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Acid Blue 9 (Uncertified FD&C Blue No. 1 or D&C Blue No. 4)

Score:

Data: Good

  • 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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hair color and bleaching10 products
conditioner3 products
shampoo1 products

Contamination concerns

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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
Color additive approved by FDA for use in cosmetics: external use onlyUS. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-002; Chemical_Name: D&C Blue 4; ;

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. 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.
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
201 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 Additives - Batch Certified by the U.S. Food and Drug AdministrationCTFA International Cosmetic Ingredient Dictionary and Handbook

Data Sources

  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-002; Chemical_Name: D&C Blue 4; ;
  • 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. 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
  • 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.

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