IRON OXIDES || Skin Deep: Cosmetic Safety Reviews

IRON OXIDES

Colorant; COSMETIC COLORANT

SCORE

	2	low hazard
	85%	data gap
(why scores have changed)

Also listed as

BLACK OXIDE OF IRON; BROWN IRON OXIDE; CI 77489; IRON OXIDE RED 10-34-PC-2045; RED IRON OXIDE; SYNTHETIC IRON OXIDE; YELLOW IRON OXIDE; YELLOW OXIDE OF IRON; IRON BLACK OXIDE; IRON YELLOW OXIDE; IRON OXIDE

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: Persistence and bioaccumulation, Enhanced skin absorption
	See products containing IRON OXIDES

About IRON OXIDES: Iron Oxides is an inorganic compound consisting of any one or combinations of syntheticallyprepared iron oxides, including the hydrated forms. See "Regulatory and Ingredient Use Information," forColorants in Volume 1, Introduction, Part A. To identify the colorant meeting the requirements for labelingpurposes in the US, the INCI Name Iron Oxides must be used. To identify the colorant allowed for use inthe European Union (EU), the INCI Names CI 77489, CI 77491, CI 77492 or CI 77499 must be usedexcept for hair dye products.

IRON OXIDES has reported used in the following product types: foundation (1541); lipstick (1103); eye shadow (1063); lip gloss (664); sunscreen: makeup (655); mascara (611); facial powder (575); eye liner (479); blush (467); nail polish (435)

Persistence and bioaccumulation

type of concern

product conditions

reference

Persistent, bioaccumulative in wildlife and humans

National Library of Medicine HazMap

Persistent, bioaccumulative in wildlife

National Library of Medicine HazMap

Enhanced skin absorption

type of concern	product conditions	reference
Suspected nano-scale ingredients with potential to absorb into the skin		Nanomaterial Database

Data gaps

type of concern	product conditions	reference
777 studies in PubMed science library may include information on the toxicity of this chemical see search results ->		PubMed

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

Organ system toxicity (non-reproductive)

type of concern	product conditions	reference
Classified as not expected to be potentially toxic or harmful		Environmental Canada Domestic Substance List

Ecotoxicology

type of concern	product conditions	reference
Not suspected to be an environmental toxin		Environmental Canada Domestic Substance List

Government, industry, academic studies and classifications

government/industry list/academic study	appears on list as	classification(s)
FDA Color Additive Status	SYNTHETIC IRON OXIDE	Cosmetics: U; Food: Y; Drugs: Y; Eye: U
FDA Color Additive Status	IRON OXIDES	•Color additive approved by FDA for use in cosmetics •Color additive approved by FDA for cosmetics used around eyes
FDA Everything Added to Food	IRON OXIDE	• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List	IRON OXIDE	•This chemical was NOT flagged by CEPA for further attention. The chemical was flagged for suspected persistence.
CTFA International Cosmetic Ingredient Dictionary and Handbook	IRON OXIDES	•Color Additives - Exempt from Batch Certification by the U.S. Food and Drug Administration
National Library of Medicine HazMap	IRON OXIDE	•PEL (OSHA) - Permissible exposure limit (OSHA): 10 mg/m3, fume; •Bioaccumulates: Yes; •TLV (ACGIH) - Threshold limit value (ACGIH): 5 mg/m3, as Fe, dust and fume; •IDLH (NIOSH) - Immediately Dangerous to Life or Health: 2500 mg/m3, as Fe; •MAK - Maximum Allowable Concentration (Federal Republic of Germany): 1.5 mg/m3, respirable fraction;
Nanomaterial Database	IRON OXIDE	•potential nano-scale ingredient

references

government/industry list/academic study	reference
FDA Color Additive Status	FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
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.
CTFA International Cosmetic Ingredient Dictionary and Handbook	CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
National Library of Medicine HazMap	NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
Nanomaterial Database	NanoWerk. 2007. Nanomaterial Database. Available online: http://www.nanowerk.com/phpscripts/n_dbsearch.php

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IRON OXIDES

Colorant; COSMETIC COLORANT

SCORE

Also listed as

Persistence and bioaccumulation

Enhanced skin absorption

Data gaps

Multiple, additive exposure sources

Organ system toxicity (non-reproductive)

Ecotoxicology

Government, industry, academic studies and classifications

references

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