Cholesterol
INCI: CHOLESTEROL
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for Cholesterol. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 1 other | oral | mouse | oral | REACH |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
Dermal Penetration Profile
Skin absorption and penetration characteristics of Cholesterol, relevant to systemic exposure and MoS calculations.
Source: Skin Pharmacol 1991
Expert Verdict
Essential co-lipid of the stratum corneum (approximately 25% of SC lipids by mole fraction), required alongside ceramides and free fatty acids for lamellar body organization and long periodicity phase formation. A ceramide-dominant 3:1:1 molar ratio (ceramides:cholesterol:fatty acids) optimally accelerates barrier recovery, with FDA approval of a barrier repair emulsion using this ratio in 2006. Cholesterol alone cannot reconstitute barrier; equimolar trilipid combinations are required. Typical use level 2–3% in barrier formulations; dissolve in oil phase at elevated temperature.
Regulatory Flags
Frequently Asked Questions
Is Cholesterol safe in cosmetics?
Essential co-lipid of the stratum corneum (approximately 25% of SC lipids by mole fraction), required alongside ceramides and free fatty acids for lamellar body organization and long periodicity phase formation. A ceramide-dominant 3:1:1 molar ratio (ceramides:cholesterol:fatty acids) optimally accelerates barrier recovery, with FDA approval of a barrier repair emulsion using this ratio in 2006. Cholesterol alone cannot reconstitute barrier; equimolar trilipid combinations are required. Typical use level 2–3% in barrier formulations; dissolve in oil phase at elevated temperature. The EU classifies Cholesterol as "permitted". Safety rating: EXCELLENT. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Cholesterol allowed in the EU?
Cholesterol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Cholesterol do in cosmetics?
Cholesterol functions as: Skin-conditioning agent, SC lipid replenisher, barrier co-lipid, essential triad component in ceramide-dominant 3:1:1 physiological moisturizer ratio. It is classified as a Active Ingredient in our database. CAS number: 57-88-5.
What is the Margin of Safety for Cholesterol?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Cholesterol?
The NOAEL (No Observed Adverse Effect Level) for Cholesterol is 1 other based on a oral study via oral route in mouse. Source: REACH.
Compliance Tools
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