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D&C Yellow No. 11 (CI 47000)

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Endocrine disruption (low), and Non-reproductive organ system toxicity (low)

Cancer

Cancer concern is LOW_MODERATE

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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nail polish57 products
hair treatment/serum13 products
polish remover7 products
conditioner2 products
nail treatment1 products
hair styling aide1 products
serums & essences1 products
styling gel/lotion1 products
beach & sport sunscreen1 products
eye shadow1 products
mask1 products

Use restrictions

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Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCTFA International Cosmetic Ingredient Dictionary and Handbook
Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive approved by FDA for use in cosmetics: external use onlyFDA Color Additive Status

Cancer

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Concern Reference
The National Toxicology Program concluded there is some evidence that this substance is carcinogenic based on animal testing.William Eastin 1991. NTP technical report on the toxicity studies of D&C Yellow No. 11 in F344/N Rats and B6C3F1 Mice (Feed Studies) (CAS No. 8003-22-3). Toxicity report series 8, 1-32.
A peer-reviewed study reports evidence that this substance may interfere with DNA repair.Farah Md Chequer, Vinicius P Venancio, Mara R. Almeida, Alexandre F. Aissa, Maria Lourdes P. Bianchi & Lusânia Mg Antunes. 2017. Erythrosine B and quinoline yellow dyes regulate DNA repair gene expression in human HepG2 cells. Toxicology and industrial health 33(10), 765-774.

Allergies/immunotoxicity

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Concern Reference
Allergic contact dermatitis reported in humans following occupational exposure.K Matsunaga, K. Hosokawa, M. Suzuki, Y. Arima & R. Hayakawa. 1988. Occupational allergic contact dermatitis in beauticians. Contact dermatitis 18(2), 94-6.
May cause an allergic skin reaction.European Chemicals Agency (ECHA) 2018. GHS Data from ECHA Website. Appears as: chemical_names: 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline; 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1,3-dione; -; 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline; 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1; cas_numbers: 8003-22-3
A peer-reviewed study reports evidence of dermal sensitization from animal testing.M J. Palazzolo & L. C. DiPasquale. 1983. The sensitization potential of D & C Yellow No. 11 in guinea pigs. Contact dermatitis 9(5), 367-71.

Developmental/reproductive toxicity

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Concern Reference
The National Toxicology Program reports evidence this substance may have developmental effects.William Eastin 1991. NTP technical report on the toxicity studies of D&C Yellow No. 11 in F344/N Rats and B6C3F1 Mice (Feed Studies) (CAS No. 8003-22-3). Toxicity report series 8, 1-32.

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.

Organ system toxicity (non-reproductive)

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Concern Reference
A peer-reviewed study reports of evidence of kidney and liver effects at high doses in animal testing.W C. Eastin, M. R. Elwell, S. Grumbein & J. H. Yuan. 1996. Effects of D&C yellow no. 11 ingestion on F344/N rats and B6C3F1 mice. Journal of toxicology and environmental health 48(2), 197-213.
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06950; Chemical_Name: C.I. Solvent yellow 33; ; CAS: 8003-22-3

Miscellaneous

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Concern Reference
Allergic contact dermatitis reported in humans following occupational exposure.K Matsunaga, K. Hosokawa, M. Suzuki, Y. Arima & R. Hayakawa. 1988. Occupational allergic contact dermatitis in beauticians. Contact dermatitis 18(2), 94-6.

Data gaps

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

Ecotoxicology

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Concern Reference
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06950; Chemical_Name: C.I. Solvent yellow 33; ; CAS: 8003-22-3

Informational

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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: external use onlyFDA 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 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.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06950; Chemical_Name: C.I. Solvent yellow 33; ; CAS: 8003-22-3
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06950; Chemical_Name: C.I. Solvent yellow 33; ; CAS: 8003-22-3

Data Sources

  • 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.
  • William Eastin 1991. NTP technical report on the toxicity studies of D&C Yellow No. 11 in F344/N Rats and B6C3F1 Mice (Feed Studies) (CAS No. 8003-22-3). Toxicity report series 8, 1-32.
  • Farah Md Chequer, Vinicius P Venancio, Mara R. Almeida, Alexandre F. Aissa, Maria Lourdes P. Bianchi & Lusânia Mg Antunes. 2017. Erythrosine B and quinoline yellow dyes regulate DNA repair gene expression in human HepG2 cells. Toxicology and industrial health 33(10), 765-774.
  • K Matsunaga, K. Hosokawa, M. Suzuki, Y. Arima & R. Hayakawa. 1988. Occupational allergic contact dermatitis in beauticians. Contact dermatitis 18(2), 94-6.
  • European Chemicals Agency (ECHA) 2018. GHS Data from ECHA Website. Appears as: chemical_names: 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline; 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1,3-dione; -; 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline; 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1; cas_numbers: 8003-22-3
  • M J. Palazzolo & L. C. DiPasquale. 1983. The sensitization potential of D & C Yellow No. 11 in guinea pigs. Contact dermatitis 9(5), 367-71.
  • 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.
  • W C. Eastin, M. R. Elwell, S. Grumbein & J. H. Yuan. 1996. Effects of D&C yellow no. 11 ingestion on F344/N rats and B6C3F1 mice. Journal of toxicology and environmental health 48(2), 197-213.
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-06950; Chemical_Name: C.I. Solvent yellow 33; ; CAS: 8003-22-3
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.

About this Ingredient's Score Range

  • This ingredient’s score is higher if used in products intended for damaged skin due to increased risk of absorption.
  • This ingredient’s score is higher if used in products intended for use around mouth due to increased risk of ingestion and absorption.
  • This ingredient’s score is higher if used in products intended for use on lips due to increased risk of ingestion and absorption.
  • This ingredient’s score is higher if used in products intended for use around the eyes due to increased risk of absorption.
  • Products with the EWG VERIFIED mark have met use restrictions and warnings based on EWG review of company data.

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Beyond providing Skin Deep® as an educational tool for consumers, EWG offers its EWG VERIFIED™ mark as a quick and easily identifiable way of conveying personal care products that meet EWG's strict health criteria. Before a company can use EWG VERIFIED™ on such products, the company must show that it fully discloses the products' ingredients on their labels or packaging, they do not contain EWG ingredients of concern, and are made with good manufacturing practices, among other criteria. Note that EWG receives licensing fees from all EWG VERIFIED™ member companies that help to support the important work we do. Learn more | Legal Disclaimer