Excellent Active Ingredient SCCS/CIR Reviewed Dermal Penetration

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). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 57-88-5 →

Auto-generated CPSR Part A draft with source citations
Function
Skin-conditioning agent, SC lipid replenisher, barrier co-lipid, essential triad component in ceramide-dominant 3:1:1 physiological moisturizer ratio
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
200-353-2

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 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/VCRP

Additional Ingredient Properties

10 property records from structured ingredient metadata.

acne
{"cas_number": "57-88-5", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "1", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction_ac…
anti_aging
{"anti_aging_claim": "barrier-repair, hydration-plumping", "mechanism_of_action": "Lipid barrier restoration, TEWL reduction, emollient", "target_skin_layer": "stratum corneum", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "8-15", "clinical_study_duration_weeks": "8", "sample_size": "30", "double_blind": "Yes", "placebo_controlled": "Yes", "published_journal":…
anti_pollution
{"cas_number": "57-88-5", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibition…
comedogenicity_detail
{"comedogenicity_rating": "1", "irritancy_rating": "0", "skin_type_suitability": "all,dry,combination,normal,mature", "acne_safe": "yes", "source": "Skin-identical lipid"}
cost_pricing
{"cost_tier": "budget", "estimated_cost_per_kg_usd_low": "15", "estimated_cost_per_kg_usd_high": "28", "natural_premium_markup_pct": "0", "organic_certified_premium_pct": "0", "supply_chain_volatility": "low", "primary_source_region": "China/Global", "bulk_discount_threshold_kg": "200", "seasonal_price_variation": "low", "commodity_or_specialty": "commodity", "substitute_ingredients": "Phytosterol…
dermal_absorption
{"molecular_weight_da": "386.7", "log_p_value": "7.0", "skin_penetration_level": "stratum-corneum", "penetration_depth": "stratum corneum", "absorption_pct": "2-5", "systemic_absorption": "minimal", "penetration_enhancer": "yes", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "strengthens", "bioavailability_topical_pct": "1-4", "safety_margin_factor": "low", "source":…
hair_care
{"hair_function": "conditioning", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "high", "protein_sensitivity": "balanced", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "ke…
humectant
{"cas_number": "57-88-5", "ingredient_class": "emollient", "molecular_weight_Da": "386.65", "chemical_type": "lipid", "water_binding_mechanism": "intercellular_lipid", "water_holding_capacity_g_per_g": "0", "hygroscopicity_at_50_RH": "poor", "hygroscopicity_at_80_RH": "poor", "NMF_component": "no", "NMF_percentage_natural": "0", "TEWL_reduction_pct": "15-25", "skin_hydration_increase_pct_2h": "25-…

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

Expert Verdict

Expert safety assessment and concern-level summary for Cholesterol.

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
View full pharmaceutical profile →

Frequently Asked Questions

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.

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.

Is Cholesterol in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Cholesterol in your formulation.