Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Potassium Fluorosilicate

INCI: POTASSIUM FLUOROSILICATE

CAS Number
16871-90-2
Function
Antiplaque, oral care
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.15%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not listed as an approved OTC anticaries active in the US FDA monograph; limited US cosmetic use

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Potassium Fluorosilicate. 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 ca.25 ppm oral rat oral REACH
LOAEL ca.4 mg/kg bw/day oral rat oral REACH
LOAEL ca.100 ppm oral rat oral REACH
LOAEL ca.50 ppm oral mouse oral REACH
LOAEL ca.25 ppm oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
skull;toxic; cancer;health haz
Hazard Statements
Toxic if swallowed May cause damage to blood and cardiovascular system May cause damage to teeth and bones through prolonged or repeated exposure
Short-term Exposure Effects
The substance may cause effects on the blood and calcium metabolism. This may result in cardiac disorders. Medical observation is indicated. See Notes.
Long-term Exposure Effects
The substance may have effects on the bones and teeth. This may result in fluorosis.
Routes of Exposure
The substance can be absorbed into the body by ingestion.

Expert Verdict

Restricted in EU to 0.15% maximum concentration due to toxicity from fluorosilicate dissociation. Classified as toxic if swallowed (H301); more acutely toxic than simple fluoride salts. Limited use in US cosmetics; not approved as OTC anticaries active.

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Concern Level: High

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is Potassium Fluorosilicate safe in cosmetics?

Restricted in EU to 0.15% maximum concentration due to toxicity from fluorosilicate dissociation. Classified as toxic if swallowed (H301); more acutely toxic than simple fluoride salts. Limited use in US cosmetics; not approved as OTC anticaries active. The EU classifies Potassium Fluorosilicate as "restricted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.

Is Potassium Fluorosilicate allowed in the EU?

Potassium Fluorosilicate EU regulatory status: restricted. Maximum allowed concentration: 0.15%. This is based on EU Regulation 1223/2009 and its amendments.

What does Potassium Fluorosilicate do in cosmetics?

Potassium Fluorosilicate functions as: Antiplaque, oral care. It is classified as a cosmetic ingredient in our database. CAS number: 16871-90-2.

What is the Margin of Safety for Potassium Fluorosilicate?

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 Fluorosilicate?

The NOAEL (No Observed Adverse Effect Level) for Potassium Fluorosilicate is ca.25 ppm based on a oral study via oral route in rat. A total of 5 study endpoints are available. Source: REACH.

Is Potassium Fluorosilicate classified as hazardous under GHS?

Potassium Fluorosilicate carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed May cause damage to blood and cardiovascular system May cause damage to teeth and bones through prolonged or repeated exposure. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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