전용 제재 개발을 위해 요구되는 동물 대체 시험법 중 가장 적극적으로 연구가 행하여지곤 실제 실용화가 예상되는 것은 안점막 자극 시험으로 지금까지 여러 가지 방법이 개발되었지만 그 중 계란 유정란의 응모요막(CAM)을 이용한 방법이 현재 가장 활발히 진행되고 있다. 이 방법이 일부 국가에서 이미 안점막 자극 시험 동물 대체 시험법으로 공인되었으며 현재까지도 validation 연구를 활발히 진행하고 있다. 본 연구에서도 국내에 적합한 안점막 자극 시험 동물 대체 시험법의 공인 시험법 개발 및 validation study를 목표로 계란 유정란의 응모요막을 이용한 방법 중 HET-CAM 방법을 시행하였으며 안점막 동물 대체 시험법으로 확립하고자 하였다. 틴ET-CAM 방법의 보완을 위해 배양된 세포를 통해 자극도를 측정할 수 있는 방법인 Cytotoxicity test를 도입하여 시행하였으며 두 방법의 data들을 분석하여 validation study를 수행하였다. 국내 유수의 6개 장업사가 본 연구에 참가하여 20가지의 화장품 전용제재를 대상으로 1차, 2차 validation study 를 진행하였다. HET-CAM test, Draize eye irritation test, Cytotoxicity test 측정 결과 HET-CAM 의 “Q” 수치는 대부분 강자극 수치인 2 이상이었고 10% sodium hydroxide가 가장 높은 수치를 보였으며 Tween 20(sorbitanpolyoxyethylene monolaurate) 100%가 가장 낮은 수치를 보였다. In vi패의 경우 10% sodium hydroxide가 가장 높은 수치를 보였으며 30군 propylene glycol 이 가장 낮은 자극수치를 보였다. HET-CAM test 와 Draize eye irritation test, Cytotoxicity test 간의 상관성 분석은 linear correlation coefficient 와 rank correlation coefficient를 구하여 비교하였으며 6개 장업사(A-F)의 실험실에서의 HET-CAM test 결과를 취합하여 각각 두 실험실간의 상관관계(linear correlation)를 분석하였다. Linear correlation coefficient 분석 결과를 보면 전반적으로 상관관계가 0.589 - 0.954의 범위였으며, 특히 A사와 B사 사이의 경우 0.954이었으며, E사와 D사 사이의 경우 0.942로 높은 상관관계를 보였다. 그 외에도 A사와 D사 사이의 경우(0.589)와 B사와 D사 사이의 경우(0.638)를 제외하고는 대체로 높은 상관관계를 나타내었다.

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Alternative Method of Determining Resilient Modulus of Subbase Materials Using Free-Free Resonant Column Test (현장공진주시험을 이용한 보조기층 재료의 대체 $M_R$ 시험법)

  • Kweon, Gi-Cheol;Kim, Dong-Su
    • International Journal of Highway Engineering
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    • v.2 no.2
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    • pp.149-161
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    • 2000
  • The stiffness of the subbase materials is represented by the resilient modulus, $M_R$, which are very important properties in the mechanistic design of flexible pavement system. However, the cyclic $M_R$ testing method is too complex, expensive, and time consuming to be applicable on a production basis. In this study, the alternative $M_R$ testing technique for subbase materials was developed using a free-free resonant column (FF-RC) test considering deformational characteristics of subbase materials. To estimate the deformational characteristics of subbase materials, effects of strain amplitude and mean effective stress on modulus of subbase materials were investigated. The $M_R$ values determined by alternative testing procedures matched well with those determined by standard $M_R$ test, showing the capability of the proposed methods being used in determining $M_R$ values.

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Comparison of Preservative Efficacy Tests for Water Non-dispersible Cosmetic Formulations (비수분산 특수 제형 화장품에 대한 방부력 시험 비교 연구)

  • Kim, Yong Hyun;Park, Sung Ha;Park, Byoung Jun;Shin, Kye Ho;Kang, Hak Hee
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.1
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    • pp.9-21
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    • 2021
  • In this study, the difference between the preservative efficacy test (PET) used for water dispersion formulations and PCPC (personal care products council) guidelines alternative test method, direct contact membrane method, and surface mold test should be studied to determine what should be considered during preservative efficacy test of water non-dispersible formulations. We conducted improved PETs when using the alternative test method compared with the test methods used for stick and pressed powder. There was no significant improvement between water-in-silicon emulsions and loose powder using alternative test methods. When we checked the results of the presence and absence of the preservative system for each product, we could see that there were differences in testing methods. As a result, improved levels of results could be obtained using both existing and alternative test methods when measuring preservatives for water non-dispersible formulations. In addition, in the case of stick and pressed powder, the results were more effective when the preservative test method applied to the consumer's method of use was applied.

Resilient Modulus Test of Subgrade Soils Using Standard Triaxial Test Equipment (표준 삼축압축 시험기를 이용한 노상토의 회복탄성계수 시험법)

  • Woo, Je Yoon;Cho, Chun Whan;Moon, Hong Deug;Kim, Dong Soo
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.13 no.4
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    • pp.239-250
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    • 1993
  • The dynamic resilient modulus tests to determine the $M_R$ of the soils require expensive equipments and well trained personnels to obtain reliable test results. These problems inherent in the dynamic resilient modulus testing have been realized as major negative factors to hinder the $M_R$ test from being practically implemented as a routine test. In this regard. it is highly desirable to develop a simpler alternative testing method incorporating inexpensive equipments and easy-to-perform testing procedures. Developed in this study is an alternative $M_R$ test method based on statically repeated loading scheme utilizing the standard static triaxial test equipments. Applicability and limitations of the developed static $M_R$ testing method are investigated for typical subgrade soils in Korea.

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Development of alternative titration method without mercuric acetate for the assay of difemerine hydrochloride in Korean Pharmaceutical Codex (디페메린염산염 시험에 사용되는 유해시약인 수은 대체 시험법의 개발)

  • Jeon, Sang-Seol;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.27 no.4
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    • pp.196-200
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    • 2014
  • Currently nonaqueous titration method for the assay method using the hazardous reagent, mercury acetate for difemerine hydrochloride has been used in Korean Pharmaceutical Codex. We developed an alternative titration assay method by substituting the use of the hazardous reagent, mercury acetate to the use of less toxic ones like ethyl alcohol. The linearity of the calibration curves in the desired concentration range was good (r>0.999). Precision was less than 0.64%. Accuracy was obtained with recoveries in range of 99.10% and 99.71%. The developed assay could be expected to become valuable tools for revising the Korean Pharmaceutical Codex.

The application of alternative methods for skin irritation evaluation on pesticides (농약에 대한 피부자극성 대체시험법 적용연구)

  • Jeong, Mi-Hye;Kim, Mi-Kyoung;Park, Soo-Jin;You, Are-Sun;Hong, Soon-Sung;Park, Kyung-Hun;Park, Jae-Eup
    • The Korean Journal of Pesticide Science
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    • v.16 no.3
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    • pp.261-266
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    • 2012
  • It is common to use many experiment animals to evaluate the toxicity of chemicals including pesticides. For protecting animal, the concepts of 3R (Reduction, Replacement, Refinement) were introduced and in vitro alternatives methods actively have been developed all over the world. Many experimental animals for toxicological tests have been used, so that it is important to establish the alternative methods. In this study, the alternative method using reconstituted human skin model (Keraskin$^{TM}$) was conducted for classification of skin irritation on pesticides. Sixteen formulations selected on the basis of the degree of irritation were treated by Keraskin$^{TM}$ test. The percent of cell viability was measured into the culture medium collected after treatment of the pesticides for 24-72 hrs. The skin irritations of formulations were evaluated by the cell viability. In this study, The 4 formulations with mild irritation in rabbits were evaluated as nonirritant, the 6 formulations with moderate and severe irritation were evaluated as irritant in human skin model test. We suggest that the alternative test using Keraskin$^{TM}$ model could be used as toxicity evaluation for primary irritation index (P.I.I.) score of greater than or equal to 2.1 of pesticides. The further studies should be required to apply for hazardous assessment of pesticides on alternative skin irritation methods because of the interindividual variability of the sensitivity of skin irritation on pesticides.

The New in vitro Oral Irritation Test Method for Toothpaste using YD-38 Oral Mucosal Cell Line (치약에 대한 YD-38 세포주를 활용한 새로운 구강 점막 자극 시험방법)

  • Nam, Gi Baeg;Cho, Sun-A;Cho, Jun-Cheol;Kim, Chanho;Kim, Yoo-Jin;Lee, John Hwan;Shin, Kyeho
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.38 no.4
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    • pp.305-310
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    • 2012
  • Through our entire life, oral care products such as toothpaste are used. Thus the safety of oral care products used every day to our mouth is very important. As the previous study in animal tests or clinical trials, surfactant in toothpaste may cause the oral irritation. However, EU cosmetics legislation prohibits animal testing of cosmetics and its ingredient for animal welfare. Therefore the development of alternative in vitro test has been actively performed to replace or reduce using the animal in many areas. However, the way to evaluate oral mucosal toxicity has been done using animal models or clinical trials from now on. Even more, the experiment with human oral 3D tissue or human oral cell line is used recently. The aim of this study is the development of oral mucosal irritation method without using animal for the safety of the oral care product. We developed in vitro test method for oral irritation by using human oral cell line (YD-38 cell) acceptable to toothpaste which contains insoluble material. By the results of this assay, we could discriminate toothpaste with or without irritating substance as same manner in animal studies reported previously. In addition, we confirmed that toothpaste for babies and children toothpaste irritated oral musoca lower than the general adult toothpaste. The present study suggest that this new in vitro method by using human oral cell line (YD-38 cell) could be used for evaluation of oral irritation without using animal.

In vitro test using chorioallantoic membrance vascular assay to assess the irritancy potential of surfactants (CAMVA(Choriollantoic Membrane Vascular Assay)를 이용한 계면활성제의 자극 평가에 관한 연구)

  • Go, Jae-Suk;An, Su-Seon;Park, Jong-Ho
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.21 no.1
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    • pp.67-83
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    • 1995
  • Skin irritations accompany the series of complex, physical and chemical changes. Alternative methods which reflect the biological phenomenon more sensitively are necessary for the purpose of reducing the animal tests and improving the accuracy and reliability. Chorioallantoic membrane (CAM) vascular assay is a in vitro method which utilizes the chorioallantoic membrane of hen's fertilized egg of about 10 days old. Test substances are placed directly onto the surface of the CAM and 1 hour later the CAM vasculature is subjectively evaluated to determine with a chemically related-injurious reponse including the appearance of haemorrage, congestion, coagulation, and so on. In this research, using the various surfactants, the correlations of CAMVA with in vivo models (intradermal safety test and human primary irritation test) were investigated. And CAMVA closely correlated to intradermal safety test (r=0.89) and human primary irritation test (r=0.90). From the result, it seems that CAMVA can also be used as a method for predicting the skin irritaions.

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