FD&C YELLOW 5

Colorant  

SCORE

2

low hazard to moderate hazard depending on product usage

3

 

82%

data gap

(why scores have changed)

Also listed as

YELLOW 5, FD&C YELLOW NO. 5


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:
yes, weakCancer
yes, weakDevelopmental/reproductive toxicity
noViolations, restrictions & warnings
noAllergies/immunotoxicity
noContamination concerns
noOther moderate concerns for this ingredient:
Neurotoxicity, Persistence and bioaccumulation, Organ system toxicity (non-reproductive)
 
See products containing FD&C YELLOW 5

About FD&C YELLOW 5: To identify the colorant allowed for use in Japan, the INCI name Ki4 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 YELLOW 5 has reported used in the following product types: moisturizer (235); shampoo (188); fragrance for women (181); body wash/cleanser (176); conditioner (167); facial cleanser (156); facial moisturizer/treatment (123); styling gel/lotion (109); fragrance for men (105); lipstick (95)


Neurotoxicity

type of concern product conditions reference
One or more animal studies show brain and nervous system effects at very low doses    RTECS®- Annals of Allergy 1959
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Persistence and bioaccumulation

type of concern product conditions reference
Persistent or bioaccumulative and moderate to high toxicity concern in humans     Environmental Canada Domestic Substance List
show more

Organ system toxicity (non-reproductive)

type of concern product conditions reference
One or more animal studies show musculoskeletal effects at very low doses    RTECS®- Annals of Allergy 1959
Classified as medium human health priority     Environmental Canada Domestic Substance List
show more

Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Mutation Research 2002
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Developmental/reproductive toxicity

type of concern product conditions reference
One or more animal studies show developmental effects at high doses    RTECS®- Journal of Toxicology and Environmental Health 1977
show more

Data gaps

type of concern product conditions reference
122 studies on toxicity in PubMed see search results ->   PubMed

Multiple, additive exposure sources

type of concern product conditions reference
Designated as safe for general or specific, limited use in food   FDA Everything Added to Food

Ecotoxicology

type of concern product conditions reference
Not suspected to be an environmental toxin     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 StatusFD&C YELLOW 5•Color additive approved by FDA for use in cosmetics
•Color additive approved by FDA for cosmetics used around eyes
FDA Everything Added to FoodFD&C YELLOW NO. 5• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance List1H-PYRAZOLE-3-CARBOXYLIC ACID, 4,5-DIHYDRO-5-OXO-1-(4-SULFOPHENYL) -4-[(4-SULFOPHENYL)AZO]-, TRISODIUM SALT•This chemical was deemed a human health priority even though it did not meet the strict criteria of the categorization exercise of CEPA. The chemical was flagged for persistence.
CTFA International Cosmetic Ingredient Dictionary and HandbookYELLOW 5•Color Additives - Batch Certified by the U.S. Food and Drug Administration
IFRA Fragrance Ingredient List1H-PYRAZOLE-3-CARBOXYLIC ACID, 4,5-DIHYDRO-5-OXO-1-(4-SULFOPHENYL)-4-[(4-SULFOPHENYL)AZO]-, TRISODIUM SALT•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
RTECS®- Annals of Allergy 1959FD&C YELLOW 5• musculoskeletal - Changes in teeth and supporting structures ( human TDLo)
• brain and nervous system - Paresthesis ( human TDLo)
RTECS®- Archives of Toxicology 1987FD&C YELLOW 5• mutagenic - Positive mutation assay: body fluid assay (rat )
RTECS®- Archives of Toxicology 1987FD&C YELLOW 5• mutagenic - Positive mutation assay: body fluid assay (rat )
RTECS®- FAO Nutrition Meetings Report Series 1966FD&C YELLOW 5• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS®- Food and Chemical Toxicology 1982FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (mammal fbr)
RTECS®- Food and Chemical Toxicology 1984FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Food and Chemical Toxicology 2004FD&C YELLOW 5• mutagenic - Positive mutation assay: Mutation in Micro-organism (Salmonella typhimurium )
RTECS®- Food and Chemical Toxicology 1982FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (mammal fbr)
RTECS®- Food and Chemical Toxicology 1984FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Food and Chemical Toxicology 2004FD&C YELLOW 5• mutagenic - Positive mutation assay: Mutation in Micro-organism (Salmonella typhimurium )
RTECS®- Food and Chemical Toxicology 2006FD&C YELLOW 5• reproductive - Behavioral (mouse TDLo)
RTECS®- Gann Monograph on Cancer Research 1981FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Gann Monograph on Cancer Research 1981FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Journal of Pharmacy and Pharmacology 1958FD&C YELLOW 5• brain and nervous system - Food intake (animal) (rat TDLo)
RTECS®- Journal of Toxicology and Environmental Health 1977FD&C YELLOW 5• developmental - Behavioral (rat TDLo)
• reproductive - Blood and lymphatic system (rat TDLo)
RTECS®- Mutation Research 1989FD&C YELLOW 5• mutagenic - Positive mutation assay: (Drosophila melanogaster orl)
RTECS®- Mutation Research 2002FD&C YELLOW 5• mutagenic - Positive mutation assay: DNA Damage (mouse orl)
RTECS®- Mutation Research 1989FD&C YELLOW 5• mutagenic - Positive mutation assay: (Drosophila melanogaster orl)
RTECS®- Mutation Research 2002FD&C YELLOW 5• mutagenic - Positive mutation assay: DNA Damage (mouse orl)
RTECS®- Oyo Yakuri 1982FD&C YELLOW 5• reproductive - Growth statistics (rat TDLo)
• reproductive - Weaning or lactation index (rat TDLo)
RTECS®- Soviet Genetics 1975FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human lym)
RTECS®- Soviet Genetics 1975FD&C YELLOW 5• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human lym)

references

government/industry list/academic study reference
FDA Color Additive StatusFDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
FDA Everything Added to FoodFDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
Environmental Canada Domestic Substance ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
CTFA International Cosmetic Ingredient Dictionary and HandbookCTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
IFRA Fragrance Ingredient ListIFRA (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®- Annals of Allergy 1959RTECS®- Annals of Allergy. (American College of Allergists, POB 20671, Bloomington, MN 55420) V.1- -1943 17,719,1959
RTECS®- Archives of Toxicology 1987RTECS®- Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.32- 1974- 60,328,1987
RTECS®- Archives of Toxicology 1987RTECS®- Archives of Toxicology. (Springer-Verlag, Heidelberger Pl. 3, D-1000 Berlin 33, Fed. Rep. Ger.) V.32- 60,328,1987
RTECS®- FAO Nutrition Meetings Report Series 1966RTECS®- FAO Nutrition Meetings Report Series. (Rome, Italy) No.?-57, 1948-77. Discontinued. 38B,88,1966
RTECS®- Food and Chemical Toxicology 1982RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 20,461,1982
RTECS®- Food and Chemical Toxicology 1984RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 22,623,1984
RTECS®- Food and Chemical Toxicology 2004RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 42,2029,2004
RTECS®- Food and Chemical Toxicology 1982RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 20,461,1982
RTECS®- Food and Chemical Toxicology 1984RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 22,623,1984
RTECS®- Food and Chemical Toxicology 2004RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 42,2029,2004
RTECS®- Food and Chemical Toxicology 2006RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 44,179,2006
RTECS®- Gann Monograph on Cancer Research 1981RTECS®- Gann Monograph on Cancer Research. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) No. 11- 1971- 27,95,1981
RTECS®- Gann Monograph on Cancer Research 1981RTECS®- Gann Monograph on Cancer Research. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) No. 11- 27,95,1981
RTECS®- Journal of Pharmacy and Pharmacology 1958RTECS®- Journal of Pharmacy and Pharmacology. (Pharmaceutical Soc. of Great Britain, 1 Lambeth High St., London SEI 7JN, UK) V.1- 1949- 10,625,1958
RTECS®- Journal of Toxicology and Environmental Health 1977RTECS®- Journal of Toxicology and Environmental Health. (Hemisphere Pub., 1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76- 2,1211,1977
RTECS®- Mutation Research 1989RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 224,479,1989
RTECS®- Mutation Research 2002RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 519,103,2002
RTECS®- Mutation Research 1989RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 224,479,1989
RTECS®- Mutation Research 2002RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 519,103,2002
RTECS®- Oyo Yakuri 1982RTECS®- Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- -1967 24,399,1982
RTECS®- Soviet Genetics 1975RTECS®- Soviet Genetics. English translation of GNKAA5. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.2- 1966- 11,528,1975
RTECS®- Soviet Genetics 1975RTECS®- Soviet Genetics. English translation of GNKAA5. (Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.2- 11,528,1975

"RTECS®" is a United States trademark owned and licensed under authority of the U.S. Government, by and through MDL Information Systems, Inc.

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