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FD&C Yellow No. 6 (CI 15985) Aluminum Lake
Score:
Data: Limited
- Other Concerns
- Functions
- About the Chemical
- Synonyms
-
Use restrictions (high), Neurotoxicity (low), Endocrine disruption (low), Non-reproductive organ system toxicity (low), 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 | 833 products |
| lip gloss | 121 products |
| blush | 95 products |
| lip balm | 91 products |
| lip liner | 77 products |
| eye shadow | 58 products |
| foundation | 30 products |
| facial powder | 16 products |
| bronzer/highlighter | 16 products |
| lip balm with SPF | 11 products |
| lip plumper | 8 products |
| makeup primer | 7 products |
| concealer | 6 products |
| bath oil/salts/soak | 4 products |
| 3 products | |
| recreational sunscreen | 1 products |
| facial cleanser | 1 products |
| exfoliant/scrub | 1 products |
| glitter | 1 products |
| mask | 1 products |
Contamination concerns
| Chemical |
|---|
| CADMIUM (pyrophoric) |
Use restrictions
| Concern | Reference |
|---|---|
| Color additive not approved by FDA for cosmetics used around eyes | US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-138; Chemical_Name: FD&C Yellow 6; ; |
| Determined safe for use in cosmetics, subject to concentration or use limitations - any | FDA Color Additive Status |
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 No. 6; |
| 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 of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330. |
Neurotoxicity
| Concern | Reference |
|---|---|
| EFSA concludes there is limited evidence that Yellow 6 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 of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330. |
Organ system toxicity (non-reproductive)
| Concern | Reference |
|---|---|
| Limited evidence of any toxicity | Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull |
| Classified as not expected to be potentially toxic or harmful | Environment Canada Domestic Substance List |
Developmental/reproductive toxicity
| Concern | Reference |
|---|---|
| The European Food Safety Authority concluded that this substance had the potential to impact testicular health. | European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330. |
| A review article reports evidence of impacts on male gonads in rats. | Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6; |
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. |
| Evidence of endocrine activity from cellular assays. | National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 2783-94-0; Chemical_Name: FD&C Yellow 6 |
Cancer
| Concern | Reference |
|---|---|
| A review article reports mixed evidence of genotoxicity. | Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6; |
| 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 |
Multiple, additive exposure sources
| Concern | Reference |
|---|---|
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
Ecotoxicology
| Concern | Reference |
|---|---|
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any | 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 gaps
| Concern | Reference |
|---|---|
| 0 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Persistence and bioaccumulation
| Concern | Reference |
|---|---|
| Not suspected to be persistent | Environment Canada Domestic Substance List |
| Not suspected to be bioaccumulative | Environment Canada Domestic Substance List |
Data Sources
- US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-138; Chemical_Name: FD&C Yellow 6; ;
- FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
- 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 No. 6;
- European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330.
- Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
- EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
- Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6;
- 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: 2783-94-0; Chemical_Name: FD&C Yellow 6
- 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
- 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.
- CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
- NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
- This ingredient’s score is higher if used in products that are inhalable (e.g., sprays, powders) because of respiratory concerns.
- 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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