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FD&C RED 4


image source: PubChem
Health Concerns of the Ingredient:
Overall Hazard
 
 
Cancer
 
 
Developmental &
reproductive toxicity
 
 
Allergies & immunotoxicity
 
 

About FD&C RED 4: FD&C Red 4 is a synthetic dye produced from petroleum; this dye is FDA-approved for use in food, pharmaceuticals and cosmetics.

This ingredient may be derived from animals. From PETA's Caring Consumer: Pigments from animal, plant, and synthetic sources used to color foods, cosmetics, and other products. Cochineal is from insects. Widely used FD&C and D&C colors are coaltar (bituminous coal) derivati ... read more

Function(s): Colorant; COSMETIC COLORANT

Synonym(s): RED 4, FD&C RED NO. 4; 12101 RED; 1306 RED; 4R PURPLE; C.I. 14700; C.I. FOOD RED 1; C.I. FOOD RED 1, DISODIUM SALT; CERTICOL PONCEAU SXS; CERVEN POTRAVINARSKA 1 (CZECH) ; CRIMSON 4R; DYE FD & C RED NO. 4

Use restrictions

Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCosIng
Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive approved by FDA for use in cosmetics: external use only (only for products for use around the mouth, lips, eyes, or on damaged skin)FDA Color Additive Status
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - CosIng

Cancer

Concern Reference
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsInt'l Agency for Research on Cancer (IARC) - Carcinogens

Data gaps

Concern Reference
74 studies in PubMed science library may include information on the toxicity of this chemical see search results ->NLM PubMed

Organ system toxicity (non-reproductive)

Concern Reference
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Persistence and bioaccumulation

Concern Reference
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Ecotoxicology

Concern Reference
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Data Sources

CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
European Commission. 2013. Cosing, the European Commission database with information on cosmetic substances and ingredients. Accessed on March 1, 2013 at http://ec.europa.eu/consumers/cosmetics/cosing/ .
FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
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.
IARC (International Agency for Research on Cancer). 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99 (a total of 935 agents, mixtures and exposures).
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
NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.

About the Skin Deep® ratings

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer

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