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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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lipstick258 products
body wash/cleanser199 products
bath oil/salts/soak161 products
shampoo126 products
liquid hand soap108 products
eye liner100 products
lip gloss89 products
toothpaste88 products
nail polish85 products
conditioner77 products
mouthwash68 products
mask56 products
exfoliant/scrub42 products
eye shadow40 products
facial cleanser36 products
moisturizer33 products
facial moisturizer/treatment32 products
bar soap30 products
fragrance for men29 products
hair styling aide28 products
after sun product26 products
hand sanitizer26 products
fragrance for women26 products
shaving cream25 products
bubble bath23 products
antiperspirant/deodorant (men's)22 products
toners/astringents21 products
glitter21 products
brow liner21 products
serums & essences18 products
hair color and bleaching17 products
styling gel/lotion16 products
hair treatment/serum15 products
antiperspirant/deodorant14 products
sunless tanning13 products
makeup primer13 products
blush13 products
tooth whitening10 products
shaving cream (men's)10 products
body firming lotion10 products
around-eye cream8 products
after shave8 products
bronzer/highlighter8 products
8 products
lip plumper8 products
makeup remover7 products
concealer7 products
body spray6 products
polish remover6 products
mascara6 products
recreational sunscreen6 products
daily use with SPF6 products
setting powder/spray6 products
lip liner4 products
foot cleansing4 products
hand cream4 products
foot moisturizer3 products
lip balm3 products
facial powder3 products
baby bubble bath3 products
beard cleanser3 products
hair relaxer2 products
baby toothpaste2 products
tanning oil2 products
eye makeup remover1 products
foundation1 products
hair-loss treatment1 products
hair spray1 products
detangler1 products
oil controller1 products
body art1 products
BB cream1 products
baby shampoo1 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

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

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. 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;
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.
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
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.

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 - 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 cosmetics: external use onlyFDA Color Additive Status

Ecotoxicology

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Concern Reference
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

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
477 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

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.
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • 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. 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;
  • 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
  • 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.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
  • 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 the program’s impurity and use restrictions based on EWG's review of the company's data.

ABOUT THE SKIN DEEP® RATINGS

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