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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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lipstick122 products
foundation118 products
concealer89 products
conditioner59 products
beach & sport sunscreen57 products
moisturizer with SPF46 products
moisturizer35 products
serums & essences30 products
facial moisturizer/treatment28 products
exfoliant/scrub17 products
BB cream13 products
CC cream11 products
mask10 products
eye liner10 products
brow liner9 products
makeup primer9 products
facial powder9 products
anti-aging9 products
blush9 products
around-eye cream8 products
shampoo7 products
hair treatment/serum7 products
body wash/cleanser6 products
lip balm6 products
liquid hand soap5 products
body firming lotion5 products
after sun product4 products
facial cleanser4 products
detangler4 products
mascara3 products
hair color and bleaching3 products
hair styling aide3 products
lip gloss3 products
bronzer/highlighter3 products
eye shadow2 products
hand cream2 products
toners/astringents2 products
hair spray2 products
hand sanitizer2 products
makeup remover2 products
baby soap2 products
2 products
bath oil/salts/soak2 products
baby shampoo2 products
body oil1 products
sunless tanning1 products
shaving cream1 products
bar soap1 products
beard oil1 products
baby bubble bath1 products
nail treatment1 products
styling gel/lotion1 products
muscle/joint soreness1 products
shaving cream (men's)1 products
other eye makeup1 products
foot cleansing1 products
damaged skin treatment1 products
lip balm with SPF1 products
baby lotion1 products

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.

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

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.

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

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

  • 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

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