UREA

Buffering Agent; Humectant; Skin-Conditioning Agent - Humectant; ANTISTATIC; SKIN CONDITIONING  

Also listed as

CARBAMIDE; UREA PERHYDRATE; B-I-K; CARBAMIDE; CARBAMIDE RESIN; CARBAMIMIDIC ACID; CARBONYL DIAMIDE; CARBONYLDIAMINE; HARNSTOFF (GERMAN) ; ISOUREA; MOCOVINA (CZECH)


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
yes, moderateViolations, restrictions & warnings
noAllergies/immunotoxicity
noContamination concerns
noOther strong concerns for this ingredient:
Enhanced skin absorption
noOther moderate concerns for this ingredient:
Irritation (skin, eyes, or lungs)
noLesser or emerging concerns for this ingredient:
Neurotoxicity, Organ system toxicity (non-reproductive), Data gaps
 
See products containing UREA

About UREA: Urea is the organic compound.

This ingredient may be derived from animals. From PETA's Caring Consumer: Excreted from urine and other bodily fluids. In deodorants, ammoniated dentifrices, mouthwashes, hair colorings, hand creams, lotions, shampoos, etc. Used to "brown" baked goods, such as pretzels. Derivatives: Imidazolidinyl Urea, Uric Acid. Alternatives: synthetics.

UREA has reported used in the following product types: facial moisturizer/treatment (88); moisturizer (59); anti-aging (46); foot moisturizer (24); hair color and bleaching (23); sunscreen: moisturizer (22); facial cleanser (14); exfoliant/scrub (13); depilatory (13); hand cream (13)


Violations, restrictions & warnings

type of concern product conditions reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics   Canada - Prohibited and Restricted Cosmetics Ingredients

Cancer

type of concern product conditions reference
One or more in vitro tests on mammalian cells show positive mutation results    RTECS®- Gann Monograph on Cancer Research 1981
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Neurotoxicity

type of concern product conditions reference
One or more animal studies show brain and nervous system effects at moderate doses    RTECS®- American Journal of Physiology 1948
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Organ system toxicity (non-reproductive)

type of concern product conditions reference
One or more animal studies show respiratory effects at moderate doses (low dose studies may be unavailable for this ingredient) products that may be aerosolized (airborne)  RTECS®- American Journal of Physiology 1948
show more

Developmental/reproductive toxicity

type of concern product conditions reference
One or more animal studies show reproductive effects at high doses    RTECS®- Indian Journal of Experimental Biology 1974
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Irritation (skin, eyes, or lungs)

type of concern product conditions reference
One or more animal studies show skin irritation at low doses    RTECS®- Journal of Occupational Medicine 1992
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Data gaps

type of concern product conditions reference
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product   Cosmetic Ingredient Review Assessments
12,750 studies in PubMed science library may include information on the toxicity of this chemical see search results ->   PubMed

Enhanced skin absorption

type of concern product conditions reference
Penetration enhancer    Cosmetic Ingredient Review Assessments

Ecotoxicology

type of concern product conditions reference
Not suspected to be an environmental toxin     Environmental Canada Domestic Substance List

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
Designated as safe for general or specific, limited use in food   FDA Food Additive Status

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be persistent     Environmental Canada Domestic Substance List
show more



Government, industry, academic studies and classifications

government/industry list/academic study appears on list as classification(s)
FDA Food Additive StatusUREA• GRAS (generally recognized as safe) - use in food presumed safe based either on a history of use before 1958 or on published scientific evidence; need not be approved by the FDA prior to use in food; most have not limit for use but must conform to good manufacturing practices; some GRAS substances have quantitative limit for use in foods; by definition under Sec 201(s) of FD&C Act, not food additives
• Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required
• As formulation/fermentation aid in yeast -raised bakery prods
• alc bevs
• and gelatin prods -184.1923
Canada - Prohibited and Restricted Cosmetics IngredientsUREA•Use is restricted in Canadian cosmetics
Cosmetic Ingredient Review AssessmentsUREA•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR)
•Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product
•Penetration enhancer - alters skin structure, allows other chemicals to penetrate deeper into the skin
FDA Everything Added to FoodUREA• Fully up-to-date toxicology information has been sought.
Environmental Canada Domestic Substance ListUREA•This chemical was NOT flagged by CEPA for further attention. The chemical was flagged for as a low human health priority.
IFRA Fragrance Ingredient ListUREA•The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008.
RTECS®- "Abdernalden's Handbuch der Biologischen Arbeitsmethoden 1935UREA• broad systemic - Broad systemic toxicity (frog LDLo)
RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977UREA• skin - Primary skin irritant ( human )
RTECS®- "Ueber die Wirkung Verschiedener Gifte Auf Vogel, Dissertation," Forchheimer, L 1931UREA• broad systemic - Broad systemic toxicity (pigeon LDLo)
RTECS®- American Journal of Physiology 1948UREA• gastrointestinal - Changes in structure or function of salivary glands (domestic LDLo)
• respiratory - Dyspnea (domestic LDLo)
• brain and nervous system - Tetany (domestic LDLo)
RTECS®- British Journal of Clinical Practice 1972UREA• reproductive - Abortion (woman TDLo)
RTECS®- British Medical Journal 1971UREA• reproductive - Abortion (woman TDLo)
RTECS®- Cancer Research 1965UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human leu)
RTECS®- Cancer Research 1965UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis ( human leu)
RTECS®- Collection of Papers Presented at the Annual Symposium on Fundamental Cancer Research 1970UREA• mutagenic - Positive mutation assay: DNA Damage (hamster fbr)
RTECS®- Cytologia 1987UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse orl)
RTECS®- Cytologia 1987UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (mouse orl)
RTECS®- Gann Monograph on Cancer Research 1981UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Gann Monograph on Cancer Research 1981UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster lng)
RTECS®- Gigiena i Sanitariya 1986UREA• broad systemic - Broad systemic toxicity (rat LD50)
RTECS®- Gigiena Truda i Professional'nye Zabolevaniya 1986UREA• brain and nervous system - Convulsions or effect on seizure threshold (rat LD50)
• respiratory - Dyspnea (rat LD50)
• blood - Methemoglobinemia-Carboxylhemoglobin (rat LD50)
RTECS®- Gigiena Truda i Professional'nye Zabolevaniya 1987UREA• broad systemic - Broad systemic toxicity (mouse LD50)
RTECS®- Indian Journal of Experimental Biology 1974UREA• reproductive - Abortion (monkey TDLo)
RTECS®- Japanese Journal of Veterinary Science 1953UREA• blood - Hemorrhage (rabbit LDLo)
• brain and nervous system - Other degenerative changes (rabbit LDLo)
• respiratory - Structural or functional change in trachea or bronchi (rabbit LDLo)
RTECS®- Journal of Environmental Pathology and Toxicology 1980UREA• cancer - blood neoplasms (rat TDLo)
• cancer - blood tumors (mouse TDLo)
RTECS®- Journal of Occupational Medicine 1992UREA• skin - Primary skin irritant ( human )
RTECS®- Journal of Occupational Medicine 1992UREA• skin - Primary skin irritant ( human )
RTECS®- Journal of Pharmacology and Experimental Therapeutics 1936UREA• brain and nervous system - Coma (mouse LDLo)
• brain and nervous system - Convulsions or effect on seizure threshold (mouse LDLo)
RTECS®- Mutagenesis 1988UREA• mutagenic - Positive mutation assay: Mutation in Mammalian Somatic Cells (mouse lym)
RTECS®- Mutagenesis 1988UREA• mutagenic - Positive mutation assay: Mutation in Mammalian Somatic Cells (mouse lym)
RTECS®- Mutation Research 1988UREA• mutagenic - Positive mutation assay: DNA Damage (mouse lym)
RTECS®- Mutation Research 1977UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Mutation Research 1988UREA• mutagenic - Positive mutation assay: DNA Damage (mouse lym)
RTECS®- Mutation Research 1977UREA• mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster fbr)
RTECS®- Obstetrics and Gynecology 1974UREA• reproductive - Abortion (woman TDLo)
RTECS®- Oyo Yakuri 1977UREA• brain and nervous system - Altered sleep time (including change in righting reflex) (mouse LD50)
• brain and nervous system - Antipsychotic (mouse LD50)
• brain and nervous system - Changes in motor activity (specific assay) (mouse LD50)
RTECS®- Proceedings of the National Academy of Sciences of the United States of America 1982UREA• mutagenic - Positive mutation assay: DNA Inhibition ( human lym)
RTECS®- Proceedings of the National Academy of Sciences of the United States of America 1982UREA• mutagenic - Positive mutation assay: DNA Inhibition ( human lym)

references

government/industry list/academic study reference
FDA Food Additive StatusFDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.
Canada - Prohibited and Restricted Cosmetics IngredientsHealth Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
Cosmetic Ingredient Review AssessmentsCIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
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.
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®- "Abdernalden's Handbuch der Biologischen Arbeitsmethoden 1935RTECS®- "Abdernalden's Handbuch der Biologischen Arbeitsmethoden." (Leipzig, Ger. Dem. Rep.) 4,1353,1935
RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 -,127,1977
RTECS®- "Ueber die Wirkung Verschiedener Gifte Auf Vogel, Dissertation," Forchheimer, L 1931RTECS®- "Ueber die Wirkung Verschiedener Gifte Auf Vogel, Dissertation," Forchheimer, L., Pharmakologischen Institut der Universitat Wurzburg, Fed. Rep. Ger., 1931 -,-,1931
RTECS®- American Journal of Physiology 1948RTECS®- American Journal of Physiology. (American Physiological Soc., 9650 Rockville Pike, Bethesda, MD 20814) V.1- 1898- 153,41,1948
RTECS®- British Journal of Clinical Practice 1972RTECS®- British Journal of Clinical Practice. (Medical News Group, 1 Bedford St., London WC2E 9HD, UK) V.10(10)- 1956- 26,24,1972
RTECS®- British Medical Journal 1971RTECS®- British Medical Journal. (British Medical Assoc., BMA House, Tavistock Sq., London WC1H 9JR, UK) V.1- 1857- 1,28,1971
RTECS®- Cancer Research 1965RTECS®- Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 1941- 25,980,1965
RTECS®- Cancer Research 1965RTECS®- Cancer Research. (Public Ledger Building, Suit 816, 6th & Chestnut Sts., Philadelphia, PA 19106) V.1- 25,980,1965
RTECS®- Collection of Papers Presented at the Annual Symposium on Fundamental Cancer Research 1970RTECS®- Collection of Papers Presented at the Annual Symposium on Fundamental Cancer Research. (Baltimore, MD) V.1-29, 1946-76. For publisher information, see AFCPDR. 23,346,1970
RTECS®- Cytologia 1987RTECS®- Cytologia. (Japan Pub. Trading Co. (USA), 1255 Howard St., San Francisco, CA 94103) V.1- -1929 52,877,1987
RTECS®- Cytologia 1987RTECS®- Cytologia. (Japan Pub. Trading Co. (USA), 1255 Howard St., San Francisco, CA 94103) V.1- 1929- 52,877,1987
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®- Gigiena i Sanitariya 1986RTECS®- Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936- 51(6),8,1986
RTECS®- Gigiena Truda i Professional'nye Zabolevaniya 1986RTECS®- Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-36, 1957-1992. For publisher information, see MTPEEI 30(3),43,1986
RTECS®- Gigiena Truda i Professional'nye Zabolevaniya 1987RTECS®- Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-36, 1957-1992. For publisher information, see MTPEEI 31(12),53,1987
RTECS®- Indian Journal of Experimental Biology 1974RTECS®- Indian Journal of Experimental Biology. (Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1- 1963- 12,372,1974
RTECS®- Japanese Journal of Veterinary Science 1953RTECS®- Japanese Journal of Veterinary Science. (Nippon Jui Gakkai, 1-37-20 Yoyogi, Shibuya-ku, Tokyo 151, Japan) V.1- 1939- 15,125,1953
RTECS®- Journal of Environmental Pathology and Toxicology 1980RTECS®- Journal of Environmental Pathology and Toxicology. (Park Forest South, IL) V.1-5(3), 1977-81(?). For publisher information, see JEPOEC. 3(5-6),149,1980
RTECS®- Journal of Occupational Medicine 1992RTECS®- Journal of Occupational Medicine. (Chicago, IL) V.1-9, 1957-67. For publisher information, see:JJOMDZ 177,44,1992
RTECS®- Journal of Occupational Medicine 1992RTECS®- Journal of Occupational Medicine. (Chicago, IL) V.1-9, information, see:JJOMDZ 177,44,1992
RTECS®- Journal of Pharmacology and Experimental Therapeutics 1936RTECS®- Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- 57,19,1936
RTECS®- Mutagenesis 1988RTECS®- Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 1986- 3,193,1988
RTECS®- Mutagenesis 1988RTECS®- Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 3,193,1988
RTECS®- Mutation Research 1988RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 203,155,1988
RTECS®- Mutation Research 1977RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 48,337,1977
RTECS®- Mutation Research 1988RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 203,155,1988
RTECS®- Mutation Research 1977RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 48,337,1977
RTECS®- Obstetrics and Gynecology 1974RTECS®- Obstetrics and Gynecology. (Elsevier Science Pub. Co., Inc., 52 Vanderbilt Ave., New York, NY 10017) V.1- 1953- 43,765,1974
RTECS®- Oyo Yakuri 1977RTECS®- Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- -1967 13,749,1977
RTECS®- Proceedings of the National Academy of Sciences of the United States of America 1982RTECS®- Proceedings of the National Academy of Sciences of the United States of America. (National Academy of Sciences, Printing & Pub. Office, 2101 Constitution Ave., Washington, DC 20418) V.1- 1915- 79,1171,1982
RTECS®- Proceedings of the National Academy of Sciences of the United States of America 1982RTECS®- Proceedings of the National Academy of Sciences of the United States of America. (National Academy of Sciences, Printing & Pub. Office, 2101 Constitution Ave., Washington, DC 20418) V.1- 79,1171,1982

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