title: Safety and risk assessment of ceramide 3 in cosmetic products.
abstract: Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3.
authors.affiliation: Division of Toxicology, College of Pharmacy, Sungkyunkwan University, Seobu-ro 2066, Changan-ku, Suwon, Gyeonggi-do, 440-746, Republic of Korea.
authors.forename: Seul Min
authors.initials: SM
authors.lastname: Choi
authors.affiliation: Division of Toxicology, College of Pharmacy, Sungkyunkwan University, Seobu-ro 2066, Changan-ku, Suwon, Gyeonggi-do, 440-746, Republic of Korea. Electronic address: bmlee@skku.edu.
authors.forename: Byung-Mu
authors.initials: BM
authors.lastname: Lee
mesh_terms: D000818:Animals; D055598:Chemical Phenomena; D000068937:Cosmeceuticals / Q000737:chemistry / Q000592:standards / Q000633:toxicity; D003358:Cosmetics / Q000737:chemistry / Q000592:standards / Q000633:toxicity*; D003902:Detergents / Q000737:chemistry / Q000633:toxicity; D006028:Glycosphingolipids / Q000737:chemistry / Q000633:toxicity*; D006203:Hair Preparations / Q000737:chemistry / Q000592:standards / Q000633:toxicity; D006801:Humans; D018570:Risk Assessment; D063465:Skin Cream / Q000737:chemistry / Q000592:standards / Q000633:toxicity; D066007:Toxicokinetics
chemical_list: D000068937:Cosmeceuticals; D003358:Cosmetics; D003902:Detergents; D006028:Glycosphingolipids; D006203:Hair Preparations; C018480:ceramide 3
keywords: Ceramide 3; Cosmetics; Margin of safety (MOS); Risk assessment