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FD&C Red No. 4 (CI 14700)
Score:
Data: Fair
- Other Concerns
- Functions
- About the Chemical
- Synonyms
-
Use restrictions (high) and Endocrine disruption (low)
Cancer 
Cancer: Ingredients linked to cancer in government, industry or academic studies or assessments.
Developmental & Reproductive Toxicity
Developmental and reproductive toxicity: Ingredients linked to developmental and reproductive toxicity, a broad class of health effects that range from infertility and reproductive organ cancers to birth defects and developmental delays in children.
Allergies & Immunotoxicity
Allergies and immunotoxicity: Ingredients linked to harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissue in the body.
Products with this Ingredient
| bath oil/salts/soak | 44 products |
| body wash/cleanser | 37 products |
| fragrance for women | 31 products |
| liquid hand soap | 29 products |
| shampoo | 22 products |
| serums & essences | 22 products |
| facial moisturizer/treatment | 21 products |
| bar soap | 21 products |
| moisturizer | 20 products |
| mask | 15 products |
| fragrance for men | 12 products |
| hair styling aide | 12 products |
| body spray | 10 products |
| exfoliant/scrub | 10 products |
| facial cleanser | 9 products |
| sunless tanning | 9 products |
| conditioner | 9 products |
| lipstick | 8 products |
| toners/astringents | 8 products |
| moisturizer with SPF | 8 products |
| bubble bath | 8 products |
| hair color and bleaching | 7 products |
| body firming lotion | 5 products |
| hand sanitizer | 4 products |
| makeup primer | 4 products |
| bronzer/highlighter | 3 products |
| makeup remover | 2 products |
| hair treatment/serum | 2 products |
| setting powder/spray | 2 products |
| hair relaxer | 2 products |
| detangler | 1 products |
| hand cream | 1 products |
| shaving cream (men's) | 1 products |
| beard oil | 1 products |
| after shave | 1 products |
Use restrictions
| Concern | Reference |
|---|---|
| Violation of government restrictions - Banned or found unsafe for use in cosmetics | CTFA International Cosmetic Ingredient Dictionary and Handbook |
| Violation of government restrictions - Banned or found unsafe for use in cosmetics | CosIng |
| Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive approved by FDA for use in cosmetics: external use only | FDA Color Additive Status |
| Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - any | CosIng |
Cancer
| 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. |
| Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gaps | 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 8, Suppl. 7 ;1987 |
| 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. |
| 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 |
Endocrine disruption
| 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 |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - The substance was formerly approved as a food additive but is now banned; there may be some toxicology data available. | FDA Everything Added to Food |
| 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 Administration | CTFA 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 only | FDA Color Additive Status |
Persistence and bioaccumulation
| Concern | Reference |
|---|---|
| Not suspected to be bioaccumulative | Environment Canada Domestic Substance List |
| Not suspected to be persistent | Environment Canada Domestic Substance List |
Organ system toxicity (non-reproductive)
| Concern | Reference |
|---|---|
| Classified as not expected to be potentially toxic or harmful | Environment Canada Domestic Substance List |
Ecotoxicology
| Concern | Reference |
|---|---|
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
Data gaps
| Concern | Reference |
|---|---|
| 74 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Data Sources
- CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
- 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/ .
- FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
- 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.
- 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 8, Suppl. 7 ;1987
- 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.
- 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
- National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 4548-53-2; Chemical_Name: FD&C Red 4
- 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.
- EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
- NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
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