Excellent Cosmetic Ingredient NOAEL Data Dermal Penetration

Disodium EDTA

Also known as: Glycine, N,N'-1,2-ethanediylbis[N-(carboxymethyl)-, disodium salt, CBC 50152966, Cheladrate, Disodium dihydrogen(ethylenedinitrilo)tetraacetate, Disodium edta, anhydrous (+15 more)

INCI: DISODIUM EDTA

Disodium EDTA (CAS 139-33-3) is a cosmetic cosmetic ingredient functioning as Chelating agent; metal ion sequestrant; preservative booster. Reported NOAEL =954 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 139-33-3 →

Auto-generated CPSR Part A draft with source citations
Function
Chelating agent; metal ion sequestrant; preservative booster
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
205-358-3

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes CIR Expert Panel concluded safe as used (2002, reaffirmed). GRAS as indirect food additive per 21 CFR 172.120 and 173.315. No pre-market FDA approval required for cosmetic use.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Disodium EDTA.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Disodium EDTA. 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 =954 mg/kg bw/day oral Rat developmental ToxValDB_ECHA_IUCLID
NOAEL =1000 mg/kg bw/day oral Rat reproduction developmental ToxValDB_ECHA_IUCLID
NOAEL =1125 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID

Dermal Penetration Profile

Skin absorption and penetration characteristics of Disodium EDTA, relevant to systemic exposure and MoS calculations.

Absorption %
0.2-1%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
336.2 Da
Log P
-5.8
Systemic Absorption
minimal
Topical Bioavailability
0.1-0.5%
Safety Margin Factor
minimal
Vehicle Dependent
Yes — absorption varies by formulation

Source: CIR

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LD50 =3735 mg/kg Rat oral - ECHA IUCLID
LD50 =3690 mg/kg Rat oral - ECHA IUCLID
LD50 =2800 mg/kg Rat oral - ECHA IUCLID
LEL ~30 mg/m3 Rat inhalation - ECHA IUCLID
LOAEC =30 mg/m3 Rat inhalation short-term ECHA IUCLID
LOAEC =15 mg/m3 Rat inhalation acute ECHA IUCLID
NOAEC >15 mg/m3 Rat inhalation acute ECHA IUCLID
NOAEC =3 mg/m3 Rat inhalation acute ECHA IUCLID
NOAEL =1000 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =1000 mg/kg-day Rat oral - ECHA IUCLID

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

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
Face Cream 0.05–0.1 0.2 CIR/VCRP
Body Lotion 0.05–0.1 0.2 CIR/VCRP

Additional Ingredient Properties

8 property records from structured ingredient metadata.

baby_pediatric
{"cas_number": "139-33-3", "ingredient_class": "other", "pediatric_safety_rating": "good", "minimum_age_months": "6", "neonatal_safe": "yes", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Disodium salt, chelator", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Chelator/buff…
deodorant
{"cas_number": "139-33-3", "ingredient_class": "other", "mechanism_of_action": "metal_ion_chelation", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "0", "odor_reduction_pct": "0", "bacteriostatic": "no", "bactericidal": "no", "microbiome_impact": "neutral", "axillary_microbiome_effect": "varies by ingredient", "MIC_value_if_antimicrobial": "varies", "astringency_l…
dermal_absorption
{"molecular_weight_da": "336.2", "log_p_value": "-5.8", "skin_penetration_level": "surface", "penetration_depth": "surface only", "absorption_pct": "0.2-1", "systemic_absorption": "minimal", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "0.1-0.5", "safety_margin_factor": "minimal", "source": "CIR…
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": "4.0", "optimal_ph_max": "10.0", "stable_ph_min": "3.5", "stable_ph_max": "11.0", "ph_dependent_function": "Most common EDTA salt", "formulation_note": "Chelates metals; boosts preservation", "source": "PMC 2023"}
preservative
{"preservative_class": "Chelator", "antimicrobial_spectrum_bacteria_gp": "No", "antimicrobial_spectrum_bacteria_gn": "No", "antimicrobial_spectrum_yeast": "No", "antimicrobial_spectrum_mold": "No", "challenge_test_pass_concentration_pct": "0.01-0.5", "optimal_pH_range": "3.0-11.0", "pH_dependent_efficacy": "Very low", "water_activity_threshold": "0.92", "oil_soluble_or_water_soluble": "Water-solub…
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "no", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv": …

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Antioxidant Biocide Chelating agent Flavouring and nutrient Preservative Surfactant (surface active agent) Viscosity modifier
Regulatory List Membership (3)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Disodium EDTA.

Regulatory Flags

cir-approved eu-permitted penetration-enhancer not-biodegradable cosmos-prohibited eco-concern hard-water-stable eu_children_restricted fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Disodium EDTA by CAS number or substance name.

Studies
3
Lowest NOAEL
954 mg/kg bw/day
Highest NOAEL
1125 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

Glycine, N,N'-1,2-ethanediylbis[N-(carboxymethyl)-, disodium salt CBC 50152966 Cheladrate Disodium dihydrogen(ethylenedinitrilo)tetraacetate Disodium edta, anhydrous Disodium ethylenediaminetetraacetic acid Disodium (ethylenedinitrilo)tetraacetic acid Disodium salt of EDTA Diso-Tate Edetic acid disodium salt EINECS 205-358-3 N,N'-1,2-Ethanediylbis(N-(carboxymethyl)glycine) disodium salt Ethylenebis(iminodiacetic acid) disodium salt (Ethylenedinitrilo)-tetraacetic acid disodium salt Kiresuto B NSC 2760 Perma kleer 50 crystals disodium salt Selekton B 2 Sequestrene sodium 2 Veresene disodium salt

Chemical Function

Chelating agent

Regulatory Lists

children; Europe; Personal care children; Europe; Personal care - specialized bath products - bubble bath Europe; Personal care Europe; Personal care Europe; Personal care Europe; Personal care Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener fracking; water active_ingredient; 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 and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
EDETATE DISODIUM ANHYDROUS
ChEMBL ID
CHEMBL1749
Max Phase
4
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Disodium EDTA
E Number
E386
ADI
2.5 mg/kg bw
Food Category
flavor_enhancer
View full food safety profile →

Frequently Asked Questions

Is Disodium EDTA safe in cosmetics?

Disodium EDTA has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 3 toxicological study endpoint(s) are available in our database.

Is Disodium EDTA allowed in the EU?

Disodium EDTA EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Disodium EDTA do in cosmetics?

Disodium EDTA functions as: Chelating agent; metal ion sequestrant; preservative booster. It is classified as a cosmetic ingredient in our database. CAS number: 139-33-3.

What is the NOAEL for Disodium EDTA?

The NOAEL (No Observed Adverse Effect Level) for Disodium EDTA is =954 mg/kg bw/day based on a developmental study via oral route in Rat. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Disodium EDTA used outside cosmetics?

Disodium EDTA also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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