Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Sodium Fluoride

INCI: SODIUM FLUORIDE

CAS Number
7681-49-4
Function
antiplaque agent and oral care ingredient in cosmetic products
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No specific restrictions

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Sodium 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.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.

Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. Ingestion could cause hypocalcaemia and hypokalaemia. This may result in central nervous system disorders and cardiac disorders.
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

Sodium Fluoride is a restricted ingredient in the EU with concentration limits for oral care use; permitted in the US with established safety guidelines for cosmetic applications.

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Concern Level: Moderate

Regulatory Flags

EU Restricted CMR endocrine_disruptor eu_children_restricted fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Sodium Fluoride safe in cosmetics?

Sodium Fluoride is a restricted ingredient in the EU with concentration limits for oral care use; permitted in the US with established safety guidelines for cosmetic applications. The EU classifies Sodium Fluoride as "restricted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.

Is Sodium Fluoride allowed in the EU?

Sodium Fluoride EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Fluoride do in cosmetics?

Sodium Fluoride functions as: antiplaque agent and oral care ingredient in cosmetic products. It is classified as a Cosmetic Ingredient in our database. CAS number: 7681-49-4.

What is the Margin of Safety for Sodium Fluoride?

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 Sodium Fluoride?

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

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