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RETINOL (VITAMIN A)

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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moisturizer with SPF28 products
facial moisturizer/treatment26 products
serums & essences26 products
around-eye cream8 products
anti-aging5 products
foundation2 products
body firming lotion2 products
bronzer/highlighter2 products
Facial Sun Care1 products
moisturizer1 products
body wash/cleanser1 products
facial cleanser1 products
mask1 products
depilatory1 products
beach & sport sunscreen1 products
hair styling aide1 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
Limited evidence of developmental 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.

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 dosesNTP 2010. NTP Draft Technical Report on the Photococarcinogenesis Study of Retinoic Acid and Retinyl Palmitate [CAS Nos. 302-79-4 (All-Trans-Retinoic Acid) and 79-81-2 (All-Trans-Retinyl Palmitate)] in SKH-1 Mice (Simulated Solar Light And Topical Application Study). NIH Publication No. 11-5910
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.

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
38937 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

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

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
  • 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.
  • 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.
  • NTP 2010. NTP Draft Technical Report on the Photococarcinogenesis Study of Retinoic Acid and Retinyl Palmitate [CAS Nos. 302-79-4 (All-Trans-Retinoic Acid) and 79-81-2 (All-Trans-Retinyl Palmitate)] in SKH-1 Mice (Simulated Solar Light And Topical Application Study). NIH Publication No. 11-5910
  • 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.
  • 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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