PEG-100 STEARATE
Surfactant - Cleansing Agent
Also listed as
POLYOXYETHYLENE (100) MONOSTEARATE
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 - ETHYLENE OXIDE, 1,4-DIOXANE |
 | Other moderate concerns for this ingredient: Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs) |
| Lesser or emerging concerns for this ingredient: Ecotoxicology, Data gaps |
|
See products containing PEG-100 STEARATE | |
About PEG-100 STEARATE: PEG-100 Stearate is the polyethylene glycol ester of stearic acid. where n has an average value of 100.
PEG-100 STEARATE has reported used in the following product types: facial moisturizer/treatment (417); moisturizer (276); anti-aging (205); sunscreen: moisturizer (150); sunless tanning (77); sunscreen: SPF 15-30 (73); around-eye cream (63); exfoliant/scrub (59); sunscreen: SPF greater than 30 (50); hand cream (41)
Violations, restrictions & warnings
| type of concern | product conditions | reference |
| Violation of industry recommendations - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Not safe for use on injured or damaged skin | products for use on damaged skin | Cosmetic Ingredient Review Assessments |
| Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications | Cosmetic Ingredient Review Assessments |
Cancer
| type of concern | product conditions | reference |
| One or more animal studies show tumor formation at moderate doses | RTECS®- Archives of Environmental Health 1963 | |
| show more | ||
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| Limited evidence of sense organ toxicity | Harvell, J, 1994 | |
| show more | ||
Developmental/reproductive toxicity
| type of concern | product conditions | reference |
| One or more animal studies show reproductive effects at high doses | RTECS®- Journal of Nutrition 1956 |
Irritation (skin, eyes, or lungs)
| type of concern | product conditions | reference |
| One or more animal studies show skin irritation at very low doses | RTECS®- National Technical Information Service 4764 | |
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Ecotoxicology
| type of concern | product conditions | reference |
| Suspected to be an environmental toxin | Environmental Canada Domestic Substance List |
Data gaps
| type of concern | product conditions | reference |
| Safety assessment was based on related chemical | Cosmetic Ingredient Review Assessments | |
| 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 | |
| 9 studies in PubMed science library may include information on the toxicity of this chemical 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 |
Persistence and bioaccumulation
| type of concern | product conditions | reference |
| Not suspected to be bioaccumulative | Environmental Canada Domestic Substance List | |
| show more | ||
Government, industry, academic studies and classifications
| government/industry list/academic study | appears on list as | classification(s) |
| Cosmetic Ingredient Review Assessments | PEG-100 STEARATE | •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 •Determined safe for use in cosmetics based on concentrations of surrogate, related chemical in cosmetics, by industry safety panel (Cosmetic Ingredient Review, CIR) •May contain harmful impurities |
| FDA Everything Added to Food | POLYOXYETHYLENE 40 MONOSTEARATE | • Fully up-to-date toxicology information has been sought. |
| Environmental Canada Domestic Substance List | POLY(OXY-1,2-ETHANEDIYL), _-(1-OXOOCTADECYL)-_-HYDROXY- | •This chemical was NOT flagged by CEPA for further attention. The chemical was flagged for suspected aquatic toxicity. |
| IFRA Fragrance Ingredient List | POLY(OXY-1,2-ETHANEDIYL), A-(1-OXOOCTADECYL)-W-HYDROXY- | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| CIR | PEG-100 STEARATE | •Ethylene oxide |
| FDA Food Additive Status | POLYETHYLENE GLYCOL | • Food additive: boiler compound • Food additive: food additive for which a petition has been filed and a regulation issued • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required • In boiler water -173.310 • Food additive: antifoaming (or defoaming) agent • Food additive: food additive for which a petition has been filed and a regulation issued • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required • Comp of defoaming agent -173.340 • CTG • Food additive: food additive for which a petition has been filed and a regulation issued • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required • Ctg on fresh citrus fruits -172.210 |
| FDA Food Additive Status | POLYETHYLENE GLYCOL | • miscellaneous • Food additive: food additive for which a petition has been filed and a regulation issued • Food additive: must be in accordance with good manufacturing practices, or sufficient for purpose; or in quantity not greater than required • Ctg • binder • plasticizing agent • and/or lubricant in tablets used for food • Adjuvant in nonnutritive sweeteners • vitamin and mineral preparations • Ctg for sodium nitrite to inhibit hygroscopic properties - CFR172.820 • ZERO - In milk - CFR172.820; 526.820 |
| Cosmetic Ingredient Review Assessments | PEG-6 | •Safe for use in cosmetics with some qualifications •Not safe for use on injured or damaged skin •May contain harmful impurities |
| CIR | PEG-6 | •Ethylene oxide |
| Harvell, J, 1994 | POLYETHYLENE GLYCOL | •Skin or sense organ toxicity hazards: suspected |
| RTECS®- Archives of Environmental Health 1963 | PEG-100 STEARATE | • cancer - Tumor types after systemic administration not seen spontaneously (rat TDLo) • cancer - Tumors at site of application (rat TDLo) |
| RTECS®- Bollettino Chimico Farmaceutico 1962 | PEG-100 STEARATE | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- Food Research 1956 | PEG-100 STEARATE | • blood - Changes in spleen (hamster TDLo) • gastrointestinal - Hypermotility, diarrhea (hamster TDLo) • gastrointestinal - Other changes (hamster TDLo) |
| RTECS®- Journal of Nutrition 1956 | PEG-100 STEARATE | • reproductive - Viability index (rat TDLo) |
| RTECS®- Journal of the American College of Toxicology 1983 | PEG-100 STEARATE | • skin - Primary skin irritant (rabbit ) |
| RTECS®- Journal of the American College of Toxicology 1983 | PEG-100 STEARATE | • skin - Primary skin irritant (rabbit ) |
| RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition 1949 | PEG-100 STEARATE | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- National Technical Information Service 4764 | PEG-100 STEARATE | • sense organ - Primary eye irritant (rabbit ) • skin - Primary skin irritant (rabbit ) |
| RTECS®- National Technical Information Service | PEG-100 STEARATE | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- National Technical Information Service 4764 | PEG-100 STEARATE | • sense organ - Primary eye irritant (rabbit ) • skin - Primary skin irritant (rabbit ) |
| RTECS®- Toxicology and Applied Pharmacology 1959 | PEG-100 STEARATE | • metabolic - Weight loss or decreased weight gain (rat TDLo) • gastrointestinal - Hypermotility, diarrhea (rat TDLo) • metabolic - Other changes (rat TDLo) |
references
| government/industry list/academic study | reference |
| 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. |
| 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 |
| Impurities - Open Scientific Literature | CIR |
| 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. |
| Impurities - Open Scientific Literature | CIR |
| Scorecard.org Toxicity Information | Harvell, J., M. Bason and H. Maibach. Contact Urticaria and its Mechanisms. Food Chemistry and Toxicology 32(2): 103-112. 1994. (Table 2: Substances identified as capable of causing contact urticaria). |
| RTECS®- Archives of Environmental Health 1963 | RTECS®- Archives of Environmental Health. (Heldref Pub., 4000 Albemarle St., NW, Washington, DC 20016) V.1- 1960- 6,484,1963 |
| RTECS®- Bollettino Chimico Farmaceutico 1962 | RTECS®- Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica, Via Ausonio 12, 20123 Milan, Italy) V.33- 1894- 101,173,1962 |
| RTECS®- Food Research 1956 | RTECS®- Food Research. (Champaign, IL) V.1-25, 1936-60. For publisher information, see JFDSAZ. 21,348,1956 |
| RTECS®- Journal of Nutrition 1956 | RTECS®- Journal of Nutrition. (Subscription Dept., 9650 Rockville Pike, Bethesda, MD 20014) V.1- -1928 60,489,1956 |
| RTECS®- Journal of the American College of Toxicology 1983 | RTECS®- Journal of the American College of Toxicology. (Mary Ann Liebert, Inc., 1651 Third Ave., New York, NY 10128) V.1-12, 1982-1993. Discontinued. 2(7),17,1983 |
| RTECS®- Journal of the American College of Toxicology 1983 | RTECS®- Journal of the American College of Toxicology. (Mary Ann Liebert, Inc., 1651 Third Ave., New York, NY 10128) V.1-12, 1982-1993. Discontinued. 2(7),17,1983 |
| RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition 1949 | RTECS®- Journal of the American Pharmaceutical Association, Scientific Edition. (Washington, DC) V.29-49, 1940-60. For publisher information, see JPMSAE. 38,428,1949 |
| RTECS®- National Technical Information Service 4764 | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. OTS0534764 |
| RTECS®- National Technical Information Service | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. AD277-689 |
| RTECS®- National Technical Information Service 4764 | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. OTS0534764 |
| RTECS®- Toxicology and Applied Pharmacology 1959 | RTECS®- Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 1,315,1959 |
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