Is Potassium Acesulfame safe in cosmetics?
Potassium Acesulfame has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Potassium Acesulfame
Also known as: 6-Methyl-1,2,3-oxathiazin-4(3h)-one 2,2-dioxide potassium salt, Potassium 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide, Acesulfam-K, EINECS 259-715-3, Acesulfame-potassium
INCI: POTASSIUM ACESULFAME
Potassium Acesulfame (CAS 55589-62-3) is a cosmetic cosmetic ingredient functioning as Fragrance (taste-masking/sweetening agent in oral care contexts). NOAEL 30000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); 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.
View industrial chemical safety profile for CAS 55589-62-3 →
Auto-generated CPSR Part A draft with source citations
Function
Fragrance (taste-masking/sweetening agent in oral care contexts)
Safety Rating
EXCELLENT
Chemistry & Identifiers
IUPAC Name
potassium 6-methyl-2,2-dioxo-1-oxa-2lambda6-thia-3-azanidacyclohex-5-en-4-one
InChIKey
WBZFUFAFFUEMEI-UHFFFAOYSA-M
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA-approved food additive (21 CFR 172.800); permitted in cosmetics; not restricted
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Potassium Acesulfame.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Potassium Acesulfame. 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 | 300 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS DB |
| NOAEL | 750 mg/kg bw/day | oral | dog | Chronic | COSMOS DB |
| NOAEL | 900 mg/kg bw/day | oral | rabbit | Developmental | COSMOS DB |
| NOAEL | 1500 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS DB |
| NOAEL | 3000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS DB |
| NOAEL | 4500 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS DB |
| NOAEL | 4700 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS DB |
| NOAEL | 5543 mg/kg bw/day | oral | rat | Subchronic | COSMOS DB |
| NOAEL | 5571 mg/kg bw/day | oral | rat | Subchronic | COSMOS DB |
| NOAEL | 5652 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Potassium Acesulfame across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
| LD50 | =10175 mg/kg | Rat | oral | - | ECHA |
| LD50 | =6971 mg/kg | Mouse | oral | - | ECHA |
| LD50 | =6713 mg/kg | Mouse | oral | - | ECHA |
| LD50 | =8783 mg/kg | Mouse | oral | - | ECHA |
| LD50 | =5438 mg/kg | Rat | oral | - | ECHA |
| LD50 | =5565 mg/kg | Rat | oral | - | ECHA |
| LD50 | =7431 mg/kg | Rat | oral | - | ECHA |
| LD50 | =2243 mg/kg | Rat | injection | - | ECHA |
| NOAEL | >5550 mg/kg-day | Mouse | oral | - | ECHA |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (2)
JECFA Evaluation
ACESULFAME POTASSIUM | 1990 | 0-15 mg/kg bw | TRS 806-JECFA 37/20 | FAS 28-JECFA 37/183
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Flavouring and nutrient
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Potassium Acesulfame.
Regulatory Flags
fragrance-component
natural-origin
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Potassium Acesulfame by CAS number or substance name.
Studies
13
Lowest NOAEL
300 mg/kg bw/day
Highest NOAEL
5863 mg/kg bw/day
COSMOS DB
Known Synonyms
6-Methyl-1,2,3-oxathiazin-4(3h)-one 2,2-dioxide potassium salt
Potassium 3,4-dihydro-6-methyl-1,2,3-oxathiazine-4-one-2,2-dioxide
Acesulfam-K
EINECS 259-715-3
Acesulfame-potassium
Chemical Function
Deodorizer
Flavouring and nutrient
Regulatory Lists
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
inert_ingredient; non_food_use; Pesticides
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
ACESULFAME POTASSIUM
ChEMBL ID
CHEMBL1351474
Max Phase
3
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Acesulfame potassium (Ace-K)
E Number
E950
ADI
15 mg/kg bw
Food Category
sweetener
Frequently Asked Questions
Is Potassium Acesulfame allowed in the EU?
Potassium Acesulfame EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Potassium Acesulfame do in cosmetics?
Potassium Acesulfame functions as: Fragrance (taste-masking/sweetening agent in oral care contexts). It is classified as a cosmetic ingredient in our database. CAS number: 55589-62-3.
What is the NOAEL for Potassium Acesulfame?
The NOAEL (No Observed Adverse Effect Level) for Potassium Acesulfame is 300 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Potassium Acesulfame used outside cosmetics?
Potassium Acesulfame 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 Potassium Acesulfame 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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