Is Sodium Fluoride safe in cosmetics?
Sodium Fluoride has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 1 toxicological study endpoint(s) are available in our database.
Sodium Fluoride
Also known as: Fluoride, sodium, Sodium fluoride (NaF), Alcoa sodium fluoride, Caswell No. 769, Cavi-trol (+15 more)
INCI: SODIUM FLUORIDE
Sodium Fluoride (CAS 7681-49-4) is a cosmetic cosmetic ingredient functioning as antiplaque agent and oral care ingredient in cosmetic products. NOAEL 0.0166667 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 7681-49-4 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Sodium Fluoride is classified GHS Danger (H301, H315, H319) in the chemicals database but is restricted in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
antiplaque agent and oral care ingredient in cosmetic products
Safety Rating
MODERATE
Regulatory Status
EU EU Status
restricted
US US Status
permitted
US Notes
No specific restrictions
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Sodium Fluoride.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint 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 | =2.52 mg/kg bw/day | oral | Mouse | chronic | ToxValDB_ECHA_IUCLID |
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.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Sodium Fluoride across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Acute Toxicity
Hazard Class and Category
Acute Tox. 3 *; Skin Irrit. 2; Eye Irrit. 2
Hazard Statements
- H301 Toxic if swallowed
- H315 Causes skin irritation
- H319 Causes serious eye irritation
Inserted via ATP: CLP00
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Suspected
Evidence: Moderate
(2024)
Health effects: Yes
Affected pathways: Thyroid, Reproductive
Regulatory framework: REACH
Source list: II
Cosmetic-Specific Mechanism
Category: other
Receptor targets: TR, steroid hormone synthesis
LOEC: 1 µM
EU status: allowed (max 0.15% F)
inhibitor (thyroid iodine uptake); modulator (steroidogenesis)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (III - Restricted)
Product type: Oral products. Max: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %.
BRIN Brazil/India Cosmetics
India: Restricted · max 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Additional Jurisdictional Restrictions (6)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | restricted | 0.15 | Oral care products (toothpaste) |
| IN | restricted | 0.1 | toothpaste only |
| IN | restricted | 0.15 | toothpaste and oral care products |
| GCC | restricted | 0.15 | Oral hygiene products |
| CA | restricted | 1500 ppm F (adult dentifrice); 600 ppm F (children's dentifrice); 500 ppm F (mouthwash) | Oral care products only |
| TH | restricted | 0.11% as fluoride ion (NOT 0.15% ACD-wide) | All oral hygiene products (toothpaste, mouthwash) |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Toothpaste | 0.1–0.15 | 0.15 | FDA OTC |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
oral_care
{"cas_number": "7681-49-4", "ingredient_class": "fluoride_source", "function_primary": "Anti-caries agent", "function_secondary": "Remineralizing agent", "anti_caries_mechanism": "Fluoride ion incorporation into hydroxyapatite forming fluorapatite, reduces enamel solubility, inhibits bacterial metabolism", "fluoride_content_ppm_if_applicable": "1450-1500 typical", "fluoride_ion_release_profile": "…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Pharmaceutical
Thickening agent
Regulatory List Membership (3)
EU Restricted for Children (Cosmetics)
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Sodium Fluoride.
Regulatory Flags
EU Restricted
CMR
endocrine_disruptor
eu_children_restricted
fda_food_additive
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Sodium Fluoride by CAS number or substance name.
Studies
1
Lowest NOAEL
2.52 mg/kg bw/day
Highest NOAEL
2.52 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Fluoride, sodium
Sodium fluoride (NaF)
Alcoa sodium fluoride
Caswell No. 769
Cavi-trol
Disodium difluoride
EINECS 231-667-8
EPA Pesticide Chemical Code 075202
Flozenges
Fluonatril
Fluorident
Fluorineed
Fluorinse
Fluoritab
Fluor-O-kote
Fluorocid
Flura-gel
Flura-loz
Flurcare
Gelution
Chemical Function
Pharmaceutical
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additive
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
active_ingredient; Europe; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
SODIUM FLUORIDE
ChEMBL ID
CHEMBL1528
Max Phase
4
Adverse Event Associations
2352
Frequently Asked Questions
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 NOAEL for Sodium Fluoride?
The NOAEL (No Observed Adverse Effect Level) for Sodium Fluoride is =2.52 mg/kg bw/day based on a chronic study via oral route in Mouse. Source: ToxValDB_ECHA_IUCLID.
Is Sodium Fluoride used outside cosmetics?
Sodium Fluoride also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Sodium Fluoride have different safety status in cosmetics vs industrial chemicals?
Sodium Fluoride is classified GHS Danger (H301, H315, H319) in the chemicals database but is restricted in EU cosmetics.
Compliance Tools
Check Sodium Fluoride compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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