Is Deoxycholic Acid safe in cosmetics?
Deoxycholic Acid has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 5 toxicological study endpoint(s) are available in our database.
Deoxycholic Acid
Also known as: 4-10-00-01608, BRN 3219882, 5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy-, Cholan-24-oic, 3,12-dihydroxy-(3alpha,5beta,12alpha)-, Choleic acid (+15 more)
INCI: DEOXYCHOLIC ACID
Deoxycholic Acid (CAS 83-44-3) is a cosmetic cosmetic ingredient functioning as Surfactant, emulsifier, skin conditioning. Reported NOAEL =50 mg/kg bw/day in rat (Sprague-Dawley; male/female) (FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z); EU Regulation 1223/2009 status: prohibited. 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.
View industrial chemical safety profile for CAS 83-44-3 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Deoxycholic Acid is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Surfactant, emulsifier, skin conditioning
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
(4R)-4-[(3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
InChIKey
KXGVEGMKQFWNSR-LLQZFEROSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Permitted in cosmetics — not restricted under 21 CFR; FDA-approved as injectable drug (Kybella/ATX-101) for submental fat reduction
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Deoxycholic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
5 study endpoints found for Deoxycholic Acid. 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 | =50 mg/kg bw/day | unspecified | rat (Sprague-Dawley; male/female) | repeated dose toxicity other | FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z |
| NOAEL | =50 mg/kg bw/day | unspecified | rat (Sprague-Dawley; male/female) | repeated dose toxicity other | FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z |
| NOAEL | =50 mg/kg bw/day | unspecified | rat (Sprague-Dawley; male/female) | repeated dose toxicity other | FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z |
| NOAEL | =50 mg/kg bw/day | unspecified | rat (Sprague-Dawley; male/female) | repeated dose toxicity other | FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z |
| NOAEL | =50 mg/kg bw/day | oral | Rat | chronic | ToxValDB_ECHA_IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Carcinogen Classification
Not listed by IARC.
Source: Toxin and Toxin Target Database (T3DB)
Regulatory (1)
JECFA Evaluation
DESOXYCHOLIC ACID | 1973 | 0-1.25 mg/kg bw | NMRS 53/TRS 539-JECFA 17/36 | FAS 5/NMRS 53A-JECFA 17/217
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Emulsifier
Humectant
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Deoxycholic Acid.
Regulatory Flags
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Deoxycholic Acid by CAS number or substance name.
Studies
5
Lowest NOAEL
50 mg/kg bw/day
Highest NOAEL
50 mg/kg bw/day
ToxValDB_ECHA_IUCLID
FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z
Known Synonyms
4-10-00-01608
BRN 3219882
5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy-
Cholan-24-oic, 3,12-dihydroxy-(3alpha,5beta,12alpha)-
Choleic acid
Deoxy cholic acid
5-beta-Deoxycholic acid
3alpha,12alpha-Dihydroxy-5beta-cholanic acid
3,12-Dihydroxycholanic acid
Dihydroxycholanoic acid
3alpha,12alpha-Dihydroxy-5beta-cholan-24-oic acid
3,12-Dihydroxycholan-24-oic acid, (3alpha,5beta,12alpha)-
3-alpha,12-alpha-Dihydroxy-5-beta-cholanoic acid
EINECS 201-478-5
l7-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
17-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
3-alpha,12-alpha-Dihydroxycholansaeure
UNII-005990WHZZ
(3alpha,5beta,12alpha)-3,12-dihydroxycholan-24-oic acid
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadecan-14-yl]pentanoic acid
Chemical Function
Humectant
Softener and conditioner
Emulsifier
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
Canada; pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
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
DEOXYCHOLIC ACID
ChEMBL ID
CHEMBL406393
Max Phase
4
Adverse Event Associations
26
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
DESOXYCHOLIC ACID
ADI
0-1.25 mg/kg bw mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Deoxycholic Acid allowed in the EU?
Deoxycholic Acid EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Deoxycholic Acid do in cosmetics?
Deoxycholic Acid functions as: Surfactant, emulsifier, skin conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 83-44-3.
What is the NOAEL for Deoxycholic Acid?
The NOAEL (No Observed Adverse Effect Level) for Deoxycholic Acid is =50 mg/kg bw/day based on a repeated dose toxicity other study via unspecified route in rat (Sprague-Dawley; male/female). A total of 5 study endpoints are available. Source: FDA_Toxicity_9e579a2f-b906-4468-a974-d217a6a58dba_dossier.i6z.
Is Deoxycholic Acid used outside cosmetics?
Deoxycholic Acid 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.
Does Deoxycholic Acid have different safety status in cosmetics vs industrial chemicals?
Deoxycholic Acid is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Compliance Tools
Check Deoxycholic Acid 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
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