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CI 42090 (FD&C Blue No. 1 or D&C Blue No. 4) Aluminum Lake

Score:

Data: None

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (moderate), Non-reproductive organ system toxicity (moderate), Multiple, additive exposure sources (low), Irritation (skin, eyes, or lungs) (moderate), 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

Products with this Ingredient

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lipstick1528 products
eye shadow365 products
lip gloss300 products
lip liner184 products
lip balm164 products
eye liner112 products
nail polish66 products
blush61 products
bronzer/highlighter51 products
concealer46 products
bath oil/salts/soak39 products
foundation33 products
brow liner28 products
lip balm with SPF27 products
mascara26 products
facial powder24 products
makeup primer15 products
lip plumper13 products
9 products
exfoliant/scrub8 products
hair color and bleaching7 products
glitter7 products
body wash/cleanser7 products
CC cream6 products
bar soap5 products
mouthwash3 products
mask3 products
other eye makeup3 products
facial moisturizer/treatment3 products
fragrance for women3 products
toothpaste3 products
body art2 products
body powder1 products
fragrance for men1 products
moisturizer1 products
baby bubble bath1 products
facial cleanser1 products
setting powder/spray1 products
hair spray1 products
eyelash glue1 products

Contamination concerns

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Use restrictions

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Concern Reference
Color Additives - Not approved by FDA for use in cosmeticsPersonal Care Products Council 2015. International Cosmetic Ingredient Dictionary and Handbook. Appears as: listid: FCOLOR-655; Chemical_Name: ACID BLUE 9 ALUMINUM LAKE; ;
Restricted in European cosmeticsEU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-54157; Chemical_Name: ACID BLUE 9 ALUMINUM LAKE; ; CAS: 68921-42-6
Color additive provisionally approved for use in cosmeticsUS. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;

Persistence and bioaccumulation

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Concern Reference
Deemed a moderate human health priority even though it did not meet the strict criteria of the categorization exercise of CEPA. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05320; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, disodium salt; ; CAS: 3844-45-9
This chemical was NOT flagged by CEPA for further attention. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-16914; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, aluminum salt; ; CAS: 68921-42-6

Organ system toxicity (non-reproductive)

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Concern Reference
Deemed a moderate human health priority even though it did not meet the strict criteria of the categorization exercise of CEPA. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05320; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, disodium salt; ; CAS: 3844-45-9
Limited evidence of any toxicityKlaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
Toxic, U.S. Environmental Protection Agency Toxics Release Inventory programsEnvironmental Protection Agency (EPA) 2015. Toxic Release Inventory (TRI) PBTs. Appears as: listid: PBT-TRI-293; Chemical_Name: DISODIUM SALTBENZENEMETHANAMINIUM, N-ETHYL-N-[4-[[4-[ETHYL[(3-SULFOPHENYL)METHYL]AMINO]PHENYL](2-SULFOPHENYL)METHYLENE]-2,5-CYCLOHEXADIEN-1-YLIDENE]-3-SULFO-, INNER SALT; Synonyms: BENZENEMETHANAMINIUM, N-ETHYL-N-[4-[[4-[ETHYL[(3-SULFOPHENYL)METHYL]AMINO]PHENYL](2-SULFOPHENYL)METHYLENE]-2,5-CYCLOHEXADIEN-1-YLIDENE]-3-SULFO-, INNER SALT, DISODIUM SALT; CAS: 3844-45-9
This chemical was NOT flagged by CEPA for further attention. Flagged for suspected persistence.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-16914; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, aluminum salt; ; CAS: 68921-42-6

Irritation (skin, eyes, or lungs)

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Concern Reference
Moderate skin irritation observed at low-moderate concentrations in human testing.The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9.

Multiple, additive exposure sources

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Concern Reference
There is no reported use of the substance and there is no toxicology information available in PAFA.US. Food and Drug Administration (FDA). 2015. Everything Added to Food. Appears as: listid: EAFUS-2082; Chemical_Name: FD&C BLUE NO. 1, CALCIUM LAKE; ;
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Neurotoxicity

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Concern Reference
A review study found that cell-based screening tests suggest the potential for neurotoxicity.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: CI 42090;
Neurobehavioral effects observed in animal study.Toyohito Tanaka, Osamu Takahashi, Akiko Inomata, Akio Ogata & Dai Nakae 2012. Reproductive and neurobehavioral effects of brilliant blue FCF in mice. Birth defects research. Part B, Developmental and reproductive toxicology 95(6), 395-409.

Endocrine disruption

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Concern Reference
Minor evidence of endocrine activity from cellular assays and models.National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 3844-45-9; Chemical_Name: FD&C BLUE NO. 1

Cancer

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Concern Reference
Little evidence of genotoxicity in animal or in vitro testing.The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9.
EFSA panel concluded there is no concern for genotoxicity.European Food Safety Authority 2010. Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive. EFSA Journal 8(11), 1853.
Not found to be carcinogenic in animal testing.The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9.
IARC Group 3 (no cancer link)IARC 2015. IRAC Carcinogens (Skin Deep®). Appears as: listid: IARC-472; Chemical_Name: Brilliant Blue FCF, disodium salt; ; CAS: 3844-45-9

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
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color additive approved by FDA for use in cosmeticsFDA Color Additive Status

Ecotoxicology

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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-16914; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, aluminum salt; ; CAS: 68921-42-6

Developmental/reproductive toxicity

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Concern Reference
No evidence of reproductive or developmental toxicity in animal testing.The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9.

Data gaps

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

Data Sources

  • Personal Care Products Council 2015. International Cosmetic Ingredient Dictionary and Handbook. Appears as: listid: FCOLOR-655; Chemical_Name: ACID BLUE 9 ALUMINUM LAKE; ;
  • EU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-54157; Chemical_Name: ACID BLUE 9 ALUMINUM LAKE; ; CAS: 68921-42-6
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05320; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, disodium salt; ; CAS: 3844-45-9
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-16914; Chemical_Name: Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[( 3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene ]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, hydroxide, inner salt, aluminum salt; ; CAS: 68921-42-6
  • Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
  • Environmental Protection Agency (EPA) 2015. Toxic Release Inventory (TRI) PBTs. Appears as: listid: PBT-TRI-293; Chemical_Name: DISODIUM SALTBENZENEMETHANAMINIUM, N-ETHYL-N-[4-[[4-[ETHYL[(3-SULFOPHENYL)METHYL]AMINO]PHENYL](2-SULFOPHENYL)METHYLENE]-2,5-CYCLOHEXADIEN-1-YLIDENE]-3-SULFO-, INNER SALT; Synonyms: BENZENEMETHANAMINIUM, N-ETHYL-N-[4-[[4-[ETHYL[(3-SULFOPHENYL)METHYL]AMINO]PHENYL](2-SULFOPHENYL)METHYLENE]-2,5-CYCLOHEXADIEN-1-YLIDENE]-3-SULFO-, INNER SALT, DISODIUM SALT; CAS: 3844-45-9
  • The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9.
  • US. Food and Drug Administration (FDA). 2015. Everything Added to Food. Appears as: listid: EAFUS-2082; Chemical_Name: FD&C BLUE NO. 1, CALCIUM LAKE; ;
  • 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.
  • 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: CI 42090;
  • Toyohito Tanaka, Osamu Takahashi, Akiko Inomata, Akio Ogata & Dai Nakae 2012. Reproductive and neurobehavioral effects of brilliant blue FCF in mice. Birth defects research. Part B, Developmental and reproductive toxicology 95(6), 395-409.
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 3844-45-9; Chemical_Name: FD&C BLUE NO. 1
  • European Food Safety Authority 2010. Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive. EFSA Journal 8(11), 1853.
  • IARC 2015. IRAC Carcinogens (Skin Deep®). Appears as: listid: IARC-472; Chemical_Name: Brilliant Blue FCF, disodium salt; ; CAS: 3844-45-9
  • 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.
  • 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 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.

ABOUT THE SKIN DEEP® RATINGS

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer

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