PEG-6 SORBITAN OLEATE
Fragrance Ingredient; Surfactant - Emulsifying Agent
Also listed as
POLYETHYLENE GLYCOL 300 SORBITAN MONOOLEATE; POLYOXYETHYLENE SORBITAN MONOOLEATE
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) |
| Lesser or emerging concerns for this ingredient: Neurotoxicity, Data gaps |
About PEG-6 SORBITAN OLEATE: PEG-6 Sorbitan Oleate is an ethoxylated sorbitan ester of oleic acid with an average of 6moles of ethylene oxide.
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 |
Allergies/immunotoxicity
| type of concern | product conditions | reference |
| Human skin toxicant - strong evidence | Cosmetic Ingredient Review Assessments |
Developmental/reproductive toxicity
| type of concern | product conditions | reference |
| One or more animal studies show reproductive effects at very low doses | RTECS®- Reproductive Toxicology 2006 | |
| show more | ||
Cancer
| type of concern | product conditions | reference |
| One or more in vitro tests on mammalian cells show positive mutation results | RTECS®- Biochemical and Biophysical Research Communications 1971 | |
| show more | ||
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| Limited evidence of sense organ toxicity | Harvell, J, 1994 | |
| show more | ||
Neurotoxicity
| type of concern | product conditions | reference |
| One or more animal studies show brain and nervous system effects at high doses | RTECS®- National Technical Information Service 3026 |
Data gaps
| type of concern | product conditions | reference |
| Safety assessment was based on related chemical | Cosmetic Ingredient Review Assessments | |
| 12 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 |
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) |
| Cosmetic Ingredient Review Assessments | PEG-6 SORBITAN OLEATE | •Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR) •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 •Sensitizer - can instigate immune system response that can include itching, burning, scaling, hives, and blistering of skin • • •Safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) is based on safety or product use data for a different, related ingredient |
| FDA Everything Added to Food | POLYSORBATE 80 | • Fully up-to-date toxicology information has been sought. |
| Environmental Canada Domestic Substance List | SORBITAN, MONO-9-OCTADECENOATE, POLY(OXY-1,2-ETHANEDIYL) DERIVS., (Z)- | •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. |
| IFRA Fragrance Ingredient List | SORBITAN, MONO-9-OCTADECENOATE, POLY(OXY-1,2-ETHANEDIYL) DERIVS., (Z)- | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| 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 Ophthalmology (Chicago) 1948 | PEG-6 SORBITAN OLEATE | • sense organ - Primary eye irritant (rabbit ) |
| RTECS®- Archives of Ophthalmology (Chicago) 1948 | PEG-6 SORBITAN OLEATE | • sense organ - Primary eye irritant (rabbit ) |
| RTECS®- Biochemical and Biophysical Research Communications 1971 | PEG-6 SORBITAN OLEATE | • mutagenic - Positive mutation assay: DNA Inhibition ( human lym) |
| RTECS®- Biochemical and Biophysical Research Communications 1971 | PEG-6 SORBITAN OLEATE | • mutagenic - Positive mutation assay: DNA Inhibition ( human lym) |
| RTECS®- Environmental Physiology and Biochemistry 1975 | PEG-6 SORBITAN OLEATE | • mutagenic - Positive mutation assay: DNA Inhibition (mouse oth) |
| RTECS®- Food and Chemical Toxicology 2003 | PEG-6 SORBITAN OLEATE | • gastrointestinal - Hypermotility, diarrhea (rat TDLo) |
| RTECS®- Food and Cosmetics Toxicology 1971 | PEG-6 SORBITAN OLEATE | • cancer - Tumors at site of application (rat TDLo) |
| RTECS®- Journal of Nutrition 1956 | PEG-6 SORBITAN OLEATE | • reproductive - Viability index (rat TDLo) |
| RTECS®- National Technical Information Service 3026 | PEG-6 SORBITAN OLEATE | • liver - Changes in liver weight (rat TDLo) • brain and nervous system - Food intake (animal) (rat TDLo) |
| RTECS®- National Technical Information Service | PEG-6 SORBITAN OLEATE | • cancer - endocrine system tumor formations - equivocal (rat TDLo) |
| RTECS®- National Toxicology Program Technical Report Series 1992 | PEG-6 SORBITAN OLEATE | • metabolic - Weight loss or decreased weight gain (rat TDLo) • cancer - endocrine system tumor formations - equivocal (rat TDLo) |
| RTECS®- Reproductive Toxicology 2006 | PEG-6 SORBITAN OLEATE | • reproductive - Ovaries, fallopian tubes (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 |
| 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 Ophthalmology (Chicago) 1948 | RTECS®- Archives of Ophthalmology (Chicago). (AMA, 535 N. Dearborn St., Chicago, IL 60610) New series: V.1-44(3), 1929-50; V.64- 1960- 40,668,1948 |
| RTECS®- Archives of Ophthalmology (Chicago) 1948 | RTECS®- Archives of Ophthalmology (Chicago). (AMA, 535 N. Dearborn St., Chicago, IL 60610) New series: V.1-44(3), 1929-50; V.64- 40,668,1948 |
| RTECS®- Biochemical and Biophysical Research Communications 1971 | RTECS®- Biochemical and Biophysical Research Communications. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 45,630,1971 |
| RTECS®- Biochemical and Biophysical Research Communications 1971 | RTECS®- Biochemical and Biophysical Research Communications. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959- 45,630,1971 |
| RTECS®- Environmental Physiology and Biochemistry 1975 | RTECS®- Environmental Physiology and Biochemistry. (Copenhagen, Denmark) V.2-5, 1972-75. Discontinued. 5,84,1975 |
| RTECS®- Food and Chemical Toxicology 2003 | RTECS®- Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982- 41,575,2003 |
| RTECS®- Food and Cosmetics Toxicology 1971 | RTECS®- Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. 9,463,1971 |
| RTECS®- Journal of Nutrition 1956 | RTECS®- Journal of Nutrition. (Subscription Dept., 9650 Rockville Pike, Bethesda, MD 20014) V.1- -1928 60,489,1956 |
| RTECS®- National Technical Information Service 3026 | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. #PB93-123026 |
| RTECS®- National Technical Information Service | RTECS®- National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information. PB92-189331/AS |
| RTECS®- National Toxicology Program Technical Report Series 1992 | RTECS®- National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206- NTP-TR-415,1992 |
| RTECS®- Reproductive Toxicology 2006 | RTECS®- Reproductive Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1- 1987- 22,263,2006 |
"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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