Safety and risk assessment of ceramide 3 in cosmetic products

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 ceram...

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Bibliographic Details
Published in:Food and chemical toxicology 2015-10, Vol.84, p.8-17
Main Authors: Choi, Seul Min, Lee, Byung-Mu
Format: Article
Language:English
Subjects:
Animals
Ceramide 3
Chemical Phenomena
Cosmeceuticals - chemistry
Cosmeceuticals - standards
Cosmeceuticals - toxicity
Cosmetics
Cosmetics - chemistry
Cosmetics - standards
Cosmetics - toxicity
Detergents - chemistry
Detergents - toxicity
Glycosphingolipids - chemistry
Glycosphingolipids - toxicity
Hair Preparations - chemistry
Hair Preparations - standards
Hair Preparations - toxicity
Humans
Margin of safety (MOS)
Risk Assessment
Skin Cream - chemistry
Skin Cream - standards
Skin Cream - toxicity
Toxicokinetics
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Summary: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. •Although ceramide 3 is widely used, data on its concentration limits are lacking.•There may be sufficient safety margin if ceramide 3 is used
ISSN:0278-6915
1873-6351
DOI:10.1016/j.fct.2015.07.012