화장품 원료의 위해성평가 과정과 예시에 대한 고찰
Review on the Process and Illustration for Risk Assessment of Cosmetic Ingredients
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약물과 다르게 화장품 성분의 위해성평가의 특이성을 잘 반영하여 우리나라에서도 화장품 위해평가 가이드라인이 식품의약품안전평가원에 의해 발간되었다. 본 연구에서는 화장품 원료에 대한 우리나라의 가이드라인에 대한 보완적 설명과 더불어 MOS(margin of safety), 평생발암위해도 그리고 MOE(margin of exposure)에 대한 예시로 화장품 위해성 평가에 대한 접근성을 보다 더 쉽게 할 수 있도록 고찰이 이루어졌다. 새로운 화학물질의 위해성평가는 독성시험을 통해 비발암물질인 경우에는 ADI(acceptable daily intake), RfD(reference dose), DNEL(derived no effect level) 등의 1일 인체노출안전용량인 HBGV(health based guidance value), 발암물질인 경우에는 risk level. DMEL 등의 위해도로 나타낸다. 이와 같은 추정을 위해 사용되는 가장 대표적인 POD(point of departure, 출발용량)는 HBGV을 위해서는 NOAEL(no observed adverse effect level), 그리고 위해도 추정을 위해서는 발암기울기가 이용된다. 그러나 화장품인 경우에는 이와 같이 독성평가 단계와 더불어 노출평가 단계가 함께 강조되는 위해성평가를 통해 위해성결정이 이루어진다. 특히 노출평가를 위해 SED가 다른 화학물질의 위해성평가와 다르게 화장품 성분의 위해성결정을 위해 응용되는 것이 특징이다. 위해성결정은 1일 인체노출안전용량의 HBGV와 위해도 등의 절대적 위험도로 평가가 아닌 MOS와 같은 MOE와 같은 상대적 위험도를 통해 위해성결정이 이루어진다. 또한 자외선차단성분과 합성향료 등을 예시를 통해 MOS와 같은 MOE와 같은 상대적 위험도를 확인하였다.
Abstract
Cosmetic products not only comprise decorative cosmetics like lipstick or make-up but also substances and preparations used exclusively or mainly for cosmetic purposes externally on the human body or inside the oral cavity. Toxicological tests have already been made for cosmetic ingredients used in the finished products. However it is commonly used to describe a cumulative effect which could occur if various cosmetic products with the same ingredient to which a similar effect is attributed were used simultaneously. And then the cumulative effect with the same ingredient is taken into account in the safety or risk assessment, especially using SED(systemic exposure dosage) since it is necessary to determine the potency of percutaneous absorption of the same ingredient used from many cosmetic products in a systemic circulation. Thus, risk characterization is performed calculating the SED, and Margin of Safety(MOS) can be calculated according to the formula; MoS = NOAEL/SED where the NOAEL is the no observed adverse effect level. MOS is the estimation for cosmetic ingredient with threshold in dose-reposne relationship. For cosmetic ingredients with non-threshold carcinogenicity, T25 should be identified to evaluate the dose-response relationship and a lifetime cancer risk is calculated from HT25, human equivalent dose of T25. The MOE is numerically defined as the ratio of the Point of Departure(POD) of the critical effect to the theoretical, predicted, or estimated exposure level. A MOE of 10,000 or more, based on animal cancer bioassay data, would be of low concern. For calculation of the MOE, the BMDL10 is also taken as a conservative approach.
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