Is Androstenedione safe in cosmetics?
Androstenedione has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 2 toxicological study endpoint(s) are available in our database.
Androstenedione
Also known as: SKF 2170, Androst-4-ene-3 ,17-diona, Fecundin, NSC 9563, delta-4-Androsten-3,17-dione (+13 more)
INCI: ANDROSTENEDIONE
Androstenedione (CAS 63-05-8) is a cosmetic cosmetic ingredient functioning as Hormone precursor (androgenic/estrogenic prohormone); endogenous steroid. Reported NOAEL =30 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 63-05-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Androstenedione is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H351, H360, H362).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Hormone precursor (androgenic/estrogenic prohormone); endogenous steroid intermediate in biosynthesis of testosterone and estrone from DHEA
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
(8R,9S,10R,13S,14S)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-3,17-dione
InChIKey
AEMFNILZOJDQLW-QAGGRKNESA-N
Regulatory Status
EU EU Status
prohibited
US US Status
prohibited
US Notes
FDA issued warning letters to 23 companies in 2004; DEA Schedule III anabolic steroid; banned by WADA, IOC, MLB, NFL, NBA, NCAA; FDA Scientific Memorandum (2022) confirms no safe use threshold established
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Androstenedione.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Androstenedione. 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 | =30 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =60 mg/kg bw/day | oral | Rat | developmental | 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 (2)
Carcinogen Classification
Androstenedione | TR-560: Toxicology and Carcinogenesis Studies of Androstenedione (CASRN 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies) (2010 ) | 02/25/09 | Equivocal Evidence | Equivocal Evidence | Clear Evidence | Clear Evidence | Under the conditions of these 2-year gavage studies, there was equivocal evidence of carcinogenic activity of androstenedione in male F344/N rats b
Source: NTP Technical Reports
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Pharmaceutical
Regulatory List Membership (1)
California Proposition 65 (OEHHA)
Expert Verdict
Expert safety assessment and concern-level summary for Androstenedione.
Regulatory Flags
eu-annex-ii-prohibited
us-prohibited-controlled-substance
endocrine-disruptor
anabolic-steroid
hormone-precursor
carcinogenicity-concern
reproductive-toxicity
systemic-absorption
schedule-iii-dea
wada-banned
not-for-cosmetic-use
prop65
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Androstenedione by CAS number or substance name.
Studies
2
Lowest NOAEL
30 mg/kg bw/day
Highest NOAEL
60 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
SKF 2170
Androst-4-ene-3 ,17-diona
Fecundin
NSC 9563
delta-4-Androsten-3,17-dione
delta-4-Androstenedione
Androtex
EINECS 200-554-5
delta(sup 4)-Androstene-3,17-dione
delta-(sup4)-Androsten-3,17-dione
UNII-409J2J96VR
(1S,2R,10R,11S,15S)-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadec-6-ene-5,14-dione
(4)-Androsten-3,17-dione
4-Androsten-3,17-dione
4-Androstenedione
Delta(4)-androsten-3,17-dione
Delta(4)-androstene-3,17-dione
Delta4-androstenedione
Chemical Function
Pharmaceutical
Regulatory Lists
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
OEHHA Proposition 65 (3/2019)
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; surface_water
detected; MN Chemical Screening; surface_water
Canada; pharmaceutical
Canada; pharmaceutical
OEHHA Proposition 65 (1/2023)
pharmaceutical; prohibited
pharmaceutical; prohibited
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
ANDROSTENEDIONE
ChEMBL ID
CHEMBL274826
Max Phase
-1
Frequently Asked Questions
Is Androstenedione allowed in the EU?
Androstenedione EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Androstenedione do in cosmetics?
Androstenedione functions as: Hormone precursor (androgenic/estrogenic prohormone); endogenous steroid intermediate in biosynthesis of testosterone and estrone from DHEA. It is classified as a cosmetic ingredient in our database. CAS number: 63-05-8.
What is the NOAEL for Androstenedione?
The NOAEL (No Observed Adverse Effect Level) for Androstenedione is =30 mg/kg bw/day based on a reproduction developmental study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Androstenedione used outside cosmetics?
Androstenedione 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.
Does Androstenedione have different safety status in cosmetics vs industrial chemicals?
Androstenedione is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H351, H360, H362).
Compliance Tools
Check Androstenedione 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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