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FD&C Red No. 40 (CI 16035) Aluminum Lake

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (low), Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (low), Non-reproductive organ system toxicity (low), 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_MODERATE

Products with this Ingredient

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lipstick242 products
eye shadow190 products
blush110 products
lip gloss38 products
bronzer/highlighter32 products
facial powder25 products
eye liner19 products
concealer19 products
foundation17 products
makeup primer8 products
exfoliant/scrub7 products
brow liner7 products
glitter5 products
lip balm3 products
bath oil/salts/soak2 products
facial cleanser1 products
lip liner1 products
eyelash glue1 products

Contamination concerns

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Allergies/immunotoxicity

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Concern Reference
Review article concluded that Red 40 caused hypersensitivity reactions.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: FD&C Red No. 40;
FSA concludes that some sensitive individuals may experience allergic reactions at dose levels within the ADI.European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
No evidence of skin sensitization in limited human and animal testing.European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.

Neurotoxicity

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Concern Reference
EFSA finds that there is "limited evidence" that Allura Red in a mixture with other synthetic colors and sodium benzoate has a "small and statistically significant effect on activity and attention in children selected from the general population."European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
A peer-reviewed study reports nervous system effects at the acceptable daily dose for humans.Ali Noorafshan, Maedeh Hashemi, Saied Karbalay-Doust & Fatemeh Karimi 2018. High dose Allura Red, rather than the ADI dose, induces structural and behavioral changes in the medial prefrontal cortex of rats and taurine can protect it. Acta histochemica 120(6), 586-594.

Organ system toxicity (non-reproductive)

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Concern Reference
Limited evidence of any toxicityKlaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Cancer

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Concern Reference
A review article reports equivocal evidence of carcinogenesis.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: FD&C Red No. 40;
EFSA reports there is equivocal evidence of genotoxiciy.European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.

Persistence and bioaccumulation

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Concern Reference
Some data submitters indicate they consider this substance as Persistent, Bioaccumulative and ToxicEuropean Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Use restrictions

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Concern Reference
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; ;

Endocrine disruption

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Concern Reference
A peer-reviewed study reports that Red 40 affects the function of an enzyme important for the endocrine system.Kanako Satoh, Rhouichi Nonaka, Fusako Ishikawa, Akio Ogata & Fumiko Nagai 2008. In vitro screening assay for detecting aromatase activity using rat ovarian microsomes and estrone ELISA. Biological & pharmaceutical bulletin 31(3), 357-62.

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
A review article reports a lack of evidence of developmental toxicity.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: FD&C Red No. 40;

Ecotoxicology

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

Multiple, additive exposure sources

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Concern Reference
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

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

Irritation (skin, eyes, or lungs)

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Concern Reference
Not classified as a skin/eye irritant based on human, animal, and in vitro testing.European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.

Data Sources

  • 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: FD&C Red No. 40;
  • European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
  • European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
  • Ali Noorafshan, Maedeh Hashemi, Saied Karbalay-Doust & Fatemeh Karimi 2018. High dose Allura Red, rather than the ADI dose, induces structural and behavioral changes in the medial prefrontal cortex of rats and taurine can protect it. Acta histochemica 120(6), 586-594.
  • Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • European Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
  • Kanako Satoh, Rhouichi Nonaka, Fusako Ishikawa, Akio Ogata & Fumiko Nagai 2008. In vitro screening assay for detecting aromatase activity using rat ovarian microsomes and estrone ELISA. Biological & pharmaceutical bulletin 31(3), 357-62.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.
  • 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.

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