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FD&C Red No. 40 (CI 16035)

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (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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eye shadow118 products
eye liner110 products
bath oil/salts/soak68 products
lipstick66 products
liquid hand soap53 products
body wash/cleanser49 products
shaving cream22 products
brow liner19 products
glitter17 products
facial moisturizer/treatment17 products
bronzer/highlighter17 products
shampoo15 products
facial cleanser13 products
conditioner13 products
serums & essences12 products
mouthwash11 products
mask11 products
lip gloss10 products
exfoliant/scrub9 products
bubble bath9 products
toothpaste8 products
sunless tanning8 products
moisturizer8 products
blush7 products
hair styling aide7 products
bar soap6 products
after sun product6 products
daily use with SPF6 products
hand sanitizer6 products
recreational sunscreen5 products
mascara5 products
hair treatment/serum4 products
4 products
body firming lotion4 products
around-eye cream4 products
nail polish3 products
concealer3 products
makeup primer3 products
facial powder3 products
toners/astringents2 products
eye makeup remover2 products
anti-aging2 products
hair color and bleaching2 products
setting powder/spray2 products
foundation2 products
styling gel/lotion2 products
other eye makeup1 products
tooth whitening1 products
body spray1 products
tanning oil1 products
body art1 products
detangler1 products
damaged skin treatment1 products
lip balm1 products
baby oil1 products
hand cream1 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.

Cancer

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Concern Reference
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.
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;

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 bioaccumulativeEnvironment Canada Domestic Substance List
Not suspected to be persistentEnvironment Canada Domestic Substance List

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.

Organ system toxicity (non-reproductive)

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Concern Reference
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
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.

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 cosmeticsFDA Color Additive Status

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

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
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;

Data gaps

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

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.
  • European Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • 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.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.

About this Ingredient's Score Range

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