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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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lipstick1306 products
eye shadow293 products
lip gloss254 products
lip liner182 products
eye liner105 products
lip balm103 products
bronzer/highlighter46 products
blush45 products
concealer45 products
foundation34 products
nail polish32 products
brow liner29 products
mascara24 products
facial powder24 products
bath oil/salts/soak19 products
lip balm with SPF14 products
makeup primer14 products
lip plumper8 products
hair color and bleaching8 products
exfoliant/scrub6 products
CC cream6 products
glitter6 products
nail treatment5 products
bar soap5 products
body wash/cleanser5 products
fragrance for women3 products
3 products
other eye makeup3 products
mouthwash2 products
toothpaste2 products
facial cleanser2 products
facial moisturizer/treatment2 products
mask2 products
shaving cream (men's)1 products
moisturizer1 products
eyelash glue1 products
hair spray1 products
baby bubble bath1 products
BB cream1 products
body powder1 products
fragrance for men1 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

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.

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

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
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.
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;

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.
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
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.
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.

Data gaps

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

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.

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

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 cosmeticsFDA 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 AdministrationCTFA International Cosmetic Ingredient Dictionary and Handbook

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
  • 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.
  • 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
  • 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.
  • 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.
  • 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;
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 3844-45-9; Chemical_Name: FD&C BLUE NO. 1
  • IARC 2015. IRAC Carcinogens (Skin Deep®). Appears as: listid: IARC-472; Chemical_Name: Brilliant Blue FCF, disodium salt; ; CAS: 3844-45-9
  • 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.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.

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

ABOUT EWG VERIFIED™

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