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FD&C Red No. 4 (CI 14700)

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high) and Endocrine disruption (low)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW

Products with this Ingredient

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bath oil/salts/soak22 products
serums & essences15 products
body wash/cleanser14 products
fragrance for women13 products
facial moisturizer/treatment11 products
bar soap9 products
liquid hand soap9 products
lipstick8 products
moisturizer7 products
hair styling aide7 products
bubble bath5 products
shampoo5 products
moisturizer with SPF5 products
facial cleanser4 products
makeup primer4 products
mask4 products
fragrance for men3 products
toners/astringents3 products
hair color and bleaching3 products
conditioner2 products
hand sanitizer2 products
body spray2 products
sunless tanning2 products
exfoliant/scrub2 products
after shave1 products
shaving cream (men's)1 products
body firming lotion1 products
beard oil1 products

Use restrictions

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Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCosIng
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCTFA International Cosmetic Ingredient Dictionary and Handbook
Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive approved by FDA for use in cosmetics: external use onlyFDA Color Additive Status
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - anyCosIng

Cancer

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Concern Reference
A peer-reviewed article reports evidence of potential carcinogenicity from in vitro testing.P J. Price, W. A. Suk, A. E. Freeman, W. T. Lane, R. L. Peters, M. L. Vernon & R. J. Huebner. 1978. In vitro and in vivo indications of the carcinogenicity and toxicity of food dyes. International journal of cancer 21(3), 361-7.
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsWorld Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 8, Suppl. 7 ;1987
IARC Group 3 (no cancer link)International Agency for Research on Cancer (IARC) 2012. Agents classified by the IARC Monographs (through Volume 127). Appears as: CAS: 4548-53-2; Name: Ponceau SX
This substance was not mutagenic in vitro.K T. Chung, G. E. Fulk & A. W. Andrews. 1981. Mutagenicity testing of some commonly used dyes. Applied and environmental microbiology 42(4), 641-8.

Endocrine disruption

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Concern Reference
Evidence of endocrine activity in cellular assays.National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 4548-53-2; Chemical_Name: FD&C Red 4

Data gaps

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Concern Reference
74 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Ecotoxicology

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

Informational

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Concern Reference
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color additive approved by FDA for use in cosmetics: external use onlyFDA Color Additive Status
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - The substance was formerly approved as a food additive but is now banned; there may be some toxicology data available.FDA Everything Added to Food
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

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

Persistence and bioaccumulation

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

Data Sources

  • 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/ .
  • 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.
  • P J. Price, W. A. Suk, A. E. Freeman, W. T. Lane, R. L. Peters, M. L. Vernon & R. J. Huebner. 1978. In vitro and in vivo indications of the carcinogenicity and toxicity of food dyes. International journal of cancer 21(3), 361-7.
  • World Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 8, Suppl. 7 ;1987
  • International Agency for Research on Cancer (IARC) 2012. Agents classified by the IARC Monographs (through Volume 127). Appears as: CAS: 4548-53-2; Name: Ponceau SX
  • K T. Chung, G. E. Fulk & A. W. Andrews. 1981. Mutagenicity testing of some commonly used dyes. Applied and environmental microbiology 42(4), 641-8.
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 4548-53-2; Chemical_Name: FD&C Red 4
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.

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