Excellent Cosmetic Ingredient NOAEL Data

Potassium Acesulfame

INCI: POTASSIUM ACESULFAME

CAS Number
55589-62-3
Function
Fragrance (taste-masking/sweetening agent in oral care contexts)
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-approved food additive (21 CFR 172.800); permitted in cosmetics; not restricted

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

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 750 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 300 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 900 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB

Expert Verdict

Minimal โ€” primarily used in oral care products for sweetening/taste masking; environmental persistence concerns emerging in wastewater literature but not relevant to product safety; if marketing natural/clean claims, note this is a synthetic sweetener

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Concern Level: None

Regulatory Flags

fragrance-component natural-origin fda_food_additive

Frequently Asked Questions

Is Potassium Acesulfame safe in cosmetics?

Minimal โ€” primarily used in oral care products for sweetening/taste masking; environmental persistence concerns emerging in wastewater literature but not relevant to product safety; if marketing natural/clean claims, note this is a synthetic sweetener The EU classifies Potassium Acesulfame as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

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 Margin of Safety for Potassium Acesulfame?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Potassium Acesulfame?

The NOAEL (No Observed Adverse Effect Level) for Potassium Acesulfame is 750 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

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