Excellent Cosmetic Ingredient NOAEL Data

Potassium Bicarbonate

INCI: POTASSIUM BICARBONATE

CAS Number
298-14-6
Function
Buffering agent, pH adjuster
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS (Generally Recognized as Safe); approved inactive ingredient in oral drug products (1.06–500 mg); CIR concluded safe when formulated to be non-irritating

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Potassium Bicarbonate. 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 2500 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 4300 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 345 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 4385 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 3133 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 941 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 931 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
dose_tested 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

Must be formulated to be non-irritating. Alkaline pH at high concentrations can cause skin irritation. Specification: ≥99% KHCO₃ on dried basis; impurities tightly controlled.

⚠️
Concern Level: Low

Regulatory Flags

epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Potassium Bicarbonate safe in cosmetics?

Must be formulated to be non-irritating. Alkaline pH at high concentrations can cause skin irritation. Specification: ≥99% KHCO₃ on dried basis; impurities tightly controlled. The EU classifies Potassium Bicarbonate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Potassium Bicarbonate allowed in the EU?

Potassium Bicarbonate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Potassium Bicarbonate do in cosmetics?

Potassium Bicarbonate functions as: Buffering agent, pH adjuster. It is classified as a cosmetic ingredient in our database. CAS number: 298-14-6.

What is the Margin of Safety for Potassium Bicarbonate?

not established 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 Bicarbonate?

The NOAEL (No Observed Adverse Effect Level) for Potassium Bicarbonate is 2500 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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