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Data: Limited

Fd&C Red No. 40 (Ci 16035)

  • Products with the EWG VERIFIED mark have met the program’s impurity restrictions based on EWG review of company data.

IMAGE SOURCE: PubChem

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Other Concerns

Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (low), and Contamination concerns (high)

SYNONYMS

● 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)-, DISODIUM SALT
● 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]-, DISODIUM SALT
● 2NAPHTHALENESULFONIC ACID, 6HYDROXY5[(2METHOXY5METHYL4SULFOPHENYL)AZO], DISODIUM SALT
● 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)- DISODIUM SALT 2-NAPHTHALENESULFONIC ACID
● 6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]- DISODIUM SALT 2-NAPHTHALENESULFONIC ACID
● 6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]-2-NAPHTHALENESULFONIC ACID, DISODIUM SALT
● ALLURA RED AC
● C.I. FOOD RED 17:1
● CI 16035
● D&C RED 40
● DISODIUM 6-HYDROXY-5-[(2-METHOXY-4-SULPHONATO-M-TOLYL)AZO]NAPHTHALENE-2-SULPHONATE
● DISODIUM SALT 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)-
● DISODIUM SALT 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]-
● DISODIUM SALT 6-HYDROXY-5-[(2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO]-2-NAPHTHALENESULFONIC ACID
● FD&C RED 40
● FD&C RED NO. 40
● FD&C RED NO. 40 (CI 16035)
● FOOD RED 17
● RED 40

Restricted

Restricted: EWG VERIFIED products cannot contain this ingredient without adequate substantiation


FD&C Red 40 is a synthetic dye produced from petroleum; this dye is FDA-approved for use in food, pharmaceuticals and cosmetics.

Common concerns

See how this product scores for common concerns.

  • LOW
    Cancer
  • MODERATE
    Allergies & Immunotoxicity
  • LOW
    Developmental and Reproductive Toxicity
  • LOW
    Use Restrictions

Ingredient concerns

  • CONCERNS
  • DATA SOURCES

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Contamination concerns

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Allergies/immunotoxicity

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CONCERN REFERENCE
Human any toxicant or allergen - moderate evidenceOpen scientific literature
One or more human case studies show possible any or allergenic effectsOpen scientific literature
Not likely to be a any toxicant or allergenic in humansOpen scientific literature

Neurotoxicity

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CONCERN REFERENCE
One or more human case studies show possible any effectsOpen scientific literature
One or more animal studies show any effects at moderate dosesOpen scientific literature

Persistence and bioaccumulation

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CONCERN REFERENCE
Found to be persistent and bioaccumulative in wildlifeOpen scientific literature
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List
Not suspected to be persistentEnvironment Canada Domestic Substance List

Cancer

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CONCERN REFERENCE
Cancer - weight of evidence unknown/unassessedOpen scientific literature
One or more in vitro tests on mammalian cells show positive mutation resultsOpen scientific literature

Endocrine disruption

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CONCERN REFERENCE
Associated with endocrine disruptionOpen scientific literature

Multiple, additive exposure sources

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CONCERN REFERENCE
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Organ system toxicity (non-reproductive)

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CONCERN REFERENCE
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Irritation (skin, eyes, or lungs)

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CONCERN REFERENCE
Not likely to be a any irritant in humansOpen scientific literature

Informational

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CONCERN REFERENCE
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color Additives - Batch Certified by the U.S. Food and Drug AdministrationCTFA International Cosmetic Ingredient Dictionary and Handbook
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color additive approved by FDA for use in cosmeticsFDA Color Additive Status

Ecotoxicology

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CONCERN REFERENCE
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Data gaps

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CONCERN REFERENCE
156 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Developmental/reproductive toxicity

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CONCERN REFERENCE
Not likely to be a any toxicant in humansOpen scientific literature
  • Open scientific/peer reviewed literature
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.

Understanding scores

Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. The Skin Deep® scoring system was designed to help the public understand whether a product is safe to use or whether it contains ingredients of concern.

Every product and ingredient in Skin Deep gets a two-part score – one for hazard and one for data availability. The safest products score well by both measures, with a low hazard rating and a fair or better data availability rating.

HOW WE DETERMINE SCORES

Hazard score

The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. The EWG VERIFIED® mark means a product meets EWG’s strictest criteria for transparency and health.

Score legend

Data availability

The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.

NONE LIMITED FAIR GOOD ROBUST
Low Availability
Moderate Availability
High Availability

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