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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: 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 | 1416 products |
| eye shadow | 405 products |
| lip gloss | 289 products |
| nail polish | 187 products |
| blush | 181 products |
| lip liner | 152 products |
| lip balm | 150 products |
| eye liner | 95 products |
| bronzer/highlighter | 77 products |
| concealer | 62 products |
| facial powder | 60 products |
| foundation | 52 products |
| brow liner | 51 products |
| mascara | 24 products |
| lip balm with SPF | 20 products |
| lip plumper | 14 products |
| bath oil/salts/soak | 14 products |
| makeup primer | 12 products |
| exfoliant/scrub | 11 products |
| glitter | 10 products |
| setting powder/spray | 7 products |
| 7 products | |
| nail treatment | 7 products |
| other eye makeup | 4 products |
| bar soap | 3 products |
| body wash/cleanser | 3 products |
| moisturizer | 2 products |
| hair color and bleaching | 2 products |
| beach & sport sunscreen | 2 products |
| mouthwash | 2 products |
| BB cream | 1 products |
| body oil | 1 products |
| mask | 1 products |
| facial cleanser | 1 products |
| facial moisturizer/treatment | 1 products |
| fragrance for men | 1 products |
| toothpaste | 1 products |
| body powder | 1 products |
| makeup remover | 1 products |
| serums & essences | 1 products |
| eyelash glue | 1 products |
Contamination concerns
| Chemical |
|---|
| BIPHENYL-2-YLAMINE |
| CADMIUM (pyrophoric) |
Persistence and bioaccumulation
| 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 |
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 |
|---|---|
| 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 toxicity | Klaassen, 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 |
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. |
| 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 |
Use restrictions
| Concern | Reference |
|---|---|
| Color additive provisionally approved for use in cosmetics | US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ; |
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 |
|---|---|
| 0 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Ecotoxicology
| 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 |
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 Lakes - Batch Certified by the U.S. Food and Drug Administration | CTFA International Cosmetic Ingredient Dictionary and Handbook |
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.
- 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.
- 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.
- 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.
- 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
- US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
- 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 and use restrictions based on EWG's review of the company's data.
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