Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Ammonium Fluoride

INCI: AMMONIUM FLUORIDE

CAS Number
12125-01-8
Function
Antiplaque agent; oral care (supports enamel remineralization)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.15%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” FDA regulates fluoride as OTC anticaries drug ingredient (21 CFR 355)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Ammonium Fluoride. 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.1695.7 mg/kg bw/day oral rat oral REACH
LOAEL ca.4 mg/kg bw/day oral rat oral REACH
NOAEL ca.25 ppm oral rat oral REACH
LOAEL ca.100 ppm oral rat oral REACH
LOAEL ca.25 ppm oral rat oral REACH
LOAEL ca.50 ppm oral mouse oral REACH

GHS Hazard Classification

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

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. Corrosive on ingestion.
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 inhalation of its aerosol and by ingestion.

Expert Verdict

Acute toxicity if ingested in excess; strictly oral care only; mandatory concentration and labeling restrictions in EU.

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Concern Level: High

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is Ammonium Fluoride safe in cosmetics?

Acute toxicity if ingested in excess; strictly oral care only; mandatory concentration and labeling restrictions in EU. The EU classifies Ammonium Fluoride as "restricted". Safety rating: MODERATE. 6 toxicological study endpoint(s) are available in our database.

Is Ammonium Fluoride allowed in the EU?

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

What does Ammonium Fluoride do in cosmetics?

Ammonium Fluoride functions as: Antiplaque agent; oral care (supports enamel remineralization). It is classified as a cosmetic ingredient in our database. CAS number: 12125-01-8.

What is the Margin of Safety for Ammonium Fluoride?

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 Ammonium Fluoride?

The NOAEL (No Observed Adverse Effect Level) for Ammonium Fluoride is ca.1695.7 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.

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