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Sodium Fluoride

Controversial1 products
CAS
7681-49-4
EC
2316678
PubChem CID
5235
Molecular Formula
FNa
Molecular Weight
41.9882 g/mol

Strengthens tooth enamel. Can be harmful if ingested in high quantities; found in limited amounts in toothpastes.

What does it do?

An oral care ingredient that helps strengthen tooth enamel.

Details

Sodium fluoride is a mineral salt that strengthens tooth enamel and prevents cavities; it is widely used in toothpastes. It can be toxic if ingested in high amounts, therefore the amount in toothpastes is strictly limited. It is recommended for use under parental supervision to ensure small children do not swallow the toothpaste.

Where is it found?

Function & Use

Oral Care

Antiplaque

Regulatory note

  • EU 1223/2009 Annex IIIRestricted

    Maximum concentration: 0.15%

Industry GHS notices (PubChem)

These are industry self-reports to ECHA, not our regulatory assessment.

  • H301(97.1%)- Toxic if swallowed
  • H314- Causes severe skin burns and eye damage
  • H315(97.9%)- Causes skin irritation
  • H318- Causes serious eye damage
  • H319(97.9%)- Causes serious eye irritation
  • H341- Suspected of causing genetic defects
  • H361- Suspected of damaging fertility or the unborn child
  • H370- Causes damage to organs
  • H402- Harmful to aquatic life
PubChem CID 5235
The verdict isn’t ours: below is what ToxValDB (EPA Toxicity Value Database), SCCS (EU Scientific Committee on Consumer Safety) said, verbatim.

What The Sources Say

SCCS (EU Scientific Committee on Consumer Safety)3
Safety assessment

EU 1223/2009 Annex III — SCCS opinion: Opinion concerning the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 years

Safety assessment

EU 1223/2009 Annex III — SCCS opinion: Opinion on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years

Safety assessment

EU 1223/2009 Annex III — SCCS opinion: Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years

ToxValDB (EPA Toxicity Value Database)10
Hazard claimView source →

EPA ToxValDB skin/eye data — endpoint: Eye Irritation, classification: Eye Irrit. 2. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

Hazard claimView source →

EPA ToxValDB skin/eye data — endpoint: Skin Irritation, classification: Skin Irrit. 2. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

Hazard claimView source →

EPA ToxValDB skin/eye data — endpoint: Eye Irritation, classification: Category 1. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

Hazard claimView source →

EPA ToxValDB skin/eye data — endpoint: Skin Sensitization, classification: Classification not possible. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

Hazard claimView source →

EPA ToxValDB skin/eye data — endpoint: Eye Irritation, classification: Category 6.4A (Category 2A). Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

+5 more records.

Scientific References

  • Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 YearsSCCS — Scientific Committee on Consumer Safety
  • EPA CompTox Chemicals Dashboard — DSSTox identifiers mapped to CAS (2021r1)US EPA, Center for Computational Toxicology and Exposure
  • EU CosIng — Cosmetic Ingredient Database full exportEuropean Commission, DG GROW
  • OpenFDA Cosmetic Adverse Events (api.fda.gov/cosmetic/event)US FDA — unvalidated adverse event reports
  • Opinion concerning the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 yearsSCCS — Scientific Committee on Consumer Safety
  • Opinion on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 YearsSCCS — Scientific Committee on Consumer Safety
  • PubChem — CID-Synonym-filtered bulk + PUG REST propertiesNCBI / National Library of Medicine
  • ToxValDB — genotoxicityUS EPA — ToxValDB v97
  • ToxValDB — skin/eyeUS EPA — ToxValDB v97

Products Containing This Ingredient