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RETINYL PALMITATE (VITAMIN A PALMITATE)

Score:

Data: Fair

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Non-reproductive organ system toxicity (low), and Biochemical or cellular level changes (high)

Cancer

Cancer concern is LOW_MODERATE

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is HIGH

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW

Products with this Ingredient

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beach & sport sunscreen250 products
foundation132 products
moisturizer with SPF107 products
concealer79 products
lipstick54 products
facial moisturizer/treatment45 products
moisturizer33 products
Tanning Sprays31 products
body firming lotion27 products
makeup with SPF26 products
serums & essences22 products
facial powder22 products
eye shadow22 products
lip balm with SPF21 products
lip balm19 products
Facial Sun Care16 products
blush15 products
BB cream15 products
exfoliant/scrub13 products
conditioner13 products
anti-aging11 products
eye liner10 products
brow liner9 products
mask9 products
baby sunscreen8 products
around-eye cream8 products
shampoo6 products
makeup primer5 products
liquid hand soap5 products
facial cleanser4 products
makeup remover4 products
body wash/cleanser4 products
tanning oil3 products
bronzer/highlighter3 products
hair styling aide3 products
detangler3 products
CC cream3 products
hair treatment/serum3 products
Oils & Serums3 products
hand cream2 products
sunless tanning2 products
hair spray2 products
baby soap2 products
body spray2 products
bath oil/salts/soak1 products
lip gloss1 products
nail treatment1 products
other eye makeup1 products
baby shampoo1 products
muscle/joint soreness1 products
shaving cream1 products
bar soap1 products
toners/astringents1 products
shaving cream (men's)1 products
styling gel/lotion1 products
lip plumper1 products
beard oil1 products

Enhanced skin absorption

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Concern Reference
Absorbs into the skinBoehnlein 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.

Biochemical or cellular level changes

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Concern 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. 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

Developmental/reproductive toxicity

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Concern Reference
Known human reproductive toxicantFDA 1995. FDA Talk Paper: Vitamin A and Birth Defects. US Food and Drug Administration
Limited evidence of reproductive toxicityYourick JJ, Jung CT, Bronaugh RL 2008. In vitro and in vivo percutaneous absorption of retinol from cosmetic formulations: significance of the skin reservoir and prediction of systemic absorption. Toxicol Appl Pharmacol 231(1): 117-21
One or more animal studies show reproductive effects at low dosesHathcock JN, Hattan DG, Jenkens MY, McDonald JT, Sundaresan PR, Wilkening VL 1990. Evaluation of vitamin A toxicity. Am J Clin Nutr 52, 183–202.

Use restrictions

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Concern Reference
Violation of government restrictions - Banned or found unsafe for use in cosmeticsGerman BfR 2014. Vitamin A: Intake via cosmetic products should be restricted. http://www.bfr.bund.de/cm/349/vitamin-a-intake-via-cosmetic-products-should-be-restricted.pdf
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmeticsCanada - Prohibited and Restricted Cosmetics Ingredients

Cancer

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Concern Reference
One or more animal studies show tumor formation at very low dosesHalliday GM, Robertson BO, Barnetson RS 2000. Topical retinoic acid enhances, and a dark tan protects, from subedemal solar-simulated photocarcinogenesis. J Invest Dermatol 114(5): 923-7.
Cancer - limited evidenceNTP 2000. All-Trans-Retinyl Palmitate [CASRN 79-81-2]. http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/RetinylPalmitate.pdf
One or more in vitro tests on mammalian cells show positive mutation resultsMei 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.
One or more in vitro tests non-mammalian cells show positive mutation resultsYan 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

Organ system toxicity (non-reproductive)

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Concern Reference
Limited evidence of skin toxicityDuell 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.
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Data gaps

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Concern 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 productCosmetic Ingredient Review Assessments
1692 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Ecotoxicology

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Concern Reference
Uncertain environmental toxin and uncertain persistent or bioaccumulativeEnvironment Canada Domestic Substance List

Multiple, additive exposure sources

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Concern Reference
Designated as safe for general or specific, limited use in foodFDA Food Additive Status
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Informational

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Concern Reference
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - anyCosmetic Ingredient Review Assessments

Persistence and bioaccumulation

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Concern Reference
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Data Sources

  • 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.
  • 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
  • FDA 1995. FDA Talk Paper: Vitamin A and Birth Defects. US Food and Drug Administration
  • Yourick JJ, Jung CT, Bronaugh RL 2008. In vitro and in vivo percutaneous absorption of retinol from cosmetic formulations: significance of the skin reservoir and prediction of systemic absorption. Toxicol Appl Pharmacol 231(1): 117-21
  • Hathcock JN, Hattan DG, Jenkens MY, McDonald JT, Sundaresan PR, Wilkening VL 1990. Evaluation of vitamin A toxicity. Am J Clin Nutr 52, 183–202.
  • German BfR 2014. Vitamin A: Intake via cosmetic products should be restricted. http://www.bfr.bund.de/cm/349/vitamin-a-intake-via-cosmetic-products-should-be-restricted.pdf
  • Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
  • Halliday GM, Robertson BO, Barnetson RS 2000. Topical retinoic acid enhances, and a dark tan protects, from subedemal solar-simulated photocarcinogenesis. J Invest Dermatol 114(5): 923-7.
  • NTP 2000. All-Trans-Retinyl Palmitate [CASRN 79-81-2]. http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/RetinylPalmitate.pdf
  • 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.
  • 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
  • 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.
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • 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.
  • 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.

About this Ingredient's Score Range

  • Products with the EWG VERIFIED mark have met use restrictions and warnings based on EWG review of company data.

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