Is Tetrasodium EDTA safe in cosmetics?
Tetrasodium EDTA has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Tetrasodium EDTA
INCI: TETRASODIUM EDTA
Tetrasodium EDTA (CAS 64-02-8) is a cosmetic cosmetic ingredient functioning as Chelating agent; metal ion sequestrant; preservative booster; antimicrobial. EU Regulation 1223/2009 status: permitted; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 64-02-8 →
Auto-generated CPSR Part A draft with source citations
Function
Chelating agent; metal ion sequestrant; preservative booster; antimicrobial synergist
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted under FD&C Act general provisions. No pre-market approval required. CIR concluded safe as used. Disodium EDTA (related salt) approved as color additive diluent under 21 CFR Part 73. Not GRASE-classified for sunscreen drug products.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Tetrasodium EDTA.
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Pictograms
Excl markWarn
Hazard Statements
Harmful if swallowed Causes mild skin irritation Causes serious eye irritation
Short-term Exposure Effects
The substance is irritating to the eyes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Tetrasodium EDTA, relevant to systemic exposure and MoS calculations.
Absorption %
0.1-0.5%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
380.2 Da
Log P
-7.2
Systemic Absorption
minimal
Topical Bioavailability
0.05-0.2%
Safety Margin Factor
minimal
Vehicle Dependent
Yes — absorption varies by formulation
Source: CIR
EPA ToxValDB — Toxicity Values
2 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | ~2700 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | =2581 mg/kg | Rat | oral | - | ECHA IUCLID |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantCorrosive
Hazard Class and Category
Acute Tox. 4 *; Eye Dam. 1
Hazard Statements
- H302 Harmful if swallowed
- H318 Causes serious eye damage
Inserted via ATP: ATP01
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
GROUP; SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Shampoo | 0.05–0.2 | 0.5 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
anti_pollution
{"cas_number": "64-02-8", "ingredient_class": "heavy_metal_chelator", "primary_mechanism": "chelation", "pollution_types_targeted": "heavy_metals", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_…
baby_pediatric
{"cas_number": "64-02-8", "ingredient_class": "other", "pediatric_safety_rating": "good", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Tetrasodium, preferred baby", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Chelator/buffer function…
dermal_absorption
{"molecular_weight_da": "380.2", "log_p_value": "-7.2", "skin_penetration_level": "surface", "penetration_depth": "surface only", "absorption_pct": "0.1-0.5", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "0.05-0.2", "safety_margin_factor": "minimal", "source": "…
ecotoxicity
{"biodegradable": "no", "biodegradation_days": "non-biodegradable", "bioaccumulative": "yes", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "unknown", "marine_toxicity": "metal chelation", "freshwater_toxicity": "environmental metal release", "soil_toxicity": "contamination", "endocrine_disruptor": "no", "persistent_organic_pollutant": "yes", "microplastic": "no", "nano_particle": "no",…
pediatric_safety
{"safe_for_newborn_0_6m": "yes", "safe_for_infant_6_12m": "yes", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.5", "adult_max_concentration_pct": "0.5", "pediatric_dermal_absorption_factor": "minimal", "diaper_area_safe": "yes", "pediatric_allergy_prevalence": "low", "banned_in_children_products_eu": "no", "banne…
ph_stability
{"optimal_ph_min": "6.0", "optimal_ph_max": "12.0", "stable_ph_min": "5.5", "stable_ph_max": "12.0", "ph_dependent_function": "Works at higher pH than disodium", "formulation_note": "Alkaline formulations", "source": "Formulation literature"}
preservative
{"preservative_class": "Chelator", "antimicrobial_spectrum_bacteria_gp": "Weak", "antimicrobial_spectrum_bacteria_gn": "Weak", "antimicrobial_spectrum_yeast": "Weak", "antimicrobial_spectrum_mold": "Weak", "mic_staph_aureus_ppm": "8500", "mic_e_coli_ppm": "8500", "mic_pseudomonas_ppm": "8500", "mic_candida_albicans_ppm": "8500", "mic_aspergillus_niger_ppm": "8500", "challenge_test_pass_concentrati…
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-scaling agent
Chelating agent
Cleaning agent
Fragrance
Preservative
Processing aids not otherwise specified
Thickening agent
Regulatory List Membership (3)
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Tetrasodium EDTA.
Regulatory Flags
eu-unrestricted
cir-approved
non-sensitizing
penetration-enhancer
eu_children_restricted
ifra_fragrance
fda_food_additive
Chemical Function
Chelating agent
Regulatory Lists
Canada; pharmaceutical
Europe; Specialty occupational products
inert_ingredient; non_food_use; Pesticides
Europe; Vehicle - car interior
CEDI
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
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
EDETATE SODIUM
ChEMBL ID
CHEMBL2104344
Max Phase
-1
Frequently Asked Questions
Is Tetrasodium EDTA allowed in the EU?
Tetrasodium EDTA EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Tetrasodium EDTA do in cosmetics?
Tetrasodium EDTA functions as: Chelating agent; metal ion sequestrant; preservative booster; antimicrobial synergist. It is classified as a cosmetic ingredient in our database. CAS number: 64-02-8.
Is Tetrasodium EDTA classified as hazardous under GHS?
Tetrasodium EDTA carries a GHS signal word of "WARNING". Hazard statements: Harmful if swallowed Causes mild skin irritation Causes serious eye irritation. 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 — at cosmetic use concentrations, hazard thresholds may not be met.
Is Tetrasodium EDTA used outside cosmetics?
Tetrasodium EDTA also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Tetrasodium EDTA compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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