POLYSORBATE-20
Fragrance Ingredient; Surfactant - Emulsifying Agent; Surfactant - Solubilizing Agent
Also listed as
POLYSORBATE 20, POLYOXYETHYLENE (20) SORBITAN MONOLAURATE; POLYOXYETHYLENE SORBITAN MONOLAURATE; SORBIMACROGOL LAURATE 300; SORBITAN, MONODODECANOATE, POLY (OXY-1,2-ETHANEDIYL) DERIVS.; POLY (OXY-1,2-ETHANEDIYL) DERIVS. SORBITAN, MONODODECANOATE; MONODODECANOATE POLY (OXY-1,2-ETHANEDIYL) DERIVS. SORBITAN; POYLSORBATE-20; TWEEN-20
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 |
| Lesser or emerging concerns for this ingredient: Endocrine disruption, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Data gaps |
|
See products containing POLYSORBATE-20 | |
About POLYSORBATE-20: Polysorbate 20 is a mixture of laurate esters of sorbitol and sorbitol anhydrides, consistingpredominantly of the monoester, condensed with approximately 20 moles of ethylene oxide. It conformsgenerally to the formula: where w + x + y + z has an average value of 20.
POLYSORBATE-20 has reported used in the following product types: facial moisturizer/treatment (500); anti-aging (372); facial cleanser (267); hair color and bleaching (232); body wash/cleanser (196); foundation (189); shampoo (176); styling gel/lotion (173); moisturizer (161); toners/astringents (140)
Endocrine disruption
| type of concern | product conditions | reference |
| One or more animal studies show endocrine system disruption at high doses | RTECS®- Archives of Biochemistry and Biophysics 1951 |
Developmental/reproductive toxicity
| type of concern | product conditions | reference |
| One or more animal studies show reproductive effects at high doses | RTECS®- Zeitschrift fuer Naturforschung, Section C: Biosciences 1981 | |
| show more | ||
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| One or more animal studies show gastrointestinal effects at high doses (low dose studies may be unavailable for this ingredient) | RTECS®- Archives of Biochemistry and Biophysics 1951 | |
| show more | ||
Irritation (skin, eyes, or lungs)
| type of concern | product conditions | reference |
| One or more animal studies show skin irritation at moderate doses | RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977 |
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 | |
| 421 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 Food Additive Status | |
| 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 Food Additive Status | SORBITOL ANHYDRIDE ESTERS (A MIXTURE OF SORBITAN MONOSTEARATE, POLYOXYETHYLENE (20) SORBITAN MONO STEARATE (POLYSORBATE 60) AND POLYOXYETHYLENE (20) SORBITAN MONOLAURATE (POLYSORBATE 20) | • Food additive: boiler compound • Food additive: food additive for which a petition has been filed and a regulation issued • Each component less than 15 parts per million in steam contacting food |
| Cosmetic Ingredient Review Assessments | POLYSORBATE-20 | •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 • |
| FDA Everything Added to Food | POLYSORBATE 20 | • Fully up-to-date toxicology information has been sought. |
| Environmental Canada Domestic Substance List | SORBITAN, MONODODECANOATE, POLY(OXY-1,2-ETHANEDIYL) DERIVS. | •This chemical was NOT flagged by CEPA for further attention. The chemical was flagged as a low human health priority and for uncertain persistence and uncertain bioaccumulation. |
| RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977 | POLYSORBATE-20 | • skin - Primary skin irritant ( human ) |
| RTECS®- Archives of Biochemistry and Biophysics 1951 | POLYSORBATE-20 | • endocrine system - Death in the "U" data type field (rat TDLo) • liver - Fatty liver degeneration (rat TDLo) • gastrointestinal - Hypermotility, diarrhea (rat TDLo) • liver - Other changes (rat TDLo) |
| RTECS®- Food Research 1956 | POLYSORBATE-20 | • blood - Changes in spleen (hamster TDLo) • gastrointestinal - Hypermotility, diarrhea (rat TDLo) • blood - Other changes (rat TDLo) |
| RTECS®- National Technical Information Service 3800 | POLYSORBATE-20 | • metabolic - Weight loss or decreased weight gain (rat TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1982 | POLYSORBATE-20 | • reproductive - Other developmental abnormalities (mouse TDLo) |
| RTECS®- Toxicology and Applied Pharmacology 1965 | POLYSORBATE-20 | • blood - Changes in erythrocyte (RBC) count (mouse TDLo) • blood - Pigmented or nucleated red blood cells (mouse TDLo) |
| RTECS®- Zeitschrift fuer Naturforschung, Section C: Biosciences 1981 | POLYSORBATE-20 | • reproductive - Musculoskeletal system (mouse TDLo) • reproductive - Post-implantation mortality (mouse TDLo) |
references
| government/industry list/academic study | reference |
| FDA Food Additive Status | FDA (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. |
| Cosmetic Ingredient Review Assessments | CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. |
| 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. |
| Environmental Canada Domestic Substance List | EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry. |
| RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V 1977 | RTECS®- "Cutaneous Toxicity, Proceedings of the 3rd Conference, 1976," Drill, V.A., and P. Lazar, eds., New York, Academic Press, Inc. 1977 -,127,1977 |
| RTECS®- Archives of Biochemistry and Biophysics 1951 | RTECS®- Archives of Biochemistry and Biophysics. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.31- 1951- 34,249,1951 |
| RTECS®- Food Research 1956 | RTECS®- Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. 21,348,1956 |
| RTECS®- National Technical Information Service 3800 | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. #PB93-123800 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1982 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 26(3),19A,1982 |
| RTECS®- Toxicology and Applied Pharmacology 1965 | RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 7,320,1965 |
| RTECS®- Zeitschrift fuer Naturforschung, Section C: Biosciences 1981 | RTECS®- Zeitschrift fuer Naturforschung, Section C: Biosciences. (Verlag der Zeitschrift fuer Naturforschung, Postfach 2645, D-7400 Tuebingen, Fed. Rep. Ger.) V.29- 1974- 36,904,1981 |
"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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