Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Potassium Carbonate. 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 | 290 mg/kg bw/day | oral | mouse | Developmental | COSMOS_DB |
| NOAEL | 180 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| dose_tested | 290 mg/kg bw/day | oral | mouse | Developmental | COSMOS_DB |
| dose_tested | 180 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 2667 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 2667 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 4326 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 2861 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 6054 mg/kg bw/day | oral | rat | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Potassium Carbonate (CAS 584-08-7) is permitted in the EU as a buffering agent with no concentration restrictions and is not listed in Annex II/III/IV/V/VI. In the US, it is GRAS-affirmed per 21 CFR 184.1619 and FDA-approved as an inactive ingredient in drug products. The CIR Expert Panel (2022) concluded it is safe as used in cosmetics, with dermal absorption demonstrated to be negligible and no sensitization or CMR concerns.
Regulatory Flags
Frequently Asked Questions
Is Potassium Carbonate safe in cosmetics?
Potassium Carbonate (CAS 584-08-7) is permitted in the EU as a buffering agent with no concentration restrictions and is not listed in Annex II/III/IV/V/VI. In the US, it is GRAS-affirmed per 21 CFR 184.1619 and FDA-approved as an inactive ingredient in drug products. The CIR Expert Panel (2022) concluded it is safe as used in cosmetics, with dermal absorption demonstrated to be negligible and no sensitization or CMR concerns. The EU classifies Potassium Carbonate as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Potassium Carbonate allowed in the EU?
Potassium Carbonate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Potassium Carbonate do in cosmetics?
Potassium Carbonate functions as: Buffering agent, pH adjuster. It is classified as a cosmetic ingredient in our database. CAS number: 584-08-7.
What is the Margin of Safety for Potassium Carbonate?
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 Carbonate?
The NOAEL (No Observed Adverse Effect Level) for Potassium Carbonate is 290 mg/kg bw/day based on a Developmental study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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