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D&C Yellow No. 10 (CI 47005) Aluminum Lake

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Neurotoxicity (low), Endocrine disruption (low), Irritation (skin, eyes, or lungs) (low), 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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lipstick49 products
bath oil/salts/soak10 products
nail polish7 products
lip balm5 products
lip gloss3 products
fragrance for women2 products
concealer2 products
body wash/cleanser2 products
baby bubble bath2 products
beach & sport sunscreen2 products
bar soap1 products
eye shadow1 products
exfoliant/scrub1 products

Contamination concerns

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Use restrictions

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Concern Reference
Color additive not approved by FDA for cosmetics used around eyesUS. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-125; Chemical_Name: D&C Yellow 10; ;
Determined safe for use in cosmetics, subject to concentration or use limitations - anyFDA Color Additive Status

Allergies/immunotoxicity

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Concern Reference
EFSA reports that Yellow 10 intolerance/sensitivity has been reported in humans.European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re‐evaluation of Quinoline Yellow (E 104) as a food additive. EFSA Journal 7(11), 1329.

Neurotoxicity

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Concern Reference
EFSA concludes there is limited evidence that Yellow 10 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 (EFSA) 2009. Scientific Opinion on the re‐evaluation of Quinoline Yellow (E 104) as a food additive. EFSA Journal 7(11), 1329.

Irritation (skin, eyes, or lungs)

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Concern Reference
SCCS notes there is limited evidence of skin and eye irritation.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 3.

Organ system toxicity (non-reproductive)

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Concern Reference
Limited evidence of any toxicityKlaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List
This chemical was NOT flagged by CEPA for further attention. Flagged for as a low human health priority.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06957; Chemical_Name: C.I. Acid Yellow 3; ; CAS: 8004-92-0

Cancer

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Concern Reference
A peer-reviewed study reports in vitro genotoxicity.Farah Maria Drumond Chequer, Vinícius de Paula Venâncio, Maíra Rocha de Souza Prado, Luiz Raimundo Campos da Silva e Cunha Junior, Thiago Mescoloto Lizier, Maria Valnice Boldrin Zanoni, Rommel Rodríguez Burbano, Maria Lourdes Pires Bianchi & Lusânia Maria Greggi Antunes 2015. The cosmetic dye quinoline yellow causes DNA damage in vitro. Mutation research. Genetic toxicology and environmental mutagenesis 777, 54-61.

Developmental/reproductive toxicity

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Concern Reference
SCCS reports that developmental effects have been observed in animal tests.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 3.

Endocrine disruption

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Concern Reference
A peer-reviewed study reports endocrine activity in cellular assays.Patrick Tarnow, Catrin Zordick, Alex Bottke, Berit Fischer, Friederike Kühne, Tewes Tralau & Andreas Luch 2020. Characterization of Quinoline Yellow Dyes As Transient Aryl Hydrocarbon Receptor Agonists. Chemical research in toxicology 33(3), 742-750.

Ecotoxicology

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Concern Reference
Suspected to be an environmental toxin and be persistent or bioaccumulative (uncertainty in environmental toxicity or persistence/bioaccumulation)Environment Canada Domestic Substance List
Uncertain environmental toxin and uncertain persistent or bioaccumulativeEnvironment Canada Domestic Substance List
This chemical was NOT flagged by CEPA for further attention. Flagged for as a low human health priority.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06957; Chemical_Name: C.I. Acid Yellow 3; ; CAS: 8004-92-0

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

Persistence and bioaccumulation

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Concern Reference
This chemical was NOT flagged by CEPA for further attention. Flagged for as a low human health priority.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06957; Chemical_Name: C.I. Acid Yellow 3; ; CAS: 8004-92-0
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Data Sources

  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-125; Chemical_Name: D&C Yellow 10; ;
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re‐evaluation of Quinoline Yellow (E 104) as a food additive. EFSA Journal 7(11), 1329.
  • 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 3.
  • 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.
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06957; Chemical_Name: C.I. Acid Yellow 3; ; CAS: 8004-92-0
  • Farah Maria Drumond Chequer, Vinícius de Paula Venâncio, Maíra Rocha de Souza Prado, Luiz Raimundo Campos da Silva e Cunha Junior, Thiago Mescoloto Lizier, Maria Valnice Boldrin Zanoni, Rommel Rodríguez Burbano, Maria Lourdes Pires Bianchi & Lusânia Maria Greggi Antunes 2015. The cosmetic dye quinoline yellow causes DNA damage in vitro. Mutation research. Genetic toxicology and environmental mutagenesis 777, 54-61.
  • Patrick Tarnow, Catrin Zordick, Alex Bottke, Berit Fischer, Friederike Kühne, Tewes Tralau & Andreas Luch 2020. Characterization of Quinoline Yellow Dyes As Transient Aryl Hydrocarbon Receptor Agonists. Chemical research in toxicology 33(3), 742-750.
  • 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.

About this Ingredient's Score Range

  • 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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