What is the NOAEL for Spironolactone?
Spironolactone has 45 NOAEL studies in the database. The lowest reported value is 0 unitless. Source: NTP ICE endocrine.
NOAEL Data
IARC Group 3
Prop 65
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)
CAS 52-01-7
Spironolactone (CAS 52-01-7) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: California Proposition 65, 7 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, IARC, CA Prop 65.
Cross-Vertical Regulatory Divergence
Spironolactone is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H312, H332, H351, H360, H373).
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
SOURCE
NOAEL studies
NOAEL studies
45
SOURCE
Chemical inventory jurisdictions
Regulatory lists
7
SOURCE
EU CLP Annex VI
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
25 fields
Name
Spironolactone
CAS Number
52-01-7
Molecular Formula
C24H32O4S
InChI Key
LXMSZDCAJNLERA-ZHYRCANASA-N
Monoisotopic Mass
416.202131
Synonyms
17-alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7-alpha-mercapto-3-oxo-, gamma-lactone acetate7-alpha-(acetylthio)-17-alpha-hydroxy-3-oxopregn-4-ene-21-carboxylic acid, gamma-lactonePregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, gamma-lactone, (7alpha,17alpha)-4-18-00-016017-alpha-Acetylthio-3-oxo-17-alpha-pregn-4-ene-21,17-beta-carbolactoneAlderonBRN 0057767EINECS 200-133-63-(3-Keto-7-alpha-acetylthio-17-beta-hydroxy-4-androsten-17-alpha-yl)propionic acid lactoneMelarcon3'-(3-Oxo-7-alpha-acetylthio-17-beta-hydroxyandrost-4-en-17-beta-yl)propionic acid lactone17alpha-Pregn-4-ene-21-carboxylic acid, 17-hydroxy-7alpha-mercapto-3-oxo-, gamma-lactone, acetate
IARC Carcinogen Classification
Carcinogenic hazard classification from IARC monograph evaluations.
SOURCE
IARC Monographs on the Identification of Carcinogenic Hazards to Humans
1 records
| Group | Meaning | Evaluated | Volume |
|---|---|---|---|
| Group 3 | Not classifiable | 2000 | Sup 7, 79 |
California Proposition 65
California OEHHA listing status and toxicity category.
SOURCE
California OEHHA Proposition 65 List
1 records
| Chemical | Toxicity Type | Cancer | Developmental | Listed |
|---|---|---|---|---|
| - | cancer | Yes | No | - |
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
3 records
No specific technical functionPharmaceutical
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
7 records
| List | Keyword | Source |
|---|---|---|
| pharmaceutical | US International Trade Commission | CPCat |
| OEHHA Proposition 65 (3/2019) | STATE OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY | OEHHA Proposition 65 List |
| Canada; pharmaceutical | DrugBank | DrugBank |
| OEHHA Proposition 65 (1/2023) | California Office of Environmental Health Hazard Assessment | OEHHA Proposition 65 List |
| pharmaceutical; prohibited | World Anti-Doping Agency | World Anti-Doping Agency |
| pharmaceutical; prohibited | World Anti-Doping Agency | World Anti-Doping Agency |
| banned; Europe; Personal care | European Commission | CosIng |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 45 of 45 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| 0.08401 | uM | AC50 | - | - | NTP ICE endocrine |
| 1.585 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 4.365 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 8.9 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 18.62 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 30.2 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 150 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 190.5 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 223.9 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 242 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 316.2 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 426.6 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 676.1 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 685 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 691.8 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 1148 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 1260 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 5000 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 6344 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 6560 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 9500 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 1.000e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 1.259e+4 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 3.162e+5 | nM | AC50/EC50/IC50 | - | - | NTP ICE endocrine |
| 0.03809 | uM | ACC | - | - | NTP ICE endocrine |
| FRcancer | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| 27O7W4T232 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 3 | IARC group | IARC carcinogenicity classification | - | - | IARC Monographs |
| 3 | unitless | IARC group | - | - | NTP ICE cancer |
| <100 | nM | IC25 | - | - | NTP ICE endocrine |
| 1.01 | nM | Ki | - | - | NTP ICE endocrine |
| =0.04 | mg | LEL | injection | Rat | ToxValDB Uterotrophic Hershberger DB |
| =0.5 | mg | LEL | injection | Rat | ToxValDB Uterotrophic Hershberger DB |
| 100 | nM | LEL | - | - | NTP ICE endocrine |
| 1000 | nM | LEL | - | - | NTP ICE endocrine |
| =40 | mg/kg bw/day | LOEL | oral | Rat | ToxValDB Uterotrophic Hershberger DB |
| 40 | mg/kg bw/day | LOEL | Oral | Rat | NTP ICE endocrine |
| 0 | unitless | Model Score | - | - | NTP ICE endocrine |
| 0.191 | unitless | Model Score | - | - | NTP ICE endocrine |
| =8 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB Uterotrophic Hershberger DB |
| 8 | mg/kg bw/day | NOEL | Oral | Rat | NTP ICE endocrine |
| 0.4467 | unitless | RBA | - | - | NTP ICE endocrine |
| 0.4479 | unitless | RBA | - | - | NTP ICE endocrine |
| 2.7 | unitless | RBA | - | - | NTP ICE endocrine |
| 67 | unitless | RBA | - | - | NTP ICE endocrine |
Showing 45 of 45 studies
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
prohibited
Max
-
Category
Cosmetic Ingredient
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
ChEMBL / DailyMed
SPIRONOLACTONE
ChEMBL Phase
4
Adverse Events
7888
Bioactivity
15
Frequently Asked Questions
What regulatory lists include Spironolactone?
Spironolactone appears on 6 regulatory/inventory lists including pharmaceutical, OEHHA Proposition 65 (3/2019), Canada; pharmaceutical, and 3 more. Source: EPA CPDat.
Is Spironolactone a carcinogen according to IARC?
Spironolactone is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 2000). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.
Is Spironolactone on the California Proposition 65 list?
Yes, Spironolactone is listed under California Proposition 65 for cancer. Source: California OEHHA Proposition 65.
Is Spironolactone used in cosmetics?
Yes, Spironolactone is also indexed as a cosmetic ingredient under the name Spironolactone. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Spironolactone come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, IARC Monographs, California Proposition 65, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does Spironolactone have different safety status in cosmetics vs industrial chemicals?
Spironolactone is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H312, H332, H351, H360, H373).
Is Spironolactone used outside industrial chemicals?
Spironolactone also appears in cosmetics, pharmaceutical databases.