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ZINC OXIDE (sunscreen grade < 100nm)

Score:

Data: Fair

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

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW

Products with this Ingredient

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moisturizer with SPF4 products
beach & sport sunscreen3 products
BB cream2 products
facial powder1 products
facial moisturizer/treatment1 products
mask1 products
mascara1 products

Enhanced skin absorption

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Concern Reference
Nano-scale ingredients with potential to absorb into the skinNanomaterial Database
Nano-scale ingredients with potential to absorb into the skinFDA (US. Food and Drug Administration). 2006. FDA Considerations for Regulation of Nanomaterial Containing Products. Presentation by Nakissa Sadrieh, Ph.D., Office of Pharmaceutical Science, CDER, FDA. Available online at http://www.fda.gov/nanotechnology/.

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.Hidaka H, Kobayashi, H, Koike, T. Sato, T., Serpone, N. 2006. DNA Damage Photoinduced by Cosmetic Pigments and Sunscreen Agents under Solar Exposure and Artifical UV Illumination. J Oleo Sci 55(5): 249-61.

Decreased skin absorption

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Concern Reference
Limited potential to absorb into the skin.{Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997}

Occupational hazards

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Concern Reference
Allowed workplace exposures restricted to moderate dosesNational Library of Medicine HazMap
Moderate evidence of occupational hazardsGordon T, Fine JM 1993. Metal fume fever. Occup Med. Jul-Sep;8(3):504-17. Review.

Use restrictions

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Concern Reference
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - anySCCNFP (2003) "Opinion concerning Zinc Oxide" European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.

Organ system toxicity (non-reproductive)

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Concern Reference
Possible human respiratory toxicantAssociation of Occupational and Environmental Clinics
Limited evidence of respiratory toxicityCalifornia EPA, Office of Environmental Health Hazard Assessment Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)EPA Toxic Release Inventory PBTs
Associated with cardiovascular toxicityGojova A, Guo B, Kota RS, Rutledge JC, Kennedy IM, Barakat AI 2007. Induction of inflammation in vascular endothelial cells by metal oxide nanoparticles: effect of particle composition. Environ Health Perspect 115(3): 403-409.

Cancer

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Concern Reference
One or more in vitro tests on mammalian cells show positive mutation results{Brunner, 2006}
One or more in vitro tests on microorganisms show positive mutation resultsDufour E, et al 2006. Clastogenicity, photo-clastogenicity or pseudo-photo-clastogenicity: Genotoxic effects of zinc oxide in the dark, in pre-irradiated or simultaneously irradiated Chinese hamster ovary cells. Mutation Research 607(2 ): 215-24.

Persistence and bioaccumulation

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Concern Reference
Found to be persistent and bioaccumulative in wildlifeBorgå K, Campbell L, Gabrielsen GW, Norstrom RJ, Muir DC, Fisk AT, 2006

Ecotoxicology

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Concern Reference
Wildlife and environmental toxicityCPS&Q - Classification & Labelling
Wildlife and environmental toxicityAdams, L K., D. Y. Lyon, et al. (2006). "Comparative eco-toxicity of nanoscale TiO2, SiO2, and ZnO water suspensions." Water Research Article in Press.

Data gaps

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Concern Reference
Insufficient data to determine safetySCCNFP (2003) "Opinion concerning Zinc Oxide" European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.
6094 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Developmental/reproductive toxicity

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Concern Reference
Not likely to be a reproductive toxicant in humansEuropean Chemicals Bureau 2004. ZINC OXIDE Part II – Human Health, CAS No: 1314-13-2, EINECS No: 215-222-5; Summary Risk Assessment Report Addendum to the Part II (Human Health) I-21020 Ispra (VA) Italy.

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 - Color additive approved by FDA for use in cosmeticsFDA Color Additive Status
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color Additives - Exempt from Batch Certification by the U.S. Food and Drug AdministrationCTFA International Cosmetic Ingredient Dictionary and Handbook

Data Sources

  • NanoWerk. 2007. Nanomaterial Database. Available online: http://www.nanowerk.com/phpscripts/n_dbsearch.php
  • FDA (US. Food and Drug Administration). 2006. FDA Considerations for Regulation of Nanomaterial Containing Products. Presentation by Nakissa Sadrieh, Ph.D., Office of Pharmaceutical Science, CDER, FDA. Available online at http://www.fda.gov/nanotechnology/.
  • Hidaka H, Kobayashi, H, Koike, T. Sato, T., Serpone, N. 2006. DNA Damage Photoinduced by Cosmetic Pigments and Sunscreen Agents under Solar Exposure and Artifical UV Illumination. J Oleo Sci 55(5): 249-61.
  • {Gasparro, 1998; Derry, 1983; Labor, 1999; Pirot, 1996; Morgan, 1983; Landsdown, 1997}
  • NLM (National Library of Medicine). 2006. HazMap &#8212; Occupational Exposure to Hazardous Agents.
  • Gordon T, Fine JM 1993. Metal fume fever. Occup Med. Jul-Sep;8(3):504-17. Review.
  • SCCNFP (2003) "Opinion concerning Zinc Oxide" European Commission - The Scientfic Committee on Cosmetic Products and Non-Food Products Intended for Consumers. SCCNFP/0649/03, final Retrieved July 21, 2006 from http://ec.europa.eu/health/ph_risk/committees/sccp/sccp_opinions_en.htm.
  • AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
  • California EPA, Office of Environmental Health Hazard Assessment Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • Gojova A, Guo B, Kota RS, Rutledge JC, Kennedy IM, Barakat AI 2007. Induction of inflammation in vascular endothelial cells by metal oxide nanoparticles: effect of particle composition. Environ Health Perspect 115(3): 403-409.
  • {Brunner, 2006}
  • Dufour E, et al 2006. Clastogenicity, photo-clastogenicity or pseudo-photo-clastogenicity: Genotoxic effects of zinc oxide in the dark, in pre-irradiated or simultaneously irradiated Chinese hamster ovary cells. Mutation Research 607(2 ): 215-24.
  • BorgÃ¥ K, Campbell L, Gabrielsen GW, Norstrom RJ, Muir DC, Fisk AT, 2006
  • CPS&Q (Consumer Products Safety & Quality) formely known as ECB (European Chemicals Bureau). 2008. Classification and Labelling: Chemicals: Annex VI of Directive 67/548/EEC through the 31st ATP.
  • Adams, L K., D. Y. Lyon, et al. (2006). "Comparative eco-toxicity of nanoscale TiO2, SiO2, and ZnO water suspensions." Water Research Article in Press.
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • European Chemicals Bureau 2004. ZINC OXIDE Part II – Human Health, CAS No: 1314-13-2, EINECS No: 215-222-5; Summary Risk Assessment Report Addendum to the Part II (Human Health) I-21020 Ispra (VA) Italy.
  • 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.
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.

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