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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: Ingredients linked to cancer in government, industry or academic studies or assessments.
Developmental & Reproductive Toxicity
Developmental and reproductive toxicity: Ingredients linked to developmental and reproductive toxicity, a broad class of health effects that range from infertility and reproductive organ cancers to birth defects and developmental delays in children.
Allergies & Immunotoxicity
Allergies and immunotoxicity: Ingredients linked to harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissue in the body.
Products with this Ingredient
| lipstick | 193 products |
| eye liner | 130 products |
| body wash/cleanser | 113 products |
| lip gloss | 101 products |
| eye shadow | 100 products |
| conditioner | 97 products |
| bath oil/salts/soak | 91 products |
| shampoo | 86 products |
| liquid hand soap | 79 products |
| nail polish | 48 products |
| fragrance for women | 37 products |
| moisturizer | 34 products |
| facial moisturizer/treatment | 29 products |
| bronzer/highlighter | 28 products |
| brow liner | 27 products |
| mask | 26 products |
| serums & essences | 25 products |
| blush | 24 products |
| glitter | 23 products |
| fragrance for men | 22 products |
| exfoliant/scrub | 20 products |
| hand sanitizer | 18 products |
| lip liner | 18 products |
| facial cleanser | 18 products |
| hair styling aide | 18 products |
| mouthwash | 14 products |
| bubble bath | 14 products |
| after sun product | 10 products |
| body firming lotion | 10 products |
| hair color and bleaching | 10 products |
| body spray | 9 products |
| makeup primer | 8 products |
| foundation | 8 products |
| bar soap | 8 products |
| moisturizer with SPF | 8 products |
| styling gel/lotion | 7 products |
| detangler | 7 products |
| lip balm with SPF | 7 products |
| sunless tanning | 7 products |
| lip plumper | 6 products |
| toners/astringents | 6 products |
| around-eye cream | 6 products |
| hair treatment/serum | 5 products |
| toothpaste | 5 products |
| beach & sport sunscreen | 5 products |
| concealer | 4 products |
| foot moisturizer | 3 products |
| after shave | 3 products |
| makeup remover | 3 products |
| 3 products | |
| foot cleansing | 3 products |
| shaving cream | 3 products |
| shaving cream (men's) | 2 products |
| antiperspirant/deodorant (men's) | 2 products |
| baby bubble bath | 2 products |
| anti-aging | 1 products |
| tooth whitening | 1 products |
| hair relaxer | 1 products |
| lip balm | 1 products |
| hair spray | 1 products |
| antiperspirant/deodorant | 1 products |
| baby oil | 1 products |
| nail treatment | 1 products |
| baby shampoo | 1 products |
| mascara | 1 products |
| other eye makeup | 1 products |
| damaged skin treatment | 1 products |
Contamination concerns
| Chemical |
|---|
| BIPHENYL-2-YLAMINE |
| CADMIUM (pyrophoric) |
Persistence and bioaccumulation
| Concern | Reference |
|---|---|
| Persistent or bioaccumulative and moderate to high toxicity concern in humans | Environment Canada Domestic Substance List |
| Not suspected to be persistent | Environment Canada Domestic Substance List |
| Not suspected to be bioaccumulative | Environment Canada Domestic Substance List |
Allergies/immunotoxicity
| 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)
| Concern | Reference |
|---|---|
| Classified as medium human health priority | Environment 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 harmful | Environment Canada Domestic Substance List |
Neurotoxicity
| 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
| 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 gaps | 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 |
| 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
| 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
| 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
| Concern | Reference |
|---|---|
| 370 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Ecotoxicology
| Concern | Reference |
|---|---|
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
Multiple, additive exposure sources
| Concern | Reference |
|---|---|
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
Informational
| 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 | FDA 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 Administration | CTFA 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.
- Products with the EWG VERIFIED mark have met the program’s impurity restrictions based on EWG review of company data.
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