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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: Ingredients linked to cancer in government, industry or academic studies or assessments.
Developmental & Reproductive Toxicity
Developmental and reproductive toxicity: Ingredients linked to developmental and reproductive toxicity, a broad class of health effects that range from infertility and reproductive organ cancers to birth defects and developmental delays in children.
Allergies & Immunotoxicity
Allergies and immunotoxicity: Ingredients linked to harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissue in the body.
Products with this Ingredient
| serums & essences | 57 products |
| facial moisturizer/treatment | 51 products |
| anti-aging | 13 products |
| around-eye cream | 10 products |
| daily use with SPF | 9 products |
| body oil | 8 products |
| mask | 7 products |
| facial cleanser | 7 products |
| moisturizer | 5 products |
| beard oil | 4 products |
| body wash/cleanser | 3 products |
| beard care | 3 products |
| body firming lotion | 3 products |
| conditioner | 2 products |
| toners/astringents | 2 products |
| bronzer/highlighter | 2 products |
| exfoliant/scrub | 2 products |
| bath oil/salts/soak | 1 products |
| 1 products | |
| makeup remover | 1 products |
| depilatory | 1 products |
| damaged skin treatment | 1 products |
| hand sanitizer | 1 products |
| beard cleanser | 1 products |
| hair styling aide | 1 products |
Biochemical or cellular level changes
| 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 |
Use restrictions
| 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 cosmetics | Canada - Prohibited and Restricted Cosmetics Ingredients |
Developmental/reproductive toxicity
| Concern | Reference |
|---|---|
| FDA recommends that women of child-bearing age limit their intake of retinol to 5000 IU (1.5 mg retinol)/day | FDA 1995. FDA Talk Paper: Vitamin A and Birth Defects. US Food and Drug Administration |
| Limited evidence of reproductive toxicity | 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 |
| skin application of Vitamin A containing products may lead to excessively high and possibly unsafe levels of systemic Vitamin A | 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. |
Enhanced skin absorption
| 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. |
Cancer
| Concern | Reference |
|---|---|
| One-year study found higher rates and greater numbers of skin tumors and lesions on RP-treated animals exposed to 4 hours of sunlight daily. | 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 |
| retinyl palmitate nominated by FDA for photocarcinogenicity testing by the National Toxicology Panel | NTP 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 cleavage | 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 |
Organ system toxicity (non-reproductive)
| Concern | Reference |
|---|---|
| topically applied retinyl palmitate induced epidermal hyperplasia in human skin | 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. |
Data gaps
| 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 product | Cosmetic Ingredient Review Assessments |
| 38937 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Multiple, additive exposure sources
| Concern | 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 |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any | Cosmetic Ingredient Review Assessments |
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
- 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
- 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.
- 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.
- 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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