RETINYL PALMITATE
Skin-Conditioning Agent - Miscellaneous; SKIN CONDITIONING
Also listed as
AXEROPHTHOL PALMITATE; RETINOL, HEXADECANOATE; RETINOL PALMITATE; VITAMIN A PALMITATE; HEXADECANOATE RETINOL; AQUASOL A; AROVIT; OPTOVIT-A; RETINOL PALMITATE; VITAMIN A PALMITATE
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 |
 | Other strong concerns for this ingredient: Biochemical or cellular level changes |
| Other moderate concerns for this ingredient: Organ system toxicity (non-reproductive) |
 | Lesser or emerging concerns for this ingredient: Neurotoxicity, Data gaps |
|
See products containing RETINYL PALMITATE | |
About RETINYL PALMITATE: Retinyl Palmitate is the ester of Retinol (q.v.) and palmitic acid.
RETINYL PALMITATE has reported used in the following product types: facial moisturizer/treatment (406); foundation (320); lipstick (298); anti-aging (265); sunscreen: makeup (260); moisturizer (207); sunscreen: SPF 15-30 (137); sunscreen: SPF greater than 30 (106); sunscreen: moisturizer (103); around-eye cream (82)
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 |
Biochemical or cellular level changes
| type of concern | product conditions | reference |
| Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease. | Cherng SH, Xia Q, Blankenship LR, Freeman JP, Wamer WG, Howard PC, et al, 2005 | |
| Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease. | Xia Q, Yin JJ, Cherng SH, Wamer WG, Boudreau M, Howard PC, et al, 2006 |
Developmental/reproductive toxicity
| type of concern | product conditions | reference |
| One or more animal studies show reproductive effects at low doses | RTECS®- Journal of Reproduction and Fertility 1977 | |
| show more | ||
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| Limited evidence of skin toxicity | Duell EA, Kang S, Voorhees JJ, 1997 | |
| show more | ||
Neurotoxicity
| type of concern | product conditions | reference |
| One or more animal studies show brain and nervous system effects at high doses | RTECS®- Voprosy Onkologii 1979 |
Enhanced skin absorption
| type of concern | product conditions | reference |
| Absorbs into the skin | Boehnlein J, Sakr A, Lichtin JL, Bronaugh RL, 1994 |
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 | |
| 403 studies in PubMed science library may include information on the toxicity of this chemical see search results -> | PubMed |
Ecotoxicology
| type of concern | product conditions | reference |
| Uncertain environmental toxin and uncertain persistent or bioaccumulative | 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 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 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 Status | VITAMIN A PALMITATE | • NUTR/DS • 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 - CFR182.5936; 184.1930 |
| Canada - Prohibited and Restricted Cosmetics Ingredients | RETINYL PALMITATE | •Use is restricted in Canadian cosmetics |
| Cosmetic Ingredient Review Assessments | RETINYL PALMITATE | •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 | VITAMIN A PALMITATE | • Fully up-to-date toxicology information has been sought. |
| Environmental Canada Domestic Substance List | RETINOL, HEXADECANOATE | •This chemical was NOT flagged by CEPA for further attention. The chemical was flagged for uncertain aquatic toxicity potential. |
| Mei N, Xia Q, Chen L, Moore MM, Fu PP, Chen T, 2005 | RETINYL PALMITATE | increased frequency of mutations in cell exposed to retinyl palmitate and UVA (synergistic effect) |
| Cherng SH, Xia Q, Blankenship LR, Freeman JP, Wamer WG, Howard PC, et al, 2005 | RETINYL PALMITATE | photoirradiation of retinyl palmitate by UVA light generates reactive oxygen species resulting in lipid peroxidation. |
| Yan J, Xia Q, Cherng SH, Wamer WG, Howard PC, Yu H, et al, 2005 | RETINYL PALMITATE | photoirradiation of retinyl palmitate with UVA light generates free radicals that initiate DNA strand cleavage |
| Xia Q, Yin JJ, Cherng SH, Wamer WG, Boudreau M, Howard PC, et al, 2006 | RETINYL PALMITATE | UVA irradiation of retinyl palmitate induces formation of reactive oxygen species |
| Boehnlein J, Sakr A, Lichtin JL, Bronaugh RL, 1994 | RETINYL PALMITATE | retinyl palmitate is absorbed into skin and converted to retinol |
| IFRA Fragrance Ingredient List | RETINOL, HEXADECANOATE | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| Canada - Prohibited and Restricted Cosmetics Ingredients | RETINYL ACETATE | •Use is restricted in Canadian cosmetics |
| Duell EA, Kang S, Voorhees JJ, 1997 | RETINYL PALMITATE | topically applied retinyl palmitate induced epidermal hyperplasia in human skin |
| Kang S, Duell EA, Fisher GJ, Datta SC, Wang ZQ, Reddy AP, et al, 1995 | VITAMIN A | topically applied retinol induced epidermal hyperplasia in human skin |
| NTP, 2000 | RETINYL PALMITATE | retinyl palmitate nominated by FDA for photocarcinogenicity testing by the National Toxicology Panel |
| RTECS®- "Environmental Variables in Oral Disease; A Symposium Presented at the Montreal Meeting of the American Association for the Advancement of Science, 1964," Kreshover, S 1966 | RETINYL PALMITATE | • reproductive - Post-implantation mortality (mouse TDLo) |
| RTECS®- Acta Anatomica 1981 | RETINYL PALMITATE | • reproductive - Musculoskeletal system (rat TDLo) |
| RTECS®- AMA Archives of Pathology 1953 | RETINYL PALMITATE | • reproductive - Testes, epididymis, sperm duct (rat TDLo) |
| RTECS®- Anatomical Record 1960 | RETINYL PALMITATE | • reproductive - Cardiovascular (mouse TDLo) • developmental - Urogenital system (mouse TDLo) |
| RTECS®- Anatomischer Anzeiger 1982 | RETINYL PALMITATE | • reproductive - Cytological changes (rat TDLo) |
| RTECS®- British Journal of Experimental Pathology 1976 | RETINYL PALMITATE | • reproductive - Post-implantation mortality (rat TDLo) |
| RTECS®- Japanese Journal of Genetics 1966 | RETINYL PALMITATE | • reproductive - Fetal death (rabbit TDLo) • reproductive - Musculoskeletal system (mouse TDLo) |
| RTECS®- Journal of Embryology and Experimental Morphology 1973 | RETINYL PALMITATE | • developmental - Central nervous system (rat TDLo) • reproductive - Eye, ear (rat TDLo) • reproductive - Musculoskeletal system (rat TDLo) • reproductive - Post-implantation mortality (rat TDLo) |
| RTECS®- Journal of Pharmacology and Experimental Therapeutics 1964 | RETINYL PALMITATE | • reproductive - Central nervous system (rat TDLo) • reproductive - Post-implantation mortality (rat TDLo) |
| RTECS®- Journal of Reproduction and Fertility 1977 | RETINYL PALMITATE | • reproductive - Other measures of fertility (rat TDLo) • reproductive - Ovaries, fallopian tubes (rat TDLo) • reproductive - Uterus, cervix, vagina (rat TDLo) |
| RTECS®- Journal of the American Academy of Dermatology 1982 | RETINYL PALMITATE | • broad systemic - Broad systemic toxicity (mouse LD50) |
| RTECS®- Journal of the Anatomical Society of India 1974 | RETINYL PALMITATE | • reproductive - Central nervous system (rat TDLo) • developmental - Craniofacial (rat TDLo) |
| RTECS®- Mutagenesis 2004 | RETINYL PALMITATE | • mutagenic - Positive mutation assay: DNA Damage (rat orl) |
| RTECS®- Mutation Research 1978 | RETINYL PALMITATE | • mutagenic - Positive mutation assay: Sister Chromatid Exchange ( human fbr) |
| RTECS®- Mutation Research 1978 | RETINYL PALMITATE | • mutagenic - Positive mutation assay: Sister Chromatid Exchange ( human fbr) |
| RTECS®- Neurotoxicology and Teratology 2005 | RETINYL PALMITATE | • reproductive - Fetotoxicity (rat TDLo) |
| RTECS®- Pharmacology, Biochemistry and Behavior 1991 | RETINYL PALMITATE | • reproductive - Behavioral (rat TDLo) |
| RTECS®- Reproductive Toxicology 2000 | RETINYL PALMITATE | • reproductive - Cardiovascular (monkey TDLo) • reproductive - Eye, ear (monkey TDLo) • developmental - Musculoskeletal system (monkey TDLo) |
| RTECS®- Senten Ijo 1974 | RETINYL PALMITATE | • reproductive - Fetal death (mouse TDLo) • developmental - Musculoskeletal system (mouse TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1974 | RETINYL PALMITATE | • reproductive - Behavioral (rat TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1980 | RETINYL PALMITATE | • reproductive - Behavioral (rat TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1981 | RETINYL PALMITATE | • reproductive - Craniofacial (mouse TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1983 | RETINYL PALMITATE | • reproductive - Eye, ear (mammal TDLo) • reproductive - Musculoskeletal system (mammal TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1987 | RETINYL PALMITATE | • reproductive - Craniofacial (mouse TDLo) |
| RTECS®- Teratology, The International Journal of Abnormal Development 1974 | RETINYL PALMITATE | • reproductive - Fetotoxicity (mouse TDLo) |
| RTECS®- Voprosy Onkologii 1979 | RETINYL PALMITATE | • metabolic - Weight loss or decreased weight gain (mouse LD50) • gastrointestinal - Hypermotility, diarrhea (mouse LD50) • brain and nervous system - Somnolence (general depressed activity) (mouse LD50) |
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. |
| Canada - Prohibited and Restricted Cosmetics Ingredients | Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007. |
| 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. |
| Open scientific literature | Mei N, Xia Q, Chen L, Moore MM, Fu PP, Chen T. 2005. Photomutagenicity of retinyl palmitate by ultraviolet a irradiation in mouse lymphoma cells. Toxicol Sci 88(1): 142-9. |
| Open scientific literature | Cherng SH, Xia Q, Blankenship LR, Freeman JP, Wamer WG, Howard PC, et al. 2005. Photodecomposition of retinyl palmitate in ethanol by UVA light-formation of photodecomposition products, reactive oxygen species, and lipid peroxides. Chem Res Toxicol 18(2): 129-38 |
| Open scientific literature | Yan J, Xia Q, Cherng SH, Wamer WG, Howard PC, Yu H, et al. 2005. Photo-induced DNA damage and photocytotoxicity of retinyl palmitate and its photodecomposition products. Toxicol Ind Health 21(7-8): 167-75 |
| Open scientific literature | Xia Q, Yin JJ, Cherng SH, Wamer WG, Boudreau M, Howard PC, et al. 2006. UVA photoirradiation of retinyl palmitate--formation of singlet oxygen and superoxide, and their role in induction of lipid peroxidation. Toxicol Lett 163(1): 30-43 |
| Open scientific literature | Boehnlein J, Sakr A, Lichtin JL, Bronaugh RL. 1994. Characterization of esterase and alcohol dehydrogenase activity in skin. Metabolism of retinyl palmitate to retinol (vitamin A) during percutaneous absorption. Pharm Res 11(8): 1155-9. |
| 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 |
| Open scientific literature | Duell EA, Kang S, Voorhees JJ. 1997. Unoccluded retinol penetrates human skin in vivo more effectively than unoccluded retinyl palmitate or retinoic acid. J Invest Dermatol 109(3): 301-5. |
| Open scientific literature | Kang S, Duell EA, Fisher GJ, Datta SC, Wang ZQ, Reddy AP, et al. 1995. Application of retinol to human skin in vivo induces epidermal hyperplasia and cellular retinoid binding proteins characteristic of retinoic acid but without measurable retinoic acid levels or irritation. J Invest Dermatol 105(4): 549-56. |
| Open scientific literature | NTP. 2000. All-Trans-Retinyl Palmitate [CASRN 79-81-2]. http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/RetinylPalmitate.pdf |
| RTECS®- "Environmental Variables in Oral Disease; A Symposium Presented at the Montreal Meeting of the American Association for the Advancement of Science, 1964," Kreshover, S 1966 | RTECS®- "Environmental Variables in Oral Disease; A Symposium Presented at the Montreal Meeting of the American Association for the Advancement of Science, 1964," Kreshover, S.J., et al., eds., Washington, DC, American Assoc. for the Advancement of Science, 1966 -,273,1966 |
| RTECS®- Acta Anatomica 1981 | RTECS®- Acta Anatomica. (S. Karger Pub., Inc., 79 Fifth Ave., New York, NY 10003) V.1- 1945- 109,89,1981 |
| RTECS®- AMA Archives of Pathology 1953 | RTECS®- AMA Archives of Pathology. (Chicago, IL) V.50(4)-69, 1950-60. For publisher information, see APLMAS. 56,333,1953 |
| RTECS®- Anatomical Record 1960 | RTECS®- Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08- 136,219,1960 |
| RTECS®- Anatomischer Anzeiger 1982 | RTECS®- Anatomischer Anzeiger. (VEB Gustav Fischer Verlag, Postfach 176, Jena DDR-6900, Ger. Dem. Rep.) V.1- 1886- 152,329,1982 |
| RTECS®- British Journal of Experimental Pathology 1976 | RTECS®- British Journal of Experimental Pathology. (Blackwell Scientific Pub. Ltd., POB 88, Oxford, UK) V.1- 1920- 57,525,1976 |
| RTECS®- Japanese Journal of Genetics 1966 | RTECS®- Japanese Journal of Genetics. Idengaku Zasshi. (Genetics Soc. of Japan, 111 Tanida, Mishima, Shizuoka-ken, Japan) V.1- 1921- 41,141,1966 |
| RTECS®- Journal of Embryology and Experimental Morphology 1973 | RTECS®- Journal of Embryology and Experimental Morphology. (Essex, UK) V.1-98, 1953-86. For Publisher information, see DEVPED 30,219,1973 |
| RTECS®- Journal of Pharmacology and Experimental Therapeutics 1964 | RTECS®- Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- 144,429,1964 |
| RTECS®- Journal of Reproduction and Fertility 1977 | RTECS®- Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- 50,223,1977 |
| RTECS®- Journal of the American Academy of Dermatology 1982 | RTECS®- Journal of the American Academy of Dermatology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63141) 1979- 6,652,1982 |
| RTECS®- Journal of the Anatomical Society of India 1974 | RTECS®- Journal of the Anatomical Society of India. (Dept. of Anatomy, Medical College, Aurangabad 431 001, India) V.1- 1952- 23,89,1974 |
| RTECS®- Mutagenesis 2004 | RTECS®- Mutagenesis. (Oxford Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford OX8 1JJ, UK) V.1- 19,231,2004 |
| RTECS®- Mutation Research 1978 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 58,317,1978 |
| RTECS®- Mutation Research 1978 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- -1964 58,317,1978 |
| RTECS®- Neurotoxicology and Teratology 2005 | RTECS®- Neurotoxicology and Teratology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.9- 1987- 27,855,2005 |
| RTECS®- Pharmacology, Biochemistry and Behavior 1991 | RTECS®- Pharmacology, Biochemistry and Behavior. (ANKHO International Inc., P.O. Box 426, Fayetteville, NY 13066) V.1- 1973- 38,739,1991 |
| RTECS®- Reproductive Toxicology 2000 | RTECS®- Reproductive Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.1- 1987- 14,311,2000 |
| RTECS®- Senten Ijo 1974 | RTECS®- Senten Ijo. Congenital Anomalies. (Nippon Senten Ijo Gakkai, c/o Kinki Daigaku Igakubu Kaibagaku Kyoshitsu, 380 Nishiyama, Sayama-cho, Mirami-Kawachi-gun, Osaka-fu, Japan) V.1-26, 1960-86. For publisher information, see CGANE7. 14,13,1974 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1974 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 10,269,1974 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1980 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 21,25A,1980 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1981 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 23,115,1981 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1983 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 28,37A,1983 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1987 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 35,105,1987 |
| RTECS®- Teratology, The International Journal of Abnormal Development 1974 | RTECS®- Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968- 9,191,1974 |
| RTECS®- Voprosy Onkologii 1979 | RTECS®- Voprosy Onkologii. Problems of Oncology. For English translation, see PONCAU. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-10, 1928-37; V.1- 1955- 25(12),84,1979 |
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