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FD&C Red No. 4 (CI 14700) ALUMINUM LAKE

Score:

Data: None

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

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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eye shadow4 products

Use restrictions

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Concern Reference
Prohibited in European cosmetics: must not form part of the composition of hair dye productsEU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-36917; Chemical_Name: Ponceau SX; ; CAS: 4548-53-2
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-001; Chemical_Name: FD&C Red 4; ;
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; ;

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
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05561; Chemical_Name: 1-Naphthalenesulfonic acid, 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-, disodium salt; ; CAS: 4548-53-2

Cancer

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Concern Reference
A peer-reviewed article reports evidence of potential carcinogenicity from in vitro testing.P J. Price, W. A. Suk, A. E. Freeman, W. T. Lane, R. L. Peters, M. L. Vernon & R. J. Huebner. 1978. In vitro and in vivo indications of the carcinogenicity and toxicity of food dyes. International journal of cancer 21(3), 361-7.
IARC Group 3 (no cancer link)International Agency for Research on Cancer (IARC) 2012. Agents classified by the IARC Monographs (through Volume 127). Appears as: CAS: 4548-53-2; Name: Ponceau SX
This substance was not mutagenic in vitro.K T. Chung, G. E. Fulk & A. W. Andrews. 1981. Mutagenicity testing of some commonly used dyes. Applied and environmental microbiology 42(4), 641-8.

Endocrine disruption

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Concern Reference
Evidence of endocrine activity in cellular assays.National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 4548-53-2; Chemical_Name: FD&C Red 4

Data gaps

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

Ecotoxicology

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Concern Reference
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05561; Chemical_Name: 1-Naphthalenesulfonic acid, 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-, disodium salt; ; CAS: 4548-53-2

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

Persistence and bioaccumulation

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Concern Reference
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05561; Chemical_Name: 1-Naphthalenesulfonic acid, 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-, disodium salt; ; CAS: 4548-53-2
This chemical was NOT flagged by CEPA for further attention.Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05561; Chemical_Name: 1-Naphthalenesulfonic acid, 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-, disodium salt; ; CAS: 4548-53-2

Data Sources

  • EU Cosmetics Directive 2015. CosIng. Appears as: listid: COSING-36917; Chemical_Name: Ponceau SX; ; CAS: 4548-53-2
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-001; Chemical_Name: FD&C Red 4; ;
  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
  • Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
  • Environment Canada 2015. Domestic Substance List. Appears as: listid: ECDSL-05561; Chemical_Name: 1-Naphthalenesulfonic acid, 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-, disodium salt; ; CAS: 4548-53-2
  • P J. Price, W. A. Suk, A. E. Freeman, W. T. Lane, R. L. Peters, M. L. Vernon & R. J. Huebner. 1978. In vitro and in vivo indications of the carcinogenicity and toxicity of food dyes. International journal of cancer 21(3), 361-7.
  • International Agency for Research on Cancer (IARC) 2012. Agents classified by the IARC Monographs (through Volume 127). Appears as: CAS: 4548-53-2; Name: Ponceau SX
  • K T. Chung, G. E. Fulk & A. W. Andrews. 1981. Mutagenicity testing of some commonly used dyes. Applied and environmental microbiology 42(4), 641-8.
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 4548-53-2; Chemical_Name: FD&C Red 4
  • 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 that are inhalable (e.g., sprays, powders) because of respiratory concerns.

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