TETRASODIUM EDTA || Skin Deep: Cosmetic Safety Reviews

TETRASODIUM EDTA

Chelating Agent

SCORE

	2	low hazard
	81%	data gap
(why scores have changed)

Also listed as

EDETATE SODIUM; N,N'-1,2-ETHANEDIYLBIS [N- (CARBOXYMETHYL) GLYCINE] , TETRASODIUM SALT; GLYCINE, N,N'-1,2-ETHANEDIYLBIS [N- (CARBOXYMETHYL) -, TETRASODIUM SALT; SODIUM EDETATE; TETRASODIUM EDETATE; TETRASODIUM EDETATE DIHYDRATE; TETRASODIUM EDE TATE TETRAHYDRATE; TETRASODIUM ETHYLENE DIAMINE TETRAACETATE; TETRASODIUM SALT N,N'-1,2-ETHANEDIYLBIS [N- (CARBOXYMETHYL) GLYCINE] ; TETRASODIUM SALT GLYCINE, N,N'-1,2-ETHANEDIYLBIS [N- (CARBOXYMETHYL) -; N,N'-1,2-ETHANEDIYLBIS [N- (CARBOXYMETHYL) - TETRASODIUM SALT GLYCINE

Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

This ingredient:
	Cancer
	Developmental/reproductive toxicity
	Violations, restrictions & warnings
	Allergies/immunotoxicity
	Contamination concerns
	Other strong concerns for this ingredient: Enhanced skin absorption, Occupational hazards
	Other moderate concerns for this ingredient: Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
	Lesser or emerging concerns for this ingredient: Data gaps
	See products containing TETRASODIUM EDTA

About TETRASODIUM EDTA: Tetrasodium EDTA is the substituted amine.

TETRASODIUM EDTA has reported used in the following product types: shampoo (233); facial moisturizer/treatment (208); body wash/cleanser (205); foundation (174); moisturizer (154); facial cleanser (120); anti-aging (119); sunscreen: makeup (111); bar soap (109); eye shadow (93)

Occupational hazards

type of concern	product conditions	reference
Allowed workplace exposures restricted to low doses		European Union - Classification & Labelling

Organ system toxicity (non-reproductive)

type of concern

product conditions

reference

Limited evidence of eye toxicity

products for use around the eyes

European Union - Classification & Labelling

Classified as expected to be toxic or harmful

Environmental Canada Domestic Substance List

Irritation (skin, eyes, or lungs)

type of concern	product conditions	reference
One or more animal studies show skin irritation at low doses		RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972

Multiple, additive exposure sources

type of concern	product conditions	reference
Designated as safe for general or specific, limited use in food		FDA Everything Added to Food

Enhanced skin absorption

type of concern	product conditions	reference
Penetration enhancer		Cosmetic Ingredient Review Assessments

Data gaps

type of concern	product conditions	reference
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		Cosmetic Ingredient Review Assessments
988 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
European Union - Classification & Labelling	TETRASODIUM ETHYLENE DIAMINE TETRAACETATE	•Harmful •Risk of serious damage to eyes
Cosmetic Ingredient Review Assessments	TETRASODIUM EDTA	•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR) •Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product • • •Penetration enhancer - alters skin structure, allows other chemicals to penetrate deeper into the skin
FDA Everything Added to Food	EDTA, TETRASODIUM	• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List	GLYCINE, N,N'-1,2-ETHANEDIYLBIS[N-(CARBOXYMETHYL)-, TETRASODIUM SALT	•This chemical was deemed a moderate human health priority and was flagged by CEPA for further attention.
IFRA Fragrance Ingredient List	GLYCINE, N,N'-1,2-ETHANEDIYLBIS[N-(CARBOXYMETHYL)-, TETRASODIUM SALT	•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972	TETRASODIUM EDTA	• sense organ - Primary eye irritant (rabbit ) • skin - Primary skin irritant (rabbit )
RTECS^®- AMA Archives of Ophthalmology 1952	TETRASODIUM EDTA	• sense organ - Primary eye irritant (rabbit )
RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V 2002	TETRASODIUM EDTA	• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS^®- Revue d'Epidemiologie, Medecine Sociale et Sante Publique 1962	TETRASODIUM EDTA	• kidney or renal system - Changes in tubules (including acute renal failure, acute tubular (mouse LD50)

references

government/industry list/academic study	reference
European Union - Classification & Labelling	CPS&Q (Consumer Products Safety & Quality) formely known as ECB (European Chemicals Bureau). 2008. Classification and Labelling: Chemicals: Annex VI of Directive 67/548/EEC through the 31st ATP.
Cosmetic Ingredient Review Assessments	CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
FDA Everything Added to Food	FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
Environmental Canada Domestic Substance List	EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
IFRA Fragrance Ingredient List	IFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25
RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J 1972	RTECS^®- "Sbornik Vysledku Toxixologickeho Vysetreni Latek A Pripravku," Marhold, J.V., Institut Pro Vychovu Vedoucicn Pracovniku Chemickeho Prumyclu Praha, Czechoslovakia, 1972 -,306,1972
RTECS^®- AMA Archives of Ophthalmology 1952	RTECS^®- AMA Archives of Ophthalmology. (Chicago, IL) V.44(4)-63, 1950-60. For publisher information, see AROPAW. 48,681,1952
RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V 2002	RTECS^®- International Journal of Toxicology (Continous: Journal of the American College of Toxicology,Taylor & Francis Health Sciences) V.16- 1997- 21,95,2002
RTECS^®- Revue d'Epidemiologie, Medecine Sociale et Sante Publique 1962	RTECS^®- Revue d'Epidemiologie, Medecine Sociale et Sante Publique. (Masson Editeur, 120 Blvd. Saint-Germain, F-75280 Paris Cedex O6, France) V.1- 1953- 10,391,1962

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