Is Cholesterol safe in cosmetics?
Cholesterol has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. This ingredient has been reviewed by CIR Safety Assessment.
Cholesterol
Also known as: 5:6-Cholesten-3beta-ol, delta5-Cholesten-3beta-ol, SyntheChol, EC No.: 200-353-2, 200-353-2 (+15 more)
INCI: CHOLESTEROL
Cholesterol (CAS 57-88-5) is a cosmetic active ingredient functioning as Skin-conditioning agent, SC lipid replenisher, barrier co-lipid, essential. EU Regulation 1223/2009 status: permitted; 1 safety opinion reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Function
Skin-conditioning agent, SC lipid replenisher, barrier co-lipid, essential triad component in ceramide-dominant 3:1:1 physiological moisturizer ratio
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Not FDA-restricted. An FDA-approved barrier repair emulsion employing the ceramide-dominant 3:1:1 molar ratio (ceramides:cholesterol:fatty acids) was approved in 2006 for dry-skin conditions. CIR reviewed; no safety concerns at cosmetic use levels (typically 2–3%). Essential co-lipid in healthy stratum corneum (approximately 25% of SC lipids by mole fraction).
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Cholesterol.
Calculate MoS for your specific formulation with the MoS Calculator.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety Assessment
Number 5, 1986
Verdict: unknown
Dermal Penetration Profile
Skin absorption and penetration characteristics of Cholesterol, relevant to systemic exposure and MoS calculations.
Absorption %
2-5%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
386.7 Da
Log P
7.0
Systemic Absorption
minimal
Topical Bioavailability
1-4%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: Skin Pharmacol 1991
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
31, Sup 7
Evaluation Year
1987
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.1–2 | 3 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Emulsifier
Fragrance
Pharmaceutical
Processing aids not otherwise specified
Softener and conditioner
Stabilizing agent
Thickening agent
Viscosity modifier
Regulatory List Membership (3)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
Consumer Product Chemical
Editorial summary
Preliminary editorial summary for Cholesterol — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
sc-lipid
barrier-repair
trilipid-triad
ceramide-dominant-3-1-1
fda-approved-ratio
cerave-mve
elias-research
lpp-formation
endogenous
ifra_fragrance
Known Synonyms
5:6-Cholesten-3beta-ol
delta5-Cholesten-3beta-ol
SyntheChol
EC No.: 200-353-2
200-353-2
Cholest-5-en-3-beta-ol
EINECS 200-353-2
3-beta-Hydroxycholest-5-ene
delta(sup 5)-Cholesten-3-beta-ol
Wool alcohols B. P.
UNII-97C5T2UQ7J
Cholesterinum
(+)-ent-Cholesterol
(1S,2R,10S,11S,14R,15R)-2,15-dimethyl-14-[(2R)-6-methylheptan-2-yl]tetracyclo[8.7.0.02,7.011,15]heptadec-7-en-5-ol
(20bFH)-cholest-5-en-3b-ol
(3b)-cholest-5-en-3-ol
(3beta)-Cholest-5-en-3-ol
20-Epi-cholesterol
20-Iso-cholesterol
20bFH-cholest-5-en-3b-ol
Chemical Function
Softener and conditioner
Emulsifier
Viscosity modifier
Stabilizing agent
Regulatory Lists
inert_ingredient; Pesticides
Canada; consumer_product; Substances in Products - Canada (4/2014)
IFRA Transparency
consumer_product
inert_ingredient; non_food_use; Pesticides
Canada; consumer_product; Substances in Products - Canada (4/2014)
detected; wastewater
Europe; Personal care
Europe; Personal care
Europe; Personal care
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; wastewater
detected; MN Chemical Screening; surface_water
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
CHOLESTEROL
ChEMBL ID
CHEMBL112570
Max Phase
2
Adverse Event Associations
84
Frequently Asked Questions
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.
Is Cholesterol used outside cosmetics?
Cholesterol also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Cholesterol compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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