생리용품과 화장품의 유해물질 위해평가와 관리 가이드라인
Challenging Risk Assessment and Management Guideline of Toxic Chemicals in Sanitary and Cosmetic Products
- 주제(키워드) volatile organic compounds , nickel
- 발행기관 아주대학교 일반대학원
- 지도교수 이범진
- 발행년도 2018
- 학위수여년월 2018. 8
- 학위명 박사
- 학과 및 전공 일반대학원 약학과
- 실제URI http://www.dcollection.net/handler/ajou/000000027772
- 본문언어 영어
- 저작권 아주대학교 논문은 저작권에 의해 보호받습니다.
초록/요약
Chapter 1 Abstract The risk assessment was conducted to identify the level of volatile organic compound (VOCs) detected from sanitary napkins marketed in and out of Korea and to check whether the detected VOCs have any harmful impact to the health of the customers. The targets of the risk assessment were 10 VOCs including benzene, toluene, xylenes, ethylbenzene, dichloromethane, chloroform, trichloroethylene, tetrachloroethylene, styrene and hexane. The risk assessment was carried out in four stages of hazard identification, hazard characterization, exposure assessment and risk characterization. In the stage of hazard identification, the physical, chemical characters and toxicity data such as cancer, reproductive and developmental toxicity of the 10 target substances were reviewed, and possible harmful effects to human bodies were examined. In the stage of hazard characterization, the reference dose (RfD) and slope factor suggested by international risk assessment organization such as United States Environmental Protection Agency (US EPA) and World Health organization (WHO) or other researches, were considered to use. In the stage of exposure assessment, systemic exposure dose (SED) was calculated to know the amount of target substances absorbed through skin when women use sanitary napkins and panty liners. The evaluation was done by making extreme and realistic scenarios which are set based on women’s usage patterns of sanitary products. The exposure factors used in the scenarios are the amount of VOCs from the products, transfer rate, skin absorption rate, number of products used in a day, used period, and body weight. According to the scenario, the exposure factors have different values for evaluation. In the stage of hazard characterization, the possibility of harmful effects to human bodies was evaluated by comparing RfD and SED which was calculated in the exposure assessment. As a result, the value of safety margin of the product whose detected VOCs were the highest among all target products was over 1, therefore the risk possibility to human bodies by the 10 VOCs is evaluated to be low. For cancer risk, all products have been evaluated as over 10-6 except 4 cloth products in the worst-case scenario. For reusable cloth products, however, it is usually washed before and after every use so that actual exposure level might be low. Hence, the risk possibility to human due to 10 VOCs is also low. Chapter 2 Abstract Nickel is the transition metal, which causes skin allergic reaction, skin rash and etc. when exposed chronically. In addition, IARC classified pure nickel into Group 1 (carcinogenic to humans) and metallic nickel in Group 2B (possibly carcinogenic to humans). Based on these toxicological data, the nickel in cosmetic products has been prohibited in Korea and EU under the cosmetic regulation. However, most marketed cosmetic products can contain traces of nickel because nickel is present naturally in the earth. Thus, technically unavoidable traces of nickel should be controlled by monitoring marketed products. Firstly, the content of nickel was analyzed by ICP-MS in 150 commercialized cosmetic products to estimate the nickel contamination level. As a result, up to 0.0039% of nickel was contained in eye make-up products (not detected in 6 items), up to 0.0029% in face make-up products (not detected in 3 items) and up to 0.0003% in all other cosmetic products (not detected in 17 items), respectively. According to the nickel content from monitoring data and HT25 value of 0.188 mg/kg/day, the life time cancer risk was evaluated for nickel in cosmetic products as 3.0 x 10-6, which is less than 10-5. Furthermore, the skin sensitization (AEL/CEL) was calculated as 1.1 by using EC3 value of 2.5%, which is greater than 1. However, considering the differences in formulations and deviation between products, which can unintentionally contain nickel in marketed cosmetic products, 0.003% for color cosmetic products excluding eye makeup products and 0.001% for other cosmetic products were set as limitation. In case of eye makeup products, the nickel was limited by 0.0035% so that there is less concern for consumers.
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CONTENTS
List of Table ....................................................................................................... viii
List of Figure ......................................................................................................... x
Chapter I. Risk assessment of volatile organic compounds in sanitary products ................................................................................................................... 1
1. Introduction ....................................................................................................... 1
2. Materials and methods .................................................................................... 10
2.1. Samples ........................................................................................................ 10
2.2. Analysis of 10 VOCs in sanitary products ................................................... 10
2.3. Structure of sanitary products ...................................................................... 16
2.4. Exposure assessment of 10 VOCs in sanitary products ............................... 17
2.4.1. Exposure scenarios for the use of disposable and reusable sanitary napkins ................................................................................................................................. 18
2.4.1.1. The worst-case exposure scenario using disposable and reusable sanitary napkins .................................................................................................................... 18
2.4.1.2. The general exposure scenario using disposable and reusable sanitary napkins .................................................................................................................... 18
2.4.2. Exposure scenarios for the use of disposable and reusable panty liners ... 19
2.4.2.1. The worst-case exposure scenario using disposable and reusable panty liners ....................................................................................................................... 19
2.4.2.2. The general exposure scenario using disposable and reusable panty liners ........................................................................................................................ 19
2.5. Risk characterization of 10 VOCs in sanitary products ............................... 20
3. Results and discussions ................................................................................... 27
3.1. Observation of surface of sanitary products by SEM .................................. 27
3.2. Observation of major constituents of parts of sanitary products by ATR microscope FT-IR ................................................................................................... 29
3.3. Hazard Characterization of 10 VOCs for risk assessment ........................... 31
3.4. Analysis of 10 VOCs content in sanitary products ...................................... 42
3.5. Exposure assessment of 10 VOCs for risk assessment ................................ 50
3.6. Risk characterization of 10 VOCs in sanitary products ............................... 56
3.6.1. MOS of 10 VOCs in sanitary products ..................................................... 56
3.6.1.1. MOS of 10 VOCs in sanitary products according to worst-case scenario ................................................................................................................................. 56
3.6.1.2. MOS of 10 VOCs in sanitary products according to general scenario .. 59
3.6.2. Cancer risk of 4 VOCs in sanitary products ............................................. 62
3.6.2.1. Cancer risk of 4 VOCs in sanitary products according to worst-case scenario ................................................................................................................... 62
3.6.2.2. Cancer risk of 4 VOCs in sanitary products according to general scenario ................................................................................................................... 65
4. Conclusions ..................................................................................................... 68
Chapter II. Risk assessment of nickel in cosmetic products ......................... 69
1. Introduction ..................................................................................................... 69
2. Materials and methods .................................................................................... 72
2.1. Monitoring of contaminated nickel in Korean cosmetic products ............... 72
2.2.1. Selection of specimen for monitoring ....................................................... 72
2.1.2. Sample preparation for analysis of nickel content in cosmetic products by ICP/MS.................................................................................................................... 72
2.1.3. Determination of nickel in cosmetic products using ICP/MS................... 73
2.1.4. Validation for establishment of nickel analysis in cosmetic products ...... 73
2.2. Risk assessment of nickel in cosmetic products .......................................... 78
2.2.1. Exposure scenario for the use of cosmetic products ................................. 78
2.2.2. Risk characterization of nickel in cosmetic products ................................ 80
2.2.2.1. Risk assessment of non-cancer for cosmetic products ........................... 80
2.2.2.2. Risk assessment of cancer for cosmetic products .................................. 80
2.2.2.3. Risk assessment of skin sensitization for cosmetic products ................. 81
3. Results and discussions ................................................................................... 85
3.1. Analytical validation of nickel in cosmetic products ................................... 85
3.2. Nickel content in cosmetic products ............................................................ 87
3.3. Risk assessment of nickel in cosmetic products .......................................... 92
3.3.1. Toxicological review on nickel from references ....................................... 92
3.3.1.1. Hazard characterization for non-cancer risk assessment of nickel in cosmetic products .................................................................................................... 92
3.3.1.2. Hazard characterization for cancer risk assessment of nickel in cosmetic products ................................................................................................................... 94
3.3.1.3. Hazard characterization for skin sensitization risk assessment of nickel in cosmetic products................................................................................................ 94
3.3.2. Non-cancer and cancer risk assessment of nickel in cosmetic products ... 98
3.3.3. Skin sensitization risk assessment of nickel in cosmetic products ......... 101
4. Conclusions ................................................................................................... 104
References ........................................................................................................ 105
Appendix .......................................................................................................... 114
Abstract ............................................................................................................ 118
Chapter 1 Abstract .............................................................................................. 118
Chapter 1 국문초록 ............................................................................................ 120
Chapter 2 Abstract .............................................................................................. 122
Chapter 2 국문초록 ............................................................................................ 123
