Is Spironolactone safe in cosmetics?
Spironolactone has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted.
Poor
Cosmetic Ingredient
Spironolactone
Also known as: 17-alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7-alpha-mercapto-3-oxo-, gamma-lactone acetate, 7-alpha-(acetylthio)-17-alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, gamma-lactone, Pregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, gamma-lactone, (7alpha,17alpha)-, 4-18-00-01601, 7-alpha-Acetylthio-3-oxo-17-alpha-pregn-4-ene-21,17-beta-carbolactone (+15 more)
INCI: SPIRONOLACTONE (INN)
Spironolactone (CAS 52-01-7) is a cosmetic cosmetic ingredient functioning as Anti-androgen (pharmaceutical); historically explored for anti-acne topical use. EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 52-01-7 →
Auto-generated CPSR Part A draft with source citations
Function
Anti-androgen (pharmaceutical); historically explored for anti-acne topical use
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
S-[(7R,8R,9S,10R,13S,14S,17R)-10,13-dimethyl-3,5'-dioxospiro[2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-17,2'-oxolane]-7-yl] ethanethioate
InChIKey
LXMSZDCAJNLERA-ZHYRCANASA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Prescription drug (oral); not approved as an OTC cosmetic ingredient. FDA classifies topical spironolactone formulations as drugs, not cosmetics.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Spironolactone.
Calculate MoS for your specific formulation with the MoS Calculator.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
Sup 7, 79
Evaluation Year
2000
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 4
(EC) 2009/1223
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 4
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| IN | banned | - | all cosmetics |
| CA | banned | - | - |
| ASEAN | banned | - | All cosmetic products prohibited |
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (4)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Spironolactone | Group 3: Not classifiable as to its carcinogenicity to humans | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 79: (2001) Some Thyrotropic Agents
Source: International Agency for Research on Cancer (IARC)
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of spironolactone. There is limited evidence in experimental animals for the carcinogenicity of spironolactone. Overall evaluation: Spironolactone is not classifiable as to its carcinogenicity to humans (Group 3).
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
No specific technical function
Pharmaceutical
Regulatory List Membership (3)
California Proposition 65 (OEHHA)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Spironolactone.
Regulatory Flags
prop65
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
17-alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7-alpha-mercapto-3-oxo-, gamma-lactone acetate
7-alpha-(acetylthio)-17-alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, gamma-lactone
Pregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, gamma-lactone, (7alpha,17alpha)-
4-18-00-01601
7-alpha-Acetylthio-3-oxo-17-alpha-pregn-4-ene-21,17-beta-carbolactone
Alderon
BRN 0057767
EINECS 200-133-6
3-(3-Keto-7-alpha-acetylthio-17-beta-hydroxy-4-androsten-17-alpha-yl)propionic acid lactone
Melarcon
3'-(3-Oxo-7-alpha-acetylthio-17-beta-hydroxyandrost-4-en-17-beta-yl)propionic acid lactone
17alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7alpha-mercapto-3-oxo-, gamma-lactone, acetate
Spiro(17H-cyclopenta(a)phenauthrene-17,2'-(3'H)-furan)
Spironocompren
Spiro(17H-cyclopenta(a)phenanthrene-17,2'(5'H)-furan), pregn-4-ene-21-carboxylic acid deriv.
Spironolactonum
UNII-27O7W4T232
Diatense
Berlactone
spironolattone
Chemical Function
No specific technical function
Pharmaceutical
Regulatory Lists
pharmaceutical
OEHHA Proposition 65 (3/2019)
Canada; pharmaceutical
OEHHA Proposition 65 (1/2023)
pharmaceutical; prohibited
pharmaceutical; prohibited
banned; Europe; Personal care
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
SPIRONOLACTONE
ChEMBL ID
CHEMBL1393
Max Phase
4
Adverse Event Associations
7888
Frequently Asked Questions
Is Spironolactone allowed in the EU?
Spironolactone EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Spironolactone do in cosmetics?
Spironolactone functions as: Anti-androgen (pharmaceutical); historically explored for anti-acne topical use. It is classified as a cosmetic ingredient in our database. CAS number: 52-01-7.
Is Spironolactone used outside cosmetics?
Spironolactone also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Spironolactone 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
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