FD&C RED 4
Colorant; COSMETIC COLORANT
Also listed as
RED 4, FD&C RED NO. 4; 12101 RED; 1306 RED; 4R PURPLE; C.I. 14700; C.I. FOOD RED 1; C.I. FOOD RED 1, DISODIUM SALT; CERTICOL PONCEAU SXS; CERVEN POTRAVINARSKA 1 (CZECH) ; CRIMSON 4R; DYE FD & C RED NO. 4
Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.
| This ingredient: | |
 | Cancer |
 | Developmental/reproductive toxicity |
 | Violations, restrictions & warnings |
| Allergies/immunotoxicity |
| Contamination concerns |
|
See products containing FD&C RED 4 | |
About FD&C RED 4: To identify the colorant allowed for use in Japan, the INCI name Aka504 must be used.
This ingredient may be derived from animals. From PETA's Caring Consumer: Pigments from animal, plant, and synthetic sources used to color foods, cosmetics, and other products. Cochineal is from insects. Widely used FD&C and D&C colors are coaltar (bituminous coal) derivatives that are continously tested on animals due to their carcinogenic properties. Alternatives: grapes, beets, turmeric, saffron, carrots, chlorophyll, annatto, alkanet.
FD&C RED 4 has reported used in the following product types: shampoo (45); moisturizer (42); fragrance for women (39); body wash/cleanser (30); conditioner (28); facial moisturizer/treatment (24); liquid hand soap (22); bar soap (20); fragrance for men (17); anti-aging (15)
Violations, restrictions & warnings
| type of concern | product conditions | reference |
| Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Color additive approved by FDA for use in cosmetics: external use only | products for use around the mouth, lips, eyes, or on damaged skin | FDA Color Additive Status |
Cancer
| type of concern | product conditions | reference |
| One or more in vitro tests on mammalian cells show positive mutation results | RTECS®- Mutation Research 2000 | |
| show more | ||
Data gaps
| type of concern | product conditions | reference |
| 19 studies in PubMed science library may include information on the toxicity of this chemical see search results -> | PubMed |
Ecotoxicology
| type of concern | product conditions | reference |
| Not suspected to be an environmental toxin | Environmental Canada Domestic Substance List |
Persistence and bioaccumulation
| type of concern | product conditions | reference |
| Not suspected to be persistent | Environmental Canada Domestic Substance List | |
| show more | ||
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| Classified as not expected to be potentially toxic or harmful | Environmental Canada Domestic Substance List |
Government, industry, academic studies and classifications
| government/industry list/academic study | appears on list as | classification(s) |
| FDA Color Additive Status | FD&C RED 4 | •Color additive approved by FDA for use in cosmetics: external use only •Color additive not approved by FDA for use in food •Color additive not approved by FDA for cosmetics used around eyes |
| FDA Everything Added to Food | FD&C RED NO. 4--PROHIBITED | • The substance was formerly approved as a food additive but is now banned; there may be some toxicology data available. |
| CTFA International Cosmetic Ingredient Dictionary and Handbook | RED 4 | •Color Additives - Batch Certified by the U.S. Food and Drug Administration |
| Int'l Agency for Research on Cancer (IARC) - Carcinogens | PONCEAU SX | •IARC Group 3 (no cancer link) |
| Environmental Canada Domestic Substance List | 1-NAPHTHALENESULFONIC ACID, 3-[(2,4-DIMETHYL-5-SULFOPHENYL)AZO]-4-HYDROXY-, DISODIUM SALT | •This chemical was NOT flagged by CEPA for further attention. |
| IFRA Fragrance Ingredient List | 1-NAPHTHALENESULFONIC ACID, 3-[(2,4-DIMETHYL-5-SULFOPHENYL)AZO]-4-HYDROXY-, DISODIUM SALT | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| RTECS®- Gastroenterology 1953 | FD&C RED 4 | • cancer - blood tumors (rat TDLo) |
| RTECS®- Mutation Research 2000 | FD&C RED 4 | • mutagenic - Positive mutation assay: DNA Damage (mouse orl) |
| RTECS®- Mutation Research 2000 | FD&C RED 4 | • mutagenic - Positive mutation assay: DNA Damage (mouse orl) |
| RTECS®- Voprosy Pitaniya 1970 | FD&C RED 4 | • mutagenic - blood tumor formations - equivocal (rat TD) • cancer - gastrointestinal tumor formations - equivocal (rat TD) |
references
| government/industry list/academic study | reference |
| FDA Color Additive Status | FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006. |
| FDA Everything Added to Food | 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. |
| CTFA International Cosmetic Ingredient Dictionary and Handbook | CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC. |
| Int'l Agency for Research on Cancer (IARC) - Carcinogens | IARC (International Agency for Research on Cancer). 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99 (a total of 935 agents, mixtures and exposures). |
| Environmental Canada Domestic Substance List | EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry. |
| IFRA Fragrance Ingredient List | IFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25 |
| RTECS®- Gastroenterology 1953 | RTECS®- Gastroenterology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1943- 23,1,1953 |
| RTECS®- Mutation Research 2000 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 465,11,2000 |
| RTECS®- Mutation Research 2000 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 465,11,2000 |
| RTECS®- Voprosy Pitaniya 1970 | RTECS®- Voprosy Pitaniya. Problems of Nutrition. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-10, 1932-41; V.11- 1952- 29,61,1970 |
"RTECS®" is a United States trademark owned and licensed under authority of the U.S. Government, by and through MDL Information Systems, Inc.
Copyright © 2010 by Environmental Working Group
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