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FD&C YELLOW 5 (CI 19140) ALUMINUM LAKE

Score:

Data: None

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (low), 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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lipstick1848 products
eye shadow526 products
lip gloss507 products
nail polish370 products
lip balm332 products
blush244 products
lip liner187 products
eye liner166 products
bronzer/highlighter105 products
concealer93 products
facial powder66 products
brow liner60 products
foundation51 products
bath oil/salts/soak45 products
lip plumper40 products
lip balm with SPF24 products
mascara23 products
exfoliant/scrub19 products
glitter16 products
makeup primer15 products
setting powder/spray13 products
10 products
body wash/cleanser7 products
hair color and bleaching5 products
other eye makeup5 products
bar soap5 products
moisturizer4 products
mask4 products
mouthwash4 products
nail treatment3 products
recreational sunscreen2 products
facial cleanser2 products
body firming lotion1 products
makeup remover1 products
BB cream1 products
fragrance for men1 products
eyelash glue1 products
body oil1 products
body art1 products
toothpaste1 products
bubble bath1 products

Contamination concerns

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Persistence and bioaccumulation

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Concern Reference
Deemed a human health priority even though it did not meet the strict criteria of the categorization exercise of CEPA. Flagged for persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-04455; Chemical_Name: 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl) -4-[(4-sulfophenyl)azo]-, trisodium salt; ; CAS: 1934-21-0
This chemical was NOT flagged by CEPA for further attention. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-08070; Chemical_Name: C.I. Pigment yellow 100; ; CAS: 12225-21-7

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.

Organ system toxicity (non-reproductive)

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Concern Reference
Deemed a human health priority even though it did not meet the strict criteria of the categorization exercise of CEPA. Flagged for persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-04455; Chemical_Name: 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl) -4-[(4-sulfophenyl)azo]-, trisodium salt; ; CAS: 1934-21-0
Limited evidence of any toxicityKlaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
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.
This chemical was NOT flagged by CEPA for further attention. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-08070; Chemical_Name: C.I. Pigment yellow 100; ; CAS: 12225-21-7

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.

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.
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.

Use restrictions

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Concern Reference
Color additive provisionally approved for use in cosmeticsUS. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;

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.

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

Data gaps

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

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 Lakes - 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
This chemical was NOT flagged by CEPA for further attention. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-08070; Chemical_Name: C.I. Pigment yellow 100; ; CAS: 12225-21-7

Data Sources

  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-04455; Chemical_Name: 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl) -4-[(4-sulfophenyl)azo]-, trisodium salt; ; CAS: 1934-21-0
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-08070; Chemical_Name: C.I. Pigment yellow 100; ; CAS: 12225-21-7
  • 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.
  • 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.
  • Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
  • 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.
  • 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.
  • 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.
  • 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.
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
  • 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.
  • 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.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.

About this Ingredient's Score Range

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