Full metadata record
DC Field | Value | Language |
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dc.contributor.advisor | 임경민 | - |
dc.contributor.author | 전소하 | - |
dc.creator | 전소하 | - |
dc.date.accessioned | 2024-08-19T16:31:53Z | - |
dc.date.available | 2024-08-19T16:31:53Z | - |
dc.date.issued | 2024 | - |
dc.identifier.other | OAK-000000232614 | - |
dc.identifier.uri | https://dcollection.ewha.ac.kr/common/orgView/000000232614 | en_US |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/268947 | - |
dc.description.abstract | Assessing the safety of botanical extract use in cosmetics faces challenges due to their diverse compositions and limited toxicological data. The Threshold of Toxicological Concern (TTC) approach is emerging as a next generation non-animal-based safety assessment tool that provides human exposure threshold values below which there is a very low probability of adverse health effects, thereby ensuring substance safety. This study applied the TTC approach to evaluate the safety of Cnidium officinale rhizome extract (CORE) and Paeonia lactiflora root (PLR) extract, which are widely used in cosmetic products. In the study of CORE, 32 constituents and their contents were identified through databases, literature, and experimental analysis. Genotoxicity was evaluated using in vitro assays and in silico prediction, and the Cramer class of each component was assigned using the Toxtree® software. Systemic exposure levels of these components from leave-on cosmetic products containing 1% CORE were below the TTC, confirming the safety of CORE. Similarly, the safety of PLR extract was assessed by identifying 50 constituents, with their concentrations derived from USDA references, literature, and experimental analysis. The genotoxicity of PLR and its constituents was evaluated in vitro and in silico. The Cramer class of each constituent was determined, and systemic exposure from cosmetic products containing 1% PLR extract was compared with TTCs. For constituents exceeding the TTC, in silico dermal absorption tools were employed to confirm their safety. This study demonstrated that the TTC approach is a valuable tool for assessing the safety of botanical extracts in cosmetics, providing a systematic and practical method that can replace animal testing. As part of next-generation safety assessment, this approach may be used in regulatory compliance, providing a scientifically robust framework that enhances the credibility of cosmetic products and ensures consumer safety.;화장품에 사용되는 천연물의 안전성 평가는 다양한 구성 성분을 가지고 있는 천연물의 특성과 제한된 독성 데이터로 인해 어려움을 겪고 있다. 독성학적 우려 임계값(TTC) 접근법은 화장품 성분에 대한 안전한 노출 수준을 제공하여 화장품 성분의 안전성을 보장하는 방법으로 차세대 비동물 안전성 평가법으로 제시되고 있다. 본 연구는 화장품에 널리 사용되는 천궁(Cnidium officinale) 뿌리 추출물과 작약(Paeonia lactiflora) 뿌리 추출물의 안전성을 평가하기 위해 독성학적 우려 임계값(TTC) 접근법을 적용하였다. 천궁 뿌리 추출물에 대한 연구에서는 데이터베이스와 문헌을 통해 32가지 성분과 함량을 규명하였으며, 일부 성분의 함량은 실험 분석을 통해 결정하였다. 유전독성은 in vitro 시험과 in silico 예측법을 사용하여 평가되었으며, Toxtree® 소프트웨어를 사용하여 각 성분에 Cramer 클래스를 할당하였다. 전신 노출 기반 안전성 평가를 위해 천궁 뿌리 추출물 1%를 함유하는 leave-on type 화장품의 전신 노출량을 예측하였고, 각각 성분의 전신 노출 수준은 TTC 임계값 이하로 나타나 천궁 뿌리 추출물의 안전성을 확인하였다. 마찬가지로, 작약 뿌리 추출물의 안전성은 USDA 데이터베이스 참조, 문헌 및 실험 분석을 통해 50가지 성분을 확인하였고, 그 함량을 평가하였다. 작약 뿌리 추출물 및 그 성분의 유전독성은 in vitro 및 in silico에서 평가되었다. 각 성분의 Cramer 클래스를 분류하여, 1% 농도의 작약 뿌리 추출물을 포함하는 화장품에서의 전신 노출 수준을 도출하였고, 각각 TTC 임계값과 비교 분석하였다. TTC 임계값을 초과하는 성분에 대해서는 in silico 피부 흡수 예측값을 추정하여 그에 따른 안전성을 확인하였다. 본 연구를 통해, TTC 접근법이 화장품에 사용되는 천연물의 안전성을 평가하는 데 유용한 도구임을 입증했으며, 동물 실험을 대체할 수 있는 체계적이고 실용적인 방법임을 확인하였다. 이 접근법은 차세대 안전성 평가의 일환으로 허가 자료로의 활용이 기대되며, 과학적으로 견고한 체계를 제공하여 화장품 제품에 대한 신뢰도를 증진하고 소비자 안전을 확보하는 데에 기여할 수 있다. | - |
dc.description.tableofcontents | I. Introduction 1 A. Safety assessment of Cosmetic ingredients 1 B. Next-Generation Risk Assessment (NGRA) 3 C. Threshold of Toxicological Concern (TTC) approach to the safety assessment of cosmetic ingredients 5 D. Application of the TTC approach to botanical extracts in cosmetics 9 E. Existing Challenges and Purpose of Study 11 II. Part 1. Cnidium officinale rhizome extract 13 A. Background of Cnidium officinale rhizome extract in cosmetics 13 B. Materials & Methods 14 1. Source and manufacturing of the botanical extract: Cnidium officinale rhizome extract 14 2. Materials 14 3. Component analysis contained in Cnidium officinale rhizome extract using chromatographic analysis 15 4. Cramer Class classification using Toxtree for TTC allocation of each component of Cnidium officinale rhizome extract 18 5. In vitro assay & In silico analysis for the genotoxicity of Cnidium officinale rhizome extract 20 6. In silico skin absorption prediction of components contained in Cnidium officinale rhizome extract 21 C. Results . 23 1. Identification & Establishment of components present in CORE 23 2. Analysis of food-related constituents of CORE 25 3. Determination of the compositions of each component present in CORE 25 4. In vitro genotoxicity test 27 5. Cramer class allocation and safety assessment of CORE using the TTC approach 31 D. Discussion 36 III. Part 2. Paeonia lactiflora root extract 38 A. Background of Paeonia lactiflora root extract in cosmetics . 38 B. Materials & Methods 39 1. Source and manufacturing of the botanical extract: Paeonia lactiflora root extract 39 2. Materials 39 3. Component analysis contained in Paeonia lactiflora root extract using chromatographic analysis 40 4. Cramer Class classification for TTC allocation of each component of Paeonia lactiflora root extract 42 5. In vitro assay & In silico analysis for the genotoxicity of Paeonia lactiflora root extract 42 C. Results . 44 1. Identification & Establishment of components present in PLR extract 44 2. Analysis of food-related constituents of PLR extract 48 3. TTC allocation of constituents present in PLR extract via integrated chemical profiling 49 4. In vitro genotoxicity test 49 5. Cramer class allocation and safety assessment of PLR extract using the TTC approach 53 D. Discussion 62 IV. Conclusion . 64 Reference 67 Appendix . 75 Abstract(in Korean) 77 | - |
dc.format | application/pdf | - |
dc.format.extent | 1524669 bytes | - |
dc.language | eng | - |
dc.publisher | 이화여자대학교 대학원 | - |
dc.subject | Threshold of toxicological concern (TTC) approach, Cosmetics, Next generation risk assessment | - |
dc.subject.ddc | 600 | - |
dc.title | Application of the Threshold of Toxicological Concern (TTC) to the Safety Assessment of Botanical Extracts used in Cosmetics | - |
dc.type | Doctoral Thesis | - |
dc.title.translated | 화장품에 사용되는 천연물의 안전성 평가를 위한 독성학적 우려 임계값(TTC) 방법 적용의 연구 | - |
dc.creator.othername | Jeon, Soha | - |
dc.format.page | vii, 78 p. | - |
dc.identifier.thesisdegree | Doctor | - |
dc.identifier.major | 대학원 제약산업학과 | - |
dc.date.awarded | 2024. 8 | - |