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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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foundation226 products
lipstick180 products
concealer149 products
moisturizer110 products
conditioner85 products
facial moisturizer/treatment85 products
daily use with SPF69 products
recreational sunscreen67 products
serums & essences64 products
exfoliant/scrub41 products
mask34 products
facial cleanser33 products
lip gloss32 products
body firming lotion30 products
around-eye cream26 products
hair treatment/serum26 products
anti-aging24 products
facial powder23 products
shampoo23 products
makeup primer20 products
hand cream17 products
16 products
hair styling aide14 products
blush13 products
bronzer/highlighter13 products
brow liner13 products
BB cream12 products
CC cream12 products
setting powder/spray11 products
eye liner10 products
baby sunscreen10 products
body wash/cleanser9 products
liquid hand soap9 products
mascara8 products
hand sanitizer8 products
lip balm8 products
baby lotion8 products
after sun product7 products
eye shadow7 products
toners/astringents7 products
baby shampoo7 products
hair color and bleaching6 products
hair spray6 products
detangler6 products
nail treatment5 products
after shave5 products
bar soap5 products
baby soap5 products
body oil4 products
foot moisturizer4 products
nail polish4 products
shaving cream4 products
tanning oil4 products
polish remover3 products
baby bubble bath3 products
skin fading/lightener2 products
muscle/joint soreness2 products
baby oil2 products
shaving cream (men's)2 products
foot cleansing2 products
hair-loss treatment2 products
makeup remover2 products
lip balm with SPF2 products
diaper cream1 products
sunless tanning1 products
lip liner1 products
styling gel/lotion1 products
styling mousse/foam1 products
toothpaste1 products
bath oil/salts/soak1 products
cuticle treatment1 products
bubble bath1 products
other eye makeup1 products
body powder1 products
damaged skin treatment1 products
pore strips1 products

Biochemical or cellular level changes

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Concern Reference
Photoirradiation of retinyl palmitate by UVA light generates reactive oxygen species resulting in lipid peroxidation.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

Enhanced skin absorption

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Concern Reference
retinyl palmitate is absorbed into skin and converted to retinol 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.

Use restrictions

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Concern Reference
The German BfR recommends that the concentration of Vitamin A ingredients should be limited in face and hand products, and not used in lip and body care products.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
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmeticsCanada - Prohibited and Restricted Cosmetics Ingredients

Developmental/reproductive toxicity

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Concern Reference
FDA recommends that women of child-bearing age limit their intake of retinol to 5000 IU (1.5 mg retinol)/dayFDA 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
Retinol is associated with birth defects at maternal intakes as low as 25,000 IU/dayHathcock JN, Hattan DG, Jenkens MY, McDonald JT, Sundaresan PR, Wilkening VL 1990. Evaluation of vitamin A toxicity. Am J Clin Nutr 52, 183–202.

Cancer

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Concern Reference
Scientists found an increase in skin tumors in animals treated wtih retinoic acid in a study using a protocol to mimic human use of the ingredient.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.
retinyl palmitate nominated by FDA for photocarcinogenicity testing by the National Toxicology PanelNTP 2000. All-Trans-Retinyl Palmitate [CASRN 79-81-2]. http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/RetinylPalmitate.pdf
increased frequency of mutations in cell exposed to retinyl palmitate and UVA (synergistic effect)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.
photoirradiation of retinyl palmitate with UVA light generates free radicals that initiate DNA strand cleavageYan 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
topically applied retinyl palmitate induced epidermal hyperplasia in human skinDuell 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

  • 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
  • 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.
  • 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.
  • 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.
  • 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.

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