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

Score:

Data: Fair

  • 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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lipstick197 products
body wash/cleanser102 products
bath oil/salts/soak89 products
eye liner76 products
nail polish65 products
shampoo64 products
liquid hand soap47 products
conditioner41 products
lip gloss36 products
mask30 products
toothpaste27 products
mouthwash25 products
exfoliant/scrub25 products
facial moisturizer/treatment20 products
facial cleanser20 products
fragrance for women18 products
glitter18 products
moisturizer16 products
eye shadow14 products
bar soap12 products
fragrance for men12 products
serums & essences12 products
toners/astringents10 products
after sun product9 products
hair treatment/serum8 products
shaving cream (men's)7 products
antiperspirant/deodorant (men's)7 products
bubble bath7 products
hand sanitizer7 products
body firming lotion7 products
shaving cream7 products
sunless tanning6 products
moisturizer with SPF6 products
hair styling aide6 products
brow liner6 products
lip liner6 products
body spray5 products
beach & sport sunscreen5 products
concealer5 products
makeup primer5 products
tooth whitening4 products
makeup remover4 products
baby bubble bath4 products
around-eye cream4 products
anti-aging3 products
after shave3 products
antiperspirant/deodorant3 products
hair color and bleaching3 products
foot cleansing2 products
styling gel/lotion2 products
polish remover2 products
hand cream2 products
detangler2 products
foot moisturizer2 products
blush1 products
lip balm1 products
baby shampoo1 products
hair relaxer1 products
bronzer/highlighter1 products
oil controller1 products
mascara1 products

Contamination concerns

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Use restrictions

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Concern Reference
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
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - anyCosIng

Persistence and bioaccumulation

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Concern Reference
Persistent or bioaccumulative and moderate to high toxicity concern in humansEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

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
Classified as medium human health priorityEnvironment Canada Domestic Substance List
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)EPA Toxic Release Inventory PBTs
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

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. Sarah Kobylewski & Michael F. Jacobson. 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.
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsWorld 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 16, Suppl.7 ;1987
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
477 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
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

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

Data Sources

  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • European Commission. 2013. Cosing, the European Commission database with information on cosmetic substances and ingredients. Accessed on March 1, 2013 at http://ec.europa.eu/consumers/cosmetics/cosing/ .
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • 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. Sarah Kobylewski & Michael F. Jacobson. 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
  • 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 16, Suppl.7 ;1987
  • 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.
  • 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 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 the program’s impurity and use restrictions based on EWG's review of the company's data.

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