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FD&C Yellow 5 (CI 19140)

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Neurotoxicity (moderate), Endocrine disruption (low), Persistence and bioaccumulation (moderate), Non-reproductive organ system toxicity (moderate), and Contamination concerns (high)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW_MODERATE

Products with this Ingredient

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lipstick165 products
body wash/cleanser89 products
eye liner87 products
bath oil/salts/soak78 products
conditioner65 products
shampoo60 products
liquid hand soap57 products
lip gloss43 products
eye shadow38 products
fragrance for women34 products
moisturizer25 products
facial moisturizer/treatment23 products
mask23 products
glitter23 products
serums & essences21 products
lip liner20 products
fragrance for men14 products
exfoliant/scrub14 products
facial cleanser13 products
blush10 products
bubble bath10 products
bronzer/highlighter9 products
brow liner9 products
hand sanitizer9 products
hair styling aide9 products
nail polish8 products
bar soap8 products
hair color and bleaching8 products
foundation8 products
after sun product8 products
moisturizer with SPF8 products
body firming lotion8 products
mouthwash7 products
lip balm with SPF7 products
sunless tanning7 products
detangler6 products
toners/astringents5 products
around-eye cream5 products
body spray5 products
beach & sport sunscreen5 products
styling gel/lotion4 products
toothpaste4 products
shaving cream3 products
hair treatment/serum3 products
makeup primer3 products
baby bubble bath2 products
foot cleansing2 products
foot moisturizer2 products
after shave2 products
makeup remover2 products
shaving cream (men's)1 products
tooth whitening1 products
antiperspirant/deodorant (men's)1 products
anti-aging1 products
lip plumper1 products
mascara1 products
baby shampoo1 products
other eye makeup1 products
lip balm1 products
hair spray1 products
antiperspirant/deodorant1 products
hair relaxer1 products
damaged skin treatment1 products

Contamination concerns

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Persistence and bioaccumulation

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Concern Reference
Persistent or bioaccumulative and moderate to high toxicity concern in humansEnvironment Canada Domestic Substance List
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Allergies/immunotoxicity

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Concern Reference
Review article concluded that chemical caused hypersensitivity reactions.Peer Reviewed Literature 2020. Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.. Appears as: Substance Name: FD&C YELLOW 5;
EFSA concludes that some sensitive individuals may experience allergic reactions at dose levels within the ADI.European Food Safety Authority 2009. Scientific Opinion on the re-evaluation Tartrazine (E 102). EFSA Journal 7(11), 1331.
Allergic reactions have been reported in humans.European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23. SCCNFP/0786/04.

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as medium human health priorityEnvironment Canada Domestic Substance List
Liver effects observed at high doses in mice.Stephanie K Meyer, George E. N. Kass, Peter G. Blain, Paul A. Jowsey, Faith M. Williams, Alistair C. Leitch, Andrew R. Axon, Anne F. Lakey, Philip M. E. Probert & Matthew C. Wright. 2017. Hepatic effects of tartrazine (E 102) after systemic exposure are independent of oestrogen receptor interactions in the mouse. Toxicology letters 273, 55-68.
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Neurotoxicity

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Concern Reference
Review article concluded that chemical can cause hyperactivity in children.Peer Reviewed Literature 2020. Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.. Appears as: Substance Name: FD&C YELLOW 5;
EFSA finds that there is "limited evidence" that Yellow 5 in a mixture with other synthetic colours and sodium benzoate has a "small and statistically significant effect on activity and attention in children selected from the general population."European Food Safety Authority 2009. Scientific Opinion on the re-evaluation Tartrazine (E 102). EFSA Journal 7(11), 1331.
A peer-reviewed study found that this substance caused neurobehavioral effects in animals at high doses.Toyohito Tanaka 2006. Reproductive and neurobehavioural toxicity study of tartrazine administered to mice in the diet. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 44(2), 179-87.
A peer-reviewed study found that this substance caused neurobehavioral effects in animals at high doses.Kamel, MM. & El-lethey, H.S. 2011. The Potential Health Hazard of Tartrazine and Levels of Hyperactivity, Anxiety-Like Symptoms, Depression and Anti-social behaviour in Rats. Journal of American Science 7(6), 1211-8.

Cancer

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Concern Reference
A review article conclused that this substance may be carcinogenic at high or cumulative exposures, which are unlikely to occur.Petra Amchova, Hana Kotolova & Jana Ruda-Kucerova 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22.
Genotoxicity observed in in vitro testing with human cells.Bruno Moreira Soares, Taíssa Maíra Thomaz Araújo, Jorge Amando Batista Ramos, Laine Celestino Pinto, Bruna Meireles Khayat, Marcelo De Oliveira Bahia, Raquel Carvalho Montenegro, Rommel Mario Rodríguez Burbano & André Salim Khayat 2015. Effects on DNA repair in human lymphocytes exposed to the food dye tartrazine yellow. Anticancer research 35(3), 1465-74.
Little evidence of genotoxicity in in vitro testing.European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23. SCCNFP/0786/04.
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
Not found to be carcinogenic in animal testing.European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23. SCCNFP/0786/04.
No genotoxicity observed in an in vivo assay with mice.Martine Poul, Gérard Jarry, Mostafa Ould Elhkim & Jean-Michel Poul 2009. Lack of genotoxic effect of food dyes amaranth, sunset yellow and tartrazine and their metabolites in the gut micronucleus assay in mice. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 47(2), 443-8.

Endocrine disruption

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Concern Reference
A peer-reviewed study reports this substance shows estrogenic activity in a human cell line.Andrew Axon, Felicity E B. May, Luke E. Gaughan, Faith M. Williams, Peter G. Blain & Matthew C. Wright. 2012. Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity. Toxicology 298(1-3), 40-51.
Possible endocrine activity suggested by cellular assays and models.National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 1934-21-0; Chemical_Name: FD&C Yellow 5

Developmental/reproductive toxicity

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Concern Reference
Developmental neurotoxicity observed in chicken embryos.Aysegul Ozdemir Ovalioglu, Talat Cem Ovalioglu, Gokhan Canaz, Aysegul Esen Aydin, Sema Arslan, Mehmet Sar & Erhan Emel 2020. Effects of Tartrazine on Neural Tube Development in the Early Stage of Chicken Embryos. Turkish neurosurgery 30(4), 583-587.
No developmental toxicity was observed in fish.Vani Joshi & Pancharatna Katti 1900. Developmental Toxicity Assay for Food Additive Tartrazine Using Zebrafish ( Danio rerio) Embryo Cultures. International journal of toxicology 37(1), 38-44.

Data gaps

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Concern Reference
370 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

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

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 cosmeticsFDA Color Additive Status
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

Data Sources

  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • Peer Reviewed Literature 2020. Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.. Appears as: Substance Name: FD&C YELLOW 5;
  • European Food Safety Authority 2009. Scientific Opinion on the re-evaluation Tartrazine (E 102). EFSA Journal 7(11), 1331.
  • European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23. SCCNFP/0786/04.
  • Stephanie K Meyer, George E. N. Kass, Peter G. Blain, Paul A. Jowsey, Faith M. Williams, Alistair C. Leitch, Andrew R. Axon, Anne F. Lakey, Philip M. E. Probert & Matthew C. Wright. 2017. Hepatic effects of tartrazine (E 102) after systemic exposure are independent of oestrogen receptor interactions in the mouse. Toxicology letters 273, 55-68.
  • Toyohito Tanaka 2006. Reproductive and neurobehavioural toxicity study of tartrazine administered to mice in the diet. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 44(2), 179-87.
  • Kamel, MM. & El-lethey, H.S. 2011. The Potential Health Hazard of Tartrazine and Levels of Hyperactivity, Anxiety-Like Symptoms, Depression and Anti-social behaviour in Rats. Journal of American Science 7(6), 1211-8.
  • Petra Amchova, Hana Kotolova & Jana Ruda-Kucerova 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22.
  • Bruno Moreira Soares, Taíssa Maíra Thomaz Araújo, Jorge Amando Batista Ramos, Laine Celestino Pinto, Bruna Meireles Khayat, Marcelo De Oliveira Bahia, Raquel Carvalho Montenegro, Rommel Mario Rodríguez Burbano & André Salim Khayat 2015. Effects on DNA repair in human lymphocytes exposed to the food dye tartrazine yellow. Anticancer research 35(3), 1465-74.
  • 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
  • Martine Poul, Gérard Jarry, Mostafa Ould Elhkim & Jean-Michel Poul 2009. Lack of genotoxic effect of food dyes amaranth, sunset yellow and tartrazine and their metabolites in the gut micronucleus assay in mice. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 47(2), 443-8.
  • Andrew Axon, Felicity E B. May, Luke E. Gaughan, Faith M. Williams, Peter G. Blain & Matthew C. Wright. 2012. Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity. Toxicology 298(1-3), 40-51.
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 1934-21-0; Chemical_Name: FD&C Yellow 5
  • Aysegul Ozdemir Ovalioglu, Talat Cem Ovalioglu, Gokhan Canaz, Aysegul Esen Aydin, Sema Arslan, Mehmet Sar & Erhan Emel 2020. Effects of Tartrazine on Neural Tube Development in the Early Stage of Chicken Embryos. Turkish neurosurgery 30(4), 583-587.
  • Vani Joshi & Pancharatna Katti 1900. Developmental Toxicity Assay for Food Additive Tartrazine Using Zebrafish ( Danio rerio) Embryo Cultures. International journal of toxicology 37(1), 38-44.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.

About this Ingredient's Score Range

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

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