Is Beta-Sitosterol safe in cosmetics?
Beta-Sitosterol has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 1 toxicological study endpoint(s) are available in our database.
Beta-Sitosterol
Also known as: Stigmast-5-en-3-ol, (3β)-, (-)-β-Sitosterol, (24R)-Ethylcholest-5-en-3β-ol, (24R)-Stigmast-5-en-3β-ol, 22,23-Dihydrostigmasterol (+15 more)
INCI: BETA-SITOSTEROL
Beta-Sitosterol (CAS 83-46-5) is a cosmetic cosmetic ingredient functioning as emulsion stabilising, skin conditioning, masking, stabilising. Reported NOAEL =2571 mg/kg bw/day in Rat (ECHA); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Function
emulsion stabilising, skin conditioning, masking, stabilising
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
(3S,8S,9S,10R,13R,14S,17R)-17-[(2R,5R)-5-ethyl-6-methylheptan-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3-ol
InChIKey
KZJWDPNRJALLNS-VJSFXXLFSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
GRAS status as food additive (E499); CIR assessed phytosterols as safe in cosmetics; no restrictions
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Beta-Sitosterol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for Beta-Sitosterol. 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 | =2571 mg/kg bw/day | oral | Rat | chronic | ECHA |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Emulsifier
Fragrance
Pharmaceutical
Softener and conditioner
Stabilizing agent
Editorial summary
Preliminary editorial summary for Beta-Sitosterol — not a computed safety verdict. See the sourced toxicological data above.
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Beta-Sitosterol by CAS number or substance name.
Studies
1
Lowest NOAEL
2571 mg/kg bw/day
Highest NOAEL
2571 mg/kg bw/day
ECHA
Known Synonyms
Stigmast-5-en-3-ol, (3β)-
(-)-β-Sitosterol
(24R)-Ethylcholest-5-en-3β-ol
(24R)-Stigmast-5-en-3β-ol
22,23-Dihydrostigmasterol
24α-Ethylcholesterol
Angelicin
Azuprostat
Betaprost
Cinchol
Cupreol
Nimbosterol
Prostasal
Quebrachol
Rhammol
Rhamnol
Sito-Lande
Sitosterol
Sobatum
Stigmasterol, 22,23-dihydro-
Chemical Function
Deodorizer
Softener and conditioner
Stabilizing agent
Emulsifier
Fragrance
Pharmaceutical
Regulatory Lists
detected; wastewater
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
Canada; pharmaceutical
detected; Europe; Other direct contact consumer goods
detected; Europe; Other direct contact consumer goods
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
BETA-SITOSTEROL
ChEMBL ID
CHEMBL221542
Adverse Event Associations
1
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Beta-sitosterol
Food Category
preservative
Frequently Asked Questions
Is Beta-Sitosterol allowed in the EU?
Beta-Sitosterol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Beta-Sitosterol do in cosmetics?
Beta-Sitosterol functions as: emulsion stabilising, skin conditioning, masking, stabilising. It is classified as a cosmetic ingredient in our database. CAS number: 83-46-5.
What is the NOAEL for Beta-Sitosterol?
The NOAEL (No Observed Adverse Effect Level) for Beta-Sitosterol is =2571 mg/kg bw/day based on a chronic study via oral route in Rat. Source: ECHA.
Is Beta-Sitosterol used outside cosmetics?
Beta-Sitosterol also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Beta-Sitosterol compliance across multiple jurisdictions:
Ingredient Decoder
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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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