Kim Doeun, Seok Jin Kyung, Kim Minhyuk, Choi Shinai, Hong Jiyeon, Yoon Young A, Chung Hyun, Bae Ok-Nam, Kwack Seung Jun, Kim Kyu-Bong, Lee Joo Young
College of Pharmacy, The Catholic University of Korea, Bucheon, 14662 Republic of Korea.
KnA CO., Ltd., Yongin, Republic of Korea.
Toxicol Res. 2024 May 21;40(3):361-375. doi: 10.1007/s43188-024-00243-2. eCollection 2024 Jul.
Cocamidopropyl betaine (CAPB) is a surfactant derived from coconut oil that is widely used in cosmetics and personal products for several purposes, such as a surfactant, foam booster, mildness, and viscosity control. Cocamidopropyl betaine is used at concentrations up to 30% in cosmetics. The acute toxicity, skin irritation, eye irritation, skin sensitization, repeated dose toxicity, genotoxicity, carcinogenicity, and phototoxicity of cocamidopropyl betaine were evaluated. Cocamidopropyl betaine was observed to induce mild skin irritation, eye irritation and skin sensitization. The NOAEL of cocamidopropyl betaine was determined to be 250 mg/kg/day based on the results of a 92-day repeated-dose oral toxicity study in rats. The systemic exposure dose of cocamidopropyl betaine was estimated to range from 0.00120 to 0.93195 mg/kg/day when used in cosmetic products. The margin of safety of cocamidopropyl betaine was calculated to be greater than 100 when used at a maximum concentration of 6% in leave-on products and 30% in rinse-off products, suggesting that its use in cosmetic products is safe under current usage conditions.
椰油酰胺丙基甜菜碱（CAPB）是一种源自椰子油的表面活性剂，广泛用于化妆品和个人护理产品，具有多种用途，如作为表面活性剂、泡沫增强剂、温和性调节剂和粘度控制剂。椰油酰胺丙基甜菜碱在化妆品中的使用浓度可达30%。对椰油酰胺丙基甜菜碱的急性毒性、皮肤刺激性、眼睛刺激性、皮肤致敏性、重复剂量毒性、遗传毒性、致癌性和光毒性进行了评估。观察到椰油酰胺丙基甜菜碱会引起轻度皮肤刺激、眼睛刺激和皮肤致敏。根据对大鼠进行的为期92天的重复剂量口服毒性研究结果，椰油酰胺丙基甜菜碱的无观察到有害作用水平（NOAEL）确定为250毫克/千克/天。当用于化妆品时，椰油酰胺丙基甜菜碱的全身暴露剂量估计在0.00120至0.93195毫克/千克/天之间。当在驻留型产品中以最高浓度6%使用，在冲洗型产品中以30%使用时，椰油酰胺丙基甜菜碱的安全系数经计算大于100，这表明在当前使用条件下，其在化妆品中的使用是安全的。
